qanastek/EMEA-V3 huggingface dataset:
The diagnosis must be confirmed by appropriate genetic testing.
Id- dijanjożi trid tkun ikkonfermata permezz ta ’ testijiet ġenetiċi addatti.
Omnitrope is also used to treat adult patients with pronounced GH deficiency as replacement therapy.
Omnitrope jintuża ukoll biex jittratta pazjenti adulti li jbagħtu minn nuqqas ferm evidenti ta ’ l- ormon ta ’ l- iżvilupp (terapija ta ’ sostituzzjoni).
How is Omnitrope used?
Kif jintuża Omnitrope?
Omnitrope treatment should be supervised by a doctor experienced in the management of patients with growth disorders.
Trattament b’ Omnitrope għandu jkun sorveljat minn tabib b’ esperjenza fil- maniġment ta ’ pazjenti b’ disturbi ta ’ l- iżvilupp.
Omnitrope is given by subcutaneous injection (under the skin), once a day at bedtime.
Omnitrope jingħata darba kuljum permezz ta ’ injezzjoni taħt il- ġilda, meta jkun wasal il- ħin ta ’ l- irqad.
The patient or caregiver can inject Omnitrope themselves, after training by a doctor or a nurse.
Il- pazjent jista ’ jinjetta lilu nnifsu jew min jieħu ħsiebu jista ’ jinjettah b’ Omnitrope, wara taħriġ minn tabib jew infermiera.
The Omnitrope cartridges should only be used with the special Omnitrope injection device.
Il- kartriġis ta ’ Omnitrope għandhom jintużaw biss ma ’ apparat speċjali għall- injezzjoni ta ’ Omnitrope.
The dose may need to be adjusted over time, depending on change in body weight and response.
It- tabib jikkalkula d- doża individwali għal kull pazjent u din tiddependi fuq il- piż tal- ġisem u l- kundizzjoni, u jista ’ jkun li jkun hemm bżonn li d - doża tiġi aġġustata matul iż- żmien, jiddependi fuq il- bidla fil- piż tal- ġisem jew fuq ir- reazzjoni tal - pazjent.
Reproduction is authorised provided the source is acknowledged. carbohydrates.
Reproduction is authorised provided the source is acknowledged Kif jaħdem Omnitrope?
The active substance in Omnitrope, somatropin, is identical to the human GH.
Is- sustanza attiva fl- Omnitrope, somatropin, hija identika għal GH fil- bniedem.
It is produced by a method known as ‘ recombinant DNA technology’: the hormone is made by a bacterium which has received a gene (DNA) that makes it able to produce it.
Hija magħmula b’ metodu magħruf bħala ‘ teknoloġija rekombinanti tad- DNA ’: l- ormon huwa magħmul minn batterju li jkun ingħata ġene (DNA) li jagħmlu kapaċi jipproduċih.
Omnitrope replaces the natural hormone.
Omnitrope jissostitwixxi l- GH.
How has Omnitrope been studied?
Kif ġie studjat Omnitrope?
Omnitrope was studied to show that it is comparable to the reference medicine, Genotropin.
Omnitrope ġie studjat biex jiġi muri li huwa komparabbli mal- mediċina ta ’ referenza, Genotropin.
Omnitrope was compared to Genotropin in 89 children with a lack of GH and who had not been treated before.
Omnitrope tqabbel ma ’ Genotropin f’ 89 tifel u tifla b’ nuqqas ta ’ GH u li ma kinux ġew ittrattati qabel.
The study lasted nine months, and measured the height at the beginning and the end of the study, and the speed of growth during the study.
L- istudju dam sejjer disa ’ xhur, u kejjel it- tul fil- bidu u fl- aħħar ta ’ l- istudju kif ukoll il- veloċità ta ’ l - iżvilupp waqt l- istudju.
To study the safety of Omnitrope, another 51 children have also received the medicine for up to a year.
Biex tiġi studjata s- sigurtà ta ’ Omnitrope, 51 tifel u tifla oħra ngħataw ukoll il - mediċina għal tnax- il xahar jew inqas.
What benefit has Omnitrope shown during the studies?
X’ benefiċċju wera Omnitrope waqt l- istudji?
After nine months, treatment with Omnitrope and Genotropin gave similar increases in height and speed of growth (equivalent to an increase of 10.7 cm per year with both medicines).
Wara disa ’ xhur, trattament b’ Omnitrope u Genotropin ipproduċa żidiet fit- tul u fil- veloċità ta ’ l - iżvilupp simili (ekwivalenti għal żjieda ta ’ 10. 7 ċm fis- sena biż- żewġ mediċini).
The effectiveness of Omnitrope has been shown to be equivalent to that of Genotropin.
Intwera li l- effikaċja ta ’ Omnitrope hija ekwivalenti għal dik ta ’ Genotropin.
What is the risk associated with Omnitrope?
X’ inhu r- riskju assoċjat ma ’ Omnitrope?
The side effects seen with Omnitrope were similar in type and severity to those seen with the reference medicine Genotropin.
L- effetti li dehru b’ Omnitrope kienu simili fit- tip u l- qawwa kumparata ma ’ dawk li dehru bil - mediċina ta ’ referenza Genotropin.
The most common side effects (seen in between 1 and 10 patients in 100) are, in children, transient local skin reactions at the site of injection, and in adults, mild oedema (accumulation of fluid), paraesthesia (numbness or tingling), joint and muscle pain (especially in the hip or knee) and stiffness of the limbs.
L- aktar effetti sekondarji komuni (dehru f’ madwar pazjent 1 u 10 pazjenti f’ 100) huma: fit- tfal, reazzjonijiet lokalizzati fil- ġilda li marru malajr fejn tingħata l- injezzjoni u fl- adulti, edema ħafifa (akkumulazzjoni ta ’ fluwidu), tnemnim jew paraesteżija (titrix, textix), uġigħ fil- ġogi u l- muskoli (speċjalment fil- ġenb u fl- irkoppa) u egħbusija tad- dirgħajn u r- riġlejn.
In addition, as with all protein medicines, some patients may develop antibodies (proteins that are produced in response to Omnitrope).
Barra minn hekk, bħal b’ kull mediċina li fiha l- proteini, xi pazjenti jistgħu jiżviluppaw antikorpi (proteini li jiġu prodotti b’ reazzjoni għal Omnitrope).
However these have no growth-inhibiting effects.
