FrancophonIA/ELRC3.0 huggingface dataset:
English: Tables 1-6 show the adverse reactions ranked under headings of System Organ Class and frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data) for each of the indicated conditions.
Maltese: Tabelli 1-6 juru r-reazzjonijiet avversi kklassifikati taħt l-intestaturi tas-Sistema tal-Klassifika talOrgani u l-frekwenza bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli) għal kull waħda mill-kundizzjonijiet indikati.
English: The clinical relevance of these findings may be limited.
Maltese: Ir-rilevanza klinika ta' dawn ir-riżultati tista' tkun limitata.
English: Arthralgia* Myalgia* Musculoskeletal stiffness*
Maltese: Artralġja* Mijalġja* Ebusija muskoluskeletali*
English: Somatropin may reduce insulin sensitivity.
Maltese: Somatropin jista' jnaqqas is-sensittività għall-insulina.
English: 1 vial of 5 mg powder 1 cartridge of 1 ml solvent 5 vials of 5 mg powder 5 cartridges of 1 ml solvent
Maltese: 1 kunjett b'5 mg ta' trab 1 skartoċċ b'1 ml ta' solvent 5 kunjetti b'5 mg ta' trab 5 skartoċċi b'1 ml ta' solvent
English: Experience in patients with Silver-Russell syndrome is limited.
Maltese: L-esperjenza f'pazjenti li jkollhom issindrome ta' Silver-Russell hi limitata.
English: • ciclosporin (a medicine that weakens the immune system after transplantation),
Maltese: • ciclosporin (mediċina li ddgħajef lis-sistema immuni wara trapjant),
English: Clinical trials in children with Turner syndrome Table 2
Maltese: Provi kliniċi fi tfal bis-sindrome ta' Turner Tabella 2:
English: Insert the needle into the pinched skin at an angle of 45° to 90°.
Maltese: Daħħal il-labra ġol-ġilda l-maqrusa f'angolu ta' 45° sa 90°.
English: Follow the instructions that come with the transfer set.
Maltese: Segwi il-struzzjonijiet li jiġu mas-sett tattrasferiment.
English: 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.
Maltese: 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).
English: Somatropin 1.3 mg (4 IU)/ml in a vial.
Maltese: Somatropin 1.3 mg (4 IU)/ ml f'kunjett.
English: For storage conditions of the in-use medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna tal-prodott mediċinali waqt l-użu, ara sezzjoni 6.3.
English: Uncommo n to <1/100
Maltese: Mhux Komuni sa <1/100
English: - Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted height SDS < -1) in short children/adolescents born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later.
Maltese: - Disturb tat-tkabbir (tul kurrenti devjazzjoni standard ta' l-iskorjar / current height standard deviation score (SDS) ta' < -2.5 u SDS tul aġġustat tal-ġenituri ta' < -1) fi tfal qosra/adolexxenti 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.
English: STATEMENT OF ACTIVE SUBSTANCE Somatropin 10 mg (30 IU)/ml.
Maltese: Somatropin 10 mg (30 IU)/ ml.
English: - Prader-Willi syndrome (PWS), for improvement of growth and body composition.
Maltese: - Is-sindrome ta' Prader-Willi (PWS), għat-titjib fit-tkabbir u kompożizzjoni tal-ġisem.
English: 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.
Maltese: 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.
English: Adults - Replacement therapy in adults with pronounced growth hormone deficiency.
Maltese: Adulti - Terapija tas-sostituzzjoni fl-adulti li jkollhom defiċjenza prominenti ta' l-ormon tat-tkabbir.
English: STATEMENT OF ACTIVE SUBSTANCE Somatropin 3.3 mg (10 IU)/ml.
Maltese: Somatropin 3.3 mg (10 IU)/ ml.
English: Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.
Maltese: L-introduzzjoni tal-kura b'somatotropin tista' tirriżulta f'inibizzjoni ta' 11βHSD-1 u tnaqqis talkonċentrazzjoni ta' cortisol fis-serum.
English: The maintenance dose rarely exceeds 1.0 mg per day.
Maltese: Id-doża ta' manteniment ta' kuljum rari taqbeż 1.0 mg kuljum.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: Paraesthesia* Benign intracranial hypertension
Maltese: Parestesija* Pressjoni għolja beninna intrakranjali
English: Mortality was higher in patients treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%.
Maltese: 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. 19%.
English: In adults with adult-onset GHD, therapy should start with a low dose, 0.15 - 0.3 mg per day.
Maltese: F'pazjenti b'GHD li tibda f'età adulta, it-terapija għandha tinbeda b'doża baxxa, 0.15 - 0.3 mg kuljum.
English: Experience in patients above 80 years is limited.
Maltese: L-esperjenza f'pazjenti ta' iktar minn 80 sena hi limitata.
English: Children with chronic renal (kidney) insufficiency
Maltese: Tfal b'insuffiċjenza kronika renali (tal-kliewi)
English: Experience with prolonged treatment in adults and in patients with PWS is limited.
Maltese: L-esperjenza bil-kura fit-tul fl-adulti u f'pazjenti b'PWS hi limitata.
English: Omnitrope is a recombinant human growth hormone (also called somatropin).
Maltese: Omnitrope hu ormon rikombinanti tat-tkabbir tal-bniedem (imsejjaħ ukoll somatropin).
English: Also see section 4.4 for statements regarding diabetes mellitus and thyroid disorder and section 4.2 for statement on oral oestrogen replacement therapy.
Maltese: 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.
English: Musculoskeletal , Connective Tissue and Bone Disorders
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi
English: Powder in a vial (type I glass) with a stopper (fluor-resin laminated butyl rubber), a strip (aluminium) and a cap (violet polypropylene flip-off), and 1 ml of solvent in a vial (type I glass) with a stopper (fluor-resin laminated chlorobutyl elastomer), a strip (lacquered aluminium) and a cap (white polypropylene flip-off).
Maltese: Trab f'kunjett (ħġieġ ta' tip I) b'tapp (lastku fluor-resin laminated butyl), strixxa (aluminju) u għatu (vjola, polypropylene flip-off), u 1 ml ta' solvent f'kunjett (ħġieġ ta' tip I) b'tapp (fluor-resin laminated chlorobutyl elastomer), strixxa (aluminju lacquered) u għatu (abjad, polypropylene flip-off).
English: Pack sizes of 1 and 5.
Maltese: Daqsijiet tal-pakkett ta' 1 u 5.
English: In 56 patients who were continuously treated and have reached (near) final height, the mean change from height at start of treatment was +1.90 SDS (0.033 mg/kg body weight per day) and +2.19 SDS (0.067 mg/kg body weight per day).
Maltese: F'56 pazjent li kienu kkurati kontinwament u li laħqu t-tul (kważi) finali, il-medja tal-bidla mit-tul fil-bidu tal-kura kienet ta' +1.90 SDS (0.033 mg kuljum għal kull kilogramm ta' piż tal-ġisem) u +2.19 SDS (0.067 mg kuljum għal kull kilogramm ta' piż tal-ġisem).
English: After reconstitution, one ml contains 15 mg benzyl alcohol.
Maltese: Wara r-rikostituzzjoni ml wieħed fih 15 mg ta' benzyl alcohol.
English: • If you have chronic renal (kidney) insufficiency.
Maltese: • Jekk għandek insuffiċjenza kronika renali (tal-kliewi).
English: Uncommon ≥ 1/1,000 to
Maltese: Komuni ≥ 1/100 sa
English: Powder in a vial (type I glass) with a stopper (fluor-resin laminated butyl rubber), a strip (aluminium) and a cap (green polypropylene flip-off), and 1 ml of solvent in a cartridge (type I glass) with a stopper (fluor-resin laminated chlorobutyl elastomer), a strip (lacquered aluminium) and a cap (white polypropylene flip-off).
