Omnitrope

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 

1. NAME OF THE MEDICINAL PRODUCT 
 
Omnitrope 1.3 mg/ml powder and solvent for solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
After reconstitution, one vial contains 1.3 mg somatropin* (corresponding to 4 IU) per ml. 
 
* produced in Escherichia coli by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder and solvent for solution for injection. 
The powder is white. 
The solvent is clear and colourless. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Infants, children and adolescents 
- Growth disturbance due to insufficient secretion of growth hormone (growth hormone 

deficiency, GHD). 
- Growth disturbance associated with Turner syndrome. 
- Growth disturbance associated with chronic renal insufficiency. 
- Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted 

height SDS < -1) in short children/adolescents born small for gestational age (SGA), with a 
birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up 
growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later. 

- Prader-Willi syndrome (PWS), for improvement of growth and body composition. The 
diagnosis of PWS should be confirmed by appropriate genetic testing. 

 
Adults 
- Replacement therapy in adults with pronounced growth hormone deficiency.  
- Adult onset: Patients who have severe growth hormone deficiency associated with multiple 

hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at 
least one known deficiency of a pituitary hormone not being prolactin. These patients should 
undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone 
deficiency. 

- Childhood onset: Patients who were growth hormone deficient during childhood as a result of 
congenital, genetic, acquired, or idiopathic causes. Patients with childhood onset GHD should 
be re-evaluated for growth hormone secretory capacity after completion of longitudinal growth. 
In patients with a high likelihood for persistent GHD, i.e. a congenital cause or GHD secondary 
to a hypothalamic-pituitary disease or insult, an insulin-like growth factor-I (IGF-I) SDS < -2 
off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of 
profound GHD. 

 
All other patients will require IGF-I assay and one growth hormone stimulation test. 
 



3 

4.2 Posology and method of administration 
 
Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are 
appropriately qualified and experienced in the diagnosis and management of patients with growth 
disorders. 
 
Posology 
 
Paediatric population 
The posology and administration schedule should be individualised. 
 
Growth disturbance due to insufficient secretion of growth hormone in paediatric patients 
Generally a dose of 0.025 - 0.035 mg/kg body weight per day or 0.7 - 1.0 mg/m2 body surface area per 
day is recommended. Even higher doses have been used. 
 
Where childhood onset GHD persists into adolescence, treatment should be continued to achieve full 
somatic development (e.g. body composition, bone mass). For monitoring, the attainment of a normal 
peak bone mass defined as a T score > -1 (i.e. standardized to average adult peak bone mass measured 
by dual energy X-ray absorptiometry taking into account sex and ethnicity) is one of the therapeutic 
objectives during the transition period. For guidance on dosing see adult section below. 
 
Prader-Willi syndrome, for improvement of growth and body composition in paediatric patients 
Generally a dose of 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day is 
recommended. Daily doses of 2.7 mg should not be exceeded. Treatment should not be used in 
paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses. 
 
Growth disturbance due to Turner syndrome 
A dose of 0.045 - 0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day is 
recommended. 
 
Growth disturbance in chronic renal insufficiency 
A dose of 0.045 - 0.050 mg/kg body weight per day (1.4 mg/m2 body surface area per day) is 
recommended. Higher doses may be needed if growth velocity is too low. A dose correction can be 
needed after six months of treatment (see section 4.4). 
 
Growth disturbance in short children/adolescents born small for gestational age (SGA) 
A dose of 0.035 mg/kg body weight per day (1 mg/m2 body surface area per day) is usually 
recommended until final height is reached (see section 5.1). Treatment should be discontinued after 
the first year of treatment if the height velocity SDS is below + 1. Treatment should be discontinued if 
height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or 
> 16 years (boys), corresponding to closure of the epiphyseal growth plates. 
 
Dose recommendations in paediatric patients 
 

Indication mg/kg body weight dose 
per day 

mg/m² body surface 
area dose per day 

Growth hormone deficiency  0.025 - 0.035 0.7 - 1.0 
Prader-Willi syndrome  0.035 1.0 
Turner syndrome 0.045 - 0.050 1.4 
Chronic renal insufficiency 0.045 - 0.050 1.4 
Children/adolescents born small for 
gestational age (SGA) 0.035 1.0 

 
Growth hormone deficient adult patients 
In patients who continue growth hormone therapy after childhood GHD, the recommended dose to 
restart is 0.2 – 0.5 mg per day. The dose should be gradually increased or decreased according to 
individual patient requirements as determined by the IGF-I concentration. 



4 

 
In adults with adult-onset GHD, therapy should start with a low dose, 0.15 - 0.3 mg per day. The dose 
should be gradually increased according to individual patient requirements as determined by the IGF-I 
concentration. 
 
In both cases treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS 
from the age corrected mean. Patients with normal IGF-I concentrations at the start of the treatment 
should be administered growth hormone up to an IGF-I level into the upper range of normal, not 
exceeding the 2 SDS. Clinical response and side effects may also be used as guidance for dose 
titration. It is recognized that there are patients with GHD who do not normalize IGF-I levels despite a 
good clinical response, and thus do not require dose escalation. The maintenance dose rarely exceeds 
1.0 mg per day. Women may require higher doses than men, with men showing an increasing IGF-I 
sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen 
replacement are under-treated while men are over-treated. The accuracy of the growth hormone dose 
should therefore be controlled every 6 months. As normal physiological growth hormone production 
decreases with age, dose requirements may be reduced. 
 
Special populations 
 
Elderly 
In patients above 60 years, therapy should start with a dose of 0.1 - 0.2 mg per day and should be 
slowly increased according to individual patient requirements. The minimum effective dose should be 
used. The maintenance dose in these patients seldom exceeds 0.5 mg per day. 
 
Method of administration 
 
The injection should be given subcutaneously and the site varied to prevent lipoatrophy. 
 
For instructions for use and handling see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours 
must be inactive and anti-tumour therapy must be completed prior to starting GH therapy. Treatment 
should be discontinued if there is evidence of tumour growth. 
 
Somatropin must not be used for growth promotion in children with closed epiphyses. 
 
Patients with acute critical illness suffering complications following open heart surgery, abdominal 
surgery, multiple accidental trauma, acute respiratory failure or similar conditions must not be treated 
with somatropin (regarding patients undergoing substitution therapy, see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
The maximum recommended daily dose should not be exceeded (see section 4.2). 
 
Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol 
concentrations. In patients treated with somatropin, previously undiagnosed central (secondary) 
hypoadrenalism may be unmasked and glucocorticoid replacement may be required. In addition, 
patients treated with glucocorticoid replacement therapy for previously diagnosed hypoadrenalism 



5 

may require an increase in their maintenance or stress doses, following initiation of somatropin 
treatment (see section 4.5). 
 
Use with oral oestrogen therapy 
 
If a woman taking somatropin begins oral oestrogen therapy, the dose of somatropin may need to be 
increased to maintain the serum IGF-1 levels within the normal age-appropriate range. Conversely, if 
a woman on somatropin discontinues oral oestrogen therapy, the dose of somatropin may need to be 
reduced to avoid excess of growth hormone and/or side effects (see section 4.5). 
 
Insulin sensitivity 
 
Somatropin may reduce insulin sensitivity. For patients with diabetes mellitus, the insulin dose may 
require adjustment after somatropin therapy is instituted. Patients with diabetes, glucose intolerance, 
or additional risk factors for diabetes should be monitored closely during somatropin therapy.  
 
Thyroid function 
 
Growth hormone increases the extrathyroidal conversion of T4 to T3 which may result in a reduction 
in serum T4 and an increase in serum T3 concentrations. Whereas the peripheral thyroid hormone 
levels have remained within the reference ranges for healthy subjects, hypothyroidism theoretically 
may develop in subjects with subclinical hypothyroidism. Consequently monitoring of thyroid 
function should therefore be conducted in all patients. In patients with hypopituitarism on standard 
replacement therapy, the potential effect of growth hormone treatment on thyroid function must be 
closely monitored 
 
In growth hormone deficiency, secondary to treatment of malignant disease, it is recommended to pay 
attention to signs of relapse of the malignancy. In childhood cancer survivors, an increased risk of a 
second neoplasm has been reported in patients treated with somatropin after their first neoplasm. 
Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their 
first neoplasm, were the most common of these second neoplasms. 
 
In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the 
hip may occur more frequently than in the general population. Patients limping during treatment with 
somatropin should be examined clinically. 
 
Benign intracranial hypertension 
 
In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for 
papilloedema is recommended. If papilloedema is confirmed, a diagnosis of benign intracranial 
hypertension should be considered and, if appropriate, the growth hormone treatment should be 
discontinued. At present there is insufficient evidence to give specific advice on the continuation of 
growth hormone treatment in patients with resolved intracranial hypertension. If growth hormone 
treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary. 
 
Leukaemia 
 
Leukaemia has been reported in a small number of growth hormone deficiency patients, some of 
whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is 
increased in growth hormone recipients without predisposition factors.  
 
Antibodies 
 
A small percentage of patients may develop antibodies to Omnitrope. Omnitrope has given rise to the 
formation of antibodies in approximately 1% of patients. The binding capacity of these antibodies is 
low and there is no effect on growth rate. Testing for antibodies to somatropin should be carried out in 
any patient with otherwise unexplained lack of response.  



6 

 
Elderly patients 
Experience in patients above 80 years is limited. Elderly patients may be more sensitive to the action 
of Omnitrope, and therefore may be more prone to develop adverse reactions. 
 
Acute critical illness 
 
The effects of somatropin on recovery were studied in two placebo controlled trials involving 
522 critically ill adult patients suffering complications following open heart surgery, abdominal 
surgery, multiple accidental trauma or acute respiratory failure. Mortality was higher in patients 
treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%. 
Based on this information, these types of patients should not be treated with somatropin. As there is no 
information available on the safety of growth hormone substitution therapy in acutely critically ill 
patients, the benefits of continued treatment in this situation should be weighed against the potential 
risks involved. 
In all patients developing other or similar acute critical illness, the possible benefit of treatment with 
somatropin must be weighed against the potential risk involved. 
 
Paediatric population 
 
Pancreatitis  
 
Although rare, pancreatitis should be considered in somatropin-treated children who develop 
abdominal pain. 
 
Prader-Willi syndrome 
 
In patients with PWS, treatment should always be in combination with a calorie-restricted diet. 
 
There have been reports of fatalities associated with the use of growth hormone in paediatric patients 
with PWS who had one or more of the following risk factors: severe obesity (those patients exceeding 
a weight/height of 200%), history of respiratory impairment or sleep apnoea or unidentified 
respiratory infection. Patients with PWS and one or more of these risk factors may be at greater risk. 
 
Before initiation of treatment with somatropin patients with PWS should be evaluated for upper 
airway obstruction, sleep apnoea or respiratory infections should be assessed. 
 
If during the evaluation of upper airway obstruction, pathological findings are observed, the child 
should be referred to an Ear, nose and throat (ENT) specialist for treatment and resolution of the 
respiratory disorder prior to initiating growth hormone treatment.  
 
Sleep apnoea should be assessed before onset of growth hormone treatment by recognised methods 
such as polysomnography or overnight oxymetry, and monitored if sleep apnoea is suspected. 
 
If during treatment with somatropin patients show signs of upper airway obstruction (including onset 
of or increased snoring), treatment should be interrupted, and a new ENT assessment performed. 
 
All patients with PWS should be evaluated for sleep apnoea and monitored if sleep apnoea is 
suspected.Patients should be monitored for signs of respiratory infections, which should be diagnosed 
as early as possible and treated aggressively. 
 
All patients with PWS should have effective weight control before and during growth hormone 
treatment. 
 
Scoliosis is common in patients with PWS. Scoliosis may progress in any child during rapid growth. 
Signs of scoliosis should be monitored during treatment.  
 



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Experience with prolonged treatment in adults and in patients with PWS is limited. 
 
Small for gestational age 
 
In short children/adolescents born SGA, other medical reasons or treatments that could explain growth 
disturbance should be ruled out before starting treatment. 
 
In SGA children/adolescents it is recommended to measure fasting insulin and blood glucose before 
start of treatment and annually thereafter. In patients with increased risk for diabetes mellitus (e.g. 
familial history of diabetes, obesity, severe insulin resistance, acanthosis nigricans) oral glucose 
tolerance testing (OGTT) should be performed. If overt diabetes occurs, growth hormone should not 
be administered. 
 
In SGA children/adolescents it is recommended to measure the IGF-I level before start of treatment 
and twice a year thereafter. If on repeated measurements IGF-I levels exceed +2 SD compared to 
references for age and pubertal status, the IGF-I / IGFBP-3 ratio could be taken into account to 
consider dose adjustment. 
 
Experience in initiating treatment in SGA patients near onset of puberty is limited. It is therefore not 
recommended to initiate treatment near onset of puberty. Experience in patients with Silver-Russell 
syndrome is limited. 
 
Some of the height gain obtained with treating short children/adolescents born SGA with growth 
hormone may be lost if treatment is stopped before final height is reached. 
 
Chronic renal insufficiency 
 
In chronic renal insufficiency, renal function should be below 50 percent of normal before institution 
of therapy. To verify growth disturbance, growth should be followed for a year preceding institution of 
therapy. During this period, conservative treatment for renal insufficiency (which includes control of 
acidosis, hyperparathyroidism and nutritional status) should have been established and should be 
maintained during treatment. 
 
The treatment should be discontinued at renal transplantation. 
 
To date, no data on final height in patients with chronic renal insufficiency treated with Omnitrope are 
available. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of Omnitrope. 
Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully 
adjusted to avoid any inhibitory effect on growth. 
 
Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously 
undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective (see 
section 4.4). 
 
In women on oral oestrogen replacement, a higher dose of growth hormone may be required to 
achieve the treatment goal (see section 4.4). 
 
Data from an interaction study performed in growth hormone deficient adults suggests that somatropin 
administration may increase the clearance of compounds known to be metabolised by cytochrome 
P450 isoenzymes. The clearance of compounds metabolised by cytochrome P450 3A4 (e.g. sex 
steroids, corticosteroids, anticonvulsants and ciclosporin) may be especially increased resulting in 
lower plasma levels of these compounds. The clinical significance of this is unknown. 



8 

Also see section 4.4 for statements regarding diabetes mellitus and thyroid disorder and section 4.2 for 
statement on oral oestrogen replacement therapy. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of somatropin in pregnant women. Animal studies 
are insufficient with respect to reproductive toxicity (see section 5.3). Somatropin is not recommended 
during pregnancy and in women of childbearing potential not using contraception. 
 
Breast-feeding 
 
There have been no clinical studies conducted with somatropin containing products in breast-feeding 
women. It is not known if somatropin is excreted into breast milk, but absorption of intact protein 
from the gastrointestinal tract of the infant is extremely unlikely. Therefore caution should be 
exercised when Omnitrope is administered to breast-feeding women. 
 
Fertility 
 
Fertility studies with Omnitrope have not been performed. 
 
4.7 Effects on ability to drive and use machines 
 
Omnitrope has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
Patients with growth hormone deficiency are characterised by extracellular volume deficit. When 
treatment with somatropin is started this deficit is rapidly corrected. In adult patients adverse reactions 
related to fluid retention, such as peripheral oedema, face oedema, musculoskeletal stiffness, 
arthralgia, myalgia and paraesthesia are common. In general these adverse reactions are mild to 
moderate, arise within the first months of treatment and subside spontaneously or with dose-reduction.  
 
The incidence of these adverse reactions is related to the administered dose, the age of patients, and 
possibly inversely related to the age of patients at the onset of growth hormone deficiency. In children 
such adverse reactions are uncommon.  
 
Omnitrope has given rise to the formation of antibodies in approximately 1% of the patients. The 
binding capacity of these antibodies has been low and no clinical changes have been associated with 
their formation, see section 4.4.  
 
Tabulated list of adverse reactions 
 
Tables 1–6 show the adverse reactions ranked under headings of System Organ Class and frequency 
using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon 
(≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be 
estimated from the available data) for each of the indicated conditions.  
 



9 

Clinical trials in children with GHD 
 
Table 1 
 
Long-term treatment of children with growth disturbance due to insufficient secretion of growth 
hormone 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

  Leukaemia†    

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

     Paraesthesia* 
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

  Rash** 

Pruritus** 

Urticaria** 

   

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

  Arthralgia*   Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

Injection 
site 
reaction$ 

    Oedema 
peripheral* 
Face oedema* 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



10 

Clinical trials in children with Turner syndrome 
 
Table 2 
 
Long-term treatment of children with growth disturbance due to Turner syndrome 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
 
mellitus 

Nervous System 
Disorders 

     Paraesthesia* 
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

     Rash** 

Pruritus** 

Urticaria** 
Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

Arthralgi
a* 

    Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

     Oedema 
peripheral* 
Face oedema* 
Injection site 
reaction$ 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



11 

Clinical trials in children with chronic renal insufficiency 
 
Table 3 
 
Long-term treatment of children with growth disturbance due to chronic renal insufficiency 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

     Paraesthesia* 
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

 Rash**    Puritus** 
 
Urticaria** 

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

     Arthralgia* 
 
Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

 Injection 
site 
reaction$ 

   Oedema 
peripheral* 
Face oedema* 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



12 

Clinical trials in children with SGA 
 
Table 4 
 
Long-term treatment of children with growth disturbance due to born small for gestational age 
System Organ 
Class 

Very 
Common 
≥ 1/10 

Common 
≥ 1/100 to 
< 1/10 

Uncommo
n ≥ 1/1,000 
to < 1/100 

Rare 
≥ 1/10,0
00 to 
< 1/1,00
0 

Very 
Rare 
< 1/10,00
0 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

     Paraesthesia*  
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

 Rash** 
 
Urticaria** 

Puritus**    

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

  Arthralgia* 
 

  Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

 Injection 
site 
reaction$ 

   Oedema 
peripheral* 
Face oedema* 
 
 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



13 

Clinical trials in PWS 
 
Table 5 
 
Long-term treatment and improvement of body composition of children with growth disturbance 
due to Prader-Willi syndrome 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

 Paraesthesia* 
 
Benign 
intracranial 
hypertension 

    

Skin and 
Subcutaneaous 
Tissues 
disorders 

 Rash**    Puritus** 
 
Urticaria** 

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

 Arthralgia* 
 
Myalgia* 

   Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

 Oedema 
peripheral* 
 

   Face oedema* 
Injection site 
reaction$ 
 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



14 

Clinical trials in adults with GHD 
 
Table 6 
 
Replacement therapy in adults with growth hormone deficiency 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommo
n 
≥ 1/1,000 
to <1/100 

Rare 
≥ 
1/10,00
0 to 
<1/1,00
0 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

 Paraesthe
sia* 
 
Carpal 
Tunnel 
Syndrome 

   Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

     Rash** 
Puritus** 
Urticaria** 

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

Arthralgia* Myalgia* 
 
Musculos
keletal 
stiffness* 

    

General 
Disorders and 
Administration 
Site Conditions 

Oedema 
peripheral* 
 

    Face oedema* 
Injection site 
reaction$ 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
Description of selected adverse reactions 
 
Reduced serum cortisol levels 
 
Somatropin has been reported to reduce serum cortisol levels, possibly by affecting carrier proteins or 
by increased hepatic clearance. The clinical relevance of these findings may be limited. Nevertheless, 
corticosteroid replacement therapy should be optimised before initiation of therapy.  
 
Prader-Willi syndrome 
 



15 

In the post-marketing experience rare cases of sudden death have been reported in patients affected by 
Prader-Willi syndrome treated with somatropin, although no causal relationship has been 
demonstrated. 
 
Leukaemia 
 
Cases of leukaemia (rare or very rare) have been reported in growth hormone deficient children treated 
with somatropin and included in the post-marketing experience. However, there is no evidence of an 
increased risk of leukaemia without predisposition factors, such as radiation to the brain or head. 
 
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease 
 
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease have been reported in children 
treated with GH. Slipped capital femoral epiphysis occurs more frequently in case of endocrine 
disorders and Legg-Calvé-Perthes is more frequent in case of short stature. But it is unknown if these 
2 pathologies are more frequent or not while treated with somatropin. Their diagnosis should be 
considered in a child with a discomfort or pain in the hip or knee. 
 
Other adverse drug reactions 
 
Other adverse drug reactions may be considered somatropin class effects, such as possible 
hyperglycaemia caused by decreased insulin sensitivity, decreased free thyroxin level and benign 
intra-cranial hypertension. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms: 
Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia. 
 
Long-term overdose could result in signs and symptoms consistent with the known effects of human 
growth hormone excess. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anterior pituitary lobe hormones and analogues, ATC code: H01AC01. 
 
Omnitrope is a biosimilar medicinal product. Detailed information is available on the website of the 
European Medicines Agency http://www.ema.europa.eu 
 
Mechanism of action 
 
Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates 
and proteins. In children with inadequate endogenous growth hormone, somatropin stimulates linear 
growth and increases growth rate. In adults as well as in children, somatropin maintains a normal body 
composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by 
mobilisation of body fat. Visceral adipose tissue is particularly responsive to somatropin. In addition 
to enhanced lipolysis, somatropin decreases the uptake of triglycerides into body fat stores. Serum 



16 

concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor 
Binding Protein 3) are increased by somatropin. In addition, the following actions have been 
demonstrated. 
 
Pharmacodynamic effects 
 
Lipid metabolism 
Somatropin induces hepatic LDL cholesterol receptors, and affects the profile of serum lipids and 
lipoproteins. In general, administration of somatropin to growth hormone deficient patients results in 
reduction in serum LDL and apolipoprotein B. A reduction in serum total cholesterol may also be 
observed. 
 
Carbohydrate metabolism 
Somatropin increases insulin but fasting blood glucose is commonly unchanged. Children with 
hypopituitarism may experience fasting hypoglycaemia. This condition is reversed by somatropin. 
 
Water and mineral metabolism 
Growth hormone deficiency is associated with decreased plasma and extracellular volumes. Both are 
rapidly increased after treatment with somatropin. Somatropin induces the retention of sodium, 
potassium and phosphorus. 
 
Bone metabolism 
 
Somatropin stimulates the turnover of skeletal bone. Long-term administration of somatropin to 
growth hormone deficient patients with osteopenia results in an increase in bone mineral content and 
density at weight-bearing sites. 
 
Physical capacity  
Muscle strength and physical exercise capacity are improved after long-term treatment with 
somatropin. Somatropin also increases cardiac output, but the mechanism has yet to be clarified. A 
decrease in peripheral vascular resistance may contribute to this effect. 
 
Clinical efficacy and safety 
 
In clinical trials in short children/adolescents born SGA doses of 0.033 and 0.067 mg/kg body weight 
per day have been used for treatment until final height is reached. In 56 patients who were 
continuously treated and have reached (near) final height, the mean change from height at start of 
treatment was +1.90 SDS (0.033 mg/kg body weight per day) and +2.19 SDS (0.067 mg/kg body 
weight per day). Literature data from untreated SGA children/adolescents without early spontaneous 
catch-up suggest a late growth of 0.5 SDS.  
 
5.2 Pharmacokinetic properties 
 
Absorption 
The bioavailability of subcutaneously administered somatropin is approximately 80% in both healthy 
subjects and growth hormone deficient patients. A subcutaneous dose of 5 mg of Omnitrope powder 
and solvent for solution for injection in healthy adults results in plasma Cmax values of 71 ± 24 µg/l 
(mean ± SD) and median tmax value of 4 hours (range 2-8 hours), respectively. 
 
Elimination 
The mean terminal half-life of somatropin after intravenous administration in growth hormone 
deficient adults is about 0.4 hours. However, after subcutaneous administration of Omnitrope powder 
and solvent for solution for injection, a half-life of 3 hours is achieved. The observed difference is 
likely due to slow absorption from the injection site following subcutaneous administration. 
 



17 

Special populations 
The absolute bioavailability of somatropin seems to be similar in males and females following 
subcutaneous administration. 
 
Information about the pharmacokinetics of somatropin in geriatric and paediatric populations, in 
different races and in patients with renal, hepatic or cardiac insufficiency is either lacking or 
incomplete. 
 
5.3 Preclinical safety data 
 
In studies with Omnitrope regarding subacute toxicity and local tolerance, no clinically relevant 
effects have been observed. 
 
In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity 
no clinically relevant effects have been observed. 
 
With somatropins, in vitro and in vivo genotoxicity studies on gene mutations and induction of 
chromosome aberrations have been negative. 
 