Madankollu dawn m’ għandhomx effett li jostakolaw l - iżvilupp.
For the full list of all side effects reported with Omnitrope, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Omnitrope, ara l- Fuljett ta ’ Tagħrif.
Omnitrope should not be used in people who may be hypersensitive (allergic) to somatropin or any of the other ingredients (the ready-to-use solution and the solvent for Omnitrope 5 mg/ ml contain benzyl alcohol).
Omnitrope m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi iżżejjed (allerġiċi) għal somatropin jew għal kwalunkwe sustanza oħra tiegħu (is- soluzzjoni magħmula lesta biex tintuża u s- solvent għal Omnitrope 5 mg/ ml fihom l- akoħol benzyl).
Omnitrope should not be used when the patient suffers from an active tumour or an acute life-threatening illness.
Omnitrope m’ għandux jintuża meta l- pazjent isofri minn tumur attiv, jew marda akuta li tipperikola l- ħajja.
For the full list of restrictions, see the Package Leaflet.
Għal- lista sħiħa ta ’ restrizzjonijiet, ara l- Fuljett ta ’ Tagħrif mehmuż mal- pakkett.
Somatropin may interfere with the body’ s use of insulin.
Somatropin jista ’ jinterferixxi ma ’ l- użu ta ’ l- insulina mill- ġisem.
Blood sugar levels will need to be checked during treatment, and treatment with insulin may sometimes need to be adjusted or started.
Il- livelli taz- zokkor fid- demm jeħtieġ li jiġu kkontrollati waqt it- trattament, u xi kultant ikun meħtieġ li jinbeda jew jiġi aġġustat trattament bl- insulina.
Why has Omnitrope been approved?
Għalxiex ġie approvat Omnitrope?
The Committee for Medicinal products for Human Use (CHMP) considered that, in accordance with EU requirements, Omnitrope has been shown to have a comparable quality, safety and efficacy profile to Genotropin.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkunsidra li, b’ mod konformi mal- ħtiġijiet ta ’ l- Unjoni Ewropea, Omnitrope wera li għandu kwalità, sigurtà u effikaċja komparabbli ma ’ dawk ta ’ Genotropin.
Therefore, the CHMP’ s view was that, as for Genotropin, the benefit outweighs the identified risk.
Għaldaqstant, il- fehma tas- CHMP kienet li, bħal f’ Genotropin, il- benefiċċji jegħlbu r- riskju identifikat.
Which measures are being taken to ensure the safe use of Omnitrope?
X’ miżuri qed jittieħdu biex jassiguraw is- sigurtà u l- użu sikur ta ’ Omnitrope?
The measures taken to ensure the safe use of Omnitrope are linked to the reasons why the medicine is used.
Il- miżuri meħuda biex jassiguraw l- użu sikur ta ’ Omnitrope huma marbuta mar- raġunijiet għal x’ hiex tintuża l- mediċina.
The company that makes Omnitrope will study in more detail potential long-term side effects of the medicine, such as the possible risk of developing diabetes or re-occurrence of some types of cancer when receiving long-term somatropin treatment, and implications of the development of antibodies on effectiveness.
Il- kumpannija li tagħmel Omnitrope se tistudja f’ aktar dettall l- effetti sekondarji potenzjali tal- mediċina bħar- riskju possibbli li tiżviluppa d- dijabete jew l- okkorrenza mill- ġdid ta ’ xi tipi ta ’ kanċer meta jingħata trattament b’ somatropin fuq tul ta ’ żmien, u l- implikazzjonijet ta ’ l - iżvilupp ta ’ antikorpi fuq l- effettività.
Other information about Omnitrope:
Tagħrif ieħor dwar Omnitrope:
The European Commission granted a marketing authorisation valid throughout the EU for Omnitrope to Sandoz GmbH on 12 April 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Omnitrope lil Sandoz GmbH fit- 12 ta ’ April 2006
The full EPAR for Omnitrope can be found here.
2/ 3 L- EPAR sħiħ għal Omnitrope jista ’ jinkiseb minn hawn.
This summary was last updated in 03-2008.
Dan is- sommarju ġie aġġornat l- aħħar f’ 3- 2008.
1.5 mg; solvent:
1. 5 mg; solvent:
powder: vial (glass); solvent: cartridge (glass)
trab: kunjett (ħġieġ); solvent: skartoċċ (ħġieġ)
5.8 mg; solvent:
5. 8 mg; solvent:
1 vial + 1 cartridge
1 kunjett + 1 skartoċċ
5 vials + 5 cartridges
5 kunjetti + 5 skartoċċi
3.3 mg/ ml
3. 3 mg/ ml
Solution for injection in a cartridge
Soluzzjoni għall - injezzjoni fi skartoċċ
6.7 mg/ ml
6. 7 mg/ ml
Omnitrope 1.3 mg/ ml powder and solvent for solution for injection
Omnitrope 1. 3 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni
After reconstitution, one vial contains 1.3 mg Somatropin* (corresponding to 4 IU) per ml.
Wara r- rikostituzzjoni kunjett wieħed fih 1. 3 mg ta ’ Somatropin * (li jikkorrispondi għal 4 IU) f’ kull ml.
* produced in Escherichia coli by recombinant DNA technology.
* prodott f’ Escherichia coli minn teknoloġija tad- DNA rikombinanti.
Powder and solvent for solution for injection The powder is white.
Trab u solvent għal soluzzjoni għall- injezzjoni It- trab huwa abjad.
The solvent is clear and colourless.
Is- solvent huwa ċar u bla kulur.
Infants, children and adolescents
Trabi, tfal u adolexxenti
- Growth disturbance due to insufficient secretion of growth hormone (GH).
- Disturb tat- tkabbir minħabba tnixxija insuffiċjenti ta ’ l- ormon tat- tkabbir (GH).
- Growth disturbance associated with Turner syndrome.
- Disturb tat- tkabbir assoċjat mas- sindrome ta ’ Turner.
- Growth disturbance associated with chronic renal insufficiency.
- Disturb tat- tkabbir assoċjat ma ’ insuffiċjenza kronika tal- kliewi.
- Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted
- Disturb tat- tkabbir (tul kurrenti devjazzjoni standard ta ’ l- iskorjar / current height standard
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.
deviation score (SDS) 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 tkabbir li laħaq (veloċita ’ tat- tul/ height velocity (HV) SDS < 0 matul l- aħħar sena) sa l- età ta ’ 4 snin jew iktar tard.
