FrancophonIA/ELRC3.0 huggingface dataset:
English: Some studies indicate that taking canagliflozin may have contributed to the risk of lower limb amputation (mainly toe and midfoot amputations).
Slovenian: Nekatere študije kažejo, da lahko jemanje kanagliflozina prispeva k tveganju za amputacije na spodnjih okončinah (večinoma prstov na nogah in dela stopala).
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 povečano koncentracijo glukoze v krvi, pod 14 mmol/l (250 mg/dl).
English: - as monotherapy when metformin is considered inappropriate due to intolerance or contraindications - in addition to other medicinal products for the treatment of diabetes.
Slovenian: - kot samostojno zdravilo pri bolnikih, pri katerih uporaba metformina ni primerna zaradi neprenašanja ali kontraindikacij, - kot dodatno zdravilo z drugimi zdravili za zdravljenje sladkorne bolezni.
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 (šibek zaviralec P-gp) na dabigatran eteksilat (substrat P-gp) niso preučevali.
English: • if you have had a lower limb amputation.
Slovenian: • če ste imeli amputacijo na spodnji okončini
English: Invokana contains the active substance canagliflozin which belongs to a group of medicines called “blood-glucose lowering drugs.”
Slovenian: Zdravilo Invokana vsebuje učinkovino kanagliflozin in sodi v skupino zdravil, ki jih imenujemo "zdravila za zniževanje koncentracije glukoze v krvi".
English: • if you experience 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, talk to a doctor or go to the nearest hospital immediately.
Slovenian: • če ste hitro izgubili telesno maso, vam je slabo ali bruhate, imate bolečine v trebuhu, ste hudo žejni, hitro in globoko dihate, ste zmedeni, neobičajno zaspani ali utrujeni, imate sladkast zadah, sladek ali kovinski okus v ustih ali spremenjen vonj urina ali znoja, takoj pokličite zdravnika ali pojdite v najbližjo bolnišnico.
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom
English: • The other ingredients are: tablet core: croscarmellose sodium, hydroxypropyl cellulose, lactose (see section 2 ‘Invokana contains lactose'), magnesium stearate, and microcrystalline cellulose film-coating: macrogol 3350, poly(vinylalcohol), talc, and titanium dioxide (E171).
Slovenian: • Druge sestavine zdravila so: jedro tablete: premrežen natrijev karmelozat, hidroksipropilceluloza, laktoza (glejte poglavje 2 "Zdravilo Invokana vsebuje laktozo"), magnezijev stearat in mikrokristalna celuloza; filmska obloga: makrogol 3350, polivinilalkohol, smukec in titanov dioksid (E171).
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 kanagliflozina pri starejših bolnikih večinoma enak kot pri mlajših bolnikih.
English: N = 4344
Slovenian: placebo N = 4344
English: Manufacturer Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina
Slovenian: Proizvajalec Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italija
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 dieta in gibanje nista bila uspešna.
English: The safety and efficacy of canagliflozin in patients with type 1 diabetes have not been established and canagliflozin should not be used for treatment of patients with type 1 diabetes.
Slovenian: Varnost in učinkovitost kanagliflozina pri bolnikih s sladkorno boleznijo tipa 1 nista bili ugotovljeni, zato se za zdravljenje teh bolnikov kanagliflozin ne sme uporabljati.
English: • The active substance is canagliflozin.
Slovenian: • Učinkovina je kanagliflozin.
English: Taking this medicine • Swallow the tablet whole with water.
Slovenian: • Tableto pogoltnite celo, z vodo.
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: • dabigatran (blood thinner medicine that lowers the risk of blood clot formation).
Slovenian: • dabigatran (zdravilo za redčenje krvi, ki zmanjšuje nastajanje krvnih strdkov)
English: • if you have severe kidney problems or are on dialysis.
Slovenian: • če imate hude težave z ledvicami ali se zdravite z dializo
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 (povečane koncentracije kreatinina ali sečnine) ali povečane koncentracije kalija
English: Table 4: Efficacy results from active-controlled clinical studies Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin Glimepiride (titrated) + metformin (N = 482)
Slovenian: Preglednica 4: Rezultati učinkovitosti iz aktivno nadzorovanih kliničnih študij V primerjavi z glimepiridom v okviru dvotirnega zdravljenja z metforminom (52 tednov) kanagliflozin + metformin glimepirid (s titracijo) + metformin (n = 482)
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Invokana, and during treatment:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Invokana in med zdravljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
Slovenian: Zdravilo Invokana je indicirano pri odraslih z neustrezno urejeno sladkorno boleznijo tipa 2 kot dodatno zdravljenje ob ustrezni dieti in telesni dejavnosti:
English: The mean steady-state volume of distribution of canagliflozin following a single intravenous infusion in healthy subjects was 83.5 litres, suggesting extensive tissue distribution.
Slovenian: Pri zdravih osebah je bil povprečen volumen porazdelitve kanagliflozina v stanju dinamičnega ravnovesja po enkratni intravenski infuziji 83,5 litrov, kar kaže na obsežno porazdelitev v tkivih.
English: 90.7% of subjects in the canagliflozin group uptitrated to 300 mg
Slovenian: 90,7% osebam s kanagliflozin so odmerek titrirali do 300 mg
English: • if you have signs of a genital yeast infection such as irritation, itching, unusual discharge or odour.
Slovenian: • če imate znake glivične genitalne okužbe kot so draženje, srbenje, neobičajen izcedek ali vonj
English: Possible signs of losing too much fluid from your body are listed in section 4.
Slovenian: Znaki morebitnega prevelikega izločanja vode iz telesa so našteti v poglavju 4 “Možni neželeni učinki”.
English: This reduces the amount of sugar in your blood and can help prevent heart disease.
Slovenian: To zdravilo deluje tako, da poveča količino sladkorja, ki se izloči iz telesa z sečem, to pa zmanjša količino sladkorja v krvi in lahko pomaga preprečevati bolezni srca.
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 priporočljiva pri bolnikih, ki jemljejo diutetike Henleyeve zanke (glejte poglavje 4.5) ali pri bolnikih s hipovolemijo, npr. zaradi akutne bolezni (kot so gastrointestinalne bolezni).
English: Pack sizes of 10 x 1, 30 x 1, 90 x 1, and 100 x 1 film-coated tablets.
Slovenian: Velikosti pakiranj so 10 x 1, 30 x 1, 90 x 1 in 100 x 1 filmsko obložena tableta.
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: Hepatic impairment For patients with mild or moderate hepatic impairment, no dose adjustment is required.
Slovenian: Okvara jeter Pri bolnikih z blago ali zmerno okvaro jeter prilagajanje odmerjanja ni potrebno.
English: • rapid weight loss
Slovenian: • hitra izguba telesne mase
English: Glycaemic efficacy and safety
Slovenian: Učinkovitost pri urejanju glikemije in varnost
English: , Blood phosphate increased
Slovenian: , povečana koncentracija fosfata v krvi
English: A total of 10,134 patients were treated in two dedicated cardiovascular studies, exposed for a mean of 149 weeks (exposed for a mean of 223 weeks in CANVAS and 94 weeks in CANVAS-R), and 8,114 patients treated in 12 double blind, controlled phase 3 and phase 4 clinical studies, followed for a mean of 49 weeks.
Slovenian: Skupno so v dveh študijah s poudarkom na kardiovaskularnih dogodkih zdravili 10.134 bolnikov, ki so bili zdravljenju izpostavljeni v povprečju 149 tednov (v študiji CANVAS v povprečju 223 tednov, v študiji CANVAS-R pa 94 tednov), 8.114 bolnikov pa so zdravili v 12 dvojno slepih nadzorovanih kliničnih študijah faze III in faze IV, v katerih so bolnike spremljali v povprečju 49 tednov.
English: Your doctor may prescribe Invokana together with another glucose-lowering medicine.
Slovenian: Zdravnik vam bo morda predpisal zdravilo Invokana skupaj z drugim zdravilom, ki znižuje koncentracijo glukoze v krvi.
English: In a 12-week clinical study, unstimulated LH did not increase in male patients treated with canagliflozin.
Slovenian: V 12-tedenski klinični študiji se pri bolnikih moškega spola, ki so prejemali kanagliflozin, koncentracija LH brez stimulacije ni povečala.
English: Renal failure h (mainly in the context of volume depletion)
Slovenian: občasni levična odpoved h (predvsem zaradi izgube tekočine)
English: • a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Slovenian: • sladkast zadah, sladek ali kovinski okus v ustih ali spremenjen vonj seča ali znoja
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Slovenian: Zdravilo Invokana vsebuje natrij To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni ‘brez natrija'.
English: Due to volume depletion, generally small mean decreases in eGFR were seen within the first 6 weeks of treatment initiation with canagliflozin.
Slovenian: Zaradi hipotenzije so večinoma opazili majhno povprečno zmanjšanje ocenjene glomerulne filtracije v prvih 6 tednih po začetku zdravljenja s kanagliflozinom.
English: Each tablet contains 117.78 mg lactose.
Slovenian: Pomožne snovi z znanim učinkom: Ena tableta vsebuje 117,78 mg laktoze.
English: Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and medicinal product-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (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) kanagliflozinu za 51% in zmanjšanje najvišje plazemske koncentracije (Cmax) za 28%.
English: However, patients should be alerted to the risk of hypoglycaemia when canagliflozin is used as add-on therapy with insulin or an insulin secretagogue, and to the elevated risk of adverse reactions related to volume depletion, such as postural dizziness (see sections 4.2, 4.4 and 4.8).
Slovenian: Kljub temu je treba bolnike opozoriti na tveganje za hipoglikemijo, kadar prejemajo kanagliflozin kot dodatno zdravilo poleg insulina ali sekretagoga insulina, in na povečano tveganje za neželene učinke, ki so povezani s hipovolemijo, na primer za položajno omotico (glejte poglavja 4.2, 4.4 in 4.8).
English: Lower limb amputations (mainly of the toe and midfoot) especially in patients at high risk for heart disease
Slovenian: Kirurški in drugi medicinski posegi občasni amputacije spodnjih okončin (v glavnem prstov na nogah in dela stopala), predvsem pri bolnikih z večjim tveganjem za srčne bolezni
English: EU/1/13/884/001 (100 mg - 10x1 film-coated tablets) EU/1/13/884/002 (100 mg - 30x1 film-coated tablets) EU/1/13/884/003 (100 mg - 90x1 film-coated tablets) EU/1/13/884/004 (100 mg - 100x1 film-coated tablets) EU/1/13/884/005 (300 mg - 10x1 film-coated tablets) EU/1/13/884/006 (300 mg - 30x1 film-coated tablets) EU/1/13/884/007 (300 mg - 90x1 film-coated tablets) EU/1/13/884/008 (300 mg - 100x1 film-coated tablets)
Slovenian: EU/1/13/884/001 (100 mg - 10 x 1 filmsko obložena tableta) EU/1/13/884/002 (100 mg - 30 x 1 filmsko obložena tableta) EU/1/13/884/003 (100 mg - 90 x 1 filmsko obložena tableta) EU/1/13/884/004 (100 mg - 100 x 1 filmsko obložena tableta) EU/1/13/884/005 (300 mg - 10 x 1 filmsko obložena tableta) EU/1/13/884/006 (300 mg - 30 x 1 filmsko obložena tableta) EU/1/13/884/007 (300 mg - 90 x 1 filmsko obložena tableta) EU/1/13/884/008 (300 mg - 100 x 1 filmsko obložena tableta)
English: Table 5: Results from 26-Week Active-Controlled Clinical Study of Canagliflozin as Initial Combination Therapy with Metformin
Slovenian: Preglednica 5: Rezultati 26-tedenske aktivno nadzorovane študije začetnega kombiniranega zdravljenja kanagliflozina in metformina
English: Via C. Janssen Borgo San Michele 04100 Latina Italy
Slovenian: Janssen Cilag SpA Via C. Janssen 04010 Borgo San Michele 04100 Latina Italija
English: Figure 2: Treatment Effect for the Primary Composite Endpoint and its Components
Slovenian: Slika 2: Učinek zdravljenja na primarni sestavljeni opazovani dogodek in na posamezne neželene dogodke, ki ga sestavljajo
English: Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
Slovenian: Ena tableta vsebuje manj kot 1 mmol natrija (23 mg), kar v bistvu pomeni ‘brez natrija'.
English: Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium
Slovenian: Jedro tablete laktoza mikrokristalna celuloza hidroksipropilceluloza premrežen natrijev karmelozat magnezijev stearat
English: The higher doses of canagliflozin (100 mg/kg) in male and female rats increased the incidence of pheochromocytomas and renal tubular tumours.
Slovenian: Večji odmerki kanagliflozina (100 mg/kg) so pri podganjih samcih in samicah povečali pogostnost feokromocitoma in tumorjev ledvičnih tubulov.
English: Canagliflozin increased the incidence of testicular Leydig cell tumours in male rats at all doses tested (10, 30, and 100 mg/kg); the lowest dose of 10 mg/kg is approximately 1.5 times the clinical dose of 300 mg based on AUC exposure.
Slovenian: Kanagliflozin je v vseh preskušanih odmerkih (10, 30 in 100 mg/kg) povečal pogostnost tumorja Leydigovih celic v modih pri podganjih samcih, pri čemer najmanjši odmerek 10 mg/kg predstavlja približno 1,5-kratnik kliničnega odmerka 300 mg glede na izpostavljenost zdravilu (AUC).
English: • other antidiabetics - either insulin or a sulphonylurea (such as glimepiride or glipizide) - your doctor may want to reduce your dose in order to avoid your blood sugar level from getting too low (hypoglycaemia)
Slovenian: • druga zdravila za zniževanje koncentracije glukoze v krvi - bodisi insulin ali sulfonilsečnino (kot sta glimepirid ali glipizid) - zdravnik vam bo morda zmanjšal odmerek teh zdravil, da se vam koncentracija sladkorja v krvi ne bi preveč znižala (da ne bi prišlo do hipoglikemije)
English: Incidence rate (per 100 subject-years) 0.34 HR (95% CI) vs. placebo Minor Amputation, n (%) Major Amputation, n (%)
Slovenian: celokupno število preiskovancev z dogodki, n (%) incidenčna stopnja (na 100 preiskovancev-let) razmerje ogroženosti (95-odstotni IZ) za primerjavo s placebom manjša amputacija, n (%)* večja amputacija, n (%)†
English: Polyuria or Pollakiuria j, Urinary tract infection (pyelonephritis and urosepsis have been reported postmarketing)
Slovenian: Bolezni sečil pogosti poliurija ali polakisurija j, okužba sečil c (v obdobju trženja zdravila so poročali o pielonefritisu in urosepsi)
English: Dehydration (uncommon, may affect up to 1 in 100 people)
Slovenian: Dehidracija (občasno; lahko se pojavijo pri največ 1 od 100 bolnikov)
English: Vulvovaginal candidiasis (including vulvovaginitis and vulvovaginal mycotic infection) was reported in 10.4% and 11.4% of female patients treated with canagliflozin 100 mg and canagliflozin 300 mg, respectively, compared to 3.2% in placebo-treated female patients.
Slovenian: O vulvovaginalni kandidozi (vključno z vulvovaginitisom in vulvovaginalno glivično okužbo) so poročali pri 10,4% bolnic s 100 mg kanagliflozina, pri 11,4% bolnic s 300 mg kanagliflozina v primerjavi s 3,2% bolnic, ki so prejemale placebo.
English: The safety of canagliflozin was evaluated in 18,248 patients with type 2 diabetes, including 11,078 patients treated with canagliflozin and 7,170 patients treated with comparator who received medicinal product in 14 double-blind, controlled phase 3 and phase 4 clinical studies.
Slovenian: Varnost uporabe kanagliflozina so ocenjevali v 14 dvojno slepih nadzorovanih kliničnih študijah faze III in faze IV pri 18.248 bolnikih s sladkorno boleznijo tipa 2, med katerimi je 11.078 bolnikov prejemalo kanagliflozin, 7.170 pa primerjalno zdravilo.
English: Poly(vinylalcohol) Titanium dioxide (E171) Macrogol 3350
Slovenian: Invokana 300 mg filmsko obložene tablete polivinilalkohol titanov dioksid (E171) makrogol 3350 smukec
English: Table 3: Efficacy results from placebo-controlled clinical studies Monotherapy (26 weeks) Canagliflozin
Slovenian: Preglednica 3: Rezultati učinkovitosti iz s placebom nadzorovanih kliničnih študij Monoterapija (26 tednov) kanagliflozin placebo (n = 192)
English: Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excluding insulins.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, antidiabetiki, brez insulinov.
English: Increases in urinary glucose excretion with Invokana can falsely lower 1,5-anhydroglucitol (1,5-AG) levels and make measurements of 1,5-AG unreliable in assessing glycemic control.
Slovenian: Zaradi povečane količine z urinom izločene glukoze so pri jemanju zdravila Invokana vrednosti 1,5-dehidro-sorbitola (1,5-AG) lahko lažno zmanjšane.
English: Medicinal product/Laboratory test interference
Slovenian: Vpliv zdravila na rezultate laboratorijskih testov
English: 300 mg exhibited mean improvements in percent change in body weight relative to placebo of -1.8% and -2.0%, respectively.
Slovenian: 300 mg kanagliflozina, so opazili povprečno boljšo odstotno spremembo telesne mase v primerjavi s placebom, in sicer za -1,8% oziroma za -2,0%.
English: The Cmax of canagliflozin was moderately increased by 13%, 29%, and 29% in subjects with mild, moderate, and severe renal failure, respectively, but not in subjects on haemodialysis.
Slovenian: Največja koncentracija (Cmax) kanagliflozina je bila zmerno povečana pri bolnikih z blago, z zmerno oziroma s hudo okvaro ledvic, in sicer za 13%, za 29% oziroma za 29%, pri bolnikih, ki so se zdravili s hemodializo, pa ni bila povečana.
English: (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: After single-dose oral administration of 100 mg and 300 mg in healthy subjects, canagliflozin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 hour to 2 hours post-dose.
Slovenian: Pri zdravih osebah je po enkratnem peroralnem odmerku 100 mg oziroma 300 mg prišlo do hitre absorpcije kanagliflozina, pri čemer je do največje koncentracije v plazmi prišlo 1 do 2 uri po odmerjanju (mediana vrednost Tmax).
English: The level of digoxin or digitoxin in your blood may need to be checked if taken with Invokana.
Slovenian: Če v času zdravljenja z zdravilom Invokana jemljete digoksin oziroma digitoksin, bo treba izmeriti njuni koncentraciji v krvi.
English: Balanitis or balanoposthitis b,l
Slovenian: Motnje reporodukcije in dojk zelo pogosti vulvovaginalna kandidoza b,k pogosti balanitis ali balanopostitis b,l
English: Canagliflozin should be discontinued when eGFR is persistently below 45 mL/min/1.73 m2 or CrCl persistently below 45 mL/min (see sections 4.4, 4.8, 5.1, and 5.2).
Slovenian: Zdravljenje s kanagliflozinom je treba prekiniti pri bolnikih, pri katerih ocenjena glomerulna filtracija vztraja pri vrednostih pod 45 ml/min/1,73 m2 ali njihov očistek kreatinina vztraja pri vrednostih pod 45 ml/min (glejte poglavja 4.4, 4.8, 5.1 in 5.2).
English: Canagliflozin was studied as monotherapy, dual therapy with metformin, dual therapy with a sulphonylurea, triple therapy with metformin and a sulphonylurea, triple therapy with metformin and pioglitazone, and as an add-on therapy with insulin (table 3).
Slovenian: Kanagliflozin so preučevali v monoterapiji, kot dvotirno zdravljenje skupaj z metforminom oziroma s sulfonilsečnino, kot trotirno zdravljenje z metforminom in s sulfonilsečnino oziroma z metforminom in s pioglitazonom ter kot dodatno zdravilo pri zdravljenju z insulinom (preglednica 3).
English: Add-on therapy with insulin d (18 weeks) Canagliflozin + insulin
Slovenian: Dodatno zdravljenje pri zdravljenju z insulinom d (18 tednov) kanagliflozin + insulin placebo + insulin (n = 565)
English: Caution should be exercised in patients for whom a canagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients with an eGFR < 60 mL/min/1.73 m2, patients on anti-hypertensive therapy with a history of hypotension, patients on diuretics, or elderly patients (≥ 65 years of age) (see sections 4.2 and 4.8).
Slovenian: Pri bolnikih, pri katerih lahko s kanagliflozinom povzročeno zmanjšanje krvnega tlaka predstavlja nevarnost, kot so bolniki z znano srčnožilno boleznijo, bolniki z ocenjeno glomerulno filtracijo < 60 ml/min/1,73 m2, bolniki, ki jemljejo antihipertenzive s hipotenzijo v anamnezi, bolniki, ki jemljejo diuretike ali starostniki (≥ 65 let) je potrebna previdnost (glejte poglavji 4.2 in 4.8).
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: Prenašalni protein za natrij in glukozo v ledvicah 2 (SGLT2 - sodium-glucose co-transporter 2) v proksimalnih ledvičnih tubulih, je odgovoren za večji del reabsorpcije filtrirane glukoze iz svetline ledvičnega tubula.
English: - Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter - For renal function approaching moderate renal impairment, at least 2 times to 4 times per year.
Slovenian: - pred uvedbo sočasnega zdravila, ki bi lahko zmanjševalo delovanje ledvic, in nato periodično v nadaljevanju zdravljenja z njim.