FrancophonIA/ELRC3.0 huggingface dataset:
English: Omnitrope 10 mg/1.5 ml solution for injection Each ml of solution contains 6.7 mg of somatropin* (corresponding to 20 IU) One cartridge contains 1.5 ml corresponding to 10 mg somatropin* (30 IU).
Maltese: Omnitrope 10 mg/1.5 ml soluzzjoni għall-injezzjoni Kull ml tas-soluzzjoni fih 6.7 mg ta' somatropin* (li jikkorrispondi għal 20
English: It may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Maltese: Jista' jikkawża reazzjonijiet tossiċi u reazzjonijiet allerġiċi fi trabi u tfal ta' età ta' mhux aktar minn 3 snin.
English: It is therefore not recommended to initiate treatment near onset of puberty.
Maltese: Għalhekk, mhux rakkomandat li tibda l-kura qrib il-bidu tal-pubertà.
English: Class
Maltese: UŻU
English: The mean terminal half-life of somatropin after intravenous administration in growth hormone deficient adults is about 0.4 hours.
Maltese: Il-medja tal-half-life terminali ta' somatropin wara l-għoti ġol-vina f'adulti li kellhom defiċjenza ta' lormon tat-tkabbir hi ta' madwar 0.4 ta' siegħa.
English: In patients with a high likelihood for persistent GHD, i.e. a congenital cause or GHD secondary to a hypothalamic-pituitary disease or insult, an insulin-like growth factor-I (IGF-I) SDS < -2 off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of profound GHD.
Maltese: F'pazjenti bi probabbiltà kbira li jkollhom GHD persistenti, i.e. kawża konġenitali jew GHD li tkun sekondarja għal mard jew insult ipotalamiku-pitwitarju, b'kura b'ormon tat-tkabbir b'fattur tat-tkabbir I qisu insulin (IGF-I) SDS < -2 għal mill-inqas 4 ġimgħat, għandu jiġi kkunsidrat bħala evidenza suffiċjenti ta' GHD profonda.
English: Omnitrope 15 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections
Maltese: Omnitrope 15 mg/1.5 ml soluzzjoni għall-injezzjoni disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol ilma għall-injezzjonijiet
English: Uncommo n
Maltese: ANNESS II
English: In clinical trials in short children/adolescents born SGA doses of 0.033 and 0.067 mg/kg body weight per day have been used for treatment until final height is reached.
Maltese: Fi provi kliniċi fi tfal/adolexxenti qosra li twieldu b'SGA, dożi ta' 0.033 u 0.067 mg kuljum għal kull kilogramm ta' piż tal-ġisem intużaw għall-kura sakemm jintlaħaq it-tul finali.
English: In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity no clinically relevant effects have been observed.
Maltese: Fi studji oħrajn b'somatropin dwar it-tossiċità ġenerali, it-tolleranza lokali u t-tossiċità tarriproduzzjoni, l-ebda effetti klinikament rilevanti ma kienu osservati.
English: 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.
Maltese: Informazzjoni miksuba minn studju dwar l-interazzjoni li twettaq f'adulti li kellhom defiċjenza ta' lormon 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.
English: - Growth disturbance associated with Turner syndrome.
Maltese: - Disturb tat-tkabbir assoċjat mas-sindrome ta' Turner.
English: Chronic renal insufficiency Children/adolescents born small for gestational age (SGA)
Maltese: Disturb tat-tkabbir fi tfal qosra/adolexxenti li twieldu żgħar għaż-żmien tat-tqala (small for gestational age - SGA)
English: Omnitrope 5 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol water for injections
Maltese: Omnitrope 5 mg/1.5 ml soluzzjoni għall-injezzjoni disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol ilma għall-injezzjonijiet
English: Uncommo n ≥ 1/1,000 to < 1/100
Maltese: Mhux komuni sa <1/100
English: Turn the vial upside down and using another sterile, disposable syringe of appropriate size (e.g. 1 ml syringe) and injection needle (e.g. 0.25 mm x 8 mm) withdraw a bit more than the dose needed back into the syringe.
Maltese: - siringa sterili, li tintrema wara li tintuża, ta' daqs adattat (eż. siringa ta' 1 ml) u labra ta' l-injezzjoni (eż. 0.25 mm x 8 mm) għallinjezzjoni taħt il-ġilda (mhux fornuti fil-pakkett). - 2 biċċiet li jnaddfu (mhux fornuti fil-pakkett).
English: - Take the vial with solvent and the sterile, disposable syringe (e.g. 2 ml syringe) and needle (e.g. 0.33 mm x 12.7 mm).
Maltese: - Ħu l-kunjett bis-solvent u s-siringa sterili, li tintrema wara li tintuża (eż. siringa ta' 2 ml u labra (eż. 0.33 mm x 12.7 mm).
English: An increased chromosome fragility has been observed in one in vitro study on lymphocytes taken from patients after long term treatment with somatropin and following the addition of the radiomimetic drug bleomycin.
Maltese: Żieda fil-fraġilità tal-kromosomi kienet osservata fi studju in vitro fuq limfoċiti meħuda minn pazjenti wara kura fit-tul b'somatropin u wara ż-żieda tal-mediċina radjumimetika bleomycin.
English: 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.
Maltese: Jekk, wara kejl ripetut, il-livelli ta' IGF-I jaqbżu +2 SD meta mqabbla marreferenzi għall-età u l-istat pubertali, il-proporzjon ta' IGF-I / IGFBP-3 għandu jiġi kkunsidrat meta tikkunsidra l-aġġustament tad-doża.
English: What Omnitrope 15 mg/1.5 ml contains
Maltese: Omnitrope 15 mg/1.5 ml
English: Other adverse drug reactions may be considered somatropin class effects, such as possible hyperglycaemia caused by decreased insulin sensitivity, decreased free thyroxin level and benign intra-cranial hypertension.
Maltese: Reazzjonijiet avversi oħra tal-mediċina jistgħu jiġu kkunsidrati bħala effetti tal-klassi ta' somatropin, bħal ipergliċemija possibbli kkawżata minn tnaqqf is-sensittività għall-insulina, tnaqqis fil-livell ta' thyroxin ħieles u pressjoni għolja beninna intrakranjali.
English: One cartridge contains 15 mg (corresponding to 45 IU) of somatropin in 1.5 ml.
Maltese: Skartoċċ fih 15 mg (li jikkorrispondu għal 45 IU) ta' somatropin f'1.5 ml.
English: For instructions for use and handling see section 6.6.
Maltese: Għal struzzjonijiet fuq l-użu u l-immaniġġjar ara sezzjoni 6.6.
English: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol water for injections
Maltese: - Is-sustanzi l-oħra huma: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol ilma għall-injezzjonijiet
English: A subcutaneous dose of 5 mg of Omnitrope powder and solvent for solution for injection in healthy adults results in plasma Cmax values of 71 ± 24 µg/l (mean ± SD) and median tmax value of 4 hours (range 2-8 hours), respectively.
Maltese: Doża ta' 5 mg ta' Omnitrope trab u solvent għal soluzzjoni għall-injezzjoni li tingħata taħt il-ġilda f'adulti b'saħħithom tirriżulta f'valuri tas-Cmax tal-plażma ta' 71 ± 24 µg/ L (medja ± SD) u l-valur medjan ta' tmax ta' 4 sigħat (medda 28 sigħat), rispettivament.
English: What Omnitrope 10 mg/1.5 ml contains
Maltese: Omnitrope 10 mg/1.5 ml
English: Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: water for injections
Maltese: Trab: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: ilma għall-injezzjonijiet
English: The effects of somatropin on recovery were studied in two placebo controlled trials involving 522 critically ill adult patients suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure.
Maltese: 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 bil-qalb miftuħa, operazzjoni fiż-żaqq, trawma aċċidentali multipla jew waqfien akut tan-nifs.
English: 0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.
Maltese: 0.045-0.050 mg/kg ta' piż tal-ġisem kuljum jew 1.4 mg/m ta' erja tas-superfiċje tal-ġisem kuljum.
English: Patients with diabetes, glucose intolerance, or additional risk factors for diabetes should be monitored closely during somatropin therapy.
Maltese: Pazjenti biddijabete, intolleranza għal glucose, jew fatturi ta' riskju addizzjonali għad-dijabete, għandhom jiġu mmonitorjati mill-qrib matul it-terapija b'somatropin.
English: All products:
Maltese: Il-prodotti kollha:
English: Benign intracranial hypertension
Maltese: Soluzzjoni għall-injezzjoni.
English: Infants, children and adolescents - Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD).
Maltese: Trabi, tfal u adolexxenti - Disturb tat-tkabbir minħabba tnixxija insuffiċjenti ta' l-ormon tat-tkabbir (defiċjenza tal-ormon tat-tkabbir, GHD).
English: What Omnitrope 5 mg/1.5 ml contains
Maltese: Omnitrope 5 mg/1.5 ml
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 1.3 mg/ml powder and solvent for solution for injection Somatropin
Maltese: Omnitrope 1.3 mg/ ml trab u solvent għal soluzzjoni għall-injezzjoni Somatropin
English: • if you are allergic (hypersensitive) to somatropin or to any of the other ingredients of Omnitrope.
Maltese: • jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal somatropin jew sustanzi oħra ta' Omnitrope.
English: Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/007
Maltese: Omnitrope 10 mg/1.5 ml soluzzjoni għall-injezzjoni EU/1/06/332/007
English: 1 cartridge for SurePal 10 5 cartridges for SurePal 10 10 cartridges for SurePal 10
Maltese: 10 skartoċċi għal SurePal 10
English: How to inject Omnitrope 5 mg/ml
Maltese: Omnitrope 5 mg/ ml
English: Powder and solvent for solution for injection (powder in a vial (5 mg), solvent in a cartridge (1 ml)) Pack sizes of 1 and 5.
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni (trab f'kunjett (5 mg), solvent f'kunjett (1 ml)).
English: 1 cartridge for SurePal 15 5 cartridges for SurePal 15 10 cartridges for SurePal 15
Maltese: 5 skartoċċi għal SurePal 15
English: In adults Omnitrope is used to
Maltese: F'persuni adulti Omnitrope jintuża biex
English: Omnitrope 15 mg/1.5 ml solution for injection Each ml of solution contains 10 mg of somatropin* (corresponding to 30 IU) One cartridge contains 1.5 ml corresponding to 15 mg somatropin* (45 IU).
Maltese: Omnitrope 15 mg/1.5 ml soluzzjoni għall-injezzjoni Kull ml tas-soluzzjoni fih 10 mg ta' somatropin* (li jikkorrispondi għal 30
English: - a pen needle for subcutaneous injection.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni.
English: Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully adjusted to avoid any inhibitory effect on growth.
Maltese: Jekk ikun meħtieġ, għandha tinbeda terapija ta' sostituzzjoni bi glukokortikojdi.
English: Clinical trials in children with Turner syndrome
Maltese: Provi kliniċi fi tfal bis-sindrome ta' Turner
English: Flip off the plastic protective cap from the vial.
Maltese: Neħħi l-għatu protettiv tal-plastik mill-kunjetti.
English: In patients with hypopituitarism on standard replacement therapy, the potential effect of growth hormone treatment on thyroid function must be closely monitored
Maltese: F'pazjenti b'ipopitwitariżmu li jkunu fuq terapija standard tas-sostituzzjoni, l-effett potenzjali tal-kura bl-ormon tat-tkabbir fuq il-funzjoni tat-tirojde jrid jiġi mmonitorjat mill-qrib.
English: One cartridge contains 1.5 ml corresponding to 10 mg somatropin (30 IU).
Maltese: Skartoċċ wieħed fih 1.5 ml li jikkorrispondu għal 10 mg ta' somatropin (30 IU).
English: Omnitrope 15 mg/1.5 ml in a cartridge for SurePal 15 is intended for multiple use.
Maltese: Omnitrope 15 mg/1.5 ml fi skartoċċ għal SurePal 15 hija maħsuba biex tintuża diversi drabi.
English: Benign intracrania l hypertensi on
Maltese: Metaboliżmu ta' l-ilma u tal-minerali
English: The incidence of these adverse effects is related to the administered dose, the age of the patients, and possibly inversely related to the age of the patients at the onset of growth hormone deficiency.
Maltese: L-inċidenza ta' dawn l-effetti avversi hi marbuta mad-doża li tingħata, l-età tal-pazjenti, u possibbilment hi marbuta b'mod invers mal-età tal-pazjenti fil-bidu tad-defiċjenza tal-ormon tat-tkabbir.
English: Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/004
Maltese: Omnitrope 5 mg/1.5 ml soluzzjoni għall-injezzjoni EU/1/06/332/004
English: Omnitrope 15 mg/1.5 ml solution for injection 18 months.
Maltese: Omnitrope 15 mg/1.5 ml soluzzjoni għall-injezzjoni 18-il xahar.
English: Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/016
Maltese: Omnitrope 10 mg/1.5 ml soluzzjoni għall-injezzjoni EU/1/06/332/016
English: Omnitrope 5 mg/1.5 ml solution for injection Each ml of solution contains 3.3 mg of somatropin* (corresponding to 10 IU) One cartridge contains 1.5 ml corresponding to 5 mg somatropin* (15 IU).
Maltese: Somatropin 3.3 mg (10 IU)/ml. Skartoċċ wieħed fih 1.5 ml li jikkorrispondi għal 5 mg ta' somatropin (15 IU).
English: Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
Maltese: Effetti sekondarji mhux komuni (x'aktarx iseħħu f'inqas minn 1 minn kull 100 pazjent) jinkludu:
English: Marketing Authorisation Holder Sandoz GmbH
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Whereas the peripheral thyroid hormone levels have remained within the reference ranges for healthy subjects, hypothyroidism theoretically may develop in subjects with subclinical hypothyroidism.
Maltese: Filwaqt li l-livelli ta' l-ormoni tat-tirojde periferali baqgħu fil-meded tar-referenza għal pazjenti b'saħħithom, lipotirojdiżmu teoretikament jista' jiżviluppa f'persuni li jkollhom ipertirojdiżmu subkliniku.
English: The powder is white.
Maltese: Il-kontenut għandu jkun ċara u bla kulur.
English: Omnitrope 15 mg/1.5 ml solution for injection EU/1/06/332/010
Maltese: Omnitrope 15 mg/1.5 ml soluzzjoni għall-injezzjoni EU/1/06/332/010
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Maltese: - Is-sustanzi l-oħra huma: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol ilma għall-injezzjonijiet
English: Information about the pharmacokinetics of somatropin in geriatric and paediatric populations, in different races and in patients with renal, hepatic or cardiac insufficiency is either lacking or incomplete.
Maltese: L-informazzjoni dwar il-farmakokinetiċi ta' somatropin f'popolazzjonijiet ġerjatriċi u pedjatriċi, f'razez differenti u f'pazjenti b'indeboliment tal-kliewi, tal-fwied jew insuffiċjenza kardijaka, ma teżistix jew hi inkompleta.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Solvent for Omnitrope (water for injections with 1.5% benzyl alcohol) Subcutaneous use.
Maltese: U MNEJN GĦANDU JINGĦATA Solvent għal Omnitrope (ilma għal injezzjonijiet ma' 1.5% ta' benzyl alcohol) Użu għal taħt il-ġilda
English: Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/013
Maltese: Omnitrope 5 mg/1.5 ml soluzzjoni għall-injezzjoni EU/1/06/332/013
English: Omnitrope 15 mg/1.5 ml solution for injection
Maltese: Omnitrope 15 mg/1.5 ml soluzzjoni għall-injezzjoni
English: INFORMATION IN BRAILLE Omnitrope 5 mg/1.5 ml
Maltese: X'fih Omnitrope 5 mg/1.5 ml
English: You may need to read it again.
Maltese: Tnaqqis ta' kortisol fiddemm‡
English: Growth disturbance due to insufficient secretion of growth hormone in paediatric patients Generally a dose of 0.025 - 0.035 mg/kg body weight per day or 0.7 - 1.0 mg/m2 body surface area per day is recommended.
Maltese: Disturb tat-tkabbir minħabba tnixxija insuffiċjenti ta' l-ormon tat-tkabbir f'pazjenti pedjatriċi Ġeneralment doża ta' 0.025-0.035 mg kuljum għal kull kilogramm ta' piż tal-ġisem jew 0.71.0 mg/m ta' erja tas-superfiċje tal-ġisem kuljum hi rakkomandata.
English: INFORMATION IN BRAILLE Omnitrope 15 mg/1.5 ml
Maltese: X'fih Omnitrope 15 mg/1.5 ml
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections
Maltese: - Is-sustanzi l-oħra huma: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol ilma għall-injezzjonijiet
English: Push the needle fitted to the syringe through the rubber membrane.