- Prader-Willi syndrome (PWS), for improvement of growth and body composition.
- Is- sindrome ta ’ Prader- Willi (PWS), għat- titjib fit- tkabbir u kompożizzjoni tal- ġisem.
The
Id -
diagnosis of PWS should be confirmed by appropriate genetic testing.
dijanjosi ta ’ PWS għandha tkun ikkonfermata permezz ta ’ test ġenetiku xieraq.
Patients with
- Terapija tas- sostituzzjoni fl- adulti li jkollhom defiċjenza prominenti ta ’ l- ormon tat- tkabbir.
severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin.
Pazjenti b’ defiċjenza severa ta ’ l- ormon tat- tkabbir fiż- żmien ta ’ meta jkunu saru adulti huma definiti bħala pazjenti li għandhom patoloġija pitwitarja ipotalamika magħrufa u mill- inqas defiċjenza waħda magħrufa ta ’ ormon pitwitarju li ma jkunx prolaktin.
These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency.
Dawn il- pazjenti għandu jkollhom test dinamiku wieħed biex id- defiċjenza ta ’ l- ormon tat- tkabbir tiġi dijanjostika jew eskluża.
In patients with childhood onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low IGF-I concentrations (SDS < -2) who may be considered for one test.
F’ pazjenti li fit- tfulija tagħhom kellhom il- bidu ta ’ defiċjenza iżolata tal- GH (l- ebda evidenza ta ’ mard ipotalamiku- pitwitarju jew irradjazzjoni kranjali), żewġ testijiet dinamiċi għandhom jiġu rakkomandati, ħlief għal dawk il- pazjenti li jkollhom konċentrazzjonijiet baxxi ta ’ IGF- I (SDS < - 2) li jistgħu jkunu kkunsidrati għal test wieħed.
The cut-off point of the dynamic test should be strict.
Il- punt tal- qtugħ tat- test dinamiku għandu jkun strett.
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.
Id- dijanjosi u t- terapija b’ somatropin 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.
The posology and administration schedule should be individualised.
Il- pożoloġija u l- iskeda ta ’ l- għoti għandhom jiġu stabbiliti fuq bażi individwali.
2 Growth disturbance due to insufficient secretion of growth hormone in paediatric patients:
2 Disturb tat- tkabbir minħabba tnixxija insuffiċjenti ta ’ l- ormon tat- tkabbir f’ pazjenti pedjatriċi:
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.
Ġeneralment doża ta ’ 0. 025 - 0. 035 mg kuljum għal kull kilogramm ta ’ piż tal- ġisem jew 0. 7 - 1. 0 mg/ m2 ta ’ erja tas- superfiċje tal- ġisem kuljum hi rakkomandata.
Even higher doses have been used.
Dożi ogħla intużaw ukoll.
Prader-Willi syndrome, for improvement of growth and body composition in paediatric patients:
Is- sindrome ta ’ Prader- Willi (PWS), għat- titjib fit- tkabbir u kompożizzjoni tal- ġisem f’ pazjenti pedjatriċi:
Generally a dose of 0.035 mg/ kg body weight per day or 1.0 mg/ m2 body surface area per day is recommended.
Ġeneralment doża ta ’ 0. 035 mg għal kull kilogramm ta ’ piż tal- ġisem kuljum jew 1. 0 mg/ m2 ta ’ erja tas- superfiċje tal- ġisem kuljum hi rakkomandata.
Daily doses of 2.7 mg should not be exceeded.
Dożi ta ’ kuljum ta ’ 2. 7 mg m’ għandhomx jinqabżu.
Treatment should not be used in paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses.
Il- kura ma tridx tintuża f’ pazjenti pedjatriċi b’ rata tat- tkabbir ta ’ inqas minn 1 ċm kull sena u near closure ta ’ l- epiphyses.
Growth disturbance due to Turner syndrome:
Disturb tat- tkabbir minħabba s- sindrome ta ’ Turner:
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.
Doża ta ’ 0. 045 - 0. 050 mg kuljum għal kull kilogramm ta ’ piż tal- ġisem jew 1. 4 mg/ m2 ta ’ erja tas - superfiċje tal- ġisem kuljum hi rakkomandata.
Growth disturbance in chronic renal insufficiency:
Disturb tat- tkabbir f’ insuffiċjenza kronika tal- kliewi:
A dose of 1.4 mg/ m2 body surface area per day (0.045 - 0.050 mg/ kg body weight per day) is recommended.
Doża ta ’ 1. 4 mg/ m2 ta ’ erja tas- superfiċje tal- ġisem kuljum (0. 045 - 0. 050 mg kuljum għal kull kilogramm ta ’ piż tal- ġisem) hi rakkomandata.
Higher doses may be needed if growth velocity is too low.
Dożi ogħla jistgħu jkunu meħtieġa jekk il- velocità tat - tkabbir tkun baxxa wisq.
A dose correction may be needed after six months of treatment (see section 4.4).
Aġġustament fid- doża jista ’ jkun meħtieġ wara sitt xhur ta ’ kura (ara sezzjoni 4. 4).
Growth disturbance in short children/ adolescents born small for gestational age (SGA):
Disturb tat- tkabbir fi tfal/ adolexxenti qosra li twieldu żgħar għaż- żmien tat- tqala (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).
Doża ta ’ 0. 035 mg kuljum għal kull kilogramm ta ’ piż tal- ġisem (1 mg/ m2 ta ’ erja tas- superfiċje tal - ġisem kuljum) hi normalment rakkomandata sakemm jintlaħaq it- tul finali (ara sezzjoni 5. 1).
Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1.
Il- kura għandha titwaqqaf wara l- ewwel sena ta ’ kura jekk l- SDS tar- rata tat- tul ikun taħt + 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 epiphyseal closure.
Il- kura għandha titwaqqaf jekk ir- rata tat- tul hi ta ’ < 2 ċm/ sena u, jekk il- konferma tkun meħtieġa, l- età ta ’ għadam tkun ta ’ > 14- il sena (bniet) jew ta ’ > 16- il sena (subien), li tikkorrispondi għall- għeluq ta ’ l - epiphyseal.
Dose recommendations for paediatric patients
Rakkomandazzjonijiet tad- doża għal pazjenti pedjatriċi
Indication
doża ta ’ kuljum doża ta ’ kuljum f’ mg għal f’ mg/ m2 ta ’ erja tas - Indikazzjoni
mg/ kg body weight dose
kull kilogramm ta ’ piż tal - ġisem
body surface
superfiċje tal- ġisem kuljum
Growth hormone deficiency Prader-Willi syndrome Turner syndrome Chronic renal insufficiency Children/ adolescents born small for
Defiċjenza ta ’ l- ormon tat- tkabbir Sindrome ta ’ Prader- Willi Sindrome ta ’ Turner Insuffiċjenza kronika tal- kliewi Tfal/ adolexxenti li twieldu żgħar għaż- żmien
per day 0.025 - 0.035 0.035 0.045 - 0.050 0.045 - 0.050
0. 025 - 0. 035 0. 035 0. 045 - 0. 050 0. 045 - 0. 050
area
0. 7 - 1. 0 1. 0 1. 4 1. 4
gestational age (SGA)
tat- tqala (SGA)
0.035
0. 035
Growth hormone deficient adult patients:
Pazjenti adulti b’ defiċjenza ta ’ l- ormon tat- tkabbir:
Therapy should start with a low dose, 0.15 - 0.3 mg per day.
It- terapija għandha tinbeda b’ doża baxxa, 0. 15 - 0. 3 mg kuljum.
The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration.
Id- doża għandha tiżdied gradwalment skond il- ħtiġijiet individwali tal- pazjent, kif stabbilita mill- konċentrazzjoni IGF- I.
Treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS from the age corrected mean of healthy adults.
Il- mira tal- kura għandha tkun konċentrazzjonijiet tal- fattur tat- tkabbir qisu insulina (insulin- like growth factor - IGF- I) sa 2 SDS mill- medja ikkoreġuta ta ’ l- età ta ’ adulti b’ saħħithom.
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.
Pazjenti b’ konċentrazzjonijiet normali ta ’ IGF- I fil- bidu tal- kura għandhom jingħataw l- ormon tat- tkabbir sa livell ta ’ IGF- I fil- medda tan - naħa ta ’ fuq tan- normal, li ma taqbiżx iż- 2 SDS.
Clinical response and undesirable effects may also be used as guidance for dose titration.
Ir- rispons kliniku u l- effetti mhux mixtieqa jistgħu jintużaw ukoll bħala gwida għat- titrazzjoni tad- doża.
The daily maintenance dose rarely exceeds 1.0 mg per day.
Id- doża tal- manutenzjoni ta ’ kuljum rari taqbeż il- 1. 0 mg kuljum.
Women may require higher doses than men, while men show an increasing IGF-I sensitivity over time.
In- nisa jista ’ jkollhom bżonn dożi ogħla mill- irġiel, filwaqt li l- irġiel juru sensittività IGF- I li tikber maż- żmien.
This means that there is a risk that women, especially those on oral oestrogen replacement are under-treated while men are over-treated.
Dan ifisser li hemm riskju li n- nisa, b’ mod speċjali dawk li jkunu fuq terapija tas- sostituzzjoni orali ta ’ l- estroġenu, huma kkurati inqas milli suppost, filwaqt li l- irġiel ikunu kkurati iktar milli suppost.
The accuracy of the growth hormone dose should therefore be controlled every 6 months.
Għalhekk, il- preċiżjoni tad- doża ta ’ l- ormon tat- tkabbir għandha tkun ikkontrollata kull 6 xhur.
As normal physiological growth hormone production decreases with age, dose requirements may be reduced.
Hekk kif il- produzzjoni normali fiżjoloġika ta ’ l- ormon tat- tkabbir tonqos ma ’ l- età, il- ħtiġijiet tad- doża jistgħu jitnaqqsu.
The minimum effective dose should be used.
Id- doża minima effettiva għandha tintuża.
The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
3 L- injezzjoni għandha tingħata taħt il- ġilda u s- sit ta ’ l- injezzjoni jinbidel biex tiġi evitata l- lipoatrofija.
For instructions for use and handling see section 6.6.
Għal struzzjonijiet dwar l- użu u l- immaniġġjar ara sezzjoni 6. 6.
3
4. 3 Kontra- indikazzjonijiet
- Somatropin must not be used when there is any evidence of tumour activity and anti-tumour
- Somatropin ma jridx jintuża meta jkun hemm kwalunkwe evidenza ta ’ attività tat- tumur u t -
therapy must be completed prior to starting therapy.
terapija ta ’ kontra t- tumuri għandha titlesta qabel ma tibda t- terapija b’ somatropin.
- Somatropin must not be used for growth promotion in patients with closed epiphyses.
- Somatropin ma jridx jintuża biex jippromwovi it- tkabbir f’ pazjenti b’ għeluq ta ’ l- epifisi.
- Patients with acute critical illness suffering complications following open heart surgery,
- Pazjenti b’ mard kritiku akut li jbatu minn komplikazzjonijiet wara operazzjoni tal- qalb miftuħa,
abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions must not be treated with somatropin.
operazzjoni fiż- żaqq, trawma aċċidentali multipla, waqfien akut tan- nifs jew kundizzjonijiet simili, m’ għandhomx jiġu kkurati b’ somatropin.
With regard to patients undergoing substitution therapy, see section 4.4.
Fir- rigward ta ’ pazjenti li jkunu qed jirċievu terapija tas- sostituzzjoni, ara sezzjoni 4. 4.
Somatropin may induce a state of insulin resistance and in some patients hyperglycaemia.
Somatropin jista ’ jikkaġuna stat ta ’ reżistenza għall- insulina, u f’ xi pazjenti, l- ipergliċemija.
Therefore patients should be observed for evidence of glucose intolerance.
Għalhekk il- pazjenti għandhom ikunu osservati għal evidenza ta ’ intolleranza għal glukows.
In rare cases the diagnostic criteria for diabetes mellitus type II may be fulfilled as a result of the somatropin therapy, but risk factors such as obesity (including obese PWS patients), family history, steroid treatment, or pre-existing impaired glucose tolerance have been present in most cases where this occurred.
