FrancophonIA/ELRC3.0 huggingface dataset:
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 prinċipali responsabbli għall-metaboliżmu limitat ta' sitagliptin hija CYP3A4, b'kontribuzzjoni minn CYP2C8.
English: EU/1/10/621/013 EU/1/10/621/014 EU/1/10/621/015 EU/1/10/621/016 EU/1/10/621/017 EU/1/10/621/018 EU/1/10/621/023 EU/1/10/621/024
Maltese: EU/1/10/621/016 EU/1/10/621/017 EU/1/10/621/018 EU/1/10/621/023 EU/1/10/621/024
English: Other medicines and Ristaben
Maltese: Mediċini oħra u Ristaben
English: Rates of Composite Cardiovascular Outcomes and Key Secondary Outcomes
Maltese: Skop Finali Kompost Sekondarju
English: Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)
Maltese: Frekwenza mhux magħrufa: problemi fil-kliewi (xi drabi jeħtieġu d-dijalisi), rimettar, uġigħ fil-ġogi, uġigħ fil-muskoli, uġigħ fid-dahar, mard tal-interstizju tal-pulmun, pemfigojd bulluż (tip ta' nuffata fil-ġilda)
English: TECOS Cardiovascular Safety Study
Maltese: L-Istudju TECOS dwar Sigurtà Kardjovaskulari
English: Elderly subjects (65 to 80 years) had approximately 19 % higher plasma concentrations of sitagliptin compared to younger subjects.
Maltese: Individwi anzjani (65 sa 80 sena) kellhom konċentrazzjonijiet ta' sitagliptin fil-plażma li kienu bejn wieħed u ieħor ta' 19 % ogħla meta mqabbla ma' individwi iżgħar.
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél: +32 (0)27766211 dpoc_belux@merck.com
Maltese: Tél: +32 (0)27766211 dpoc_belux@merck.com
English: C]sitagliptin oral dose, approximately 16 % of the radioactivity was excreted as metabolites of sitagliptin.
Maltese: Wara doża orali ta' [14C]sitagliptin, bejn wieħed u ieħor 16 % tar-radjuattività tneħħiet bħala metabolit ta' sitagliptin.
English: There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score > 9).
Maltese: M'hemmx esperjenza klinika f'pazjenti b'indeboliment epatiku qawwi (Punteġġ Child-Pugh > 9).
English: Frequency of adverse reaction angioedema
Maltese: Frekwenza tar-reazzjoni avversa
English: Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin.
Maltese: Iżżidiet minimi fi QTc, li ma tqisux klinikament relevanti, kienu osservati fi studju wieħed b'doża ta' sitagliptin ta' 800 mg.
English: How to store Ristaben
Maltese: X'fih Ristaben
English: Renal and urinary disorders impaired renal function
Maltese: Disturbi fil-kliewi u fis-sistema urinarja funzjoni tal-kliewi indebolita*
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: The overall incidence of gastrointestinal adverse reactions considered as drug-related in patients treated with sitagliptin was 2.7 % compared with 12.6 % in patients treated with metformin.
Maltese: L-inċidenza ġenerali ta' reazzjonijiet gastrointestinali avversi meqjusin bħala relatati mal-mediċina f'pazjenti kkurati b'sitagliptin kienet ta' 2.7 % meta mqabbla ma' 12.6 % f'pazjenti ikkurati b'metaformin.
English: Sitagliptin prevents the hydrolysis of incretin hormones by DPP-4, thereby increasing plasma concentrations of the active forms of GLP-1 and GIP.
Maltese: Sitagliptin tipprevjeni l-idroliżi tal-ormoni incretin mill-DPP-4, u dan ghalkekk iwassal għal żieda filkonċentrazzjonijiet ta' forom attivi ta' GLP-1 u GIP fil-plażma.
English: The study population included 2,004 patients ≥ 75 years of age and 3,324 patients with renal impairment (eGFR < 60 mL/min/1.73 m
Maltese: Il-popolazzjoni tal-istudju kienet tinkludi 2,004 pazjenti ta' ≥ 75 sena u 3,324 pazjent b'indeboliment tal-kliewi (eGFR < 60 mL/min/1.73 m2).
English: For patients with mild renal impairment (glomerular filtration rate [GFR]  60 to < 90 ml/min), no dose adjustment is required.
Maltese: [GFR - glomerular filtration rate] ≥ 60 sa < 90 ml/min), m'hemmx bżonn bidla fid-doża.
English: Improvement of 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: Omeostatiku ta' Assessjar-β (Homeostasis Model Assessment)), il-proporzjon bejn proinsulina u insulina, u l-kejl tar-rispons taċ-ċelluli beta minn kampjuni meħuda frekwentament fit-test tattolleranza għall-ikel ġew osservati.
English: - an allergic reaction to Ristaben (see section 4).
Maltese: - reazzjoni allerġika għal Ristaben (ara sezzjoni 4).
English: Sitagliptin may be a mild inhibitor of p-glycoprotein in vivo.
Maltese: Sitagliptin jista' jkun inibitur ħafif ta' p-glycoprotein in vivo.
English: Blood and lymphatic system disorders thrombocytopenia
Maltese: Disturbi tad-demm u tas-sistema limfatika tromboċitopenija
English: Magyarország MSD Pharma Hungary Kft. Tel.: +36 1 888 5300 hungary_msd@merck.com
Maltese: +36 1 888 5300 hungary_msd@merck.com
English: Sitagliptin, but not metformin, increased active GIP concentrations.
Maltese: Sitagliptin, iżda mhux metformin, żied il-konċentrazzjonijiet attivi ta' GIP.
English: The TECOS was a randomised study in 14,671 patients in the intention-to-treat population with an HbA1c of ≥ 6.5 to 8.0 % with established CV disease who received sitagliptin (7,332) 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 mL/min/1.73 m2) or placebo (7,339) added to usual care targeting regional standards for HbA1c and CV risk factors.
Maltese: It-TECOS kien studju każwali f'14,671 pazjent fil-popolazzjoni bl-intenzjoni li tiġi ttrattata b'HbA1c ta' ≥ 6.5 sa 8.0 % b'mard CV stabbilit li rċivew sitagliptin (7,332) 100 mg kuljum (jew 50 mg kuljum jekk l-eGFR fil-linja bażi kienet ≥ 30 u < 50 mL/min/1.73 m2) jew plaċebo (7,339) miżjud mal-kura tas-soltu li l-mira tagħha kienet l-standards reġjonali għal HbA1c u fatturi ta' riskju CV.
English: Merck Sharp & Dohme OÜ Tel: +372 6144 200 msdeesti@merck.com
Maltese: Tel: +372 6144 200 msdeesti@merck.com
English: Bullous pemphigoid
Maltese: Pazjenti pedjatriċi
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: (i.e. ketoconazole, itraconazole, ritonavir, clarithromycin) jistgħu jibdlu l-farmakokinetika ta' sitagliptin f'pazjenti b'indeboliment renali qawwi jew ESRD.
English: Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11 %, and the plasma Cmax on average by 18 %.
Maltese: Wara l-għoti ta' 0.25 mg digoxin flimkien ma' 100 mg ta' sitagliptin kuljum għal 10 ijiem, l-AUC ta' digoxin filplażma żdiedet b'medja ta' 11 %, u s-Cmax fil-plażma b'medja ta' 18 %.
English: Treatment by stratum (metformin and insulin use) interactions were not significant (p > 0.10).
Maltese: Kura skont linterazzjonijiet tal-istratum (użu tal-metformin u l-użu tal-insulina) ma kinitx sinifikanti (p > 0.10).
English: Κύπρος
Maltese: LISTA
English: Digoxin: Sitagliptin had a small effect on plasma digoxin concentrations.
Maltese: Effetti ta' sitagliptin fuq prodotti mediċinali oħra Digoxin:
English: In the intention-to-treat population, among patients who were using insulin and/or a sulfonylurea at baseline, the incidence of severe hypoglycaemia was 2.7 % in sitagliptin-treated patients and 2.5 % in placebo-treated patients; among patients who were not using insulin and/or a sulfonylurea at baseline, the incidence of severe hypoglycaemia was 1.0 % in sitagliptin-treated patients and 0.7 % in placebo-treated patients.
