FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall incidence of withdrawals from controlled monotherapy trials due to adverse reactions was no greater for patients treated with vildagliptin at doses of 100 mg daily (0.3%) than for placebo (0.6%) or comparators (0.5%).
Maltese: L-inċidenza globali tat-twaqqif mill-provi bil-kontroll b'monoterapija minħabba r-reazzjonijiet avversi ma kienitx akbar għall-pazjenti kkurati b'vildagliptin b'dożi ta' 100 mg kuljum (0.3%) milli għallplaċebo (0.6%) jew kumparaturi (0.5%).
English: - Each Zomarist 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Maltese: - Kull pillola miksija b'rita ta' Zomarist fiha 50 mg vildagliptin u 850 mg metformin hydrochloride (jikkorrispondu għal 660 mg metformin).
English: Zomarist is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multipacks containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Maltese: Zomarist jiġi f'pakketti li jkun fihom 10, 30, 60, 120, 180 jew 360 pillola miksija b'rita u f'pakketti b'ħafna li jkun fihom 120 (2x60), 180 (3x60) jew 360 (6x60) pillola miksija b'rita.
English: In a 24-week trial the efficacy of the fixed dose combination of vildagliptin and metformin (gradually titrated to a dose of 50 mg/500 mg twice daily or 50 mg/1000 mg twice daily) as initial therapy in drug-naïve patients was evaluated.
Maltese: Waqt prova li damet għaddejja 24 ġimgħa saret evalwazzjoni tal-effikaċja ta' doża fissa ta' vildagliptin u metformin mogħtija flimkien (miżjuda gradwalment għal doża ta' 50 mg/500 mg darbtejn kuljum jew għal 50 mg/1000 mg darbtejn kuljum) fil-bidu tal-kura lil pazjenti naive għallmediċini.
English: It is especially important to mention the following: - glucocorticoids generally used to treat inflammation - beta-2 agonists generally used to treat respiratory disorders - other medicines used to treat diabetes - medicines which increase urine production (diuretics) - medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) - certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II
Maltese: Huwa importanti ħafna li wieħed isemmi dan li ġej: - glukokortikojdi li b'mod ġenerali jintużaw għall-kura ta' l-infjammazzjoni - agonisti beta-2 li b'mod ġenerali jintużaw għall-kura ta' disturbi respiratorji - mediċini oħrajn li jintużaw għall-kura tad-dijabete - mediċini li jżidu l-produzzjoni tal-awrina (dijuretiċi) - mediċini użati biex jittrattaw l-uġigħ u l-infjammazzjoni (NSAID u inibituri ta' COX-2, bħal ibuprofen u celecoxib) - ċerti mediċini għat-trattament ta' pressjoni għolja (impedituri ACE u antagonisti tar-riċetturi ta'
English: GFR should be assessed before treatment initiation and regularly thereafter (see section 4.2).
Maltese: Il-GFR għandha tiġi evalwata qabel jinbeda t-trattament u b'mod regolari wara dan, ara sezzjoni 4.2.
English: - if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Maltese: - jekk għandek dijabete mhux ikkontrollata, b'pereżempju, ipergliċemija severa (glucose għoli fid-demm), dardir, rimettar, dijarea, telf mgħaġġel fil-piż, aċidożi lattika (ara "Riskju ta' aċidożi lattika" hawn taħt) jew ketoaċidożi.
English: There have been no therapeutic clinical trials conducted with Zomarist.
Maltese: Ma sarux provi kliniċi terapewtiċi b'Zomarist.
English: In a 24-week trial, vildagliptin (50 mg twice daily) was compared to pioglitazone (30 mg once daily) in patients inadequately controlled with metformin (mean daily dose: 2020 mg).
Maltese: Waqt prova li damet għaddejja 24 ġimgħa, vildagliptin (50 mg darbtejn kuljum) tqabbel ma' pioglitazone (30 mg darba kuljum) f'pazjenti kkontrollati b'mod mhux adegwat b'metformin (doża medja kuljum: 2020 mg).
English: Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
Maltese: Fil-bniedem il-metaboliżmu huwa l-mezz ewlieni li bih jitnehha vildagliptin, li jgħodd 69% tad-doża.
English: • Common: headache, chills, nausea (feeling sick), low blood glucose, heartburn.
Maltese: • Komuni: uġigħ ta ras, sirdat, dardir (tħossok ma tiflaħx), glukosju baxx fid-demm, uġigħ fl istonku.
English: Cardiovascular risk
Maltese: Ir-riskju kardjovaskulari
English: Dizziness, tremor Skin and subcutaneous tissue disorders Common
Maltese: Stitikezza Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Maltese: Metformin huwa biguanide b'effetti kontra l-ipergliċemija, inaqqas kemm il-glucose fil-plasma bażiku kif ukoll dak ta' wara l-ikel.
English: C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose was recovered in the faeces.
Maltese: C] mill-ħalq, madwar 85% tad-doża tneħħiet fl-awrina u 15% tad-doża instabet fl-ippurgar.
English: Summary of the safety profile
Maltese: Sommarju tal-profil dwar is-sigurtà
English: - Zomarist is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulphonylurea.
Maltese: - Zomarist huwa indikat biex jingħata flimkien ma' sulphonylurea (i.e terapija ta' kombinazzjoni tripla) bħala aġġunt għad-dieta u l-eżerċizzju f'pazjenti adulti li mhux qed jiġu kkontrollati b'mod adegwat b'metformin u b'sulphonylurea.
English: Flaking skin, peeling skin, scabs and tail sores with correlating histopathological changes were noted at doses ≥ 20 mg/kg/day (approximately 3 times human AUC exposure at the 100 mg dose).
Maltese: Ġilda li tinqala, ġilda li titqaxxar, qxur u selħiet fid-denb flimkien ma' bidliet istopatoloġiċi korrelatanti kienu nnutati b'dożi ≥ 20 mg/kg/jum (madwar 3 darbiet l-esponiment ta' l-AUC filbniedem b'doża ta' 100 mg).
English: Two patients reported severe hypoglycaemic events in the vildagliptin group, and 6 patients in the placebo group.
Maltese: Żewġ pazjenti rraportaw każijiet ta' ipogliċemija severa fil-grupp ta' vildagliptin, u 6 pazjenti fil-grupp tal-plaċebo.
English: - Zomarist is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Maltese: - Zomarist huwa indikat għal terapija ta' kombinazzjoni tripla mal-insulina bħala aġġunt għad-dieta u l-eżerċizzju sabiex jitjieb il-kontroll gliċemiku f'pazjenti adulti meta l-insulina f'doża stabbli u metformin waħedhom ma jipprovdix kontroll gliċemiku xieraq.
English: However, vildagliptin cannot be removed by haemodialysis, although the major hydrolysis metabolite (LAY 151) can.
Maltese: Madankollu, vildagliptin ma jistax jitneħħa bl-emodijalisi, għalkemm il-metabolu ewlieni tal-hydrolysis (LAY 151) jista'.
English: Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin.
Maltese: Studji dwar interazzjonijiet bejn il-mediċini f'individwi b'saħħithom saru b'amlodipine, ramipril, valsartan u simvastatin.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ml, even at maximum doses.
Maltese: Fi provi kliniċi bil-kontroll, l-ogħla livelli ta' metformin filplażma (Cmax) ma qabżux 4 µg/ml, anki bl-ogħla dożi.
English: Patients receiving vildagliptin experienced no weight gain (+0.2 kg) while those receiving placebo experienced weight reduction (-0.7 kg).
Maltese: Pazjenti li kienu qed jieħdu vildagliptin ma esperjenzawx żieda fil-piż (+0.2 kg) waqt li dawk li kienu qed jirċievu plaċebo esperjenzaw tnaqqis fil-piż (-0.7 kg).
English: • Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).
Maltese: • Mard tal-fwied (epatite) (rari): Sintomi jinkludu ġilda u għajnejn sofor, tqalligħ, telf ta' l-aptit jew awrina skura, li jista' jindika mard tal-fwied (epatite).
English: In clinical trials, the incidence of hypoglycaemia was common in patients receiving vildagliptin in combination with metformin (1%) and uncommon in patients receiving placebo + metformin (0.4%).
Maltese: Fi provi kliniċi, l-inċidenza ta' l-ipogliċemija kienet komuni f'pazjenti li kienu qed jirċievu vildagliptin flimkien ma' metformin (1%) u mhux komuni f'pazjenti li kienu qed jirċievu plaċebo flimkien ma' metformin (0.4%).
English: Zomarist 50 mg/850 mg film-coated tablets
Maltese: U KWANTITATTIVA Zomarist 50 mg/850 mg pilloli miksija b'rita
English: - Each Zomarist 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Maltese: - Kull pillola miksija b'rita ta' Zomarist fiha 50 mg vildagliptin u 1000 mg metformin hydrochloride (jikkorrispondu għal 780 mg metformin).
English: Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see also sections 4.3 and 4.5).
Maltese: Fatturi oħra ta' riskju għal aċidożi lattika huma konsum eċċessiv ta' alkoħol, insuffiċjenza epatika, dijabete ikkontrollata b'mod mhux adegwat, ketożi, sawm fit-tul u kwalunkwe kundizzjoni assoċjata ma' nuqqas ta' ossiġnu fit-tessuti, kif ukoll l-użu fl-istess waqt ta' prodotti mediċinali li jistgħu jikkawżaw aċidożi lattika (ara sezzjonijiet 4.3 u 4.5).
English: The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.
Maltese: It-titjib fil-proporzjon tal-insulina/glucagon waqt l-ipergliċemija minħabba ż-żieda fil-livelli tal-ormoni inkretin tirriżulta f'tnaqqis fil-produzzjoni ta' glucose waqt is-sawm u wara l-ikel, li twassal għal tnaqqis fil-gliċemija.
English: Patients receiving vildagliptin in combination with a sulphonylurea may be at risk for hypoglycaemia.
Maltese: Pazjenti mogħtija vildagliptin flimkien ma' sulfhonylurea jista' jkollhom riskju ta' ipogliċemija.
English: In comparative controlled monotherapy studies, hypoglycaemia was uncommon, reported in 0.4% (7 of 1,855) of patients treated with vildagliptin 100 mg daily compared to 0.2% (2 of 1,082) of patients in the groups treated with an active comparator or placebo, with no serious or severe events reported.
Maltese: Fi studji għat-tqabbil bil-kontroll b'monoterapija, ipogliċemija kienet irrappurtata rari f'0.4% (7 minn 1,855) tal-pazjenti kkurati b'vildagliptin 100 mg kuljum mqabbla ma' 0.2% (2 minn 1,082) talpazjenti fil-gruppi ikkurati b'kumparatur attiv jew plaċebo, mingħajr ma kienu rrappurtati każijiet serji jew severi.
English: DPP-4 contributes partially to the hydrolysis of vildagliptin based on an in vivo study using DPP-4 deficient rats.
Maltese: DPP-4 jikkontribwixxi parzjalment għall-isdroliżi ta' vildagliptin ibbażat minn studju in vivo bl-użu ta' firien li ma kellhomx DPP-4.
English: • Frequency not known (cannot be estimated from the available data): itchy rash, inflammation of the pancreas, localised peeling of skin or blisters, muscle pain.
Maltese: - Frekwenza mhux magħrufa (ma tistax tiġi stabbilita mid-dejta disponibbli): raxx bil-ħakk infjammazzjoni tal-frixa, tqaxxir lokalizzat tal-ġilda jew infafet, uġigħ fil-muskoli.
English: What Zomarist looks like and contents of the pack Zomarist 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Maltese: Zomarist 50 mg/850 mg pilloli miksija b'rita huma pilloli sofor, ovali b'“NVR” fuq naħa waħda u “SEH” fuq l-oħra.
English: Avoid excessive alcohol intake while taking Zomarist since this may increase the risk of lactic acidosis (please see section “Warnings and precautions”).
Maltese: Evita konsum eċċessiv ta' alkoħol meta tkun qed tieħu Zomarist peress li dan jista' jżid ir-riskju ta' aċidożi lattika (jekk jogħġbok ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: Intra-cardiac impulse conduction delays were observed in dogs with a no-effect dose of 15 mg/kg (7fold human exposure based on Cmax).
Maltese: Ittardjar fil-konduzzjoni ta' impulsi fil-qalb dehru fi klieb b'doża mingħajr effett ta' 15 mg/kg (7-darbiet l-esponiment fil-bniedem ibbażat fuq Cmax).
English: An increased incidence of wavy ribs was observed in rats in association with reduced maternal body weight parameters, with a no-effect dose of 75 mg/kg (10-fold human exposure).
Maltese: Żieda fl-inċidenza ta' kustilji imbewqa dehret fil-firien b'assoċjazzjoni ma' tnaqqis fil-parametri tal-piż tal-ġisem ta' l-omm, b'doża mingħajr effett ta' 75 mg/kg (10-il darba l-esponiment fil-bniedem).
English: Accumulation of foamy alveolar macrophages in the lung was observed in rats and mice.
Maltese: Tossiċità fl-embriju u l-fetu kienet evalwata fil-firien u l-fniek.
English: The dose of Zomarist should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Maltese: Id-doża ta' Zomarist għandha tipprovdi doża ta' 50 mg vildagliptin darbtejn kuljum (100 mg doża totali ta' kuljum) u doża ta' metformin simili għad-doża li qed tittieħed diġà.
English: In controlled clinical trials using vildagliptin 50 mg twice daily in combination with insulin, with or without concomitant metformin, the overall incidence of withdrawals due to adverse reactions was 0.3% in the vildagliptin treatment group and there were no withdrawals in the placebo group.
Maltese: Fi provi kliniċi b'kontrolli li fihom intuża vildagliptin 50 mg darbtejn kuljum f'kombinazzjoni mal-insulina, bi jew mingħajr metformin fl-istess waqt, l-inċidenza globali ta' tiżmim minħabba reazzjonijiet avversi kienet ta' 0.3% fil-grupp ta' trattament b'vildagliptin u ma kien hemm ebda tiżmim fil-grupp tal-plaċebo.
English: Adverse reactions listed in Table 5 are based on information available from the metformin Summary of Product Characteristics available in the EU.
Maltese: Reazzjonijiet avversi elenkati f'Tabella 5 huma bbażati fuq l-informazzjoni li hemm fis-Sommarju tal-Karatteristiċi tal-Prodott ta' metformin li hemm fl-EU.
English: Acute or chronic disease which may cause tissue hypoxia, such as: cardiac or respiratory failure, recent myocardial infarction, shock.
Maltese: Mard akut jew kroniku li jista' jikkawża ipoksja tat-tessuti, bħal: insuffiċjenza kardijaka jew respiratorja, infart mijokardijaku reċenti, xokk.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) Diabetic pre-coma Severe renal failure (GFR < 30 ml/min) (see section 4.4) Acute conditions with the potential to alter renal function, such as: dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section 4.4).
Maltese: Kundizzjonijiet akuti li jistgħu jibdlu l-funzjoni renali, bħal: deidrazzjoni, infezzjoni severa, xokk, l-għotja minn ġol-vini ta' aġenti tal-kuntrast li fihom l-jodju (ara sezzjoni 4.4).
English: - Store in the original package (blister) in order to protect from moisture.
Maltese: - Aħżen fil-pakkett oriġinali (folja) sabiex tilqa' mill-umdità.
English: Additional information on the individual active substances of the fixed combination
Maltese: Informazzjoni oħra fuq is-sustanzi attivi individwali għall-kombinazzjoni fissa Vildagliptin
English: Sulphonylureas are known to cause hypoglycaemia.
Maltese: Sulphonylureas huma magħrufa li jikkaġunaw ipogliċemija.
English: Zomarist is indicated in the treatment of type 2 diabetes mellitus: - Zomarist is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Maltese: Zomarist huwa indikat għall-kura ta' dijabete mellitus tat-tip 2: - Zomarist huwa indikat għall-kura ta' pazjenti adulti li ma jistgħux jiksbu kontroll gliċemiku xieraq bl-ogħla doża li jifilħu ta' metformin li jittieħed mill-ħalq waħdu jew li diġà qed jiġu kkurati b'taħlita ta' vildagliptin u metformin bħala pilloli separati.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Zomarist.
Maltese: Id-dikjarazzjonijiet li ġejjin jirriflettu il-kwalitajiet farmakokinetiċi tas-sustanzi attivi f'Zomarist.
English: Liver enzyme monitoring
Maltese: Monitoragg ta' l-enzimi tal-fwied
English: In controlled clinical trials with the combination of vildagliptin 100 mg daily plus metformin, no withdrawal due to adverse reactions was reported in either the vildagliptin 100 mg daily plus metformin or the placebo plus metformin treatment groups.
Maltese: Fi provi kliniċi bil-kontroll bit-taħlita ta' vildagliptin 100 mg kuljum ma' metformin, l-ebda twaqqif minħabba reazzjonijiet avversi ma kien irrappurtat la fil-gruppi ta' trattament b'vildagliptin 100 mg kuljum flimkien ma' metformin jew fil-grupp tal-plaċebo ma' metformin.
English: Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Zomarist (see sections 4.2, 4.3 and 4.8).
Maltese: Pazjenti b'indeboliment epatik, inklużi pazjenti li jkollhom ALT jew AST qabel il-kura > 3 darbiet ULN, m'għandhomx jiġu kkurati b'Zomarist (ara sezzjonijiet 4.2, 4.3 u 4.8).
English: Musculoskeletal and connective tissue disorders Not known
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Zomarist 50 mg/1000 mg film-coated tablets
Maltese: Zomarist 50 mg/1000 mg pilloli miksija b'rita
English: • Lactic acidosis (very rare: may affect up to 1 user in 10,000): Zomarist may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Maltese: • Aċidożi lattika (rari ħafna: tista' taffettwa sa persuna 1 minn kull 10,000 li qed jużawh):
English: A fertility and early embryonic development study in rats revealed no evidence of impaired fertility, reproductive performance or early embryonic development due to vildagliptin.
Maltese: Studju dwar il-fertilità u żvilupp bikri fil-firien ma wera l-ebda evidenza ta' tixkil fil-fertilità, ħila riproduttiva jew żvilupp bikri ta' l-embriju minnħabba vildagliptin.
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' eċċipjenti Qalba tal-pillola
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces serum levels of total cholesterol, LDL cholesterol and triglycerides.
Maltese: Dan intwera b'dożi terapewtiċi fi studji kliniċi bil-kontroll fuq żmien medju jew twil: meformin inaqqas il-livelli fis-serum tal-kolesterol totali, kolesterol tat-tip LDL u livelli tat-trigliċeridi.
English: The recommended dose is one film-coated tablet of either 50 mg/850 mg or 50 mg/1000 mg taken twice a day
Maltese: Id-doża rakkomandata hija pillola waħda miksija b'rita ta' 50 mg/850 mg jew ta' 50 mg/1000 mg meħuda darbtejn kuljum.
English: How to store Zomarist
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “FLO” on the other side.
Maltese: Pillola miksija b'rita safra skura, b'għamla li tagħti fl-ovali b'xifer imżerżaq, ittimbrata b'“NVR” fuq naħa waħda u “FLO” fuq in-naħa l-oħra.
English: Vascular disorders Uncommon
Maltese: Disturbi vaskulari Mhux komuni
English: No new toxicities associated with the combination were identified.
Maltese: Ma nstabux tossiċitajiet ġodda assoċjati mal-kombinazzjoni.
English: Caution should be exercised in patients with history of acute pancreatitis.
Maltese: Għandu jkun hemm attenzjoni f'pazjenti b'passat ta' pankreatite akuta.
English: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in cases of fasting, malnutrition or hepatic impairment.
Maltese: Intossikazzjoni bl-alkoħol hija assoċjata ma' riskju akbar ta' aċidożi lattika, b'mod partikulari f'każijiet ta' sawm, malnutrizzjoni jew indeboliment epatiku.
English: Renal excretion of the unchanged vildagliptin accounted for 23% of the dose after oral administration.
Maltese: L-eskrezzjoni renali ta' vildagliptin mhux mibdul kienet tgħodd għall 23% taddoża wara li ngħata mill-ħalq.
English: Metformin must be discontinuedat the time of surgery under general, spinal or epidural anaesthesia.
Maltese: Metformin għandu jitwaqqaf fil-ħin ta' kirurġija taħt anestesija ġenerali, fis-sinsla tad-dahar jew epidurali.
English: All symptoms and laboratory abnormalities resolved without treatment after discontinuation of the study medicinal product.
Maltese: Issintomi kollha u anormalitajiet tal-laboratorju għaddew mingħajr kura wara li twaqqaf il-prodott mediċinali li kien qed jiġi studjat.
English: Do not take Zomarist - if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tiħux Zomarist - jekk inti allerġiku għal vildagliptin, metformin jew għal xi sustanza oħra ta' din il-mediċina Zomarist(imniżżla fis-sezzjoni 6).
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: {Isem u indirizz} <{telefon}> <{fax}> <{e-mail}>
English: - KLIM/PD/11/USA study:
Maltese: - L-istudju KLIM/PD/11/USA:
English: Activelle contains lactose monohydrate.
Maltese: Activelle fih lactose monohydrate.
English: MANUFACTURER Novo Nordisk A/S
Maltese: MANIFATTUR Novo Nordisk A/S
English: • Systemic lupus erythematosus
Maltese: • Lupus eritematosu sistemiku
English: NET binds to SHBG (36%) and to albumin (61%).
Maltese: NET jintrabat ma' SHBG (36 %) u ma' l-albumina (61 %).
English: Novo Nordisk Pharmaceutique S.A. 30 Rue De Valmy FR-92936 Paris La Defence Cedex France
Maltese: 30 Rue De Valmy FR-92936 Paris La Defence Cedex Franza
English: Riverside Business Park Boulevard International BE-1070 Brussels Belgium
Maltese: Business Park Boulevard International BE-1070
English: NL-2408 AV Alphen a/d Rijn
Maltese: Flemingweg 18 NL-2408 AV Alphen a/d Rijn l-Olanda
English: Dementia
Maltese: Demenzja
English: • Nervousness
Maltese: • Nervożità
English: Coronary artery disease (CAD)
Maltese: Mard fl-arterji koronarji (CAD)
English: Alopecia Acne
Maltese: Alopeċja Akne
English: • Otosclerosis
Maltese: • Otosklerosi
English: - Pickar J.H.
Maltese: - Pickar J.H. et al.:
English: Treatment should be symptomatic.
Maltese: Il-kura għandha tkun sintomatika.
English: The tablets are engraved with “NOVO 291” on one side and the “APIS” on the other side.
Maltese: Il-pilloli għandhom imnaqqax “NOVO 291” fuq naħa u “APIS” fuq in-naħa l-oħra.
English: System organ class
Maltese: Sistema talklassifika ta' lorgani
English: You may need to read it again
Maltese: DATA TA' META ĠIET RIVEDUTA
English: Between 18 and 20 (best estimate = 19) for 10 years' use.
Maltese: Bejn 18 u 20 (l-aħjar stima = 19) għall-użu ta' 10 snin.
English: Novo Nordisk Pharma N.V
Maltese: Novo Nordisk Pharma N
English: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark
Maltese: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Id-Danimarka
English: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd
Maltese: Novo Nordisk A/S Novo Allé DK-2880
English: • Medicines used for tuberculosis (such as rifampicin, rifabutin)
Maltese: • Mediċini użati għat-tuberkulożi (bħal rifampicin, rifabutin)
English: Nervousness
Maltese: Nervożità
English: Endometrial Safety
Maltese: Sigurtà Endometrijali
English: • Herbal products containing St John's Wort (Hypericum perforatum).
Maltese: • Prodotti magħmula mill-ħxejjex li fihom St.John's Wort (Hypericum perforatum)