FrancophonIA/ELRC3.0 huggingface dataset:
English: Ibandronic Acid Hexal was to be used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Slovenian: Zdravilo Ibandronic Acid Hexal naj bi se uporabljalo za preprečevanje z okostjem povezanih dogodkov (zlomov kosti ali z okostjem povezanih zapletov, ki zahtevajo zdravljenje) pri bolnicah z rakom dojke in metastazami v kosteh (ko se je rak razširil v kosti).
English: Because Ibandronic Acid Hexal was developed as a generic medicine, the company presented the results of studies carried out to investigate whether it is ‘bioequivalent' to the reference medicine.
Slovenian: Ker je bilo zdravilo Ibandronic Acid Hexal razvito kot generično zdravilo, je družba predložila rezultate študij, ki so bile opravljene za proučitev, ali je zdravilo biološko enakovredno referenčnemu zdravilu.
English: The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Hexal had been shown to have comparable quality and to be bioequivalent to Bondronat.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ibandronic Acid Hexal primerljivo raven kakovosti kot zdravilo Bondronat in da mu je biološko enakovredno.
English: The Committee recommended that Ibandronic Acid Hexal be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Ibandronic Acid Hexal odobri dovoljenje za promet.
English: Therefore, the CHMP's view was that, as for Bondronat, the benefit outweighs the identified risk.
Slovenian: Zaradi tega je CHMP menil, da njegove koristi tako kot pri zdravilu Bondronat odtehtajo z njim povezana tveganja.
English: Ibandronic Acid Hexal was developed as a ‘generic medicine'.
Slovenian: Zdravilo Ibandronic Acid Hexal je bilo razvito kot „generično zdravilo“.
English: This means that Ibandronic Acid Hexal was intended to be similar to a ‘reference medicine' already authorised in the European Union called Bondronat.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji, in sicer zdravilu Bondronat.
English: Ibandronic Acid Hexal is a medicine that contains the active substance ibandronic acid.
Slovenian: Ibandronic Acid Hexal je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
English: Ibandronic Acid Hexal is expected to work in the same way as the reference medicine, Bondronat.
Slovenian: Zdravilo Ibandronic Acid Hexal naj bi delovalo na enak način kot referenčno zdravilo Bondronat.
English: The active substance in Ibandronic Acid Hexal and Bondronat, ibandronic acid, is a bisphosphonate.
Slovenian: Zdravilna učinkovina v zdravilih Ibandronic Acid Hexal in Bondronat ibandronska kislina je difosfonat.
English: What is Ibandronic Acid Hexal?
Slovenian: Kaj je zdravilo Ibandronic Acid Hexal?
English: How is Ibandronic Acid Hexal expected to work?
Slovenian: Kako naj bi zdravilo Ibandronic Acid Hexal delovalo?
English: What was Ibandronic Acid Hexal expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Ibandronic Acid Hexal uporabljalo?
English: Therefore pack sizes of 100g should be withdrawn from all EU member states where they are currently authorised.
Slovenian: Velikost pakiranja po 100 g je zato treba umakniti iz vseh držav članic EU, kjer je trenutno odobreno.
English: National Competent Authorities of Member States or reference Member States, if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Slovenian: Pristojni nacionalni organi držav članic ali referenčnih držav članic bodo zagotovili, kadar je to primerno, da imetniki dovoljenj za promet z zdravilom izpolnjujejo naslednje pogoje:
English: The maximum duration of a treatment course with 0.01% w/w estradiol containing medicinal products for topical use is limited to 4 weeks (not repeated use).
Slovenian: Najdaljše trajanje cikla zdravljenja z zdravili za topično uporabo, ki vsebujejo 0,01 % m/m estradiola, je omejeno na 4 tedne (brez ponavljajoče se uporabe).
English: As the maximum duration of a treatment course with 0.01% w/w estradiol containing medicinal products for topical use is limited to 4 weeks (not repeated use), the MAHs should provide a detailed plan including precise short timelines on the adaptation of the lower pack size (25g) and the withdrawal of the 35g and 50g pack sizes, in all EU member states where they are currently authorised.
Slovenian: Ker je najdaljše trajanje cikla zdravljenja z zdravili za topično uporabo, ki vsebujejo 0,01 % m/m estradiola, omejeno na 4 tedne (brez ponavljajoče se uporabe), bo imetnik dovoljenja za promet z zdravilom predložil podroben načrt, vključno z natančnim kratkim odmerjanjem ob prehodu na manjše pakiranje (25 g) in umiku velikosti pakiranja po 35 g ter 50 g v vseh državah članicah EU, kjer so ta zdravila trenutno odobrena.
English: EU/1/16/1110/001 Chenodeoxycholic acid Leadiant
Slovenian: EU/1/16/1110/001
English: 250 mg Capsule, hard
Slovenian: 250 mg kapsula, trda peroralna uporaba pretisni omot (PVC/alu) 100 kapsul
English: EU/1/04/289/001
Slovenian: EU/1/04/289/001 Angiox
English: 250 mg Powder for concentrate for solution for
Slovenian: 250 mg Prašek za koncentrat za raztopino za
English: Intravenous use Vial (glass)
Slovenian: Intravenski uporaba Viala (steklo)
English: Angiox
Slovenian: Ovojnina
English: Combinations not recommended
Slovenian: Kombinacije, ki niso priporočene
English: See section “Look out for side effects” and section 4.
Slovenian: Glejte poglavje “Bodite pozorni na neželene učinke” in poglavje 4.
English: • if you have kidney or liver problems
Slovenian: • če imate težave z ledvicami ali jetri
English: If you take more Vokanamet than you should If you take more of this medicine than you should, talk to a doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Vokanamet, kot bi smeli Če vzamete več zdravila, kot bi smeli, takoj obvestite zdravnika.
English: This is more likely if you are already fasting, have malnutrition, or liver problems.
Slovenian: Možnost za to je še večja, če stradate, ste podhranjeni ali imate težave z jetri.
English: • too much lactic acid in your blood (lactic acidosis).
Slovenian: • preveč mlečne kisline v krvi (laktacidoza).
English: • an X-ray where you will be injected with a dye.
Slovenian: • rentgensko slikanje, pri katerem vam bodo vbrizgali kontrastno sredstvo.
English: Vokanamet has not been studied in patients with type 1 diabetes and is therefore not recommended for use in these patients.
Slovenian: Zdravila Vokanamet niso proučevali pri bolnikih s sladkorno boleznijo tipa 1, zato uporaba pri teh bolnikih ni priporočena.
English: Lactic acidosis may also be caused by excessive alcohol intake or prolonged fasting.
Slovenian: Laktacidozo lahko povzroči tudi prekomerno zaužitje alkohola ali dolgotrajno stradanje.
English: If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient should be hospitalised immediately (see section 4.9).
Slovenian: Pri sumu na metabolično acidozo je treba zdravljenje s tem zdravilom prekiniti in bolnika takoj hospitalizirati (glejte poglavje 4.9).
English: See section “Operations and X-rays”.
Slovenian: Glejte poglavje “Kirurški posegi in rentgensko slikanje”
English: You will need to stop taking Vokanamet before, or at the time of the X-ray and for 2 or more days after.
Slovenian: Z uporabo zdravila Vokanamet boste morali prenehati pred ali med rentgenskim slikanjem ter še 2 dneva po njem.
English: ● at least two to four times a year in patients with eGFR (creatinine clearance) at the lower limit of normal and in elderly patients.
Slovenian: • najmanj dvakrat do štirikrat na leto pri bolnikih z ocenjeno glomerulno filtracijo (ali očistkom kreatinina) na spodnji meji normalnih vrednosti in pri starostnikih.
English: Lactic acidosis (very rare, may affect up to 1 in 10,000 people)
Slovenian: laktacidoza (zelo redki, pojavijo se lahko pri največ 1 od 10.000 bolnikov)
English: • an operation under general, spinal, or peridural anaesthetic.
Slovenian: • kirurški poseg v splošni, spinalni ali epidurani anesteziji.
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Slovenian: Najvišja koncentracija v krvi je nižja od največje koncentracije v plazmi, nastopi pa ob približno istem času.
English: As Vokanamet contains metformin, therapy must be discontinued 48 hours before elective surgery with general, spinal, or peridural anaesthesia.
Slovenian: Zdravilo Vokanamet vsebuje metformin, zato je treba zdravljenje z njim prekiniti 48 ur pred načrtovanim kirurškim posegom s splošno, spinalno ali epiduralno anestezijo.
English: Most infections were mild to moderate with no increase in the occurrence of serious adverse reactions.
Slovenian: Večina okužb je bila blago do zmerno izražena, pogostnost resnih neželenih učinkov pri tem ni bila povečana.
English: • medicines used to lower your blood pressure (anti-hypertensives), including diuretics (medicines used to remove levels of excess water in the body, also known as water tablets) since this medicine can also lower your blood pressure by removing levels of excess water in the body.
Slovenian: • zdravila za zniževanje krvnega tlaka (antihipertenzivi), vključno z diuretiki (zdravila za izločanje prevelike količine vode iz telesa), ker tudi to zdravilo lahko zniža vaš krvni tlak tako, da poveča izločanje vode iz telesa.
English: 1 x 20 film-coated tablets 1 x 60 film-coated tablets 180 (3 x 60) film-coated tablets.
Slovenian: 1 x 20 filmsko obloženih tablet 1x 60 filmsko obloženih tablet 180 (3 x 60) filmsko obloženih tablet
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: • if you have diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, feeling sick [nausea], or being sick [vomiting])
Slovenian: • če imate diabetično ketoacidozo (zaplet sladkorne bolezni z visoko ravnijo sladkorja v krvi, s hitro izgubo telesne mase, siljenjem na bruhanje [navzeo] ali bruhanjem
English: Single dose study: After single doses of metformin hydrochloride 500 mg, paediatric patients have shown a similar pharmacokinetic profile to that observed in healthy adults.
Slovenian: Študija z enkratnim odmerkom: Po enkratnem odmerku 500 mg metforminijevega klorida je bil farmakokinetični profil pri pediatričnih bolnikih enak kot pri zdravih odraslih.
English: Lactic acidosis is a medical emergency and must be treated in hospital.
Slovenian: Laktacidoza je nujno zdravstveno stanje, ki ga je treba zdraviti v bolnišnici.
English: Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/L, and an increased anion gap and lactate/pyruvate ratio.
Slovenian: Diagnostični laboratorijski izvidi so znižan pH krvi, koncentracija laktata v plazmi nad 5 mmol/l ter povečana anionska vrzel in povečano razmerje laktat/piruvat.
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 ocenjene glomerulne filtracije (za > 30%), kar se je sčasoma popravilo, in le redko je bila potrebna prekinitev zdravljenja s kanagliflozinom (glejte poglavje 4.8).
English: • if you drink alcohol to excess (either every day or from time to time)
Slovenian: • če prekomerno uživate alkohol (bodisi vsakodnevno ali samo občasno) • če ste pred nedavnim doživeli srčno odpoved.
English: • blood tests may show changes in blood fat (cholesterol) levels and increases in the amount of red blood cells in your blood (haematocrit).
Slovenian: • krvni testi lahko pokažejo spremembe koncentracij maščob (holesterola) in povečanje števila rdečih krvničk (hematokrita) v krvi.
English: When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Slovenian: Če je delovanje ledvic moteno, se ledvični očistek zmanjša sorazmerno z zmanjšanjem očistka kreatinina, zato je razpolovni čas izločanja podaljšan, kar povzroči zvišane koncentracije metformina v plazmi.
English: Lactic acidosis is a rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation.
Slovenian: Laktacidoza je redek, a resen presnovni zaplet (z veliko umrljivostjo, če ni takojšnjega zdravljenja), do katerega lahko pride zaradi kopičenja metformina.
English: If necessary, the dose of glucose-lowering medicinal products should be adjusted during therapy with the other medicinal product and on its discontinuation.
Slovenian: Odmerek zdravila, ki znižuje vrednost glukoze v krvi je treba med sočasno uporabo drugega zdravila in ob njegovi ukinitvi prilagoditi po potrebi.
English: ● Hepatic impairment, acute alcohol intoxication, alcoholism (see sections 4.2 and 4.5).
Slovenian: • Okvara jeter, akutna zastrupitev z alkoholom, alkoholizem (glejte poglavji 4.2 in 4.5).
English: • if you have recently had a heart attack or have severe blood circulation problems, such as
Slovenian: • če ste pred nedavnim doživeli srčni infarkt ali če imate resne težave s krvnim obtokom, kot sta šok ali oteženo dihanje
English: Physicians should alert the patients on the risk and on the symptoms of lactic acidosis.
Slovenian: Bolnike je treba poučiti o možnosti pojava in o simptomih laktacidoze.
English: In two studies conducted in special populations (older patients 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 dveh študijah, ki so ju izvajali pri posebnih skupinah bolnikov (pri starejših bolnikih 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: Children and adolescents Vokanamet is not recommended for children and adolescents under 18 years.
Slovenian: Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Vokanamet ni priporočena.
English: The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic impairment, and any conditions associated with hypoxia.
Slovenian: Pogostnost laktacidoze je mogoče in tudi potrebno zmanjšati, in sicer s presojo drugih sočasnih dejavnikov tveganja, kot so slabo urejena sladkorna bolezen, ketoza, dolgotrajno stradanje, prekomerno uživanje alkohola, okvara jeter in katera koli s hipoksijo povezana bolezen.
English: Adverse reactions in table 1 are based on the pooled analysis of the four 26-week placebo-controlled studies (n=2,313) described above.
Slovenian: Podatki o neželenih učinkih v preglednici 1 izhajajo iz zgoraj opisane analize združenih podatkov štirih 26-tedenskih s placebom nadzorovanih študij (n = 2.313).
English: Following oral administration of an 850 mg tablet, a 40% lower plasma peak concentration, a 25% decrease in AUC, and a 35-minute prolongation of time to peak plasma concentration were observed.
Slovenian: Po zaužitju 850-miligramske tablete je bila največja koncentracija v plazmi manjša za 40%, AUC za 25%, čas do najvišje koncentracije v plazmi pa daljši za 35 minut.
English: The mean steady-state volume of distribution (Vd) of canagliflozin following a single intravenous infusion in healthy subjects was 119 litres, suggesting extensive tissue distribution.
Slovenian: Pri zdravih osebah je bil povprečen volumen porazdelitve kanagliflozina v stanju dinamičnega ravnovesja (Vd) po enkratni intravenski infuziji 119 litrov, kar kaže na obsežno porazdelitev v tkivih.
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and only if normal renal function has been established.
Slovenian: Ponovno se ga sme uvesti šele 48 ur po posegu oziroma po ponovni uvedbi prehranjevanja per os in samo pod pogojem, da je bilo potrjeno normalno delovanje ledvic.
English: Before taking Vokanamet again, your kidney function should be tested.
Slovenian: Preden boste spet začeli jemati zdravilo Vokanamet, morajo pregledati delovanje vaših ledvic.
English: • Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock (see section 4.4);
Slovenian: • Akutna stanja, ki lahko vplivajo na delovanje ledvic, kot so dehidracija, huda okužba in šok (glejte poglavje 4.4);
English: This can be followed by acidotic dyspnea, abdominal pain, hypothermia and coma.
Slovenian: Kasneje lahko pride do acidotične dispneje, bolečin v trebuhu, hipotermije in kome.
English: Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Slovenian: Do primerov laktacidoze, o katerih so poročali pri bolnikih, ki so jemali metformin, je prišlo zlasti pri sladkornih bolnikih s pomembno stopnjo ledvične odpovedi.
English: If you experience some of the signs of lactic acidosis which include feeling sick (nausea) or being sick (vomiting), stomach ache, severe weakness, muscle cramps, unexplained weight loss, rapid breathing, or feeling cold or uncomfortable, stop taking Vokanamet immediately and contact a doctor or go to the nearest hospital straight away.
Slovenian: Če opazite katerega od znakov laktacidoze, ki lahko vključujejo siljenje na bruhanje (navzeo) ali bruhanje, bolečine v trebuhu, hudo oslabelost, mišične krče, nepojasnjeno hujšanje, hitro dihanje ali občutek mraza ali neprijeten občutek, takoj prenehajte jemati zdravilo Vokanamet in pokličite zdravnika ali pojdite v najbližjo bolnišnico.
English: • iodinated contrast agents (medicines used during an X-ray).
Slovenian: • jodirana kontrastna sredstva (barvila, ki se uporabljajo pri rentgenskem slikanju).
English: Vokanamet with alcohol
Slovenian: Zdravilo Vokanamet in alkohol
English: Operations and X-rays Tell your doctor you are taking Vokanamet if you are going to have:
Slovenian: Zdravniku povejte, da jemljete zdravilo Vokanamet, če boste imeli:
English: Possible signs of losing too much fluid from your body are listed under “Dehydration” in section 4.
Slovenian: Znaki morebitnega prevelikega izločanja vode iz telesa so našteti na začetku poglavja 4 “Možni neželeni učinki”.
English: For patients switching from separate tablets of canagliflozin and metformin For patients switching from separate tablets of canagliflozin and metformin, Vokanamet should be initiated at the same total daily dose of canagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
Slovenian: Bolniki, ki prehajajo z uporabe ločenih tablet kanagliflozina in metformina Bolniki, ki prehajajo z uporabe ločenih tablet kanagliflozina in metformina, naj zdravilo Vokanamet začnejo jemati v odmerku, ki vsebuje enaka dnevna odmerka kanagliflozina in metformina, kot so ju že jemali, oziroma najbližji približek terapevtsko ustreznega odmerka metformina.
English: This happens more often in people with kidney problems.
Slovenian: Laktacidoza se pogosteje pojavi pri ljudeh, ki imajo težave z ledvicami.
English: g Vulvovaginal candidiasis includes the terms vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis,
Slovenian: g Izraz vulvovaginalbna kandidoza vključuje vulvovaginalno kandidozo, vulvovaginalno glivično okužbo,
English: Vokanamet has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Vokanamet nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: ● Diabetic ketoacidosis, diabetic pre-coma;
Slovenian: • Diabetična ketoacidoza, diabetična predkoma.
English: Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): increased levels of “ketone bodies” in your urine or blood rapid weight loss feeling sick or being sick stomach pain excessive thirst fast and deep breathing confusion unusual sleepiness or tiredness a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Slovenian: Če se pri vas pojavi kateri koli od naslednjih neželenih učinkov, takoj pokličite zdravnika ali pojdite v najbližjo bolnišnico: Diabetična ketoacidoza (redko, lahko se pojavi pri največ 1 od 1.000 bolnikov) Znaki diabetične ketoacidoze so (glejte tudi poglavje 2, Opozorila in previdnostni ukrepi): povečane koncentracije “ketonskih teles” v urinu in krvi hitra izguba telesne mase slabost ali bruhanje bolečine v trebuhu huda žeja hitro in globoko dihanje zmedenost neobičajna zaspanost ali utrujenost sladkast zadah, sladek ali kovinski okus v ustih ali spremenjen vonj seča ali znoja.
English: Vokanamet is not recommended in patients with hepatic impairment due to the active substance metformin (see sections 4.3 and 5.2).
Slovenian: Pri bolnikih z okvaro jeter uporaba zdravila Vokanamet ni priporočena, ker zdravilo vsebuje zdravilno učinkovino metformin (glejte poglavji 4.3 in 5.2).
English: Table 3: Efficacy results from placebo-controlled clinical studiesa
Slovenian: Prgelednica 3: Rezultati učinkovitosti iz s placebom nadzorovanih kliničnih študija
English: As metformin is excreted by the kidney, and metformin accumulation may precipitate lactic acidosis, eGFR or creatinine clearance should be determined before initiating treatment and regularly thereafter:
Slovenian: Ker se metformin izloča preko ledvic, in kopičenje metformina lahko pospeši pojav laktacidoze, je treba ocenjeno glomerulno filtracijo ali očistek kreatinina določati pred začetkom zdravljenja in redno med zdravljenjem, in sicer: • najmanj enkrat na leto pri bolnikih z normalnim delovanjem ledvic,
English: • Hypersensitivity to the active substances or any of the excipients (see section 6.1);
Slovenian: • Preobčutljivost na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: ● Acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock;
Slovenian: • akutna ali kronična bolezen, ki lahko povzroča tkivno hipoksijo, kot so srčno popuščanje,
English: For patients with an estimated glomerular filtration rate (eGFR) 60 mL/min/1.73 m2 to < 90 mL/min/1.73m2 or creatinine clearance (CrCl) of 60 mL/min to < 90 mL/min, no dose adjustment is needed.
Slovenian: Pri bolnikih z ocenjeno glomerulno filtracijo 60 ml/min/1,73 m2 do < 90 ml/min/1,73 m2 ali z očistkom kreatinina 60 ml/min do < 90 ml/min ni potrebno prilagajati odmerka.
English: There is an increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition, or hepatic impairment) due to the metformin active substance of Vokanamet (see section 4.4).
Slovenian: Zaradi učinkovine metformin v zdravilu Vokanamet, obstaja pri akutni zastrupitvi z alkoholom (še posebej v primeru stradanja, podhranjenosti ali okvare jeter) povečano tveganje za laktacidozo (glejte poglavje 4.4).
English: Decreases in eGFR (-3.6% and -5.2%) were reported with canagliflozin 100 mg and canagliflozin 300 mg, respectively, compared to the control group (-3.0%) (see sections 4.2 and 4.4).
Slovenian: Zmanjšanje ocenjene glomerulne filtracije je bilo -3,6% oziroma -5,2% pri uporabi kanagliflozina v odmerku 100 mg oziroma 300 mg v primerjavi s kontrolno skupino (-3,0%) (glejte poglavji 4.2 in 4.4).