FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered (see sections 4.4 and 5.1).
Slovenian: Zato je pri sočasni uporabi kationskih zdravil, ki se s tubulno sekrecijo izločajo skozi ledvice, treba skrbno spremljati urejenost glikemije, ustrezno prilagajati odmerke v okviru priporočenega odmerjanja in pretehtati možnost spremembe zdravljenja sladkorne bolezni (glejte poglavji 4.4 in 5.1).
English: • a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p = 0.01).
Slovenian: • statistično značilno zmanjšanje absolutnega tveganja za miokardni infarkt: metformin 11 dogodkov/1.000 bolnikov-let, samo dieta 18 dogodkov/1.000 bolnikov-let (p = 0,01).
English: • severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing).
Slovenian: Redki (lahko se pojavijo pri več kot 1 od 1.000 bolnikov) • hude alergijske reakcije (lahko vključujejo otekanje obraza, ustnic, ust, jezika, grla, zaradi česar je lahko oteženo dihanje ali požiranje)
English: Enzyme inducers (such as St. John's wort [Hypericum perforatum], rifampicin, barbiturates, phenytoin, carbamazepine, ritonavir, efavirenz) may give rise to decreased exposure of canagliflozin.
Slovenian: Induktorji encimov (kot so šentjanževka [Hypericum perforatum], rifampicin, barbiturati, fenitoin,
English: The incidence of hypoglycaemia episodes/events with canagliflozin 300 mg once daily and sitagliptin 100 mg was 40.7% and 43.2%, respectively.
Slovenian: Pogostnost hipoglikemij pri uporabi 300 mg kanagliflozina enkrat na dan je bila 40,7%, pri uporabi 100 mg sitagliptina pa 43,2%.
English: • cholestyramine (medicine used to reduce cholesterol levels in the blood).
Slovenian: • holestiramin (zdravilo za zmanjševanje koncentracije holesterola v krvi) Glejte poglavje 3
English: Canagliflozin has not been studied in severe renal impairment.
Slovenian: Kanagliflozina pri hudi jetrni okvari niso preučevali.
English: Risk factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with GFR < 60 mL/min.
Slovenian: Pri bolnikih z GFR < 60 ml/min je treba pred uvedbo metformina pregledati dejavnike tveganja, ki lahko povečajo tveganje za laktacidozo (glejte poglavje 4.4).
English: A dedicated study demonstrated that co-administration of canagliflozin 50 mg and 150 mg dosed twice daily as dual therapy with metformin produced clinically and statistically significant results relative to placebo in glycemic control, including HbA1c, the percentage of patients achieving HbA1c < 7%, change from baseline FPG, and in reductions in body weight as shown in table 4.
Slovenian: 150 mg dvakrat na dan v okviru dvotirnega zdravljenja z metforminom povzročila klinično pomembne in statistično značilne rezultate nadzora glikemije v primerjavi s placebom, vključno z odstotkom bolnikov, ki so dosegli HbA1c < 7%, spremembo koncentracije glukoze na tešče od izhodiščne vrednosti in zmanjšanjem telesne mase, kot je prikazano v preglednici 4.
English: Sitagliptin 100 mg + metformin and sulfonylurea (N = 378)
Slovenian: sitagliptin 100 mg + metformin in sulfonilsečnina
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 180 (3 packs of 60) film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 180 filmsko obloženih tablet (3 plastenke s 60 tabletami).
English: In patients ≥ 75 years of age, the incidences were 4.9% on canagliflozin 100 mg once daily and 8.7% on canagliflozin 300 mg once daily compared to 2.6% in the control group (see sections 4.2 and 4.4).
Slovenian: Pri bolnikih, ki so bili stari ≥ 75 let, je bila pogostnost teh neželenih učinkov 4,9% pri uporabi 100 mg kanagliflozina enkrat na dan in 8,7% pri uporabi 300 mg kanagliflozina enkrat na dan v primerjavi z 2,6% v kontrolni skupini (glejte poglavji 4.2 in 4.4).
English: • carbamazepine, phenytoin, or phenobarbital (medicines used to control seizures)
Slovenian: • šentjanževka (zeliščno zdravilo proti depresiji) • karbamazepin, fenitoin ali fenobarbital (zdravila proti epileptičnim krčem)
English: From a starting value of RTG of approximately 13 mmol/L, maximal suppression of 24-hour mean RTG was seen with the 300 mg daily dose to approximately 4 mmol/L to 5 mmol/L in patients with type 2 diabetes in phase 1 studies, suggesting a low risk for treatment-induced hypoglycaemia.
Slovenian: V študijah faze I so pri bolnikih s sladkorno boleznijo tipa 2 z začetno vrednostjo praga za izločanje glukoze v ledvicah približno 13 mmol/l pri meritvi 24 ur po 300 mg odmerku opazili največje znižanje tega praga na približno 4 mmol/l do 5 mmol/l, kar kaže, da je tveganje za hipoglikemijo zaradi zdravljenja majhno.
English: As dabigatran concentrations may be increased in the presence of canagliflozin, monitoring (looking for signs of bleeding or anaemia) should be exercised when dabigatran is combined with canagliflozin.
Slovenian: Pri sočasni uporabi dabigatrana in kanagliflozina lahko pride do zvečanja koncentracij dabigatrana, zato je treba bolnika spremljati (za znake krvavitve ali anemije).
English: Tablet core: microcrystalline cellulose, hypromellose, croscarmellose sodium, and magnesium stearate.
Slovenian: • Druge sestavine zdravila so: jedro tablete: mikrokristalna celuloza, hipromeloza, premrežen natrijev karmelozat in magnezijev stearat.
English: Table 4: Efficacy results from placebo-controlled clinical study of canagliflozin dosed twice dailya
Slovenian: Preglednica 4: Rezultati učinkovitosti kanagliflozina, pri odmerjanju dvakrat na dan v s placebom nadzorovanih kliničnih študijaha kanagliflozin placebo (n = 93)
English: The efficacy of canagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2).
Slovenian: Pri bolnikih z zmerno okvaro ledvic je zmanjšana, pri bolnikih s hudo okvaro ledvic pa kanagliflozin najverjetneje ni učinkovit (glejte poglavje 4.2).
English: The level of digoxin or digitoxin in your blood may need to be checked if taken with Vokanamet.
Slovenian: Če v času zdravljenja z zdravilom Vokanamet jemljete digoksin oziroma digitoksin, bo treba izmeriti njuni koncentraciji v krvi.
English: Your doctor will decide whether you need any other treatment to control your blood sugar while you have stopped taking Vokanamet.
Slovenian: Zdravnik bo določil, ali v času, ko ne jemljete zdravila Vokanamet, potrebujete katero od drugih zdravil za uravnavanje sladkorja v krvi.
English: Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin
Slovenian: V primerjavi z glimepiridom pri dvotirnem zdravljenju z metforminom (52 tednov) kanagliflozin + metformin glimepirid (s titracijo) + metformin (n = 482)
English: 1 x 60 film-coated tablets
Slovenian: 1x 60 filmsko obloženih tablet
English: Elderly patients may be at a greater risk for volume depletion, are more likely to be treated with diuretics, and to have impaired renal function.
Slovenian: Starostniki (≥ 65 let) Pri starostnikih je tveganje za hipovolemijo lahko večje, večja je tudi možnost, da jemljejo diuretike in da imajo zmanjšano delovanje ledvic.
English: A substudy of patients with baseline HbA1c > 10% to ≤ 12% with canagliflozin as monotherapy resulted in reductions from baseline in HbA1c (not-placebo-adjusted) of -2.13% and -2.56% for canagliflozin 100 mg and 300 mg once daily, respectively.
Slovenian: V podštudiji z bolniki z izhodiščno ravnijo HbA1c od > 10% do ≤ 12% so se pri monoterapiji s kanagliflozinom vrednosti HbA1c (niso bile prirejene glede na placebo) zmanjšale za -2,13% od izhodiščne vrednosti pri odmerku 100 mg enkrat na dan in za -2,56% pri odmerku 300 mg enkrat na dan.
English: The mean Vd ranged between 63- 276 litres.
Slovenian: 63-276 litrov.
English: In a cardiovascular study of 4,327 patients with known or at high risk for cardiovascular disease, the incidence rates of bone fracture were 1.6, 1.6, and 1.1 per 100 patient years of exposure to canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively, with the fracture imbalance initially occurring within the first 26 weeks of therapy.
Slovenian: V študiji srčnožilnih učinkov pri 4.327 bolnikih z znano srčnožilno boleznijo ali z velikim tveganjem zanjo, je bila pojavnost za zlom kosti (preračunana na 100 bolnikov-let izpostavljenosti) 1,6 pri bolnikih, ki so jemali 100 mg ali 300 mg kanagliflozina in 1,1 pri bolnikih, ki so jemali placebo.
English: In addition, an 18-week double-blind, placebo-controlled phase 2 study with twice daily dosing (canagliflozin 50 mg or 150 mg as add-on therapy with metformin 500 mg) was conducted in 279 patients in which 186 patients were treated with canagliflozin as add-on therapy with metformin.
Slovenian: Poleg tega so izvedli 18-tedensko, dvojno slepo, s placebom nadzorovano študijo faze II z dvakrat dnevnim odmerjanjem (kanagliflozin v odmerku 50 mg ali 150 mg kot dodano zdravilo metforminu v odmerku 500 mg).
English: For patients inadequately controlled on maximal tolerated dose of metformin For patients not adequately controlled on metformin, the recommended starting dose of Vokanamet should provide canagliflozin dosed at 50 mg twice daily plus the dose of metformin already being taken or the nearest therapeutically appropriate dose.
Slovenian: Bolniki, pri katerih glikemija ni dovolj urejena z uporabo metformina, naj s priporočenim začetnim odmerkom zdravila Vokanamet prejmejo kanagliflozin v odmerku 50 mg dvakrat na dan in metformin v odmerku, ki so ga jemali do tedaj, oziroma v najbližjem približku terapevtsko ustreznega odmerka.
English: The SGLT2 transporter, expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen.
Slovenian: KANAGLIFLOZIN Prenašalni protein za natrij in glukozo v ledvicah 2 (SGLT2 - sodium-glucose co-transporter 2), ki je prisoten v proksimalnih ledvičnih tubulih, je odgovoren za večji del reabsorpcije filtrirane glukoze iz svetline ledvičnega tubula.
English: • bone fracture
Slovenian: • zlomi kosti
English: Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
Slovenian: Simptomi vključujejo bolečine v trebuhu, hitro in globoko dihanje,
English: Risk of lactic acidosis
Slovenian: Opozorila in previdnostni ukrepi Tveganje za laktacidozo
English: Lactic acidosis, Vitamin B12 deficiencya
Slovenian: Presnovne in prehranske motnje zelo redki laktacidoza, pomanjkanje vitamina B12
English: Lactic acidosis is a medical emergency and must be treated in hospital.
Slovenian: • znižano telesno temperaturo in počasen srčni utrip Laktacidoza je urgentno zdravstveno stanje in ga je treba zdraviti v bolnišnici.
English: In a pooled analysis of patients (N = 721) with a baseline GFR 45 mL/min to < 60 mL/min, canagliflozin provided clinically meaningful reduction in HbA1c compared to placebo, with -0.47% for canagliflozin 100 mg and -0.52% for canagliflozin 300 mg.
Slovenian: Bolniki z GRF 45 ml/min do < 60 ml/min V analizi združenih podatkov bolnikov (N = 721) z izhodiščno GFR 45 ml/min do < 60 ml/min so ugotovili klinično pomembno zmanjšanje v HbA1c pri kanagliflozinu v primerjavi s placebom, in sicer za -0,47% pri 100 mg in za -0,52% pri 300 mg.
English: There is no clinical experience with Vokanamet in patients with hepatic impariment.
Slovenian: Pri bolnikih z okvaro jeter ni nobenih kliničnih izkušenj z uporabo zdravila Vokanamet.
English: Other special populations
Slovenian: Druge posebne populacije Farmakogenetika
English: Cationic medicinal products that are eliminated by renal tubular secretion (e.g., cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Slovenian: Zaradi kompeticije za skupne ledvične tubulne transportne sisteme lahko pride do medsebojnega delovanja med metforminom in kationskimi zdravili, ki se skozi ledvice izločajo s tubulno sekrecijo (npr. s cimetidinom).
English: Temporary interruption of treatment with Vokanamet may be considered for patients who develop volume depletion while on Vokanamet therapy until the condition is corrected.
Slovenian: Če pride do hipovolemije med zdravljenjem z zdravilom Vokanamet, velja razmisliti o začasni prekinitvi uporabe zdravila Vokanamet, dokler se stanje ne izboljša.
English: In an analysis of four 26-week, placebo-controlled studies (N = 2,313), treatment with canagliflozin 100 mg and 300 mg once daily resulted in mean reductions in systolic blood pressure of -3.9 mmHg and -5.3 mmHg, respectively, compared to placebo (-0.1 mmHg) and a smaller effect on diastolic blood pressure with mean changes for canagliflozin 100 mg once daily and 300 mg once daily of -2.1 mmHg and -2.5 mmHg, respectively, compared to placebo (-0.3 mmHg).
Slovenian: Po rezultatih analize podatkov štirih, 26-tedenskih, s placebom nadzorovanih študij (n = 2.313) je zdravljenje s 100 mg oziroma 300 mg kanagliflozina enkrat na dan povzročilo povprečno znižanje sistoličnega krvnega tlaka za -3,9 mmHg oziroma za -5,3 mmHg v primerjavi s placebom (znižanje za
English: Vokanamet 50 mg/850 mg film-coated tablets Vokanamet 50 mg/1000 mg film-coated tablets Vokanamet 150 mg/850 mg film-coated tablets Vokanamet 150 mg/1000 mg film-coated tablets canagliflozin/metformin hydrochloride
Slovenian: Vokanamet 50 mg/850 mg filmsko obložene tablete Vokanamet 50 mg/1.000 mg filmsko obložene tablete Vokanamet 150 mg/850 mg filmsko obložene tablete Vokanamet 150 mg/1.000 mg filmsko obložene tablete kanagliflozin/metforminijev klorid
English: recent myocardial infarction, shock;
Slovenian: respiratorna odpoved, nedaven miokardni infarkt in šok.
English: The tablet is purple, capsule-shaped, 22 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “611” on the other side.
Slovenian: Tableta s takojšnjim sproščanjem je vijolična, ovalna, dolga 22 mm, filmsko obložena z vtisnjeno oznako "CM" na eni in "611" na drugi strani.
English: In patients ≥ 75 years of age, a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) was reported with canagliflozin therapy.
Slovenian: Pri bolnikih, ki so stari ≥ 75 let, so pri zdravljenju s kanagliflozinom poročali o večji pogostnosti s hipovolemijo povezanih neželenih učinkov (na primer položajna omotica, ortostatska hipotenzija in hipotenzija).
English: Relative to subjects with normal hepatic function, the geometric mean ratios for Cmax and AUC∞ of canagliflozin were 107% and 110%, respectively, in subjects with Child-Pugh class A (mild hepatic impairment) and 96% and 111%, respectively, in subjects with Child-Pugh class B (moderate) hepatic impairment following administration of a single 300 mg dose of canagliflozin.
Slovenian: Pri bolnikih z blago okvaro jeter (Child-Pugh razreda A) oziroma z zmerno okvaro jeter (Child-Pugh razreda B) so po enkratnem odmerku 300 mg kanagliflozina vrednosti geometričnega povprečja Cmax kanagliflozina znašale 107% oziroma 96% teh vrednosti pri osebah z normalno jetrno funkcijo, geometrično povprečje AUC∞ kanagliflozina pa je znašalo 110% oziroma 111% te vrednosti pri osebah z normalno jetrno funkcijo.
English: In a study on embryo-fetal development in rats, metformin alone (300 mg/kg/day) caused absent/incomplete ossification, while canagliflozin alone (60 mg/kg/day) had no effects.
Slovenian: V študiji embrio-fetalnega razvoja pri podganah je uporaba samo metformina (300 mg/kg/dan)
English: For oral use
Slovenian: peroralna uporaba
English: Vokanamet 50 mg/850 mg film-coated tablets Vokanamet 50 mg/1000 mg film-coated tablets Vokanamet 150 mg/850 mg film-coated tablets Vokanamet 150 mg/1000 mg film-coated tablets
Slovenian: Vokanamet 50 mg/850 mg filmsko obložene tablete Vokanamet 50 mg/1.000 mg filmsko obložene tablete Vokanamet 150 mg/850 mg filmsko obložene tablete Vokanamet 150 mg/1.000 mg filmsko obložene tablete
English: The Leydig cell tumours are associated with an increase in luteinising hormone (LH), which is a known mechanism of Leydig cell tumour formation in rats.
Slovenian: (LH), kar je že znan mehanizem tvorbe tumorja Leydigovih celic pri podganah.
English: The tablet is light yellow, capsule-shaped, 21 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “418” on the other side.
Slovenian: Tableta s takojšnjim sproščanjem je svetlo rumena, ovalna, dolga 21 mm, filmsko obložena z vtisnjeno oznako "CM" na eni in "418" na drugi strani.
English: e Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3% for placebo.
Slovenian: e O zlomu kosti so poročali pri 0,7% pri 100 mg kanagliflozina, 0,6% pri 300 mg kanagliflozina in 0,3% pri placebu.
English: Canagliflozin is not recommended for use in patients receiving loop diuretics.
Slovenian: Uporaba kanagliflozina pri bolnikih, ki jemljejo diuretike Henleyeve zanke ni priporočena.
English: Janssen-Cilag s.r.o.
Slovenian: Česká republika Janssen-Cilag s.r.o.
English: Among male patients taking canagliflozin, 0.9% had more than one infection.
Slovenian: je pri 0,9% prišlo do več kot ene okužbe.
English: In ongoing, long-term clinical studies of canagliflozin in type 2 diabetes patients with cardiovascular disease (CVD) or at high risk for CVD, an increase in cases of lower limb amputation (primarily of the toe) has been observed in patients treated with canagliflozin.
Slovenian: V dolgoročnih kliničnih študijah kanagliflozina pri bolnikih s sladkorno boleznijo tipa 2 in s srčnožilno boleznijo ali z velikim tveganjem za srčnožilno bolezen, ki še potekajo, so pri bolnikih,
English: Because of the way canagliflozin works, your urine will test positive for sugar (glucose) while you are taking this medicine.
Slovenian: V času jemanja tega zdravila bo zaradi načina delovanja kanagliflozina izvid preiskave prisotnosti sladkorja (glukoze) v urinu pozitiven.
English: Canagliflozin showed no effects on fertility and early embryonic development in the rat at exposures up to 19 times the human exposure at the maximum recommended human dose (MRHD).
Slovenian: Pri izpostavljenostih, ki so do 19-krat presegale izpostavljenosti pri ljude, pri največjem priporočenem odmerku (MRHD-Maximum Recommended Human Dose) pri podganah kanagliflozin ni imel učinka na plodnost in zgodnji razvoj zarodka.
English: Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (area under the curve, AUC) and peak concentration (Cmax) were observed.
Slovenian: Pri sočasni uporabi kanagliflozina z rifampicinom (ki je induktor številnih aktivnih prenašalcev in encimov, ki presnavljajo učinkovine) so opazili zmanjšanje sistemske izpostavljenosti (AUC- Area
English: Nervous system disorders uncommon
Slovenian: Organski sistem Pogostnost neželen učinek
English: • blood tests may show changes related to kidney function (increased creatinine or urea) or increased potassium
Slovenian: • koprivnica • krvni testi lahko pokažejo spremembe delovanja ledvic (povečana koncentracija kreatinina ali sečnine) ali povečana koncentracija kalija • krvni testi lahko pokažejo povečano koncentracijo fosfata v krvi
English: When canagliflozin was added to a sulphonylurea therapy, hypoglycaemia was observed in 4.1%, 12.5%, and 5.8% of patients treated with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, and placebo, respectively (see sections 4.2 and 4.5).
Slovenian: Pri dodajanju zdravila sulfonilsečnini so hipoglikemijo opazili pri 4,1%, bolnikov, ki so prejemali 100 mg kanagliflozina enkrat na dan, pri 12,5% bolnikov, ki so prejemali 300 mg kanagliflozina enkrat na dan, in pri 5,8% bolnikov, ki so prejemali s placebo (glejte poglavji 4.2 in 4.5).
English: For patients on loop diuretics, the incidences were 3.2% on canagliflozin 100 mg once daily and 8.8% on canagliflozin 300 mg once daily compared to 4.7% in the control group.
Slovenian: Pri bolnikih, ki so jemali diuretike Henleyeve zanke, je bila pogostnost teh neželenih učinkov 3,2% pri uporabi 100 mg kanagliflozina enkrat na dan in 8,8% pri uporabi 300 mg kanagliflozina enkrat na dan v primerjavi s 4,7% v kontrolni skupini.
English: • Vokanamet 50 mg/1000 mg film-coated tablets (tablets) are beige, capsule-shaped, 21 mm in length, and debossed with “CM” on one side and “551” on the other side.
Slovenian: • Filmsko obložene tablete Vokanamet 50 mg/1000 mg (tablete) so bež barve, v obliki kapsule, dolžine 21 mm in imajo vtisnjeno oznako "CM" na eni strani in "551" na drugi.
English: There have been no clinical efficacy studies conducted with Vokanamet; however, bioequivalence of Vokanamet to canagliflozin and metformin co-administered as individual tablets was demonstrated in healthy subjects.
Slovenian: Pri zdravih osebah pa so dokazali, da je zdravilo Vokanamet bioekvivalentno kanagliflozinu in metforminu, ki so ju preiskovancem odmerjali sočasno v obliki ločenih tablet.
English: In patients with evidence of volume depletion, correcting this condition prior to initiation of Vokanamet is recommended (see section 4.4).
Slovenian: Pred začetkom jemanja zdravila Vokanamet je priporočljivo odpraviti hipovolemijo (glejte poglavje 4.4).
English: Immune system disorders rare
Slovenian: Bolezni imunskega sistema redki anafilaktična reakcija
English: (E171), iron oxide red (E172) and iron oxide black (E172).
Slovenian: rdeči železov oksid (E172) in črni železov oksid (E172).
English: Canagliflozin was compared to glimepiride as dual therapy with metformin and compared to sitagliptin as triple therapy with metformin and a sulphonylurea (table 5).
Slovenian: Študije nadzorovane z učinkovino Kanagliflozin so primerjali z glimepiridom v okviru dvotirnega zdravljenja z metforminom, s sitagliptinom v okviru trotirnega zdravljenja z metforminom in s sulfonilsečnino (preglednica 5).
English: GFR mL/min
Slovenian: GFR ml/min metformin kanagliflozin
English: Vokanamet 150 mg/850 mg film-coated tablets
Slovenian: Vokanamet 150 mg/850 mg filmsko obložene tablete
English: Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see sections 4.3 and 4.5).
Slovenian: Drugi dejavniki tveganja za laktacidozo so pretirano uživanje alkohola, jetrna insuficienca, neustrezno nadzorovana sladkorna bolezen, ketoacidoza, dolgotrajno postenje in vsa stanja, povezana s hipoksijo,
English: Canagliflozin was negligibly removed by haemodialysis.
Slovenian: Kanagliflozin se pri hemodializi odstrani v zanemarljivo majhnem obsegu.
English: Film-coating: - 50 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Slovenian: filmska obloga: - tablete 50 mg/850 mg: makrogol (3350), polivinilalkohol, smukec, titanov dioksid,
English: • Vokanamet 150 mg/1000 mg film-coated tablets (tablets) are purple, capsule-shaped, 22 mm in length, and debossed with “CM” on one side and “611” on the other side.
Slovenian: • Filmsko obložene tablete Vokanamet 150 mg/1000 mg (tablete) so vijolične barve, v obliki kapsule, dolžine 22 mm in imajo vtisnjeno oznako "CM" na eni strani in "611" na drugi.
English: • a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p = 0.017
Slovenian: • statistično značilno zmanjšanje absolutnega tveganja za umrljivost, povezano s sladkorno boleznijo: metformin 7,5 dogodka /1.000 bolnikov-let, samo dieta: