natgillin/translations-raw huggingface dataset:
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).
Zmanjšanje ocenjene glomerulne filtracije je bilo -3,6% oziroma -5,2% pri uporabi zdravila Invokana v odmerku 100 mg oziroma 300 mg v primerjavi s kontrolno skupino (-3,0%) (glejte poglavji 4.2 in 4.4).
m Mean percent changes from baseline in blood potassium were 0.5% and 1.0% for canagliflozin 100 mg and 300 mg,
m Povprečni odstotek spremembe koncentracije kalija v krvi je bil 0,5% za 100 mg kanagliflozina in 1,0% za
A subset of patients (N = 208) from the active-controlled dual therapy study with metformin who underwent dual energy X-ray densitometry (DXA) and abdominal computed tomography (CT) scans for evaluation of body composition demonstrated that approximately two-thirds of the weight loss with canagliflozin was due to loss of fat mass with similar amounts of visceral and abdominal subcutaneous fat being lost.
Pri podskupini bolnikov (n = 208), ki je bila del aktivno nadzorovane študije dvotirnega zdravljenja z metforminom, so bolnikom opravili preiskavo z metodo DEXA (DEXA - Dual Energy X-ray densitometry) in opravili računalniško tomografijo trebuha za oceno sestave telesa.
3.2% of the administered radioactive dose was recovered in faeces as canagliflozin, a hydroxylated metabolite, and an O-glucuronide metabolite, respectively.
41,5% danega radioaktivnega odmerka prestregli v blatu v obliki kanagliflozina, 7,0% v obliki hidroksiliranega metabolita in 3,2% v obliki O-glukuronidnega presnovka.
Vulvovaginal candidiasis includes the terms vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis,
g Izraz vulvovaginalbna kandidoza vključuje vulvovaginalno kandidozo, vulvovaginalno glivično okužbo,
At study endpoint, 3.0% of patients treated with canagliflozin 100 mg, 4.0% with canagliflozin 300 mg, and 3.3% with placebo had such decreases (see section 4.4).
Ob zaključku študije so takšno znižanje vrednosti izmerili pri 3,0% oziroma4,0% bolnikov, ki so uporabljali 100 mg oziroma 300 mg kanagliflozina, ter pri 3,3% bolnikov, ki so prejemali placebo (glejte poglavje 4.4).
In patients tolerating canagliflozin 100 mg once daily who have an eGFR ≥ 60 mL/min/1.73 m2 or CrCl ≥ 60 mL/min and need tighter glycaemic control, the dose can be increased to 300 mg once daily orally (see below and section 4.4).
Priporočeni začetni odmerek kanagliflozina je 100 mg enkrat na dan Pri bolnikih, ki odmerek 100 mg kanagliflozina enkrat na dan dobro prenašajo, imajo ocenjeno glomerulno filtracijo ≥ 60 ml/min/1,73 m2 ali CrCl ≥ 60 ml/min in potrebujejo boljši nadzor glikemije, se odmerek lahko poveča na 300 mg enkrat na dan, peroralno (glejte spodaj in poglavje 4.4).
Constipation, Thirstb, Nausea
Bolezni prebavil pogosti obstipacija, žejab, navzea
Triple therapy with metformin and sulphonylurea (26 weeks) Canagliflozin + metformin and sulphonylurea
Trotirno zdravljenje z metforminom in s sulfonilsečnino (26 tednov) Kanagliflozin + metformin in sulfonilsečnina placebo + metformin in sulfonilsečnina
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).
Pri izpostavljenostih, ki so do 19-krat presegale izpostavljenosti pri ljudeh, pri največjem priporočenem odmerku (MRHD-Maximum Recommended Human Dose) pri podganah kanagliflozin ni imel učinka na plodnost in zgodnji razvoj zarodka.
In two 52-week active-controlled studies comparing canagliflozin to glimepiride and sitagliptin, sustained and statistically significant mean reductions in the percentage of body weight for canagliflozin as add-on therapy to metformin were -4.2% and -4.7% for canagliflozin 100 mg and 300 mg, respectively, compared to the combination of glimepiride and metformin (1.0%) and -2.5%
V dveh 52-tedenskih aktivno nadzorovanih študijah, v katerih so kanagliflozin primerjali z glimepiridom oziroma s sitagliptinom, je 100 mg oziroma 300 mg kanagliflozina kot dodatno zdravilo pri zdravljenju z metforminom povzročilo trajno in statistično značilno zmanjšanje telesne mase s povprečno spremembo odstotka telesne mase -4,2% oziroma -4,7% v primerjavi z uporabo kombinacije glimepirida in metformina (1,0%).
Because of how this medicine works, your urine will test positive for sugar (glucose) while you are on this medicine.
To zdravilo deluje tako, da poveča količino sladkorja, ki se izloči iz telesa z sečem, zato bo v med jemanjem tega zdravila izvid preiskave prisotnosti sladkorja (glukoze) v seču pozitiven.
See bone fracture section below for additional information.
Dodatni podatki so navedeni v nadaljevanju v poglavju Zlom kosti.
You should not take this medicine if you are breast-feeding.
Če dojite ne smete jemati tega zdravila.
For patients on loop diuretics, the incidences were 3.2% on canagliflozin 100 mg and 8.8% on canagliflozin 300 mg compared to 4.7% in the control group.
Pri bolnikih, ki so jemali diuretike Henleyeve zanke, je bila pogostnost teh neželenih učinkov 3,2% pri uporabi 100 mg kanagliflozina in 8,8% pri uporabi 300 mg kanagliflozina v primerjavi s 4,7% v kontrolni skupini.
Following single and multiple oral doses of canagliflozin to patients with type 2 diabetes, dose-dependent decreases in RTG and increases in UGE were observed.
Po odmerjanju posameznih in večkratnih peroralnih odmerkov kanagliflozina bolnikom s sladkorno boleznijo tipa 2 so opazili od odmerka odvisno znižanje praga za izločanje glukoze v ledvicah in povečano izločanje glukoze z urinom.
Hypoglycaemia in add-on therapy with insulin or insulin secretagogues
Hipoglikemija in dodajanje zdravila insulinu ali spodbujevalcu izločanja insulina
Dyslipidemiai, Haematocrit increased**, j uncommon
Dislipidemija j, povečan hematokrit**
Canagliflozin did not increase the incidence of tumours in male and female mice in a 2-year study at doses of 10, 30, and 100 mg/kg.
V dvoletni študiji kanagliflozin pri odmerjanju 10, 30 ali 100 mg/kg ni povečal pogostnosti pojavljanja tumorjev pri mišjih samcih in samicah.
Balanitis or balanoposthitis**, h
Motnje reporodukcije in dojk zelo pogosti vulvovaginalna kandidoza**,g pogosti balanitis ali balanopostitis**,h
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.
Pri zdravih osebah je po enkratnem peroralnem odmerku 100 mg oziroma 300 mg prišlo do hitre absorpcije kanagliflozina, pri čemer je do najvišje koncentracije v plazmi prišlo
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 300 mg kanagliflozina.
However, based on the potential to reduce postprandial plasma glucose excursions due to delayed intestinal glucose absorption, it is recommended that Invokana be taken before the first meal of the day (see sections 4.2 and 5.1).
Sočasno odmerjanje kanagliflozina z obrokom, ki vsebuje veliko maščob, ni vplivalo na farmakokinetiko kanagliflozina, zato je zdravilo Invokana mogoče jemati s hrano ali brez nje, vendar je glede na njegovo zmožnost, da zmanjša nihanje koncentracije glukoze po obroku zaradi zakasnitve absorpcije glukoze v črevesju, priporočeno jemati zdravilo Invokana pred prvim dnevnim obrokom (glejte poglavji 4.2 in 5.1).
You may already be taking one or more of these to treat your type 2 diabetes.
že jemljete eno ali več navedenih zdravil.
• St. John's wort (an herbal medicine to treat depression)
• šentjanževka (zeliščno zdravilo proti depresiji)
In placebo-controlled studies, treatment with canagliflozin 100 mg and 300 mg 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 and 300 mg of -2.1 mmHg and -2.5 mmHg, respectively, compared to placebo (-0.3 mmHg).
V s placebom nadzorovanih študijah je zdravljenje s 100 mg oziroma 300 mg kanagliflozina povzročilo povprečno znižanje sistoličnega krvnega tlaka za -3,9 mmHg oziroma za -5,3 mmHg v primerjavi s placebom (znižanje za -0,1 mmHg).
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, canagliflozin 300 mg, and placebo, respectively (see sections 4.2 and 4.5).
Pri dodajanju zdravila sulfonilsečnini so hipoglikemijo opazili pri 4,1%, bolnikov, ki so prejemali 100 mg kanagliflozina, pri 12,5% bolnikov, ki so prejemali 300 mg kanagliflozina in pri 5,8% bolnikov, ki so prejemali s placebo (glejte poglavji 4.2 in 4.5).
Canagliflozin was negligibly removed by haemodialysis.
Kanagliflozin se pri hemodializi odstrani le v zanemarljivo majhnem obsegu.
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.
1,5-dehidro-sorbitola (1,5-AG) lahko lažno zmanjšane.
Invokana has no or negligible influence on the ability to drive, cycle, and use tools or machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Invokana nima vpliva oziroma ima zanemarljiv vpliv na sposobnost vožnje, kolesarjenja in upravljanje z napravami ali s stroji, vendar so poročali o omotičnosti oziroma začasni stemnitvi pred očmi, kar bi lahko vplivalo na sposobnost vožnje, kolesarjenja in upravljanja z napravami ali s stroji.
Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin.
Ena filmsko obložena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 300 mg kanagliflozina.
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.
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.
A lower proportion of patients treated with canagliflozin 100 mg (5.6%) and canagliflozin 300 mg (4.9%) experienced at least one episode/event of hypoglycaemia over 52 weeks of treatment compared to the group treated with glimepiride (34.2%).
Do najmanj ene hipoglikemije v 52 tednih zdravljenja je prišlo pri manjšem deležu bolnikov, ki so prejemali 100 mg kanagliflozina (5,6%) oziroma 300 mg kanagliflozina (4,9%) kot pri zdravljenju z glimepiridom (34,2%).
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.
for placebo.
bolnikov, ki so prejemali placebo.
Tell your doctor as soon as possible if you have any of the following side effects: Hypoglycaemia (very common, may affect more than 1 in 10 people)
Hipoglikemija (zelo pogosto; lahko se pojavijo pri več kot 1 od 10 bolnikov)
Monotherapy (26 weeks) Canagliflozin
Monoterapija (26 tednov) Kanagliflozin placebo (n = 192)
Dual therapy with metformin (26 weeks) Canagliflozin + metformin
Dvotirno zdravljenje z metforminom (26 weeks) Kanagliflozin + metformin placebo + metformin (n = 183)
Sitagliptin 100 mg + metformin and sulphonylurea (N=378)
sitagliptin 100 mg + metformin in sulfonilsečnina
Using a mixed-meal challenge, canagliflozin as monotherapy or add-on therapy with one or two oral glucose-lowering medicinal products reduced postprandial glucose (PPG) from baseline relative to placebo by -1.5 mmol/L to -2.7 mmol/L for canagliflozin 100 mg and -2.1 mmol/L to -3.5 mmol/L for 300 mg, respectively, due to reductions in the pre-meal glucose concentration and reduced postprandial glucose excursions.
Po stimulaciji z mešanim obrokom je kanagliflozin v monoterapiji ali kot dodatno zdravilo v kombinaciji z enim ali dvema peroralnima antihiperglikemičnima zdraviloma zmanjšal koncentracije glukoze v krvi po obroku (PPG- postprandial glucose) od izhodišča v primerjavi s placebom za -1,5 mmol/l do -2,7 mmol/l pri 100 mg kanagliflozina in za -2,1 mmol/l do -3,5 mmol/l pri 300 mg kanagliflozina.
e Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3%
e O zlomu kosti so poročali pri 0,7% pri 100 mg kanagliflozina, 0,6% pri 300 mg kanagliflozina in 0,3% pri placebu.
j Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively,
j Povprečna sprememba hematokrita glede na začetno vrednost je bila 2,4% za 100 mg kanagliflozina in 2,5% za
In patients with an eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 or CrCl 45 mL/min to
Pri bolnikih z ocenjeno glomerulno filtracijo 45 ml/min/1,73 m2 do < 60 ml/min/1,73 m2 ali očistkom kreatinina 45 ml/min do
Kidney function Your kidneys will be tested by a blood test before you start taking and while you are on this medicine.
Preden začnete jemati to zdravilo in med jemanja tega zdravila bo zdravnik preverjal delovanje vaših ledvic s krvno preiskavo.
Canagliflozin 100 mg as dual therapy with metformin produced similar reductions in HbA1c from baseline and 300 mg produced superior (p<0.05) reductions in HbA1c compared to glimepiride, thus demonstrating non-inferiority.
100 mg kanagliflozina je v kombinaciji z metforminom povzročilo podobno znižanje odstotka HbA1c od izhodišča kot glimepirid, odmerek 300 mg pa večje znižanje odstotka HbA1c od izhodišča kot glimepirid (p < 0,05), kar dokazuje neinferiornost kanagliflozina.
Postprandial glucose
Koncentracije glukoze po obroku
• blood tests may show changes related to kidney function (creatinine or urea) or potassium
• urtikarija • krvni testi lahko pokažejo spremembe delovanja ledvic (spremembe koncentracije kreatinina ali sečnine) ali kalija • krvni testi lahko pokažejo povečano koncentracijo fosfata v krvi
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).
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,
The majority of patients with a baseline eGFR 45 mL/min/1.73 m to < 60 mL/min/1.73 m were on insulin and/or a sulphonylurea (85% [614/721]).
< 60 ml/min/1,73 m je prejemala insulin in/ali sulfonilsečnino (85% [614/721]).
Contact a doctor or the nearest hospital straight away if you have any of the following side effects:
Če se pri vas pojavi kateri koli od naslednjih neželenih učinkov, takoj pokličite zdravnika ali pojdite v najbližjo bolnišnico:
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).
< 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).
k Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg,
k Povprečni odstotek spremembe glede na začetno vrednost kreatinina je bil 2,8% za 100 mg kanagliflozina in 4,0%
Placebo (N = 192)
Kanagliflozin placebo (n = 192)
n Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg,
n V primerjavi s placebom je bil povprečni odstotek spremembe koncentracije fosfata v serumu, glede na začetno vrednost 3,6% za 100 mg kanagliflozina in 5,1% za 300 mg kanagliflozina.
300 mg, respectively, compared to 2.7% for placebo.
300 mgkanagliflozina v primerjavi z 0,6% za placebo.
The higher doses of canagliflozin (100 mg/kg) in male and female rats increased the incidence of pheochromocytomas and renal tubular tumours.
so pri podganjih samcih in samicah povečali pogostnost feokromocitoma in tumorjev ledvičnih tubulov.
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).
Pri bolnikih, ki imajo zmerno okvaro ledvic je njegova učinkovitost zmanjšana, pri bolnikih, s hudo okvaro ledvic pa najverjetneje ni učinkovito.
In patients ≥ 75 years of age, the incidences were 4.9% on canagliflozin 100 mg and 8.7% on canagliflozin 300 mg compared to 2.6% in the control group (see sections 4.2 and 4.4).
pri uporabi 100 mg kanagliflozina in 8,7% pri uporabi 300 mg kanagliflozina v primerjavi z 2,6% v kontrolni skupini (glejte poglavji 4.2 in 4.4).
• cholestyramine (medicine used to reduce cholesterol levels in the blood).
• holestiramin (zdravilo za zniževanje koncentracije holesterola v krvi) Glejte poglavje 3 “Koliko zdavila je potrebno vzeti”.
rare
Diuretiki
Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.
Ena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 100 mg kanagliflozina.
If renal function falls persistently below eGFR 45 mL/min/1.73 m2 or CrCl < 45 mL/min,
Če se zmanjša ocenjena glomerulna filtracija pod 45 ml/min/1,73 m2
However, dilatation of the renal pelvis was noticed with a No Observed Effect Level (NOEL) at exposures 2.4 times and 0.6 times the clinical exposures at 100 mg and 300 mg doses, respectively, and did not fully reverse within the approximately 1-month recovery period.
Pri izpostavljenostih, ki so 2,4-krat in 0,6-krat presegale klinične izpostavljenosti pri odmerkih 100 mg in 300 mg so opazili razširjenje ledvičnega meha, pri čemer niso opazili učinka te spremembe (NOEL
Mean percent changes from baseline in blood urea nitrogen were 17.1% and 18.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 2.7% for placebo.
za 100 mg kanagliflozina in 18,0% za 300 mg kanagliflozina v primerjavi z 2,7% za placebo.
c Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular.
c Izraz izpuščaj vključuje eritematozni izpuščaj, generaliziran izpuščaj, makulozen izpuščaj, makulopapularen izpuščaj, papulozen izpuščaj, srbeč izpuščaj, pustulozen izpuščaj in vezikulozen izpuščaj.
respectively, compared to 1.5% for placebo.
300 mg kanagliflozina v primerjavi z 1,5% za placebo.
Skin and subcutaneous tissue disorders uncommon
Bolezni kože in podkožja občasni izpuščajc, urtikarija neznana angioedemd Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni zlom kostie
< 60 mL/min/1.73 m2, canagliflozin provided clinically meaningful reduction in HbA1c compared to placebo, with -0.47% for canagliflozin 100 mg and -0.52% for canagliflozin 300 mg.
V analizi združenih podatkov bolnikov (n = 721) z izhodiščno ocenjeno glomerulno filtracijo od 45 ml/min/1,73 m2 do < 60 ml/min/1,73 m2 je kanagliflozin povzročil klinično pomemben nižji odstotek HbA1c v primerjavi s placebom, in sicer za -0,47% pri uporabi 100 mg kanagliflozina in za -0,52% pri uporabi 300 mg kanagliflozina.
Patients with renal impairment For patients with an eGFR 60 mL/min/1.73 m2 to < 90 mL/min/1.73 m2 or CrCl 60 mL/min to
Bolniki z okvaro ledvic 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.
In patients with an eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min, a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) was reported, particularly with the 300 mg dose.
< 60 ml/min so poročali o večji pogostnosti neželenih učinkov, ki so povezani s hipovolemijo (na primer o položajni omotici, ortostatski hipotenziji in hipotenziji), predvsem pri bolnikih, ki so jemali odmerek 300 mg.
Canagliflozin
Delovanje ledvic
Canagliflozin has not been studied in severe renal impairment (eGFR < 30 mL/min/1.73 m2 or CrCl < 30 mL/min) or ESRD.
Pri bolnikih s hudo ledvično okvaro (ocenjena glomerulna filtracija < 30 ml/min/1,73 m2 ali očistek kreatinina < 30 ml/min) ali s končno ledvično odpovedjo kanagliflozina niso preskušali.
Based on postmarketing experience with canagliflozin.
Vpliv drugih učinkovin na kanagliflozin
Following administration of a single oral [14C]canagliflozin dose to healthy subjects, 41.5%, 7.0%, and
Po odmerjanju enkratnega s [14C] označenega peroralnega odmerka kanagliflozina zdravim osebam so 41,5% danega radioaktivnega odmerka prestregli v blatu v obliki kanagliflozina, 7,0% v obliki hidroksiliranega metabolita in 3,2% v obliki O-glukuronidnega presnovka.
< 90 mL/min, no dose adjustment is needed.
< 60 ml/min kanagliflozina ne smete uvesti.
• urinary tract infections
• okužbe sečil
The recommended starting dose of canagliflozin is 100 mg once daily.
Višji odmerki kanagliflozina (100 mg/kg)
Therefore, the canagliflozin dose should be limited to 100 mg once daily in patients with eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min and canagliflozin should not be used in patients with an eGFR < 45 mL/min/1.73 m2 or CrCl < 45 mL/min (see section 4.2).
Zato je treba dnevni odmerek kanagliflozina pri bolnikih z ocenjeno glomerulno filtracijo < 60 ml/min/1,73 m2 ali CrCl < 60 ml/min omejiti na 100 mg.
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).
45 ml/min (glejte poglavja 4.4, 4.8, 5.1 in 5.2).
Stop taking Invokana and see a doctor as soon as possible if you have any of the following serious side effects: Dehydration (uncommon, may affect up to 1 in 100 people)
Razmerje ogroženosti za skupni primarni cilj opazovanja (čas do dogodka, ki je lahko kardiovaskularna smrt,
The frequency of hypoglycaemia was low (approximately 4%) among treatment groups, including placebo, when used as monotherapy or as an add-on to metformin.
vključno s skupino s placebom, pogostnost hipoglikemije majhna (približno 4%).
The reductions in RTG and increases in UGE were sustained over a 26-week dosing period in patients with type 2 diabetes.
Pri bolnikih s sladkorno boleznijo tipa 2 sta se znižan prag za izločanje glukoze in povečano izločanje glukoze z urinom ohranila v celotnem 26-tedenskem obdobju odmerjanja.
canagliflozin treatment should be discontinued.
zato se za zdravljenje teh bolnikov kanagliflozin ne sme uporabljati.
% change from baseline (adjusted mean)
izhodiščna (povprečna) vrednost sprememba od izhodiščne vrednosti (prilagojena povprečna vrednost)
Canagliflozin + metformin
Kanagliflozin + metformin in sulfonilsečnina placebo + metformin in sulfonilsečnina
In controlled clinical studies of canagliflozin, increases in adverse reactions related to volume depletion (e.g., postural dizziness, orthostatic hypotension, or hypotension) were seen more commonly with the 300 mg dose and occurred most frequently in the first three months (see section 4.8).
V nadzorovanih kliničnih študijah s kanagliflozinom so pri uporabi odmerka 300 mg opazili povečano pogostnost neželenih učinkov, povezanih s hipovolemijo (na primer položajne omotice, ortostatske hipotenzije ali hipotenzije).
Nervous system disorders uncommon
Pogostnost neželen učinek
Canagliflozin was negligibly removed during a 4-hour haemodialysis session.
S 4-urno hemodializo se je kanagliflozin izločil v zanemarljivo majhnem obsegu.