FrancophonIA/ELRC3.0 huggingface dataset:
English: On 25 July 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Methylphenidate Hexal.
Maltese: Fil-25 ta' Lulju 2013, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Methylphenidate Hexal.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the failure to show bioequivalence between Methylphenidate Hexal and its reference medicine in the immediate-release phase under fed conditions were due to differences between patients in the effects of a high-fat meal on the way medicines are handled by the body, and not to differences between the formulations of the two medicinal products, and that bioequivalence to the reference medicinal product has been shown.
Maltese: Abbażi tal-valutazzjoni tad-dejta attwalment disponibbli u d-diskussjoni xjentifika fi ħdan il-Kumitat, isCHMP ikkonkluda li n-nuqqas ta' turija ta' bijoekwivalenza bejn Methylphenidate Hexal u l-mediċina ta' referenza tiegħu fil-fażi ta' rilaxx immedjat taħt kondizzjonijiet ta' wara l-ikel kienu dovuti għal differenzi bejn il-pazjenti fl-effetti ta' ikla b'kontenut għoli ta' xaħam dwar il-mod kif il-mediċini jiġu ttrattati mill-ġisem, u mhux għal differenzi bejn il-formulazzjonijiet taż-żewġ prodotti mediċinali, u li lbijoekwivalenza għall-prodott mediċinali ta' referenza kienet intweriet.
English: Why was Methylphenidate Hexal reviewed?
Maltese: Għalxiex ġie rivedut Methylphenidate Hexal?
English: The company wanted the authorisation to be recognised in Germany (the ‘concerned Member State').
Maltese: Il-kumpanija riedet li l-awtorizzazzjoni tkun rikonoxxuta fil-Ġermanja (l‘Istat Membru kkonċernat').
English: However, the Member States were not able to reach an agreement and the Danish medicines regulatory agency referred the matter to the CHMP for arbitration on 21 December 2012.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu qbil u l-aġenzija regolatorja tal-mediċini Daniża rriferiet il-kwistjoni lis-CHMP għal arbitraġġ fil-21 ta' Diċembru 2012.
English: It has been available since the 1950s as both immediate-release tablets and capsules, which release methylphenidate straight away, and as modified-release tablets that release some or all of the active substance more slowly over several hours.
Maltese: Ilu disponibbli sa mill-ħamsinijiet kemm bħala pilloli u kapsuli b'rilaxx immedjat, li jerħu methylphenidate minnufih, kif ukoll bħala pilloli b'rilaxx modifikat li jerħu ftit mis-sustanza attiva jew is-sustanza attiva kollha aktar bil-mod fuq bosta sigħat.
English: Str. Grigore Alexandrescu nr. 59, clădirea HQ Sector 1, 010623, Bucureşti,
Maltese: Grigore Alexandrescu nr. 59, clădirea HQ Sector 1, 010623, Bucureşti,
English: Repeat steps 8 and 9 until it appears.
Maltese: Irrepeti passi 8 u 9 sakemm tidher.
English: Do not use alcohol.
Maltese: Tużax alkoħol.
English: Part I: Preparing and Injecting
Maltese: Parti I: Preparazzjoni u Injezzjoni
English: • Avoid excessive temperatures.
Maltese: • Evita temperaturi eċċessivi.
English: Uncommon: Vertigo
Maltese: Mhux komuni: Vertigo
English: Avoid areas of extreme temperature.
Maltese: Evita postijiet ta' temperatura estrema.
English: Ελλάδα, Κύπρος, Malta Ipsen EΠΕ
Maltese: Ελλάδα, Κύπρος, Malta
English: Acute critical illness
Maltese: Mard akut kritiku
English: Environmental Risk Assessment (ERA)
Maltese: Stima tar-Riskju Ambjentali (ERA)
English: 1 DNA Way South San Francisco CA 94080-4990 USA
Maltese: South San Francisco CA 94080-4990
English: The active substance of NutropinAq is somatropin*.
Maltese: Is-sustanza attiva ta' NutropinAq hi somatropin*.
English: Al. Jana Pawła II 29 00-867 Warszawa Tel.: + 48 (0) 22 653 6800
Maltese: Jana Pawła II 29 00-867 Warszawa Tel.: + 48 (0) 22 653 6800
English: Approximately 2.5 % of patients from the NCGS have experienced drug related adverse reactions.
Maltese: Madwar 2.5 % talpazjenti minn NCGS kellhom reazzjonijiet avversi marbuta mal-mediċina.
English: Pack sizes of 1, 3 and 6 cartridges.
Maltese: Daqsijiet tal-pakkett ta' 1, 3 u 6 skrataċ.
English: Uncommon: Anaemia
Maltese: Mhux komuni: Anemija
English: (See illustration.)
Maltese: (Ara l-istampa.)
English: België/Belgique/Belgien Luxembourg/Luxemburg Ipsen NV Guldensporenpark 87 B-9820 Merelbeke België /Belgique/Belgien Tél/Tel: + 32 - 9 - 243 96 00
Maltese: België/Belgique/Belgien Luxembourg/Luxemburg Ipsen NV Guldensporenpark 87 B-9820
English: 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
Maltese: 65 quai Georges Gorse, 92100 Boulogne-Billancourt, Franza
English: Ipsen Portugal - Produtos Farmacêuticos, S.A. Alameda Fernão Lopes, nº 16A, 1ºB 1495-190 Algés
Maltese: Alameda Fernão Lopes, no 16A, 1 B, 1495-190
English: EU/1/00/164/003 EU/1/00/164/004 EU/1/00/164/005
Maltese: EU/1/00/164/004
English: The final dose is rarely above 1.0 mg/day.
Maltese: Id-doża finali rrakkomandata rarament taqbeż 1.0 mg/kuljum.
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D <Barcode 2D li jkollu l-identifikatur uniku inkluż>
English: SL1 3XE
Maltese: 3XE
English: EU/1/00/164/003 1 cartridge EU/1/00/164/004 3 cartridges EU/1/00/164/005 6 cartridges
Maltese: EU/1/00/164/003 skartoċċ wieħed EU/1/00/164/004 3 skrataċ
English: Table 1 contains very common (≥ 1/10), common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1,000) adverse reactions which occurred in clinical trials and a post-marketing surveillance survey.
Maltese: Tabella 1 telenka reazzjonijiet avversi komuni ħafna (≥ 1/10), komuni (≥ 1/100, < 1/10); mhux komuni (≥ 1/1000, < 1/100); rari (≥ 1/10,000, < 1/1,000) li seħħew fi provi kliniċi u f'servej ta' sorveljanza ta' wara t-tqegħid fis-suq.
English: Rare (may effect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000)
English: IGF-I levels increased from a baseline of 43 ng/ml to 252 ng/ml at 36 months, which approximate to the normal levels expected in children of this age.
Maltese: Il-livelli ta' IGF-I żdiedu minn linja bażi ta' 43 ng/ml sa 252 ng/ml wara 36 xahar, li jqarreb il-livelli normali mistennija fi tfal ta' din l-età.
English: In both studies, somatropin treatment resulted in significant changes compared to placebo in total body % fat (-6.3 to -3.6 vs +0.2 to-0.1), trunk % fat (-7.6 to -4.3 vs +0.6 to 0.0) and total body % lean (+3.6 to +6.4 vs -0.2 to +0.2).
Maltese: Fiż-żewġ studji, kura b'somatropin wasslet għal bidliet sinifikanti meta mqabbel mal-plaċebo fil-% ta' xaħam totali fil-ġisem (-6.3 sa -3.6 vs +0.2 sa -0.1), fil-% ta' xaħam fil-parti ċentrali tal-ġisem (-7.6 sa -4.3 vs +0.6 sa 0.0) u fil-% ta' massa bla xaħam totali tal-ġisem (+3.6 sa +6.4 vs -0.2 sa +0.2).
English: The recommended dose is:
Maltese: DATA TA' SKADENZA JIS:
English: The dose of somatropin was 0.0125 mg/kg/day sc in adultonset AGHD and 0.0125 or 0.025 mg/kg/day in childhood-onset AGHD.
Maltese: Id-doża ta' somatropin kienet ta' 0.0125 mg/kg/jum s.c. f'AGHD li tfaċċat f'età adulta u ta' 0.0125 jew 0.025 mg/kg/jum f'AGHD li tfaċċat fit-tfulija.
English: The adverse reactions reported in both adults and children receiving Nutropin, NutropinAq, Nutropin Depot or Protropin (somatrem) are listed in the table below, based on experience from clinical trials all approved indications (642 patients) and post-marketing sources which included a surveillance survey (National Cooperative Growth Study [NCGS] in 35,344 patients).
Maltese: Ir-reazzjonijiet avversi rrappurtati kemm f'persuni adulti kif ukoll fit-tfal li jkunu qed jirċievu Nutropin, NutropinAq, Nutropin Depot jew Protropin (somatrem) huma elenkati fit-tabella hawn taħt, ibbażati fuq esperjenza minn provi kliniċi dwar l-indikazzjonijiet approvati kollha (642 pazjent) u sorsi ta' wara t-tqegħid fis-suq li kienu jinkludu servej ta' sorveljanza (Studju Nazzjonali Kooperattiv dwar it-Tkabbir [NCGS - National Cooperative Growth Study] f'35,344 pazjent).
English: Difficulty to hold-in urine (urinary incontinence), high frequency (pollakiuria) and volume (polyuria) of urination.
Maltese: Diffikultà biex iżżomm l-awrina (inkontinenza tal-awrina), frekwenza għolja (pollakjurja) u volum (poliurja) tal-awrina.
English: Connective tissue metabolism
Maltese: Metaboliżmu tat-tessut konnettiv
English: • When priming a new cartridge, you may need to repeat Part I, steps 8 and 9 up to a total of
Maltese: • Meta qed tipprepara skartoċċ ġdid, jista' jkollok bżonn tirrepeti Parti I, passi 8 u 9 sa total ta' 6
English: Protein metabolism
Maltese: Metaboliżmu tal-proteini
English: • if you have complications after a major surgery (open-heart or abdominal surgery), a multiple trauma, acute respiratory failure, or similar conditions.
Maltese: • jekk għandek komplikazzjonijiet wara kirurġija maġġuri (kirurġija open-heart jew addominali), trawma multipla, insuffiċjenza respiratorja akuta, jew kondizzjonijiet simili.
English: Uncommon: Tachycardia
Maltese: Mhux komuni: Takikardija
English: Monitoring is advisable when somatropin is administered in combination with medicinal products known to be metabolised by CYP450 liver enzymes, such as corticosteroids, sex steroids, anticonvulsants, and cyclosporin.
Maltese: Sorveljanza hija rrakkomandata meta somatropin jingħata flimkien ma' prodotti mediċinali li huma magħrufa li jiġu metabolizzati mill-enzimi CYP450 tal-fwied, bħal kortikosterojdi, sterojdi tas-sess, antikonvulżivi u cyclosporin.
English: Uncommon: Urinary incontinence, pollakiuria, polyuria, urine abnormality
Maltese: Mhux komuni: Inkontinenza talawrina, pollakiurja, poliurija, anormalità fl-awrina
English: Children with growth failure associated with chronic renal insufficiency (n=171) Common: renal failure, peritonitis, osteonecrosis, blood creatinine increase.
Maltese: Tfal b'falliment tat-tkabbir assoċjat ma' insuffiċjenza kronika tal-kliewi (n=171) Komuni: insuffiċjenza tal-kliewi, peritonite, osteonekrosi, żieda tal-krejatinina fid-demm.
English: Other ingredients: sodium chloride, liquefied phenol, polysorbate 20, sodium citrate dihydrate, citric acid anhydrous and water for injections.
Maltese: Ingredjenti oħra: sodium chloride, phenol likwifikat, polysorbate 20, sodium citrate dihydrate, citric acid anidru u ilma għall-injezzjonijiet.
English: One pivotal, multicentre, open label, controlled study has been conducted in Turner Syndrome.
Maltese: Sar studju wieħed pivitali, b'aktar minn ċentru wieħed, open label u kkontrollat dwar is-Sindrome ta' Turner.
English: A: The NutropinAq Pen can give a minimum dose of 0.1 mg up to a maximum dose of 4.0 mg (40 clicks).
Maltese: T: Il-Pinna NutropinAq tista' tagħti doża minima ta' 0.1 mg sa doża massima ta' 4.0 mg (40 ċekċika).
English: Sodium Citrate Dihydrate Citric Acid, Anhydrous Water for Injections
Maltese: Sodium Citrate Dihydrate
English: Mineral metabolism
Maltese: Metaboliżmu tal-minerali
English: Somatropin is known to be associated with inhibition of the reproduction in male and female rats at doses of 3 IU/kg/day (1 mg/kg/day) or more, with reduced copulation and conception rates, lengthened or absent oestrous cycles, and at 10 IU/kg/day (3.3 mg/kg/day).
Maltese: Somatropin huwa magħruf li huwa assoċjat ma' inibizzjoni tar-riproduzzjoni f'firien maskili u femminili f'dożi ta' 3 IU/kg/jum (1 mg/kg/jum) jew aktar, b'rati ta' kopulazzjoni u ta' konċepiment imnaqqsa u ċikli estrus imtawla jew nieqsa, u ta' 10 IU/kg/jum (3.3 mg/kg/jum).
English: Girls with growth failure associated with Turner syndrome (n=108) Common: menorrhagia.
Maltese: Bniet b'falliment tat-tkabbir assoċjat mas-sindrome ta' Turner (n=108) Komuni: fsada qawwija aktar min-normal waqt il-mestrwazzjoni.
English: Compared with matched historical controls, early somatropin therapy (mean duration of 5.6 years) combined with oestrogen replacement at age 12 years resulted in an adult height gain of 5.9 cm (n=26), whereas girls who initiated oestrogen at age 15 years (mean duration of somatropin therapy 6.1 years) had a mean adult height gain of 8.3 cm (n=29).
Maltese: Meta mqabbla ma' kontrolli storiċi mqabbla, terapija bikrija b'somatropin (tul medju ta' 5.6 snin) flimkien ma' sostituzzjoni ta' estroġeni fl-età ta' 12-il sena wasslet għal żieda fit-tul adult ta' 5.9 ċm (n=26), filwaqt li bniet li bdew estroġeni fl-età ta' 15-il sena (tul medju ta' terapija b'somatropin ta' 6.1 snin) kellhom żieda medja fit-tul adult ta' 8.3 ċm (n=29).
English: A total of 117 patients were treated with somatropin; 36 received somatropin 0.125 mg/kg three times a week and 81 patients received 0.054 mg/kg somatropin daily.
Maltese: Total ta' 117-il pazjent kienu kkurati b'somatropin; 36 irċevew 0.125 mg/kg somatropin tliet darbiet fil-ġimgħa u 81 pazjent irċevew 0.054 mg/kg somatropin kuljum.
English: NutropinAq is a solution for injection (in a cartridge (10 mg/2 ml) - pack size of 1, 3 and 6).
Maltese: NutropinAq huwa soluzzjoni għall-injezzjoni (fi skartoċċ (10 mg/2 ml) - daqs tal-pakkett ta' 1, 3 u 6).
English: Rapid involuntary movements of the eyes (nystagmus), swelling of the optic nerve in the eye (papilloedema), double vision (diplopia), headache, somnolence and vertigo.
Maltese: Movimenti involuntarji rapidi tal-għajnejn (nistagmus), nefħa tan-nerv ottiku fil-għajn (papilloedima), vista doppja (diplopja), uġigħ ta' ras, ngħas u vertigo.
English: Do not use NutropinAq:
Maltese: Tużax NutropinAq:
English: After intravenous bolus administration of somatropin, the mean terminal half-life t½ or t½is about 20 minutes and the mean clearance is reported to be in the range of 116 - 174 ml/h/kg.
Maltese: Wara għoti bolus ta' somatropin fil-vina, il-half-life terminali medja t½β jew t½γ hija ta' madwar 20 minuta u t-tneħħija medja hija rrappurtata li hija fil-firxa ta' 116 - 174 ml/h/kg.
English: Of the 139 patients included, 128 completed the first 12 months of therapy, with an average treatment time of 3.2 and 4.6 years and a total exposure of 542 patient years.
Maltese: Minn 139 pazjent inklużi, 128 temmew l-ewwel 12-il xahar ta' terapija, b'medja ta' żmien ta' kura ta' 3.2 u 4.6 snin u esponiment totali ta' 542 sena ta' pazjent.
English: Linear growth is facilitated in part by growth hormone-stimulated protein synthesis.
Maltese: Tkabbir lineari huwa ffaċilitat parzjalment minn sintesi ta' proteini stimulati mill-ormon tat-tkabbir.
English: • When you have Turner syndrome.
Maltese: • Meta jkollok is-sindrome ta' Turner.
English: Rare: Generalised pruritus, urticaria, rash
Maltese: Ħakk ġeneralizzat, urtikarja, raxx
English: Rare: Neoplasm malignant recurrence, melanocytic naevus
Maltese: Rikorrenza ta' neoplażma malinna, naevus melanoċitiku
English: Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
Maltese: Ipsen Pharma, 65 quai Georges Gorse, 92100
English: Manufacturer : IPSEN PHARMA BIOTECH S.A.S., Parc d'Activités du Plateau de Signes, CD no 402, 83870 Signes, France
Maltese: IPSEN PHARMA BIOTECH S.A.S., Parc d'Activités du Plateau de Signes, CD no 402, 83870 Signes, France
English: Curvature of the spine (scoliosis).
Maltese: Kurvatura fis-sinsla (skoljosi).
English: Common: Headache, hypertonia, Uncommon: Carpal tunnel syndrome, somnolence, nystagmus
Maltese: Disturbi fis-sistema nervuża Komuni: Uġigħ ta' ras, ipertonija, Mhux komuni: Sindrome carpal tunnel, ngħas, nystagmus
English: These events are expected in children and were mild/moderate AEs.
Maltese: Dawn l-avvenimenti huma mistennija fit-tfal u kienu AEs ħfief/moderati.
English: Reported values for half-lives for endogenous GH in normal adult black males are not different from observed values for normal adult white males.
Maltese: Valuri rrappurtati għall-half-lives ta' GH endoġenu f'irġiel suwed adulti normali mhumiex differenti minn valuri osservati għall-irġiel bojod adulti normali.
English: Q: What does a blinking “bt‟ mean in the LCD?
Maltese: Xi tfisser “bt” itteptep fl-LCD?
English: Thus, the risk for humans is unknown.
Maltese: Għalhekk, ir-riskju għall-bnedmin mhux magħruf.
English: Growth rate increased significantly from 3.6-4.1 cm/year at baseline to 6.7-8.1 cm/year at Month 12, 6.7-6.8 cm/year at Month 24 and 4.5-5.1 cm/year at Month 48.
Maltese: Ir-rata ta' tkabbir żdiedet b'mod sinifikanti minn 3.6-4.1 ċm/sena fil-linja bażi għal 6.7-8.1 ċm/sena f'Xahar 12, 6.7-6.8 ċm/sena f'Xahar 24 u 4.5-5.1 ċm/sena f'Xahar 48.
English: A total of 58% and 65% of somatropin-treated patients, who were below normal range at baseline, had reached heights within the normal range by Month 24.
Maltese: Total ta' 58% u 65% tal-pazjenti kkurati b'somatropin, li kienu taħt ilfirxa normali fil-linja bażi, laħqu tul fi ħdan il-firxa normali f'Xahar 24.
English: Gently swirl.
Maltese: Aħżen fi friġġ.
English: From the 236 patients enrolled into the clinical studies 3 patients had a central nervous system tumour.
Maltese: Mill-236 pazjent irreġistrat fl-istudji kliniċi 3 pazjenti kellhom tumur fis-sistema nervuża ċentrali.
English: Manufacturer: IPSEN PHARMA BIOTECH S.A.S., Parc d'Activités du Plateau de Signes, CD no 402, 83870 Signes, France
Maltese: IPSEN PHARMA BIOTECH S.A.S., Parc d'Activités du Plateau de Signes, CD no 402, 83870 Signes, Franza
English: Turner syndrome is a genetic abnormality in girls (absence of female sexual chromosome(s)) that prevents growth.
Maltese: Is-sindrome ta' Turner huwa anormalità ġenetika fil-bniet (nuqqas ta' kromożoma(i) sesswali femminili) li tipprevjeni t-tkabbir.
English: Two pivotal, multicentre, placebo-controlled, double-blind studies have been conducted in patients diagnosed with adult growth hormone deficiency (AGHD), one in adult-onset AGHD (n=166) and the other in childhood-onset AGHD (n=64).
Maltese: Saru żewġ studji pivitali, b'aktar minn ċentru wieħed, ikkontrollati bil-plaċebo u double-blind f'pazjenti dijanjostikati b'defiċjenza tal-ormon tat-tkabbir fl-adulti (AGHD - adult growth hormone deficiency), wieħed b'AGHD li tfaċċat f'età adulta (n=166) u l-ieħor b'AGHD li tfaċċat fit-tfulija (n=64).
English: IGF-I levels, which were low at study entry, were restored to within the normal range with somatropin therapy.
Maltese: Livelli ta' IGF-I, li kienu baxxi meta ddaħħlu fl-istudju, reġgħu lura għall-firxa normali b'terapija b'somatropin.
English: Children with growth failure due to inadequate growth hormone secretion (n=236) Common: central nervous system neoplasm (2 patients experienced a recurrent medulloblastoma, 1 patient experienced a histiocytoma).
Maltese: Tfal b'falliment tat-tkabbir ikkawżat minn sekrezzjoni inadegwata tal-ormon tat-tkabbir (n=236) Komuni: neoplażma fis-sistema nervuża ċentrali (2 pazjenti kellhom medulloblastoma rikorrenti, pazjent wieħed kellu istjoċitoma).
English: Persistent stinging, burning sensation, pain and/or numbness in the palm of the hand due to a trapped nerve at the wrist (carpal tunnel syndrome).
Maltese: Tingiż persistenti, sensazzjoni ta' ħruq, uġigħ u/jew tnemnim fil-pala tal-id ikkawżati minn nerv maqrus fil-polz (sindrome carpal tunnel).
English: After subcutaneous bolus administration, the mean terminal half-life t½ of somatropin is about 2.3 hours.
Maltese: Wara għoti bolus taħt il-ġilda, il-half-life terminali medja t½ ta' somatropin hija ta' madwar 2.3 sigħat.
English: Batteries typically last 24 months and have a 4-week life from the time the „bt‟ first starts blinking.
Maltese: Batteriji ġeneralment iservu 24 xahar u għandhom ħajja ta' 4 ġimgħat minn meta “bt” tibda tteptep.
English: One cartridge contains 10 mg (30 IU) of somatropin * Somatropin is a human growth hormone produced in Escherichia coli cells by recombinant DNA technology.
Maltese: Skartoċċ wieħed fih 10 mg (30 IU) ta' somatropin * Somatropin huwa ormon tat-tkabbir uman magħmul f'ċelluli ta' Escherichia coli permezz ta' teknoloġija tat-tfassil tad-DNA.
English: * Somatropin is a human growth hormone produced in Escherichia coli cells by recombinant DNA technology.
Maltese: * Somatropin huwa ormon tat-tkabbir uman magħmul f'ċelluli ta' Escherichia coli permezz ta' teknoloġija tat-tfassil tad-DNA.
English: NutropinAq is essentially “sodium free”
Maltese: NutropinAq huwa essenzjalment “mingħajr sodium”
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, Somatropin and analogues, ATC Code: H01 AC 01
Maltese: Ormoni u analogi tal-pitwitarja u tal-ipotalamu, Somatropin u analogi, Kodiċi ATC:
English: Overall, 171 patients were exposed to somatropin for an average of 3.5 or 2.8 years.
Maltese: B'mod globali, 171 pazjent kienu esposti għal somatropin għal medja ta' 3.5 snin jew 2.8 snin.
English: Lot: {number}
Maltese: Lot:
English: Predicted adult height (PAH) increased from 157.7-161.0 cm at baseline to 161.4-167.4 cm at Month 12 and 166.2-171.1 cm at Month 36.
Maltese: ċm fil-linja bażi għal 161.4-167.4 ċm f'Xahar 12 u 166.2-171.1 ċm f'Xahar 36.
English: Uncommon: Peripheral oedema, oedema, injection site reaction (irritation, pain)
Maltese: Mhux komuni: Edima periferali, edima, reazzjoni fis-sit tal-injezzjoni (irritazzjoni, uġigħ)
English: Rare: Asthenia, face oedema, fatigue, irritability, pain, pyrexia, injection site reaction (haemorrhage, haematoma, atrophy, urticaria, pruritus, swelling, erythema)
Maltese: Astenja, edima fil-wiċċ, għeja kbira, irritabilità, uġigħ, deni, reazzjoni fis-sit tal-injezzjoni (emorraġija, ematoma, atrofija, urtikarja, ħakk, nefħa, eritema)
English: Somatropin induces retention of sodium, potassium and phosphorus.
Maltese: Somatropin jinduċi żamma ta' sodju, potassju u fosforu.
English: The dose in both studies was 0.043 mg/kg/day, administered subcutaneously (s.c.).
Maltese: Id-doża fiż-żewġ studji kienet ta' 0.043 mg/kg/jum, mogħtija taħt il-ġilda (s.c. - subcutaneously).
English: Somatropin stimulates the synthesis of chondroitin sulphate and collagen as well as the urinary excretion of hydroxyproline.
Maltese: Somatropin jistimula is-sintesi ta' chondroitin sulphate u collagen kif ukoll it-tneħħija fl-awrina ta' hydroxyproline.
English: One ml contains 5 mg of somatropin*
Maltese: U KWANTITATTIVA Ml wieħed (1 ml) fih 5 mg ta' somatropin*
English: Growth failure associated with chronic renal insufficiency
Maltese: Falliment tat-tkabbir assoċjat ma' insuffiċjenza kronika tal-kliewi
English: Growth failure associated with Turner Syndrome
Maltese: Falliment tat-tkabbir assoċjat mas-Sindrome ta' Turner
English: Growth hormone deficiency in adults
Maltese: Defiċjenza tal-ormon tat-tkabbir fl-adulti
English: The results to Month 60 show continued improvement, and more patients reached height SDS in the normal range.
Maltese: Ir-riżultati sa Xahar 60 juru titjib kontinwu, u aktar pazjenti laħqu SDS tat-tul fil-firxa normali.
English: Uncommon: Neoplasm malignant, neoplasm benign
Maltese: Mhux komuni: Neoplażma malinna, neoplażma beninna
English: In adults, it helps to maintain normal body shape and metabolism for example lipid profile and glucose levels.
Maltese: Fl-adulti, dan jgħin biex tinżamm forma tal-ġisem u metaboliżmu normali pereżempju profil tal-lipidi u livelli tal-glucose.
English: Both studies demonstrated a statistically significant increase in growth rate compared to placebo over the first year (9.1-10.9 cm/year vs 6.2-6.6 cm/year), which decreased slightly in the second year (7.4-7.9 cm/year vs 5.5-6.6 cm/year).
Maltese: Iż-żewġ studji wrew żieda statistikament sinifikanti fir-rata tat-tkabbir meta mqabbla mal-plaċebo matul l-ewwel sena (9.1-10.9 ċm/sena vs 6.2-6.6 ċm/sena), li naqset ftit fit-tieni sena (7.4-7.9 ċm/sena vs 5.5-6.6 ċm/sena).
English: Growth hormone therapy may decrease insulin sensitivity and impair glucose tolerance.
Maltese: Terapija bl-ormon tat-tkabbir tista' tnaqqas is-sensittività għallinsulina u tnaqqas it-tolleranza għall-glucose.
English: Chemical and physical in-use stability has been demonstrated for 28 days at 2°C - 8°C.
Maltese: Stabbilità kimika u fiżika waqt l-użu ġiet murija għal 28 ġurnata f'temperatura ta' 2°C - 8°C.
English: One ml contains 5 mg of somatropin One cartridge contains 10 mg (30 IU) of somatropin
Maltese: Ml wieħed (1 ml) fih 5 mg ta' somatropin Skartoċċ wieħed fih 10 mg (30 IU) ta' somatropin