An increased chromosome fragility has been observed in one in vitro study on lymphocytes taken 
from patients after long term treatment with somatropin and following the addition of the 
radiomimetic drug bleomycin. The clinical significance of this finding is unclear. 
 
In another study with somatropin, no increase in chromosomal abnormalities was found in the 
lymphocytes of patients who had received long-term somatropin therapy. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Powder: 
glycine 
disodium hydrogen phosphate heptahydrate 
sodium dihydrogen phosphate dihydrate 
 
Solvent: 
water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
2 years 
 
Shelf life after reconstitution 
After reconstitution, from a microbiological point of view, an immediate use is recommended. 
However, the in-use stability has been demonstrated for up to 24 hours at 2°C - 8°C, in the original 
package. Store and transport refrigerated (2°C - 8°C). Do not freeze. Store in the original package in 
order to protect from light.  
 



18 

6.4 Special precautions for storage 
 
Unopened vial 
Store and transport refrigerated (2°C - 8°C). Do not freeze. Store in the original package in order to 
protect from light. 
 
For storage conditions of the in-use medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
Powder in a vial (type I glass) with a stopper (fluor-resin laminated butyl rubber), a strip (aluminium) 
and a cap (violet polypropylene flip-off), and 1 ml of solvent in a vial (type I glass) with a stopper 
(fluor-resin laminated chlorobutyl elastomer), a strip (lacquered aluminium) and a cap (white 
polypropylene flip-off). 
Pack size of 1. 
 
6.6 Special precautions for disposal and other handling 
 
Omnitrope 1.3 mg/ml is supplied in a vial containing the active substance as a powder and the solvent 
filled in a vial for single use. Each vial must be reconstituted with the accompanying solvent only. 
The reconstituted solution should be administered using sterile, disposable syringes. 
The following is a general description of the reconstitution and administration process. Reconstitution 
should be performed in accordance with good practice rules, particularly in the respect of asepsis. 
 
1. Hands should be washed. 
2. Flip off the plastic protective caps from the vials. 
3. The top of the vials should be wiped with an antiseptic solution to prevent contamination of the 

contents. 
4. Use a sterile, disposable syringe (e.g. 2 ml syringe) and needle (e.g. 0.33 mm x 12.7 mm) to 

withdraw all the solvent from the vial. 
5. Take the vial with the powder, push the needle through the rubber closure and inject the solvent 

slowly into the vial aiming the stream of liquid against the glass wall in order to avoid foam. 
6. Gently swirl the vial a few times until the content is completely dissolved. Do not shake; this 

may cause denaturation of the active substance. 
7. If the solution is cloudy or contains particulate matter, it should not be used. The content must 

be clear and colourless after reconstitution. 
8. Turn the vial upside down and using another sterile, disposable syringe of appropriate size (e.g. 

1 ml syringe) and injection needle (e.g. 0.25 mm x 8 mm) withdraw a bit more than the dose 
needed back into the syringe. Remove any air bubbles from the syringe. Bring the syringe to the 
correct dose needed. 

9. Clean the injection site with an alcohol swab and administer Omnitrope by subcutaneous 
injection. 

 
The solution is for single use only. Any unused product or waste material should be disposed of in 
accordance with local requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
 
8. MARKETING AUTHORISATION NUMBER 
 



19 

EU/1/06/332/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 12 April 2006 
 
Date of latest renewal: 28 February 2011 
 
 
10. DATE OF REVISION OF THE TEXT 
 
<{MM/YYYY}>  
 
 



20 

1. NAME OF THE MEDICINAL PRODUCT 
 
Omnitrope 5 mg/ml powder and solvent for solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
After reconstitution, one vial contains 5 mg somatropin* (corresponding to 15 IU) per ml. 
 
* produced in Escherichia coli by recombinant DNA technology. 
 
Excipient(s) with known effect: 
After reconstitution this medicine contains 15 mg benzyl alcohol in each ml. 
Benzyl alcohol may cause allergic reactions.  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder and solvent for solution for injection. 
The powder is white. 
The solvent is clear and colourless. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Infants, children and adolescents 
- Growth disturbance due to insufficient secretion of growth hormone (growth hormone 

deficiency, GHD). 
- Growth disturbance associated with Turner syndrome. 
- Growth disturbance associated with chronic renal insufficiency. 
- Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted 

height SDS < -1) in short children/adolescents born small for gestational age (SGA), with a 
birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up 
growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later. 

- Prader-Willi syndrome (PWS), for improvement of growth and body composition. The 
diagnosis of PWS should be confirmed by appropriate genetic testing. 
 

Adults 
- Replacement therapy in adults with pronounced growth hormone deficiency.  
- Adult onset: Patients who have severe growth hormone deficiency associated with multiple 

hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at 
least one known deficiency of a pituitary hormone not being prolactin. These patients should 
undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone 
deficiency. 

- Childhood onset: Patients who were growth hormone deficient during childhood as a result of 
congenital, genetic, acquired, or idiopathic causes. Patients with childhood onset GHD should 
be re-evaluated for growth hormone secretory capacity after completion of longitudinal growth. 
In patients with a high likelihood for persistent GHD, i.e. a congenital cause or GHD secondary 
to a hypothalamic-pituitary disease or insult, an insulin-like growth factor-I (IGF-I) SDS < -2 
off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of 
profound GHD. 
 

All other patients will require IGF-I assay and one growth hormone stimulation test. 



21 

 
4.2 Posology and method of administration 
 
Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are 
appropriately qualified and experienced in the diagnosis and management of patients with growth 
disorders. 
 
Posology 
 
Paediatric population 
The posology and administration schedule should be individualised. 
 
Growth disturbance due to insufficient secretion of growth hormone in paediatric patients 
Generally a dose of 0.025 - 0.035 mg/kg body weight per day or 0.7 - 1.0 mg/m2 body surface area per 
day is recommended. Even higher doses have been used. 
 
Where childhood onset GHD persists into adolescence, treatment should be continued to achieve full 
somatic development (e.g. body composition, bone mass). For monitoring, the attainment of a normal 
peak bone mass defined as a T score > -1 (i.e. standardized to average adult peak bone mass measured 
by dual energy X-ray absorptiometry taking into account sex and ethnicity) is one of the therapeutic 
objectives during the transition period. For guidance on dosing see adult section below. 
 
Prader-Willi syndrome, for improvement of growth and body composition in paediatric patients 
Generally a dose of 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day is 
recommended. Daily doses of 2.7 mg should not be exceeded. Treatment should not be used in 
paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses. 
 
Growth disturbance due to Turner syndrome 
A dose of 0.045 - 0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day is 
recommended. 
 
Growth disturbance in chronic renal insufficiency 
A dose of 0.045 - 0.050 mg/kg body weight per day (1.4 mg/m2 body surface area per day) is 
recommended. Higher doses may be needed if growth velocity is too low. A dose correction can be 
needed after six months of treatment (see section 4.4). 
 
Growth disturbance in short children/adolescents born small for gestational age (SGA) 
A dose of 0.035 mg/kg body weight per day (1 mg/m2 body surface area per day) is usually 
recommended until final height is reached (see section 5.1). Treatment should be discontinued after 
the first year of treatment if the height velocity SDS is below + 1. Treatment should be discontinued if 
height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or 
> 16 years (boys), corresponding to closure of the epiphyseal growth plates. 
 
Dose recommendations in paediatric patients 
 



22 

Indication mg/kg body weight dose 
per day 

mg/m² body surface 
area dose per day 

Growth hormone deficiency  0.025 - 0.035 0.7 - 1.0 
Prader-Willi syndrome  0.035 1.0 
Turner syndrome 0.045 - 0.050 1.4 
Chronic renal insufficiency 0.045 - 0.050 1.4 
Children/adolescents born small for 
gestational age (SGA) 0.035 1.0 

 
Growth hormone deficient adult patients 
In patients who continue growth hormone therapy after childhood GHD, the recommended dose to 
restart is 0.2 – 0.5 mg per day. The dose should be gradually increased or decreased according to 
individual patient requirements as determined by the IGF-I concentration.  
 
In adults with adult-onset GHD, therapy should start with a low dose, 0.15 - 0.3 mg per day. The dose 
should be gradually increased according to individual patient requirements as determined by the IGF-I 
concentration. 
 
In both cases treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS 
from the age corrected mean. Patients with normal IGF-I concentrations at the start of the treatment 
should be administered growth hormone up to an IGF-I level into the upper range of normal, not 
exceeding the 2 SDS. Clinical response and side effects may also be used as guidance for dose 
titration. It is recognized that there are patients with GHD who do not normalize IGF-I levels despite a 
good clinical response, and thus do not require dose escalation. The maintenance dose rarely exceeds 
1.0 mg per day. Women may require higher doses than men, with men showing an increasing IGF-I 
sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen 
replacement are under-treated while men are over-treated. The accuracy of the growth hormone dose 
should therefore be controlled every 6 months. As normal physiological growth hormone production 
decreases with age, dose requirements may be reduced. 
 
Special populations 
 
Elderly 
In patients above 60 years, therapy should start with a dose of 0.1 - 0.2 mg per day and should be 
slowly increased according to individual patient requirements. The minimum effective dose should be 
used. The maintenance dose in these patients seldom exceeds 0.5 mg per day. 
 
Method of administration 
 
The injection should be given subcutaneously and the site varied to prevent lipoatrophy. 
 
For instructions for use and handling see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours 
must be inactive and anti-tumour therapy must be completed prior to starting GH therapy. Treatment 
should be discontinued if there is evidence of tumour growth. 
 
Somatropin must not be used for growth promotion in children with closed epiphyses. 
 
Patients with acute critical illness suffering complications following open heart surgery, abdominal 
surgery, multiple accidental trauma, acute respiratory failure or similar conditions must not be treated 
with somatropin (regarding patients undergoing substitution therapy, see section 4.4). 
 



23 

4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
The maximum recommended daily dose should not be exceeded (see section 4.2). 
 
Intravenous administration of benzyl alcohol has been associated with serious adverse events and 
death in neonates (“gasping syndrome”). The minimum amount of benzyl alcohol at which toxicity 
may occur is not known. 
 
Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol 
concentrations. In patients treated with somatropin, previously undiagnosed central (secondary) 
hypoadrenalism may be unmasked and glucocorticoid replacement may be required. In addition, 
patients treated with glucocorticoid replacement therapy for previously diagnosed hypoadrenalism 
may require an increase in their maintenance or stress doses, following initiation of somatropin 
treatment (see section 4.5). 
 
Use with oral oestrogen therapy 
 
If a woman taking somatropin begins oral oestrogen therapy, the dose of somatropin may need to be 
increased to maintain the serum IGF-1 levels within the normal age-appropriate range. Conversely, if 
a woman on somatropin discontinues oral oestrogen therapy, the dose of somatropin may need to be 
reduced to avoid excess of growth hormone and/or side effects (see section 4.5). 
 
Insulin sensitivity 
 
Somatropin may reduce insulin sensitivity. For patients with diabetes mellitus, the insulin dose may 
require adjustment after somatropin therapy is instituted. Patients with diabetes, glucose intolerance, 
or additional risk factors for diabetes should be monitored closely during somatropin therapy.  
 
Thyroid function 
 
Growth hormone increases the extrathyroidal conversion of T4 to T3 which may result in a reduction 
in serum T4 and an increase in serum T3 concentrations. Whereas the peripheral thyroid hormone 
levels have remained within the reference ranges for healthy subjects, hypothyroidism theoretically 
may develop in subjects with subclinical hypothyroidism. Consequently monitoring of thyroid 
function should therefore be conducted in all patients. In patients with hypopituitarism on standard 
replacement therapy, the potential effect of growth hormone treatment on thyroid function must be 
closely monitored 
 
In growth hormone deficiency, secondary to treatment of malignant disease, it is recommended to pay 
attention to signs of relapse of the malignancy. In childhood cancer survivors, an increased risk of a 
second neoplasm has been reported in patients treated with somatropin after their first neoplasm. 
Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their 
first neoplasm, were the most common of these second neoplasms. 
 
In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the 
hip may occur more frequently than in the general population. Patients limping during treatment with 
somatropin should be examined clinically. 
 



24 

Benign intracranial hypertension 
 
In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for 
papilloedema is recommended. If papilloedema is confirmed, a diagnosis of benign intracranial 
hypertension should be considered and, if appropriate, the growth hormone treatment should be 
discontinued. At present there is insufficient evidence to give specific advice on the continuation of 
growth hormone treatment in patients with resolved intracranial hypertension. If growth hormone 
treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary. 
 
Leukaemia 
 
Leukaemia has been reported in a small number of growth hormone deficiency patients, some of 
whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is 
increased in growth hormone recipients without predisposition factors.  
 
Antibodies 
 
A small percentage of patients may develop antibodies to Omnitrope. Omnitrope has given rise to the 
formation of antibodies in approximately 1% of patients. The binding capacity of these antibodies is 
low and there is no effect on growth rate. Testing for antibodies to somatropin should be carried out in 
any patient with otherwise unexplained lack of response.  
 
Elderly patients 
Experience in patients above 80 years is limited. Elderly patients may be more sensitive to the action 
of Omnitrope, and therefore may be more prone to develop adverse reactions. 
 
Acute critical illness 
 
The effects of somatropin on recovery were studied in two placebo controlled trials involving 
522 critically ill adult patients suffering complications following open heart surgery, abdominal 
surgery, multiple accidental trauma or acute respiratory failure. Mortality was higher in patients 
treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%. 
Based on this information, these types of patients should not be treated with somatropin. As there is no 
information available on the safety of growth hormone substitution therapy in acutely critically ill 
patients, the benefits of continued treatment in this situation should be weighed against the potential 
risks involved. 
In all patients developing other or similar acute critical illness, the possible benefit of treatment with 
somatropin must be weighed against the potential risk involved. 
 
Paediatric population 
 
Pancreatitis  
 
Although rare, pancreatitis should be considered in somatropin-treated children who develop 
abdominal pain. 
 
Prader-Willi syndrome 
 
In patients with PWS, treatment should always be in combination with a calorie-restricted diet. 
 
There have been reports of fatalities associated with the use of growth hormone in paediatric patients 
with PWS who had one or more of the following risk factors: severe obesity (those patients exceeding 
a weight/height of 200%), history of respiratory impairment or sleep apnoea or unidentified 
respiratory infection. Patients with PWS and one or more of these risk factors may be at greater risk. 
 
Before initiation of treatment with somatropin patients with PWS should be evaluated for upper 
airway obstruction, sleep apnoea or respiratory infections should be assessed. 



25 

 
If during the evaluation of upper airway obstruction, pathological findings are observed, the child 
should be referred to an Ear, nose and throat (ENT) specialist for treatment and resolution of the 
respiratory disorder prior to initiating growth hormone treatment.  
 
Sleep apnoea should be assessed before onset of growth hormone treatment by recognised methods 
such as polysomnography or overnight oxymetry, and monitored if sleep apnoea is suspected. 
 
If during treatment with somatropin patients show signs of upper airway obstruction (including onset 
of or increased snoring), treatment should be interrupted, and a new ENT assessment performed. 
 
All patients with PWS should be evaluated for sleep apnoea and monitored if sleep apnoea is 
suspected.Patients should be monitored for signs of respiratory infections, which should be diagnosed 
as early as possible and treated aggressively. 
 
All patients with PWS should have effective weight control before and during growth hormone 
treatment. 
 
Scoliosis is common in patients with PWS. Scoliosis may progress in any child during rapid growth. 
Signs of scoliosis should be monitored during treatment.  
 
Experience with prolonged treatment in adults and in patients with PWS is limited. 
 
Small for gestational age 
 
In short children/adolescents born SGA, other medical reasons or treatments that could explain growth 
disturbance should be ruled out before starting treatment. 
 
In SGA children/adolescents it is recommended to measure fasting insulin and blood glucose before 
start of treatment and annually thereafter. In patients with increased risk for diabetes mellitus (e.g. 
familial history of diabetes, obesity, severe insulin resistance, acanthosis nigricans) oral glucose 
tolerance testing (OGTT) should be performed. If overt diabetes occurs, growth hormone should not 
be administered. 
 
In SGA children/adolescents it is recommended to measure the IGF-I level before start of treatment 
and twice a year thereafter. If on repeated measurements IGF-I levels exceed +2 SD compared to 
references for age and pubertal status, the IGF-I / IGFBP-3 ratio could be taken into account to 
consider dose adjustment. 
 
Experience in initiating treatment in SGA patients near onset of puberty is limited. It is therefore not 
recommended to initiate treatment near onset of puberty. Experience in patients with Silver-Russell 
syndrome is limited. 
 
Some of the height gain obtained with treating short children/adolescents born SGA with growth 
hormone may be lost if treatment is stopped before final height is reached. 
 
Chronic renal insufficiency 
 
In chronic renal insufficiency, renal function should be below 50 percent of normal before institution 
of therapy. To verify growth disturbance, growth should be followed for a year preceding institution of 
therapy. During this period, conservative treatment for renal insufficiency (which includes control of 
acidosis, hyperparathyroidism and nutritional status) should have been established and should be 
maintained during treatment. 
 
The treatment should be discontinued at renal transplantation. 
 



26 

To date, no data on final height in patients with chronic renal insufficiency treated with Omnitrope are 
available. 
 
Because of the presence of benzyl alcohol the medicinal product must not be given to premature 
babies or neonates. It may cause toxic reactions and anaphylactoid reactions in infants and children up 
to 3 years old. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of Omnitrope. 
Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully 
adjusted to avoid any inhibitory effect on growth. 
 
Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously 
undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective (see 
section 4.4). 
 
In women on oral oestrogen replacement, a higher dose of growth hormone may be required to 
achieve the treatment goal (see section 4.4). 
 
Data from an interaction study performed in growth hormone deficient adults suggests that somatropin 
administration may increase the clearance of compounds known to be metabolised by cytochrome 
P450 isoenzymes. The clearance of compounds metabolised by cytochrome P450 3A4 (e.g. sex 
steroids, corticosteroids, anticonvulsants and ciclosporin) may be especially increased resulting in 
lower plasma levels of these compounds. The clinical significance of this is unknown. 
Also see section 4.4 for statements regarding diabetes mellitus and thyroid disorder and section 4.2 for 
statement on oral oestrogen replacement therapy. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of somatropin in pregnant women. Animal studies 
are insufficient with respect to reproductive toxicity (see section 5.3). Somatropin is not recommended 
during pregnancy and in women of childbearing potential not using contraception. 
 
Breast-feeding 
 
There have been no clinical studies conducted with somatropin containing products in breast-feeding 
women. It is not known if somatropin is excreted into breast milk, but absorption of intact protein 
from the gastrointestinal tract of the infant is extremely unlikely. Therefore caution should be 
exercised when Omnitrope is administered to breast-feeding women. 
 
Fertility 
 
Fertility studies with Omnitrope have not been performed. 
 
4.7 Effects on ability to drive and use machines 
 
Omnitrope has no or negligible influence on the ability to drive and use machines. 
 



27 

4.8 Undesirable effects 
 
Summary of the safety profile 
 
Patients with growth hormone deficiency are characterised by extracellular volume deficit. When 
treatment with somatropin is started this deficit is rapidly corrected. In adult patients adverse reactions 
related to fluid retention, such as peripheral oedema, face oedema, musculoskeletal stiffness, 
arthralgia, myalgia and paraesthesia are common. In general these adverse reactions are mild to 
moderate, arise within the first months of treatment and subside spontaneously or with dose-reduction.  
 
The incidence of these adverse reactions is related to the administered dose, the age of patients, and 
possibly inversely related to the age of patients at the onset of growth hormone deficiency. In children 
such adverse reactions are uncommon.  
 
Omnitrope has given rise to the formation of antibodies in approximately 1% of the patients. The 
binding capacity of these antibodies has been low and no clinical changes have been associated with 
their formation, see section 4.4.  
 
Tabulated list of adverse reactions 
 
Tables 1–6 show the adverse reactions ranked under headings of System Organ Class and frequency 
using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon 
(≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be 
estimated from the available data) for each of the indicated conditions.  
 



28 

Clinical trials in children with GHD 
 
Table 1 
 
Long-term treatment of children with growth disturbance due to insufficient secretion of growth 
hormone 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

  Leukaemia†    

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

     Paraesthesia* 
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

  Rash** 

Pruritus** 

Urticaria** 

   

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

  Arthralgia*   Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

Injection 
site 
reaction$ 
 

    Oedema 
peripheral* 
Face oedema* 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



29 

Clinical trials in children with Turner syndrome 
 
Table 2 
 
Long-term treatment of children with growth disturbance due to Turner syndrome 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

     Paraesthesia* 
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

     Rash** 

Pruritus** 

Urticaria** 
Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

Arthralgia*     Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

     Oedema 
peripheral* 
Face oedema* 
Injection site 
reaction$ 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



30 

Clinical trials in children with chronic renal insufficiency 
 
Table 3 
 
Long-term treatment of children with growth disturbance due to chronic renal insufficiency 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

     Paraesthesia* 
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

 Rash**    Puritus** 
 
Urticaria** 

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

     Arthralgia* 
 
Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

 Injection 
site 
reaction$ 

   Oedema 
peripheral* 
Face oedema* 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



31 

Clinical trials in children with SGA 
 
Table 4 
 
Long-term treatment of children with growth disturbance due to born small for gestational age 
System Organ 
Class 

Very 
Common 
≥ 1/10 

Common 
≥ 1/100 to 
< 1/10 

Uncommon 
≥ 1/1,000 to 
< 1/100 

Rare 
≥ 1/10,000 
to 
< 1/1,000 

Very 
Rare 
< 1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

     Paraesthesia*  
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

 Rash** 
 
Urticaria** 

Puritus**    

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

  Arthralgia* 
 

  Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

 Injection 
site 
reaction$ 

   Oedema 
peripheral* 
Face oedema* 
 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



32 

Clinical trials in PWS 
 
Table 5 
 
Long-term treatment and improvement of body composition of children with growth disturbance 
due to Prader-Willi syndrome 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

 Paraesthesia* 
 
Benign 
intracranial 
hypertension 

    

Skin and 
Subcutaneaous 
Tissues 
disorders 

 Rash**    Puritus** 
 
Urticaria** 

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

 Arthralgia* 
 
Myalgia* 

   Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

 Oedema 
peripheral* 
 

   Face oedema* 
Injection site 
reaction$ 
 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



33 

Clinical trials in adults with GHD 
 
Table 6 
 
Replacement therapy in adults with growth hormone deficiency 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated 
from 
available 
data) 

Metabolism and 
Nutrition 
Disorders 

     Type 2 
diabetes 
mellitus 

Nervous System 
Disorders 

 Paraesthesia* 
 
Carpal Tunnel 
Syndrome 

   Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

     Rash** 
Puritus** 
Urticaria** 

Musculoskeletal
, Connective 
Tissue and Bone 
Disorders 

Arthralgia* Myalgia* 
 
Musculoskelet
al stiffness* 

    

General 
Disorders and 
Administration 
Site Conditions 

Oedema 
peripheral* 
 

    Face oedema* 
Injection site 
reaction$ 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
Description of selected adverse reactions 
 
Reduced serum cortisol levels 
 
Somatropin has been reported to reduce serum cortisol levels, possibly by affecting carrier proteins or 
by increased hepatic clearance. The clinical relevance of these findings may be limited. Nevertheless, 
corticosteroid replacement therapy should be optimised before initiation of therapy.  
 
Prader-Willi syndrome 
 
In the post-marketing experience rare cases of sudden death have been reported in patients affected by 
Prader-Willi syndrome treated with somatropin, although no causal relationship has been 
demonstrated. 
 



34 

Leukaemia 
 
Cases of leukaemia (rare or very rare) have been reported in growth hormone deficient children treated 
with somatropin and included in the post-marketing experience. However, there is no evidence of an 
increased risk of leukaemia without predisposition factors, such as radiation to the brain or head. 
 
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease 
 
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease have been reported in children 
treated with GH. Slipped capital femoral epiphysis occurs more frequently in case of endocrine 
disorders and Legg-Calvé-Perthes is more frequent in case of short stature. But it is unknown if these 
2 pathologies are more frequent or not while treated with somatropin. Their diagnosis should be 
considered in a child with a discomfort or pain in the hip or knee. 
 
Other adverse drug reactions 
 
Other adverse drug reactions may be considered somatropin class effects, such as possible 
hyperglycaemia caused by decreased insulin sensitivity, decreased free thyroxin level and benign 
intra-cranial hypertension. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms: 
Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia. 
 