F’ każijiet rari, il - kriterji dijanjostiċi għad- dijabete mellitus ta ’ tip II jistgħu jintlaħqu bħala riżultat tat- terapija ta ’ somatropin, iżda fatturi ta ’ riskju bħall- ħxuna żejda (li jinkludu pazjenti PWS ħoxnin), l- istorja medika tal- familja, il- kura bl- isterojdi, jew indeboliment li kien jeżisti minn qabel fit- tolleranza għal glukows, kienu preżenti fil- biċċa l- kbira tal- każijiet fejn dan seħħ.
In patients with already manifested diabetes mellitus, the anti-diabetic therapy might require adjustment when somatropin is instituted.
F’ pazjenti li diġà kellhom dijabete mellitus, it- terapija kontra d- dijabete jista ’ jkollha bżonn ta ’ aġġustament meta somatropin jinbeda.
During treatment with somatropin, an enhanced T4 to T3 conversion has been found which may result in a reduction in serum T4 and an increase in serum T3 concentrations.
Matul il- kura b’ somatropin, instabet konverżjoni mtejba minn T4 għal T3, li tista ’ tirriżulta fi tnaqqis tal- konċentrazzjonijiet tas- serum T4 u fi żieda tal- konċentrazzjonijiet tas- serum T3.
In general, the peripheral thyroid hormone levels have remained within the reference ranges for healthy subjects.
B’ mod ġenerali, il- livelli ta ’ l- ormoni tat- tirojde periferali baqgħu fil- meded tar- referenza għal pazjenti b’ saħħithom.
The effects of somatropin on thyroid hormone levels may be of clinical relevance in patients with central subclinical hypothyroidism in whom hypothyroidism theoretically may develop.
L - effetti ta ’ somatropin fuq il- livelli ta ’ l- ormoni fit- tirojde jistgħu jkunu ta ’ rilevanza klinika f’ pazjenti b’ ipotirojdiżmu sottokliniku ċentrali li fihom l- ipotirojdiżmu teoretikament jista ’ jiżviluppa.
Conversely, in patients receiving replacement therapy with thyroxin mild hyperthyroidism may occur.
Mill - banda l- oħra, f’ pazjenti li jkunu qed jirċievu terapija tas- sostituzzjoni b’ thyroxin ipertirojdiżmu ħafif jista ’ jseħħ.
It is therefore particularly advisable to test thyroid function after starting treatment with somatropin and after dose adjustments.
Għalhekk, hu partikularment rakkomandabbli li tiġi ttestjata l- funzjoni tat- tirojde wara li tibda l- kura b’ somatropin u wara aġġustamenti fid- doża.
Somatropin has been reported to reduce serum cortisol levels, possibly by affecting carrier proteins or by increasing hepatic clearance.
Kien irrappurtat li Somatropin inaqqas il- livelli tas- serum cortisol, possibbilment billi jaffettwa l - proteini li jġorruh jew billi jżid it- tneħħija mill- fwied.
The clinical relevance of these findings may be limited.
Ir- rilevanza klinika ta ’ dawn is- sejbiet tista ’ tkun limitata.
Nevertheless, corticosteroid replacement therapy should be optimised before initiation of Omnitrope therapy.
Madankollu, it- terapija tas- sostituzzjoni tal- kortikosterojdi għandha tkun ottimizzata qabel il- bidu tat- terapija b’ Omnitrope.
In growth hormone deficiency, secondary to treatment of malignant disease, it is recommended to pay attention to signs of relapse of the malignancy.
F’ defiċjenza ta ’ l- ormon tat- tkabbir, li tkun sekondarja għall- kura ta ’ mard malinn, hu rakkomandat li tingħata attenzjoni għal sinjali ta ’ rikaduta tal- malinn.
In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the hip may occur more frequently than in the general population.
F’ pazjenti b’ mard endokrinali, li jinkludi defiċjenza ta ’ l- ormon tat- tkabbir, epifisi imżerżqa tal - ġenbejn tista ’ sseħħ iktar ta ’ spiss milli fil- popolazzjoni ġenerali.
Patients limping during treatment with somatropin, should be examined clinically.
Pazjenti li jkunu jzappu matul il- kura b’ somatropin, għandhom jiġu eżaminati klinikament.
In case of severe or recurrent headache, visual problems, nausea and/ or vomiting, a fundoscopy for papilloedema is recommended.
F’ każ ta ’ uġigħ ta ’ ras sever jew rikorrenti, problemi tal- vista, dardir u/ jew rimettar, fundoskopija għal papilloedema hi rakkomandata.
If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, the growth hormone treatment should be discontinued.
Jekk il- papilloedema tkun ikkonfermata, dijanjosi ta ’ pressjoni tad - demm għolja intrakranjali beninna għandha tkun ikkunsidrata u, jekk ikun xieraq, il- kura bl- ormon tat - tkabbir għandha titwaqqaf.
At present there is insufficient evidence to give specific advice on the continuation of growth hormone treatment in patients with resolved intracranial hypertension.
Bħalissa hemm evidenza insuffiċjenti biex jingħata parir speċifiku dwar it - tkomplija tal- kura bl- ormon tat- tkabbir f’ pazjenti li jkunu fiequ minn pressjoni tad- demm għolja intrakranjali.
However, clinical experience has shown that reinstitution of the therapy is often possible without recurrence of the intracranial hypertension.
Madankollu, l- esperjenza klinika wriet li l- bidu mill- ġdid tat- terapija ta ’ spiss ikun possibbli mingħajr ir- rikorrenza tal- pressjoni tad- demm għolja intrakranjali.
If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Jekk il- kura bl- ormon tat - tkabbir tinbeda mill- ġdid, monitoraġġ bl- attenzjoni għal sintomi ta ’ pressjoni tad- demm għolja intrakranjali hu meħtieġ.
Experience in patients above 60 years is limited.
4 L- esperjenza f’ pazjenti ta ’ iktar minn 60 sena hi limitata.
In patients with PWS, treatment should always be in combination with a calorie-restricted diet.
F’ pazjenti b’ PWS, il- kura għandha dejjem tingħata flimkien ma ’ dieta b’ kaloriji ristretti.
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, history of respiratory impairment, sleep apnoea or unidentified respiratory infection.
Kien hemm rapporti ta ’ mwiet marbuta ma ’ l- użu ta l- ormon tat- tkabbir f’ pazjenti pedjatriċi li kellhom PWS, u li kellhom wieħed jew iktar mill- fatturi ta ’ riskju li ġejjin: obeżita ’ severa, storja ta ’ indeboliment respiratorju jew apnea waqt l- irqad jew infezzjoni respiratorja mhix identifikata.
