qanastek/EMEA-V3 huggingface dataset:
After reconstitution, one vial contains 1.3 mg Somatropin (corresponding to 4 IU) per ml.
Wara r- rikostituzzjoni, kunjett wieħed ikun fih 1. 3 mg ta ’ Somatropin (li jikkorrispondi għal 4 IU) f’ kull millilitru.
Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: water for injections
Trab: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: ilma għall- injezzjonijiet
Powder and solvent for solution for injection (powder in a vial (1.3 mg) and solvent in a vial (1 ml)).
Trab u solvent għal soluzzjoni għall- injezzjoni (trab f’ kunjett (1. 3 mg) u solvent f’ kunjett (1 ml)).
For subcutaneous use after reconstitution.
Użu għal taħt il- ġilda wara r- rikostituzzjoni.
Read package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Use only clear solution.
Uża biss soluzzjoni li tkun ċara.
EXP After reconstitution, use within 24 hours.
JIS Wara r- rikostituzzjoni, uża fi żmien 24 siegħa.
Store in the original package in order to protect from light.
Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Omnitrope 1.3 mg/ ml
Omnitrope 1. 3 mg/ ml
45 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
48 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT/ OMNITROPE POWDER
KLIEM FUQ IL- KUNJETT/ TRAB OMNITROPE
Omnitrope 1.3 mg/ ml powder and solvent for solution for injection Somatropin Subcutaneous use
Omnitrope 1. 3 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni Somatropin Użu għal taħt il- ġilda
1.3 mg somatropin
1. 3 mg somatropin
46 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT/ SOLVENT
KLIEM FUQ IL- KUNJETT / SOLVENT
1 ml water for injections
1 ml ilma għal injezzjonijiet
Omnitrope 5 mg/ ml powder and solvent for solution for injection Somatropin
Omnitrope 5 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni Somatropin
Somatropin 5 mg (15 IU)/ ml in a vial.
Somatropin 5 mg (15 IU) / ml f’ kunjett.
After reconstitution, one cartridge contains 5 mg Somatropin (corresponding to 15 IU) per ml.
Wara r- rikostituzzjoni, skartoċċ wieħed ikun fih 5 mg ta ’ Somatropin (li jikkorrispondi għal 15 IU) f’ kull millilitru.
Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: benzyl alcohol, water for injections Contains benzyl alcohol.
Trab: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: benzyl alcohol, ilma għall- injezzjonijiet Fih benzyl alcohol.
Powder and solvent for solution for injection (powder in a vial (5 mg) and solvent in a cartridge (1 ml)).
Trab u solvent għal soluzzjoni għall- injezzjoni (trab f’ kunjett (5 mg) u solvent fi skartoċċ (1 ml)).
OTHER SPECIAL WARNING, IF NECESSARY
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA
EXP After reconstitution, use within 21 days.
JIS Wara r- rikostituzzjoni, uża fi żmien 21 jum.
Use only with Omnitrope Pen L.
Uża biss ma ’ Omnitrope Pen L.
49 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
52 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT/ OMNITROPE POWDER
KLIEM FUQ IL- KUNJETT/ OMNITROPE TRAB
Omnitrope 5 mg/ ml powder and solvent for solution for injection Somatropin Subcutaneous use
Omnitrope 5 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni Somatropin Użu għal taħt il- ġilda
CARTRIDGE TEXT/ SOLVENT
KLIEM FUQ L- ISKARTOĊĊ/ SOLVENT
Omnitrope 5 mg/ ml powder and solvent for solution for injection Somatropin Subcutaneous use
Omnitrope 5 mg/ ml solvent għal soluzzjoni għall- injezzjoni Somatropin Użu għal taħt il- ġilda
1 ml water for injections with 1.5% benzyl alcohol.
1 ml ilma għal injezzjonijiet b’ 1. 5% benzyl alcohol.
Omnitrope 3.3 mg/ ml solution for injection Somatropin
Omnitrope 3. 3 mg/ ml soluzzjoni għall- injezzjoni Somatropin
Somatropin 3.3 mg (10 IU)/ ml.
Somatropin 3. 3 mg (10 IU) / ml.
One cartridge contains 1.5 ml corresponding to 5 mg Somatropin (15 IU).
Skartoċċ wieħed fih 1. 5 ml li jikkorrispondi għal 5 mg ta ’ Somatropin (15 IU).
Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, water for injections Contains benzyl alcohol.
Sustanzi oħra: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, ilma għall- injezzjonijiet Fih benzyl alcohol.
Solution for injection in a cartridge (1.5 ml).
Soluzzjoni għall- injezzjoni fi skartoċċ (1. 5 ml).
EXP After first opening, use within 28 days.
JIS Wara li jinfetaħ għall- ewwel darba, użah fi żmien 28 jum.
Use only with Omnitrope Pen 5.
Uża biss ma ’ Omnitrope Pen 5.
Omnitrope 3.3 mg/ ml
Omnitrope 3. 3 mg/ ml
53 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
56 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIDGE TEXT
KLIEM FUQ L- ISKARTOĊĊ
Omnitrope 3.3 mg/ ml solution for injection Somatropin Subcutaneous use
Omnitrope 3. 3 mg/ ml soluzzjoni għall- injezzjoni Somatropin Użu għal taħt il- ġilda
5 mg somatropin in 1.5 ml
5 mg somatropin f’ 1. 5 ml
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
57 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Omnitrope 6.7 mg/ ml solution for injection Somatropin
Omnitrope 6. 7 mg/ ml soluzzjoni għall- injezzjoni Somatropin
Somatropin 6.7 mg (20 IU)/ ml.
Somatropin 6. 7 mg (20 IU) / ml.
One cartridge contains 1.5 ml corresponding to 10 mg Somatropin (30 IU).
Skartoċċ wieħed fih 1. 5 ml li jikkorrispondu għal 10 mg ta ’ Somatropin (30 IU)..
Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, glycine, poloxamer 188, phenol, water for injections
Sustanzi oħra: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, glycine, poloxamer 188, phenol, ilma għall- injezzjonijiet
Use only with Omnitrope Pen 10.
Uża biss ma ’ Omnitrope Pen 10.
Omnitrope 6.7 mg/ ml
Omnitrope 6. 7 mg/ ml
56 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
59 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Omnitrope 6.7 mg/ ml solution for injection Somatropin Subcutaneous use
Omnitrope 6. 7 mg/ ml soluzzjoni għall- injezzjoni Somatropin Użu għal taħt il- ġilda
10 mg somatropin in 1.5 ml
10 mg somatropin f’ 1. 5 ml
58 PACKAGE LEAFLET:
61 FULJETT TA ’ TAGĦRIF:
What Omnitrope is and what it is used for 2.
X’ inhu Omnitrope u għalxiex jintuża 2.
Before you use Omnitrope 3.
Qabel ma tuża Omnitrope 3.
How to use Omnitrope 4.
Kif għandek tuża Omnitrope 4.
How to store Omnitrope 6.
Kif taħżen Omnitrope 6.
WHAT OMNITROPE IS AND WHAT IT IS USED FOR
X’ INHU OMNITROPE U GĦALXIEX JINTUŻA
Omnitrope is a human growth hormone which is made by a method known as ‘ recombinant DNA technology using the bacterial microorganism E. coli.
Omnitrope hu ormon tat- tkabbir tal- bniedem magħmul minn metodu magħruf bħala ‘ teknoloġija tad - DNA rikombinanti ’ billi jintuża l- mikroorganiżmu batterjali E. coli.
The structure is identical to the human body´s own growth hormone.
L- istruttura hi identika għal dik ta ’ l- ormon tat- tkabbir tal- ġisem tal- bniedem stess.
Omnitrope 1.3 mg/ ml is for single use only.
Omnitrope 1. 3 mg/ ml jintuża darba biss.
Omnitrope is used for
Omnitrope jintuża għal
• Treatment of infants, children, and adolescents:
• Kura ta ’ trabi, tfal u adolexxenti:
- with growth disturbance due to insufficient secretion of growth hormone (GH).
- b’ disturb tat- tkabbir minħabba tnixxija insuffiċjenti ta ’ l- ormon tat- tkabbir (growth ormon -
- with growth disturbance associated with Turner syndrome.
- b’ disturb tat- tkabbir assoċjat mas- sindrome ta ’ Turner.
- with growth disturbance associated with chronic renal insufficiency (CRI).
- b’ disturb tat- tkabbir assoċjat ma ’ insuffiċjenza kronika tal- kliewi (chronic renal insufficiency -
- with growth disturbance in short children/ adolescents born small for gestational age (SGA),
- b’ disturb tat- tkabbir (devjazzjoni standard ta ’ l- iskorjar/ standard deviation score (SDS) kurrenti
who failed to show catch-up growth by 4 years of age or later.
ta ’ < - 2. 5 u SDS aġġustat tal- ġenituri ta ’ < - 1) fi tfal/ adolexxenti qosra li twieldu żgħar għaż - żmien tat- tqala (small for gestational age - SGA), li jkollhom piż u/ jew tul taħt - 2 devjazzjonijiet standard/ standard deviations (SD), u li ma jkunx irnexxielhom juru li laħqu tkabbir (veloċita ’ ta ’ tul/ height velocity (HV) SDS < 0 matul l- aħħar sena) sa l- età ta ’ 4 snin jew iktar tard.
- with Prader-Willi syndrome (PWS), for improvement of growth and body composition.
- bis- sindrome ta ’ Prader- Willi (PWS), għat- titjib fit- tkabbir u kompożizzjoni tal- ġisem.
diagnosis of PWS should be confirmed by appropriate genetic testing. • Replacement of growth hormone in adults with confirmed pronounced growth hormone deficiency (GHD) originating in either childhood or adulthood.
dijanjosi ta ’ PWS għandha tkun ikkonfermata permezz ta ’ test ġenetiku xieraq. • Is- sostituzzjoni ta ’ l- ormon tat- tkabbir fl- adulti li jkollhom defiċjenza prominenti ta ’ l- ormon tat- tkabbir (GHD) li toriġina jew fit- tfulija jew meta l- persuna ssir adulta.
BEFORE YOU USE OMNITROPE
QABEL MA TUŻA OMNITROPE
Diagnosis and therapy with Omnitrope should be initiated and monitored by doctors who are appropriately qualified and experienced in the diagnosis and management of patients with growth disorders.
Id- dijanjosi u t- terapija b’ Omnitrope għandhom jinbdew u jkunu mmonitorjati minn tobba li huma kkwalifikati kif suppost u li għandhom esperjenza fid- dijanjosi u fl- immaniġġjar ta ’ pazjenti b’ mard tat- tkabbir.
Do not use Omnitrope
62 Tużax Omnitrope
- If you are allergic (hypersensitive) to somatropin or to any of the other ingredients of
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal somatropin jew sustanzi oħra ta ’
- If there is any evidence of an active tumour.
- Jekk hemm xi evidenza ta ’ tumur attiv.
Anti-tumour therapy must be completed before
It- terapija ta ’ kontra t- tumuri għandha titlesta qabel ma
starting therapy.
tibda t- terapija b’ somatropin.
- To stimulate growth if growing is already finished (closed epiphyses).
- Biex tistimula t- tkabbir jekk it- tkabbir ikun diġà ntemm (epifisi magħluq).
- During acute life-threatening illness due to complications following open-heart surgery,
- Matul mard akut li jkun ta ’ periklu għall- ħajja minħabba komplikazzjonijiet wara operazzjoni
abdominal surgery, multiple trauma caused by an accident, acute respiratory failure, or similar conditions.
tal- qalb miftuħa, operazzjoni fiż- żaqq, trawma aċċidentali multipla kkawżata minn inċident, waqfien akut tan- nifs jew kundizzjonijiet simili.
Take special care with Omnitrope
Oqgħod attent ħafna b’ Omnitrope
- Somatropin may interfere with your body’ s use of insulin.
- Somatropin jista ’ jinterferixxi ma ’ l- użu ta ’ l- insulina ta ’ ġismek.
Your blood glucose values will have
Il- valuri tal- glukows fid -
to be checked regularly during therapy with somatropin.
demm tiegħek ser ikollhom jiġu ċċekkjati regolarment matul it- terapija b’ somatropin.
- If you have diabetes mellitus or a family history of diabetes mellitus.
- Jekk għandek dijabete mellitus jew storja medika tal- familja ta ’ dijabete mellitus.
Insulin therapy may need
It- terapija ta ’
to be adjusted or started after somatropin therapy is initiated.
l- insulina jista ’ jkollha bżonn li tiġi aġġustata jew tinbeda wara li tinbeda t- terapija b’ somatropin.
- Hypothyroidism (decrease in thyroid gland function) may develop during therapy with
- L- ipotirojdiżmu (tnaqqis fil- funzjoni tal- glandola tat- tirojde) jista ’ jiżviluppa matul it- terapija
somatropin.
b’ somatropin.
Hypothyroidism may reduce the optimal response to somatropin.
L- ipotirojdiżmu jista ’ jnaqqas l- aħjar rispons possibbli għal somatropin.
Therefore, thyroid hormone levels must be checked periodically during therapy.
Għalhekk, il- livelli ta ’ l- ormoni fit- tirojde, iridu jkunu ċċekkjati perjodikament matul it- terapija.
- Benign intracranial hypertension (high pressure within the brain) has been reported during
- Pressjoni tad- demm għolja intrakranjali beninna (pressjoni għolja fil- moħħ) kienet irrappurtata
treatment with somatropin.
matul il- kura b’ somatropin.
If symptoms, such as recurrent headache, visual problems, nausea, or vomiting occur, please ask your doctor for advice.
Jekk iseħħu sintomi bħal uġigħ ta ’ ras rikorrenti, problemi tal- vista, dardir u/ jew rimettar, jekk jogħġbok staqsi lit- tabib tiegħek għal parir.
Your doctor may decide to perform an examination of the eyes to detect increased brain pressure.
It- tabib tiegħek jista ’ jiddeċiedi li jagħmel eżami ta ’ l- għajnejn biex josserva żieda fil- pressjoni fil- moħħ.
Depending on the results of this test, treatment with Omnitrope may have to be interrupted.
Skond ir - riżultati ta ’ dan it- test, il- kura b’ Omnitrope jista ’ jkollha tiġi interrotta.
- Patients with endocrine (hormonal) disorders are more likely to have problems with their hips.
- Hu mistenni li pazjenti b’ mard endokrinali (ormonali) għandhom iktar ċans li jkollhom
If you develop a limp or pain in the hip, please ask your doctor for advice.
Jekk tibda zzappap jew jekk tiżviluppa uġigħ fil- ġenbejn, jekk jogħġbok staqsi lit- tabib tiegħek għal parir.
- Progression of scoliosis (a spine curved sideways) can occur in patients who experience rapid
- Il- progressjoni ta ’ skoljosi (sinsla tad- dahar li tkun milwija fuq naħa waħda) tista ’ sseħħ
growth.
f’ pazjenti li jkollhom tkabbir mgħaġġel.
Therefore, signs of scoliosis should be monitored during treatment with somatropin.
Għalhekk, is- sinjali ta ’ skoljosi għandhom ikunu mmonitorjati matul il- kura b’ somatropin.
However, somatropin treatment has not been shown to increase the frequency of occurrence or the severity of scoliosis.
Madankollu, ma ntweriex li l- kura b’ somatropin iżżid il- frekwenza ta ’ l- okkorrenza jew is- severità ta ’ l- iskoljosi.
- If you have had a previous malignant disease.
- Jekk inti kellek xi marda malinna.
You will have to be examined regularly for
Inti ser tkun eżaminat/ a regolarment għar- rikorrenza tal -
recurrence of the malignancy.
malinn.
- There is no information available on the safety of growth hormone substitution therapy in
- M’ hemm l- ebda informazzjoni disponibbli dwar is- sigurtà tat- terapija tas- sostituzzjoni ta ’ l -
patients with acute critical illness.
ormon tat- tkabbir f’ pazjenti b’ mard kritiku akut.
If acute critical illness occurs, your doctor will have to carefully evaluate the safety of continuing somatropin treatment.
Jekk mard kritiku akut iseħħ, it- tabib tiegħek ser ikollu jevalwa bl- attenzjoni s- sigurtà li tkompli bil- kura b’ somatropin.
- Experience in patients above 60 years of age is limited.
- L- esperjenza f’ pazjenti ta ’ iktar minn 60 sena hi limitata.
Patients with chronic renal insufficiency (CRI)
Pazjenti li għandhom insuffiċjenza kronika renali (CRI)
- In patients with CRI, somatropin therapy should not be started unless the function of the kidney
- F’ pazjenti li għandhom CRI, it- terapija b’ somatropin m’ għandhiex tinbeda ħlief jekk il- funzjoni
is below 50 percent of normal.
tal- kliewi tkun taħt il- 50 fil- mija ta ’ dik normali.
To verify growth disturbance, growth should be followed for one year before starting therapy.
Biex ikun ivverifikat disturb tat- tkabbir, it - tkabbir għandu jkun segwit għal sena qabel ma tinbeda t- terapija.
Conservative treatment for CRI should be continued during treatment with somatropin.
Kura konservattiva għal CRI għandha titkompla matul il- kura b’ somatropin.
After kidney transplantation, treatment with somatropin should be stopped.
Wara trapjant tal- kliewi, il- kura b’ somatropin għandha titwaqqaf.
Patients with Prader-Willi syndrome (PWS)
Pazjenti li għandhom is- sindrome ta ’ Prader- Willi (PWS)
- In patients with PWS, treatment with somatropin should always be combined with a calorie-
- F’ pazjenti b’ PWS, il- kura b’ somatropin għandha dejjem tingħata flimkien ma ’ dieta b’ kaloriji
restricted diet.
ristretti.
- Experience with prolonged treatment in patients with PWS is limited.
- L- esperjenza b’ kura fit- tul f’ pazjenti b’ PWS hi limitata.
- There have been reports of deaths associated with the use of growth hormone in patients with
- Kien hemm rapporti ta ’ mwiet marbuta ma ’ l- użu ta l- ormon tat- tkabbir f’ pajenti li kellhom il -
PWS who had one or more of the following risk factors: severe obesity, history of severe breathing problems, especially during sleep, or infection of the lungs or airways.
PWS, u li kellhom wieħed jew iktar mill- fatturi ta ’ riskju li ġejjin: ħxuna żejda severa, storja ta ’ problemi severi biex jieħdu n- nifs, speċjalment waqt l- irqad, jew infezzjoni tal- pulmuni jew tal - passaġġi tan- nifs.
Before starting on Omnitrope, you should be checked for breathing problems and respiratory infections by a doctor, even if you have not been experiencing any symptoms of breathing difficulty.
Qabel tibda l- kura b’ Omnitrope, inti għandek tkun iċċekkjat/ a minn tabib għal problemi biex tieħu n- nifs u infezzjonijiet respiratorji, anki jekk inti ma kellek l- ebda sintomi ta ’ diffikultà biex tieħu n- nifs.
- If any infection of your lungs or airways is found, you must be treated sufficiently before
- Jekk tinstab xi infezzjoni fil- pulmuni tiegħek jew fil- passaġġi tan- nifs, inti jkollok tiġi kkurat/ a
starting treatment with somatropin.
biżżejjed qabel tibda l- kura b’ somatropin.
You should be monitored for signs of infection while being treated with somatropin.
Għandek tkun immonitorjat/ a għal sinjali ta ’ infezzjoni waqt li tkun qed tiġi kkurat/ a b’ somatropin.
- Difficulty breathing while asleep, called sleep apnoea, should be examined by a specialist.
- Diffikultà biex tieħu n- nifs waqt l- irqad, imsejħa apnea waqt l- irqad, għandha tkun eżaminata
Before initiation of growth hormone therapy, you should be observed for breathing problems during the night using a special monitor.
Qabel tinbeda t- terapija bl- ormon tat- tkabbir, għandek tiġi osservat/ a għal problemi biex tieħu n- nifs matul il- lejl, bl- użu ta ’ monitor speċjali.
If any problems are found, then you should continue to be monitored during sleep.
Jekk jinstabu kwalunkwe problemi, allura għandek tkompli tkun immonitorjat/ a waqt l- irqad.
- If during treatment with somatropin you show signs of breathing problems (onset or increase of
- Jekk matul il- kura b’ somatropin inti turi sinjali ta ’ problemi biex tieħu n- nifs (il- bidu jew żieda
snoring), treatment should be interrupted and the cause should be examined by a doctor.
fl- inħir), il- kura għandha tiġi interrotta u l- kawża tkun eżaminata minn tabib.
- All patients with PWS should have effective weight control before and during treatment with
- Il- pazjenti kollha b’ PWS għandu jkollhom kontroll effettiv tal- piż qabel u matul il- kura
Patients born SGA
Pazjenti li jitwieldu b’ SGA
- In patients born SGA, other medical reasons or treatments that could explain the growth
- F’ pazjenti li jitwieldu b’ SGA, raġunijiet mediċi jew kuri oħrajn li jistgħu jispjegaw id- disturb
disturbance should be ruled out.
tat- tkabbir għandhom jiġu esklużi qabel ma tibda l- kura.
- Experience in starting treatment in SGA patients near the onset of puberty is limited.
- L- esperjenza fil- bidu tal- kura f’ pazjenti b’ SGA qrib il- bidu tal- pubertà hi limitata.
Therefore,
Għalhekk, il -
treatment should not be started near the onset of puberty.
kura m’ għandhiex tinbeda qrib il- bidu tal- pubertà.
- Experience in patients with Silver-Russell syndrome is limited.
- L- esperjenza f’ pazjenti li jkollhom is- sindrome ta ’ Silver- Russell hi limitata.
- Some of the height gain obtained with treating short children/ adolescents born SGA with
- Ftit mit- tul li jinkiseb bil- kura ta ’ tfal/ adolexxenti qosra li jitwieldu b’ SGA b’ somatropin jista ’
somatropin may be lost if treatment is stopped before final height is reached.
jintilef jekk il- kura titwaqqaf qabel it- tul finali jintlaħaq.
- Blood sugar and insulin levels should be checked before the start of treatment and annually
- Iz- zokkor fid- demm u l- livelli ta ’ l- insulina għandhom jiġu ċċekkjati qabel il- bidu tal- kura u
during treatment with growth hormone.
kull sena matul il- kura bl- ormon tat- tkabbir.
- Please tell your doctor or pharmacist if you are taking or have recently taken any other
- Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi
medicines, including medicines obtained without a prescription.
mediċini oħra, anki dawk mingħajr riċetta.
It is especially important to tell your doctor if you are taking any medicine for diabetes, thyroid disorder or any anticonvulsants, ciclosporin or steroid hormones such as oestrogens, progesterone or corticosteroids.
Hu importanti ħafna li tgħid lit- tabib tiegħek jekk qed tieħu kwalunkwe mediċina għad- dijabete, għall - mard tat- tirojde jew kwalunkwe mediċini kontra l- konvulżjoni, ciclosporin jew ormoni sterojdi bħal estroġeni, progesterone jew kortikosterojdi.
A dose adjustment may be needed for these medicines.
Aġġustament tad- doża jista ’ jkun meħtieġ għal dawn il - mediċini.
Treatment with Omnitrope should be interrupted during pregnancy.
Il- kura b’ Omnitrope għandha tiġi interrotta matul it- tqala.
Ask your doctor for advice before using Omnitrope if you are breast-feeding.
Staqsi lit- tabib tiegħek għal parir qabel tuża Omnitrope jekk tkun qed tredda ’.
Important information about some of the ingredients of Omnitrope
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Omnitrope
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i. e. essentially ‘ sodium- free’.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodium (23 mg) f’ kull ml, i. e. hu essenzjalment ‘ sodium- free ’.
HOW TO USE OMNITROPE
KIF GĦANDEK TUŻA OMNITROPE
Omnitrope is intended for subcutaneous use.
Omnitrope hu intenzjonat għall- użu taħt il- ġilda.
This means that it is injected through a short injection needle into the fatty tissue just under your skin.
Dan ifisser li jkun injettat minn ġo labra qasira ta ’ l - injezzjoni ġot- tessut tax- xaħam kemm kemm taħt il- ġilda tiegħek.
You will receive appropriate training and instruction on the proper use of Omnitrope from your doctor or other suitably qualified health professional.
Inti ser tirċievi taħriġ adattat u struzzjonijiet dwar l- użu kif suppost ta ’ Omnitrope mit- tabib tiegħek jew minn persuni oħrajn professjonali fil- qasam tas- saħħa li jkunu mħarrġa kif suppost.
For instructions on how to inject Omnitrope, see section “ How to inject Omnitrope” below.
Għal struzzjonijiet dwar kif tinjetta Omnitrope, ara s- sezzjoni “ Kif tinjetta Omnitrope ” hawn taħt.
Treatment with somatropin is a long-term treatment.
64 Il- kura b’ somatropin hi kura fit- tul.
If you want to know more about what that means for you, please ask your doctor.
Jekk tixtieq tkun taf iktar dwar x’ ifisser dan għalik, jekk jogħġbok staqsi lit- tabib tiegħek.
How much and how often to use Omnitrope
Kemm għandek tuża Omnitrope, u kemm ta ’ spiss
Your doctor will advise you about your individualised dose of Omnitrope and treatment schedule.
It- tabib tiegħek ser jagħtik parir dwar id- doża individwalizzata tiegħek ta ’ Omnitrope u l- iskeda tal - kura.
Usually Omnitrope is injected once a day in the evening.
Normalment Omnitrope jiġi injettat darba kuljum filgħaxija.
Please do not change the dosage and treatment schedule without consulting your doctor.
Jekk jogħġbok tibdilx id- dożaġġ u l- iskeda tal- kura mingħajr ma tgħid lit- tabib tiegħek.
Dose adjustments may be required over time, depending on your increase in body weight and response.
Aġġustamenti fid- doża jistgħu jkunu meħtieġa matul iż- żmien tal- kura, skond iż- żieda fil- piż u r - rispons ta ’ ġismek.
61 If you use more Omnitrope than you should
Jekk tieħu Omnitrope aktar milli suppost
Acute overdose may lead initially to hypoglycaemia (decrease in blood glucose) and subsequently to hyperglycaemia (increase in blood glucose).
Doża eċċessiva akuta tista ’ twassal, inizjalment, għal ipogliċemija (tnaqqis fil- glucose tad- demm) u, sussegwentement, għal ipergliċemija (żieda fil- glucose tad- demm).
Long-term overdosage could result in signs and symptoms of gigantism or acromegaly (enhanced growth of ears, nose, lips, tongue, and cheekbones).
Doża eċċessiva fit- tul tista ’ tirriżulta f’ sinjali ta ’ ġgantiżmu jew akromegalija (tkabbir esaġerat tal- widnejn, imnieħer, xufftejn, ilsien, u l- għadma ta ’ taħt l- għajn).
If you have used more Omnitrope than you should, please ask your doctor for advice.
Jekk tkun użajt iktar Omnitrope milli suppost, jekk jogħġbok staqsi lit- tabib tiegħek għal parir.
If you forget to take Omnitrope
Jekk tinsa tieħu Omnitrope
Do not inject a double dose to make up for forgotten individual doses.
Tinjettax doża doppja biex tpatti għal dożi li tkun insejt tieħu.
Continue with the prescribed dosage regimen.
Kompli bil- kors tad- doża li għalih ingħatajt ir- riċetta.
If you forget to take Omnitrope, please ask your doctor for advice.
Jekk tinsa tieħu Omnitrope, jekk jogħġbok staqsi lit- tabib għal parir.
How to inject Omnitrope 1.3 mg/ ml
Kif tinjetta Omnitrope 1. 3 mg/ ml
The following instructions explain how to inject Omnitrope 1.3 mg/ ml yourself.
L- istruzzjonijiet li ġejjin jispjegaw kif inti stess għandek tinjetta Omnitrope 1. 3 mg/ ml.
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra l- istruzzjonijiet bl- attenzjoni u segwihom pass pass.
Your doctor or other suitably qualified health professional will show you how to inject Omnitrope.
It- tabib tiegħek jew persuna oħra professjonali fil- qasam tas- saħħa li jkunu mħarrġa kif suppost, ser juruk kif għandek tinjetta Omnitrope.
Do not attempt to inject unless you are sure you understand the procedure and requirements for injection.
Tippruvax tinjetta ħlief jekk inti ċert/ a li tifhem il- proċedura u l- ħtiġijiet għall- injezzjoni.
- After reconstitution, Omnitrope is given as an injection under the skin.
- Wara r- rikostituzzjoni, Omnitrope jingħata bħala injezzjoni taħt il- ġilda.
- Carefully inspect the solution before injecting it and use only if clear and colourless.
Eżamina bl- attenzjoni s- soluzzjoni qabel ma tinjettaha u użaha biss jekk tkun ċara u bla kulur.
- Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty
- Ibdel is- siti ta ’ l- injezzjoni biex timminimizza r- riskju ta ’ lipoatrofija lokali (tnaqqis lokali ta ’
tissue under the skin).
tessut tax- xaħam taħt il- ġilda).
Preparation Collect necessary items before you begin:
Preparazzjoni Iġbor l- oġġetti meħtieġa qabel ma tibda:
- a vial with Omnitrope 1.3 mg/ ml powder for solution for injection.
- kunjett bit- trab Omnitrope 1. 3 mg/ ml trab għal soluzzjoni għall -
- a vial with solvent for Omnitrope 1.3 mg/ ml.
- kunjett bis- solvent għal Omnitrope 1. 3 mg/ ml.
2 ml syringe) and needle (e. g.
- siringa sterili, li tintrema wara li tintuża (eż. siringa ta ’ 2 ml) u
0.33 mm x 12.7 mm) for withdrawing the solvent from the vial (not supplied in the pack).
0. 33 mm x 12. 7 mm) biex tiġbed is- solvent mill- kunjett (mhux fornuti fil- pakkett).
1 ml syringe)
- siringa sterili, li tintrema wara li tintuża, ta ’ daqs adattat (eż. siringa
and injection needle (e. g.
ta ’ 1 ml) u labra ta ’ l- injezzjoni (eż.
0.25 mm x 8 mm) for subcutaneous injection (not supplied in the pack).
0. 25 mm x 8 mm) għall - injezzjoni taħt il- ġilda (mhux fornuti fil- pakkett).
- 2 cleansing swabs (not supplied in the pack).
- 2 biċċiet li jnaddfu (mhux fornuti fil- pakkett).
Wash your hands before you continue with the next steps.
Aħsel idejk qabel ma tkompli bil- passi li jmiss.
Reconstituting Omnitrope
Kif tirrikostitwixxi Omnitrope
- Remove the protective caps from the two vials in the box.
- Neħħi l- għatjien protettivi miż- żewġ kunjetti fil- kaxxa.
With a
Bil- biċċa li
cleansing swab, disinfect the rubber membranes of both the powder-filled and the solvent-filled vial.
tnaddaf, iddiżinfetta l- membrani tal- lastku kemm tal- kunjett mimli bit- trab, kif ukoll tal- kunjett mimli bis- solvent.
- Take the vial with solvent and the sterile, disposable syringe (e. g.
- Ħu l- kunjett bis- solvent u s- siringa sterili, li tintrema wara li tintuża
2 ml syringe) and needle (e. g.
(eż. siringa ta ’ 2 ml u labra (eż.
Push the needle fitted to the syringe through the rubber membrane.
Imbotta l - labra mwaħħla mas- siringa minn ġol- membrana tal- lastku.
- Turn the vial with the solvent upside down and withdraw all the
- Dawwar il- kunjett bis- solvent ta ’ taħt fuq u iġbed is- solvent kollu
solvent from the vial.
minn ġol- kunjett.
- Take the vial with the powder and push the needle through the
- Ħu l- kunjett bit- trab u imbotta l- labra minn ġol- membrana tal -
rubber membrane of the vial.
lastku tal- kunjett.
Inject the solvent slowly.
Injetta s- solvent bil- mod.
Aim the stream of liquid against the glass wall in order to avoid foam.
Immira t- tnixxija tal - likwidu lejn il- ġenb tal- ħġieġ biex tevita l- formazzjoni tar- ragħwa.
Remove the syringe and needle.
Neħħi s- siringa u l- labra.
- Gently swirl the reconstituted vial until the content is completely
- Dawwar il- kunjett rikostitwit bil- mod sakemm il- kontenut jinħall
dissolved.
kollu.
- If the solution is cloudy (and the cloudiness does not disappear
- Jekk is- soluzzjoni tkun imċajpra (u ma tgħibx wara għaxar minuti)
within ten minutes) or contains particles, it should not be used.
jew ikun fiha l- partikuli, din m’ għandhiex tintuża.
The contents must be clear and colourless.
Il- kontenut għandu jkun ċar u bla kulur.
- Use the solution immediately.
- Uża s- soluzzjoni immedjatament.
Measuring the dose of Omnitrope to be injected
Kif tkejjel id- doża ta ’ Omnitrope li ser tkun injettata
1 ml
- Ħu s- siringa sterili, li tintrema wara li tintuża, ta ’ daqs adattat (eż.
syringe) and injection needle (e. g.
siringa ta’ 1 ml) u l- labra ta ’ l- injezzjoni (eż.
- Push the needle through the rubber stopper of the vial with the
- Imbotta l- labra minn ġot- tapp tal- lastku tal- kunjett bis- soluzzjoni
reconstituted solution.
rikostitwita.
- Turn the vial and the syringe upside down in one hand.
- Aqleb il- kunjett u s- siringa ta ’ taħt fuq f’ id waħda.
- Be sure that the tip of the syringe is in the Omnitrope reconstituted
- Kun żgur li t- tarf tas- siringa ikun ġos- soluzzjoni rikostitwita ta ’
Your other hand will be free to move the plunger.
Idek l- oħra ser tkun ħielsa biex tħarrek il- planġer.
- Pull back on the plunger slowly and withdraw just a bit more than
- Iġbed il- planġer lura bil- mod u iġbed ġos- siringa ftit iktar mid- doża
the dose prescribed by your doctor into the syringe.
li għalik tak riċetta t- tabib tiegħek.
- Hold the syringe with the needle in the vial pointing up and remove
- Żomm is- siringa bil- labra fil- kunjett tipponta ‘ l fuq u neħħi s -
the syringe from the vial.
siringa mill- kunjett.
- Check for air bubbles in the syringe.
- Iċċekkja għal bżieżaq ta ’ l- arja fis- siringa.
If you see any bubbles, pull
Jekk tara xi bżieżaq,
the plunger slightly back; tap the syringe gently, with the needle pointing upwards, until the bubbles disappear.
iġbed il- planġer ftit lura; tektek is- siringa bil- mod, bil- labra tipponta ’ l fuq, sakemm il- bżieżaq jgħibu.
Push up the plunger slowly back to the correct dose.
Imbotta l- planġer bil - mod ’ il fuq lura sad- doża korretta.
- Inspect the reconstituted solution visually prior to administration.
- Eżamina viżwalment s- soluzzjoni rikostitwita qabel l- għoti.
Do not use if the solution is cloudy or contains particles.
Tużax jekk is- soluzzjoni tkun imċajpra jew fiha l- partikuli.
You are now ready to inject the dose.
Issa inti lest/ a biex tinjetta d- doża.
Injecting Omnitrope
Kif tinjetta Omnitrope
- Select the site of injection.
- Agħżel is- sit ta ’ l- injezzjoni.
The best sites for injection are tissues
L- aħjar postijiet għall- injezzjoni huma
with a layer of fat between skin and muscle, such as the thigh or belly (except the navel or waistline).
tessuti b’ saff ta ’ xaħam bejn il- ġilda u l- muskoli, bħal koxxa jew iż- żaqq (ħlief iż- żokra jew il- qadd).
- Make sure you inject at least 1 cm from your last injection site and
- Aċċerta ruħek li tinjetta mill- inqas 1 ċm ’ il bogħod mis- sit ta ’ l -
that you change the places where you inject, as you have been taught.
aħħar injezzjoni tiegħek u li tibdel il- postijiet fejn tinjetta, kif għallmuk tagħmel.
- Before you make an injection, clean your skin well with an alcohol
- Qabel ma tagħmel injezzjoni, naddaf il- ġilda tiegħek sewwa
swab.
b’ biċċa li tnaddaf bl- alkoħol.
Wait for the area to dry.
Stenna sakemm iż- żona tinxef.
- With one hand, pitch a fold of loose skin.
- B’ id waħda, oqros parti tal- ġilda.
With your other hand,
Bl- id l- oħra, żomm is- siringa kif
hold the syringe as you would a pencil.
iżżomm lapes.
Insert the needle into the pinched skin at an angle of 45° to 90°.
Daħħal il- labra ġol- ġilda l- maqrusa f’ angolu ta ’ 45° sa 90°.
After the needle is in, remove the hand used to pinch the skin and use it to hold the syringe barrel.
Iġbed lura
Pull back the plunger very slightly with one hand.
66 l- planġer bil- mod ħafna b’ id waħda.
If blood comes into the syringe, the needle has entered a blood vessel.
Jekk id- demm jidħol ġos - siringa, il- labra tkun daħlet ġo xi vina.
Do not inject into this site; withdraw the needle and repeat this step.
Tinjettax f’ dan is- sit; iġbed il- labra ’ l barra u irrepeti dan il- pass.
Inject the solution by pushing the plunger all the way down gently.
Injetta s- soluzzjoni billi timbotta l- planġer ’ l isfel kemm tista ’ bil- mod.
- Pull the needle straight out of the skin.
- Iġbed il- labra bi dritt ’ il barra minn ġol- ġilda.
After injecting
Wara li tinjetta
- After injection, press the injection site with a small bandage or
- Wara l- injezzjoni, agħfas is- sit ta ’ l- injezzjoni bi stikka żgħira jew
sterile gauze for several seconds.
b’ garża sterili għal diversi sekondi.
Do not massage the injection site.
Timmassaġġjax is- sit ta ’ l - injezzjoni.
- The residual solution, vials, and injection materials intended for
- Is- soluzzjoni residwa, kunjetti u materjali ta ’ l- injezzjoni, huma
single use must be discarded.
maħsuba biex jintużaw darba biss, u għandhom jintremew.
Dispose of the syringes safely in a closed container.
Armi s - siringi b’ mod sikur f’ kontenitur magħluq.
63 If you stop using Omnitrope
Jekk tieqaf tuża Omnitrope
A disruption or early ending of treatment with somatropin may impair the success of growth hormone therapy.
L- interruzzjoni jew it- temmija bikrija tal- kura b’ somatropin tista ’ tagħmel ttellef lis- suċċess tat - terapija bl- ormon tat- tkabbir.
Please ask your doctor for advice before stopping treatment.
Jekk jogħġbok staqsi lit- tabib tiegħek għal parir qabel twaqqaf il- kura.
Like all medicines, Omnitrope can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Omnitrope jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Please ask your doctor for advice when you experience any of the symptoms described below.
Jekk tinnota xi wieħed mill- effetti sekondarji imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
General disorders and reactions at the injection site
u kundizzjonijiet
Common (occurring in at least 1 of 100 but less than 1 of 10 patients) In infants/ children/ adolescents: transient local skin reactions
ta ’ mnejn jingħata
Uncommon (occurring in at least 1 of 1,000 but less than 1 of 100 patients) In infants/ children/ adolescents: mild oedema
reazzjonijiet lokali tal- ġilda li jgħaddu malajr
Rare (occurring in at least 1 of 10,000 but less than 1 of 1,000 patients)
Fl- adulti: edema ħafifa
Very Rare (occurring in less than 1 of 10,000 patients)
Disturbi muskolu -
In adults: mild oedema
Fl- adulti:
Musculoskeletal system, connective tissues, bones
skeltrali u tal - connective tissue
In adults: stiffness of the limbs, joint and muscle pain
ebusija tad - dirgħajn/ riġlejn, uġigħ tal- ġogi u tal- muskoli
In infants/ children/ adolescents: stiffness of the limbs, joint and muscle pain
adolexxenti: ebusija tad - dirgħajn/ riġlejn, uġigħ tal- ġogi u tal- muskoli
Nervous system
Disturbi fis - sistema nervuża
In adults: sensory disturbances
Fl- adulti: disturbi sensorjali
In infants/ children/ adolescents: sensory disturbances
Fit- trabi/ tfal / / adolexxenti: disturbi sensorjali Fl- adulti: sindrome tal - carpal tunnel
Benign intracranial hypertension
Pressjoni tad - demm għolja intrakranjali beninna
In adults: carpal tunnel syndrome Endocrine disorders
Disturbi fis - sistema endokrinarja
Disorders of the immune system Benign and malignant neoplasms
Disturbi fis - sistema immuni Neoplażmi beninni u malinni
Development of antibodies
Żvilupp ta ’ antikorpi
Leukemia
Lewkimja
General disorders and
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata
- Temporary local reactions at the injection site, such as pain, numbness, reddening, and swelling
- Reazzjonijiet temporanji lokali fis- sit ta ’ l- injezzjoni, bħal uġigħ, tmewwit, ħmura, u nefħa
are common side effects.
huma effetti sekondarji komuni.
In isolated cases, subcutaneous administration of somatropin can lead to loss of fatty tissue at the injection site.
F’ każijiet iżolati, l- għoti taħt il- ġilda ta ’ somatropin jista ’ jwassal għal telf ta ’ tessut tax- xaħam fis- sit ta ’ l- injezzjoni.
- Mild oedema (accumulation of water in the tissues) has been observed.
- Edema ħafifa (akkumulazzjoni ta ’ ilma fit- tessuti) kienet osservata.
This side effect is a
Dan l- effett sekondarju hu
consequence of disturbances in fluid balance and occurs only at the start of treatment with somatropin and is dose-dependent.
konsegwenza ta ’ disturbi fil- bilanċ tal- fluwidu u jseħħ biss fil- bidu tal- kura b’ somatropin u jiddependi mid- doża.
It is common in adult patients, but uncommon in infants, children and adolescents.
Hu komuni f’ pazjenti adulti, iżda mhux komuni fit- trabi, tfal u adolexxenti.
64 Musculoskeletal system, connective tissues, and bones
Disturbi muskolu- skeltrali u tal- connective tissue, u ta ’ l- għadam
- Joint and muscle pain (especially in the hip or knee) and stiffness of the limbs have been
- Uġigħ fil- ġogi u fil- muskoli (speċjalment fil- ġenbejn jew fl- irkoppa) u ebusija tad -
observed.
dirgħajn/ riġlejn kienu osservati.
These side effects occur only at the start of treatment with somatropin and are dose- dependent.
Dawn l- effetti sekondarji jseħħu biss fil- bidu tal- kura b’ somatropin u jiddependu mid- doża.
They are common in adult patients, but uncommon in infants, children and adolescents.
Huma komuni f’ pazjenti adulti, iżda mhux komuni fit - trabi, tfal u adolexxenti.
Nervous system
Disturbi fis- sistema nervuża
- Sensory disturbances, such as numbness and tingling, have been observed.
- Disturbi sensorjali, bħal tmewwit u tnemnim, kienu osservati.
These usually occur
Dawn l- effetti sekondarji
at the start of treatment with somatropin and are dose-dependent.
normalment iseħħu fil- bidu tal- kura b’ somatropin u jiddependu mid- doża.
They are common in adult patients, but uncommon in infants, children and adolescents.
68
- Muscular atrophy (reduction of muscular tissue) of the ball of the thumb and sensory
- Atrofija muskolari tal- parti (tnaqqis fit- tessut tal- muskoli) tonda tas- saba ’ l- kbir u disturbi
disturbances in the fingers and palm of the hand are uncommon side effects.
sensorjali fis- swaba ’ u fil- keffa ta ’ l- id huma effetti sekondarji mhux komuni.
They are consequences of carpal tunnel syndrome (constriction of the nerve supplying part of the palm of the hand), which has been observed mainly in adults.
Dawn huma konsegwenzi tas- sindrome tal- carpal tunnel (restrizzjoni tan- nerv li jforni parti tal- keffa ta ’ l - id), li kien osservata primarjament fl- adulti.
- Visual disturbances, headaches, nausea, and vomiting have been observed.
- Disturbi tal- vista, uġigħ ta ’ ras, dardir, u rimettar kienu osservati.
These symptoms
Dawn is- sintomi jistgħu
could indicate benign intracranial hypertension (increased brain pressure), which is a rare side effect of treatment with somatropin.
jindikaw pressjoni tad- demm għolja intrakranjali beninna (żieda fil- pressjoni tal- moħħ), li hi effett sekondarju rari tal- kura b’ somatropin.
- Diabetes has been observed as a rare side effect.
- Id- dijabete kienet osservata bħala effett sekondarju rari.
Disorders of the immune system
Disturbi fis- sistema immuni
- As with all protein based medicines, some patients may develop antibodies to the protein.
- Bħal mediċini kollha bbażati fuq il- proteini, xi pazjenti jistgħu jiżviluppaw l- antikorpi għall -
However, these have not been found to have growth-inhibiting effects.
Madankollu, ma nstabx li dawn kellhom effetti li jinibixxu t- tkabbir.
This is a common side effect.
Dan hu effett sekondarju komuni.
Benign and malignant neoplasms
Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
- Very rare cases of leukemia have been reported in growth-hormone deficient children treated
- Każjiiet rari ħafna ta ’ lewkimja kienu rrappurtati fi tfal b’ defiċjenza ta ’ l- ormon tat- tkabbir
with somatropin.
ikkurati b’ somatropin.
A causal relationship to somatropin therapy is unlikely.
Mhix mistennija relazzjoni kawżali għat- terapija b’ somatropin.
HOW TO STORE OMNITROPE
KIF TAĦŻEN OMNITROPE
Do not use after the expiry date which is stated on the label and carton.
Tużax wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna.
- Store and transport refrigerated (2°C - 8°C).
- Żommu kiesaħ waqt il- ħażna u l- ġarr (2°C - 8°C).
- Store in the original package in order to protect from light.
- Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
- After reconstitution, from a microbiological point of view, the product should be used
- Wara r- rikostituzzjoni, mill- aspett mikrobijoloġiku, il- prodott għandu jintuża immedjatament.
However, the in-use stability has been demonstrated for up to 24 hours at 2°C - 8°C, in the original package.
Madankollu, l- istabbiltà waqt l- użu ntweriet għal 24 siegħa f’ temperatura ta ’ 2°C - 8°C fil - pakkett oriġinali.
- For single use only.
- Jintuża darba biss.
Do not use Omnitrope if it was frozen or subject to high temperatures.
Tużax Omnitrope jekk kien iffriżat jew suġġett għal temperaturi għoljin.
Do not use Omnitrope if you notice that the solution is cloudy.
Tużax Omnitrope jekk tinnota li s- soluzzjoni hi mċajpra.
What Omnitrope contains
X’ fih Omnitrope
The active substance of Omnitrope is somatropin (1.3 mg) in a vial.
Is- sustanza attiva ta ’ Omnitrope hi somatropin (1. 3 mg) f’ kunjett.
One vial contains 1.3 mg (corresponding to 4 IU) of somatropin after reconstitution with 1 ml solvent.
Kunjett wieħed fih 1. 3 mg (li jikkorrispondu għal 4 IU) ta ’ somatropin wara r- rikostituzzjoni b’ 1 ml ta ’ solvent.
Powder: glycine disodium hydrogen phosphate heptyhydrate sodium dihydrogen phosphate dihydrate
Trab: glycine disodium hydrogen phosphate heptyhydrate sodium dihydrogen phosphate dihydrate
Solvent: water for injections
69 ilma għall- injezzjonijiet
What Omnitrope looks like and contents of the pack
Id- dehra ta ’ Omnitrope u l- kontenuti tal- pakkett
Powder and solvent for solution for injection (powder in a vial (1.3 mg), solvent in a vial (1 ml)).
Trab u solvent għal soluzzjoni għall- injezzjoni (trab f’ kunjett (1. 3 mg) u solvent f’ kunjett (1 ml)).
The powder is white and the solvent is a clear, colourless solution.
It- trab hu abjad u s- solvent hu soluzzjoni ċara u bla kulur.
Norge Sandoz AS Jernbaneveien 4 N-1400 Ski Tlf: + 47 64 91 30 00
70 Österreich Eesti Sandoz GmbH Sandoz d. d.
Eesti Sandoz d. d.
Eesti filiaal Biochemiestr.
Eesti filiaal Pärnu mnt 105 EE - 11312 Tallinn Tel: +372 665 2400
10 Pärnu mnt 105 A- 6250 Kundl EE - 11312 Tallinn Tel: + 43 - (0) 5338 2000 Tel: +372 665 2400
Österreich Sandoz GmbH Biochemiestr.
Polska Ελλάδα Lek Polska Sp. z o. o.
This leaflet was last approved in {MM/ YYYY}
Dan il- fuljett kien approvat l- aħħar fi {XX/ SSSS}.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu.
68 PACKAGE LEAFLET:
72 FULJETT TA ’ TAGĦRIF:
Do not use Omnitrope
Tużax Omnitrope
After reconstitution, one ml contains 15 mg benzyl alcohol.
Wara r- rikostituzzjoni, kull ml ikun fih 15 mg ta ’ benzyl alkoħol.
May cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Jista ’ jikkawża reazzjonijiet tossiċi u reazzjonijiet allerġiċi fit - trabi u fi tfal sa l- età ta ’ 3 snin.
Omnitrope 5 mg/ ml is intended for multiple use.
Omnitrope 5 mg/ ml hu maħsub biex jintuża diversi drabi.
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.
Għandha tingħata biss b’ Omnitrope Pen L, tagħmir ta ’ l- injezzjoni li kien żviluppat speċifikament għall- użu ma ’ Omnitrope 5 mg/ ml solvent għal soluzzjoni għall- injezzjoni.
Omnitrope is given through a short injection needle into the fatty tissue just under your skin.
75 Omnitrope jingħata minn ġo labra qasira ta ’ l- injezzjoni ġot- tessut tax- xaħam kemm kemm taħt il - ġilda tiegħek.
You will receive appropriate training and instruction on the proper use of Omnitrope from your doctor or other suitably qualified health professional.
Inti ser tirċievi taħriġ adattat u struzzjonijiet dwar l- użu kif suppost ta ’ Omnitrope mit - tabib tiegħek jew minn persuna oħra professjonali fil- qasam tas- saħħa li jkunu mħarrġa kif suppost.
Treatment with somatropin is a long-term treatment.
Il- kura b’ somatropin hi kura fit- tul.
71 How much and how often to use Omnitrope
Kemm għandek tuża Omnitrope, u kemm ta ’ spiss
If you use more Omnitrope than you should
Jekk tieħu Omnitrope aktar milli suppost
How to inject Omnitrope 5 mg/ ml
Kif tinjetta Omnitrope 5 mg/ ml
The following instructions explain how to inject Omnitrope 5 mg/ ml yourself.
L- istruzzjonijiet li ġejjin jispjegaw kif inti stess għandek tinjetta Omnitrope 5 mg/ ml.
- Carefully inspect the solution before injecting it and use only if clear and colourless.
- Eżamina bl- attenzjoni s- soluzzjoni qabel ma tinjettaha u użaha biss jekk tkun ċara u bla kulur.
- Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty
Ibdel is- siti ta ’ l- injezzjoni biex timminimizza r- riskju ta ’ lipoatrofija lokali (tnaqqis lokali ta ’
- a vial with Omnitrope 5 mg/ ml powder for solution for injection.
- kunjett bit- trab Omnitrope 5 mg/ ml trab għal soluzzjoni għall -
- a cartridge with solvent for Omnitrope 5 mg/ ml.
- skartoċċ bis- solvent għal Omnitrope 5 mg/ ml.
- a transfer set for mixing and transferring the reconstituted solution
- sett tat- trasferiment biex tħallat u tittrasferixxi s- soluzzjoni
back into the cartridge (see Instructions for Use of the pen injector).
rikostitwita lura ġo l- iskartoċċ (ara l- Istruzzjonijiet għall- Użu tal - pinna injettur).
- the Omnitrope Pen L, an injection device specifically developed for
- Omnitrope Pen L, tagħmir ta ’ l- injezzjoni li kien żviluppat
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).
speċifikament għall- użu ma ’ Omnitrope 5 mg/ ml soluzzjoni għall - injezzjoni (mhux fornuta fil- pakkett; ara l- Istruzzjonijiet għall- Użu pprovduti tas- sett tat- trasferiment u tat- tagħmir ta ’ l- injezzjoni).
- a pen needle for subcutaneous injection.
- labra tal- pinna għall- injezzjoni li tingħata taħt il- ġilda.
Reconstituting Omnitrope
76 Kif tirrikostitwixxi Omnitrope
- Remove the protective cap from the vial.
- Neħħi l- għatu protettiv minn fuq il- kunjett.
With a cleansing swab,
Billi tuża biċċa li
disinfect both the rubber membrane of the vial with powder and the rubber membrane of the cartridge with solvent.
tnaddaf, iddiżinfetta kemm il- membrana tal- kunjett bit- trab, kif ukoll il- membrana tal- lastku ta ’ l- iskartoċċ bis- solvent.
- Use the transfer set for transferring all the solvent from the
- Uża s- sett tat- trasferiment biex tittrasferixxi s- solvent mill- iskartoċċ
cartridge into the vial.
għal ġol- kunjett.