FrancophonIA/ELRC3.0 huggingface dataset:
English: Temporarily stop taking Vokanamet if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Slovenian: Začasno prenehajte jemati zdravilo Vokanamet, če imate stanje, ki je lahko povezano z dehidracijo (znatna izguba telesnih tekočin), kot je hudo bruhanje, driska, povišana telesna temperatura, izpostavljenost vročini ali, če pijete manj tekočine kot običajno.
English: Canagliflozin may add to the effect of diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Slovenian: Kanagliflozin lahko okrepi delovanje diuretikov in poveča tveganje za dehidracijo in hipotenzijo (glejte poglavje 4.4).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Vokanamet in all subsets of the paediatric population in type 2 diabetes (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Vokanamet za eno ali več podskupin pediatrične populacije pri sladkorni bolezni tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: • Severe renal failure (eGFR < 30 mL/min) (see sections 4.2 and 4.4);
Slovenian: • Huda ledvična odpoved (eGFR < 30 ml/min ) (glejte poglavji 4.2 in 4.4).
English: Safety data profiles from individual pivotal studies (including studies in moderately renally impaired patients; older patients [≥ 55 years of age to ≤ 80 years of age]; patients with increased CV-risk) were generally consistent with the adverse reactions identified in this table.
Slovenian: Profili varnostnih podatkov iz posameznih ključnih študij (vključno s študijami z bolniki z zmerno okvaro ledvic, s starejšimi bolniki [starih od ≥ 50 do ≤ 80 let]; bolnikih s povečanim tveganjem za kardiovaskularne bolezni) so se večinoma ujemali z neželenimi učinki, ki so navedeni v tej preglednici.
English: The racial distribution of patients who received canagliflozin was 72% White, 16% Asian, 5% Black, and 8% other groups.
Slovenian: Med bolniki, ki so prejemali kanagliflozin, je bila pripadnost različnim rasam naslednja: 72% bolnikov je bilo bele rase, 16% azijske rase, 5% črne rase, 8% je bilo pripadnikov drugih etničnih skupin.
English: The effect of concomitant administration of canagliflozin (a weak P-gp inhibitor) on dabigatran etexilate (a P-gp substrate) has not been studied.
Slovenian: Učinka sočasne uporabe kanagliflozina (šibkega zaviralca P-gp) na dabigatran eteksilat (substrat P-gp) niso preučevali.
English: Lactic acidosis (very rare, may affect up to 1 in 10,000 people) Vokanamet may cause a very rare but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Slovenian: Laktacidoza (zelo redko, pojavi se lahko pri največ 1 od 10.000 bolnikov) Zdravilo Vokanamet lahko povzroči zelo redek a zelo resen neželeni učinek, imenovan laktacidoza (glejte poglavje “Opozorila in previdnostni ukrepi”).
English: The mean HbA1c at baseline was 8.2% and mean duration of diabetes was 13.5 years.
Slovenian: Povprečna koncentracija HbA1c ob izhodišču je bila 8,2%, povprečno trajanje sladkorne bolezni pa je bilo 13,5 let.
English: N = 4,344
Slovenian: placebo N = 4.344
English: Lactic acidosis, a very rare but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis.
Slovenian: Laktacidoza, zelo redek, a resen presnovni zaplet, se najpogosteje pojavi ob akutnem poslabšanju delovanja ledvic, ob kardiorespiratorni bolezni ali sepsi.
English: The safety of canagliflozin was evaluated in 18,248 patients with type 2 diabetes, including 13,791 patients treated with canagliflozin in combination with metformin.
Slovenian: Varnost uporabe kanagliflozina so ocenjevali pri 18.248 bolnikih s sladkorno boleznijo tipa 2, med katerimi je 13.791 bolnikov prejemalo kanagliflozin v kombinaciji z metforminom.
English: In general, elevations were transient and did not require specific treatment.
Slovenian: Zvišanja vrednosti kalija v serumu so bila večinoma prehodna in zaradi njih ni bilo potrebno posebno zdravljenje.
English: Cardiovascular outcomes
Slovenian: Kardiovaskularni izidi
English: Canagliflozin/metformin
Slovenian: Kanagliflozin/metformin
English: Table 3: The frequency of metformin adverse reactions identified from clinical study and postmarketing data
Slovenian: Preglednica 3: Pogostnost neželenih učinkov metformina, ugotovljena iz podatkov klinične študije in izkušenj v obdobju trženja
English: To assess risk factors for these adverse reactions, a larger pooled analysis (N = 12,441) of patients from 13 controlled phase 3 and phase 4 studies including both doses of canagliflozin was conducted.
Slovenian: Za oceno dejavnikov tveganja za navedene neželene učinke so izvedli večjo analizo združenih podatkov bolnikov (n = 12.441) iz 13 nadzorovanih študij faze III in faze IV z obema odmerkoma kanagliflozina.
English: Adults with normal renal function (estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m
Slovenian: Odrasli z normalnim delovanjem ledvic (z ocenjeno glomerulno filtracijo [eGFR] ≥ 90 ml/min/1,73 m
English: Heart failure requiring hospitalization
Slovenian: Srčno popuščanje, zaradi katerega je potreben sprejem v bolnišnico
English: In case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake), Vokanamet should be temporarily discontinued and contact with a healthcare professional is recommended.
Slovenian: V primeru dehidracije (huda driska ali bruhanje, zvišana telesna temperatura ali zmanjšan vnos tekočine) je treba jemanje zdravila Vokanamet začasno prekiniti; priporoča se posvet z zdravstvenim delavcem.
English: CARTON FOR MULTIPACK COMPRISING 3 PACKS (INCLUDING BLUE BOX)
Slovenian: ŠKATLA SKUPNEGA PAKIRANJA, KI OBSEGA 3 POSAMEZNA PAKIRANJA (VKLJUČNO S PODATKI V MODREM OKENCU)
English: The pack sizes are cartons of 20 and 60 tablets, and multipack cartons of 180 tablets (3 bottles containing 60 tablets each).
Slovenian: Velikosti pakiranj so škatle z 20 ali 60 tabletami in škatle skupnega pakiranja s 180 tabletami (3 plastenke, vsaka s 60 tabletami).
English: Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and non-steroidal anti-inflammatory drugs [NSAIDs]) should be initiated with caution in Vokanamettreated patients.
Slovenian: Zdravila, ki lahko akutno okvarijo delovanje ledvic (kot so antihipertenzivi, diuretiki in nesteroidna protivnetna zdravila), je treba pri bolnikih, ki se zdravijo z zdravilom Vokanamet, uvesti previdno.
English: Vokanamet may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Slovenian: Zdravilo Vokanamet lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti, če ledvice ne delujejo pravilno.
English: A paediatric phase 1 study examined the pharmacokinetics and pharmacodynamics of canagliflozin in children and adolescents ≥ 10 to < 18 years of age with type 2 diabetes mellitus.
Slovenian: V pediatrični študiji faze 1 so preučevali farmakokinetiko in farmakodinamiko kanagliflozina pri otrocih in mladostnikih s sladkorno boleznijo tipa 2, starih ≥ 10 do < 18 let.
English: Concomitant antidiabetic and atherosclerotic therapies could be adjusted, according to the standard care for these diseases.
Slovenian: Sočasno odmerjanje antidiabetikov in zdravil za aterosklerozo so smeli prilagoditi skladno z načeli standardne oskrbe pri teh dveh boleznih.
English: • if you have had a lower limb amputation.
Slovenian: • če ste imeli amputacijo na spodnji okončini.
English: 1,5-AG assay
Slovenian: Preiskava 1,5-AG
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, ter sočasna uporaba zdravil, ki lahko povzročijo laktacidozo (glejte poglavja 4.3 in 4.5).
English: Before initiating Vokanamet, consider factors in the patient history that may increase the risk for amputation.
Slovenian: Pred uvedbo zdravljenja z zdravilom Vokanamet je treba upoštevati tiste dejavnike v bolnikovi anamnezi, ki lahko povečajo tveganje za amputacije.
English: Further symptoms are reduced body temperature and heartbeat.
Slovenian: Med drugimi simptomi so še znižana telesna temperatura in upočasnjeno bitje srca.
English: • if you are allergic to canagliflozin, metformin or any of the other ingredients of this medicine
Slovenian: • če ste alergični na kanagliflozin, metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: Canagliflozin
Slovenian: Kanagliflozin
English: Adverse reactions listed below are classified according to frequency and system organ class.
Slovenian: Neželeni učinki so razvrščeni po pogostnosti in po organskih sistemih.
English: Adverse reactions in table 1 are based on the pooled analysis of the placebo- and active-controlled studies described above.
Slovenian: Podatki o neželenih učinkih v preglednici 1 izhajajo iz zgoraj opisane analize združenih podatkov s placebom in aktivno nadzorovanih študij.
English: Related to bone fracture; see description of AR below.
Slovenian: V povezavi z zlomom kosti, glejte opis neželenega učinka spodaj.
English: Hypotension a, Orthostatic hypotension
Slovenian: Žilne bolezni občasni hipotenzija a, ortostatska hipotenzija
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL).
Slovenian: Potek bolezni je bil v številnih primerih atipičen, z le zmerno zvečano koncentracijo glukoze v krvi pod 14 mmol/l (250 mg/dl).
English: Canagliflozin is transported by P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP).
Slovenian: P-glikoprotein (P-gp) in membranski transporterski protein (BCRP - Breast Cancer Resistance Protein).
English: • blood tests may show increases in your blood phosphate level
Slovenian: • krvni testi lahko pokažejo povečano koncentracijo fosfata v krvi
English: In patients susceptible to greater reductions in intravascular volume as described above, larger decreases in eGFR (> 30%) were sometimes seen, which subsequently improved, and infrequently required interruption of treatment with canagliflozin (see section 4.8).
Slovenian: Pri bolnikih, ki so nagnjeni k bolj obsežnemu zmanjšanju znotrajžilnega volumna, kot je opisano v prejšnjem odstavku, so včasih opazili tudi bolj obsežno zmanjšanje GFR (za > 30%), kar se je sčasoma popravilo, in le redko je bila potrebna prekinitev zdravljenja s kanagliflozinom (glejte poglavje 4.8).
English: Canagliflozin is not recommended for use in patients receiving loop diuretics (see section 4.5) or who are volume depleted, e.g., due to acute illness (such as gastrointestinal illness).
Slovenian: Uporaba kanagliflozina ni priporočena pri bolnikih, ki jemljejo diuretike Henleyeve zanke (glejte poglavje 4.5) ali pri bolnikih s hipovolemijo, npr. zaradi akutne bolezni (kot so gastrointestinalne bolezni).
English: Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g; although, lactic acidosis has occurred in such circumstances.
Slovenian: Pri odmerjanju metforminijevega klorida v odmerkih do 85 g niso opažali hipoglikemije, je pa v teh pogojih prišlo do laktacidoze.
English: Mundipharma AS Dicks vei 10B NO-1366-Lysaker Tlf: +47 67 51 89 00
Slovenian: Mundipharmaq AS Dicks vei 10B NO-1366-Lysaker Tlf: +47 67 51 89 00
English: Mean eGFR returned to baseline after treatment discontinuation suggesting that haemodynamic changes may play a role in these renal function changes.
Slovenian: Povprečna vrednost eGFR se je po prekinitvi zdravljenja vrnila na izhodiščno, kar kaže, da hemodinamske spremembe lahko vplivajo na navedene spremembe ledvične funkcije.
English: If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma.
Slovenian: V takem primeru potrebujete takojšnje zdravljenje v bolnišnici, saj laktacidoza lahko vodi v komo.
English: Special caution should be exercised in situations where renal function may become impaired; for example, when initiating antihypertensive or diuretic therapy and when starting treatment with a NSAID.
Slovenian: Posebna previdnost je potrebna v primerih, ko lahko pride do zmanjšanega delovanja ledvic, na primer pri uvajanju antihipertenzivnih ali diuretičnih zdravil in na začetku zdravljenja z nesteroidnimi protivnetnimi zdravili.
English: Due to its mechanism of action, canagliflozin, by increasing urinary glucose excretion (UGE), induces an osmotic diuresis, which may reduce intravascular volume and decrease blood pressure (see section 5.1).
Slovenian: Kanagliflozin zaradi svojega mehanizma delovanja povečuje izločanje glukoze z urinom in tako povzroča osmotsko diurezo, ki lahko zmanjša znotrajžilni volumen in zniža krvni tlak (glejte poglavje 5.1).
English: Haematocrit increase was observed with canagliflozin treatment (see section 4.8); therefore, careful monitoring in patients with already elevated haematocrit is warranted.
Slovenian: Pri zdravljenju s kanagliflozinom so opazili povečan hematokrit (glejte poglavje 4.8), zato je treba bolnike s predhodno povečanim hematokritom skrbno spremljati.
English: Limited data from clinical studies suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Slovenian: Omejeni podatki kliničnih študij kažejo, da se DKA pri bolnikih s sladkorno boleznijo tipa 1, ki so bili zdravljeni z zaviralci SGLT2, pojavi pogosto.
English: What Vokanamet is and what it is used for What you need to know before you take Vokanamet How to take Vokanamet
Slovenian: Kaj je zdravilo Vokanamet in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Vokanamet Kako jemati zdravilo Vokanamet Možni neželeni učinki
English: Maximum total daily dose is 300 mg.
Slovenian: Največji celokupni dnevni odmerek je 300 mg.
English: The metabolism of canagliflozin is primarily via glucuronide conjugation mediated by UDP glucuronosyl transferase 1A9 (UGT1A9) and 2B4 (UGT2B4).
Slovenian: Metabolizem kanagliflozina poteka predvsem s konjugacijo v glukuronide s posredovanjem UDP glukuronozil transferaze 1A9 (UGT1A9) in 2B4 (UGT2B4).
English: Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Slovenian: Nekatera zdravila lahko škodljivo vplivajo na delovanje ledvic, kar lahko poveča tveganje za laktacidozo, npr. nesteriodna protivnetna zdravila, vključno s selektivnimi zaviralci ciklooksigenaze (COX) II, zaviralci ACE, antagonisti receptorjev angiotenzina II in diuretiki, zlasti diuretiki Henlejeve zanke.
English: Canagliflozin was evaluated in combination with metformin as initial combination therapy in patients with type 2 diabetes failing diet and exercise.
Slovenian: Kanagliflozin so ocenjevali v kombinaciji z metforminom kot začetno kombinirano zdravljenje pri bolnikih s sladkorno boleznijo tipa 2, pri katerih diete in gibanje niso bile uspešne.
English: • necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus.
Slovenian: • nekrotizirajoči fasciitis presredka ali Fournierova gangrena, resna okužba mehkega tkiva spolovil ali predela med spolovili in zadnjikom
English: Stop taking Vokanamet and talk to a doctor or go to the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Slovenian: Takoj prenehajte jemati zdravilo Vokanamet in se posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico, če se pojavijo nekateri od simptomov laktacidoze, saj lahko to stanje vodi v komo.
English: In addition, in such patients more events of elevated potassium and greater increases in serum creatinine and blood urea nitrogen (BUN) were reported (see section 4.8).
Slovenian: Dodatno so pri teh bolnikih poročali tudi o več dogodkih zvečane koncentracije kalija in večjem povečanju koncentracije kreatinina v serumu in koncentracije dušika iz sečnine v krvi (BUN) (glejte poglavje 4.8).
English: If you forget to take Vokanamet
Slovenian: Če ste pozabili vzeti zdravilo Vokanamet
English: • phimosis - difficulty pulling back the foreskin around the tip of the penis.
Slovenian: • fimoza - otežen poteg kožice čez glavico penisa
English: In a pooled analysis of 13 placebo-controlled and active-controlled studies, the safety profile of canagliflozin in elderly patients was generally consistent with younger patients.
Slovenian: V združeni analizi podatkov iz 13 s placebom in z učinkovino nadzorovanih študij je bil varnostni profil zdravila pri starejših bolnikih večinoma enak kot pri mlajših bolnikih.
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin AUC by 50% and Cmax by 81%.
Slovenian: V študiji s sedmimi normalnimi zdravimi prostovoljci se je pokazalo, da je uporaba cimetidina v odmerku 400 mg dvakrat na dan za 50% povečala AUC metformina, njegovo Cmax pa za 81%.
English: • Hypersensitivity to the active substances or any of the excipients (see section 6.1);
Slovenian: • Preobčutljivost na učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Table 2: Integrated analysis of amputations in CANVAS and CANVAS-R Placebo
Slovenian: Preglednica 2: Združena analiza podatkov o amputacijah v študijah CANVAS in CANVAS-R
English: p = 0.013 compared to placebo.
Slovenian: N/A - navedba ni smiselna p = 0,013 v primerjavi s placebom
English: 90.7% of subjects in the canagliflozin group uptitrated to 300 mg
Slovenian: 90,7% oseb v skupini, ki je prejemala kanagliflozin in so jim odmerek titrirali do 300 mg
English: Triple therapy with metformin and sitagliptin e (26 weeks)
Slovenian: Trotirno zdravljenje z metforminom in s sitagliptinom e (26 tednov)
English: • The active substances are canagliflozin and metformin hydrochloride.
Slovenian: • Učinkovini sta kanagliflozin in metforminijev klorid.
English: Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier's gangrene), have been reported in female and male patients taking SGLT2 inhibitors.
Slovenian: Po začetku trženja so poročali o primerih nekrotizirajočega fasciitisa presredka (znan tudi kot Fournierova gangrena) pri bolnikih in bolnicah, ki so jemali zaviralce SGLT2.
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) preprečila zakostenevanje oziroma povzročila nepopolno zakostenevanje, medtem ko samostojna uporaba kanagliflozina (60 mg/kg/dan) ni imela nobenega učinka.
English: • blood tests may show changes related to kidney function (increased creatinine or urea) or increased potassium
Slovenian: • krvni testi lahko pokažejo spremembe delovanja ledvic (povečana koncentracija kreatinina ali sečnine) ali povečana koncentracija kalija
English: Vokanamet contains two different active substances, canagliflozin and metformin.
Slovenian: Zdravilo Vokanamet vsebuje dve različni učinkovini: kanagliflozin in metformin.
English: Of the subjects who had an amputation, the toe and midfoot were the most frequent sites (71%) in both treatment groups (see table 2).
Slovenian: V obeh zdravljenih skupinah je šlo pri bolnikih, ki so imeli amputacijo, najpogosteje za amputacijo prstov na nogi ali dela stopala (71 %) (glejte preglednico 2).
English: Among male patients taking canagliflozin, 2.4% had more than one infection.
Slovenian: Med bolniki, ki so jemali kanagliflozin, je pri 2,4 % prišlo do več kot ene okužbe.
English: See description of AR below.
Slovenian: Glejte opis neželenega učinka spodaj.
English: In three studies conducted in special populations (elderly patients, patients with an eGFR of 30 mL/min/1.73 m2 to < 50 mL/min/1.73 m2 and patients with or at high risk for cardiovascular disease), canagliflozin was added to patients' current stable diabetes treatments (diet, monotherapy, or combination therapy).
Slovenian: V treh študijah, ki so jih izvajali pri posebnih skupinah bolnikov (pri starejših bolnikih, pri bolnikih z eGFR od 30 ml/min/1,73 m2 do < 50 ml/min/1,73 m2 in pri bolnikih s tveganjem oziroma s povečanim tveganjem za kardiovaskularne bolezni), so kanagliflozin dodali k stabilni shemi zdravljenja sladkorne bolezni posameznega bolnika (dieti, monoterapiji ali kombinaciji zdravil).
English: • in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products
Slovenian: • v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni pri bolnikih, pri katerih glikemija z uporabo metformina skupaj s temi zdravili ni dovolj urejena,
English: Related to volume depletion; see section 4.4 and description of adverse reaction (AR) below.
Slovenian: V povezavi s hipovolemijo; glejte poglavje 4.4 in opis neželenega učinka spodaj.
English: Thereafter, eGFR was maintained or gradually increased during continued treatment.
Slovenian: V nadaljevanju zdravljenja je ostala eGFR enaka oziroma se je povečala.
English: Effects of other medicinal products on canagliflozin
Slovenian: Vpliv drugih učinkovin na kanagliflozin
English: The primary assessment of safety and tolerability was conducted in a pooled analysis (N = 2,313) of four 26-week placebo-controlled clinical studies (monotherapy and add-on therapy with metformin, metformin and a sulphonylurea, and metformin and pioglitazone).
Slovenian: Do primarne ocene varnosti in prenosljivosti zdravila so prišli z analizo združenih podatkov (N = 2.313) iz štirih 26-tedenskih s placebom nadzorovanih kliničnih študij (z monoterapijo oziroma z dodajanjem zdravila bodisi metforminu, kombinaciji metformina in sulfonilsečnine ali kombinaciji metformina in pioglitazona).
English: The study included 8 subjects with normal renal function (CrCl ≥ 80 mL/min), 8 subjects with mild renal impairment (CrCl 50 mL/min to < 80 mL/min), 8 subjects with moderate renal impairment (CrCl 30 mL/min to < 50 mL/min), and 8 subjects with severe renal impairment (CrCl < 30 mL/min) as well as 8 subjects with ESRD on haemodialysis.
Slovenian: V študijo je bilo vključenih 8 oseb z normalno ledvično funkcijo (z očistkom kreatinina ≥ 80 ml/min), 8 oseb z blago okvaro ledvic (z očistkom kreatinina od 50 ml/min do < 80 ml/min), 8 oseb z zmerno okvaro ledvic (z očistkom kreatinina od 30 ml/min do < 50 ml/min), 8 oseb s hudo okvaro ledvic (z očistkom kreatinina < 30 ml/min) in 8 oseb s končno ledvično odpovedjo, ki so se zdravili s hemodializo.
English: The dose of glucose-lowering therapy with Vokanamet should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability, using the recommended daily dose of 100 mg or 300 mg canagliflozin and not exceeding the maximum recommended daily dose of metformin orally.
Slovenian: Odmerek zdravila Vokanamet je treba prilagoditi trenutnemu bolnikovemu režimu za zniževanje koncentracije glukoze v krvi, učinkovitosti in prenašanju zdravila, z uporabo priporočenega peroralnega 100 mg ali 300 mg odmerka kanagliflozina na dan, pri čemer se ne sme preseči največjega priporočenega dnevnega odmerka metformina.