Patients with PWS and one or more of these risk factors may be at greater risk.
Pazjenti b’ PWS u wieħed jew iktar minn dawn il- fatturi ta ’ riskju jistgħu jkunu f’ riskju akbar.
Patients with PWS should be evaluated for upper airway obstruction, sleep apnoea or respiratory infections before initiation of treatment with somatropin.
Pazjenti b’ PWS għandhom ikunu evalwati għal ostruzzjoni fil- passaġġ tan- nifs, apnea waqt l- irqad jew infezzjonijiet respiratorji qabel il- bidu tal- kura b’ somatropin.
4 In case of signs of upper airway obstruction, the problem should be solved by a specialist before starting treatment with somatropin.
F’ każ ta ’ sinjali ta ’ ostruzzjoni fin- naħa ta ’ fuq tal- passaġġ tan- nifs, il- problema għandha tiġi solvuta minn speċjalista qabel ma tibda l- kura b’ somatropin.
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.
L- apnea waqt l- irqad għandha tkun evalwata qabel il- bidu tal- kura bl- ormon tat- tkabbir permezz ta ’ metodi rikonoxxuti bħal polisomnografija jew oksimetrija matul il- lejl, u tkun immonitorjata jekk ikun hemm suspett ta ’ apnea waqt l- irqad.
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.
Jekk matul il- kura b’ somatropin il- pazjenti juru sinjali ta ’ ostaklu fin- naħa ta ’ fuq tal- passaġġ tan- nifs (li tinkludi l- bidu ta ’ jew żieda fl- inħir), il- kura għandha tiġi interrotta, u titwettaq evalwazzjoni ENT ġdida.
All patients with PWS should be evaluated for sleep apnoea and monitored if sleep apnoea is suspected.
Il- pazjenti kollha b’ PWS għandhom jiġu evalwati għall- apnea waqt l- irqad u immonitorjati jekk ikun hemm suspett ta ’ apnea waqt l- irqad.
All patients with PWS should be monitored for signs of respiratory infections which should be diagnosed as early as possible and treated aggressively.
Il- pazjenti kollha b’ PWS għandhom jiġu mmonitorjati għal sinjali ta ’ infezzjonijiet respiratorji li għandhom ikunu dijanjostikati kmieni kemm jista ’ jkun u kkurati b’ mod aggressiv.
All patients with PWS should have effective weight control before and during treatment with somatropin.
Il- pazjenti kollha b’ PWS għandu jkollhom kontroll effettiv tal- piż qabel u matul il- kura b’ somatropin.
Scoliosis is common in patients with PWS.
L- iskoljosi hi komuni f’ pazjenti b’ PWS.
Scoliosis may progress in any child during rapid growth.
L- iskoljosi tista ’ ssir aktar serja fi kwalunkwe tifel/ tifla matul tkabbir mgħaġġel.
Signs of scoliosis should be monitored during treatment.
Sinjali ta ’ skoljosi għandhom jiġu mmonitorjati matul il- kura.
However, growth hormone treatment has not been shown to increase the incidence or severity of scoliosis.
Madankollu, ma ntweriex li l- kura bl- ormon tat- tkabbir iżżid l- inċidenza jew is- severità ta ’ l- iskoljosi.
Experience with long term treatment in adults and in patients with PWS is limited.
L- esperjenza bil- kura fit- tul fl- adulti u f’ pazjenti b’ PWS hi limitata.
In short children/ adolescents born SGA, other medical reasons or treatments that could explain growth disturbance should be ruled out before starting treatment.
Fi tfal/ adolexxenti qosra li jitwieldu b’ SGA, raġunijiet mediċi jew kuri oħrajn li jistgħu jispjegaw id - disturb tat- tkabbir għandhom jiġu esklużi qabel ma tibda l- kura.
In SGA children/ adolescents it is recommended to measure fasting insulin and blood glucose before start of treatment and annually thereafter.
Fi tfal/ adolexxenti b’ SGA hu rakkomandat li titkejjel l- insulina fl- istat sajjem u l- glukows fid- demm qabel il- bidu tal- kura u kull sena wara dan.
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.
F’ pazjenti b’ żieda fir- riskju għal dijabete mellitus (eż. storja familjali ta ’ dijabete, obeżita ’, reżistenza severa għall- insulina, acanthosis nigricans) għandu jitwettaq ittestjar orali għat- tolleranza għall- glukows (oral glucose tolerance testing - OGTT).
If overt diabetes occurs, growth hormone should not be administered.
Jekk isseħħ dijabete evidenti, l- ormon tat- tkabbir m’ għandux jingħata.
In SGA children/ adolescents it is recommended to measure the IGF-I level before start of treatment and twice a year thereafter.
Fi tfal/ adolexxenti b’ SGA hu rakkomandat li tkejjel il- livell ta ’ IGF- I qabel il- bidu tal- kura, u darbtejn fis- sena wara dan.
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.
Jekk, wara kejl ripetut, il- livelli ta ’ IGF- I jaqbżu +2 SD meta mqabbla mar - referenzi għall- età u l- istat pubertali, il- proporzjon ta ’ IGF- I / IGFBP- 3 għandu jiġi kkunsidrat meta tikkunsidra l- aġġustament tad- doża.
Experience in initiating treatment in SGA patients near onset of puberty is limited.
L- esperjenza fil- bidu tal- kura f’ pazjenti b’ SGA li jkunu qrib il- bidu tal- pubertà hi limitata.
It is therefore not recommended to initiate treatment near onset of puberty.
Għalhekk, mhux rakkomandat li tibda l- kura 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 growth hormone may be lost if treatment is stopped before final height is reached.
Ftit mit- tul li jinkiseb bil- kura ta ’ tfal/ adolexxenti qosra li jitwieldu b’ SGA bl- ormon tat- tkabbir, jista ’ jintilef jekk il- kura titwaqqaf qabel jintlaħaq it- tul finali.
In chronic renal insufficiency, renal function should be below 50 percent of normal before institution of therapy.
5 F’ insuffiċjenza kronika tal- kliewi, il- funzjoni tal- kliewi għandha tkun taħt il- 50 fil- mija ta ’ dik normali qabel ma tinbeda t- terapija.
To verify growth disturbance, growth should be followed for a year preceding institution of therapy.
Biex ikun ivverifikat disturb tat- tkabbir, it- tkabbir għandu jkun segwit għal sena qabel ma tinbeda t- terapija.
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.
Matul dan perjodu, kura konservattiva għal insuffiċjenza tal- kliewi (li tinkludi l- kontroll ta ’ l- aċidożi, ta ’ l- iperparatirojdiżmu u l- istat tan- nutriment) għandha tiġi stabbilita u għandha tinżamm matul il- kura.
The treatment should be discontinued at renal transplantation.
Il- kura għandha titwaqqaf jekk isir trapjant tal- kliewi.
To date, no data on final height in patients with chronic renal insufficiency treated with Omnitrope are available.
S’ issa, m’ hemm l- ebda informazzjoni disponibbli dwar it- tul finali f’ pazjenti b’ insuffiċjenza kronika tal- kliewi li kienu kkurati b’ Omnitrope.
Mortality was higher in patients
L- effetti ta ’ somatropin fuq l- irkuprar kienu studjati f’ żewġ provi kkontrollati bil- plaċebo li kienu jinvolvu 522 pazjent adult li kienu morda b’ mod kritiku, li kienu qed isofru minn komplikazzjonijiet wara operazzjoni tal- qalb miftuħa, operazzjoni fl- addome, trawma aċċidentali multipla jew waqfien akut tan- nifs.
5 treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs.
Il- mortalità kienet ogħla f’ pazjenti kkurati b’ 5. 3 jew 8 mg ta ’ somatropin kuljum meta mqabbla ma ’ pazjenti li jkunu qed jirċievu l- plaċebo, 42% vs.
Based on this information, these types of patients should not be treated with somatropin.
Ibbażat fuq din informazzjoni, dawn it- tipi ta ’ pazjenti m’ għandhomx jiġu kkurati b’ 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.
Billi m’ hemm l- ebda informazzjoni disponibbli dwar is- sigurtà tat- terapija tas- sostituzzjoni ta ’ l- ormon tat- tkabbir f’ pazjenti li huma morda b’ mod kritiku, il- benefiċċji tat- tkomplija tal- kura f’ din sitwazzjoni għandhom jitqabblu mar - riskji potenzjali involuti.
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.
Fil- pazjenti kollha li jiżviluppaw mard kritiku akut ieħor jew mard simili, il- benefiċċju possibbli tal - kura b’ somatropin għandu jitqabbel mar- riskju potenzjali involut.
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 1 ml, i. e. hu essenzjalment ‘ sodium- free ’.
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.
Informazzjoni miksuba minn studju dwar l- interazzjoni li twettaq f’ adulti li kellhom defiċjenza ta ’ l - ormon tat- tkabbir, tissuġġerixxi li l- għoti ta ’ somatropin jista ’ jżid it- tneħħija ta ’ komposti li hu magħruf li jkunu metabolati mill- isoenzimi ta ’ ċitokrom P 450.
The clearance of compounds metabolised by cytochrome P 450 3A4 (e. g. sex steroids, corticosteroids, anticonvulsants and ciclosporin) may be especially increased resulting in lower plasma levels of these compounds.
It- tneħħija ta ’ komposti metabolati minn ċitokrom P 450 3A4 (eż. sterojdi tas- sess, kortikosterojdi, mediċini kontra l- konvulżjoni u ciclosporin) jistgħu jiżdiedu b’ mod partikulari, u dan jirriżulta f’ livelli iktar baxxi fil- plażma ta ’ dawn il- komposti.
The clinical significance of this is unknown.
Ir- rilevanza klinika ta ’ dan il- fatt mhijiex magħrufa.
Also see section 4.4 for statements regarding diabetes mellitus and thyroid disorder and section 4.2 for statement on oral oestrogen replacement therapy.
Ara wkoll sezzjoni 4. 4 għal dikjarazzjonijiet dwar id- dijabete mellitus u mard tat- tirojde u sezzjoni 4. 2 għal dikjarazzjoni dwar it- terapija tas- sostituzzjoni orali ta ’ l- estroġenu.
For Omnitrope no clinical data on exposed pregnancies are available.
Għall Omnitrope m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal experimental data on reproductive toxicity of Omnitrope are not available.
Informazzjoni sperimentali dwar l- annimali fuq it- tossiċità riproduttiva ta ’ Omnitrope mhijiex disponibbli.
Treatment with Omnitrope should be interrupted if pregnancy occurs.
Il- kura b’ Omnitrope għandha tiġi interrotta jekk isseħħ it- tqala.
During normal pregnancy levels of pituitary growth hormone fall markedly after 20 gestation weeks, being replaced almost entirely by placental growth hormone by 30 weeks.
Matul tqala normali, il- livelli ta ’ l- ormon tat- tkabbir pitwitarju jaqgħu b’ mod qawwi wara 20 ġimgħa ta ’ tqala, u dawn jinbidlu kważi kompletament mill- ormon tat- tkabbir tal- plaċenta sa 30 ġimgħa.
In view of this, it is unlikely that continued replacement therapy with somatropin would be necessary in growth hormone deficient women in the third trimester of pregnancy.
Minħabba dan il- fatt, mhux mistenni li t- tkomplija tat- terapija tas- sostituzzjoni b’ somatropin ser tkun meħtieġa f’ nisa b’ defiċjenza ta ’ l- ormon tat- tkabbir fit- tielet tliet xhur tat- tqala.
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.
Mhux magħruf jekk somatropin jitneħħiex fil- ħalib tas- sider, iżda l- assorbiment ta ’ proteina intatta mill- apparat gastrointestinali tat- tarbija hu estremament mhux mistenni.
Caution should be exercised when Omnitrope is administered to breast-feeding women.
Wieħed għandu joqgħod attent meta jikteb riċetta għal Omnitrope jingħata għal nisa li jkunu qed ireddgħu.
Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
Fil- kategoriji tas- sistemi ta ’ l- organi, ir- reazzjonijiet avversi huma elenkati taħt titli ta ’ frekwenza (numru ta ’ pazjenti li huma mistennija li jkollhom ir- reazzjoni), bl- użu tal- kategoriji li ġejjin: komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100, < 1/ 10); mhux komuni (≥ 1/ 1, 000, < / 100); rari (≥ 1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000).
Patients with growth hormone deficiency are characterised by extracellular volume deficit.
Pazjenti b’ defiċjenza ta ’ l- ormon tat- tkabbir huma kkaratterizzati minn defiċit tal- volum ekstraċellulari.
When treatment with somatropin is started this deficit is rapidly corrected.
Meta l- kura b’ somatropin tinbeda, dan id- defiċit jiġi kkoreġut malajr.
In adult patients, adverse reactions related to fluid retention, such as peripheral oedema, stiffness in the extremities, arthralgia, myalgia and paraesthesia are common.
F’ pazjenti adulti, reazzjonijiet avversi marbuta maż- żamma tal- fluwidu, bħal edema periferali, ebusija fl- estremitajiet, artralġja, mijalġja u parestesija huma komuni.
In general these adverse reactions are mild to moderate, arise within the first months of treatment and subside spontaneously or with dose-reduction.
B’ mod ġenerali, dawn ir- reazzjonijiet avversi huma minn ħfief sa moderati, u jseħħu matul l- ewwel xhur tal- kura u jfiequ spontanjament jew bi tnaqqis tad- doża.
The incidence of these undesirable effects 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.
L- inċidenza ta ’ dawn l- effetti mhux mixtieqa hi marbuta mad- doża li tingħata, l- età tal - pazjenti, u possibbilment hi marbuta b’ mod invers ma ’ l- età tal- pazjenti fil- bidu tad- defiċjenza ta ’ l - ormon tat- tkabbir.
In paediatric patients such undesirable effects are uncommon.
F’ pazjenti pedjatriċi, effetti mhux mixtieqa bħal dawn mhumiex komuni.
6 Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
Leukemia.
Lewkimja.
Very rare cases of leukaemia have been reported in growth hormone deficient paediatric patients treated with somatropin, but the incidence appears to be similar to that in the paediatric subjects without growth hormone deficiency.
Każijiet rari ħafna ta ’ lewkimja kienu rrappurtati f’ pazjenti b’ defiċjenza ta ’ l- ormon tat- tkabbir li kienu kkurati b’ somatropin, iżda l- inċidenza tidher li hi simili għal dik f’ pazjenti pedjatriċi mingħajr defiċjenza ta ’ l- ormon tat- tkabbir.
Formation of antibodies.
Formazzjoni ta ’ antikorpi.
Somatropin has given rise to the formation of antibodies in approximately 1% of the patients.
Somatropin ikkawża l- formazzjoni ta ’ antikorpi f’ madwar 1% tal- pazjenti.
The binding capacity of these antibodies has been low and no clinical changes have been associated with their formation.
Il- kapaċità tat- twaħħil ta ’ dawn l- antikorpi kienet baxxa u l- ebda bidliet kliniċi ma kienu assoċjati mal- formazzjoni tagħhom.
Diabetes mellitus type II
Dijabete mellitus ta ’ tip II
In adults: paraesthesia In adults: carpal tunnel syndrome; In paediatric patients: paraesthesia Benign intracranial hypertension
Fl- adulti: parestesija Fl- adulti: sindrome tal- carpal tunnel; F’ pazjenti pedjatriċi: parestesija Pressjoni tad- demm għolja intrakranjali beninna
and connective tissue disorders
Disturbi muskolu- skeltrali u tal- connective tissue
In adults: stiffness in the extremities, arthralgia, myalgia In paediatric patients: stiffness in the extremities, arthralgia, myalgia
Fl- adulti: ebusija fl- estremitajiet, artralġja, mijalġja F’ pazjenti pedjatriċi: ebusija fl- estremitajiet, artralġja, mijalġja
In adults: peripheral oedema; In paediatric patients: transient local skin reactions at the injection site
Fl- adulti: edema periferali; F’ pazjenti pedjatriċi: reazzjonijiet lokali tal- ġilda li jgħaddu malajr fis- sit ta ’ l- injezzjoni
In paediatric patients: peripheral oedema
F’ pazjenti pedjatriċi: edema periferali
4.9 Overdose
eċċessiva
Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Doża eċċessiva akuta tista ’ twassal, inizjalment, għal ipogliċemija u, sussegwentement, għal ipergliċemija.
Long-term overdose could result in signs and symptoms consistent with the known effects of human growth hormone excess.
Doża eċċessiva fit- tul tista ’ tirriżulta f’ sinjali u f’ sintomi konsistenti ma ’ l- effetti magħrufa ta ’ l- eċċess ta ’ l- ormon tat- tkabbir tal- bniedem.
Pharmacotherapeutic group: anterior pituitary lobe hormones and analogues.
Kategorija farmakoterapewtika: ormoni tal- lobu pitwitarju anterjuri u analogi.
Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates and proteins.
Somatropin hu ormon metaboliku qawwi li hu importanti għall- metaboliżmu tal- lipidi, karboidrati u proteini.
In children with inadequate endogenous growth hormone, somatropin stimulates linear growth and increases growth rate.
Fi tfal b’ ormon tat- tkabbir endoġeniku inadegwat, somatropin jistimula tkabbir lineari u jżid ir- rata tat- tkabbir.
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.
Fl- adulti kif ukoll fit- tfal, somatropin iżomm kompożizzjoni normali tal- ġisem billi jżid iż- żamma tan- nitroġenu u l- istimulazzjoni tat- tkabbir tal- muskoli skeletriċi, u bil- mobilizzazzjoni tax- xaħam tal- ġisem.
Visceral adipose tissue is particularly responsive to somatropin.
It- tessut imxaħħam tal- vixxri, b’ mod partikulari, jirrispondi għal somatropin.
In addition to enhanced lipolysis, somatropin decreases the uptake of triglycerides into body fat stores.
Flimkien ma ’ lipolisi mtejba, somatropin inaqqas it- teħid tat- triglycerides għall- ħażna tax- xaħam fil - ġisem.
Serum concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor Binding Protein 3) are increased by somatropin.
Il- konċentrazzjonijiet tas- serum ta ’ IGF- I (Fattur tat- tkabbir li jixbaħ lil insulina/ Insulin- like Growth Factor- I) u ta ’ IGFBP3 (Proteina li torbot 3 Fattur tat- tkabbir li jixbaħ lil insulina / Insulin- like Growth Factor Binding Protein 3) jiżdiedu b’ somatropin.
In addition, the following actions have been demonstrated.
Flimkien ma ’ dan, intwerew dawn l - azzjonijiet li ġejjin.
7 Lipid metabolism:
Metaboliżmu tal- lipidi: