FrancophonIA/ELRC3.0 huggingface dataset:
English: The Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) included 7,332 patients treated with sitagliptin, 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 mL/min/1.73 m2), and 7,339 patients treated with placebo in the intention-to-treat population.
Maltese: Cardiovascular Outcomes with sitagliptin) kienet tinkludi 7,332 pazjent ittrattati b'sitagliptin, 100 mg kuljum (jew 50 mg kuljum jekk l-eGFR fil-linja bażi kienet ≥ 30 u < 50 mL/min/1.73 m2), u
English: For this reason, it is possible that potent CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the pharmacokinetics of sitagliptin in patients with severe renal impairment or ESRD.
Maltese: Għal din ir-raġuni, huwa possibbli li impedituri qawwija ta' CYP3A4 (jiġifieri, ketoconazole, itraconazole, ritonavir, clarithromycin) jistgħu jbiddlu l-farmakokinetika ta' sitagliptin f'pazjenti b'indeboliment tal-kliewi sever jew ESRD.
English: Pack of 50 x 1 film-coated tablets in perforated unit dose blisters.
Maltese: Pakkett ta' 50 x 1 pilloli miksijin b'rita f'folji pperforati b'doża singola.
English: Sitagliptin 50 mg + metformin 1,000 mg (N=178)
Maltese: Sitagliptin 50 mg + metformin 1,000 mg
English: Concomitant administration of OAT3 inhibitors has not been evaluated in vivo.
Maltese: Għoti konkomitanti ta' impedituri OAT3 ma kienx evalwat in vivo.
English: Some medicinal products can adversely affect renal function, which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Maltese: NSAIDs, inklużi inibituri selettivi ta' cyclo-oxygenase (COX) II, inibituri ta' ACE, antagonisti tar-riċetturi ta' angiotensin II u dijuretiċi, speċjalment dijuretiċi loop.
English: Ristfor contains two different medicines called sitagliptin and metformin.
Maltese: Ristfor fih żewġ mediċini differenti msejħin sitagliptin u metformin.
English: Plasma AUC of sitagliptin was increased approximately 2-fold in patients with moderate renal impairment (GFR ≥ 30 to < 45 mL/min), and approximately 4-fold in patients with severe renal impairment (GFR < 30 mL/min), including patients with ESRD on haemodialysis.
Maltese: L-AUC ta' sitagliptin fil-plażma żdiedet b'madwar darbtejn f'pazjenti b'indeboliment moderat talkliewi (GFR ≥ 30 sa < 45 mL/min) u b'madwar 4 darbiet f'pazjenti b'indeboliment sever tal-kliewi (GFR < 30 mL/min), inklużi pazjenti b'ESRD li kienu fuq l-emodijalisi.
English: By inhibiting the DPP--4 enzyme, sitagliptin increases the levels of two known active incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
Maltese: Sitagliptin iżid il-livelli ta' żewġ ormoni incretin attivi magħrufin, glucagon-like peptide-1 (GLP-1) u glucose-dependent insulinotropic polypeptide (GIP), billi jimpedixxi l-enzima DPP-4.
English: Improvements in surrogate markers of beta cell function, including HOMA-β (Homeostasis Model Assessment-β), proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test were observed.
Maltese: Kien osservat titjib f'markers sostituti tal-funzjoni taċ-ċelloli beta, inklużi HOMA-β (Stima ta' Mudell ta' Ħomeostażi-β), fil-proporzjon ta' proinsulina għal insulina, u f'miżuri ta' reazzjoni ta' ċelloli beta mit-test ta' tolleranza għall-ikla b'kampjuni meħudin spiss.
English: - The active substances are sitagliptin and metformin.
Maltese: - Is-sustanzi attivi huma sitagliptin u metformin.
English: In a 52-week study, comparing the efficacy and safety of the addition of sitagliptin 100 mg once daily or glipizide (a sulphonylurea) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c (-0.7 % mean change from baselines at week 52, with baseline HbA1c of approximately 7.5 % in both groups).
Maltese: Fi studju ta' 52 ġimgħa, li qabbel l-effikaċja u s-sigurtà taż-żieda ta' sitagliptin 100 mg darba kuljum jew glipizide (sulphonylurea) f'pazjenti b'kontroll gliċemiku inadegwat fuq monoterapija b'metformin, sitagliptin kien simili għal glipizide fit-tnaqqis ta' HbA1c (-0.7 % bidla medja mil-linji bażi f'ġimgħa 52, b' HbA1c fil-linja bażi ta' madwar 7.5 % fiż-żewġ gruppi).
English: C]sitagliptin oral dose, approximately 16 % of the radioactivity was excreted as metabolites of sitagliptin.
Maltese: Wara doża orali ta' [14C]sitagliptin, madwar 16 % tar-radjuattività kienet eliminata bħala metaboliti ta' sitagliptin.
English: • digoxin (to treat irregular heart beat and other heart problems).
Maltese: • digoxin (biex jikkura taħbit irregolari tal-qalb u problemi oħra tal-qalb).
English: Do not take a double dose of this medicine.
Maltese: Tiħux doża doppja ta'din il-mediċina.
English: Capsule-shaped, red film-coated tablet with “577” debossed on one side.
Maltese: Pillola ħamra miksija b'rita, forma ta' kapsula b'“577” imnaqqxa fuq naħa waħda.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Maltese: Metformin iżid il-kapaċità ta' trasport minn ġol-membrana ta' tipi speċifiċi ta' trasportaturi ta' zokkor (GLUT-1
English: For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea
Maltese: Għal pazjenti mhux ikkontrollati adegwatament fuq terapija doppja kombinata bid-doża massima ttollerata ta' metformin u sulphonylurea
English: Capsule-shaped, pink film-coated tablet with “515” debossed on one side.
Maltese: Pillola roża miksija b'rita, forma ta' kapsula b' “515” imnaqqxa fuq naħa waħda.
English: Among patients taking metformin, baseline HbA1c was 8.70 % and baseline insulin dose was 37 IU/day.
Maltese: Fost pazjenti li jieħdu metformin, l-HbA1c fil-linja bażi kien ta' 8.70 % u d-doża tal-insulina fil-linja bażi kienet ta' 37 IU/jum.
English: Common acute pancreatitis
Maltese: Komuni pankreatite akuta*,†,‡
English: Frequencies are defined as: 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) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma ddefiniti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (> 5 mmol/L) and an increased anion gap and lactate/pyruvate ratio.
Maltese: Sejbiet dijanjostiċi tal-laboratorju huma tnaqqis fil-pH tad-demm (< 7.35), żieda fil-livelli ta' lactate fil-plażma (>5 mmol/l) u żieda fl-anion gap u l-proporzjon ta' lactate/pyruvate.
English: The most effective method to remove lactate and metformin is haemodialysis.
Maltese: L-aktar metodu effettiv biex tneħħi lactate u metformin huwa permezz ta' emodijaliżi.
English: What is type 2 diabetes?
Maltese: X'inhi dijabete tip 2?
English: The clinical relevance of this decrease is unknown.
Maltese: Ir-relevanza klinika ta'
English: Sitagliptin was modestly removed by haemodialysis (13.5 % over a 3- to 4-hour haemodialysis session starting 4 hours post-dose).
Maltese: Sitagliptin kien modestament imneħħi permezz ta' emodijaliżi (13.5 % fuq sessjoni ta' emodijaliżi ta' 3 sa 4 sigħat li jibdew 4 sigħat wara d-doża).
English: 50 x 1 film-coated tablets
Maltese: 50 x 1 pillola miksija b'rita
English: 98 film-coated tablets.
Maltese: 98 pillola miksija b'rita.
English: For adult patients with type 2 diabetes mellitus:
Maltese: Għal pazjenti adulti b'dijabete mellitus tip 2:
English: The renal clearance was approximately 350 mL/min.
Maltese: Ir-rata ta' eliminazzjoni tal-kliewi kienet ta' madwar 350 mL/min.
English: Additional adverse reactions associated with metformin include metallic taste (common); lactic acidosis, liver function disorders, hepatitis, urticaria, erythema, and pruritus (very rare).
Maltese: metall (komuni); aċidożi lattika, disturbi fil-funzjoni tal-fwied, epatite, urtikarja, eritema, u ħakk (rari ħafna).
English: Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Maltese: Dejta ta' qabel l-użu kliniku għal metformin ma turi l-ebda riskju speċjali għal bnedmin abbażi talfarmakoloġija ta' sigurtà, tossiċità ta' doża ripetuta, ġenotossiċità, potenzjal karċinoġenetiku, tossiċità għar-riproduzzjoni.
English: EU/1/10/620/001 14 film-coated tablets EU/1/10/620/002 28 film-coated tablets EU/1/10/620/003 56 film-coated tablets EU/1/10/620/019 60 film-coated tablets EU/1/10/620/004 112 film-coated tablets EU/1/10/620/005 168 film-coated tablets EU/1/10/620/020 180 film-coated tablets EU/1/10/620/006 196 film-coated tablets EU/1/10/620/007 50 x 1 film-coated tablets EU/1/10/620/008 196 (2 x 98) film-coated tablets EU/1/10/620/017 168 (2 x 84) film-coated tablets
Maltese: EU/1/10/620/019 60 pillola miksija b'rita EU/1/10/620/004 112-il pillola miksija b'rita EU/1/10/620/005 168 pillola miksija b'rita EU/1/10/620/020 180 pillola miksija b'rita EU/1/10/620/006 196 pillola miksija b'rita EU/1/10/620/007 50 x 1 pillola miksija b'rita EU/1/10/620/008 196 (2 pakketti ta' 98) pillola miksija b'rita EU/1/10/620/017 168 (2 pakketti ta' 84) pillola miksija b'rita
English: Table 2: HbA1c results in placebo-controlled combination therapy studies of sitagliptin and metformin*
Maltese: Il-Prova ta' Valutazzjoni tar-Riżultati Kardjovaskulari b'sitagliptin (TECOS - Trial Evaluating
English: Pharmacotherapeutic group: Drugs used in diabetes, Combinations of oral blood glucose lowering drugs, ATC code: A10BD07
Maltese: Mediċini użati fid-dijabete, Kumbinazzjonijiet ta' mediċini orali li jbaxxu z-zokkor, Kodiċi ATC:
English: Glucocorticoids (given by systemic and local routes) beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Maltese: Il-glukokortikosterojdi (mogħtija permezz ta' rotot sistemiċi u lokali), agonisti tar-riċetturi ta' beta 2, u dijuretiċi għandhom attività ipergliċemika minnhom infushom.
English: Merck Sharp & Dohme Ltd. Shotton Lane, Cramlington Northumberland NE23 3JU
Maltese: Shotton Lane, Cramlington
English: Uncommon upper abdominal pain
Maltese: Skop Finali Kompost Primarju
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Maltese: L-istudju prospettiv randomizzat (UKPDS) stabbilixxa l-benefiċċju ta' tul ta' żmien fuq kontroll intensiv ta' zokkor fid-demm f'dijabete tip 2.
English: - hypersensitivity to the active substances or to any of the excipients listed in section 6.1 (see sections 4.4 and 4.8); - 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); - acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock; - hepatic impairment; - acute alcohol intoxication, alcoholism; - breast-feeding.
Maltese: - stat ta' qabel koma tad-dijabete; - insuffiċjenza renali severa (GFR < 30 mL/min) (ara sezzjoni 4.4); - kundizzjonijiet akuti bil-potenzjal li jbiddlu l-funzjoni tal-kliewi bħalma huma: deidratazzjoni, infezzjoni severa, xokk, għoti intravaskulari ta' mediċini ta' kuntrast li fihom il-jodju (ara sezzjoni 4.4);
English: • Take one tablet:
Maltese: • Ħu pillola waħda:
English: ANNEX II
Maltese: angiotensin II)
English: Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
Maltese: Kull pillola fiha sitagliptin phosphate monohydrate ekwivalenti għal 50 mg ta' sitagliptin u 1,000 mg ta' metformin hydrochloride.
English: Co-administration of multiple doses of sitagliptin (50 mg twice daily) and metformin (1,000 mg twice daily) did not meaningfully alter the pharmacokinetics of either sitagliptin or metformin in patients with type 2 diabetes.
Maltese: L-għoti konkomitanti ta' dożi multipli ta' sitagliptin (50 mg darbtejn kuljum) u metformin (1,000 mg darbtejn kuljum) ma biddilx b'mod sinifikanti l-farmakokinetika ta' sitagliptin jew ta' metformin f'pazjenti b'dijabete tip 2.
English: Maximum daily dose is 50 mg.
Maltese: Doża massima ta' kuljum hi 50 mg.
English: Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.
Maltese: Ristfor huwa indikat bħala terapija tripla kombinata ma' agonist ta' peroxisome proliferator-activated receptor gamma (PPARγ) (jiġifieri, thiazolidinedione) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament b'metformin u agonist ta' PPARγ bid-doża massima ttollerata tagħhom.
English: Following administration of a dose of 850 mg, a 40 % lower plasma peak concentration, a 25 % decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Maltese: Wara l-għoti ta' doża ta' 850 mg, kienet osservata konċentrazzjoni massima fil-plażma ta' 40 % inqas, tnaqqis ta' 25 % fl-AUC u 35 min titwil fil-ħin għal konċentrazzjoni massima fil-plażma.
English: In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for periods of up to 28 days.
Maltese: Fi studji ta' Fażi I b'dożi multipli, ma kien hemm l-ebda reazzjoni avversa klinika relatata mad-doża osservata b'sitagliptin b'dożi sa 600 mg kuljum għal perjodi sa 10 ijiem u 400 mg kuljum għal perijodi sa 28 jum.
English: Sitagliptin 100 mg once daily added to ongoing metformin therapy (N=453)
Maltese: Sitagliptin 100 mg darba kuljum miżjud ma' terapija b'metformin li diġà tkun qegħda tittieħed (N=453)
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30 %.
Maltese: Wara doża orali, il-frazzjoni mhux assorbita rkuprata mill-purgar kienet 20-30 %.
English: Ristfor is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Maltese: Ristfor huwa indikat f'kumbinazzjoni ma' sulphonylurea (jiġifieri, terapija ta' kumbinazzjoni tripla) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u sulphonylurea.
English: These included hypoglycaemia (frequency very common with sulphonylurea or insulin), constipation (common with sulphonylurea), peripheral oedema (common with pioglitazone), and headache and dry mouth (uncommon with insulin).
Maltese: Dawn kienu jinkludu ipogliċemija (frekwenza komuni ħafna b'sulphonylurea jew insulina), stitikezza (komuni b'sulphonylurea), edima periferali (komuni b'pioglitazone), u uġigħ ta' ras u ħalq xott (mhux komuni bl-insulina).
English: Uncommon angioedema
Maltese: Mhux komuni anġjoedima*,†
English: Česká republika Merck Sharp & Dohme s.r.o.
Maltese: Merck Sharp & Dohme s.r.o.
English: Renal and urinary disorders impaired renal function
Maltese: Disturbi fl-kliewi u fis-sistema urinarja indeboliment fil-funzjoni tal-kliewi*
English: The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis.
Maltese: L-incretins huma parti minn sistema endoġena nvoluta li tirregola l-fisjoloġija ta' l-omejostażi taz-zokkor.
English: For the different doses on metformin, Ristfor is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
Maltese: Għal dożi differenti ta' metformin, Ristfor jinsab bħala 50 mg sitagliptin u 850 mg metformin hydrochloride jew 1,000 mg metformin hydrochloride.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: MSD (Norge) AS
English: The red blood cells most likely represent a secondary compartment of distribution.
Maltese: Iċ ċelloli tad-demm ħomor x'aktarx jirrappreżentaw kompartiment sekondarju ta' distribuzzjoni.
English: Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose, mean plasma AUC of sitagliptin was 8.52 M•hr, Cmax was 950 nM.
Maltese: Wara għoti orali ta' doża ta' 100 mg lil suġġetti b'saħħithom, sitagliptin kien assorbit malajr, bl-ogħla konċentrazzjonijiet fil-plażma (Tmax medjan) jseħħu 1 sa 4 sigħat wara d-doża, l-AUC fil-plażma medja ta' sitagliptin kienet ta' 8.52 µM•siegħa, is-Cmax kienet ta' 950 nM.
English: In a two-day study in healthy subjects, sitagliptin alone increased active GLP-1 concentrations, whereas metformin alone increased active and total GLP-1 concentrations to similar extents.
Maltese: Fi studju ta' jumejn f'individwi b'saħħithom, sitagliptin żied il-konċentrazzjonijiet attivi ta' GLP-1, filwaqt li metformin waħdu żied il-konċentrazzjonijiet attivi u totali ta' GLP-1 f'livelli simili.
English: In monotherapy studies of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions reported were headache, hypoglycaemia, constipation, and dizziness.
Maltese: Fi studji ta' monoterapija ta' 100 mg ta' sitagliptin mogħti waħdu darba kuljum u mqabbel ma' plaċebo, reazzjonijiet avversi rrappurtati kienu uġigħ ta' ras, ipogliċemija, stitikezza, u sturdament.
English: At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/mL.
Maltese: metformin, konċentrazzjonijiet ta' stat fiss fil-plażma jintlaħqu fi żmien 24-48 siegħa u huma ġeneralment inqas minn 1 µg/mL.
English: Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
Maltese: Kull pillola fiha sitagliptin phosphate monohydrate ekwivalenti għal 50 mg ta' sitagliptin u 850 mg ta' metformin hydrochloride.
English: Age did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Maltese: L-età ma kellhiex impatt klinikament sinifikanti fuq il-farmakokinetika ta' sitagliptin ibbażat fuq analiżi farmakokinetika ta' popolazzjoni ta' dejta Fażi I u Fażi
English: The addition of sitagliptin to glimepiride and metformin provided significant improvements in glycaemic parameters.
Maltese: Iż-żieda ta' sitagliptin ma' glimepiride u metformin ġabet titjib sinifikanti fil-parametri gliċemiċi.
English: Ristfor 50 mg/1,000 mg tablets sitagliptin/metformin HCl
Maltese: Pilloli Ristfor 50 mg/1,000 mg sitagliptin/metformin hydrochloride
English: Magyarország MSD Pharma Hungary Kft. Tel.: +36 1 888 53 00 hungary_msd@merck.com
Maltese: +36 1 888 53 00 hungary_msd@merck.com
English: Study of sitagliptin in combination with metformin and a PPAR agonist A 26-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to the combination of pioglitazone and metformin.
Maltese: Ġie mfassal studju ta' 26 ġimgħa kkontrollat bil-plaċebo sabiex jiġu evalwati l-effikaċja u s-sigurtà ta' sitagliptin (100 mg darba kuljum) miżjud mal-kombinazzjoni ta' pioglitazone u metformin.
English: Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no-effect level for this finding was 58-fold based on the 14-week rat study.
Maltese: Anormalitajiet fis-snien ta' quddiem kienu osservati f'firien f'livelli ta' esponiment ta' 67 darba l-livell ta' esponiment sistemiku; il-livell ta' bla effett għal din issejba kien ta' 58 darba, ibbażat fuq studju ta' 14-il ġimgħa fil-firien.
English: EU/1/10/620/009 14 film-coated tablets EU/1/10/620/010 28 film-coated tablets EU/1/10/620/011 56 film-coated tablets EU/1/10/620/021 60 film-coated tablets EU/1/10/620/012 112 film-coated tablets EU/1/10/620/013 168 film-coated tablets EU/1/10/620/022 180 film-coated tablets EU/1/10/620/014 196 film-coated tablets EU/1/10/620/015 50 x 1 film-coated tablets EU/1/10/620/016 196 (2 x 98) film-coated tablets EU/1/10/620/018 168 (2 x 84) film-coated tablets
Maltese: EU/1/10/620/022 180 pillola miksija b'rita EU/1/10/620/014 196 pillola miksija b'rita EU/1/10/620/015 50 x 1 pillola miksija b'rita EU/1/10/620/016 196 (2 pakketti ta' 98) pillola miksija b'rita EU/1/10/620/018 168 (2 pakketti ta' 84) pillola miksija b'rita
English: The dose of antihyperglycaemic therapy with Ristfor should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Maltese: Id-doża ta' terapija kontra l-ipergliċemija b'Ristfor għandha tkun individwalizzata fuq il-bażi tal-kors kurrenti, l-effettività, u t-tolerabbilità tal-pazjent waqt li ma tinqabiżx id-doża massima ta' kuljum irrakkomandata ta' 100 mg sitagliptin.
English: Reproductive toxicity studies showed a slight treatment-related increased incidence of foetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels.
Maltese: Studji ta' tossiċità riproduttiva wrew żieda żgħira fl-inċidenza ta' malformazzjonijiet tal-kustilji fetali (nuqqas, ipoplastiċi u kustilji mmewwġin) relatati mad-doża, fil-wild ta' firien f'livelli ta' esponiment sistemiku aktar minn 29 darba l-livelli ta' esponiment fil-bniedem.
English: Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
Maltese: Tel: +353 (0)1 2998700
English: Maximum daily dose is 100 mg.
Maltese: Doża massima ta' kuljum hi 100 mg.
English: Ristfor 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride
Maltese: Pilloli Ristfor 50 mg/850 mg sitagliptin/metformin hydrochloride
English: In addition, the effects of renal impairment on sitagliptin pharmacokinetics in patients with type 2 diabetes and mild, moderate, or severe renal impairment (including ESRD) were assessed using population pharmacokinetic analyses.
Maltese: ħafif, moderat jew qawwi (inkluż ESRD) ġew ivvalutati bl-użu ta' analiżi farmakokinetika tal popolazzjoni.
English: INTERMEDIATE CARTON for Multi-packs 2 packs - without blue box - 50 mg/850 mg film-coated tablets
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TAN-NOFS għal Pakketti multipli 2 pakketti - mingħajr kaxxa blu - 50 mg/850 mg pilloli miksija b'rita
English: There was no difference in the incidence of severe hypoglycaemia.
Maltese: Ir-relevanza klinika ta' dan it-tnaqqis mhijiex magħrufa.
English: There is no experience with doses above 800 mg in clinical studies.
Maltese: M'hemm l-ebda esperjenza b'dożi ta' aktar minn 800 mg fi studji kliniċi.
English: Common flatulence
Maltese: Pemfigojd bulluż
English: In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
Maltese: Studji in vitro indikaw li l-enzima primarja responsabbli għall-metaboliżmu limitat ta' sitagliptin kienet CYP3A4, b'kontribuzzjoni minn
English: Merck Sharp & Dohme, Lda Tel: +351 21 4465700 inform_pt@merck.com
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204201 msd_slovenia@merck.com
English: Sitagliptin 100 mg once daily added to ongoing glimepiride + metformin therapy (N=115)
Maltese: metformin li diġà tkun qegħda tittieħed (N=115)
English: • ranolazine, a medicine used to treat angina
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: However, ciclosporin, a p-glycoprotein inhibitor, did not reduce the renal clearance of sitagliptin.
Maltese: Madankollu, ciclosporine, impeditur ta' p-glycoprotein, ma naqqasx ir-rata ta' eliminazzjoni ta' sitagliptin mill-kliewi.