FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients treated with sitagliptin had a modest increase in body weight compared to those given placebo.
Slovenian: Bolnikom, ki so prejemali sitagliptin, se je telesna masa v primerjavi z bolniki, ki so prejemali placebo, zmerno povečala.
English: The addition of sitagliptin to pioglitazone and metformin provided significant improvements in glycaemic parameters.
Slovenian: Pri dodatku sitagliptina pioglitazonu in metforminu so se glikemični parametri pomembno izboljšali.
English: With higher insulin levels, tissue glucose uptake is enhanced.
Slovenian: Zaradi višje koncentracije insulina se poveča vstop glukoze v tkiva.
English: The usual recommended dose is: one 100mg film-coated tablet once a day by mouth
Slovenian: Običajni priporočeni odmerek je: - ena 100 mg filmsko obložena tableta,
English: Sitagliptin 100 mg once daily (N= 193) Sitagliptin 100 mg once daily (N= 229)
Slovenian: Sitagliptin 100 mg enkrat na dan (N = 229)
English: Ristaben should not be used during breast-feeding.
Slovenian: Med dojenjem se zdravila Ristaben ne sme jemati.
English: Nervous system disorders headache
Slovenian: Bolezni živčevja glavobol pogosti omotica občasni
English: 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.
Slovenian: Zasnovana je bila 26-tedenska s placebom nadzorovana študija, v kateri so vrednotili učinkovitost in varnost sitagliptina (100 mg enkrat na dan), če so ga dodali kombinaciji pioglitazona in metformina.
English: Metabolism and nutrition disorders hypoglycaemia
Slovenian: Presnovne in prehranske motnje hipoglikemija pogosti
English: Primary Composite Endpoint (Cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina)
Slovenian: Primarni sestavljeni opazovani dogodek (Srčno-žilna smrt, miokardni infarkt brez smrtnega izida, možganska kap brez smrtnega izida ali sprejem v bolnišnico zaradi nestabilne angine pektoris)
English: Always take this medicine exactly as your doctor has told you.
Slovenian: Za urejenost sladkorne bolezni zdravilo jemljite tako dolgo, kot vam je predpisal zdravnik.
English: Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/or hunched posture were observed in dogs at exposure levels approximately
Slovenian: Pri psih so pri izpostavljenosti, ki je bila približno 23-krat večja od izpostavljenosti pri klinični uporabi, opazili z zdravljenjem povezane prehodne fizične znake, med katerimi so nekateri kazali na škodljive učinke na živčevje, npr. dihanje z odprtimi usti, slinjenje, bruhanje bele spenjene vsebine, ataksija, tresenje, zmanjšana aktivnost in/ali zgrbljena drža.
English: Some patients have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency is common).
Slovenian: Po začetku zdravljenja s kombinacijo sitagliptina in metformina so se pri nekaterih bolnikih pojavile različne prebavne težave (pojavijo se pogosto).
English: No dose adjustment is necessary for patients with mild to moderate hepatic impairment.
Slovenian: Pri bolnikih z blago do zmerno jetrno okvaro odmerka ni treba prilagoditi.
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.
Slovenian: Pri bolnikih z zmerno ledvično okvaro (GFR ≥ 30 do < 45 ml/min) je bila plazemska AUC sitagliptina približno 2-krat večja, pri bolnikih s hudo ledvično okvaro (GFR < 30 ml/min), vključno s tistimi s končno ledvično odpovedjo na hemodializi, pa približno 4-krat večja.
English: A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to insulin (at a stable dose for at least 10 weeks) with or without metformin (at least 1,500 mg).
Slovenian: Zasnovana je bila 24-tedenska s placebom nadzorovana študija, v kateri so vrednotili učinkovitost in varnost sitagliptina (100 mg enkrat na dan), če so ga dodali insulinu (vsaj 10 tednov stabilen odmerek) z ali brez metformina (vsaj 1.500 mg).
English: In addition, very slight to slight skeletal muscle degeneration was also observed histologically at doses resulting in systemic exposure levels of approximately 23 times the human exposure level.
Slovenian: Poleg tega so pri odmerkih, ki so povzročili približno 23-krat večjo sistemsko izpostavljenost od izpostavljenosti človeka pri klinični uporabi, s histološko preiskavo ugotovili zelo blago do blago degeneracijo skeletnih mišic.
English: Tabulated list of adverse reactions
Slovenian: Tabelarični pregled neželenih učinkov
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.
Slovenian: Zasnovana je bila 24-tedenska s placebom nadzorovana študija, ki je vključevala 660 bolnikov in v kateri so vrednotili učinkovitost varčevanja z insulinom in varnost sitagliptina (100 mg enkrat na dan), ki so ga tekom intenziviranja insulinskega zdravljenja dodajali insulinu glargin, z ali brez metformina (najmanj 1.500 mg).
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.
Slovenian: • z agonistom PPAR in z metforminom, če je uporaba agonista PPAR primerna in če urejenost glikemije z dieto in s telesno aktivnostjo ter z dvojnim zdravljenjem s tema zdraviloma ni zadostna.
English: Mean change from baseline HbA1c (%)
Slovenian: Srednja sprememba vrednosti HbA1c od izhodišča (%)
English: A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride alone or glimepiride in combination with metformin.
Slovenian: Zasnovana je bila 24-tedenska s placebom nadzorovana študija, v kateri so vrednotili učinkovitost in varnost sitagliptina (100 mg enkrat na dan), če so ga dodali glimepiridu samemu ali glimepiridu v kombinaciji z metforminom.
English: Adverse reactions were identified through postmarketing surveillance.
Slovenian: Neželeni učinki so bili zabeleženi v obdobju trženja zdravila.
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).
Slovenian: Za doseg podobnih plazemskih koncentracij sitagliptina, kot so pri bolnikih z normalno ledvično funkcijo, se pri bolnikih z GFR < 45 ml/min ter bolnikih s končno ledvično odpovedjo, ki potrebujejo hemodializo ali peritonealno dializo, priporočajo manjši odmerki zdravila (glejte poglavji 4.2 in 5.2).
English: Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level.
Slovenian: Pri glodavcih so pri sistemski izpostavljenosti, ki je bila 58-krat večja od izpostavljenosti pri človeku, opazili škodljive učinke na ledvice in jetra, izpostavljenost brez škodljivih učinkov pa je bila 19-krat večja od izpostavljenosti pri človeku.
English: A no-effect level for these findings was found at an exposure 6-fold the clinical exposure level.
Slovenian: Pri tem je bila izpostavljenost brez škodljivega učinka 6-krat večja od izpostavljenosti pri klinični uporabi.
English: The decrease in body weight with the combination of sitagliptin and metformin was similar to that observed with metformin alone or placebo; there was no change from baseline for patients on sitagliptin alone.
Slovenian: Zmanjšanje telesne mase je bilo pri uporabi kombinacije sitagliptina in metformina podobno kot pri uporabi metformina samega ali placeba.
English: Incidence rate per patientyears*
Slovenian: Pojavnost na 100 bolniklet*
English: Rates of Composite Cardiovascular Outcomes and Key Secondary Outcomes
Slovenian: Deleži sestavljenih srčno-žilnih izidov in ključnih sekundarnih izidov sitagliptin 100 mg placebo
English: Round, pink film-coated tablet with “221” on one side.
Slovenian: Okrogla, rožnata filmsko obložena tableta z oznako “221” na eni strani.
English: - If you get any side effects, talk to your doctor, pharmacist, or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Sitagliptin 100 mg once daily added to ongoing insulin (+/- metformin) therapy (N=305)
Slovenian: Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z insulinom (+/- metformin) (N = 305)
English: Blood and lymphatic system disorders thrombocytopenia
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija redki
English: In a pre-/postnatal development study performed in rats sitagliptin showed no adverse effects.
Slovenian: Študije, izvedene s sitagliptinom na podganah, niso pokazale neželenih vplivov na pre-/post-natalni razvoj.
English: The addition of sitagliptin to insulin provided significant improvements in glycaemic parameters.
Slovenian: Pri dodatku sitagliptina insulinu so se glikemični parametri pomembno izboljšali.
English: The pharmacokinetics of sitagliptin were generally similar in healthy subjects and in patients with type 2 diabetes.
Slovenian: Pri zdravih osebah in bolnikih s sladkorno boleznijo tipa 2 je farmakokinetika sitagliptina na splošno podobna.
English: Round, beige film-coated tablet with “277” on one side.
Slovenian: okrogla, sivorjava filmsko obložena tableta z oznako “277” na eni strani
English: No adverse effects upon fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
Slovenian: Pri samcih in samicah podgan, ki so sitagliptin prejemali pred in med obdobjem parjenja, niso opazili neželenih učinkov na plodnost.
English: Sitagliptin is renally excreted.
Slovenian: Sitagliptin se izloča skozi ledvice.
English: Sitagliptin is also a substrate of p-glycoprotein, which may also be involved in mediating the renal elimination of sitagliptin.
Slovenian: Sitagliptin je tudi substrat za p-glikoprotein, ki je prav tako lahko vključen pri izločanju sitagliptina skozi ledvice, vendar pa ciklosporin, zaviralec p-glikoproteina, ni zmanjšal ledvičnega očistka sitagliptina.
English: Ristaben 25 mg tablets Sitagliptin
Slovenian: Ristaben 25 mg tablete sitagliptin
English: Frequency not known fatal and non-fatal haemorrhagic and necrotizing pancreatitis
Slovenian: Bolezni prebavil zaprtje občasni bruhanje neznana pogostnost akutni pankreatitis neznana pogostnost smrtni in nesmrtni hemoragični in nekrotizirajoči pankreatitis neznana pogostnost
English: Merck Sharp & Dohme B.V. Tel.: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com
Slovenian: Tel.: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com
English: If you get any side effects, talk to your doctor, pharmacist, or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Sitagliptin may be a mild inhibitor of p-glycoprotein in vivo.
Slovenian: Sitagliptin lahko in vivo blago zavira p-glikoprotein.
English: In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).
Slovenian: V kliničnih študijah sitagliptin ni pomembno spremenil farmakokinetike metformina, gliburida, simvastatina, rosiglitazona, varfarina ali peroralnih kontraceptivov.
English: If pancreatitis is suspected, Ristaben and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Ristaben should not be restarted.
Slovenian: Ob sumu na pankreatitis je treba prenehati z jemanjem zdravila Ristaben in drugih zdravil, ki bi lahko povzročila pankreatitis.
English: Sitagliptin 100 mg once daily added to ongoing glimepiride therapy (N=102)
Slovenian: Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z glimepiridom (N = 102)
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.
Slovenian: Zdravilo Ristaben vsebuje učinkovino sitagliptin, ki spada v skupino zdravil, imenovano zaviralci DPP-4 (zaviralci dipeptidil peptidaze 4).
English: Paediatric No studies with Ristaben have been performed in paediatric patients.
Slovenian: Otroci Pri otrocih študij z zdravilom Ristaben niso izvedli.
English: Change from baseline in body weight was similar for patients treated with sitagliptin relative to placebo.
Slovenian: Sprememba telesne mase glede na začetno vrednost je bila podobna pri bolnikih, ki so se zdravili s sitagliptinom, in pri bolnikih, ki so prejemali placebo.
English: No dose adjustment for Ristaben is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Slovenian: Pri bolnikih z blago ali zmerno jetrno okvaro (ocena po Child-Pugh-u  9) odmerka ni treba prilagoditi.
English: Sitagliptin 100 mg once daily added to ongoing metformin therapy (N=453)
Slovenian: Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z metforminom (N = 453)
English: Mean change from baseline HbA1c
Slovenian: S placebom korigirana srednja sprememba vrednosti HbA1c
English: Ristaben 100 mg tablets Sitagliptin
Slovenian: Ristaben 100 mg tablete sitagliptin
English: Secondary Composite Endpoint (Cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke)
Slovenian: Sekundarni sestavljeni opazovani dogodek (Srčno-žilna smrt, miokardni infarkt brez smrtnega izida ali možganska kap brez smrtnega izida)
English: Number of patients
Slovenian: Starejši bolniki
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.
Slovenian: V študiji so primerjali učinkovitost in varnost dodatnega zdravljenja s sitagliptinom v odmerku 100 mg enkrat na dan ali z glipizidom (sulfonilsečnina) pri bolnikih z nezadostno urejeno glikemijo pri zdravljenju samo z metforminom.
English: Frequency not known exfoliative skin conditions including Stevens-Johnson syndrome
Slovenian: Pogostnost neželenega učinka kožni vaskulitis neznana pogostnost eksfoliativna stanja na koži, vključno s Stevens-Johnsonovim sindromom neznana pogostnost bulozni pemfigoid neznana pogostnost
English: - type 1 diabetes - diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss,
Slovenian: - sladkorno bolezen tipa 1 - diabetično ketoacidozo (zaplet sladkorne bolezni z visokim krvnim sladkorjem, hitrim hujšanjem, siljenjem na bruhanje ali bruhanjem) - kakršne koli težave z ledvicami v sedanjosti ali v preteklosti - alergijsko reakcijo na zdravilo Ristaben (glejte poglavje 4)
English: Sitagliptin 100 mg once daily added to ongoing pioglitazone therapy (N=163)
Slovenian: Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju s pioglitazonom (N = 163)
English: Sitagliptin is modestly dialysable.
Slovenian: Odstranitev sitagliptina z dializo je zmerna.
English: Some patients have experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:
Slovenian: Pri nekaterih bolnikih, ki so jemali sitagliptin v kombinaciji s pioglitazonom in metforminom, so se pojavili naslednji neželeni učinki:
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.
Slovenian: Pri bolnikih z zmerno do hudo ledvično okvaro so izvedli študijo za primerjavo sitagliptina v odmerkih 25 ali 50 mg enkrat na dan in glipizida v odmerkih 2,5 do 20 mg/dan.
English: In these studies there was a similar incidence of hypoglycaemia reported for patients treated with sitagliptin or placebo.
Slovenian: V teh študijah so pri bolnikih, ki so prejemali sitagliptin, poročali o podobni pojavnosti hipoglikemije, kot pri bolnikih, ki so prejemali placebo.
English: Ristaben 50 mg tablets Sitagliptin
Slovenian: Ristaben 50 mg tablete sitagliptin
English: • a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Slovenian: • s sulfonilsečnino in z metforminom, če urejenost glikemije z dieto in s telesno aktivnostjo ter z dvojnim zdravljenjem s tema zdraviloma ni zadostna.
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.
Slovenian: Glede na analizo populacijske farmakokinetike na podlagi podatkov iz I. in II.
English: • metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
Slovenian: • z metforminom, če urejenost glikemije z dieto in s telesno aktivnostjo ter z zdravljenjem z metforminom samim ni zadostna.
English: Round, light beige film-coated tablet with “112” on one side.
Slovenian: Okrogla, svetlo sivorjava filmsko obložena tableta z oznako “112” na eni strani.
English: Sitagliptin 100 mg once daily added to ongoing glimepiride + metformin therapy (N=115)
Slovenian: Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z glimepiridom in metforminom (N = 115)
English: Some patients have experienced the following side effects while taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other diabetes medicines: Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain
Slovenian: Pogosti: nizek krvni sladkor, glavobol, okužba zgornjih dihal, zamašen nos ali izcedek iz nosu in vnetje grla, osteoartritis, bolečine v rokah ali nogah Občasni: omotica, zaprtje, srbenje
English: If bullous pemphigoid is suspected, Ristaben should be discontinued.
Slovenian: Ob sumu na bulozni pemfigoid je treba zdravljenje z zdravilom Ristaben prekiniti.
English: The incidence of hypoglycaemia was also similar in patients treated with sitagliptin or placebo.
Slovenian: Tudi pojavnost hipoglikemije je bila pri bolnikih, ki so prejemali sitagliptin, in tistih, ki so prejemali placebo, podobna.
English: Common dizziness
Slovenian: Bulozni pemfigoid
English: Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin.
Slovenian: V eni študiji so pri odmerku 800 mg sitagliptina opazili minimalno podaljšanje intervala QTc, ki pa ni veljalo za klinično pomembno.
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.
Slovenian: V drugi študiji so primerjali sitagliptin v odmerku 25 mg enkrat na dan in glipizid v odmerkih 2,5 do 20 mg/dan.
English: Treatment with sitagliptin at 100 mg once daily as monotherapy provided significant improvements in HbA1c, fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hour PPG), compared to placebo in two studies, one of 18- and one of 24-weeks duration.
Slovenian: V dveh študijah, od katerih je ena trajala 18 druga pa 24 tednov, so se v primerjavi s placebom pri samostojnem zdravljenju s sitagliptinom v odmerku 100 mg enkrat na dan pomembno izboljšale vrednosti HbA1c, vrednosti glukoze v plazmi na tešče in vrednosti glukoze v plazmi 2 uri po obroku.
English: Some patients have experienced the following side effects while taking sitagliptin in combination with a sulphonylurea and metformin:
Slovenian: Pri nekaterih bolnikih, ki so jemali sitagliptin v kombinaciji s sulfonilsečnino in metforminom, so se pojavili naslednji neželeni učinki:
English: Marketing Authorisation Holder Merck Sharp & Dohme B.V. Waarderweg 39
Slovenian: Imetnik dovoljenja za promet z zdravilom Merck Sharp & Dohme B.V.
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
Slovenian: EU/1/10/621/013 14 filmsko obloženih tablet EU/1/10/621/014 28 filmsko obloženih tablet EU/1/10/621/023 30 filmsko obloženih tablet EU/1/10/621/015 56 filmsko obloženih tablet EU/1/10/621/016 84 filmsko obloženih tablet EU/1/10/621/024 90 filmsko obloženih tablet EU/1/10/621/017 98 filmsko obloženih tablet EU/1/10/621/018 50 x 1 filmsko obložena tableta
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
Slovenian: EU/1/10/621/001 14 filmsko obloženih tablet EU/1/10/621/002 28 filmsko obloženih tablet EU/1/10/621/019 30 filmsko obloženih tablet EU/1/10/621/003 56 filmsko obloženih tablet EU/1/10/621/004 84 filmsko obloženih tablet EU/1/10/621/020 90 filmsko obloženih tablet EU/1/10/621/005 98 filmsko obloženih tablet EU/1/10/621/006 50 x 1 filmsko obložena tableta
English: Ristaben 25 mg film-coated tablets
Slovenian: Ristaben 25 mg filmsko obložene tablete
English: Frequency of adverse reaction angioedema
Slovenian: Bolezni kože in podkožja pruritus občasni angioedem neznana pogostnost
English: Some patients have experienced the following side effects after adding sitagliptin to metformin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 ljudi): nizek krvni sladkor, siljenje na bruhanje, napenjanje, bruhanje
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
Slovenian: EU/1/10/621/007 14 filmsko obloženih tablet EU/1/10/621/008 28 filmsko obloženih tablet EU/1/10/621/021 30 filmsko obloženih tablet EU/1/10/621/009 56 filmsko obloženih tablet EU/1/10/621/010 84 filmsko obloženih tablet EU/1/10/621/022 90 filmsko obloženih tablet EU/1/10/621/011 98 filmsko obloženih tablet EU/1/10/621/012 50 x 1 filmsko obložena tableta
English: Ristaben 100 mg film-coated tablets
Slovenian: Ristaben 100 mg filmsko obložene tablete
English: In addition, patients should be alerted to the risk of hypoglycaemia when Ristaben is used in combination with a sulphonylurea or with insulin.
Slovenian: Poleg tega je treba bolnike, ki jemljejo zdravilo Ristaben skupaj s sulfonilsečnino ali z insulinom, opozoriti na tveganje za pojav hipoglikemije.
English: Frequency not known acute renal failure
Slovenian: Bolezni sečil okvara ledvične funkcije neznana pogostnost akutna odpoved ledvic neznana pogostnost
English: Ristaben 100 mg film-coated tablets Sitagliptin
Slovenian: Ristaben 100 mg filmsko obložene tablete sitagliptin
English: Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy (N=152)
Slovenian: Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju s pioglitazonom in metforminom (N = 152)