Maltese: Trab f'kunjett (ħġieġ ta' tip I) b'tapp (lastku fluor-resin laminated butyl), strixxa (aluminju) u għatu (aħdar, polypropylene flip-off), u 1 ml ta' solvent fi skartoċċ (ħġieġ ta' tip I) b'tapp (fluor-resin laminated chlorobutyl elastomer), strixxa (aluminju lacquered) u għatu (abjad, polypropylene flip-off).
English: In studies with Omnitrope regarding subacute toxicity and local tolerance, no clinically relevant effects have been observed.
Maltese: Fi studji b'Omnitrope dwar it-tossiċità sotto-akuta u t-tolleranza lokali, l-ebda effetti klinikament rilevanti ma kienu osservati.
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium- free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull ml, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: In adult patients adverse reactions related to fluid retention, such as peripheral oedema, musculoskeletal stiffness, arthralgia, myalgia and paraesthesia are common.
Maltese: F'pazjenti adulti, reazzjonijiet avversi marbuta maż-żamma tal-fluwidu, bħal edema periferali, ebusija muskoluskeletrika, artralġja, mijalġja u parestesija huma komuni.
English: Serum concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor Binding Protein 3) are increased by somatropin.
Maltese: 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.
English: Metabolism and Nutrition Disorders
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni
English: Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: benzyl alcohol, water for injections
Maltese: Trab: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: benzyl alcohol, ilma għall-injezzjonijiet
English: Replacement therapy in adults with growth hormone deficiency System Organ
Maltese: Terapija ta' sostituzzjoni f'adulti b'defiċjenza tal-ormon tat-tkabbir Sistema tal
English: Growth disturbance in chronic renal insufficiency A dose of 0.045 - 0.050 mg/kg body weight per day (1.4 mg/m2 body surface area per day) is recommended.
Maltese: Disturb tat-tkabbir f'insuffiċjenza kronika tal-kliewi Doża ta' 0.045 - 0.050 mg kuljum għal kull kilogramm ta' piż tal-ġisem (1.4 mg/m2 ta' erja tassuperfiċje tal-ġisem kuljum) hi rakkomandata.
English: 1.5 ml of solution in a cartridge (colourless type I glass) with plunger and a blue ring (for Omnitrope 15 mg/1.5 ml solution for injection only) on one side (siliconised bromobutyl), a disc (bromobutyl) and a cap (aluminium) on the other side.
Maltese: 1.5 ml ta' soluzzjoni fi skartoċċ (tal-ħġieġ ta' tip I, bla kulur), bi planġer u ċirku blu (għal Omnitrope 15 mg/1.5 ml soluzzjoni għall-injezzjoni biss) fuq naħa waħda (siliconised bromobutyl), disk (bromobutyl) u għatu (aluminju) fuq in-naħa l-oħra.
English: Neoplasms Benign, Malignant and Unspecified (including cysts and polyps)
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
English: Chronic renal insufficiency
Maltese: GĦAMLA KWALITATTIVA
English: Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease have been reported in children treated with GH.
Maltese: Slipped capital femoral epiphysis u l-marda ta' Legg-Calvé-Perthes jistgħu jiġu kkunsidrati mit-tabib tiegħek jekk ikollok skonfort jew uġigħ fil-ġenbejn jew fl-irkoppa waqt li tkun qed tiġi kkurat b'Omnitrope.
English: Rare side effects (likely to occur in fewer than 1 in 1,000 patients) include:
Maltese: Effetti sekondarji rari (x'aktarx iseħħu f'inqas minn 1 minn kull 1,000 pazjent) jinkludu:
English: Powder: glycine disodium hydrogen phosphate heptyhydrate sodium dihydrogen phosphate dihydrate
Maltese: glycine disodium hydrogen phosphate heptyhydrate sodium dihydrogen phosphate dihydrate
English: - 2 cleansing swabs (not supplied in the pack).
Maltese: - 2 biċċiet li jnaddfu (mhux fornuti fil-pakkett).
English: Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions must not be treated with somatropin (regarding patients undergoing substitution therapy, see section 4.4).
Maltese: Pazjenti b'mard kritiku akut li jbatu minn komplikazzjonijiet wara operazzjoni tal-qalb miftuħa, operazzjoni fiż-żaqq, trawma aċċidentali multipla, waqfien akut tan-nifs jew kundizzjonijiet simili, m'għandhomx jiġu kkurati b'somatropin (fir-rigward ta' pazjenti li jkunu qed jirċievu terapija tassostituzzjoni, ara sezzjoni 4.4).
English: 0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m2 body surface area per day.
Maltese: 0.025-0.035 mg/kg ta' piż tal-ġisem kuljum jew 0.7-1.0 mg/m ta' erja tas-superfiċje tal-ġisem kuljum.
English: Table 2
Maltese: Tabella 2:
English: Myalgia* Musculoskel etal stiffness*
Maltese: Mijalġja* Ebusija muskoluskeletali*
English: - Growth disturbance associated with chronic renal insufficiency.
Maltese: - Disturb tat-tkabbir assoċjat ma' insuffiċjenza kronika tal-kliewi.
English: Powder: glycine disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate
Maltese: Trab: glycine disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate
English: Omnitrope 5 mg/1.5 ml solution for injection Omnitrope 10 mg/1.5 ml solution for injection Omnitrope 15 mg/1.5 ml solution for injection
Maltese: Omnitrope 5 mg/1.5 ml soluzzjoni għall-injezzjoni Omnitrope 10 mg/1.5 ml soluzzjoni għall-injezzjoni
English: • If you have Turner syndrome.
Maltese: • Jekk għandek is-sindrome ta' Turner.
English: Nevertheless, corticosteroid replacement therapy should be optimised before initiation of therapy.
Maltese: Madankollu, it-terapija ta' sostituzzjoni tal-kortikosterojdi għandha tiġi ottimizzata qabel ilbidu tat-terapija.
English: 1.5 ml of solution in a cartridge (colourless type I glass) with plunger on one side (siliconised bromobutyl), a disc (bromobutyl) and a cap (aluminium) on the other side.
Maltese: 1.5 ml ta' soluzzjoni fi skartoċċ (tal-ħġieġ ta' tip I, bla kulur), bi planġer fuq naħa waħda (siliconised bromobutyl), disk (bromobutyl) u għatu (aluminju) fuq in-naħa l-oħra.
English: Everyone is different.
Maltese: Kulħadd hu differenti.
English: With somatropins, in vitro and in vivo genotoxicity studies on gene mutations and induction of chromosome aberrations have been negative.
Maltese: B'somatropini, studji in vitro u in vivo dwar il-ġenotossiċità fuq mutazzjonijiet tal-ġeni u l-induzzjoni ta' aberrazzjonijiet tal-kromosomi kienu negattivi.
English: Powder and solvent for solution for injection (powder in a vial (1.3 mg), solvent in a vial (1 ml)).
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni (trab f'kunjett (1.3 mg) u solvent f'kunjett (1 ml)).
English: Each ml of solution contains 10 mg of somatropin (corresponding to 30 IU).
Maltese: Kull ml ta' soluzzjoni fih 10 mg ta' somatropin (li jikkorrispondu għal 30 IU).
English: The top of the vials should be wiped with an antiseptic solution to prevent contamination of the contents.
Maltese: In-naħa ta' fuq tal-kunjetti għandha tintmesaħ b'soluzzjoni antisettika biex tiġi evitata lkontaminazzjoni tal-kontenut.
English: Clinical trials in children with SGA
Maltese: Provi kliniċi fi tfal b'SGA
English: • if you are seriously ill (for example, complications following open heart surgery, abdominal surgery, accidental trauma, acute respiratory failure, or similar conditions).
Maltese: • jekk inti marid serjament (pereżempju, ikollok kumplikazzjonijiet wara operazzjoni tat-tip openheart, operazzjoni fiż-żaqq, trawma aċċidentali, waqfien akut tan-nifs, jew kundizzjonijiet simili).
English: <{MM/YYYY}>
Maltese: TA' EĊĊIPJENTI
English: INFORMATION IN BRAILLE Omnitrope 5 mg/ml
Maltese: Kif tinjetta Omnitrope 5 mg/ ml
English: Children with Prader-Willi syndrome:
Maltese: Tfal bis-sindrome ta' Prader-Willi:
English: For monitoring, the attainment of a normal peak bone mass defined as a T score > -1 (i.e. standardized to average adult peak bone mass measured by dual energy X-ray absorptiometry taking into account sex and ethnicity) is one of the therapeutic objectives during the transition period.
Maltese: Għal monitoraġġ, il-kisba ta' massa massima ta' għadam normali definita bħala punteġġ T ta' > -1 (i.e. standardizzata għal massa massima ta' għadam f'persuni adulti kif imkejla permezz ta' dual energy X-ray absorptiometry, meta wieħed jikkunsidra s-sess u l-etniċità tal-persuna) hi waħda mill-objettivi terapewtiċi matul il-perjodu ta' transizzjoni.
English: Oedema periphera l*
Maltese: IL-PROVVISTA U L
English: Children with Turner syndrome: 0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.
Maltese: Tfal bis-sindrome ta' Turner: 0.045-0.050 mg/kg ta' piż tal-ġisem kuljum jew 1.4 mg/m ta' erja tas-superfiċje tal-ġisem kuljum.
English: A subcutaneous dose of 5 mg of Omnitrope 15 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 52 ± 19 µg/l and 3.7 ± 1.2 hours, respectively.
Maltese: Doża ta' 5 mg ta' Omnitrope 15 mg/1.5 ml soluzzjoni għall-injezzjoni f'adulti b'saħħithom tirriżulta f'valuri tas-Cmax u tat-tmax tal-plażma ta' 52 + 19 µg/ L l u 3.7 ± 1.2 sigħat, rispettivament.
English: Long-term treatment of children with growth disturbance due to Turner syndrome System Organ
Maltese: Kura fit-tul ta' tfal b'disturb tat-tkabbir minħabba s-sindrome ta' Turner Sistema tal
English: Arthralgia*
Maltese: Artralġja*
English: Growth hormone increases the extrathyroidal conversion of T4 to T3 which may result in a reduction in serum T4 and an increase in serum T3 concentrations.
Maltese: L-ormon tat-tkabbir iżid il-konverżjoni extrathyroidal ta' T4 għal T3 li tista' tirriżulta fi tnaqqis talkonċentrazzjonijiet tas-serum T4 u fi żieda tal-konċentrazzjonijiet tas-serum T3.
English: Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective (see section 4.4).
Maltese: L-ormon tat-tkabbir inaqqas il-konverżjoni ta' cortisone f'cortisol u jista' jikxef ipoadrenaliżmu ċentrali mhux iddijanjostikat minn qabel jew jirrendi ineffettivi dożi baxxi ta' sostituzzjoni bi glukokortikojdi (ara sezzjoni 4.4).
English: Do not shake; this may cause denaturation of the active substance.
Maltese: Iċċaqlaqx; dan jista' jibdel in-natura tas-sustanza attiva.
English: 1 cartridge for SurePal 5
Maltese: 1 skartoċċ għal SurePal 5
English: 5 cartridges 10 cartridges
Maltese: 5 skartoċċi
English: Use with oral oestrogen therapy
Maltese: Reazzjonijiet avversi oħra tal-mediċina
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, water for injections.
Maltese: Sustanzi oħra: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, ilma għall-injezzjonijiet.
English: Omnitrope has given rise to the formation of antibodies in approximately 1% of the patients.
Maltese: Omnitrope ikkawża l-formazzjoni ta' antikorpi f'madwar 1% tal-pazjenti.
English: Omnitrope 5 mg/1.5 ml solution for injection:
Maltese: Omnitrope 5 mg/1.5 ml soluzzjoni għall-injezzjoni:
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, poloxamer 188, phenol, water for injections.
Maltese: Sustanzi oħra: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, poloxamer 188, phenol, ilma għall-injezzjonijiet.
English: A subcutaneous dose of 5 mg of Omnitrope 10 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 74 ± 22 µg/l and 3.9 ± 1.2 hours, respectively.
Maltese: Doża ta' 5 mg ta' Omnitrope 10 mg/1.5 ml soluzzjoni għall-injezzjoni f'adulti b'saħħithom tirriżulta f'valuri tas-Cmax u tat-tmax tal-plażma ta' 74 + 22 µg/l u 3.9 ± 1.2 sigħat, rispettivament.
English: However, the in-use stability has been demonstrated for up to 24 hours at 2°C - 8°C, in the original package.
Maltese: Madankollu, l-istabbiltà waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 2°C-8°C fil pakkett oriġinali.
English: Other medicines and Omnitrope
Maltese: Mediċini oħra u Omnitrope
English: INFORMATION IN BRAILLE Omnitrope 1.3 mg/ml
Maltese: Omnitrope 1.3 mg/ ml
English: ≥ 1/1,000 to
Maltese: Rari sa <1/1,000
English: - Adult onset: Patients who have severe growth hormone deficiency associated with multiple hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at least one known deficiency of a pituitary hormone not being prolactin.
Maltese: - Bidu f'età adulta: Pazjenti li għandhom defiċjenza severa ta' l-ormon tat-tkabbir assoċjata ma' defiċjenzi multipli tal-ormoni bħala riżultat ta' patoloġija pitwitarja ipotalamika jew ipotalamika magħrufa u li għandhom mill-inqas defiċjenza waħda magħrufa ta' ormon pitwitarju li ma jkunx prolaktin.
English: Blood cortisol decreased‡
Maltese: Tnaqqis ta' kortisol fiddemm
English: A subcutaneous dose of 5 mg of Omnitrope 5 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 72 ± 28 µg/l and 4.0 ± 2.0 hours, respectively.
Maltese: Doża ta' 5 mg ta' Omnitrope 5 mg/1.5 ml soluzzjoni għall-injezzjoni f'adulti b'saħħithom tirriżulta f'valuri tas-Cmax u tat-tmax tal-plażma ta' 72 ± 28 µg/l u 4.0 ± 2.0 sigħat, rispettivament.
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, glycine, poloxamer 188, phenol, water for injections.
Maltese: Sustanzi oħra: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, glycine, poloxamer 188, phenol, ilma għall-injezzjonijiet.
English: Omnitrope 10 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Maltese: Omnitrope 10 mg/1.5 ml soluzzjoni għall-injezzjoni disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol ilma għall-injezzjonijiet
English: Injecting Omnitrope
Maltese: X'fih Omnitrope
English: • Store and transport refrigerated (2°C-8°C).
Maltese: • Żommu kiesaħ waqt il-ħażna u l-ġarr (2°C-8°C.
English: Each ml of solution contains 3.3 mg of somatropin (corresponding to 10 IU) One cartridge contains 5.0 mg (corresponding to 15 IU) of somatropin in 1.5 ml.
Maltese: Kull ml ta' soluzzjoni fih 3.3 mg ta' somatropin (li jikkorrispondi għal 10 IU) Skartoċċ fih 5.0 mg (li jikkorrispondu għal 15 IU) ta' somatropin f'1.5 ml.
English: 5 cartridges for SurePal 5 10 cartridges for SurePal 5
Maltese: 5 skartoċċi għal SurePal 5