Long-term overdose could result in signs and symptoms consistent with the known effects of human 
growth hormone excess. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anterior pituitary lobe hormones and analogues, ATC code: H01AC01. 
 
Omnitrope is a biosimilar medicinal product. Detailed information is available on the website of the 
European Medicines Agency http://www.ema.europa.eu 
 
Mechanism of action 
 
Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates 
and proteins. In children with inadequate endogenous growth hormone, somatropin stimulates linear 
growth and increases growth rate. In adults as well as in children, somatropin maintains a normal body 
composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by 
mobilisation of body fat. Visceral adipose tissue is particularly responsive to somatropin. In addition 
to enhanced lipolysis, somatropin decreases the uptake of triglycerides into body fat stores. Serum 
concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor 
Binding Protein 3) are increased by somatropin. In addition, the following actions have been 
demonstrated. 
 



35 

Pharmacodynamic effects 
 
Lipid metabolism 
Somatropin induces hepatic LDL cholesterol receptors, and affects the profile of serum lipids and 
lipoproteins. In general, administration of somatropin to growth hormone deficient patients results in 
reduction in serum LDL and apolipoprotein B. A reduction in serum total cholesterol may also be 
observed. 
 
Carbohydrate metabolism 
Somatropin increases insulin but fasting blood glucose is commonly unchanged. Children with 
hypopituitarism may experience fasting hypoglycaemia. This condition is reversed by somatropin. 
 
Water and mineral metabolism 
Growth hormone deficiency is associated with decreased plasma and extracellular volumes. Both are 
rapidly increased after treatment with somatropin. Somatropin induces the retention of sodium, 
potassium and phosphorus. 
 
Bone metabolism 
Somatropin stimulates the turnover of skeletal bone. Long-term administration of somatropin to 
growth hormone deficient patients with osteopenia results in an increase in bone mineral content and 
density at weight-bearing sites. 
 
Physical capacity  
Muscle strength and physical exercise capacity are improved after long-term treatment with 
somatropin. Somatropin also increases cardiac output, but the mechanism has yet to be clarified. A 
decrease in peripheral vascular resistance may contribute to this effect. 
 
Clinical efficacy and safety 
 
In clinical trials in short children/adolescents born SGA doses of 0.033 and 0.067 mg/kg body weight 
per day have been used for treatment until final height is reached. In 56 patients who were 
continuously treated and have reached (near) final height, the mean change from height at start of 
treatment was +1.90 SDS (0.033 mg/kg body weight per day) and +2.19 SDS (0.067 mg/kg body 
weight per day). Literature data from untreated SGA children/adolescents without early spontaneous 
catch-up suggest a late growth of 0.5 SDS.  
 
5.2 Pharmacokinetic properties 
 
Absorption 
The bioavailability of subcutaneously administered somatropin is approximately 80% in both healthy 
subjects and growth hormone deficient patients. A subcutaneous dose of 5 mg of Omnitrope powder 
and solvent for solution for injection in healthy adults results in plasma Cmax values of 71 ± 24 µg/l 
(mean ± SD) and median tmax value of 4 hours (range 2-8 hours), respectively. 
 
Elimination 
The mean terminal half-life of somatropin after intravenous administration in growth hormone 
deficient adults is about 0.4 hours. However, after subcutaneous administration of Omnitrope 5 mg/ml 
powder and solvent for solution for injection, a half-life of 3 hours is achieved. The observed 
difference is likely due to slow absorption from the injection site following subcutaneous 
administration. 
 
Special populations 
The absolute bioavailability of somatropin seems to be similar in males and females following 
subcutaneous administration. 
 



36 

Information about the pharmacokinetics of somatropin in geriatric and paediatric populations, in 
different races and in patients with renal, hepatic or cardiac insufficiency is either lacking or 
incomplete. 
 
5.3 Preclinical safety data 
 
In studies with Omnitrope regarding subacute toxicity and local tolerance, no clinically relevant 
effects have been observed. 
 
In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity 
no clinically relevant effects have been observed. 
 
With somatropins, in vitro and in vivo genotoxicity studies on gene mutations and induction of 
chromosome aberrations have been negative. 
 
An increased chromosome fragility has been observed in one in vitro study on lymphocytes taken 
from patients after long term treatment with somatropin and following the addition of the 
radiomimetic drug bleomycin. The clinical significance of this finding is unclear. 
 
In another study with somatropin, no increase in chromosomal abnormalities was found in the 
lymphocytes of patients who had received long-term somatropin therapy. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Powder: 
glycine 
disodium hydrogen phosphate heptahydrate 
sodium dihydrogen phosphate dihydrate 
 
Solvent: 
water for injections 
benzyl alcohol  
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
3 years 
 
Shelf life after reconstitution 
After reconstitution and the first use the cartridge should remain in the pen and has to be kept in a 
refrigerator (2°C - 8°C) for a maximum of 21 days. Store and transport refrigerated (2°C - 8°C). Do 
not freeze. Store in the original pen in order to protect from light. 
 
6.4 Special precautions for storage 
 
Unopened vial 
Store and transport refrigerated (2°C - 8°C). Do not freeze. Store in the original package in order to 
protect from light. 
 
For storage conditions of the in-use medicinal product, see section 6.3. 



37 

 
6.5 Nature and contents of container 
 
Powder in a vial (type I glass) with a stopper (fluor-resin laminated butyl rubber), a strip (aluminium) 
and a cap (green polypropylene flip-off), and 1 ml of solvent in a cartridge (type I glass) with a 
stopper (fluor-resin laminated chlorobutyl elastomer), a strip (lacquered aluminium) and a cap (white 
polypropylene flip-off). 
Pack sizes of 1 and 5. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Omnitrope 5 mg/ml is supplied in a vial containing the active substance as a powder and the solvent 
filled in a cartridge. It should be reconstituted with a transfer set as recommended in the information 
provided with the transfer set. 
 
This presentation is intended for multiple use. It should only be administered with the 
Omnitrope Pen L, an injection device specifically developed for use with Omnitrope 5 mg/ml 
reconstituted solution for injection. It has to be administered using sterile, disposable pen needles. 
Patients and caregivers have to receive appropriate training and instruction on the proper use of the 
Omnitrope vials, the cartridges with solvent, the transfer set and the pen from the physician or other 
suitable qualified health professionals. 
 
The following is a general description of the reconstitution and administration process. The 
manufacturer’s instructions with each individual transfer set and pen must be followed for 
reconstituting Omnitrope 5 mg/ml powder for solution for injection, loading the cartridge, attaching 
the injection needle and for the administration.  
 
1. Hands should be washed. 
2. Flip off the plastic protective cap from the vial. The top of the vial and of the cartridge should 

be wiped with an antiseptic solution in order to prevent contamination of the contents. 
3. Use the transfer set for transferring the solvent from the cartridge into the vial. 
4. Gently swirl the vial a few times until the content is completely dissolved. Do not shake; this 

may cause denaturation of the active substance. 
5. If the solution is cloudy or contains particulate matter, it should not be used. The content must 

be clear and colourless after reconstitution. 
6. Transfer the solution back into the cartridge using the transfer set. 
7. Assemble the pen following the instructions for use.  
8. Eliminate air bubbles if necessary. 
9. Clean the site of injection with an alcohol swab. 
10. Administer the appropriate dose by subcutaneous injection using a sterile pen needle. Remove 

the pen needle and dispose of it in accordance with local requirements. 
 
Any unused product or waste material should be disposed of in accordance with local requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/06/332/002 



38 

EU/1/06/332/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 12 April 2006 
Date of latest renewal: 28 February 2011 
 
 
10. DATE OF REVISION OF THE TEXT 
 
<{MM/YYYY}>  
 
 



39 

1. NAME OF THE MEDICINAL PRODUCT 
 
Omnitrope 5 mg/1.5 ml solution for injection in cartridge 
Omnitrope 10 mg/1.5 ml solution for injection in cartridge 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Omnitrope 5 mg/1.5 ml solution for injection 
Each ml of solution contains 3.3 mg of somatropin* (corresponding to 10 IU) 
One cartridge contains 1.5 ml corresponding to 5 mg somatropin* (15 IU). 
 
Excipient(s) with known effect: 
This medicine contains 9 mg benzyl alcohol in each ml. 
Benzyl alcohol may cause allergic reactions.  
 
Omnitrope 10 mg/1.5 ml solution for injection 
Each ml of solution contains 6.7 mg of somatropin* (corresponding to 20 IU) 
One cartridge contains 1.5 ml corresponding to 10 mg somatropin* (30 IU).  
 
* produced in Escherichia coli by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection. 
The solution is clear and colourless. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Infants, children and adolescents 
- Growth disturbance due to insufficient secretion of growth hormone (growth hormone 

deficiency, GHD). 
- Growth disturbance associated with Turner syndrome. 
- Growth disturbance associated with chronic renal insufficiency. 
- Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted 

height SDS < -1) in short children/adolescents born small for gestational age (SGA), with a 
birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up 
growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later. 

- Prader-Willi syndrome (PWS), for improvement of growth and body composition. The 
diagnosis of PWS should be confirmed by appropriate genetic testing. 

 
Adults 
- Replacement therapy in adults with pronounced growth hormone deficiency.  
- Adult onset: Patients who have severe growth hormone deficiency associated with multiple 

hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at 
least one known deficiency of a pituitary hormone not being prolactin. These patients should 
undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone 
deficiency. 

- Childhood onset: Patients who were growth hormone deficient during childhood as a result of 
congenital, genetic, acquired, or idiopathic causes. Patients with childhood onset GHD should 
be re-evaluated for growth hormone secretory capacity after completion of longitudinal growth. 



40 

In patients with a high likelihood for persistent GHD, i.e. a congenital cause or GHD secondary 
to a hypothalamic-pituitary disease or insult, an insulin-like growth factor-I (IGF-I) SDS < -2 
off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of 
profound GHD. 

 
All other patients will require IGF-I assay and one growth hormone stimulation test. 
 
4.2 Posology and method of administration 
 
Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are 
appropriately qualified and experienced in the diagnosis and management of patients with growth 
disorders. 
 
Posology 
 
Paediatric population 
The posology and administration schedule should be individualised. 
 
Growth disturbance due to insufficient secretion of growth hormone in paediatric patients 
Generally a dose of 0.025 - 0.035 mg/kg body weight per day or 0.7 - 1.0 mg/m2 body surface area per 
day is recommended. Even higher doses have been used. 
 
Where childhood onset GHD persists into adolescence, treatment should be continued to achieve full 
somatic development (e.g. body composition, bone mass). For monitoring, the attainment of a normal 
peak bone mass defined as a T score > -1 (i.e. standardized to average adult peak bone mass measured 
by dual energy X-ray absorptiometry taking into account sex and ethnicity) is one of the therapeutic 
objectives during the transition period. For guidance on dosing see adult section below. 
 
Prader-Willi syndrome, for improvement of growth and body composition in paediatric patients 
Generally a dose of 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day is 
recommended. Daily doses of 2.7 mg should not be exceeded. Treatment should not be used in 
paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses. 
 
Growth disturbance due to Turner syndrome 
A dose of 0.045 - 0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day is 
recommended. 
 
Growth disturbance in chronic renal insufficiency 
A dose of 0.045 - 0.050 mg/kg body weight per day (1.4 mg/m2 body surface area per day) is 
recommended. Higher doses may be needed if growth velocity is too low. A dose correction can be 
needed after six months of treatment (see section 4.4). 
 
Growth disturbance in short children/adolescents born small for gestational age (SGA) 
A dose of 0.035 mg/kg body weight per day (1 mg/m2 body surface area per day) is usually 
recommended until final height is reached (see section 5.1). Treatment should be discontinued after 
the first year of treatment if the height velocity SDS is below + 1. Treatment should be discontinued if 
height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or 
> 16 years (boys), corresponding to closure of the epiphyseal growth plates. 
 



41 

Dose recommendations in paediatric patients 
 

Indication mg/kg body weight dose 
per day 

mg/m² body surface 
area dose per day 

Growth hormone deficiency  0.025 - 0.035 0.7 - 1.0 
Prader-Willi syndrome  0.035 1.0 
Turner syndrome 0.045 - 0.050 1.4 
Chronic renal insufficiency 0.045 - 0.050 1.4 
Children/adolescents born small for 
gestational age (SGA) 0.035 1.0 

 
Growth hormone deficient adult patients 
In patients who continue growth hormone therapy after childhood GHD, the recommended dose to 
restart is 0.2 – 0.5 mg per day. The dose should be gradually increased or decreased according to 
individual patient requirements as determined by the IGF-I concentration.  
 
In adults with adult-onset GHD, therapy should start with a low dose, 0.15 - 0.3 mg per day. The dose 
should be gradually increased according to individual patient requirements as determined by the IGF-I 
concentration. 
 
In both cases treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS 
from the age corrected mean. Patients with normal IGF-I concentrations at the start of the treatment 
should be administered growth hormone up to an IGF-I level into the upper range of normal, not 
exceeding the 2 SDS. Clinical response and side effects may also be used as guidance for dose 
titration. It is recognized that there are patients with GHD who do not normalize IGF-I levels despite a 
good clinical response, and thus do not require dose escalation. The maintenance dose rarely exceeds 
1.0 mg per day. Women may require higher doses than men, with men showing an increasing IGF-I 
sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen 
replacement are under-treated while men are over-treated. The accuracy of the growth hormone dose 
should therefore be controlled every 6 months. As normal physiological growth hormone production 
decreases with age, dose requirements may be reduced. 
 
Special populations 
 
Elderly 
In patients above 60 years, therapy should start with a dose of 0.1 - 0.2 mg per day and should be 
slowly increased according to individual patient requirements. The minimum effective dose should be 
used. The maintenance dose in these patients seldom exceeds 0.5 mg per day. 
 
Method of administration 
 
The injection should be given subcutaneously and the site varied to prevent lipoatrophy. 
 
For instructions for use and handling see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours 
must be inactive and anti-tumour therapy must be completed prior to starting GH therapy. Treatment 
should be discontinued if there is evidence of tumour growth. 
 
Somatropin must not be used for growth promotion in children with closed epiphyses. 
 



42 

Patients with acute critical illness suffering complications following open heart surgery, abdominal 
surgery, multiple accidental trauma, acute respiratory failure or similar conditions must not be treated 
with somatropin (regarding patients undergoing substitution therapy, see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
The maximum recommended daily dose should not be exceeded (see section 4.2). 
 
Intravenous administration of benzyl alcohol has been associated with serious adverse events and 
death in neonates (“gasping syndrome”). The minimum amount of benzyl alcohol at which toxicity 
may occur is not known. 
 
Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol 
concentrations. In patients treated with somatropin, previously undiagnosed central (secondary) 
hypoadrenalism may be unmasked and glucocorticoid replacement may be required. In addition, 
patients treated with glucocorticoid replacement therapy for previously diagnosed hypoadrenalism 
may require an increase in their maintenance or stress doses, following initiation of somatropin 
treatment (see section 4.5). 
 
Use with oral oestrogen therapy 
 
If a woman taking somatropin begins oral oestrogen therapy, the dose of somatropin may need to be 
increased to maintain the serum IGF-1 levels within the normal age-appropriate range. Conversely, if 
a woman on somatropin discontinues oral oestrogen therapy, the dose of somatropin may need to be 
reduced to avoid excess of growth hormone and/or side effects (see section 4.5). 
 
Insulin sensitivity 
 
Somatropin may reduce insulin sensitivity. For patients with diabetes mellitus, the insulin dose may 
require adjustment after somatropin therapy is instituted. Patients with diabetes, glucose intolerance, 
or additional risk factors for diabetes should be monitored closely during somatropin therapy.  
 
Thyroid function 
 
Growth hormone increases the extrathyroidal conversion of T4 to T3 which may result in a reduction 
in serum T4 and an increase in serum T3 concentrations. Whereas the peripheral thyroid hormone 
levels have remained within the reference ranges for healthy subjects, hypothyroidism theoretically 
may develop in subjects with subclinical hypothyroidism. Consequently monitoring of thyroid 
function should therefore be conducted in all patients. In patients with hypopituitarism on standard 
replacement therapy, the potential effect of growth hormone treatment on thyroid function must be 
closely monitored 
 
In growth hormone deficiency, secondary to treatment of malignant disease, it is recommended to pay 
attention to signs of relapse of the malignancy. In childhood cancer survivors, an increased risk of a 
second neoplasm has been reported in patients treated with somatropin after their first neoplasm. 
Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their 
first neoplasm, were the most common of these second neoplasms. 
 
In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the 
hip may occur more frequently than in the general population. Patients limping during treatment with 
somatropin should be examined clinically. 



43 

 
Benign intracranial hypertension 
 
In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for 
papilloedema is recommended. If papilloedema is confirmed, a diagnosis of benign intracranial 
hypertension should be considered and, if appropriate, the growth hormone treatment should be 
discontinued. At present there is insufficient evidence to give specific advice on the continuation of 
growth hormone treatment in patients with resolved intracranial hypertension. If growth hormone 
treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary. 
 
Leukaemia 
 
Leukaemia has been reported in a small number of growth hormone deficiency patients, some of 
whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is 
increased in growth hormone recipients without predisposition factors.  
 
Antibodies 
 
A small percentage of patients may develop antibodies to Omnitrope. Omnitrope has given rise to the 
formation of antibodies in approximately 1% of patients. The binding capacity of these antibodies is 
low and there is no effect on growth rate. Testing for antibodies to somatropin should be carried out in 
any patient with otherwise unexplained lack of response.  
 
Elderly patients 
Experience in patients above 80 years is limited. Elderly patients may be more sensitive to the action 
of Omnitrope, and therefore may be more prone to develop adverse reactions. 
 
Acute critical illness 
 
The effects of somatropin on recovery were studied in two placebo controlled trials involving 
522 critically ill adult patients suffering complications following open heart surgery, abdominal 
surgery, multiple accidental trauma or acute respiratory failure. Mortality was higher in patients 
treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%. 
Based on this information, these types of patients should not be treated with somatropin. As there is no 
information available on the safety of growth hormone substitution therapy in acutely critically ill 
patients, the benefits of continued treatment in this situation should be weighed against the potential 
risks involved. 
 
In all patients developing other or similar acute critical illness, the possible benefit of treatment with 
somatropin must be weighed against the potential risk involved. 
 
Paediatric population 
 
Pancreatitis  
 
Although rare, pancreatitis should be considered in somatropin-treated children who develop 
abdominal pain. 
 
Prader-Willi syndrome 
 
In patients with PWS, treatment should always be in combination with a calorie-restricted diet. 
 
There have been reports of fatalities associated with the use of growth hormone in paediatric patients 
with PWS who had one or more of the following risk factors: severe obesity (those patients exceeding 
a weight/height of 200%), history of respiratory impairment or sleep apnoea or unidentified 
respiratory infection. Patients with PWS and one or more of these risk factors may be at greater risk. 
 



44 

Before initiation of treatment with somatropin patients with PWS should be evaluated for upper 
airway obstruction, sleep apnoea or respiratory infections should be assessed. 
 
If during the evaluation of upper airway obstruction, pathological findings are observed, the child 
should be referred to an Ear, nose and throat (ENT) specialist for treatment and resolution of the 
respiratory disorder prior to initiating growth hormone treatment.  
 
Sleep apnoea should be assessed before onset of growth hormone treatment by recognised methods 
such as polysomnography or overnight oxymetry, and monitored if sleep apnoea is suspected. 
 
If during treatment with somatropin patients show signs of upper airway obstruction (including onset 
of or increased snoring), treatment should be interrupted, and a new ENT assessment performed. 
 
All patients with PWS should be evaluated for sleep apnoea and monitored if sleep apnoea is 
suspected.Patients should be monitored for signs of respiratory infections, which should be diagnosed 
as early as possible and treated aggressively. 
 
All patients with PWS should have effective weight control before and during growth hormone 
treatment. 
 
Scoliosis is common in patients with PWS. Scoliosis may progress in any child during rapid growth. 
Signs of scoliosis should be monitored during treatment.  
 
Experience with prolonged treatment in adults and in patients with PWS is limited. 
 
Small for gestational age 
 
In short children/adolescents born SGA, other medical reasons or treatments that could explain growth 
disturbance should be ruled out before starting treatment. 
 
In SGA children/adolescents it is recommended to measure fasting insulin and blood glucose before 
start of treatment and annually thereafter. In patients with increased risk for diabetes mellitus (e.g. 
familial history of diabetes, obesity, severe insulin resistance, acanthosis nigricans) oral glucose 
tolerance testing (OGTT) should be performed. If overt diabetes occurs, growth hormone should not 
be administered. 
 
In SGA children/adolescents it is recommended to measure the IGF-I level before start of treatment 
and twice a year thereafter. If on repeated measurements IGF-I levels exceed +2 SD compared to 
references for age and pubertal status, the IGF-I / IGFBP-3 ratio could be taken into account to 
consider dose adjustment. 
 
Experience in initiating treatment in SGA patients near onset of puberty is limited. It is therefore not 
recommended to initiate treatment near onset of puberty. Experience in patients with Silver-Russell 
syndrome is limited. 
 
Some of the height gain obtained with treating short children/adolescents born SGA with growth 
hormone may be lost if treatment is stopped before final height is reached. 
 
Chronic renal insufficiency 
 
In chronic renal insufficiency, renal function should be below 50 percent of normal before institution 
of therapy. To verify growth disturbance, growth should be followed for a year preceding institution of 
therapy. During this period, conservative treatment for renal insufficiency (which includes control of 
acidosis, hyperparathyroidism and nutritional status) should have been established and should be 
maintained during treatment. 
 
The treatment should be discontinued at renal transplantation. 



45 

 
To date, no data on final height in patients with chronic renal insufficiency treated with Omnitrope are 
available. 
 
Omnitrope 5 mg/1.5 ml solution for injection: 
Because of the presence of benzyl alcohol the medicinal product must not be given to premature 
babies or neonates. It may cause toxic reactions and anaphylactoid reactions in infants and children up 
to 3 years old. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of Omnitrope. 
Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully 
adjusted to avoid any inhibitory effect on growth. 
 
Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously 
undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective (see 
section 4.4). 
 
In women on oral oestrogen replacement, a higher dose of growth hormone may be required to 
achieve the treatment goal (see section 4.4). 
 
Data from an interaction study performed in growth hormone deficient adults suggests that somatropin 
administration may increase the clearance of compounds known to be metabolised by cytochrome 
P450 isoenzymes. The clearance of compounds metabolised by cytochrome P450 3A4 (e.g. sex 
steroids, corticosteroids, anticonvulsants and ciclosporin) may be especially increased resulting in 
lower plasma levels of these compounds. The clinical significance of this is unknown. 
Also see section 4.4 for statements regarding diabetes mellitus and thyroid disorder and section 4.2 for 
statement on oral oestrogen replacement therapy. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of somatropin in pregnant women. Animal studies 
are insufficient with respect to reproductive toxicity (see section 5.3). Somatropin is not recommended 
during pregnancy and in women of childbearing potential not using contraception. 
 
Breast-feeding 
 
There have been no clinical studies conducted with somatropin containing products in breast-feeding 
women. It is not known if somatropin is excreted into breast milk, but absorption of intact protein 
from the gastrointestinal tract of the infant is extremely unlikely. Therefore caution should be 
exercised when Omnitrope is administered to breast-feeding women. 
 
Fertility 
 
Fertility studies with Omnitrope have not been performed. 
 
4.7 Effects on ability to drive and use machines 
 
Omnitrope has no or negligible influence on the ability to drive and use machines. 
 



46 

4.8 Undesirable effects 
 
Summary of the safety profile 
 
Patients with growth hormone deficiency are characterised by extracellular volume deficit. When 
treatment with somatropin is started this deficit is rapidly corrected. In adult patients adverse reactions 
related to fluid retention, such as peripheral oedema, face oedema, musculoskeletal stiffness, 
arthralgia, myalgia and paraesthesia are common. In general these adverse reactions are mild to 
moderate, arise within the first months of treatment and subside spontaneously or with dose-reduction.  
 
The incidence of these adverse reactions is related to the administered dose, the age of patients, and 
possibly inversely related to the age of patients at the onset of growth hormone deficiency. In children 
such adverse reactions are uncommon.  
 
Omnitrope has given rise to the formation of antibodies in approximately 1% of the patients. The 
binding capacity of these antibodies has been low and no clinical changes have been associated with 
their formation, see section 4.4.  
 
Tabulated list of adverse reactions 
 
Tables 1–6 show the adverse reactions ranked under headings of System Organ Class and frequency 
using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon 
(≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be 
estimated from the available data) for each of the indicated conditions.  
 
Clinical trials in children with GHD 
 
Table 1 
 
Long-term treatment of children with growth disturbance due to insufficient secretion of growth 
hormone 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

  Leukaemia†    

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

     Paraesthesia* 
 
Benign 
intracranial 
hypertension 



47 

Skin and 
Subcutaneaous 
Tissues 
disorders 

  Rash** 

Pruritus** 

Urticaria** 

   

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

  Arthralgia*   Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

Injection 
site 
reaction$ 
 

    Oedema 
peripheral* 
Face oedema* 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 
Clinical trials in children with Turner syndrome 
 



48 

Table 2 
 
Long-term treatment of children with growth disturbance due to Turner syndrome 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
 
mellitus 

Nervous System 
Disorders 

     Paraesthesia* 
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

     Rash** 

Pruritus** 

Urticaria** 
Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

Arthralgia*     Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

     Oedema 
peripheral* 
Face oedema* 
Injection site 
reaction$ 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 
Clinical trials in children with chronic renal insufficiency 
 



49 

Table 3 
 
Long-term treatment of children with growth disturbance due to chronic renal insufficiency 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

     Paraesthesia* 
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

 Rash**    Puritus** 
 
Urticaria** 

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

     Arthralgia* 
 
Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

 Injection 
site 
reaction$ 

   Oedema 
peripheral* 
Face oedema* 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 
Clinical trials in children with SGA 
 



50 

Table 4 
 
Long-term treatment of children with growth disturbance due to born small for gestational age 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
 
mellitus 

Nervous System 
Disorders 

     Paraesthesia*  
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

 Rash** 
 
Urticaria** 

Puritus**    

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

  Arthralgia* 
 

  Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

 Injection 
site 
reaction$ 

   Oedema 
peripheral* 
Face oedema* 
 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



51 

Clinical trials in PWS 
Table 5 
 
Long-term treatment and improvement of body composition of children with growth 
disturbance due to Prader-Willi syndrome 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

 Paraesthesia* 
 
Benign 
intracranial 
hypertension 

    

Skin and 
Subcutaneaous 
Tissues 
disorders 

 Rash**    Puritus** 
 
Urticaria** 

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

 Arthralgia* 
 
Myalgia* 

   Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

 Oedema 
peripheral* 
 

   Face oedema* 
Injection site 
reaction$ 
 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



52 

Clinical trials in adults with GHD 
Table 6 
 
Replacement therapy in adults with growth hormone deficiency 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommo
n 
≥ 1/1,000 
to <1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,0
00 

Not Known 
(cannot be 
estimated 
from 
available 
data) 

Metabolism and 
Nutrition 
Disorders 

     Type 2 
diabetes 
mellitus 

Nervous System 
Disorders 

 Paraesthesia* 
 
Carpal Tunnel 
Syndrome 

   Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

     Rash** 
Puritus** 
Urticaria** 

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

Arthralgia* Myalgia* 
 
Musculoskelet
al stiffness* 

    

General 
Disorders and 
Administration 
Site Conditions 

Oedema 
peripheral* 

    Face oedema* 
Injection site 
reaction$ 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
Description of selected adverse reactions 
 
Reduced serum cortisol levels 
 
Somatropin has been reported to reduce serum cortisol levels, possibly by affecting carrier proteins or 
by increased hepatic clearance. The clinical relevance of these findings may be limited. Nevertheless, 
corticosteroid replacement therapy should be optimised before initiation of therapy.  
 
Prader-Willi syndrome 
 
In the post-marketing experience rare cases of sudden death have been reported in patients affected by 
Prader-Willi syndrome treated with somatropin, although no causal relationship has been 
demonstrated. 
 



53 

Leukaemia 
 
Cases of leukaemia (rare or very rare) have been reported in growth hormone deficient children treated 
with somatropin and included in the post-marketing experience. However, there is no evidence of an 
increased risk of leukaemia without predisposition factors, such as radiation to the brain or head. 
 
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease 
 
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease have been reported in children 
treated with GH. Slipped capital femoral epiphysis occurs more frequently in case of endocrine 
disorders and Legg-Calvé-Perthes is more frequent in case of short stature. But it is unknown if these 
2 pathologies are more frequent or not while treated with somatropin. Their diagnosis should be 
considered in a child with a discomfort or pain in the hip or knee. 
 
Other adverse drug reactions 
 
Other adverse drug reactions may be considered somatropin class effects, such as possible 
hyperglycaemia caused by decreased insulin sensitivity, decreased free thyroxin level and benign 
intra-cranial hypertension. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms: 
 
Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia. 
 
Long-term overdose could result in signs and symptoms consistent with the known effects of human 
growth hormone excess. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anterior pituitary lobe hormones and analogues, ATC code: H01AC01. 
 
Omnitrope is a biosimilar medicinal product. Detailed information is available on the website of the 
European Medicines Agency http://www.ema.europa.eu 
 
Mechanism of action 
 
Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates 
and proteins. In children with inadequate endogenous growth hormone, somatropin stimulates linear 
growth and increases growth rate. In adults as well as in children, somatropin maintains a normal body 
composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by 
mobilisation of body fat. Visceral adipose tissue is particularly responsive to somatropin. In addition 
to enhanced lipolysis, somatropin decreases the uptake of triglycerides into body fat stores. Serum 
concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor 
Binding Protein 3) are increased by somatropin. In addition, the following actions have been 
demonstrated. 



54 

 
Pharmacodynamic effects 
 
Lipid metabolism 
Somatropin induces hepatic LDL cholesterol receptors, and affects the profile of serum lipids and 
lipoproteins. In general, administration of somatropin to growth hormone deficient patients results in 
reduction in serum LDL and apolipoprotein B. A reduction in serum total cholesterol may also be 
observed. 
 
Carbohydrate metabolism 
Somatropin increases insulin but fasting blood glucose is commonly unchanged. Children with 
hypopituitarism may experience fasting hypoglycaemia. This condition is reversed by somatropin. 
 
Water and mineral metabolism 
Growth hormone deficiency is associated with decreased plasma and extracellular volumes. Both are 
rapidly increased after treatment with somatropin. Somatropin induces the retention of sodium, 
potassium and phosphorus. 
 
Bone metabolism 
Somatropin stimulates the turnover of skeletal bone. Long-term administration of somatropin to 
growth hormone deficient patients with osteopenia results in an increase in bone mineral content and 
density at weight-bearing sites. 
 
Physical capacity  
Muscle strength and physical exercise capacity are improved after long-term treatment with 
somatropin. Somatropin also increases cardiac output, but the mechanism has yet to be clarified. A 
decrease in peripheral vascular resistance may contribute to this effect. 
 
Clinical efficacy and safety 
 
In clinical trials in short children/adolescents born SGA doses of 0.033 and 0.067 mg/kg body weight 
per day have been used for treatment until final height is reached. In 56 patients who were 
continuously treated and have reached (near) final height, the mean change from height at start of 
treatment was +1.90 SDS (0.033 mg/kg body weight per day) and +2.19 SDS (0.067 mg/kg body 
weight per day). Literature data from untreated SGA children/adolescents without early spontaneous 
catch-up suggest a late growth of 0.5 SDS.  
 
5.2 Pharmacokinetic properties 
 
Absorption 
The bioavailability of subcutaneously administered somatropin is approximately 80% in both healthy 
subjects and growth hormone deficient patients.  
 
A subcutaneous dose of 5 mg of Omnitrope 5 mg/1.5 ml solution for injection in healthy adults results 
in plasma Cmax and tmax values of 72 ± 28 µg/l and 4.0 ± 2.0 hours, respectively. 
 
A subcutaneous dose of 5 mg of Omnitrope 10 mg/1.5 ml solution for injection in healthy adults 
results in plasma Cmax and tmax values of 74 ± 22 µg/l and 3.9 ± 1.2 hours, respectively. 
 
Elimination 
The mean terminal half-life of somatropin after intravenous administration in growth hormone 
deficient adults is about 0.4 hours. However, after subcutaneous administration of Omnitrope 
5 mg/1.5 ml, Omnitrope 10 mg/1.5 ml solution for injection, a half-life of 3 hours is achieved. The 
observed difference is likely due to slow absorption from the injection site following subcutaneous 
administration. 
 



55 

Special populations 
The absolute bioavailability of somatropin seems to be similar in males and females following 
subcutaneous administration. 
 
Information about the pharmacokinetics of somatropin in geriatric and paediatric populations, in 
different races and in patients with renal, hepatic or cardiac insufficiency is either lacking or 
incomplete. 
 
5.3 Preclinical safety data 
 
In studies with Omnitrope regarding subacute toxicity and local tolerance, no clinically relevant 
effects have been observed. 
 
In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity 
no clinically relevant effects have been observed. 
 
With somatropins, in vitro and in vivo genotoxicity studies on gene mutations and induction of 
chromosome aberrations have been negative. 
 
An increased chromosome fragility has been observed in one in vitro study on lymphocytes taken 
from patients after long term treatment with somatropin and following the addition of the 
radiomimetic drug bleomycin. The clinical significance of this finding is unclear. 
 
In another study with somatropin, no increase in chromosomal abnormalities was found in the 
lymphocytes of patients who had received long-term somatropin therapy. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Omnitrope 5 mg/1.5 ml solution for injection 
disodium hydrogen phosphate heptahydrate 
sodium dihydrogen phosphate dihydrate 
mannitol 
poloxamer 188 
benzyl alcohol 
water for injections 
 
Omnitrope 10 mg/1.5 ml solution for injection 
disodium hydrogen phosphate heptahydrate 
sodium dihydrogen phosphate dihydrate 
glycine 
poloxamer 188 
phenol 
water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
Omnitrope 5 mg/1.5 ml solution for injection 
2 years 
 



56 

Omnitrope 10 mg/1.5 ml solution for injection 
18 months. 
 
Shelf life after first use 
After first use the cartridge should remain in the pen and has to be kept in a refrigerator (2°C - 8°C) 
for a maximum of 28 days. Store and transport refrigerated (2°C - 8°C). Do not freeze. Store in the 
original pen in order to protect from light. 
 
6.4 Special precautions for storage 
 
Unopened cartridge 
Store and transport refrigerated (2°C - 8°C). Do not freeze. Store in the original package in order to 
protect from light. 
 
For storage conditions of the in-use medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
1.5 ml of solution in a cartridge (colourless type I glass) with plunger on one side (siliconised 
bromobutyl), a disc (bromobutyl) and a cap (aluminium) on the other side. 
Pack sizes of 1, 5 and 10. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Omnitrope 5 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous 
injection filled in a glass cartridge. 
 
This presentation is intended for multiple use. It should only be administered with the 
Omnitrope Pen 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml 
solution for injection. It has to be administered using sterile, disposable pen needles. Patients and 
caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope 
cartridges and the pen from the physician or other suitable qualified health professionals. 
 
Omnitrope 10 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous 
injection filled in a glass cartridge. 
 
This presentation is intended for multiple use. It should only be administered with the 
Omnitrope Pen 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml 
solution for injection. It has to be administered using sterile, disposable pen needles. Patients and 
caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope 
cartridges and the pen from the physician or other suitable qualified health professionals. 
 
The following is a general description of the administration process. The manufacturer’s instructions 
with each pen must be followed for loading the cartridge, attaching the injection needle and for the 
administration. 
 
1. Hands should be washed. 
2. If the solution is cloudy or contains particulate matter, it should not be used. The content must 

be clear and colourless. 
3. Disinfect the rubber membrane of the cartridge with a cleansing swab 
4. Insert the cartridge into the Omnitrope Pen following the instructions for use provided with the 

pen.  
5. Clean the site of injection with an alcohol swab. 
6. Administer the appropriate dose by subcutaneous injection using a sterile pen needle. Remove 

the pen needle and dispose of it in accordance with local requirements. 
 



57 

Any unused product or waste material should be disposed of in accordance with local requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
Omnitrope 5 mg/1.5 ml solution for injection 
 
EU/1/06/332/004 
EU/1/06/332/005 
EU/1/06/332/006 
 
Omnitrope 10 mg/1.5 ml solution for injection 
EU/1/06/332/007 
EU/1/06/332/008 
EU/1/06/332/009 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 12 April 2006 
Date of latest renewal: 28 February 2011 
 
 
10. DATE OF REVISION OF THE TEXT 
 
<{MM/YYYY}>  
 
 



58 

1. NAME OF THE MEDICINAL PRODUCT 
 
Omnitrope 5 mg/1.5 ml solution for injection in cartridge 
Omnitrope 10 mg/1.5 ml solution for injection in cartridge 
Omnitrope 15 mg/1.5 ml solution for injection in cartridge 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Omnitrope 5 mg/1.5 ml solution for injection 
Each ml of solution contains 3.3 mg of somatropin* (corresponding to 10 IU) 
One cartridge contains 1.5 ml corresponding to 5 mg somatropin* (15 IU). 
 
Excipient(s) with known effect: 
This medicine contains 9 mg benzyl alcohol in each ml. 
Benzyl alcohol may cause allergic reactions.  
 
Omnitrope 10 mg/1.5 ml solution for injection 
Each ml of solution contains 6.7 mg of somatropin* (corresponding to 20 IU) 
One cartridge contains 1.5 ml corresponding to 10 mg somatropin* (30 IU). 
 
Omnitrope 15 mg/1.5 ml solution for injection 
Each ml of solution contains 10 mg of somatropin* (corresponding to 30 IU) 
One cartridge contains 1.5 ml corresponding to 15 mg somatropin* (45 IU). 
 
* produced in Escherichia coli by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection in a cartridge for SurePal 5, SurePal 10, SurePal 15. 
The solution is clear and colourless. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Infants, children and adolescents 
- Growth disturbance due to insufficient secretion of growth hormone (growth hormone 

deficiency, GHD). 
- Growth disturbance associated with Turner syndrome. 
- Growth disturbance associated with chronic renal insufficiency. 
- Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted 

height SDS < -1) in short children/adolescents born small for gestational age (SGA), with a 
birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up 
growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later. 

- Prader-Willi syndrome (PWS), for improvement of growth and body composition. The 
diagnosis of PWS should be confirmed by appropriate genetic testing. 
 

Adults 
- Replacement therapy in adults with pronounced growth hormone deficiency.  
- Adult onset: Patients who have severe growth hormone deficiency associated with multiple 

hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at 
least one known deficiency of a pituitary hormone not being prolactin. These patients should 



59 

undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone 
deficiency. 

- Childhood onset: Patients who were growth hormone deficient during childhood as a result of 
congenital, genetic, acquired, or idiopathic causes. Patients with childhood onset GHD should 
be re-evaluated for growth hormone secretory capacity after completion of longitudinal growth. 
In patients with a high likelihood for persistent GHD, i.e. a congenital cause or GHD secondary 
to a hypothalamic-pituitary disease or insult, an insulin-like growth factor-I (IGF-I) SDS < -2 
off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of 
profound GHD. 
 

All other patients will require IGF-I assay and one growth hormone stimulation test. 
 
4.2 Posology and method of administration 
 
Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are 
appropriately qualified and experienced in the diagnosis and management of patients with growth 
disorders. 
 
Posology 
 
Paediatric population 
The posology and administration schedule should be individualised. 
 
Growth disturbance due to insufficient secretion of growth hormone in paediatric patients 
Generally a dose of 0.025 - 0.035 mg/kg body weight per day or 0.7 - 1.0 mg/m2 body surface area per 
day is recommended. Even higher doses have been used. 
 
Where childhood onset GHD persists into adolescence, treatment should be continued to achieve full 
somatic development (e.g. body composition, bone mass). For monitoring, the attainment of a normal 
peak bone mass defined as a T score > -1 (i.e. standardized to average adult peak bone mass measured 
by dual energy X-ray absorptiometry taking into account sex and ethnicity) is one of the therapeutic 
objectives during the transition period. For guidance on dosing see adult section below. 
 
Prader-Willi syndrome, for improvement of growth and body composition in paediatric patients 
Generally a dose of 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day is 
recommended. Daily doses of 2.7 mg should not be exceeded. Treatment should not be used in 
paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses. 
 
Growth disturbance due to Turner syndrome 
A dose of 0.045 - 0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day is 
recommended. 
 
Growth disturbance in chronic renal insufficiency 
A dose of 0.045 - 0.050 mg/kg body weight per day (1.4 mg/m2 body surface area per day) is 
recommended. Higher doses may be needed if growth velocity is too low. A dose correction can be 
needed after six months of treatment (see section 4.4). 
 
Growth disturbance in short children/adolescents born small for gestational age (SGA) 
A dose of 0.035 mg/kg body weight per day (1 mg/m2 body surface area per day) is usually 
recommended until final height is reached (see section 5.1). Treatment should be discontinued after 
the first year of treatment if the height velocity SDS is below + 1. Treatment should be discontinued if 
height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or 
> 16 years (boys), corresponding to closure of the epiphyseal growth plates. 
 



60 

Dose recommendations in paediatric patients 

Indication mg/kg body weight dose 
per day 

mg/m² body surface 
area dose per day 

Growth hormone deficiency  0.025 - 0.035 0.7 - 1.0 
Prader-Willi syndrome  0.035 1.0 
Turner syndrome 0.045 - 0.050 1.4 
Chronic renal insufficiency 0.045 - 0.050 1.4 
Children/adolescents born small for 
gestational age (SGA) 0.035 1.0 

 
Growth hormone deficient adult patients 
In patients who continue growth hormone therapy after childhood GHD, the recommended dose to 
restart is 0.2 – 0.5 mg per day. The dose should be gradually increased or decreased according to 
individual patient requirements as determined by the IGF-I concentration.  
 
In adults with adult-onset GHD, therapy should start with a low dose, 0.15 - 0.3 mg per day. The dose 
should be gradually increased according to individual patient requirements as determined by the IGF-I 
concentration. 
 
In both cases treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS 
from the age corrected mean. Patients with normal IGF-I concentrations at the start of the treatment 
should be administered growth hormone up to an IGF-I level into the upper range of normal, not 
exceeding the 2 SDS. Clinical response and side effects may also be used as guidance for dose 
titration. It is recognized that there are patients with GHD who do not normalize IGF-I levels despite a 
good clinical response, and thus do not require dose escalation. The maintenance dose rarely exceeds 
1.0 mg per day. Women may require higher doses than men, with men showing an increasing IGF-I 
sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen 
replacement are under-treated while men are over-treated. The accuracy of the growth hormone dose 
should therefore be controlled every 6 months. As normal physiological growth hormone production 
decreases with age, dose requirements may be reduced. 
 
Special populations 
 
Elderly 
In patients above 60 years, therapy should start with a dose of 0.1 - 0.2 mg per day and should be 
slowly increased according to individual patient requirements. The minimum effective dose should be 
used. The maintenance dose in these patients seldom exceeds 0.5 mg per day. 
 
Method of administration 
 
The injection should be given subcutaneously and the site varied to prevent lipoatrophy. 
 
For instructions for use and handling see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours 
must be inactive and anti-tumour therapy must be completed prior to starting GH therapy. Treatment 
should be discontinued if there is evidence of tumour growth. 
 
Somatropin must not be used for growth promotion in children with closed epiphyses. 
 
Patients with acute critical illness suffering complications following open heart surgery, abdominal 
surgery, multiple accidental trauma, acute respiratory failure or similar conditions must not be treated 
with somatropin (regarding patients undergoing substitution therapy, see section 4.4). 



61 

 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
The maximum recommended daily dose should not be exceeded (see section 4.2). 
 
Intravenous administration of benzyl alcohol has been associated with serious adverse events and 
death in neonates (“gasping syndrome”). The minimum amount of benzyl alcohol at which toxicity 
may occur is not known. 
 
Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol 
concentrations. In patients treated with somatropin, previously undiagnosed central (secondary) 
hypoadrenalism may be unmasked and glucocorticoid replacement may be required. In addition, 
patients treated with glucocorticoid replacement therapy for previously diagnosed hypoadrenalism 
may require an increase in their maintenance or stress doses, following initiation of somatropin 
treatment (see section 4.5). 
 
Use with oral oestrogen therapy 
 
If a woman taking somatropin begins oral oestrogen therapy, the dose of somatropin may need to be 
increased to maintain the serum IGF-1 levels within the normal age-appropriate range. Conversely, if 
a woman on somatropin discontinues oral oestrogen therapy, the dose of somatropin may need to be 
reduced to avoid excess of growth hormone and/or side effects (see section 4.5). 
 
Insulin sensitivity 
 
Somatropin may reduce insulin sensitivity. For patients with diabetes mellitus, the insulin dose may 
require adjustment after somatropin therapy is instituted. Patients with diabetes, glucose intolerance, 
or additional risk factors for diabetes should be monitored closely during somatropin therapy.  
 
Thyroid function 
 
Growth hormone increases the extrathyroidal conversion of T4 to T3 which may result in a reduction 
in serum T4 and an increase in serum T3 concentrations. Whereas the peripheral thyroid hormone 
levels have remained within the reference ranges for healthy subjects, hypothyroidism theoretically 
may develop in subjects with subclinical hypothyroidism. Consequently monitoring of thyroid 
function should therefore be conducted in all patients. In patients with hypopituitarism on standard 
replacement therapy, the potential effect of growth hormone treatment on thyroid function must be 
closely monitored 
 
In growth hormone deficiency, secondary to treatment of malignant disease, it is recommended to pay 
attention to signs of relapse of the malignancy. In childhood cancer survivors, an increased risk of a 
second neoplasm has been reported in patients treated with somatropin after their first neoplasm. 
Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their 
first neoplasm, were the most common of these second neoplasms. 
 
In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the 
hip may occur more frequently than in the general population. Patients limping during treatment with 
somatropin should be examined clinically. 
 



62 

Benign intracranial hypertension 
 
In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for 
papilloedema is recommended. If papilloedema is confirmed, a diagnosis of benign intracranial 
hypertension should be considered and, if appropriate, the growth hormone treatment should be 
discontinued. At present there is insufficient evidence to give specific advice on the continuation of 
growth hormone treatment in patients with resolved intracranial hypertension. If growth hormone 
treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary. 
 
Leukaemia 
 
Leukaemia has been reported in a small number of growth hormone deficiency patients, some of 
whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is 
increased in growth hormone recipients without predisposition factors.  
 
Antibodies 
 
A small percentage of patients may develop antibodies to Omnitrope. Omnitrope has given rise to the 
formation of antibodies in approximately 1% of patients. The binding capacity of these antibodies is 
low and there is no effect on growth rate. Testing for antibodies to somatropin should be carried out in 
any patient with otherwise unexplained lack of response.  
 
Elderly patients 
Experience in patients above 80 years is limited. Elderly patients may be more sensitive to the action 
of Omnitrope, and therefore may be more prone to develop adverse reactions. 
 
Acute critical illness 
 
The effects of somatropin on recovery were studied in two placebo controlled trials involving 
522 critically ill adult patients suffering complications following open heart surgery, abdominal 
surgery, multiple accidental trauma or acute respiratory failure. Mortality was higher in patients 
treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%. 
Based on this information, these types of patients should not be treated with somatropin. As there is no 
information available on the safety of growth hormone substitution therapy in acutely critically ill 
patients, the benefits of continued treatment in this situation should be weighed against the potential 
risks involved. 
In all patients developing other or similar acute critical illness, the possible benefit of treatment with 
somatropin must be weighed against the potential risk involved. 
 
Paediatric population 
 
Pancreatitis  
 
Although rare, pancreatitis should be considered in somatropin-treated children who develop 
abdominal pain. 
 
Prader-Willi syndrome 
 
In patients with PWS, treatment should always be in combination with a calorie-restricted diet. 
 
There have been reports of fatalities associated with the use of growth hormone in paediatric patients 
with PWS who had one or more of the following risk factors: severe obesity (those patients exceeding 
a weight/height of 200%), history of respiratory impairment or sleep apnoea or unidentified 
respiratory infection. Patients with PWS and one or more of these risk factors may be at greater risk. 
 
Before initiation of treatment with somatropin patients with PWS should be evaluated for upper 
airway obstruction, sleep apnoea or respiratory infections should be assessed. 



63 

 
If during the evaluation of upper airway obstruction, pathological findings are observed, the child 
should be referred to an Ear, nose and throat (ENT) specialist for treatment and resolution of the 
respiratory disorder prior to initiating growth hormone treatment.  
 
Sleep apnoea should be assessed before onset of growth hormone treatment by recognised methods 
such as polysomnography or overnight oxymetry, and monitored if sleep apnoea is suspected. 
 
If during treatment with somatropin patients show signs of upper airway obstruction (including onset 
of or increased snoring), treatment should be interrupted, and a new ENT assessment performed. 
 
All patients with PWS should be evaluated for sleep apnoea and monitored if sleep apnoea is 
suspected.Patients should be monitored for signs of respiratory infections, which should be diagnosed 
as early as possible and treated aggressively. 
 
All patients with PWS should have effective weight control before and during growth hormone 
treatment. 
 
Scoliosis is common in patients with PWS. Scoliosis may progress in any child during rapid growth. 
Signs of scoliosis should be monitored during treatment.  
 
Experience with prolonged treatment in adults and in patients with PWS is limited. 
 
Small for gestational age 
 
In short children/adolescents born SGA, other medical reasons or treatments that could explain growth 
disturbance should be ruled out before starting treatment. 
 
In SGA children/adolescents it is recommended to measure fasting insulin and blood glucose before 
start of treatment and annually thereafter. In patients with increased risk for diabetes mellitus (e.g. 
familial history of diabetes, obesity, severe insulin resistance, acanthosis nigricans) oral glucose 
tolerance testing (OGTT) should be performed. If overt diabetes occurs, growth hormone should not 
be administered. 
 
In SGA children/adolescents it is recommended to measure the IGF-I level before start of treatment 
and twice a year thereafter. If on repeated measurements IGF-I levels exceed +2 SD compared to 
references for age and pubertal status, the IGF-I / IGFBP-3 ratio could be taken into account to 
consider dose adjustment. 
 
Experience in initiating treatment in SGA patients near onset of puberty is limited. It is therefore not 
recommended to initiate treatment near onset of puberty. Experience in patients with Silver-Russell 
syndrome is limited. 
 
Some of the height gain obtained with treating short children/adolescents born SGA with growth 
hormone may be lost if treatment is stopped before final height is reached. 
 
Chronic renal insufficiency 
 
In chronic renal insufficiency, renal function should be below 50 percent of normal before institution 
of therapy. To verify growth disturbance, growth should be followed for a year preceding institution of 
therapy. During this period, conservative treatment for renal insufficiency (which includes control of 
acidosis, hyperparathyroidism and nutritional status) should have been established and should be 
maintained during treatment. 
 
The treatment should be discontinued at renal transplantation. 
 



64 

To date, no data on final height in patients with chronic renal insufficiency treated with Omnitrope are 
available. 
 
Omnitrope 5 mg/1.5 ml solution for injection: 
Because of the presence of benzyl alcohol the medicinal product must not be given to premature 
babies or neonates. It may cause toxic reactions and anaphylactoid reactions in infants and children up 
to 3 years old. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of Omnitrope. 
Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully 
adjusted to avoid any inhibitory effect on growth. 
 
Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously 
undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective (see 
section 4.4). 
 
In women on oral oestrogen replacement, a higher dose of growth hormone may be required to 
achieve the treatment goal (see section 4.4). 
 
Data from an interaction study performed in growth hormone deficient adults suggests that somatropin 
administration may increase the clearance of compounds known to be metabolised by cytochrome 
P450 isoenzymes. The clearance of compounds metabolised by cytochrome P450 3A4 (e.g. sex 
steroids, corticosteroids, anticonvulsants and ciclosporin) may be especially increased resulting in 
lower plasma levels of these compounds. The clinical significance of this is unknown. 
 
Also see section 4.4 for statements regarding diabetes mellitus and thyroid disorder and section 4.2 for 
statement on oral oestrogen replacement therapy. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of somatropin in pregnant women. Animal studies 
are insufficient with respect to reproductive toxicity (see section 5.3). Somatropin is not recommended 
during pregnancy and in women of childbearing potential not using contraception. 
 
Breast-feeding 
 
There have been no clinical studies conducted with somatropin containing products in breast-feeding 
women. It is not known if somatropin is excreted into breast milk, but absorption of intact protein 
from the gastrointestinal tract of the infant is extremely unlikely. Therefore caution should be 
exercised when Omnitrope is administered to breast-feeding women. 
 
Fertility 
 
Fertility studies with Omnitrope have not been performed. 
 
4.7 Effects on ability to drive and use machines 
 
Omnitrope has no or negligible influence on the ability to drive and use machines. 
 



65 

4.8 Undesirable effects 
 
Summary of the safety profile 
 
Patients with growth hormone deficiency are characterised by extracellular volume deficit. When 
treatment with somatropin is started this deficit is rapidly corrected. In adult patients adverse reactions 
related to fluid retention, such as peripheral oedema, face oedema, musculoskeletal stiffness, 
arthralgia, myalgia and paraesthesia are common. In general these adverse reactions are mild to 
moderate, arise within the first months of treatment and subside spontaneously or with dose-reduction.  
 
The incidence of these adverse reactions is related to the administered dose, the age of patients, and 
possibly inversely related to the age of patients at the onset of growth hormone deficiency. In children 
such adverse reactions are uncommon.  
 
Omnitrope has given rise to the formation of antibodies in approximately 1% of the patients. The 
binding capacity of these antibodies has been low and no clinical changes have been associated with 
their formation, see section 4.4.  
 
Tabulated list of adverse reactions 
 
Tables 1–6 show the adverse reactions ranked under headings of System Organ Class and frequency 
using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon 
(≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be 
estimated from the available data) for each of the indicated conditions.  
 
Clinical trials in children with GHD 
 
Table 1 
 
Long-term treatment of children with growth disturbance due to insufficient secretion of growth 
hormone 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

  Leukaemia†    

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

     Paraesthesia* 
 
Benign 
intracranial 
hypertension 



66 

Skin and 
Subcutaneaous 
Tissues 
disorders 

  Rash** 

Pruritus** 

Urticaria** 

   

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

  Arthralgia*   Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

Injection 
site 
reaction$ 
 

    Oedema 
peripheral* 
Face oedema* 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 
Clinical trials in children with Turner syndrome 
 



67 

Table 2 
 
Long-term treatment of children with growth disturbance due to Turner syndrome 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

     Paraesthesia* 
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

     Rash** 

Pruritus** 

Urticaria** 
Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

Arthralgia*     Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

     Oedema 
peripheral* 
Face oedema* 
Injection site 
reaction$ 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



68 

Clinical trials in children with chronic renal insufficiency 
Table 3 
 
Long-term treatment of children with growth disturbance due to chronic renal insufficiency 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

     Paraesthesia* 
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

 Rash**    Puritus** 
 
Urticaria** 

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

     Arthralgia* 
 
Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

 Injection 
site 
reaction$ 

   Oedema 
peripheral* 
Face oedema* 

Investigations      Blood cortisol 
decreased‡ 

*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



69 

Clinical trials in children with SGA 
 
Table 4 
 
Long-term treatment of children with growth disturbance due to born small for gestational age 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
 
mellitus 

Nervous System 
Disorders 

     Paraesthesia*  
 
Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

 Rash** 
 
Urticaria** 

Puritus**    

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

  Arthralgia* 
 

  Myalgia* 
 
Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

 Injection 
site 
reaction$ 

   Oedema 
peripheral* 
Face oedema* 
 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



70 

Clinical trials in PWS 
 
Table 5 
 
Long-term treatment and improvement of body composition of children with growth 
disturbance due to Prader-Willi syndrome 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommon 
≥ 1/1,000 to 
<1/100 

Rare 
≥ 
1/10,000 
to 
<1/1,000 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Neoplasms 
Benign, 
Malignant and 
Unspecified 
(including cysts 
and polyps) 

     Leukaemia† 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

 Paraesthesia* 
Benign 
intracranial 
hypertension 

    

Skin and 
Subcutaneaous 
Tissues 
disorders 

 Rash**    Puritus** 
 
Urticaria** 

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

 Arthralgia* 
 
Myalgia* 

   Musculoskeletal 
stiffness* 

General 
Disorders and 
Administration 
Site Conditions 

 Oedema 
peripheral* 
 

   Face oedema* 
Injection site 
reaction$ 
 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to 
be similar to that in children without growth hormone deficiency. 
 



71 

Clinical trials in adults with GHD 
 
Table 6 
 
Replacement therapy in adults with growth hormone deficiency 
System Organ 
Class 

Very 
Common  
≥ 1/10 

Common 
≥ 1/100 to 
<1/10 

Uncommo
n 
≥ 1/1,000 
to <1/100 

Rare 
≥ 
1/10,00
0 to 
<1/1,00
0 

Very 
Rare 
<1/10,000 

Not Known 
(cannot be 
estimated from 
available data) 

Metabolism and 
Nutrition 
Disorders 

     Type 2 diabetes 
mellitus 

Nervous System 
Disorders 

 Paraesthe
sia* 
 
Carpal 
Tunnel 
Syndrome 

   Benign 
intracranial 
hypertension 

Skin and 
Subcutaneaous 
Tissues 
disorders 

     Rash** 
Puritus** 
Urticaria** 

Musculoskeletal, 
Connective 
Tissue and Bone 
Disorders 

Arthralgia* Myalgia* 
 
Musculos
keletal 
stiffness* 

    

General 
Disorders and 
Administration 
Site Conditions 

Oedema 
peripheral* 
 

    Face oedema* 
Injection site 
reaction$ 

Investigations      Blood cortisol 
decreased‡ 

 
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and 
subside spontaneously or with dose-reduction. The incidence of these adverse effects is related to the 
administered dose, the age of the patients, and possibly inversely related to the age of the patients at 
the onset of growth hormone deficiency. 
**Adverse drug reaction (ADR) identified post-marketing. 
 
$ Transient injection site reactions in children have been reported. 
 
‡ Clinical significance is unknown 
 
Description of selected adverse reactions 
 
Reduced serum cortisol levels 
 
Somatropin has been reported to reduce serum cortisol levels, possibly by affecting carrier proteins or 
by increased hepatic clearance. The clinical relevance of these findings may be limited. Nevertheless, 
corticosteroid replacement therapy should be optimised before initiation of therapy.  
 
Prader-Willi syndrome 
 



72 

In the post-marketing experience rare cases of sudden death have been reported in patients affected by 
Prader-Willi syndrome treated with somatropin, although no causal relationship has been 
demonstrated. 
 
Leukaemia 
 
Cases of leukaemia (rare or very rare) have been reported in growth hormone deficient children treated 
with somatropin and included in the post-marketing experience. However, there is no evidence of an 
increased risk of leukaemia without predisposition factors, such as radiation to the brain or head. 
 
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease 
 
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease have been reported in children 
treated with GH. Slipped capital femoral epiphysis occurs more frequently in case of endocrine 
disorders and Legg-Calvé-Perthes is more frequent in case of short stature. But it is unknown if these 
2 pathologies are more frequent or not while treated with somatropin. Their diagnosis should be 
considered in a child with a discomfort or pain in the hip or knee. 
 
Other adverse drug reactions 
 
Other adverse drug reactions may be considered somatropin class effects, such as possible 
hyperglycaemia caused by decreased insulin sensitivity, decreased free thyroxin level and benign 
intra-cranial hypertension. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms: 
Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia. 
 
Long-term overdose could result in signs and symptoms consistent with the known effects of human 
growth hormone excess. 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anterior pituitary lobe hormones and analogues, ATC code: H01AC01. 
 
Omnitrope is a biosimilar medicinal product. Detailed information is available on the website of the 
European Medicines Agency http://www.ema.europa.eu 
 
Mechanism of action 
 
Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates 
and proteins. In children with inadequate endogenous growth hormone, somatropin stimulates linear 
growth and increases growth rate. In adults as well as in children, somatropin maintains a normal body 
composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by 
mobilisation of body fat. Visceral adipose tissue is particularly responsive to somatropin. In addition 
to enhanced lipolysis, somatropin decreases the uptake of triglycerides into body fat stores. Serum 
concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor 



73 

Binding Protein 3) are increased by somatropin. In addition, the following actions have been 
demonstrated. 
 
Pharmacodynamic effects 
 
Lipid metabolism 
Somatropin induces hepatic LDL cholesterol receptors, and affects the profile of serum lipids and 
lipoproteins. In general, administration of somatropin to growth hormone deficient patients results in 
reduction in serum LDL and apolipoprotein B. A reduction in serum total cholesterol may also be 
observed. 
 
Carbohydrate metabolism 
Somatropin increases insulin but fasting blood glucose is commonly unchanged. Children with 
hypopituitarism may experience fasting hypoglycaemia. This condition is reversed by somatropin. 
 
Water and mineral metabolism 
Growth hormone deficiency is associated with decreased plasma and extracellular volumes. Both are 
rapidly increased after treatment with somatropin. Somatropin induces the retention of sodium, 
potassium and phosphorus. 
 
Bone metabolism 
Somatropin stimulates the turnover of skeletal bone. Long-term administration of somatropin to 
growth hormone deficient patients with osteopenia results in an increase in bone mineral content and 
density at weight-bearing sites. 
 
Physical capacity  
Muscle strength and physical exercise capacity are improved after long-term treatment with 
somatropin. Somatropin also increases cardiac output, but the mechanism has yet to be clarified. A 
decrease in peripheral vascular resistance may contribute to this effect. 
 
Clinical efficacy and safety 
 
In clinical trials in short children/adolescents born SGA doses of 0.033 and 0.067 mg/kg body weight 
per day have been used for treatment until final height is reached. In 56 patients who were 
continuously treated and have reached (near) final height, the mean change from height at start of 
treatment was +1.90 SDS (0.033 mg/kg body weight per day) and +2.19 SDS (0.067 mg/kg body 
weight per day). Literature data from untreated SGA children/adolescents without early spontaneous 
catch-up suggest a late growth of 0.5 SDS.  
 
5.2 Pharmacokinetic properties 
 
Absorption 
The bioavailability of subcutaneously administered somatropin is approximately 80% in both healthy 
subjects and growth hormone deficient patients.  
 
A subcutaneous dose of 5 mg of Omnitrope 5 mg/1.5 ml solution for injection in healthy adults results 
in plasma Cmax and tmax values of 72 ± 28 µg/l and 4.0 ± 2.0 hours, respectively. 
 
A subcutaneous dose of 5 mg of Omnitrope 10 mg/1.5 ml solution for injection in healthy adults 
results in plasma Cmax and tmax values of 74 ± 22 µg/l and 3.9 ± 1.2 hours, respectively. 
 
A subcutaneous dose of 5 mg of Omnitrope 15 mg/1.5 ml solution for injection in healthy adults 
results in plasma Cmax and tmax values of 52 ± 19 µg/l and 3.7 ± 1.2 hours, respectively. 
 
Elimination 
The mean terminal half-life of somatropin after intravenous administration in growth hormone 
deficient adults is about 0.4 hours. However, after subcutaneous administration of Omnitrope 



74 

5 mg/1.5 ml, Omnitrope 10 mg/1.5 ml solution for injection, a half-life of 3 hours is achieved. 
However, after subcutaneous administration of Omnitrope 15 mg/1.5 ml solution for injection, a half-
life of 2.76 hours is achieved. The observed difference is likely due to slow absorption from the 
injection site following subcutaneous administration. 
 
Special populations 
The absolute bioavailability of somatropin seems to be similar in males and females following 
subcutaneous administration. 
 
Information about the pharmacokinetics of somatropin in geriatric and paediatric populations, in 
different races and in patients with renal, hepatic or cardiac insufficiency is either lacking or 
incomplete. 
 
5.3 Preclinical safety data 
 
In studies with Omnitrope regarding subacute toxicity and local tolerance, no clinically relevant 
effects have been observed. 
 
In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity 
no clinically relevant effects have been observed. 
 
With somatropins, in vitro and in vivo genotoxicity studies on gene mutations and induction of 
chromosome aberrations have been negative. 
 
An increased chromosome fragility has been observed in one in vitro study on lymphocytes taken 
from patients after long term treatment with somatropin and following the addition of the 
radiomimetic drug bleomycin. The clinical significance of this finding is unclear. 
 
In another study with somatropin, no increase in chromosomal abnormalities was found in the 
lymphocytes of patients who had received long-term somatropin therapy. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Omnitrope 5 mg/1.5 ml solution for injection 
disodium hydrogen phosphate heptahydrate 
sodium dihydrogen phosphate dihydrate 
mannitol 
poloxamer 188 
benzyl alcohol 
water for injections 
 
Omnitrope 10 mg/1.5 ml solution for injection 
disodium hydrogen phosphate heptahydrate 
sodium dihydrogen phosphate dihydrate 
glycine 
poloxamer 188 
phenol 
water for injections 
 
Omnitrope 15 mg/1.5 ml solution for injection 
disodium hydrogen phosphate heptahydrate 
sodium dihydrogen phosphate dihydrate 
sodium chloride 
poloxamer 188 



75 

phenol 
water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
Omnitrope 5 mg/1.5 ml solution for injection 
2 years 
 
Omnitrope 10 mg/1.5 ml solution for injection 
18 months 
 
Omnitrope 15 mg/1.5 ml solution for injection 
18 months 
 
Shelf life after first use 
After first use the cartridge should remain in the pen and has to be kept in a refrigerator (2°C - 8°C) 
for a maximum of 28 days. Store and transport refrigerated (2°C - 8°C). Do not freeze. Store in the 
original pen in order to protect from light. 
 
6.4 Special precautions for storage 
 
Unopened cartridge 
Store and transport refrigerated (2°C - 8°C). Do not freeze. Store in the original package in order to 
protect from light. 
 
For storage conditions of the in-use medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
1.5 ml of solution in a cartridge (colourless type I glass) with plunger and a blue ring (for Omnitrope 
15 mg/1.5 ml solution for injection only) on one side (siliconised bromobutyl), a disc (bromobutyl) 
and a cap (aluminium) on the other side. The glass cartridge is irreversibly integrated in a transparent 
container and assembled to a plastic mechanism with a threaded rod at one extremity. 
Pack sizes of 1, 5 and 10. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Omnitrope 5 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous 
injection filled in a glass cartridge. 
 
This presentation is intended for multiple use. It should only be administered with SurePal 5, an 
injection device specifically developed for use with Omnitrope 5 mg/1.5 ml solution for injection. It 
has to be administered using sterile, disposable pen needles. Patients and caregivers have to receive 
appropriate training and instruction on the proper use of the Omnitrope cartridges and the pen from the 
physician or other suitable qualified health professionals. 
 
Omnitrope 10 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous 
injection filled in a glass cartridge. 
 
This presentation is intended for multiple use. It should only be administered with SurePal 10, an 
injection device specifically developed for use with Omnitrope 10 mg/1.5 ml solution for injection. It 



76 

has to be administered using sterile, disposable pen needles. Patients and caregivers have to receive 
appropriate training and instruction on the proper use of the Omnitrope cartridges and the pen from the 
physician or other suitable qualified health professionals. 
 
Omnitrope 15 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous 
injection filled in a glass cartridge. 
 
This presentation is intended for multiple use. It should only be administered with SurePal 15, an 
injection device specifically developed for use with Omnitrope 15 mg/1.5 ml solution for injection. It 
has to be administered using sterile, disposable pen needles. Patients and caregivers have to receive 
appropriate training and instruction on the proper use of the Omnitrope cartridges and the pen from the 
physician or other suitable qualified health professionals. 
 
The following is a general description of the administration process. The manufacturer’s instructions 
with each pen must be followed for loading the cartridge, attaching the injection needle and for the 
administration. 
 
1. Hands should be washed. 
2. If the solution is cloudy or contains particulate matter, it should not be used. The content must 

be clear and colourless. 
3. Disinfect the rubber membrane of the cartridge with a cleansing swab 
4. Insert the cartridge into SurePal following the instructions for use provided with the pen.  
5. Clean the site of injection with an alcohol swab. 
6. Administer the appropriate dose by subcutaneous injection using a sterile pen needle. Remove 

the pen needle and dispose of it in accordance with local requirements. 
 
Any unused product or waste material should be disposed of in accordance with local requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
Omnitrope 5 mg/1.5 ml solution for injection 
EU/1/06/332/013 
EU/1/06/332/014 
EU/1/06/332/015 
 
Omnitrope 10 mg/1.5 ml solution for injection 
EU/1/06/332/016 
EU/1/06/332/017 
EU/1/06/332/018 
 
Omnitrope 15 mg/1.5 ml solution for injection 
EU/1/06/332/010 
EU/1/06/332/011 
EU/1/06/332/012 
 
 



77 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 12 April 2006 
Date of latest renewal: 28 February 2011 
 
 
10. DATE OF REVISION OF THE TEXT 
 
<{MM/YYYY}>  



78 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX II 

 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 



79 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
Name and address of the manufacturer responsible for batch release 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6336 Langkampfen 
Austria 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 

 
The requirements for submission of PSUR for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT  
 
• Risk Management Plan (RMP) 

 
The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 
and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 
 

 
 



80 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 



81 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



82 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Omnitrope 1.3 mg/ml powder and solvent for solution for injection 
somatropin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Somatropin 1.3 mg (4 IU)/ml in a vial. After reconstitution, one vial contains 1.3 mg somatropin 
(corresponding to 4 IU) per ml. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: 
Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate 
Solvent: water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 vial of 1.3 mg powder 
1 vial of 1 ml solvent 
Pack size of 1 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
For single use only. Use only clear solution. 
Read package leaflet before use. 
Subcutaneous use after reconstitution 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
After reconstitution, use within 24 hours. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



83 

Store and transport refrigerated (2°C - 8°C).  
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER 
 
EU/1/06/332/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Omnitrope 1.3 mg/ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



84 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
OMNITROPE VIAL LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Omnitrope 1.3 mg/ml powder for solution for injection 
somatropin 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
For single use only. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
 
 



85 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SOLVENT VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Solvent for Omnitrope (water for injections) 
Subcutaneous use. 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
For single use only. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
 
 



86 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Omnitrope 5 mg/ml powder and solvent for solution for injection 
somatropin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Somatropin 5 mg (15 IU)/ml in a vial. After reconstitution, one cartridge contains 5 mg somatropin 
(corresponding to 15 IU) per ml. 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: 
Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate 
Solvent: benzyl alcohol, water for injections 
Contains benzyl alcohol. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 vial of 5 mg powder  
1 cartridge of 1 ml solvent 
5 vials of 5 mg powder 
5 cartridges of 1 ml solvent 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Use only clear solution. Use only with Omnitrope Pen L.  
Read package leaflet before use. 
Subcutaneous use after reconstitution 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
After reconstitution, use within 21 days. 
 
 



87 

9. SPECIAL STORAGE CONDITIONS 
 
Store and transport refrigerated (2°C - 8°C).  
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/06/332/002 
EU/1/06/332/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Omnitrope 5 mg/ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 



88 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
OMNITROPE VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Omnitrope 5 mg/ml powder for solution for injection 
somatropin 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
 
 



89 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SOLVENT CARTRIDGE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Solvent for Omnitrope (water for injections with 1.5% benzyl alcohol) 
Subcutaneous use. 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
 
 



90 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Omnitrope 5 mg/1.5 ml solution for injection in cartridge 
somatropin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Somatropin 3.3 mg (10 IU)/ml. 
One cartridge contains 1.5 ml corresponding to 5 mg somatropin (15 IU). 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate 
dihydrate, mannitol, poloxamer 188, benzyl alcohol, water for injections. 
Contains benzyl alcohol. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. 
1 cartridge  
5 cartridges  
10 cartridges  
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Use only clear solution. Use only with Omnitrope Pen 5.  
Read package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening, use within 28 days. 
 
 



91 

9. SPECIAL STORAGE CONDITIONS 
 
Store and transport refrigerated (2°C - 8°C).  
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/06/332/004 
EU/1/06/332/005 
EU/1/06/332/006 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Omnitrope 5 mg/1.5 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 



92 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
OMNITROPE CARTRIDGE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Omnitrope 5 mg/1.5 ml Injection in cartridge 
somatropin 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
 
 



93 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Omnitrope 10 mg/1.5 ml solution for injection in cartridge 
somatropin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Somatropin 6.7 mg (20 IU)/ml. 
One cartridge contains 1.5 ml corresponding to 10 mg somatropin (30 IU). 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate 
dihydrate, glycine, poloxamer 188, phenol, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. 
1 cartridge  
5 cartridges  
10 cartridges  
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Use only clear solution. Use only with Omnitrope Pen 10. 
Read package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening, use within 28 days. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



94 

Store and transport refrigerated (2°C - 8°C).  
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/06/332/007 
EU/1/06/332/008 
EU/1/06/332/009 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Omnitrope 10 mg/1.5 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 



95 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
OMNITROPE CARTRIDGE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Omnitrope 10 mg/1.5 ml Injection in cartridge 
somatropin 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
 
 



96 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Omnitrope 5 mg/1.5 ml solution for injection in cartridge 
somatropin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Somatropin 3.3 mg (10 IU)/ml. 
One cartridge contains 1.5 ml corresponding to 5 mg somatropin (15 IU). 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate 
dihydrate, mannitol, poloxamer 188, benzyl alcohol, water for injections. 
Contains benzyl alcohol. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. 
1 cartridge for SurePal 5 
5 cartridges for SurePal 5 
10 cartridges for SurePal 5 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Use only clear solution. Use only with SurePal 5.  
Read package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening, use within 28 days. 
 
 



97 

9. SPECIAL STORAGE CONDITIONS 
 
Store and transport refrigerated (2°C - 8°C).  
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/06/332/013 
EU/1/06/332/014 
EU/1/06/332/015 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Omnitrope 5 mg/1.5 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 



98 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
OMNITROPE CARTRIDGE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Omnitrope 5 mg/1.5 ml Injection in cartridge 
somatropin 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
 
 



99 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Omnitrope 10 mg/1.5 ml solution for injection in cartridge 
somatropin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Somatropin 6.7 mg (20 IU)/ml. 
One cartridge contains 1.5 ml corresponding to 10 mg somatropin (30 IU). 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate 
dihydrate, glycine, poloxamer 188, phenol, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. 
1 cartridge for SurePal 10 
5 cartridges for SurePal 10 
10 cartridges for SurePal 10 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Use only clear solution. Use only with SurePal 10. 
Read package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening, use within 28 days. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



100 

Store and transport refrigerated (2°C - 8°C).  
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/06/332/016 
EU/1/06/332/017 
EU/1/06/332/018 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Omnitrope 10 mg/1.5 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



101 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
OMNITROPE CARTRIDGE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Omnitrope 10 mg/1.5 ml Injection in cartridge 
somatropin 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
 
 



102 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Omnitrope 15 mg/1.5 ml solution for injection in cartridge 
somatropin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Somatropin 10 mg (30 IU)/ml. 
One cartridge contains 1.5 ml corresponding to 15 mg somatropin (45 IU). 
 
 
3. LIST OF EXCIPIENTS 
 
Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate 
dihydrate, sodium chloride, poloxamer 188, phenol, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. 
1 cartridge for SurePal 15 
5 cartridges for SurePal 15 
10 cartridges for SurePal 15 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Use only clear solution. Use only with SurePal 15. 
Read package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening, use within 28 days. 
 
 



103 

9. SPECIAL STORAGE CONDITIONS 
 
Store and transport refrigerated (2°C - 8°C).  
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/06/332/010 
EU/1/06/332/011 
EU/1/06/332/012 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Omnitrope 15 mg/1.5 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 



104 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
OMNITROPE CARTRIDGE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Omnitrope 15 mg/1.5 ml Injection in cartridge 
somatropin 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
 
 



105 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



106 

Package leaflet: Information for the user 
 

Omnitrope 1.3 mg/ml powder and solvent for solution for injection  
 

somatropin 
 

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 

What is in this leaflet:  
1. What Omnitrope is and what it is used for 
2. What you need to know before you use Omnitrope 
3. How to use Omnitrope 
4. Possible side effects 
5. How to store Omnitrope 
6. Contents of the pack and other information 

 
 
1. What Omnitrope is and what it is used for  
 
Omnitrope is a recombinant human growth hormone (also called somatropin). It has the same structure 
as natural human growth hormone which is needed for bones and muscles to grow. It also helps your 
fat and muscle tissues to develop in the right amounts. It is recombinant meaning it is not made from 
human or animal tissue. 
 
In children Omnitrope is used to treat the following growth disturbances: 
• If you are not growing properly and you do not have enough of your own growth hormone.  
• If you have Turner syndrome. Turner syndrome is a genetic disorder in girls that can affect 

growth – your doctor will have told you if you have this. 
• If you have chronic renal (kidney) insufficiency. As kidneys lose their ability to function 

normally, this can affect growth. 
• If you were small or too light at birth. Growth hormone can help you grow taller if you have not 

been able to catch up or maintain normal growth by 4 years of age or later. 
• If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help you 

grow taller if you are still growing, and will also improve your body composition. Your 
excessive fat will decrease and your reduced muscle mass will improve. 
 

In adults Omnitrope is used to 
• treat persons with pronounced growth hormone deficiency. This can start during either adult life 

or it can continue from childhood. 
If you have been treated with Omnitrope for growth hormone deficiency during childhood, your 
growth hormone status will be retested after completion of growth. If severe growth hormone 
deficiency is confirmed, your doctor will propose continuation of Omnitrope treatment. 
 

You should only be given this medicine by a doctor who has experience with growth hormone 
treatment and who has confirmed your diagnosis. 
 
 



107 

2. What you need to know before you use Omnitrope 
 
Do not use Omnitrope 
• if you are allergic (hypersensitive) to somatropin or to any of the other ingredients of 

Omnitrope. 
• and tell your doctor if you have an active tumour (cancer). Tumours must be inactive and you 

must have finished your anti-tumour treatment before you start your treatment with Omnitrope. 
• and tell your doctor if Omnitrope has been prescribed to stimulate growth but you have already 

stopped growing (closed epiphyses). 
• if you are seriously ill (for example, complications following open heart surgery, abdominal 

surgery, accidental trauma, acute respiratory failure, or similar conditions). If you are about to 
have, or have had, a major operation, or go into hospital for any reason, tell your doctor and 
remind the other doctors you are seeing that you use growth hormone. 

 
Warnings and precautions 
 
Talk to your doctor before using Omnitrope. 
• If you have a replacement therapy with glucocorticoids, you should consult your doctor 

regularly, as you may need adjustment of your glucocorticoid dose. 
• If you are at risk of developing diabetes, your doctor will need to monitor your blood sugar 

level during therapy with somatropin. 
• If you have diabetes, you should closely monitor your blood sugar level during treatment with 

somatropin and discuss the results with your doctor to determine whether you need to change 
the dose of your medicines to treat diabetes. 

• After starting somatropin treatment some patients may need to start thyroid hormone 
replacement. 

• If you are receiving treatment with thyroid hormones it may become necessary to adjust your 
thyroid hormone dose. 

• If you have raised intracranial pressure (which causes symptoms, such as strong headache, 
visual disturbances or vomiting) you should inform your doctor about it. 

• If you walk with a limp or if you start to limp during your growth hormone treatment, you 
should inform your doctor. 

• If you are receiving somatropin for growth hormone deficiency following a previous tumour 
(cancer), you should be examined regularly for recurrence of the tumour or any other cancer. 

• If you experience worsening abdominal pain you should inform your doctor. 
• Experience in patients above 80 years is limited. Elderly persons may be more sensitive to the 

action of somatropin, and therefore may be more prone to develop side effects. 
 

Children with chronic renal (kidney) insufficiency  
• Your doctor should examine your kidney function and your growth rate before starting 

somatropin. Medical treatment for your kidney should be continued. Somatropin treatment 
should be stopped at kidney transplantation. 
 

Children with Prader-Willi syndrome  
• Your doctor will give you diet restrictions to follow to control your weight. 
• Your doctor will assess you for signs of upper airway obstruction, sleep apnoea (where your 

breathing is interrupted during sleep), or respiratory infection before you start treatment with 
somatropin. 

• During treatment with somatropin, tell your doctor if you show signs of upper airway 
obstruction (including starting to snore or worsening of snoring), your doctor will need to 
examine you and may interrupt treatment with somatropin. 

• During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity. 
• During treatment, if you develop a lung infection, tell your doctor so that he can treat the 

infection. 
 



108 

Children born small or too light at birth 
• If you were too small or too light at birth and are aged between 9 and 12 years, ask your doctor 

for specific advice relating to puberty and treatment with this medicine. 
• Treatment should be continued until you have stopped growing. 
• Your doctor will check your blood sugar and insulin levels before the start of treatment and 

every year during treatment. 
 

Other medicines and Omnitrope 
 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
In particular, inform your doctor if you are taking or have recently taken any of the following 
medicines. Your doctor may need to adjust the dose of Omnitrope or of the other medicines: 
 
• medicine to treat diabetes,  
• thyroid hormones, 
• medicines to control epilepsy (anticonvulsants),  
• ciclosporin (a medicine that weakens the immune system after transplantation), 
• oestrogen taken orally or other sex hormones,  
• synthetic adrenal hormones (corticosteroids).  
Your doctor may need to adjust the dose of these medicines or the dose of somatropin. 
 
Pregnancy and breast-feeding 
 
You should not use Omnitrope if you are pregnant or trying to become pregnant. 
 
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Important information about some of the ingredients of Omnitrope 
 
This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium- free’. 
 
 
3. How to use Omnitrope 
 
Always use this medicine exactly as your doctor or pharmacist or nurse has told you. Check with your 
doctor, nurse or pharmacist if you are not sure. 
The dose depends on your size, the condition for which you are being treated and how well growth 
hormone works for you. Everyone is different. Your doctor will advise you about your individualised 
dose of Omnitrope in milligrams (mg) from either your body weight in kilograms (kg) or your body 
surface area calculated from your height and weight in square metres (m2), as well as your treatment 
schedule. Do not change the dosage and treatment schedule without consulting your doctor.  
 
The recommended dose is for:  
 
Children with growth hormone deficiency:  
0.025–0.035 mg/kg body weight per day or 0.7–1.0 mg/m2 body surface area per day. Higher doses 
can be used. When growth hormone deficiency continues into adolescence, Omnitrope should be 
continued until completion of physical development.  
 
Children with Turner syndrome:  
0.045–0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.  
 



109 

Children with chronic renal (kidney) insufficiency:  
0.045–0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day. Higher doses may be 
necessary if the rate of growth is too low. Dosage adjustment may be necessary after 6 months of 
treatment.  
 
Children with Prader-Willi syndrome:  
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. The daily dosage should 
not exceed 2.7 mg. Treatment should not be used in children who have almost stopped growing after 
puberty.  
 
Children born smaller or lighter than expected and with growth disturbance:  
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. It is important to continue 
treatment until final height is reached. Treatment should be discontinued after the first year if you are 
not responding or if you have reached your final height and stopped growing.  
 
Adults with growth hormone deficiency:  
If you continue Omnitrope after treatment during childhood you should start with 0.2–0.5 mg per day. 
This dosage should be gradually increased or decreased according to blood test results as well as 
clinical response and side effects. 
 
If your growth hormone deficiency starts during adult life you should start with 0.15–0.3 mg per day. 
This dosage should be gradually increased according to blood test results as well as clinical response 
and side effects. The daily maintenance dose seldom exceeds 1.0 mg per day. Women may require 
higher doses than men. Dosage should be monitored every 6 months. Persons above 60 years should 
start with a dose of 0.1–0.2 mg per day which should be slowly increased according to individual 
requirements. The minimum effective dose should be used. The maintenance dose seldom exceeds 0.5 
mg per day. Follow the instructions given to you by your doctor. 
 
Injecting Omnitrope 
 
Inject your growth hormone at about the same time every day. Bedtime is a good time because it is 
easy to remember. It is also natural to have a higher level of growth hormone at night. 
 
Omnitrope is intended for subcutaneous use. This means that it is injected through a short injection 
needle into the fatty tissue just under your skin. Most people do their injections into their thigh or their 
bottom. Do your injection in the place you have been shown by your doctor. Fatty tissue of the skin 
can shrink at the site of injection. To avoid this, use a slightly different place for your injection each 
time. This gives your skin and the area under your skin time to recover from one injection before it 
gets another one in the same place. 
 
Your doctor should have already shown you how to use Omnitrope. Always inject Omnitrope exactly 
as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.  
 
How to inject Omnitrope 1.3 mg/ml 
 
The following instructions explain how to inject Omnitrope 1.3 mg/ml yourself. Please read the 
instructions carefully and follow them step by step. Your doctor will show you how to inject 
Omnitrope. Do not attempt to inject unless you are sure you understand the procedure and 
requirements for the injection. 
 
- After reconstitution, Omnitrope is given as an injection under the skin.  
- Carefully inspect the solution before injecting it and use only if clear and colourless. 
- Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty 

tissue under the skin). 
 

 



110 

Preparation  
Collect necessary items before you begin: 

 

- a vial with Omnitrope 1.3 mg/ml powder for solution for injection. 
- a vial with solvent (liquid) for Omnitrope 1.3 mg/ml. 
- a sterile, disposable syringe (e.g. 2 ml syringe) and needle (e.g. 

0.33 mm x 12.7 mm) for withdrawing the solvent from the vial (not 
supplied in the pack). 

- a sterile, disposable syringe of appropriate size (e.g. 1 ml syringe) 
and injection needle (e.g. 0.25 mm x 8 mm) for subcutaneous 
injection (not supplied in the pack). 

 

- 2 cleansing swabs (not supplied in the pack).  
  
Wash your hands before you continue with the next steps.  
  
Reconstituting Omnitrope  
- Remove the protective caps from the two vials in the box. With a 

cleansing swab, disinfect the rubber membranes of both the 
powder-filled and the solvent-filled vial. 

 
- Take the vial with solvent and the sterile, disposable syringe (e.g. 

2 ml syringe) and needle (e.g. 0.33 mm x 12.7 mm). Push the 
needle fitted to the syringe through the rubber membrane. 

 
- Turn the vial with the solvent upside down and withdraw all the 

solvent from the vial. 

 
- Take the vial with the powder and push the needle through the 

rubber membrane of the vial. Inject the solvent slowly. Aim the 
stream of liquid against the glass wall in order to avoid foam. 
Remove the syringe and needle.  

- Gently swirl the reconstituted vial until the content is completely 
dissolved. Do not shake. 

 
- If the solution is cloudy (and the cloudiness does not disappear 

within ten minutes) or contains particles, it should not be used. The 
contents must be clear and colourless. 

 

 

- Use the solution immediately.  
  
Measuring the dose of Omnitrope to be injected  
- Take the sterile, disposable syringe of appropriate size (e.g. 1 ml 

syringe) and injection needle (e.g. 0.25 mm x 8 mm). 
 

- Push the needle through the rubber stopper of the vial with the 
reconstituted solution. 

 

- Turn the vial and the syringe upside down in one hand. 

 
- Be sure that the tip of the syringe is in the Omnitrope reconstituted 

solution. Your other hand will be free to move the plunger. 
 

- Pull back on the plunger slowly and withdraw just a bit more than 
the dose prescribed by your doctor into the syringe. 

 

- Hold the syringe with the needle in the vial pointing up and remove 
the syringe from the vial. 

 

- Check for air bubbles in the syringe. If you see any bubbles, pull 
the plunger slightly back; tap the syringe gently, with the needle 
pointing upwards, until the bubbles disappear. Push up the plunger 

 



111 

slowly back to the correct dose. 
- Inspect the reconstituted solution visually prior to administration.  

Do not use if the solution is cloudy or contains particles. You 
are now ready to inject the dose.  

 

  
Injecting Omnitrope  
- Select the site of injection. The best sites for injection are tissues 

with a layer of fat between skin and muscle, such as the thigh or 
belly (except the navel or waistline). 

 

- Make sure you inject at least 1 cm from your last injection site and 
that you change the places where you inject, as you have been 
taught. 

 

- Before you make an injection, clean your skin well with an alcohol 
swab. Wait for the area to dry. 

 
- With one hand, pitch a fold of loose skin. With your other hand, 

hold the syringe as you would a pencil. Insert the needle into the 
pinched skin at an angle of 45° to 90°. After the needle is in, 
remove the hand used to pinch the skin and use it to hold the 
syringe barrel. Pull back the plunger very slightly with one hand. If 
blood comes into the syringe, the needle has entered a blood vessel. 
Do not inject into this site; withdraw the needle and repeat this step. 
Inject the solution by pushing the plunger all the way down gently. 

 

- Pull the needle straight out of the skin.   
  
After injecting  
- After injection, press the injection site with a small bandage or 

sterile gauze for several seconds. Do not massage the injection site. 
 

- The residual solution, vials, and injection materials intended for 
single use must be discarded. Dispose of the syringes safely in a 
closed container. 

 

 
If you use more Omnitrope than you should 
 
If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your 
blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or 
“not yourself”, and you might faint. 
 
If you forget to use Omnitrope 
 
Do not use a double dose to make up for a forgotten dose. It is best to use your growth hormone 
regularly. If you forget to use a dose, have your next injection at the usual time the next day. Keep a 
note of any missed injections and tell your doctor at your next check-up. 
 
If you stop using Omnitrope 
 
Ask for advice from your doctor before you stop using Omnitrope. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. The very 
common and common side effects in adults may start within the first months of treatment and may 
either stop spontaneously or if your dose is reduced. 
 



112 

Very common side effects (may affect more than 1 in 10 people) include: 
 
In adults 
• Joint pain 
• Water retention (which shows as puffy fingers or swollen ankles) 
 
Common side effects (may affect up to 1 in 10 people) include: 
 
In children 
• Temporary reddening, itchiness or pain at the injection site 
• Joint pain 
• Rash 
• Raised itchy bumps on the skin. 

 
In adults 
• Numbness/tingling 
• Stiffness in the arms and legs, muscle pain 
• Pain or burning sensation in the hands or underarms (known as Carpal Tunnel syndrome) 

 
Uncommon side effects (may affect up to 1 in 100 people) include: 
 
In children 
• Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of 

treatment) 
• Itching 
 
Rare side effects (may affect up to 1 in 1,000 people) include: 
 
In children 
• Numbness/tingling 
• Leukaemia (This has been reported in a small number of growth hormone deficiency patients, 

some of whom have been treated with somatropin. However, there is no evidence that 
leukaemia incidence is increased in growth hormone recipients without predisposing factors.) 

• Increased intracranial pressure (which causes symptoms, such as strong headache, visual 
disturbances or vomiting) 

• Muscle pain 
 

Not known (frequency cannot be estimated from the available data): 
 
• Type 2 diabetes 
• A decrease in the levels of the hormone Cortisol in your blood 
• Facial swelling 

 
In children 
• Stiffness in the arms and legs 

 
In adults 
• Increased intracranial pressure (which causes symptoms such as strong headache, visual 

disturbances or vomiting) 
• Reddening, itchiness or pain at the injection site 
• Rash 
• Itching 
• Raised itchy bumps on the skin. 
 

 



113 

Formation of antibodies to the injected growth hormone but these do not seem to stop the growth 
hormone from working. 
 
The skin around the injection area can get uneven or lumpy, but this should not happen if you inject in 
a different place each time. 
 
There have been rare cases of sudden death in patients with Prader-Willi syndrome. However, no link 
has been made between these cases and treatment with Omnitrope. 
 
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease may be considered by your doctor if 
discomfort or pain in the hip or knee is experienced whilst being treated with Omnitrope. 
 
Other possible side effects related to your treatment with growth hormone may include the following: 
 
You (or your child) may experience a high blood sugar or reduced levels of thyroid hormone. This can 
be tested by your doctor and if necessary your doctor will prescribe the adequate treatment. Rarely, an 
inflammation of the pancreas has been reported in patients treated with growth hormone. 
 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Omnitrope 
 
Keep out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 
expiry date refers to the last day of that month. 
• Store and transport refrigerated (2°C–8°C). 
• Do not freeze. 
• Store in the original package in order to protect from light. 
• After reconstitution, from a microbiological point of view, the product should be used 

immediately. However, the in-use stability has been demonstrated for up to 24 hours at 2°C–
8°C in the original package. 

• For single use only. 
Do not use Omnitrope if you notice that the solution is cloudy. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Omnitrope contains 
 
The active substance of Omnitrope is somatropin.  
One vial contains 1.3 mg (corresponding to 4 IU) of somatropin after reconstitution with 1 ml solvent. 
 
The other ingredients are: 
Powder: 
 glycine 
 disodium hydrogen phosphate heptyhydrate 



114 

 sodium dihydrogen phosphate dihydrate 
 
Solvent: 
 water for injections 
 
What Omnitrope looks like and contents of the pack 
 
Powder and solvent for solution for injection (powder in a vial (1.3 mg), solvent in a vial (1 ml)). 
Pack size of 1. 
The powder is white and the solvent is a clear, colourless solution. 
 
Marketing Authorisation Holder  
 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Austria 
 
Manufacturer 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6336 Langkampfen 
Austria 
 
This leaflet was last revised in {MM/YYYY} 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 



115 

Package leaflet: Information for the user 
 

Omnitrope 5 mg/ml powder and solvent for solution for injection  
 

somatropin 
 

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 

What is in this leaflet:  
1. What Omnitrope is and what it is used for 
2. What you need to know before you use Omnitrope 
3. How to use Omnitrope 
4. Possible side effects 
5. How to store Omnitrope 
6. Contents of the pack and other information 

 
 
1. What Omnitrope is and what it is used for  
 
Omnitrope is a recombinant human growth hormone (also called somatropin). It has the same structure 
as natural human growth hormone which is needed for bones and muscles to grow. It also helps your 
fat and muscle tissues to develop in the right amounts. It is recombinant meaning it is not made from 
human or animal tissue. 
 
In children Omnitrope is used to treat the following growth disturbances: 
• If you are not growing properly and you do not have enough of your own growth hormone.  
• If you have Turner syndrome. Turner syndrome is a genetic disorder in girls that can affect 

growth – your doctor will have told you if you have this. 
• If you have chronic renal (kidney) insufficiency. As kidneys lose their ability to function 

normally, this can affect growth. 
• If you were small or too light at birth. Growth hormone can help you grow taller if you have not 

been able to catch up or maintain normal growth by 4 years of age or later. 
• If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help you 

grow taller if you are still growing, and will also improve your body composition. Your 
excessive fat will decrease and your reduced muscle mass will improve. 
 

In adults Omnitrope is used to 
• treat persons with pronounced growth hormone deficiency. This can start during either adult life 

or it can continue from childhood. 
If you have been treated with Omnitrope for growth hormone deficiency during childhood, your 
growth hormone status will be retested after completion of growth. If severe growth hormone 
deficiency is confirmed, your doctor will propose continuation of Omnitrope treatment. 
 

You should only be given this medicine by a doctor who has experience with growth hormone 
treatment and who has confirmed your diagnosis. 
 
 



116 

2. What you need to know before you use Omnitrope 
 
Do not use Omnitrope 
• if you are allergic (hypersensitive) to somatropin or to any of the other ingredients of 

Omnitrope. 
• and tell your doctor if you have an active tumour (cancer). Tumours must be inactive and you 

must have finished your anti-tumour treatment before you start your treatment with Omnitrope. 
• and tell your doctor if Omnitrope has been prescribed to stimulate growth but you have already 

stopped growing (closed epiphyses). 
• if you are seriously ill (for example, complications following open heart surgery, abdominal 

surgery, accidental trauma, acute respiratory failure, or similar conditions). If you are about to 
have, or have had, a major operation, or go into hospital for any reason, tell your doctor and 
remind the other doctors you are seeing that you use growth hormone. 
 

Warnings and precautions 
 
Talk to your doctor before using Omnitrope. 
• If you have a replacement therapy with glucocorticoids, you should consult your doctor 

regularly, as you may need adjustment of your glucocorticoid dose. 
• If you are at risk of developing diabetes, your doctor will need to monitor your blood sugar 

level during therapy with somatropin. 
• If you have diabetes, you should closely monitor your blood sugar level during treatment with 

somatropin and discuss the results with your doctor to determine whether you need to change 
the dose of your medicines to treat diabetes. 

• After starting somatropin treatment some patients may need to start thyroid hormone 
replacement. 

• If you are receiving treatment with thyroid hormones it may become necessary to adjust your 
thyroid hormone dose. 

• If you have raised intracranial pressure (which causes symptoms, such as strong headache, 
visual disturbances or vomiting) you should inform your doctor about it. 

• If you walk with a limp or if you start to limp during your growth hormone treatment, you 
should inform your doctor. 

• If you are receiving somatropin for growth hormone deficiency following a previous tumour 
(cancer), you should be examined regularly for recurrence of the tumour or any other cancer. 

• If you experience worsening abdominal pain you should inform your doctor. 
• Experience in patients above 80 years is limited. Elderly persons may be more sensitive to the 

action of somatropin, and therefore may be more prone to develop side effects. 
 

Children with chronic renal (kidney) insufficiency  
• Your doctor should examine your kidney function and your growth rate before starting 

somatropin. Medical treatment for your kidney should be continued. Somatropin treatment 
should be stopped at kidney transplantation. 
 

Children with Prader-Willi syndrome  
• Your doctor will give you diet restrictions to follow to control your weight. 
• Your doctor will assess you for signs of upper airway obstruction, sleep apnoea (where your 

breathing is interrupted during sleep), or respiratory infection before you start treatment with 
somatropin. 

• During treatment with somatropin, tell your doctor if you show signs of upper airway 
obstruction (including starting to snore or worsening of snoring), your doctor will need to 
examine you and may interrupt treatment with somatropin. 

• During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity. 
• During treatment, if you develop a lung infection, tell your doctor so that he can treat the 

infection. 
 



117 

Children born small or too light at birth 
• If you were too small or too light at birth and are aged between 9 and 12 years, ask your doctor 

for specific advice relating to puberty and treatment with this medicine. 
• Treatment should be continued until you have stopped growing. 
• Your doctor will check your blood sugar and insulin levels before the start of treatment and 

every year during treatment. 
 
Other medicines and Omnitrope 
 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
In particular, inform your doctor if you are taking or have recently taken any of the following 
medicines. Your doctor may need to adjust the dose of Omnitrope or of the other medicines: 
 
• medicine to treat diabetes,  
• thyroid hormones, 
• medicines to control epilepsy (anticonvulsants),  
• ciclosporin (a medicine that weakens the immune system after transplantation), 
• oestrogen taken orally or other sex hormones,  
• synthetic adrenal hormones (corticosteroids).  
Your doctor may need to adjust the dose of these medicines or the dose of somatropin. 
 
Pregnancy and breast-feeding 
 
You should not use Omnitrope if you are pregnant or trying to become pregnant. 
 
Ask your doctor or pharmacist for advice if you are pregnant or breast‑feeding. This is because benzyl 
alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). 
 
Important information about some of the ingredients of Omnitrope 
 
This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium- free’. 
 
After reconstitution this medicine contains 15 mg benzyl alcohol in each ml. 
Benzyl alcohol may cause allergic reactions.  
 
Benzyl alcohol has been linked with the risk of severe side effects including breathing problems 
(called “gasping syndrome”) in young children. 
 
Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor. 
 
Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because 
large amounts of benzyl alcohol can build-up in your body and may cause side effects (called 
“metabolic acidosis”).  
 
Because of the presence of benzyl alcohol the medicinal product must not be given to premature 
babies or neonates. It may cause toxic reactions and allergic reactions in infants and children up to 
3 years old. 
 
Do not use for more than a week in young children (less than 3 years old), unless advised by your 
doctor or pharmacist. 
 
 



118 

3. How to use Omnitrope 
 
Always use this medicine exactly as your doctor or pharmacist or nurse has told you. Check with your 
doctor, nurse or pharmacist if you are not sure. 
The dose depends on your size, the condition for which you are being treated and how well growth 
hormone works for you. Everyone is different. Your doctor will advise you about your individualised 
dose of Omnitrope in milligrams (mg) from either your body weight in kilograms (kg) or your body 
surface area calculated from your height and weight in square metres (m2), as well as your treatment 
schedule. Do not change the dosage and treatment schedule without consulting your doctor.  
 
The recommended dose is for:  
 
Children with growth hormone deficiency:  
0.025–0.035 mg/kg body weight per day or 0.7–1.0 mg/m2 body surface area per day. Higher doses 
can be used. When growth hormone deficiency continues into adolescence, Omnitrope should be 
continued until completion of physical development.  
 
Children with Turner syndrome:  
0.045–0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.  
 
Children with chronic renal (kidney) insufficiency:  
0.045–0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day. Higher doses may be 
necessary if the rate of growth is too low. Dosage adjustment may be necessary after 6 months of 
treatment.  
 
Children with Prader-Willi syndrome:  
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. The daily dosage should 
not exceed 2.7 mg. Treatment should not be used in children who have almost stopped growing after 
puberty.  
 
Children born smaller or lighter than expected and with growth disturbance:  
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. It is important to continue 
treatment until final height is reached. Treatment should be discontinued after the first year if you are 
not responding or if you have reached your final height and stopped growing.  
 
Adults with growth hormone deficiency:  
If you continue Omnitrope after treatment during childhood you should start with 0.2–0.5 mg per day. 
This dosage should be gradually increased or decreased according to blood test results as well as 
clinical response and side effects. 
 
If your growth hormone deficiency starts during adult life you should start with 0.15–0.3 mg per day. 
This dosage should be gradually increased according to blood test results as well as clinical response 
and side effects. The daily maintenance dose seldom exceeds 1.0 mg per day. Women may require 
higher doses than men. Dosage should be monitored every 6 months. Persons above 60 years should 
start with a dose of 0.1–0.2 mg per day which should be slowly increased according to individual 
requirements. The minimum effective dose should be used. The maintenance dose seldom exceeds 0.5 
mg per day. Follow the instructions given to you by your doctor. 
 
Injecting Omnitrope 
 
Inject your growth hormone at about the same time every day. Bedtime is a good time because it is 
easy to remember. It is also natural to have a higher level of growth hormone at night. 
 
Omnitrope 5 mg/ml is intended for multiple use. It should only be administered with the Omnitrope 
Pen L, an injection device specifically developed for use with Omnitrope 5 mg/ml powder and solvent 
for solution for injection. 
 



119 

Omnitrope is intended for subcutaneous use. This means that it is injected through a short injection 
needle into the fatty tissue just under your skin. Most people do their injections into their thigh or their 
bottom. Do your injection in the place you have been shown by your doctor. Fatty tissue of the skin 
can shrink at the site of injection. To avoid this, use a slightly different place for your injection each 
time. This gives your skin and the area under your skin time to recover from one injection before it 
gets another one in the same place. 
 
Your doctor should have already shown you how to use Omnitrope. Always inject Omnitrope exactly 
as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.  
 
How to inject Omnitrope 5 mg/ml 
 
The following instructions explain how to inject Omnitrope 5 mg/ml yourself. Please read the 
instructions carefully and follow them step by step. Your doctor will show you how to inject 
Omnitrope. Do not attempt to inject unless you are sure you understand the procedure and 
requirements for the injection. 
 
- After reconstitution, Omnitrope is given as an injection under the skin.  
- Carefully inspect the solution before injecting it and use only if clear and colourless. 
- Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty 

tissue under the skin). 
 
Preparation  
Collect necessary items before you begin: 

 

- a vial with Omnitrope 5 mg/ml powder for solution for injection. 
- a cartridge with solvent for Omnitrope 5 mg/ml. 
- a transfer set for mixing and transferring the reconstituted solution 

back into the cartridge (see Instructions for Use of the pen injector). 
- the Omnitrope Pen L, an injection device specifically developed for 

use with Omnitrope 5 mg/ml reconstituted solution for injection 
(not supplied in the pack; see Instructions for Use of the transfer set 
and of the injection device). 

 

- a pen needle for subcutaneous injection.  
- 2 cleansing swabs (not supplied in the pack).  
  
Wash your hands before you continue with the next steps.  
  
Reconstituting Omnitrope  
- Remove the protective cap from the vial. With a cleansing swab, 

disinfect both the rubber membrane of the vial with powder and the 
rubber membrane of the cartridge with solvent. 

 
- Use the transfer set for transferring all the solvent from the 

cartridge into the vial. Follow the instructions that come with the 
transfer set. 

 

- Gently swirl the reconstituted vial until the content is completely 
dissolved. Do not shake 

 

- If the solution is cloudy (and the cloudiness does not disappear 
within ten minutes) or contains particles, it should not be used. The 
contents must be clear and colourless.  

 

- Transfer all of the dissolved solution back into the cartridge using 
the transfer set. 

 

  
Injecting Omnitrope  
- Put the cartridge with the dissolved Omnitrope into the pen for 

injection. Follow the Instructions for Use of the pen injector. To 
setup the pen dial the dose. 

 



120 

- Eliminate any air bubbles.  
- Select the site of injection. The best sites for injection are tissues 

with a layer of fat between skin and muscle, such as the thigh or 
belly (except the navel or waistline). 

 

- Make sure you inject at least 1 cm from your last injection site and 
that you change the places where you inject, as you have been 
taught. 

 

- Before you make an injection, clean your skin well with an alcohol 
swab. Wait for the area to dry. 

 
- Insert the needle into the skin in the way your doctor has taught 

you.  
 

  
After injecting  
- After injection, press the injection site with a small bandage or 

sterile gauze for several seconds. Do not massage the injection site. 
 

- Take the needle off the pen using the outer needle cap, and discard 
the needle. This will keep the Omnitrope solution sterile and 
prevent leaking. It will also stop air going back into the pen and the 
needle clogging up. Do not share your needles. Do not share your 
pen. 

 

- Leave the cartridge in the pen, put the cap on the pen, and store it in 
the refrigerator. 

 

- The solution should be clear after removal from the refrigerator. Do 
not use if the solution is cloudy or contains particles.  

 

 
If you use more Omnitrope than you should 
 
If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your 
blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or 
“not yourself”, and you might faint. 
 
If you forget to use Omnitrope 
 
Do not use a double dose to make up for a forgotten dose. It is best to use your growth hormone 
regularly. If you forget to use a dose, have your next injection at the usual time the next day. Keep a 
note of any missed injections and tell your doctor at your next check-up. 
 
If you stop using Omnitrope 
 
Ask for advice from your doctor before you stop using Omnitrope. 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. The very 
common and common side effects in adults may start within the first months of treatment and may 
either stop spontaneously or if your dose is reduced. 
 
Very common side effects (may affect more than 1 in 10 people) include: 
 
In adults 
• Joint pain 
• Water retention (which shows as puffy fingers or swollen ankles) 

 



121 

Common side effects (may affect up to 1 in 10 people) include: 
 
In children 
• Temporary reddening, itchiness or pain at the injection site 
• Joint pain 
• Rash 
• Raised itchy bumps on the skin. 

 
In adults 
• Numbness/tingling 
• Stiffness in the arms and legs, muscle pain 
• Pain or burning sensation in the hands or underarms (known as Carpal Tunnel syndrome) 

 
Uncommon side effects (may affect up to 1 in 100 people) include: 
 
In children 
• Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of 

treatment) 
• Itching 

 
Rare side effects (may affect up to 1 in 1,000 people) include: 
 
In children 
• Numbness/tingling 
• Leukaemia (This has been reported in a small number of growth hormone deficiency patients, 

some of whom have been treated with somatropin. However, there is no evidence that 
leukaemia incidence is increased in growth hormone recipients without predisposing factors.) 

• Increased intracranial pressure (which causes symptoms, such as strong headache, visual 
disturbances or vomiting) 

• Muscle pain 
 

Not known (frequency cannot be estimated from the available data): 
 
• Type 2 diabetes 
• A decrease in the levels of the hormone Cortisol in your blood 
• Facial swelling 

 
In children 
• Stiffness in the arms and legs 

 
In adults 
• Increased intracranial pressure (which causes symptoms such as strong headache, visual 

disturbances or vomiting) 
• Reddening, itchiness or pain at the injection site 
• Rash 
• Itching 
• Raised itchy bumps on the skin. 

 
Formation of antibodies to the injected growth hormone but these do not seem to stop the growth 
hormone from working. 
 
The skin around the injection area can get uneven or lumpy, but this should not happen if you inject in 
a different place each time. 
 
There have been rare cases of sudden death in patients with Prader-Willi syndrome. However, no link 
has been made between these cases and treatment with Omnitrope. 



122 

 
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease may be considered by your doctor if 
discomfort or pain in the hip or knee is experienced whilst being treated with Omnitrope. 
 
Other possible side effects related to your treatment with growth hormone may include the following: 
 
You (or your child) may experience a high blood sugar or reduced levels of thyroid hormone. This can 
be tested by your doctor and if necessary your doctor will prescribe the adequate treatment. Rarely, an 
inflammation of the pancreas has been reported in patients treated with growth hormone. 
 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Omnitrope 
 
Keep out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 
expiry date refers to the last day of that month. 
• Store and transport refrigerated (2°C–8°C). 
• Do not freeze. 
• Store in the original package in order to protect from light. 
• After the first injection, the cartridge should remain in the pen injector and has to be stored in a 

refrigerator (2°C–8°C) and only used for a maximum of 21 days.  
Do not use Omnitrope if you notice that the solution is cloudy. 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Omnitrope contains 
 
The active substance of Omnitrope is somatropin.  
One cartridge contains 5 mg (corresponding to 15 IU) of somatropin after reconstitution with 1 ml 
solvent. 
 
The other ingredients are: 
Powder: 
 glycine 
 disodium hydrogen phosphate heptahydrate 
 sodium dihydrogen phosphate dihydrate 
 
Solvent: 
 water for injections 
 benzyl alcohol 
 
What Omnitrope looks like and contents of the pack 
 
Powder and solvent for solution for injection (powder in a vial (5 mg), solvent in a cartridge (1 ml)) 
Pack sizes of 1 and 5. 



123 

The powder is white and the solvent is a clear, colourless solution.  
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
 
Sandoz GmbH  
Biochemiestr. 10  
A-6250 Kundl  
Austria 
 
Manufacturer 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6336 Langkampfen 
Austria 
 
This leaflet was last revised in {MM/YYYY} 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 



124 

Package leaflet: Information for the user 
 

Omnitrope 5 mg/1.5 ml solution for injection in cartridge 
 

Omnitrope 10 mg/1.5 ml solution for injection in cartridge 
 

somatropin 
 

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 

What is in this leaflet:  
1. What Omnitrope is and what it is used for 
2. What you need to know before you use Omnitrope 
3. How to use Omnitrope 
4. Possible side effects 
5. How to store Omnitrope 
6. Contents of the pack and other information 

 
 
1. What Omnitrope is and what it is used for  
 
Omnitrope is a recombinant human growth hormone (also called somatropin). It has the same structure 
as natural human growth hormone which is needed for bones and muscles to grow. It also helps your 
fat and muscle tissues to develop in the right amounts. It is recombinant meaning it is not made from 
human or animal tissue. 
 
In children Omnitrope is used to treat the following growth disturbances: 
• If you are not growing properly and you do not have enough of your own growth hormone.  
• If you have Turner syndrome. Turner syndrome is a genetic disorder in girls that can affect 

growth – your doctor will have told you if you have this. 
• If you have chronic renal (kidney) insufficiency. As kidneys lose their ability to function 

normally, this can affect growth. 
• If you were small or too light at birth. Growth hormone can help you grow taller if you have not 

been able to catch up or maintain normal growth by 4 years of age or later. 
• If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help you 

grow taller if you are still growing, and will also improve your body composition. Your 
excessive fat will decrease and your reduced muscle mass will improve. 
 

In adults Omnitrope is used to 
• treat persons with pronounced growth hormone deficiency. This can start during either adult life 

or it can continue from childhood. 
If you have been treated with Omnitrope for growth hormone deficiency during childhood, your 
growth hormone status will be retested after completion of growth. If severe growth hormone 
deficiency is confirmed, your doctor will propose continuation of Omnitrope treatment. 
 

You should only be given this medicine by a doctor who has experience with growth hormone 
treatment and who has confirmed your diagnosis. 
 
 



125 

2. What you need to know before you use Omnitrope 
 
Do not use Omnitrope 
• if you are allergic (hypersensitive) to somatropin or to any of the other ingredients of 

Omnitrope. 
• and tell your doctor if you have an active tumour (cancer). Tumours must be inactive and you 

must have finished your anti-tumour treatment before you start your treatment with Omnitrope. 
• and tell your doctor if Omnitrope has been prescribed to stimulate growth but you have already 

stopped growing (closed epiphyses). 
• if you are seriously ill (for example, complications following open heart surgery, abdominal 

surgery, accidental trauma, acute respiratory failure, or similar conditions). If you are about to 
have, or have had, a major operation, or go into hospital for any reason, tell your doctor and 
remind the other doctors you are seeing that you use growth hormone. 
 

Warnings and precautions 
 
Talk to your doctor before using Omnitrope. 
• If you have a replacement therapy with glucocorticoids, you should consult your doctor 

regularly, as you may need adjustment of your glucocorticoid dose. 
• If you are at risk of developing diabetes, your doctor will need to monitor your blood sugar 

level during therapy with somatropin. 
• If you have diabetes, you should closely monitor your blood sugar level during treatment with 

somatropin and discuss the results with your doctor to determine whether you need to change 
the dose of your medicines to treat diabetes. 

• After starting somatropin treatment some patients may need to start thyroid hormone 
replacement. 

• If you are receiving treatment with thyroid hormones it may become necessary to adjust your 
thyroid hormone dose. 

• If you have raised intracranial pressure (which causes symptoms, such as strong headache, 
visual disturbances or vomiting) you should inform your doctor about it. 

• If you walk with a limp or if you start to limp during your growth hormone treatment, you 
should inform your doctor. 

• If you are receiving somatropin for growth hormone deficiency following a previous tumour 
(cancer), you should be examined regularly for recurrence of the tumour or any other cancer. 

• If you experience worsening abdominal pain you should inform your doctor. 
• Experience in patients above 80 years is limited. Elderly persons may be more sensitive to the 

action of somatropin, and therefore may be more prone to develop side effects. 
 

Children with chronic renal (kidney) insufficiency  
• Your doctor should examine your kidney function and your growth rate before starting 

somatropin. Medical treatment for your kidney should be continued. Somatropin treatment 
should be stopped at kidney transplantation. 
 

Children with Prader-Willi syndrome  
• Your doctor will give you diet restrictions to follow to control your weight. 
• Your doctor will assess you for signs of upper airway obstruction, sleep apnoea (where your 

breathing is interrupted during sleep), or respiratory infection before you start treatment with 
somatropin. 

• During treatment with somatropin, tell your doctor if you show signs of upper airway 
obstruction (including starting to snore or worsening of snoring), your doctor will need to 
examine you and may interrupt treatment with somatropin. 

• During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity. 
• During treatment, if you develop a lung infection, tell your doctor so that he can treat the 

infection. 
 



126 

Children born small or too light at birth 
• If you were too small or too light at birth and are aged between 9 and 12 years, ask your doctor 

for specific advice relating to puberty and treatment with this medicine. 
• Treatment should be continued until you have stopped growing. 
• Your doctor will check your blood sugar and insulin levels before the start of treatment and 

every year during treatment. 
 

Other medicines and Omnitrope 
 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
In particular, inform your doctor if you are taking or have recently taken any of the following 
medicines. Your doctor may need to adjust the dose of Omnitrope or of the other medicines: 
 
• medicine to treat diabetes,  
• thyroid hormones, 
• medicines to control epilepsy (anticonvulsants),  
• ciclosporin (a medicine that weakens the immune system after transplantation), 
• oestrogen taken orally or other sex hormones,  
• synthetic adrenal hormones (corticosteroids).  
Your doctor may need to adjust the dose of these medicines or the dose of somatropin. 
 
Pregnancy and breast-feeding 
 
You should not use Omnitrope if you are pregnant or trying to become pregnant. 
 
Ask your doctor or pharmacist for advice if you are pregnant or breast‑feeding. This is because benzyl 
alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). 
 
Important information about some of the ingredients of Omnitrope 
 
This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium- free’. 
 
Omnitrope 5 mg/1.5 ml solution for injection: 
This medicine contains 9 mg benzyl alcohol in each ml. 
Benzyl alcohol may cause allergic reactions.  
 
Benzyl alcohol has been linked with the risk of severe side effects including breathing problems 
(called “gasping syndrome”) in young children. 
 
Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor. 
 
Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because 
large amounts of benzyl alcohol can build-up in your body and may cause side effects (called 
“metabolic acidosis”).  
 
Because of the presence of benzyl alcohol the medicinal product must not be given to premature 
babies or neonates. It may cause toxic reactions and allergic reactions in infants and children up to 
3 years old. 
 
Do not use for more than a week in young children (less than 3 years old), unless advised by your 
doctor or pharmacist. 
 
 



127 

3. How to use Omnitrope 
 
Always use this medicine exactly as your doctor or pharmacist or nurse has told you. Check with your 
doctor, nurse or pharmacist if you are not sure. 
The dose depends on your size, the condition for which you are being treated and how well growth 
hormone works for you. Everyone is different. Your doctor will advise you about your individualised 
dose of Omnitrope in milligrams (mg) from either your body weight in kilograms (kg) or your body 
surface area calculated from your height and weight in square metres (m2), as well as your treatment 
schedule. Do not change the dosage and treatment schedule without consulting your doctor.  
 
The recommended dose is for:  
 
Children with growth hormone deficiency:  
0.025–0.035 mg/kg body weight per day or 0.7–1.0 mg/m2 body surface area per day. Higher doses 
can be used. When growth hormone deficiency continues into adolescence, Omnitrope should be 
continued until completion of physical development.  
 
Children with Turner syndrome:  
0.045–0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.  
 
Children with chronic renal (kidney) insufficiency:  
0.045–0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day. Higher doses may be 
necessary if the rate of growth is too low. Dosage adjustment may be necessary after 6 months of 
treatment.  
 
Children with Prader-Willi syndrome:  
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. The daily dosage should 
not exceed 2.7 mg. Treatment should not be used in children who have almost stopped growing after 
puberty.  
 
Children born smaller or lighter than expected and with growth disturbance:  
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. It is important to continue 
treatment until final height is reached. Treatment should be discontinued after the first year if you are 
not responding or if you have reached your final height and stopped growing.  
 
Adults with growth hormone deficiency:  
If you continue Omnitrope after treatment during childhood you should start with 0.2–0.5 mg per day. 
This dosage should be gradually increased or decreased according to blood test results as well as 
clinical response and side effects. 
 
If your growth hormone deficiency starts during adult life you should start with 0.15–0.3 mg per day. 
This dosage should be gradually increased according to blood test results as well as clinical response 
and side effects. The daily maintenance dose seldom exceeds 1.0 mg per day. Women may require 
higher doses than men. Dosage should be monitored every 6 months. Persons above 60 years should 
start with a dose of 0.1–0.2 mg per day which should be slowly increased according to individual 
requirements. The minimum effective dose should be used. The maintenance dose seldom exceeds 0.5 
mg per day. Follow the instructions given to you by your doctor. 
 
Injecting Omnitrope 
 
Inject your growth hormone at about the same time every day. Bedtime is a good time because it is 
easy to remember. It is also natural to have a higher level of growth hormone at night. 
 
Omnitrope 5 mg/1.5 ml is intended for multiple use. It should only be administered with the 
Omnitrope Pen 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml 
solution for injection. 
 



128 

Omnitrope 10 mg/1.5 ml is intended for multiple use. It should only be administered with the 
Omnitrope Pen 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml 
solution for injection. 
 
Omnitrope is intended for subcutaneous use. This means that it is injected through a short injection 
needle into the fatty tissue just under your skin. Most people do their injections into their thigh or their 
bottom. Do your injection in the place you have been shown by your doctor. Fatty tissue of the skin 
can shrink at the site of injection. To avoid this, use a slightly different place for your injection each 
time. This gives your skin and the area under your skin time to recover from one injection before it 
gets another one in the same place. 
 
Your doctor should have already shown you how to use Omnitrope. Always inject Omnitrope exactly 
as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.  
 
How to inject Omnitrope  
 
The following instructions explain how to inject Omnitrope yourself. Please read the instructions 
carefully and follow them step by step. Your doctor will show you how to inject Omnitrope. Do not 
attempt to inject unless you are sure you understand the procedure and requirements for the injection. 
 
- Omnitrope is given as an injection under the skin.  
- Carefully inspect the solution before injecting it and use only if clear and colourless. 
- Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty 

tissue under the skin). 
 
Preparation  
Collect necessary items before you begin: 

 

- a cartridge with Omnitrope solution for injection. 

- the Omnitrope Pen , an injection device specifically developed for 
use with Omnitrope  solution for injection (not supplied in the 
pack; see Instructions for Use provided with the Omnitrope Pen). 

- a pen needle for subcutaneous injection (not supplied in the pack).  
- 2 cleansing swabs (not supplied in the pack).  
  
