FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/10/621/001 14 film-coated tablets EU/1/10/621/002 28 film-coated tablets EU/1/10/621/019 30 film-coated tablets EU/1/10/621/003 56 film-coated tablets EU/1/10/621/004 84 film-coated tablets EU/1/10/621/020 90 film-coated tablets EU/1/10/621/005 98 film-coated tablets EU/1/10/621/006 50 x 1 film-coated tablets
Maltese: EU/1/10/621/001 14-il pillola miksija b'rita EU/1/10/621/002 28 pillola miksija b'rita EU/1/10/621/019 30 pillola miksija b'rita EU/1/10/621/003 56 pillola miksija b'rita EU/1/10/621/004 84 pillola miksija b'rita EU/1/10/621/020 90 pillola miksija b'rita EU/1/10/621/005 98 pillola miksija b'rita EU/1/10/621/006 50 x 1 pillola miksija b'rita
English: Mean change from baseline HbA1c (%)
Maltese: Bidla medja kkoreġuta bi plaċebo f'HbA1c (%)†
English: Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with sitagliptin (not reaching the 5 % level, but occurring with an incidence of > 0.5 % higher with sitagliptin than that in the control group) included osteoarthritis and pain in extremity.
Maltese: Esperjenzi avversi addizjonali rrappurtati mingħajr ma tqies jekk ilkawża tagħhom kinitx il-mediċina, li seħħew b'mod aktar frekwenti f'pazjenti kkurati b'sitagliptin (li ma laħqux il-livell ta' 5 %, iżda li seħħew b'inċidenza ta' > 0.5 % ogħla b'sitagliptin minn dik filgrupp ta' kontroll) kienu jinkludu osteoartrite u uġigħ fid-dirgħajn u fir-riġlejn.
English: In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin.
Maltese: F'pazjenti b'funzjoni renali normali, il-metaboliżmu, inkluż dak permezz ta' CYP3A4, għandu biss sehem żgħir fit-tneħħija ta' sitagliptin.
English: General
Maltese: Ġenerali
English: Maternal toxicity was seen in rabbits at more than 29 times the human exposure levels.
Maltese: Fil-fniek kien hemm tossiċita materna fl-livelli ta'espożizzjoni ta' aktar minn 29 darba dawk umani.
English: A study comparing sitagliptin at 25 or 50 mg once daily to glipizide at 2.5 to 20 mg/day was conducted in patients with moderate to severe renal impairment.
Maltese: Studju li qabbel sitagliptin b'doża ta' 25 jew 50 mg darba kuljum ma' glipizide b'doża ta' 2.5 sa 20 mg/jum sar f'pazjenti b'indeboliment minn moderat sa qawwi tal-kliewi.
English: Belgique/België/Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32 (0)27766211 dpoc_belux@merck.com
Maltese: Belgique/België/Belgien MSD Belgium BVBA/SPRL Tél/Tel:
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: II, l-età ma kellhiex impatt kliniku sinifikanti fuq l-effett farmakokinetiku ta' sitagliptin.
English: • a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
Maltese: • sulphonylurea meta d-dieta u l-eżerċizzju flimkien ma' doża massima tollerata ta' sulphonylurea waħedhom ma jipprovdux kontroll gliċemiku adegwat u meta metformin ma jkunx adegwat minħabba kontraindikazzjonijiet jew intolleranza.
English: When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP.
Maltese: Meta l-konċentrazzjonijiet ta' glucose fid-demm ikunu normali jew elevati, GLP-1 and GIP ikattru sintesi u r-reħa tal-insulina miċ-ċelluli beta tal-frixa permezz ta'
English: To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis (see section 4.2 and 5.2).
Maltese: Biex fil-plażma jinkisbu konċentrazzjonijiet ta' sitagliptin jixbhu li dawk ta' pazjenti b'funzjoni normali tal-kliewi, huma rrakkomandati dożi aktar baxxi f'pazjenti b'GFR < 45 mL/min, kif ukoll f'pazjenti b'ESRD li jeħtieġu dijalisi tad-demm jew dijalisi mill peritonew (ara sezzjoni 4.2 u 5.2).
