FrancophonIA/ELRC3.0 huggingface dataset:
English: An increased incidence of wavy ribs was observed in rats in association with reduced maternal body weight parameters, with a no-effect dose of 75 mg/kg (10-fold human exposure).
Slovenian: Pri podganah so opažali zvišano incidenco valovite deformacije reber v povezavi s parametri zmanjšane telesne mase mater, pri tem je bil odmerek brez učinka 75 mg/kg (kar pomeni izpostavljenost, ki je 10-krat večja od izpostavljenosti pri človeku).
English: FOLDING BOX FOR UNIT PACK
Slovenian: ŠKATLA ZA POSAMIČNO PAKIRANJE
English: Rare cases of hepatic dysfunction (including hepatitis) have been reported with vildagliptin.
Slovenian: Pri zdravljenju z vildagliptinom so poročali o redkih primerih motenega delovanja jeter (vključno s hepatitisom).
English: In rabbits, decreased foetal weight and skeletal variations indicative of developmental delays were noted only in the presence of severe maternal toxicity, with a no-effect dose of 50 mg/kg (9-fold human exposure).
Slovenian: Pri kuncih so samo v primerih hude toksičnosti za mater zabeležili zmanjšano telesno maso zarodkov in skeletne različice, ki nakazujejo zaostanke v razvoju, pri tem je bil odmerek brez učinka 50 mg/kg (kar pomeni izpostavljenost, ki je 9-krat večja od izpostavljenosti pri človeku).
English: - Zomarist is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Slovenian: - Zdravilo Zomarist je indicirano kot del zdravljenja s trojno kombinacijo z insulinom poleg diete in telesne dejavnosti pri odraslih bolnikih, pri katerih diabetesa ni mogoče ustrezno urediti samo z metforminom in insulinom v stabilnem odmerku.
English: In the overall population, the placebo-adjusted mean reduction from a mean baseline HbA1c 8.8% was -0.72%.
Slovenian: V celotni populaciji je povprečno znižanje vrednosti HbA1c od povprečne izhodiščne vrednosti 8,8 % z upoštevanjem vrednosti pri uporabi placeba znašalo 0,72 %.
English: In the subgroups treated with insulin with or without concomitant metformin the placebo-adjusted mean reduction in HbA1c was -0.63% and -0.84%, respectively.
Slovenian: V podskupini bolnikov, ki so prejemali insulin in sočasno metformin, je povprečno znižanje vrednosti HbA1c z upoštevanjem vrednosti pri uporabi placeba znašalo 0,63 %, v skupini brez sočasne uporabe metformina pa 0,84 %.
English: Body weight change with vildagliptin was +0.1 kg compared to a weight gain of +1.4 kg with gliclazide.
Slovenian: Pri uporabi vildagliptina je prišlo do povečanja telesne mase za 0,1 kg v primerjavi s povečanjem telesne mase za 1,4 kg pri uporabi gliklazida.
English: One severe hypoglycaemic event was reported in the vildagliptin group.
Slovenian: Poročali so o enem primeru hude hipoglikemije, in sicer v skupini z vildagliptinom.
English: The dose of Zomarist should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Slovenian: Z odmerkom zdravila Zomarist naj bolnik prejme po 50 mg vildagliptina dvakrat na dan (kar pomeni celotni dnevni odmerek 100 mg vildagliptina) in približno tolikšen odmerek metformina, kot ga je prejemal do tedaj.
English: DPP-4 inhibition by vildagliptin is not affected by gender.
Slovenian: Spol ne vpliva na zaviranje DPP-4 z vildagliptinom.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) Diabetic pre-coma Severe renal failure (GFR < 30 ml/min) (see section 4.4) Acute conditions with the potential to alter renal function, such as: dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section 4.4).
Slovenian: - preobčutljivost na učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1; - vse vrste akutne metabolične acidoze (kot sta laktacidoza, diabetična ketoacidoza); - diabetična predkoma; - huda ledvična odpoved (GFR < 30 ml/min) (glejte poglavje 4.4); - akutna stanja, ki bi lahko vplivala na delovanje ledvic, kot so: dehidracija, huda okužba, šok, intravaskularna aplikacija jodiranih kontrastnih sredstev (glejte poglavje 4.4); - akutna ali kronična bolezen, ki lahko povzroča tkivno hipoksijo, kot je: srčno popuščanje ali odpoved dihanja, nedaven miokardni infarkt, šok; - okvara jeter (glejte poglavja 4.2, 4.4 in 4.8); - akutna zastrupitev z alkoholom, alkoholizem; - dojenje (glejte poglavje 4.6).
English: Vildagliptin was not mutagenic in conventional in vitro and in vivo tests for genotoxicity.
Slovenian: V običajnih testih genotoksičnosti in vitro in in vivo vildagliptin ni bil mutagen.
English: In a 52-week trial, vildagliptin (50 mg twice daily) was compared to gliclazide (mean daily dose: 229.5 mg) in patients inadequately controlled with metformin (metformin dose at baseline 1928 mg/day).
Slovenian: V preskušanju, ki je trajalo 52 tednov, so primerjali vildagliptin (50 mg dvakrat na dan) z gliklazidom (v povprečnem dnevnem odmerku 229,5 mg) pri bolnikih z neustrezno urejeno sladkorno boleznijo ob zdravljenju z metforminom (z izhodiščnim odmerkom metformina1928 mg/dan).
English: The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.
Slovenian: Pri hiperglikemiji zaradi zvišanih koncentracij hormonov inkretinov pride do dodatnega zvišanja razmerja insulin/glukagon, kar povzroči zmanjšanje tvorbe glukoze v jetrih na tešče in po obroku, to pa zniža koncentracije glukoze v krvi.
English: The placebo-adjusted mean reduction from a mean baseline HbA1c of 8.8% was -0.76%.
Slovenian: Povprečno znižanje vrednosti HbA1c od povprečne izhodiščne vrednosti 8,8 % je z upoštevanjem vrednosti pri uporabi placeba znašalo 0,76 %.
English: Caution should be exercised in patients with history of acute pancreatitis.
Slovenian: Pri bolnikih z anamnezo akutnega pankreatitisa je potrebna previdnost.
English: When and how to take Zomarist - Swallow the tablets whole with a glass of water, - Take one tablet in the morning and the other in the evening with or just after food.
Slovenian: • Eno tableto vzemite zjutraj, drugo pa zvečer s hrano ali takoj po njej.
English: Maximum daily dose is 3000 mg.
Slovenian: Največji dnevni odmerek je 3.000 mg.
English: Mean reductions from baseline HbA1c of 8.4% were -0.9% with vildagliptin added to metformin and -1.0% with pioglitazone added to metformin.
Slovenian: Pri dodajanju vildagliptina metforminu je prišlo do povprečnega znižanja vrednosti HbA1c za 0,9 % od izhodiščne vrednosti 8,4 %, pri dodajanju pioglitazona metforminu pa do znižanja za 1,0 %.
English: After an oral dose of metformin, the maximum plasma concentration (Cmax) is achieved after about 2.5 h.. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Slovenian: Pri zdravih odraslih je absolutna biološka uporabnost 500-miligramske tablete metformina približno 50-60 %.
English: Zomarist 50 mg/1000 mg film-coated tablets
Slovenian: Zomarist 50 mg/1000 mg filmsko obložene tablete
English: Aluminium/Aluminium (PA/Alu/PVC/Alu) blister Available in packs containing 10, 30, 60, 120,180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.
Slovenian: 6.5 Vrsta ovojnine in vsebina pretisni omot iz aluminija/aluminija (PA/Alu/PVC/Alu) Na voljo so v pakiranjih, ki vsebujejo po 10, 30, 60, 120, 180 ali 360 filmsko obloženih tablet, in v skupnih pakiranjih, ki vsebujejo po 120 (2 pakiranji po 60), 180 (3 pakiranja po 60) ali 360 (6 pakiranj po 60) filmsko obloženih tablet.
English: receptor antagonists) - certain medicines affecting the thyroid, or - certain medicines affecting the nervous system.
Slovenian: • določena zdravila, ki vplivajo na živčevje.
English: Maximum daily dose is 2000 mg.
Slovenian: Največji dnevni odmerek je 2.000 mg.
English: Zomarist 50 mg/850 mg film-coated tablets
Slovenian: Zomarist 50 mg/850 mg filmsko obložene tablete
English: No severe hypoglycaemic events were reported in the vildagliptin arms.
Slovenian: V krakih z vildagliptinom ni bilo poročil o hudih epizodah hipoglikemije.
English: A pre- and postnatal development study was performed in rats.
Slovenian: Pri podganah so opravili študijo razvoja pred rojstvom in po njem.
English: Maximum daily dose is 1000 mg.
Slovenian: Največji dnevni odmerek je 1.000 mg.
English: Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “FLO” on the other side.
Slovenian: Temno rumena ovalna filmsko obložena tableta z zaobljenim robom in vtisnjeno oznako “NVR” na eni strani in “FLO” na drugi.
English: Therefore, you should not receive Zomarist for the treatment of type 1 diabetes.
Slovenian: Zdravilo Zomarist ni nadomestek insulina, zato zdravila Zomarist ne smete prejemati za zdravljenje sladkorne bolezni tipa 1.
English: Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “SEH” on the other side.
Slovenian: Rumena ovalna filmsko obložena tableta z zaobljenim robom in vtisnjeno oznako “NVR” na eni strani in “SEH” na drugi.
English: Metabolism and nutrition disorders Very Rare
Slovenian: Presnovne in prehranske motnje pogosti hipoglikemija
English: Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets
Slovenian: Zomarist 50 mg/850 mg filmsko obložene tablete Zomarist 50 mg/1000 mg filmsko obložene tablete
English: Table 4 Adverse reactions reported in patients who received vildagliptin 100 mg daily as monotherapy in double-blind studies (N=1855)
Slovenian: Preglednica 4 Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali 100 mg vildagliptina dnevno v monoterapiji v dvojno slepih študijah (N=1.855)
English: In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was added to metformin (+0.2 kg and -1.0 kg for vildagliptin and placebo, respectively).
Slovenian: Telesna masa se v kliničnih preskušanjih ni bistveno spremenila od izhodiščne: pri dodajanju 100 mg vildagliptina metforminu se je povečala za 0,2 kg, pri kombinaciji metformina s placebom pa se je zmanjšala za 1,0 kg.
English: Gastrointestinal disorders Very common Nausea, vomiting, diarrhoea, abdominal pain and loss of appetite Hepatobiliary disorders Very rare
Slovenian: Bolezni prebavil zelo pogosti navzea, bruhanje, driska, bolečine v trebuhu in izguba apetita Bolezni jeter, žolčnika in žolčevodov zelo redki nenormalne vrednosti jetrnih testov ali hepatitis**
English: Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention.
Slovenian: Za laktacidozo so značilni acidozna dispneja, bolečina v trebuhu, mišični krči, astenija in hipotermija, ki ji sledi koma.
English: DPP-4 contributes partially to the hydrolysis of vildagliptin based on an in vivo study using DPP-4 deficient rats.
Slovenian: Glede na izsledke in vivo študije na podganah s pomanjkanjem DPP-4 kaže, da DPP-4 deloma sodeluje pri hidrolizi vildagliptina.
English: Skin lesions, including blistering and ulceration have been reported with vildagliptin in extremities of monkeys in non-clinical toxicology studies (see section 5.3).
Slovenian: V nekliničnih toksikoloških študijah z vildagliptinom so poročali o kožnih spremembah, med drugim o mehurčastem izpuščaju in razjedah na okončinah opic (glejte poglavje 5.3).
English: - Each Zomarist 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Slovenian: - Ena filmsko obložena tableta Zomarist 50 mg/850 mg vsebuje 50 mg vildagliptina in 850 mg metforminijevega klorida (kar ustreza 660 mg metformina).
English: No metabolites have been identified in humans.
Slovenian: Presnovkov pri ljudeh niso ugotovili.
English: Body weight change with vildagliptin was -0.2 kg vs +1.6 kg with glimepiride.
Slovenian: Pri uporabi vildagliptina je prišlo do zmanjšanja telesne mase za 0,2 kg, pri uporabi glimepirida pa do povečanja za 1,6 kg.
English: Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Slovenian: Zomarist 50 mg/1000 mg filmsko obložene tablete vildagliptin/metforminijev klorid
English: Adults with normal renal function (GFR ≥ 90 ml/min) The dose of antihyperglycaemic therapy with Zomarist 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 vildagliptin.
Slovenian: Odrasli z normalnim delovanjem ledvic (GFR ≥ 90 ml/min) Odmerek zdravila Zomarist za preprečevanje hiperglikemije je treba določiti vsakemu posameznemu bolniku glede na njegovo trenutno shemo zdravljenja in njeno učinkovitost ter glede na bolnikovo prenašanje zdravljenja, pri tem pa se ne sme preseči najvišjega priporočenega dnevnega odmerka vildagliptina 100 mg. Zdravljenje z zdravilom Zomarist je mogoče začeti z uporabo tablet bodisi jakosti 50 mg/850 mg ali 50 mg/1000 mg dvakrat dnevno in sicer eno tableto zjutraj, drugo pa zvečer.
English: Each tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Slovenian: Ena tableta vsebuje 50 mg vildagliptina in 1000 mg metforminijevega klorida (kar ustreza 780 mg metformina).
English: Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Slovenian: Zomarist 50 mg/850 mg filmsko obložene tablete Zomarist 50 mg/1000 mg filmsko obložene tablete vildagliptin/metforminijev klorid
English: Patients receiving vildagliptin in combination with a sulphonylurea may be at risk for hypoglycaemia.
Slovenian: Pri bolnikih, ki prejemajo vildagliptin v kombinaciji s sulfonilureo, je lahko tveganje za hipoglikemijo povečano, zato je treba razmisliti o nižjem odmerku sulfoniluree, da bi zmanjšali tveganje za hipoglikemijo.
English: In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).
Slovenian: Telesna masa se v kliničnih preskušanjih ni bistveno spremenila od izhodiščne: pri jemanju 100 mg vildagliptina v monoterapiji se je zmanjšala za 0,3 kg, pri uporabi vildagliptina skupaj s placebom pa se je zmanjšala za 1,3 kg.
English: There were no withdrawals due to adverse reactions reported in the vildagliptin + metformin + glimepiride treatment group versus 0.6% in the placebo + metformin + glimepiride treatment group.
Slovenian: V skupini bolnikov, ki so prejemali vildagliptin, metformin in glimepirid, ni noben bolnik prekinil zdravljenja zaradi neželenih učinkov v primerjavi z 0,6 % bolnikov, ki so prekinili zdravljenje v skupini, v kateri so prejemali placebo, metformin in glimepirid.
English: In a 24-week trial the efficacy of the fixed dose combination of vildagliptin and metformin (gradually titrated to a dose of 50 mg/500 mg twice daily or 50 mg/1000 mg twice daily) as initial therapy in drug-naïve patients was evaluated.
Slovenian: V preskušanju, ki je trajalo 24 tednov, so pri bolnikih, ki prej še niso prejemali nobenih zdravil za sladkorno bolezen, ocenjevali učinkovitost začetnega zdravljenja s fiksno kombinacijo vildagliptina in metformina (odmerek so postopno titrirali do 50 mg/500 mg dvakrat na dan ali do 50 mg/1000 mg dvakrat na dan).
English: - Each Zomarist 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Slovenian: - Ena filmsko obložena tableta Zomarist 50 mg/1000 mg vsebuje 50 mg vildagliptina in 1000 mg metforminijevega klorida (kar ustreza 780 mg metformina).
English: Zomarist 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Slovenian: Zomarist 50 mg/850 mg filmsko obložene tablete vildagliptin/metforminijev klorid
English: Headache
Slovenian: zgaga.
English: - if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Slovenian: Če menite, da bi lahko bili alergični na karkoli od navedenega, se posvetujte z zdravnikom, preden začnete jemati zdravilo Zomarist; - če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnjo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte spodaj "Tveganje za laktacidozo") ali ketoacidozo.
English: Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Slovenian: Ena tableta vsebuje 50 mg vildagliptina in 850 mg metforminijevega klorida (kar ustreza 660 mg metformina).
English: Constipation Musculoskeletal and connective tissue disorders Uncommon
Slovenian: Bolezni prebavil občasni zaprtje Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni artralgija
English: Accumulation of foamy alveolar macrophages in the lung was observed in rats and mice.
Slovenian: Pri miših in podganah so opažali kopičenje penastih alveolarnih makrofagov v pljučih.
English: There have been no formal interaction studies for Zomarist.
Slovenian: Formalnih študij medsebojnega delovanja zdravila Zomarist z drugimi zdravili niso opravili.
English: How to store Zomarist
Slovenian: Shranjevanje zdravila Zomarist
English: Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
Slovenian: Ena filmsko obložena tableta vsebuje 50 mg vildagliptina in 850 mg metforminijevega klorida (kar ustreza 660 mg metformina).
English: Some patients have experienced the following side effects while taking Zomarist and a sulphonylurea: • Common: dizziness, tremor, weakness, low blood glucose, excessive sweating.
Slovenian: • Pogosti: omotičnost, tremor, šibkost, nizka koncentracija glukoze v krvi, čezmerno znojenje.
English: Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent, and accordingly the metabolic clearance of vildagliptin is not anticipated to be affected by comedications that are CYP 450 inhibitors and/or inducers.
Slovenian: Glede na to ni pričakovati, da bi na presnovni očistek vildagliptina vplivala sočasna uporaba zdravil, ki so zaviralci in/ali induktorji encimov CYP 450.
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces serum levels of total cholesterol, LDL cholesterol and triglycerides.
Slovenian: Metformin znižuje koncentracije skupnega holesterola, LDL holesterola in trigliceridov v serumu.
English: Cationic active substances
Slovenian: SEZNAM POMOŽNIH SNOVI
English: Flaking skin, peeling skin, scabs and tail sores with correlating histopathological changes were noted at doses ≥ 20 mg/kg/day (approximately 3 times human AUC exposure at the 100 mg dose).
Slovenian: Pri odmerku ≥ 20 mg/kg/dan (kar približno ustreza 3-kratni izpostavljenosti AUC pri človeku pri odmerku 100 mg) so opažali luskavost in luščenje kože, kraste in ranice na repu z ustreznimi histopatološkimi spremembami.
English: Talk to your doctor, pharmacist or nurse before taking Zomarist if you are taking an anti-diabetic medicine known as a sulphonylurea.
Slovenian: Če jemljete antidiabetično zdravilo, ki ga imenujemo sulfonilurea, se pred začetkom jemanja zdravila Zomarist posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
English: Talk to your doctor, pharmacist or nurse before taking Zomarist if you have or have had a disease of the pancreas.
Slovenian: Če imate ali ste imeli kdaj prej težave s trebušno slinavko, se pred začetkom jemaja zdravila Zomarist posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: EU/1/08/483/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/030 360 film-coated tablets (PCTFE/PVC/Alu)
Slovenian: EU/1/08/483/007 10 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/008 30 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/009 60 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/010 120 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/011 180 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/012 360 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/025 10 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/483/026 30 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/483/027 60 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/483/028 120 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/483/029 180 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/483/030 360 filmsko obloženih tablet (PCTFE/PVC/Alu)
English: The known effect of increased GLP-1 levels delaying gastric emptying is not observed with vildagliptin treatment.
Slovenian: Pri zdravljenju z vildagliptinom niso opažali počasnejšega praznjenja želodca, kar je sicer znan učinek pri zvišanih koncentracijah GLP-1.
English: EU/1/08/483/001 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/002 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/003 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/004 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/005 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/006 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/019 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/020 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/021 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/022 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/023 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/024 360 film-coated tablets (PCTFE/PVC/Alu)
Slovenian: EU/1/08/483/001 10 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/002 30 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/003 60 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/004 120 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/005 180 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/006 360 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/019 10 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/483/020 30 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/483/021 60 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/483/022 120 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/483/023 180 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/483/024 360 filmsko obloženih tablet (PCTFE/PVC/Alu)
English: There may be an increased risk of angioedema in patients concomitantly taking ACE inhibitors.
Slovenian: Kombinacija z zaviralci angiotenzinske konvertaze Pri bolnikih, ki sočasno jemljejo zaviralce angitenzinske konvertaze, je lahko prisotno povečano tveganje za angioedem (glejte poglavje 4.8).
English: EU/1/08/483/016 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/017 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/018 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/034 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/035 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/036 360 film-coated tablets (PCTFE/PVC/Alu)
Slovenian: EU/1/08/483/016 120 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/017 180 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/018 360 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/483/034 120 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/483/035 180 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/483/036 360 filmsko obloženih tablet (PCTFE/PVC/Alu)