Maltese: Imbotta llabra mwaħħla mas-siringa minn ġol-membrana tal-lastku.
English: Patients with growth hormone deficiency are characterised by extracellular volume deficit.
Maltese: Pazjenti b'defiċjenza ta' l-ormon tat-tkabbir huma kkaratterizzati minn defiċit tal-volum ekstraċellulari.
English: • For single use only.
Maltese: • Jintuża darba biss.
English: Omnitrope 10 mg/1.5 ml solution for injection
Maltese: Omnitrope 10 mg/1.5 ml soluzzjoni għall-injezzjoni
English: If a woman taking somatropin begins oral oestrogen therapy, the dose of somatropin may need to be increased to maintain the serum IGF-1 levels within the normal age-appropriate range.
Maltese: Jekk mara li tkun qed tieħu somatotropin tibda t-terapija b'estroġenu orali, id-doża ta' somatotropin jaf ikollha bżonn tiżdied sabiex iżżomm il-livelli ta' IGF-1 fis-serum fil-medda normali adattata għall-età.
English: INFORMATION IN BRAILLE Omnitrope 10 mg/1.5 ml
Maltese: X'fih Omnitrope 10 mg/1.5 ml
English: Omnitrope 10 mg/1.5 ml solution for injection 18 months.
Maltese: Omnitrope 10 mg/1.5 ml soluzzjoni għall-injezzjoni 18-il xahar.
English: Omnitrope 1.3 mg/ml powder and solvent for solution for injection
Maltese: Omnitrope 1.3 mg/ ml trab u solvent għal soluzzjoni għall-injezzjoni
English: Omnitrope 10 mg/1.5 ml in a cartridge for SurePal 10 is intended for multiple use.
Maltese: Omnitrope 10 mg/1.5 ml fi skartoċċ għal SurePal 10 hija maħsuba biex tintuża diversi drabi.
English: - a sterile, disposable syringe (e.g. 2 ml syringe) and needle (e.g.
Maltese: Żommu kiesaħ waqt il-ħażna u l-ġarr (2C - 8C).
English: One cartridge contains 1.5 ml corresponding to 5 mg somatropin (15 IU).
Maltese: Skartoċċ wieħed fih 1.5 ml li jikkorrispondi għal 5 mg ta' somatropin (15 IU).
English: 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day.
Maltese: 0.035 mg/kg ta' piż tal-ġisem kuljum jew 1.0 mg/m2 ta' erja tas-superfiċje tal-ġisem kuljum.
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 10 mg/1.5 ml solution for injection Somatropin
Maltese: Omnitrope 10 mg/1.5 ml soluzzjoni għall-injezzjoni Somatropin
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/ml powder and solvent for solution for injection Somatropin
Maltese: Omnitrope 5 mg/ ml trab u solvent għal soluzzjoni għall-injezzjoni Somatropin
English: Omnitrope 5 mg/ml is intended for multiple use.
Maltese: Omnitrope 5 mg/ ml hu maħsub biex jintuża diversi drabi.
English: Solvent: water for injections
Maltese: Solvent: ilma għall-injezzjonijiet
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 15 mg/1.5 ml solution for injection Somatropin
Maltese: Omnitrope 15 mg/1.5 ml soluzzjoni għall-injezzjoni Somatropin
English: Omnitrope 5 mg/1.5 ml in a cartridge for SurePal 5 is intended for multiple use.
Maltese: Omnitrope 5 mg/1.5 ml fi skartoċċ għal SurePal 5 hija maħsuba biex tintuża diversi drabi.
English: Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1.
Maltese: Il-kura għandha titwaqqaf wara l-ewwel sena ta' kura jekk l-SDS tal-veloċita' tat-tul ikun taħt + 1.
English: Growth disturbance in short children/adolescents born small for gestational age (SGA) A dose of 0.035 mg/kg body weight per day (1 mg/m2 body surface area per day) is usually recommended until final height is reached (see section 5.1).
Maltese: Doża ta' 0.035 mg kuljum għal kull kilogramm ta' piż tal-ġisem (1 mg/m ta' erja tas-superfiċje talġisem kuljum) hi normalment rakkomandata sakemm jintlaħaq it-tul finali (ara sezzjoni 5.1).
English: For patients with diabetes mellitus, the insulin dose may require adjustment after somatropin therapy is instituted.
Maltese: Għal pazjenti b'dijabete mellitus, id-doża talinsulina jista' jkollha bżonn ta' aġġustament wara li tinbeda t-terapija b'somatropin.
English: There have been rare cases of sudden death in patients with Prader-Willi syndrome.
Maltese: Kien hemm każijiet rari ta' mewt f'daqqa f'pazjenti bis-Sindrome ta' Prader-Willi.
English: Measuring the dose of Omnitrope to be injected - Take the sterile, disposable syringe of appropriate size (e.g. 1 ml syringe) and injection needle (e.g. 0.25 mm x 8 mm).
Maltese: siringa ta'1 ml) u l-labra ta' l-injezzjoni (eż. 0.25 mm x 8 mm).
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/1.5 ml solution for injection Somatropin
Maltese: Omnitrope 5 mg/1.5 ml soluzzjoni għall-injezzjoni Somatropin
English: Omnitrope 5 mg/1.5 ml solution for injection
Maltese: Omnitrope 5 mg/1.5 ml soluzzjoni għall-injezzjoni
English: Somatropin induces hepatic LDL cholesterol receptors, and affects the profile of serum lipids and lipoproteins.
Maltese: Somatropin jikkaġuna r-riċetturi tal-kolesterol LDL tal-fwied u jaffettwa l-profil tal-lipidi tas-serum u tal-lipoproteini.
English: Replacement therapy in adults with growth hormone deficiency
Maltese: Terapija ta' sostituzzjoni f'adulti b'defiċjenza tal-ormon tat-tkabbir
English: Use only with SurePal 15.
Maltese: Uża biss ma' SurePal 15.
English: Other ingredients:
Maltese: Sintomi:
English: There have been reports of fatalities associated with the use of growth hormone in paediatric patients with PWS who had one or more of the following risk factors: severe obesity (those patients exceeding a weight/height of 200%), history of respiratory impairment or sleep apnoea or unidentified respiratory infection.
Maltese: 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 (dawk il-pazjenti li jaqbżu piż/tul ta' 200%), storja ta' indeboliment respiratorju jew apnea waqt l-irqad jew infezzjoni respiratorja mhix identifikata.
English: • Stiffness in the arms and legs, muscle pain
Maltese: • Ebusija fid-dirgħajn u riġlejn, uġigħ fil-ġogi, uġigħ fil-muskoli
English: - Keep this leaflet.
Maltese: Iċċaqlaqx.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS OMNITROPE CARTRIDGE LABEL
Maltese: Id-doża minima effettiva għandha tintuża.
English: Use a sterile, disposable syringe (e.g. 2 ml syringe) and needle (e.g. 0.33 mm x 12.7 mm) to withdraw all the solvent from the vial.
Maltese: Preparazzjoni Iġbor l-oġġetti meħtieġa qabel ma tibda: - kunjett bit-trab Omnitrope 1.3 mg/ ml trab għal soluzzjoni għallinjezzjoni. - kunjett bis-solvent (likwidu) għal Omnitrope 1.3 mg/ ml - siringa sterili, li tintrema wara li tintuża (eż. siringa ta' 2 ml) u labra (eż. 0.33 mm x 12.7 mm) biex tiġbed is-solvent mill-kunjett (mhux fornuti fil-pakkett).
English: Growth hormone deficiency is associated with decreased plasma and extracellular volumes.
Maltese: Id-defiċjenza ta' l-ormon tat-tkabbir hi assoċjata ma' volumi mnaqqsa tal-plażma u dawk ekstraċellulari.
English: Leukaemia
Maltese: FARMAĊEWTIKU
English: ‡ Clinical significance is unknown
Maltese: Rilevanza klinika mhux magħrufa †
English: Sandoz GmbH
Maltese: Kif taħżen Omnitrope
English: Growth disturbance due to Turner syndrome
Maltese: Tfal bis-sindrome ta' Turner:
English: INSTRUCTIONS ON USE
Maltese: Investigazzjonij iet
English: Clinical trials in children with chronic renal insufficiency Table 3
Maltese: Provi kliniċi fi tfal b'insuffiċjenza kronika tal-kliewi
English: Use only with SurePal 5.
Maltese: Uża biss ma' SurePal 5.
English: Clinical Pharmacology
Maltese: Farmakoloġija Klinika