FrancophonIA/ELRC3.0 huggingface dataset:
English: (95 % CI) Subjects (%) achieving: HbA1c < 7 % Adjusted for baseline Body weight (kg) Baseline (mean) Change from baseline Difference from placebo c
Maltese: (95 % CI) Individwi (%) li kisbu: HbA1c < 7 % Aġġustat għallinja bażi Piż tal-ġisem (kg) Linja bażi (medja) Bidla mil-linja bażi Differenza millplaċebo c
English: In an add-on to insulin study, episodes of major hypoglycaemia were reported in 0.5 % and 1.0 % of subjects treated with dapagliflozin 10 mg plus insulin at Weeks 24 and 104, respectively, and in 0.5 % of subjects treated with placebo plus insulin groups at Weeks 24 and 104.
Maltese: Fi studju fejn ġie miżjud mal-insulina, ġew irrapportati episodji ta' ipogliċemija maġġuri f'0.5 % u f'1.0 % tas-suġġetti kkurati b'dapagliflozin 10 mg miżjud mal-insulina f'Ġimgħa 24 u 104 rispettivament u f'0.5 % tas-suġġetti kkurati ma' gruppi ta' plaċebo miżjud mal-insulina f'Ġimgħat 24 u 104.
English: In subjects ≥ 65 years of age, adverse reactions of volume depletion, most commonly reported as hypotension, were reported in 1.7 % and 0.8 % of dapagliflozin-treated subjects and placebo-treated subjects, respectively (see section 4.4).
Maltese: F'individwi ≥ 65 sena, reazzjonijiet avversi ta' tnaqqis fil-volum, irrappurtati bl-aktar mod komuni bħala pressjoni baxxa, kienu rrappurtati f'1.7 % u 0.8 % tal-individwi ikkurati b'dapagliflozin u tal-pazjenti ikkurati bi plaċebo rispettivament (ara sezzjoni 4.4).
English: The proportion of subjects remaining in the study at Week 104 and Week 208 was 56.2 % and 39.7 % for the group treated with dapagliflozin and 50.0 % and 34.6 % for the group treated with glipizide.
Maltese: Il-proporzjon ta' suġġetti li baqgħu fl-istudju fil-Ġimgħa 104 u fil-Ġimgħa 208 kien ta' 56.2 % u 39.7 % għall-grupp ikkurat b'dapagliflozin u 50.0 % u 34.6 % għall-grupp ikkurat b'glipizide.
English: Adverse reactions in placebo-controlled studies System organ class
Maltese: Reazzjonijiet avversi fl-istudji a kkontrollati bil-plaċebo
English: In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 ml/min/1.73 m2) this grouping of reactions were reported in 1.3 % and 0.8 % of patients who received dapagliflozin 10 mg and placebo, respectively.
Maltese: F'pazjenti b'funzjoni renali normali jew b'indeboliment renali ħafif (eGFR tal-linja bażi ≥ 60 ml/min/1.73 m2) dan irraggruppament ta' reazzjonijiet ġie rrapportat f'1.3 % u 0.8 % tal-pazjenti li rċevew dapagliflozin 10 mg u plaċebo, rispettivament.
English: A Direct Healthcare Professional Communication (DHPC) was circulated on 2 May 2016 to inform healthcare professionals that a two-fold higher incidence of lower limb amputation (primarily of the toe) had been seen in a clinical trial with canagliflozin; in addition, the need to counsel patients about the importance of routine preventative foot care was highlighted.
Maltese: Fit-2 ta' Mejju 2016, ġiet iċċirkolata Komunikazzjoni Diretta tal-Professjonisti fil-Qasam tal-Kura tas-Saħħa (DHPC, Direct Healthcare Professional Communication) sabiex tinforma lill-professjonisti fil-qasam tal-kura tas-saħħa li fi prova klinika b'canagliflozin, ġiet innutata inċidenza ta' darbtejn aktar fin-numru ta' amputazzjonijiet tan-naħa ta' isfel tar-riġlejn (primarjament tas-saba' tas-sieq); barra minn hekk, ġie enfasizzat il-bżonn li l-pazjenti jingħataw parir dwar l-importanza ta' kura tassaqajn preventiva ta' rutina.
English: The proportion of subjects remaining in the study at Week 104 was 72.4 % for the group treated with dapagliflozin 10 mg and 54.8 % for the placebo group.
Maltese: Il-proporzjon ta' suġġetti li baqgħu fl-istudju f'Ġimgħa 104 kien ta' 72.4 % għall-grupp ikkurat b'dapagliflozin 10 mg u 54.8 % għall-grupp talplaċebo.
English: In a 52-week, active-controlled non-inferiority study (with 52- and 104-week extension periods), Edistride was evaluated as add-on therapy to metformin compared with a sulphonylurea (glipizide) as add-on therapy to metformin in subjects with inadequate glycaemic control (HbA1c > 6.5 % and ≤ 10 %).
Maltese: Fi studju mhux inferjuri ta' 52-ġimgħa, kontrollat b'mod attiv (b'perjodi ta' estensjoni ta' 52 ġimgħa u ta' 104 ġimgħat), Edistride kien evalwat bħala terapija add-on imqabbel ma' sulphonylurea (glipizide) miżjud ma' terapija b'metformin f'individwi b'kontroll gliċemiku mhux xieraq (HbA1c > 6.5 % u ≤ 10 %).
English: At Week 104, adjusted mean change from baseline in HbA1c was -0.32 % for dapagliflozin and -0.14 % for glipizide.
Maltese: 32 % għal dapagliflozin u -0.14 % għal glipizide.
English: Diabetic Ketoacidosis
Maltese: Ketoaċidożi dijabetika
English: Edistride has not been studied in severe renal impairment (CrCl < 30 ml/min or eGFR < 30 ml/min/1.73 m 2) or end-stage renal disease (ESRD).
Maltese: Edistride mhux rakkomandat għall-użu f'pazjenti b'indeboliment renali moderat għal sever (pazjenti b'CrCl < 60 ml/min jew [eGFR] < 60 ml/min/1.73 m2).Edistride ma ġiex studjat f'każijiet ta' indeboliment renali sever (CrCl < 30 ml/min jew eGFR < 30 ml/min/1.73 m2) jew mard renali fl-aħħar-stadju (ESRD).
English: Improvement in homeostasis model assessment for beta cell function (HOMA beta-cell) has been observed in clinical studies with Edistride.
Maltese: Titjib fl-istima tal-mudell tal-omejostasi għall-funzjoni taċ-ċelluli beta (HOMO ċelluli-beta) deher fi studji kliniċi b'Edistride.
English: Metformin ≥ 1500 mg/day; sitagliptin 100 mg/day LOCF: Last observation (prior to rescue for rescued subjects) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product p-value < 0.05 versus placebo + oral glucose-lowering medicinal product
Maltese: Medja tal-anqas kwadri aġġustata għall-valur tal-linja bażi valur-p < 0.0001 kontra plaċebo + prodott mediċinali orali li jbaxxi l-glukows valur-p < 0.05 kontra plaċebo + prodott mediċinali li jbaxxi l-glukows
English: Edistride is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:
Maltese: Edistride huwa indikat f'adulti li għandhom aktar minn 18-il sena jew aktar b'dijabete mellitus tattip 2 sabiex itejjeb il-kontroll gliċemiku bħala:
English: Diuretics
Maltese: Dislipidemja
English: glimepiride 4 mg/day; Metformin (immediate- or extended-release formulations) ≥1500 mg/day plus maximum tolerated dose, which must be at least half maximum dose, of a sulphonylurea for at least 8 weeks prior to enrolment.
Maltese: glimepiride 4 mg/jum; Metformin (formulazzjonijiet li jerħu l-mediċina mill-ewwel jew bil-mod) ≥1500 mg/jum flimkien mad-doża massima ttollerata, li trid tkun mill-anqas nofs id-doża massima, ta' sulphonylurea għal mill-anqas 8 ġimgħat qabel irreġistrazzjoni.
English: Thirteen double-blind, randomised, controlled clinical trials were conducted with 6,362 subjects with type 2 diabetes to evaluate the efficacy and safety of Edistride; 4,273 subjects in these studies were treated with dapagliflozin.
Maltese: Tlettax-il prova klinika double-blind, randomised, ikkontrollati twettqu b' 6,362 individwu b'dijabete mellitus tat-tip 2 sabiex ikunu evalwati s-sigurtà u l-effikaċja ta' Edistride; 4,273 individwu f'dawn listudji kienu kkurati b'dapagliflozin.
English: These infections were more frequent in females (8.4 % and 1.2 % for dapagliflozin and placebo, respectively), and subjects with a prior history were more likely to have a recurrent infection.
Maltese: Dawn l-infezzjonijiet kienu aktar frekwenti fin-nisa (8.4 % u 1.2 % għal dapagliflozin u plaċebo, rispettivament), u individwi li kellhom fil-passat kellhom aktar probabilità li tirkadilhom linfezzjoni.
English: Fifty percent of subjects were on insulin monotherapy at baseline; 50 % were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80 % were on metformin alone, 12 % were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Maltese: Minn dan il-grupp tal-aħħar, 80 % kienu fuq metformin waħdu, 12 % kienu fuq metformin flimkien ma' terapija b'sulphonylurea, u l-oħrajn kienu fuq prodotti mediċinali orali li jbaxxu l-glukows.
English: Dapagliflozin and related metabolites are primarily eliminated via urinary excretion with less than 2 % as unchanged dapagliflozin.
Maltese: Dapagliflozin u l-metaboli relatati jiġu eliminati fil-parti lkbira permezz ta' eskrezzjoni mal-awrina b'anqas minn 2 % bħala dapagliflozin mhux mibdul.
English: Following coadministration of dapagliflozin with mefenamic acid (an inhibitor of UGT1A9), a 55 % increase in dapagliflozin systemic exposure was seen, but with no clinically meaningful effect on 24-hour urinary glucose excretion.
Maltese: Wara l-għotja ta'dapagliflozin flimkien ma' mefenamic acid (inibitur ta' UGT1A9), żieda ta' 55 % flesponiment sistemiku ta' dapagliflozin deher, iżda ma' kienx hemm effett ta' sinifikat kliniku fuq leskrezzjoni tal-glukows mal-awrina fuq 24-siegħa.
English: Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Maltese: Dejta limitata minn provi kliniċi tissuġġerixxi li d-DKA sseħħ bi frekwenza komuni meta l-pazjenti b'dijabete tat-tip 1 jiġu kkurati b'inibituri SGLT2.
English: How to store Edistride
Maltese: X'fih Edistride
English: Very common Common
Maltese: Komuni ħafna Komuni*
English: Primary episodes occurred at a rate of 1.62 % per patient-year in subjects treated with dapagliflozin and 2.06 % in comparator-treatment subjects, per patient-year.
Maltese: L-episodji primarji seħħew bir-rata ta' 1.62 % kull sena ta' pazjent f'pazjenti ttrattati b'dapagliflozin u b'rata ta' 2.06 % f'pazjenti ttrattati bi prodott ta' paragun.
English: Edistride 10 mg film-coated tablets Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Maltese: Edistride 10 mg pilloli miksijin b'rita Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 10 mg dapagliflozin
English: tablet core: microcrystalline cellulose (E460i), anhydrous lactose (see section 2 ‘Edistride contains lactose'), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b).
Maltese: Kull pillola Edistride 5 mg miksija b'rita (pillola) fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin Kull pillola Edistride 10 mg miksija b'rita (pillola) fiha dapagliflozin propanediol monohydrate ekwivalenti għal 10 mg dapagliflozin Is-sustanzi l-oħra huma: - qalba tal-pillola: microcrystalline cellulose (E460i), anhydrous lactose (ara sezzjoni 2 ‘Edistride fih lactose'), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b). - kisja tar-rita: polyvinyl alcohol (E1203), titanium dioxide (E171),macrogol 3350, talc (E553b), yellow iron oxide (E172).
English: The CANVAS and CANVAS-R studies and the CREDENCE and DECLARE Studies are planned to be completed in 2017 and 2020, respectively.
Maltese: L-istudji CANVAS u CANVAS-R u l-Istudji CREDENCE u DECLARE huma ppjanati li jitlestew fl-2017 u fl2020, rispettivament.
English: Edistride 5 mg film-coated tablets Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Maltese: Edistride 5 mg pilloli miksijin b'rita Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin
English: Further evaluation of patients who had renal-related adverse events showed that most had serum creatinine changes of ≤ 0.5 mg/dl from baseline.
Maltese: Evalwazzjoni ulterjuri tal-pazjenti li kellhom avvenimenti avversi relatati mal-kliewi uriet li ħafna kellhom tibdil fil-kreatinina fis-serum ta' ≤ 0.5 mg/dl mil-linja bażi.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Maltese: Klassi tassistema talorgani
English: • diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Maltese: Dawn huma s-sinjali ta' ketoaċidożi dijabetika (ara wkoll sezzjoni 2 Twissijiet u prekawzjonijiet): - żieda fil-livelli ta' “korpi ketone” fl-awrina jew fid-demm tiegħek - telf fil-piż f'qasir żmien - tħossok ma tiflaħx jew tkun ma tiflaħx - uġigħ fl-istonku - għatx eċċessiv - nifs mgħaġġel u fil-fond - konfużjoni - ngħas jew għejja mhux tas-soltu - riħa ħelwa fin-nifs tiegħek, togħma ħelwa jew metallika f'ħalqek jew riħa tal-awrina jew talgħaraq tiegħek differenti minn tas-soltu.
English: • A valid GMP compliance statement for the manufacturer of the absorbable collagen sponge (ACS), fulfilling the requirements set out in Article 46 of Directive 2001/83/EC.
Maltese: • Dikjarazzjoni valida ta' konformità mal-PTM għall-manifattur tal-isponża tal-kollaġen assorbibbli (ACS), li tissodisfa r-rekwiżiti stabbiliti fl-Artikolu 46 tad-Direttiva 2001/83/KE.
English: Annex II Conditions for lifting the suspension of the marketing authorisation(s)
Maltese: Anness II Kundizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjoni(jiet)
English: For the suspension to be lifted, the Marketing Authorisation Holder for InductOs shall ensure that the following condition is fulfilled:
Maltese: Sabiex titneħħa s-sospensjoni, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għal InductOs għandu jiżgura li l-kundizzjoni li ġejja tiġi ssodisfata:
English: EMA/734632/2015 EMEA/H/C/003970
Maltese: EMA/635362/2015 EMA/H/C/003970
English: The full EPAR and risk management plan summary for Pemetrexed Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Pemetrexed Hospira jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Pemetrexed Hospira is a ‘generic medicine'.
Maltese: Pemetrexed Hospira huwa ‘mediċina ġenerika'.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Maltese: Fil-ġisem, pemetrexed jinbidel f'forma attiva li timblokka l-attività tal-enzimi li huma involuti fil-produzzjoni ta' ‘nukleotidi' ( li fuqhom jinbnew DNA u RNA, il-materjal ġenetiku taċ-ċelloli).
English: Pemetrexed Hospira contains the active substance pemetrexed.
Maltese: Pemetrexed Hospira fih is-sustanza attiva pemetrexed.
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Maltese: • mesoteljoma plewrika malinna (kanċer tar-rita tal-pulmun, normalment ikkawżat minn esponiment għall-ażbestos), fejn jintuża flimkien ma' ċisplatin f'pazjenti li ma ngħatawx il-kimoterapija qabel u li l-kanċer li għandhom ma jistax jitneħħa b'intervent kirurġiku;
English: Other information about Pemetrexed Hospira
Maltese: Informazzjoni oħra dwar Pemetrexed Hospira
English: Pemetrexed Hospira is a cancer medicine used to treat two types of lung cancer:
Maltese: Pemetrexed Hospira huwa mediċina kontra l-kanċer li tintuża biex tikkura żewġ tipi ta' kanċers talpulmun:
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Hospira.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pemetrexed Hospira.
English: The active substance in Pemetrexed Hospira, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Maltese: Is-sustanza attiva f'Pemetrexed Hospira, pemetrexed, hija mediċina ċitotossika (mediċina li toqtol iċċelloli li jkunu qegħdin jimmultiplikaw, bħaċ-ċelloli tal-kanċer), li jagħmlu parti mill-grupp tal‘antimetaboliti'.
English: Pemetrexed Hospira is available as a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Pemetrexed Hospira huwa disponibbli bħala trab li jsir soluzzjoni għal infużjoni (dripp) ġol-vina.
English: When Pemetrexed Hospira is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Maltese: Meta Pemetrexed Hospira jingħata ma' ċisplatin, mediċina 'antiemetika' (biex tipprevjeni r-rimettar) u fluwidi (biex jipprevjenu ddeidrazzjoni) għandha tingħata wkoll qabel jew wara d-doża ta' cisplatin.
English: Why is Pemetrexed Hospira approved?
Maltese: Għaliex ġie approvat Pemetrexed Hospira?
English: This means that Pemetrexed Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Maltese: Dan ifisser li Pemetrexed Hospira huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Alimta.
English: No additional studies were needed as Pemetrexed Hospira is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Maltese: Ma kien jinħtieġ lebda studju addizzjonali peress li Pemetrexed Hospira huwa mediċina ġenerika mogħtija permezz ta' infużjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Alimta.
English: A risk management plan has been developed to ensure that Pemetrexed Hospira is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Pemetrexed Hospira jintuża bl-aktar mod sigur possibbli.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Hospira.
Maltese: Biex jitnaqqsu l-effetti sekondarji, il-pazjenti għandhom jieħdu kortikosterojde (tip ta' mediċina li tnaqqas l-infjammazzjoni) u aċidu foliku (tip ta' vitamina), u għandhom jingħataw injezzjonijiet ta' vitamina
English: What are the benefits and risks of Pemetrexed Hospira?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Pemetrexed Hospira?
English: Because Pemetrexed Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Pemetrexed Hospira huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: • synthetic adrenal hormones (corticosteroids).
Maltese: • ormoni adrenali sintetiċi (kortikosterojdi).
English: Physical capacity
Maltese: Kapaċità fiżika
English: 10 A-6336 Langkampfen Austria
Maltese: A-6336 Langkampfen L-Awstrija
English: Date of first authorisation: 12 April 2006 Date of latest renewal: 12 April 2011
Maltese: Data tal-aħħar tiġdid: 12 t'April, 2011
English: Contains benzyl alcohol.
Maltese: Fih benzyl alcohol.
English: Paraesthesia* Carpal Tunnel Syndrome
Maltese: Parestesija* Sindrome talCarpal Tunnel
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}>
Maltese: DATA TA' REVIŻJONI TAT-TEST <{XX/SSSS}>
English: Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease
Maltese: Slipped capital femoral epiphysis u l-marda ta' Legg-Calvé-Perthes
English: Clinical trials in PWS
Maltese: Provi kliniċi f'PWS
English: In adults
Maltese: Fl-adulti
English: • thyroid hormones,
Maltese: • ormoni tat-tirojde,
English: Oedema peripheral*
Maltese: Edema periferali*
English: Very Rare
Maltese: Rari sa
English: Omnitrope (MAH: Sandoz), Zomacton and associated names (MAH: Ferring), Norditropin and associated names (MAH: Novo Nordisk), Genotropin and associated names (MAH: Pfizer)
Maltese: Omnitrope (MAH: Sandoz), Zomacton u ismijiet assoċjati (MAH: Ferring), Norditropin u ismijiet assoċjati (MAH: Novo Nordisk), Genotropin u ismijiet assoċjati (MAH: Pfizer).
English: Common to < 1/10
Maltese: Komuni sa <1/10
English: Acute critical illness
Maltese: Mard kritiku akut
English: Myalgia*
Maltese: Mijalġja*
English: Carbohydrate metabolism
Maltese: Metaboliżmu tal-karboidrati
English: • Numbness/tingling
Maltese: • Tmewwit/tnemnim
English: • Experience in patients above 80 years is limited.
Maltese: • L-esperjenza f'pazjenti ta' aktar minn 80 sena hi limitata.
English: Omnitrope is a biosimilar medicinal product.
Maltese: Omnitrope hu prodott mediċinali bijoloġiku simili.
English: Solvent: water for injections benzyl alcohol
Maltese: Solvent: ilma għall-injezzjonijiet benzyl alcohol
English: Use only with Omnitrope Pen 5.
Maltese: Uża biss ma' Omnitrope Pen 5.
English: Clinical trials in adults with GHD
Maltese: Provi kliniċi f'adulti b'GHD
English: The active substance of Omnitrope is somatropin.
Maltese: Is-sustanza attiva ta' Omnitrope hi somatropin.
English: Solution for injection in a cartridge for SurePal 5, SurePal 10, SurePal 15.
Maltese: Soluzzjoni għall-injezzjoni fi skartoċċ għal SurePal 5, SurePal 10, SurePal 15.
English: Use only with Omnitrope Pen 10.
Maltese: Uża biss ma' Omnitrope Pen 10.
English: Growth hormone deficiency Prader-Willi syndrome Turner syndrome
Maltese: Defiċjenza ta' l-ormon tat-tkabbir Sindrome ta' Prader-Willi Sindrome ta' Turner
English: Reduced serum cortisol levels
Maltese: Tnaqqis tal-livelli ta' kortisol fis-serum
English: Pack sizes of 1, 5 or 10.
Maltese: Daqsijiet tal-pakkett ta' 1, 5 u 10.
English: The maintenance dose seldom exceeds 0.5 mg per day.
Maltese: Id-doża ta' manteniment rari taqbeż 0.5 mg kuljum.
English: Excipient(s) with known effect: One ml contains 9 mg benzyl alcohol.
Maltese: Eċċipjent(i) b'effett magħruf: 1 ml fih 9 mg ta' benzyl alcohol.
English: Leukaemia†
Maltese: Lewkimja†
English: • medicines to control epilepsy (anticonvulsants),
Maltese: • mediċini li jikkontrollaw l-epilessija (mediċini kontra l-konvulżjonijiet),
English: * produced in Escherichia coli by recombinant DNA technology.
Maltese: * prodott f'Escherichia coli minn teknoloġija tad-DNA rikombinanti.
English: STATEMENT OF ACTIVE SUBSTANCE Somatropin 6.7 mg (20 IU)/ml.
Maltese: Somatropin 6.7 mg (20 IU)/ ml.
English: - The active substance of Omnitrope is somatropin.
Maltese: - Is-sustanza attiva ta' Omnitrope hi somatropin.
English: Arthralgia* Myalgia*
Maltese: Artralġja* Mijalġja*
English: Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates and proteins.
Maltese: Somatropin hu ormon metaboliku qawwi li hu importanti għall-metaboliżmu tal-lipidi, karboidrati u proteini.
English: Rare to
Maltese: Rari Ħafna
English: Somatropin induces the retention of sodium, potassium and phosphorus.
Maltese: Somatropin jikkaġuna ż-żamma ta' sodium, potassium u phosphorus.
English: Lipid metabolism
Maltese: Metaboliżmu tal-lipidi
English: In chronic renal insufficiency, renal function should be below 50 percent of normal before institution of therapy.
Maltese: F'insuffiċjenza kronika tal-kliewi, il-funzjoni tal-kliewi għandha tkun taħt il-50 fil-mija ta' dik normali qabel ma tinbeda t-terapija.
English: Pharmacotherapeutic group: Anterior pituitary lobe hormones and analogues, ATC code: H01AC01.
Maltese: Ormoni tal-lobu pitwitarju anterjuri u analogi, kodiċi ATC:
English: Musculoskeletal stiffness*
Maltese: Ebusija muskoluskeletali*
English: Somatropin 5 mg (15 IU)/ml in a vial.
Maltese: Somatropin 5 mg (15 IU)/ ml f'kunjett.
English: • If you have Prader-Willi syndrome (a chromosomal disorder).
Maltese: • Jekk għandek is-sindrome ta' Prader-Willi (disturb kromosomali).
English: Prader-Willi syndrome
Maltese: Sindrome ta' Prader-Willi