English: No dose adjustment is necessary based on gender, race, or body mass index (BMI).
Maltese: M'hemmx bżonn bidla fid-doża minħabba sess, razza jew l-indiċi tal-massa tal-ġisem (BMI - body mass index).
English: Plasma AUC of sitagliptin increased in a dose-proportional manner.
Maltese: L-AUC ta' sitagliptin fil-plażma żdiedet b'mod proporzjonali mad-doża.
English: Decreased glucagon concentrations, along with higher insulin levels, lead to reduced hepatic glucose production, resulting in a decrease in blood glucose levels.
Maltese: Konċentrazzjonijiet inqas ta' glucagons, flimkien ma' livelli ogħla ta' insulina, iwasslu għal tnaqqis fil-produzzjoni ta' glucose mill-fwied, li jwassal għal tnaqqis fil-livell ta' glucose fid-demm.
English: Sitagliptin 100 mg once daily added to ongoing glimepiride + metformin therapy (N=115)
Maltese: Sitagliptin 100 mg darba kuljum miżjud ma' terapija bi glimepiride + metformin għaddiena
English: EU/1/10/621/007 14 film-coated tablets EU/1/10/621/008 28 film-coated tablets EU/1/10/621/021 30 film-coated tablets EU/1/10/621/009 56 film-coated tablets EU/1/10/621/010 84 film-coated tablets EU/1/10/621/022 90 film-coated tablets EU/1/10/621/011 98 film-coated tablets EU/1/10/621/012 50 x 1 film-coated tablets
Maltese: EU/1/10/621/007 14-il pillola miksija b'rita EU/1/10/621/008 28 pillola miksija b'rita EU/1/10/621/021 30 pillola miksija b'rita EU/1/10/621/009 56 pillola miksija b'rita EU/1/10/621/010 84 pillola miksija b'rita EU/1/10/621/022 90 pillola miksija b'rita EU/1/10/621/011 98 pillola miksija b'rita EU/1/10/621/012 50 x 1 pillola miksija b'rita
English: For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of Ristaben is 25 mg once daily.
Maltese: Għal pazjenti b'indeboliment qawwi tal-kliewi (GFR ≥ 15 sa <30 ml/min) jew b'mard tal-kliewi talaħħar stadju (ESRD - End Stage Renal Disease) (GFR < 15 mL/min), inklużi dawk li jeħtieġu dijalisi tad-demm jew dijalisi mill-peritonew, id-doża ta' Ristaben hija 25 mg darba kuljum.
English: For both GLP-1 and GIP, stimulation of insulin release is enhanced as glucose rises above normal concentrations.
Maltese: Kemm għal GLP-1 kif ukoll għal GIP, ir-rilaxx tal-insulina jiġi stimulat aktar hekk kif glucose jogħla iktar mill-konċentrazzjonijiet normali.
English: Further, GLP-1 does not impair the normal glucagon response to hypoglycaemia.
Maltese: Apparti dan, GLP-1 ma jfixkilx ir rispons normali tal-glucagon għall-ipogliċemija.
English: Sitagliptin was modestly removed by haemodialysis (13.5 % over a 3- to 4-hour haemodialysis session starting 4 hours postdose).
Maltese: Sitagliptin tneħħa xi ftit blemodijalisi (13.5 % wara sessjoni ta' emodijalisi ta' bejn 3 u 4 sigħat li bdiet 4 sigħat wara d-dożaġġ).
English: This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.
Maltese: Dan jista' jwassal għal problemi mediċi serji bħal mard tal-qalb, mard tal-kliewi, għama u amputazzjoni.
English: For patients with moderate renal impairment (GFR  45 to < 60 mL/min), no dosage adjustment is required.
Maltese: Għal pazjenti b'indeboliment moderat tal-kliewi (GFR ≥ 45 sa < 60 mL/min), m'hemmx bżonn bidla fid-doża.
English: Sitagliptin accumulates only minimally with multiple doses.
Maltese: Sitagliptin jakkumula bl-inqas mod b'dożi multipli.
English: If a hypersensitivity reaction is suspected, Ristaben should be discontinued.
Maltese: Jekk ikun hemm suspett ta' reazzjoni ta' sensittività eċċessiva, Ristaben għandu jitwaqqaf.
English: Overall, sitagliptin improved glycaemic control when used as monotherapy or in combination treatment (see Table 2).
Maltese: B'mod ġenerali, sitagliptin tejjeb il-kontroll gliċemiku meta użat bħala monoterapija jew f'kura ta' kombinazzjoni (ara t-Tabella 2).
English: Hrvatska
Maltese: Pożoloġija
English: Common dizziness
Maltese: Mhux komuni
English: (see section 4.2 and 5.2).
Maltese: (N=453)
English: The incidence of hypoglycaemia was 25.2 % in patients treated with sitagliptin and insulin (with or without metformin) and 36.8 % in patients treated with placebo and insulin (with or without metformin).
Maltese: 2 % f'pazjenti kkurati b' sitagliptin u linsulina (b'metformin jew mingħajru) u 36.8 % f'pazjenti kkurati bi plaċebo u l-insulina (b'metformin jew mingħajru).
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: Norge MSD (Norge) AS
English: Initial therapy (twice daily) Sitagliptin 50 mg + metformin 500 mg (N=183)
Maltese: 500 mg (N=183)
English: Elderly No dose adjustment is necessary based on age.
Maltese: M'hemmx bżonn aġġustament tad-doża skont l-età.
English: Each tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.
Maltese: Kull pillola fiha sitagliptin phosphate monohydrate, ekwivalenti għal 25 mg ta' sitagliptin.
English: United Kingdom Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com
Maltese: (0) 1992 467272 medicalinformationuk@merck.com
English: Each tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.
Maltese: Kull pillola fiha sitagliptin phosphate monohydrate, ekwivalenti għal 100 mg ta' sitagliptin.
English: In clinical studies, approximately 13.5 % of the dose was removed over a 3- to 4-hour haemodialysis session.
Maltese: Fi studji kliniċi, bejn wieħed u ieħor 13.5% tad-doża tneħħiet wara sessjoni ta' emodijalisi ta' bejn 3 u 4 sigħat.
English: The effects of GLP-1 and GIP are glucose-dependent such that when blood glucose concentrations are low, stimulation of insulin release and suppression of glucagon secretion by GLP-1 are not observed.
Maltese: L-effetti ta' GLP-1 u GIP-2 jiddependu mill-glucose b'tali mod li meta l-konċentrazzjonijiet ta' glucose fid demm huma baxxi, stimulazzjoni ta'rilaxx tal-insulina u trażżin tat-tnixxija tal-glucagon mil-GLP-1, ma humiex osservati.
English: Ristaben contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Maltese: Ristaben fih is-sustanza attiva sitagliptin li hija membru tal-klassi ta' mediċini msejħa inibituri DPP-4 (inibituri dipeptidyl peptidase-4) li tbaxxi l-livell taz-zokkor fid-demm f'pazjenti adulti li għandhom id-dijabete mellitus tat-tip 2.
English: Dose-proportionality was not established for Cmax and C24hr (Cmax increased in a greater than dose-proportional manner and C24hr increased in a less than dose-proportional manner).
Maltese: Il-proporzjonalità mad-doża ma ġietx stabbilita għal Cmax u C24hr (Cmax tkattar b'mod ikbar mill-proporzjon mad-doża u C24hr tkattar b'mod inqas mill-proporzjon mad-doża).
English: Merck Sharp & Dohme B.V. Waarderweg 39
Maltese: Merck Sharp & Dohme B.V.
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 in 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
English: Co-administration of a single 100 mg oral dose of sitagliptin and a single 600 mg oral dose of ciclosporin increased the AUC and Cmax of sitagliptin by approximately 29 % and 68 %, respectively.
Maltese: L-amministrazzjoni flimkien ta' doża orali waħda ta' 100 mg ta' sitagliptin u doża orali waħda ta' 600 mg ta' ciclosporine kattar l-AUC u Cmax ta' sitagliptin b'madwar
English: A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50 mg) in patients with varying degrees of chronic renal impairment compared to normal healthy control subjects.
Maltese: Sar studju bil-mediċina magħrufa u b'doża waħda biex jevalwa l-effetti farmakokinetiċi ta' doża mnaqqsa ta' sitagliptin (50 mg) f'pazjenti b'indeboliment renali kroniku fi stadji differenti, meta mqabbel mal-individwi ta' kontroll b'saħħithom normali.
English: The frequency of adverse reactions identified from placebo-controlled clinical studies of sitagliptin monotherapy and post-marketing experience
Maltese: Il-Prova ta' Valutazzjoni tar-Riżultati Kardjovaskulari b'sitagliptin (TECOS - Trial Evaluating
English: In a 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.
Maltese: Fi studju li qabbel l-effikaċja u s-sigurtà taż-żieda ta' sitagliptin 100 mg darba kuljum jew glipizide (sulphonylurea) f'pazjenti li ma kellhomx kontroll gliċemiku tajjeb b'kura ta' metformin biss, sitagliptin kien simili għal glipizide biex inaqqas l-HbA1c.
English: Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea.
Maltese: Ipogliċemija ġiet osservata meta sitagliptin intuża flimkien mal-insulina jew ma' sulphonylurea.
English: Another study comparing sitagliptin at 25 mg once daily to glipizide at 2.5 to 20 mg/day was conducted in 129 patients with ESRD who were on dialysis.
Maltese: Studju ieħor li qabbel sitagliptin b'doża ta' 25 mg darba kuljum ma' glipizide b'doża ta' 2.5 sa 20 mg/jum sar f'129 pazjent b'ESRD li kienu fuq id-dijalisi.
English: When Ristaben is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Maltese: Meta Ristaben jintuża flimkien ma' sulphonylurea jew mal-insulina, jista' jiġi kkonsidrat li tingħata doża aktar baxxa ta' sulphonylurea jew ta' insulina biex jitnaqqas ir-riskju ta' ipogliċemija (ara sezzjoni 4.4).
English: In a 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 The mean glipizide dose used in the comparator group was 10 mg per day with approximately 40 % of patients requiring a glipizide dose of  5 mg/day throughout the study.
Maltese: Barra mill-esperjenzi avversi marbuta mal-mediċina deskritti fuq, esperjenzi avversi li ġew irrappurtati mingħajr ma tqies jekk il-kawża tagħhom kinitx il-mediċina u li seħħew f'mill-inqas 5 % u b'mod aktar komuni f'pazjenti kkurati b'sitagliptin kienu jinkludu infezzjoni fil-parti ta' fuq talapparat tan-nifs u nażofarinġite.
English: • a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Maltese: • sulphonylurea u metformin meta d-dieta u l-eżerċizzju flimkien ma' terapija b'dawn iż-żewġ prodotti mediċinali ma jipprovdux kontroll gliċemiku adegwat.
English: Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.
Maltese: Kull pillola fiha sitagliptin phosphate monohydrate, ekwivalenti għal 50 mg ta' sitagliptin.
English: Some adverse reactions were observed more frequently in studies of combination use of sitagliptin with other anti-diabetic medicinal products than in studies of sitagliptin monotherapy.
Maltese: Xi reazzjonijiet avversi kienu osservati b'mod aktar frekwenti fi studji fejn sitagliptin intuża flimkien ma' prodotti mediċinali oħra kontra d-dijabete milli fi studji ta' monoterapija b'sitagliptin.
English: Concomitant administration of OAT3 inhibitors has not been evaluated in vivo.
Maltese: Ma ġietx evalwata in vivo l-amministrazjoni fl-istess ħin ta' inibituri ta' OAT3.
English: In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of p-glycoprotein.
Maltese: Fi studju kliniku sitagliptin kellu effett żgħir fuq il-konċentrazzjonijiet ta' digoxin fil-plażma, li jindika li sitagliptin jista` jkun inibitur ħafif ta' p-glycoprotein.
English: Resolution of pancreatitis has been observed after discontinuation of sitagliptin (with or without supportive treatment), but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported.
Maltese: Fejqan tal-pankreatite ġie osservat wara l-waqfien ta' sitagliptin (bi jew mingħajr kura ta' appoġġ), iżda ġew irrapportati każijiet rari ħafna ta' pankreatite nekrotizzanti jew emorraġika u/jew mewt.
English: Pregnancy
Maltese: Manufattur
English: The safety and efficacy of sitagliptin in children and adolescents under 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' sitagliptin fit-tfal u adolexxenti taħt it-18-il sena ma ġewx determinati s'issa.
English: Patients were instructed to titrate their insulin glargine dose based on fingerstick fasting glucose values.
Maltese: Iż-żieda tal-insulina ma' sitagliptin ipprovdiet titjib sinjifikanti fil-parametri gliċemiċi.
English: Ristaben 50 mg film-coated tablets Sitagliptin
Maltese: Ristaben 50 mg pilloli miksija b'rita Sitagliptin
English: Sitagliptin is secreted in considerable amounts into the milk of lactating rats (milk/plasma ratio: 4:1).
Maltese: Sitagliptin jintreħa f'ammonti konsiderevoli fil-ħalib ta' firien li qed ireddgħu (proporzjon ħalib/plażma: 4:1).
English: Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
Maltese: Kull pillola miksija b'rita (pillola) fiha sitagliptin phosphate monohydrate, ekwivalenti għal 100 mg ta' sitagliptin.
English: To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min (see section 4.2).
Maltese: Biex jinkisbu konċentrazzjonijiet ta' sitagliptin fil-plażma jixbhu lil dawk ta' pazjenti b'funzjoni normali tal-kliewi, huma rrakkomandati dożi aktar baxxi f'pazjenti b'GFR < 45 mL/min (ara sezzjoni 4.2).
English: Frequency not known acute renal failure
Maltese: Frekwenza mhux magħrufa insuffiċjenza akuta tal-kliewi*
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: firien li ġew esposti għal livelli ta' 67 darba ikbar mil-livell kliniku ta' espożizzjoni; għal dan irriżultat il-livell ta' mingħajr effett kien 58 darba bbażat fuq studju fuq il-firien ta' 14-il ġimgħa.
English: Pregnancy and breast-feeding
Maltese: - marda tal-frixa (bħal pankreatite)
English: The incidence of hypoglycaemia was not significantly different between the treatment groups (sitagliptin, 6.3 %; glipizide, 10.8 %).
Maltese: L-inċidenza ta' ipogliċemija ma kinitx differenti b'mod sinifikanti bejn il-gruppi ta' kura (sitagliptin, 6.3 %; glipizide,
English: Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
Maltese: Kull pillola miksija b'rita (pillola) fiha sitagliptin phosphate monohydrate, ekwivalenti għal 25 mg ta' 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 fir-riproduzzjoni wrew li kien hemm inċidenza kemxejn ikbar marbuta mal-kura ta' malformazzjonijiet fil-kustilji fil-ġuf(kustilji neqsin, ipoplastiċi jew immewġin) fil-friegħ tal-firien li kienu esposti għal dożi sistemiċi iktar minn 29 darba l-livell uman.
English: Post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported.
Maltese: Ġew irrapportati rapporti ta' reazzjonijiet ta' sensittività eċċessiva ta' wara t-tqegħid fis-suq f'pazjenti ttrattati b'sitagliptin.
English: Frequency not known bullous pemphigoid
Maltese: Frekwenza mhux magħrufa pemfigojd bl-infafet*
English: During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were administered.
Maltese: Waqt provi kliniċi kkontrollati f'persuni f'saħħithom, ingħataw dożi waħdiet sa 800 mg sitagliptin.
English: Study
Maltese: Studju
English: Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
Maltese: Kull pillola miksija b'rita (pillola) fiha sitagliptin phosphate monohydrate, ekwivalenti għal 50 mg ta' sitagliptin.
English: Sitagliptin 100 mg once daily provided significant improvements in glycaemic parameters compared with placebo in two 24-week studies of sitagliptin as add-on therapy, one in combination with metformin and one in combination with pioglitazone.
Maltese: Sitagliptin 100 mg darba kuljum wassal għal titjib sinifikanti fil-parametri gliċemiċi meta mqabbel ma' plaċebo f'żewġ studji ta' 24 ġimgħa ta' sitagliptin bħala terapija miżjuda, wieħed flimkien ma' metformin u l-ieħor flimkien ma' pioglitazone.
English: The incidence of adjudication-confirmed pancreatitis events was 0.3 % in sitagliptin-treated patients and 0.2 % in placebo-treated patients.
Maltese: L-inċidenza ta' każijiet ta' pankreatite kkonfermati permezz ta' aġġudikazzjoni kienet 0.3 % f'pazjenti ttrattati b'sitagliptin u 0.2 % f'pazjenti ttrattati bi plaċebo.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after 'EXP'.
Maltese: M'għandekx tuża din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-folja u l-kartuna wara ‘JIS'.
English: Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea or insulin may be considered (see section 4.2).
Maltese: Għalhekk, biex jitnaqqas ir-riskju ta' ipogliċemija, għandha tiġi kkunsidrata doża aktar baxxa ta' sulphonylurea jew insulina (ara sezzjoni 4.2).
English: Frequency not known rash
Maltese: Frekwenza mhux magħrufa
English: Prolonged haemodialysis may be considered if clinically appropriate.
Maltese: Dawn il-bidliet fl-effetti farmakokinetiċi ta' ciclosporine ma tqisux li għandhom relevanza klinika.
English: Sitagliptin 100 mg once daily added to ongoing glimepiride therapy (N=102)
Maltese: Sitagliptin 100 mg darba kuljum miżjud ma' terapija bi glimepiride għaddiena
English: Ristaben 25 mg film-coated tablets Sitagliptin
Maltese: Informazzjoni għall-pazjent Ristaben 25 mg pilloli miksija b'rita
English: The mean volume of distribution at steady state following a single 100-mg intravenous dose of sitagliptin to healthy subjects is approximately 198 litres.
Maltese: Distribuzzjoni Il-volum medju ta' distribuzzjoni fi stat fiss wara doża waħda fil-vina ta' 100 mg ta' sitagliptin f'individwi f'saħħithom hija ta' madwar 198 litru.
English: Effects of other medicinal products on sitagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by co-administered medicinal products is low.
Maltese: It-tagħrif kliniku ta' hawn taħt jagħti x'jifhem li r-riskju ta' interazzjonijiet b'relevanza klinika ma' prodotti mediċinali mogħtija flimkien huwa baxx.
English: In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Maltese: Fil-firien, kien hemm inċidenza ikbar ta' adenoma u karċinoma fil-fwied b'espożizzjoni sistemika li kienet 58 darba iktar minn dik fl-umani.
English: * Incidence rate per 100 patient-years is calculated as 100 × (total number of patients with ≥ 1 event during eligible exposure period per total patient-years of follow-up).
Maltese: * Rata ta' inċidenza għal kull 100 sena ta' pazjent hija kkalkulata bħala 100 × (in-numru totali ta' pazjenti b'każ ≥ 1 matul ilperjodu eliġibbli ta' esponiment għas-snin totali ta' segwitu tal-pazjenti).