Maltese: Fil-popolazzjoni bl-intenzjoni li tiġi ttrattata, fost pazjenti li kienu qed jużaw l-insulina u/jew xi wieħed mis-sulphonylureas fil-linja bażi, l-inċidenza ta' ipogliċemija severa kienet 2.7 % f'pazjenti ttrattati b'sitagliptin u 2.5 % f'pazjenti ttrattati bi plaċebo; fost pazjenti li ma kinux qed jużaw insulina u/jew xi wieħed mis-sulphonylureas fil-linja bażi, l-inċidenza ta' ipogliċemija severa kienet 1.0 % f'pazjenti ttrattati b'sitagliptin u 0.7 % f'pazjenti ttrattati bi plaċebo.
English: Ciclosporin: A study was conducted to assess the effect of ciclosporin, a potent inhibitor of p-glycoprotein, on the pharmacokinetics of sitagliptin.
Maltese: Ciclosporin: Sar studju biex iqis l-effett ta' ciclosporine, inibitur qawwi ta' p-glycoprotein, fuq l effett farmakokinetiku ta' sitagliptin.
English: • metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
Maltese: • metformin meta d-dieta u l-eżerċizzju, flimkien ma' metformin waħedhom ma jipprovdux kontroll gliċemiku adegwat.
English: HbA1c (%) at week 24.
Maltese:  HbA1c (%) f'ġimgħa 24. #
English: In patients with type 2 diabetes with hyperglycaemia, these changes in insulin and glucagon levels lead to lower haemoglobin A1c (HbA1c) and lower fasting and postprandial glucose concentrations.
Maltese: F'pazjenti b'dijabete tat-tip 2 bl-ipergliċemija, dawn il-bidliet fil-livelli tal-insulina u glucagon inaqqsu l-emoglobina A1c (HbA1c) u jnaqqsu l-livelli ta' konċentrazzjonijiet ta' glucose meta sajjem u wara l-ikel.
English: Compared to normal healthy control subjects, plasma AUC of sitagliptin was increased by approximately 1.2-fold and 1.6-fold in patients with mild renal impairment (GFR ≥ 60 to < 90 mL/min) and patients with moderate renal impairment (GFR ≥ 45 to < 60 mL/min), respectively.
Maltese: Meta mqabbla ma' individwi normali f'saħħithom bħala kontroll, l-AUC ta' sitagliptin fil-plażma żdiedet b'madwar 1.2 drabi u 1.6 drabi f'pazjenti b'indeboliment ħafif tal-kliewi (GFR ≥ 60 sa < 90 mL/min) u pazjenti b'indeboliment moderat tal-kliewi (GFR ≥ 45 sa < 60 mL/min),
English: There is no experience with doses above 800 mg in clinical studies.
Maltese: M'hemmx esperjenza b'dożi ikbar minn 800 mg fi studji kliniċi.
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 l-amministrazzjoni orali ta' doża ta' 100 mg f'individwi f'saħħithom, sitagliptin kien assorbit malajr, b'konċentrazzjonijiet massimi fil-plażma (Tmax medjana) jintlaħqu minn siegħa sa 4 sigħat wara d-doża, l-AUC medja ta' sitagliptin fil-plażma kienet ta' 8.52 µM•hr, Cmax kienet 950 nM.
English: Tabulated list of adverse reactions
Maltese: Reazzjonijiet avversi miġbura f'tabella
English: Merck Sharp & Dohme, Lda Tel: +351 21 4465700 inform_pt@merck.com
Maltese: Tel: +351 21 4465700 inform_pt@merck.com
English: Patients with an eGFR < 30 mL/min/1.73 m2 were not to be enrolled in the study.
Maltese: Pazjenti b'eGFR < 30 mL/min/1.73 m2 ma kellhomx jiġu rreġistrati fl-istudju.
English: The reduction in HbA1c in patients treated with sitagliptin and insulin (with or without metformin) was -1.31 % compared to -0.87 % in patients treated with placebo and insulin (with or without metformin), a difference of -0.45 % [95 % CI: -0.60, -0.29].
Maltese: 87 % f'pazjenti kkurati bi plaċebo u l-insulina (b'metformin jew mingħajru), differenza ta' -0.45 % [CI ta' 95 %: -0.
English: Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal impairment or end-stage renal disease (ESRD).
Maltese: Il-metaboliżmu jista' jkollu sehem iktar sinifikanti fl-eliminazzjoni ta' sitagliptin fil-każ ta' indeboliment renali qawwi jew marda tal-kliewi fl-aħħar fażi (ESRD - end-stage renal disease).
English: Initial therapy (twice daily) Sitagliptin 50 mg + metformin 1,000 mg (N=178)
Maltese: 1,000 mg (N=178)
English: For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of Ristaben is 50 mg once daily.
Maltese: Għal pazjenti b'indeboliment moderat tal-kliewi (GFR ≥ 30 sa < 45 mL/min), id-doża ta' Ristaben hija 50 mg darba kuljum.
English: Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of Ristaben as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Maltese: Ipogliċemija meta jintuża flimkien ma' prodotti mediċinali anti-iperglimiċi oħrajn Fi provi kliniċi ta' Ristaben bħala terapija waħedha u f'terapija flimkien ma' prodotti mediċinali li mhumiex magħrufin li jikkawżaw ipogliċemija (i.e. metformin u/jew agonist ta' PPARγ), ir-rati ta' ipogliċemija li ġew irrappurti b'sitagliptin kienu simili għar-rati f'pazjenti li kienu qed jieħdu plaċebo.
English: The addition of sitagliptin to pioglitazone and metformin provided significant improvements in glycaemic parameters.
Maltese: Iż-żieda ta' sitagliptin ma' pioglitazone u metformin ġabet titjib sinifikanti fil-parametri glikemiċi.
English: Round, beige film-coated tablet with “277” on one side.
Maltese: Pillola tonda u beige miksija b'rita bi “277” fuq naħa waħda.
English: The reduction in HbA1c from mean baseline values of 7.2 % was -0.43 % for sitagliptin and -0.57 % for metformin (Per Protocol Analysis).
Maltese: għal sitagliptin u -0.57 % għal metformin (Skont l-Analiżi tal-Protokoll).
English: Frequency not known arthropathy
Maltese: Frekwenza mhux magħrufa artropatija*
English: Secondary cardiovascular endpoints included the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke; first occurrence of the individual components of the primary composite; all-cause mortality; and hospital admissions for congestive heart failure.
Maltese: Skopijiet finali kardjovaskluari sekondarji kienu jinkludu l-ewwel okkorrenza ta' mewt kardjovaskulari, infart mijokardijaku mhux fatali, jew puplesija mhux fatali; l-ewwel okkorrenza talkomponenti individwali tal-kompost primarju; mortalità minn kull kawża; u rikoverar l-isptar minħabba insuffiċjenza konġestiva tal-qalb.
English: In addition, after 12 weeks, the mean reductions in HbA1c (sitagliptin -0.59 %; placebo -0.18 %) and FPG (sitagliptin -25.5 mg/dL; placebo -3.0 mg/dL) were generally similar to those observed in other monotherapy studies in patients with normal renal function (see section 5.2).
Maltese: Barra dan, wara 12-il ġimgħa, it-tnaqqis medju ta' HbA1c (sitagliptin -0.59 %; plaċebo -0.18 %) u FPG (sitagliptin -25.5 mg/dl; plaċebo -3.0 mg/dl) kienu fil-biċċa l-kbira jixbhu lil dawk osservati fi studji oħrajn ta' monoterapija fuq pazjenti b'funzjoni normali tal-kliewi (ara sezzjoni 5.2).
English: Metformin: Co-administration of multiple twice-daily doses of 1,000 mg metformin with 50 mg sitagliptin did not meaningfully alter the pharmacokinetics of sitagliptin in patients with type 2 diabetes.
Maltese: L-amministrazzjoni flimkien ta' dożi multipli darbtejn kuljum ta' 1,000 mg ta' metformin ma' 50 mg ta' sitagliptin ma biddilx b'mod sinifikanti l-effett farmakokinetiku ta' sitagliptin f'pazjenti b'dijabete tat-tip 2.
English: In addition, GLP-1 lowers glucagon secretion from pancreatic alpha cells.
Maltese: Barra dan, GLP-1 inaqqas it-tnixxija ta' glucagons miċ-ċelluli alfa tal-frixa.
English: The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyzes the incretin hormones to produce inactive products.
Maltese: DPP-4, li malajr tidrolizza l-ormoni incretin biex b'hekk tipproduċi prodotti inattivi.
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 klinika avversa 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
English: Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin.
Maltese: Ġew identifikati sitt metaboliti fil-livell ta' traċċa u mhux mistennija li jikkontribwixxu għall-attività inibitorja ta' DPP-4 fil-plażma ta' sitagliptin.
English: In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1,000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy.
Maltese: Fi studju fattorjali ta' 24 ġimgħa kkontrollat bi plaċebo ta' terapija inizjali, sitagliptin 50 mg darbtejn kuljum f'kombinazzjoni ma' metformin (500 mg jew 1,000 mg darbtejn kuljum) irriżulta f'titjib sinifikanti fil-parametri gliċemiċi meta mqabbel ma' monoterapija waħda jew l-oħra.
English: Round, pink film-coated tablet with “221” on one side.
Maltese: Pillola tonda u roża miksija b'rita bi “221” fuq naħa waħda.
English: Round, light beige film-coated tablet with “112” on one side.
Maltese: Pillola tonda u beige ċar miksija b'rita bi “112” fuq naħa waħda.
English: Ristaben 25 mg tablets Sitagliptin
Maltese: Pilloli Ristaben 25 mg
English: Sitagliptin is renally excreted.
Maltese: Sitagliptin huwa kemxejn dijaliżabbli.
English: OAT3 mediated transport of sitagliptin was inhibited in vitro by probenecid, although the risk of clinically meaningful interactions is considered to be low.
Maltese: It-trasport ta' Sitagliptin li kien medjat minn OAT3 kien inibit in vitro minn probenecid, għalkemm ir-riskju ta' interazzjonijiet klinikament rilevanti huwa meqjus li hu baxx.
English: With higher insulin levels, tissue glucose uptake is enhanced.
Maltese: F'livelli ogħla ta' insulina, it-tessuti iktar jieħdu insulina.
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 waħdu żied il-konċentrazzjonijiet attivi ta' GLP-1, filwaqt li metformin waħdu żied il-konċentrazzjonijiet attivi u totali ta' GLP-1 f'livelli simili.
English: Sitagliptin is a potent and highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.
Maltese: Sitagliptin huwa inibitur qawwi u selettiv ħafna tal-enzima DPP-4 u ma jrażżanx l-enzimi DPP-8 u DPP-9 li huma relatati mill-qrib, f'konċentrazzjonijiet terapewtiċi.
English: UAB Merck Sharp & Dohme Tel.: +370 5 278 02 47 msd_lietuva@merck.com
Maltese: +370 5 278 02 47 msd_lietuva@merck.com
English: as dual oral therapy in combination with
Maltese: bħala terapija orali doppja f'kombinazzjoni ma'
English: HbA1c (%) at week 26.
Maltese: HbA1c (%) f'ġimgħa 26. ¶
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: Barra dan, l-effetti ta' indeboliment tal-kliewi fuq il-farmakokinetika ta' sitagliptin f'pazjenti b'dijabete tat-tip 2 u indeboliment tal-kliewi, ħafif, moderat jew qawwi (inkluż ESRD) ġew ivvalutati bl-użu ta' analiżi farmakokinetika tal-popolazzjoni.
English: There was also a significant difference between groups with respect to change from baseline body weight (sitagliptin -0.6 kg; glipizide +1.2 kg).
Maltese: Kien hemm ukoll differenza sinifikanti bejn il-gruppi rigward il-bidla fil-piż tal-ġisem millinja bażi (sitagliptin -0.6 kg; glipizide +1.2 kg).
English: A 24-week active (metformin)-controlled study was designed to evaluate the efficacy and safety of sitagliptin 100 mg once daily (N=528) compared to metformin (N=522) in patients with inadequate glycaemic control on diet and exercise and who were not on anti-hyperglycaemic therapy (off therapy for at least 4 months).
Maltese: Tfassal studju attiv ta' 24 ġimgħa b'kontroll (ta' metaformin) biex jevalwa l-effikaċja u s-sigurtà ta' sitagliptin 100 mg darba kuljum (N=528) meta mqabbel ma' metaformin (N=522) f'pazjenti b'kontroll gliċemiku mhux adegwat fuq dieta u eżerċizzju u li ma kinux fuq terapija kontra lipergliċemija (ma ħadux it-terapija għal mill-inqas 4 xhur).
English: EU/1/10/621/001 EU/1/10/621/002 EU/1/10/621/003 EU/1/10/621/004 EU/1/10/621/005 EU/1/10/621/006 EU/1/10/621/019 EU/1/10/621/020
Maltese: EU/1/10/621/001 EU/1/10/621/002 EU/1/10/621/003 EU/1/10/621/004
English: Ristaben 50 mg tablets Sitagliptin
Maltese: Pilloli Ristaben 50 mg
English: Ristaben 100 mg tablets Sitagliptin
Maltese: Pilloli Ristaben 100 mg
English: Sitagliptin 100 mg once daily added to ongoing insulin (+/- metformin) therapy (N=305)
Maltese: Sitagliptin 100 mg darba kuljum miżjud ma' terapija għaddejja 'l ħin kollu talinsulina (+/- metformin) 
English: Ιtalia
Maltese: sitagliptin.
English: • a PPAR agonist and metformin when use of a PPAR agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Maltese: • agonista PPARγ u metformin meta l-użu ta' agonista PPARγ ikun xieraq u meta d-dieta u l eżerċizzju flimkien ma' terapija doppja ma' dawn il-prodotti mediċinali ma jipprovdux kontroll gliċemiku adegwat.
English: A 24-week placebo-controlled study involving 660 patients was designed to evaluate the insulin-sparing efficacy and safety of sitagliptin (100 mg once daily) added to insulin glargine with or without metformin (at least 1,500 mg) during intensification of insulin therapy.
Maltese: Studju ta' 24 ġimgħa kkontrollat bi plaċebo li kien jinvolvi 660 pazjent ġie mfassal biex jevalwa l effikaċja u s-sigurtà ta' kif sitagliptin (100 mg darba kuljum) inaqqas il-bżonn tal-insulina meta jiżdied ma' insulin glargine flimkien ma' metformin (mill-inqas 1,500 mg) jew mingħajru waqt terapija aktar intensa bl-insulina.
English: Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal.
Maltese: L-ormoni incretins, li jinkludu l-peptide-1 (GLP-1) li qisu glucagon, u l-polypeptide insulinotropiku li jiddependi mill-glucose (GIPglucose-dependent insulinotrophic polypeptide), jintreħħew mill-intestini matul il-ġurnata, u l-livelli jogħlew wara ikla.
English: Ristaben 100 mg film-coated tablets Sitagliptin
Maltese: Ristaben 100 mg pilloli miksija b'rita Sitagliptin
English: This study involved 423 patients with chronic renal impairment (estimated glomerular filtration rate < 50 ml/min).
Maltese: Dan l-istudju kien jinvolvi 423 pazjent b'indeboliment kroniku tal-kliewi (rata stmata ta' filtrazzjoni mill-glomeruli ta' < 50 ml/min).
English: EU/1/10/621/013 14 film-coated tablets EU/1/10/621/014 28 film-coated tablets EU/1/10/621/023 30 film-coated tablets EU/1/10/621/015 56 film-coated tablets EU/1/10/621/016 84 film-coated tablets EU/1/10/621/024 90 film-coated tablets EU/1/10/621/017 98 film-coated tablets EU/1/10/621/018 50 x 1 film-coated tablets
Maltese: EU/1/10/621/013 14-il pillola miksija b'rita EU/1/10/621/014 28 pillola miksija b'rita EU/1/10/621/023 30 pillola miksija b'rita EU/1/10/621/015 56 pillola miksija b'rita EU/1/10/621/016 84 pillola miksija b'rita EU/1/10/621/024 90 pillola miksija b'rita EU/1/10/621/017 98 pillola miksija b'rita EU/1/10/621/018 50 x 1 pillola miksija b'rita
English: Immune system disorders hypersensitivity reactions including anaphylactic responses
Maltese: Disturbi fis-sistema immuni reazzjonijiet ta' sensittività eċċessiva li jinkludu risponsi anafilattiċi *,†