Wash your hands before you continue with the next steps.  
  
Injecting Omnitrope  
- With a cleansing swab, disinfect the rubber membrane of the 

cartridge. 
- The contents must be clear and colourless.  

 

- Insert the cartridge into the pen for injection. Follow the 
Instructions for Use of the pen injector. To setup the pen dial the 
dose. 

 

- Select the site of injection. The best sites for injection are tissues 
with a layer of fat between skin and muscle, such as the thigh or 
belly (except the navel or waistline). 

 

- Make sure you inject at least 1 cm from your last injection site and 
that you change the places where you inject, as you have been 
taught. 

 

- Before you make an injection, clean your skin well with an alcohol 
swab. Wait for the area to dry. 

 
- Insert the needle into the skin in the way your doctor has taught  



129 

you.  
  
After injecting  
- After injection, press the injection site with a small bandage or 

sterile gauze for several seconds. Do not massage the injection site. 
 

- Take the needle off the pen using the outer needle cap, and discard 
the needle. This will keep the Omnitrope solution sterile and 
prevent leaking. It will also stop air going back into the pen and the 
needle clogging up. Do not share your needles. Do not share your 
pen. 

 

- Leave the cartridge in the pen, put the cap on the pen, and store it in 
the refrigerator. 

 

- The solution should be clear after removal from the refrigerator. Do 
not use if the solution is cloudy or contains particles.  

 

 
If you use more Omnitrope than you should 
 
If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your 
blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or 
“not yourself”, and you might faint. 
 
If you forget to use Omnitrope 
 
Do not use a double dose to make up for a forgotten dose. It is best to use your growth hormone 
regularly. If you forget to use a dose, have your next injection at the usual time the next day. Keep a 
note of any missed injections and tell your doctor at your next check-up. 
 
If you stop using Omnitrope 
 
Ask for advice from your doctor before you stop using Omnitrope. 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. The very 
common and common side effects in adults may start within the first months of treatment and may 
either stop spontaneously or if your dose is reduced. 
 
Very common side effects (may affect more than 1 in 10 people) include: 
 
In adults 
• Joint pain 
• Water retention (which shows as puffy fingers or swollen ankles) 

 
Common side effects (may affect up to 1 in 10 people) include: 
 
In children 
• Temporary reddening, itchiness or pain at the injection site 
• Joint pain 
• Rash 
• Raised itchy bumps on the skin. 
 

 
In adults 
• Numbness/tingling 
• Stiffness in the arms and legs, muscle pain 
• Pain or burning sensation in the hands or underarms (known as Carpal Tunnel syndrome) 



130 

 
Uncommon side effects (may affect up to 1 in 100 patients) include: 
 
In children 
• Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of 

treatment) 
• Itching 

 
Rare side effects (may affect up to 1 in 1,000 patients) include: 
 
In children 
• Numbness/tingling 
• Leukaemia (This has been reported in a small number of growth hormone deficiency patients, 

some of whom have been treated with somatropin. However, there is no evidence that 
leukaemia incidence is increased in growth hormone recipients without predisposing factors.) 

• Increased intracranial pressure (which causes symptoms, such as strong headache, visual 
disturbances or vomiting) 

• Muscle pain 
 

Not known (frequency cannot be estimated from the available data): 
 
• Type 2 diabetes 
• A decrease in the levels of the hormone Cortisol in your blood 
• Facial swelling 

 
In children 
• Stiffness in the arms and legs 

 
In adults 
• Increased intracranial pressure (which causes symptoms such as strong headache, visual 

disturbances or vomiting) 
• Reddening, itchiness or pain at the injection site 
• Rash 
• Itching 
• Raised itchy bumps on the skin. 

 
Formation of antibodies to the injected growth hormone but these do not seem to stop the growth 
hormone from working. 
 
The skin around the injection area can get uneven or lumpy, but this should not happen if you inject in 
a different place each time. 
 
There have been rare cases of sudden death in patients with Prader-Willi syndrome. However, no link 
has been made between these cases and treatment with Omnitrope. 
 
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease may be considered by your doctor if 
discomfort or pain in the hip or knee is experienced whilst being treated with Omnitrope. 
 
Other possible side effects related to your treatment with growth hormone may include the following: 
 
You (or your child) may experience a high blood sugar or reduced levels of thyroid hormone. This can 
be tested by your doctor and if necessary your doctor will prescribe the adequate treatment. Rarely, an 
inflammation of the pancreas has been reported in patients treated with growth hormone. 
 
 



131 

Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Omnitrope 
 
Keep out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 
expiry date refers to the last day of that month. 
• Store and transport refrigerated (2°C–8°C). 
• Do not freeze. 
• Store in the original package in order to protect from light. 
• After the first injection, the cartridge should remain in the pen injector and has to be stored in a 

refrigerator (2°C–8°C) and only used for a maximum of 28 days.  
Do not use Omnitrope if you notice that the solution is cloudy.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Omnitrope 5 mg/1.5 ml contains 
 
- The active substance of Omnitrope is somatropin.  

Each ml of solution contains 3.3 mg of somatropin (corresponding to 10 IU) 
One cartridge contains 5.0 mg (corresponding to 15 IU) of somatropin in 1.5 ml. 

 
- The other ingredients are: 

disodium hydrogen phosphate heptahydrate 
sodium dihydrogen phosphate dihydrate 
mannitol 
poloxamer 188 
benzyl alcohol 
water for injections 
 

What Omnitrope 10 mg/1.5 ml contains 
 
- The active substance of Omnitrope is somatropin.  

Each ml of solution contains 6.7 mg of somatropin (corresponding to 20 IU) 
One cartridge contains 10.0 mg (corresponding to 30 IU) of somatropin in 1.5 ml. 

 
- The other ingredients are: 

disodium hydrogen phosphate heptahydrate 
sodium dihydrogen phosphate dihydrate 
glycine 
poloxamer 188 
phenol 
water for injections 
 



132 

What Omnitrope looks like and contents of the pack 
 
Omnitrope is a clear and colourless solution for injection. 
Pack sizes of 1, 5 or 10. 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
 
Sandoz GmbH  
Biochemiestr. 10  
A-6250 Kundl  
Austria 
 
Manufacturer 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6336 Langkampfen 
Austria 
 
This leaflet was last revised in {MM/YYYY} 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 



133 

Package leaflet: Information for the user 
 

Omnitrope 5 mg/1.5 ml solution for injection in cartridge 
 

Omnitrope 10 mg/1.5 ml solution for injection in cartridge 
 

Omnitrope 15 mg/1.5 ml solution for injection in cartridge 
 

somatropin 
 

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 

What is in this leaflet:  
1. What Omnitrope is and what it is used for 
2. What you need to know before you use Omnitrope 
3. How to use Omnitrope 
4. Possible side effects 
5. How to store Omnitrope 
6. Contents of the pack and other information 

 
1. What Omnitrope is and what it is used for  
 
Omnitrope is a recombinant human growth hormone (also called somatropin). It has the same structure 
as natural human growth hormone which is needed for bones and muscles to grow. It also helps your 
fat and muscle tissues to develop in the right amounts. It is recombinant meaning it is not made from 
human or animal tissue. 
 
In children Omnitrope is used to treat the following growth disturbances: 
• If you are not growing properly and you do not have enough of your own growth hormone.  
• If you have Turner syndrome. Turner syndrome is a genetic disorder in girls that can affect 

growth – your doctor will have told you if you have this. 
• If you have chronic renal (kidney) insufficiency. As kidneys lose their ability to function 

normally, this can affect growth. 
• If you were small or too light at birth. Growth hormone can help you grow taller if you have not 

been able to catch up or maintain normal growth by 4 years of age or later. 
• If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help you 

grow taller if you are still growing, and will also improve your body composition. Your 
excessive fat will decrease and your reduced muscle mass will improve. 
 

In adults Omnitrope is used to 
• treat persons with pronounced growth hormone deficiency. This can start during either adult life 

or it can continue from childhood. 
If you have been treated with Omnitrope for growth hormone deficiency during childhood, your 
growth hormone status will be retested after completion of growth. If severe growth hormone 
deficiency is confirmed, your doctor will propose continuation of Omnitrope treatment. 
 

You should only be given this medicine by a doctor who has experience with growth hormone 
treatment and who has confirmed your diagnosis. 
 
 



134 

2. What you need to know before you use Omnitrope 
 
Do not use Omnitrope 
• if you are allergic (hypersensitive) to somatropin or to any of the other ingredients of 

Omnitrope. 
• and tell your doctor if you have an active tumour (cancer). Tumours must be inactive and you 

must have finished your anti-tumour treatment before you start your treatment with Omnitrope. 
• and tell your doctor if Omnitrope has been prescribed to stimulate growth but you have already 

stopped growing (closed epiphyses). 
• if you are seriously ill (for example, complications following open heart surgery, abdominal 

surgery, accidental trauma, acute respiratory failure, or similar conditions). If you are about to 
have, or have had, a major operation, or go into hospital for any reason, tell your doctor and 
remind the other doctors you are seeing that you use growth hormone. 
 

Warnings and precautions 
 
Talk to your doctor before using Omnitrope. 
• If you have a replacement therapy with glucocorticoids, you should consult your doctor 

regularly, as you may need adjustment of your glucocorticoid dose. 
• If you are at risk of developing diabetes, your doctor will need to monitor your blood sugar 

level during therapy with somatropin. 
• If you have diabetes, you should closely monitor your blood sugar level during treatment with 

somatropin and discuss the results with your doctor to determine whether you need to change 
the dose of your medicines to treat diabetes. 

• After starting somatropin treatment some patients may need to start thyroid hormone 
replacement. 

• If you are receiving treatment with thyroid hormones it may become necessary to adjust your 
thyroid hormone dose. 

• If you have raised intracranial pressure (which causes symptoms, such as strong headache, 
visual disturbances or vomiting) you should inform your doctor about it. 

• If you walk with a limp or if you start to limp during your growth hormone treatment, you 
should inform your doctor. 

• If you are receiving somatropin for growth hormone deficiency following a previous tumour 
(cancer), you should be examined regularly for recurrence of the tumour or any other cancer. 

• If you experience worsening abdominal pain you should inform your doctor. 
• Experience in patients above 80 years is limited. Elderly persons may be more sensitive to the 

action of somatropin, and therefore may be more prone to develop side effects. 
 

Children with chronic renal (kidney) insufficiency  
• Your doctor should examine your kidney function and your growth rate before starting 

somatropin. Medical treatment for your kidney should be continued. Somatropin treatment 
should be stopped at kidney transplantation. 
 

Children with Prader-Willi syndrome  
• Your doctor will give you diet restrictions to follow to control your weight. 
• Your doctor will assess you for signs of upper airway obstruction, sleep apnoea (where your 

breathing is interrupted during sleep), or respiratory infection before you start treatment with 
somatropin. 

• During treatment with somatropin, tell your doctor if you show signs of upper airway 
obstruction (including starting to snore or worsening of snoring), your doctor will need to 
examine you and may interrupt treatment with somatropin. 

• During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity. 
• During treatment, if you develop a lung infection, tell your doctor so that he can treat the 

infection. 
 



135 

Children born small or too light at birth 
• If you were too small or too light at birth and are aged between 9 and 12 years, ask your doctor 

for specific advice relating to puberty and treatment with this medicine. 
• Treatment should be continued until you have stopped growing. 
• Your doctor will check your blood sugar and insulin levels before the start of treatment and 

every year during treatment. 
 

Other medicines and Omnitrope 
 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
In particular, inform your doctor if you are taking or have recently taken any of the following 
medicines. Your doctor may need to adjust the dose of Omnitrope or of the other medicines: 
 
• medicine to treat diabetes,  
• thyroid hormones, 
• medicines to control epilepsy (anticonvulsants),  
• ciclosporin (a medicine that weakens the immune system after transplantation), 
• oestrogen taken orally or other sex hormones,  
• synthetic adrenal hormones (corticosteroids).  
Your doctor may need to adjust the dose of these medicines or the dose of somatropin. 
 
Pregnancy and breast-feeding 
 
You should not use Omnitrope if you are pregnant or trying to become pregnant. 
 
Ask your doctor or pharmacist for advice if you are pregnant or breast‑feeding. This is because benzyl 
alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). 
 
Important information about some of the ingredients of Omnitrope 
 
This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium- free’. 
 
Omnitrope 5 mg/1.5 ml solution for injection: 
This medicine contains 9 mg benzyl alcohol in each ml. 
Benzyl alcohol may cause allergic reactions.  
 
Benzyl alcohol has been linked with the risk of severe side effects including breathing problems 
(called “gasping syndrome”) in young children. 
 
Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor. 
 
Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because 
large amounts of benzyl alcohol can build-up in your body and may cause side effects (called 
“metabolic acidosis”).  
 
Because of the presence of benzyl alcohol the medicinal product must not be given to premature 
babies or neonates. It may cause toxic reactions and allergic reactions in infants and children up to 
3 years old. 
 
Do not use for more than a week in young children (less than 3 years old), unless advised by your 
doctor or pharmacist. 
 
 



136 

3. How to use Omnitrope 
 
Always use this medicine exactly as your doctor or pharmacist or nurse has told you. Check with your 
doctor, nurse or pharmacist if you are not sure. 
The dose depends on your size, the condition for which you are being treated and how well growth 
hormone works for you. Everyone is different. Your doctor will advise you about your individualised 
dose of Omnitrope in milligrams (mg) from either your body weight in kilograms (kg) or your body 
surface area calculated from your height and weight in square metres (m2), as well as your treatment 
schedule. Do not change the dosage and treatment schedule without consulting your doctor.  
 
The recommended dose is for:  
 
Children with growth hormone deficiency:  
0.025–0.035 mg/kg body weight per day or 0.7–1.0 mg/m2 body surface area per day. Higher doses 
can be used. When growth hormone deficiency continues into adolescence, Omnitrope should be 
continued until completion of physical development.  
 
Children with Turner syndrome:  
0.045–0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.  
 
Children with chronic renal (kidney) insufficiency:  
0.045–0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day. Higher doses may be 
necessary if the rate of growth is too low. Dosage adjustment may be necessary after 6 months of 
treatment.  
 
Children with Prader-Willi syndrome:  
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. The daily dosage should 
not exceed 2.7 mg. Treatment should not be used in children who have almost stopped growing after 
puberty.  
 
Children born smaller or lighter than expected and with growth disturbance:  
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. It is important to continue 
treatment until final height is reached. Treatment should be discontinued after the first year if you are 
not responding or if you have reached your final height and stopped growing.  
 
Adults with growth hormone deficiency:  
If you continue Omnitrope after treatment during childhood you should start with 0.2–0.5 mg per day. 
This dosage should be gradually increased or decreased according to blood test results as well as 
clinical response and side effects. 
 
If your growth hormone deficiency starts during adult life you should start with 0.15–0.3 mg per day. 
This dosage should be gradually increased according to blood test results as well as clinical response 
and side effects. The daily maintenance dose seldom exceeds 1.0 mg per day. Women may require 
higher doses than men. Dosage should be monitored every 6 months. Persons above 60 years should 
start with a dose of 0.1–0.2 mg per day which should be slowly increased according to individual 
requirements. The minimum effective dose should be used. The maintenance dose seldom exceeds 0.5 
mg per day. Follow the instructions given to you by your doctor. 
 
Injecting Omnitrope 
 
Inject your growth hormone at about the same time every day. Bedtime is a good time because it is 
easy to remember. It is also natural to have a higher level of growth hormone at night. 
 
Omnitrope 5 mg/1.5 ml in a cartridge for SurePal 5 is intended for multiple use. It should only be 
administered with SurePal 5, an injection device specifically developed for use with Omnitrope 
5 mg/1.5 ml solution for injection. 
 



137 

Omnitrope 10 mg/1.5 ml in a cartridge for SurePal 10 is intended for multiple use. It should only be 
administered with SurePal 10, an injection device specifically developed for use with Omnitrope 
10 mg/1.5 ml solution for injection. 
 
Omnitrope 15 mg/1.5 ml in a cartridge for SurePal 15 is intended for multiple use. It should only be 
administered with SurePal 15, an injection device specifically developed for use with Omnitrope 
15 mg/1.5 ml solution for injection. 
 
Omnitrope is intended for subcutaneous use. This means that it is injected through a short injection 
needle into the fatty tissue just under your skin. Most people do their injections into their thigh or their 
bottom. Do your injection in the place you have been shown by your doctor. Fatty tissue of the skin 
can shrink at the site of injection. To avoid this, use a slightly different place for your injection each 
time. This gives your skin and the area under your skin time to recover from one injection before it 
gets another one in the same place. 
 
Your doctor should have already shown you how to use Omnitrope. Always inject Omnitrope exactly 
as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.  
 
How to inject Omnitrope  
 
The following instructions explain how to inject Omnitrope yourself. Please read the instructions 
carefully and follow them step by step. Your doctor will show you how to inject Omnitrope. Do not 
attempt to inject unless you are sure you understand the procedure and requirements for the injection. 
 
- Omnitrope is given as an injection under the skin.  
- Carefully inspect the solution before injecting it and use only if clear and colourless. 
- Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty 

tissue under the skin). 
 
Preparation  
Collect necessary items before you begin: 

 

- a cartridge with Omnitrope solution for injection. 

- SurePal, an injection device specifically developed for use with 
Omnitrope solution for injection (not supplied in the pack; see 
Instructions for Use provided with SurePal). 

- a pen needle for subcutaneous injection (not supplied in the pack).  
- 2 cleansing swabs (not supplied in the pack).  
  
Wash your hands before you continue with the next steps.  
  
Injecting Omnitrope  
- With a cleansing swab, disinfect the rubber membrane of the 

cartridge. 
- The contents must be clear and colourless.  

 

- Insert the cartridge into the pen for injection. Follow the 
Instructions for Use of the pen injector. To setup the pen dial the 
dose. 

 

- Select the site of injection. The best sites for injection are tissues 
with a layer of fat between skin and muscle, such as the thigh or 
belly (except the navel or waistline). 

 

- Make sure you inject at least 1 cm from your last injection site and 
that you change the places where you inject, as you have been 
taught. 

 



138 

- Before you make an injection, clean your skin well with an alcohol 
swab. Wait for the area to dry. 

 
- Insert the needle into the skin in the way your doctor has taught 

you.  
 

  
After injecting  
- After injection, press the injection site with a small bandage or 

sterile gauze for several seconds. Do not massage the injection site. 
 

- Take the needle off the pen using the outer needle cap, and discard 
the needle. This will keep the Omnitrope solution sterile and 
prevent leaking. It will also stop air going back into the pen and the 
needle clogging up. Do not share your needles. Do not share your 
pen. 

 

- Leave the cartridge in the pen, put the cap on the pen, and store it in 
the refrigerator. 

 

- The solution should be clear after removal from the refrigerator. Do 
not use if the solution is cloudy or contains particles.  

 

 
If you use more Omnitrope than you should 
 
If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your 
blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or 
“not yourself”, and you might faint. 
 
If you forget to use Omnitrope 
 
Do not use a double dose to make up for a forgotten dose. It is best to use your growth hormone 
regularly. If you forget to use a dose, have your next injection at the usual time the next day. Keep a 
note of any missed injections and tell your doctor at your next check-up. 
 
If you stop using Omnitrope 
 
Ask for advice from your doctor before you stop using Omnitrope. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. The very 
common and common side effects in adults may start within the first months of treatment and may 
either stop spontaneously or if your dose is reduced. 
 
Very common side effects (may affect more than 1 in 10 people) include: 
 
In adults 
• Joint pain 
• Water retention (which shows as puffy fingers or swollen ankles) 

 
Common side effects (may affect up to 1 in 10 people) include: 
 
In children 
• Temporary reddening, itchiness or pain at the injection site 
• Joint pain 
• Rash 



139 

• Raised itchy bumps on the skin. 
 

In adults 
• Numbness/tingling 
• Stiffness in the arms and legs, muscle pain 
• Pain or burning sensation in the hands or underarms (known as Carpal Tunnel syndrome) 

 
Uncommon side effects (may affect up to 1 in 100 people) include: 
 
In children 
• Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of 

treatment) 
• Itching 
 
Rare side effects (may affect up to 1 in 1,000 people) include: 
 
In children 
• Numbness/tingling 
• Leukaemia (This has been reported in a small number of growth hormone deficiency patients, 

some of whom have been treated with somatropin. However, there is no evidence that 
leukaemia incidence is increased in growth hormone recipients without predisposing factors.) 

• Increased intracranial pressure (which causes symptoms, such as strong headache, visual 
disturbances or vomiting) 

• Muscle pain 
 

Not known (frequency cannot be estimated from the available data): 
 
• Type 2 diabetes 
• A decrease in the levels of the hormone Cortisol in your blood 
• Facial swelling 
 
In children 
• Stiffness in the arms and legs 

 
In adults 
• Increased intracranial pressure (which causes symptoms such as strong headache, visual 

disturbances or vomiting) 
• Reddening, itchiness or pain at the injection site 
• Rash 
• Itching 
• Raised itchy bumps on the skin. 

 
Formation of antibodies to the injected growth hormone but these do not seem to stop the growth 
hormone from working. 
 
The skin around the injection area can get uneven or lumpy, but this should not happen if you inject in 
a different place each time. 
 
There have been rare cases of sudden death in patients with Prader-Willi syndrome. However, no link 
has been made between these cases and treatment with Omnitrope. 
 
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease may be considered by your doctor if 
discomfort or pain in the hip or knee is experienced whilst being treated with Omnitrope. 
 
Other possible side effects related to your treatment with growth hormone may include the following: 
 



140 

You (or your child) may experience a high blood sugar or reduced levels of thyroid hormone. This can 
be tested by your doctor and if necessary your doctor will prescribe the adequate treatment. Rarely, an 
inflammation of the pancreas has been reported in patients treated with growth hormone. 
 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Omnitrope 
 
Keep out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 
expiry date refers to the last day of that month. 
• Store and transport refrigerated (2°C–8°C). 
• Do not freeze. 
• Store in the original package in order to protect from light. 
• After the first injection, the cartridge should remain in the pen injector and has to be stored in a 

refrigerator (2°C–8°C) and only used for a maximum of 28 days.  
Do not use Omnitrope if you notice that the solution is cloudy.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Omnitrope 5 mg/1.5 ml contains 
 
- The active substance of Omnitrope is somatropin.  

Each ml of solution contains 3.3 mg of somatropin (corresponding to 10 IU) 
One cartridge contains 5.0 mg (corresponding to 15 IU) of somatropin in 1.5 ml. 

 
- The other ingredients are: 

disodium hydrogen phosphate heptahydrate 
sodium dihydrogen phosphate dihydrate 
mannitol 
poloxamer 188 
benzyl alcohol 
water for injections 
 

What Omnitrope 10 mg/1.5 ml contains 
 
- The active substance of Omnitrope is somatropin.  

Each ml of solution contains 6.7 mg of somatropin (corresponding to 20 IU) 
One cartridge contains 10.0 mg (corresponding to 30 IU) of somatropin in 1.5 ml. 

 
- The other ingredients are: 

disodium hydrogen phosphate heptahydrate 
sodium dihydrogen phosphate dihydrate 
glycine 
poloxamer 188 



141 

phenol 
water for injections 
 

What Omnitrope 15 mg/1.5 ml contains 
 
- The active substance of Omnitrope is somatropin.  

Each ml of solution contains 10 mg of somatropin (corresponding to 30 IU). 
One cartridge contains 15.0 mg (corresponding to 45 IU) of somatropin in 1.5 ml. 
 

- The other ingredients are: 
disodium hydrogen phosphate heptahydrate 
sodium dihydrogen phosphate dihydrate 
sodium chloride 
poloxamer 188 
phenol 
water for injections 
 

What Omnitrope looks like and contents of the pack 
 
Omnitrope is a clear and colourless solution for injection. 
Omnitrope 5 mg/1.5 ml solution for injection is for use in SurePal 5 only. 
Omnitrope 10 mg/1.5 ml solution for injection is for use in SurePal 10 only. 
Omnitrope 15 mg/1.5 ml solution for injection is for use in SurePal 15 only. 
Pack sizes of 1, 5 or 10. 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
 
Sandoz GmbH  
Biochemiestr. 10  
A-6250 Kundl  
Austria 
 
Manufacturer 
 
Sandoz GmbH 
Biochemiestr. 10 
A-6336 Langkampfen 
Austria 
 
This leaflet was last revised in {MM/YYYY} 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURer RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET