natgillin/translations-raw huggingface dataset:
No effects on fertility were observed in animal studies (see section 5.3).
U ispitivanjima na životinjama nije zamijećeno djelovanje na plodnost (vidjeti dio 5.3).
Lactose intolerance
Nepodnošenje laktoze
Dizziness postural*, Syncope*
Posturalna omaglica*, sinkopa*
EU/1/13/884/001 (100 mg - 10 tablets) EU/1/13/884/002 (100 mg - 30 tablets) EU/1/13/884/003 (100 mg - 90 tablets) EU/1/13/884/004 (100 mg - 100 tablets) EU/1/13/884/005 (300 mg - 10 tablets) EU/1/13/884/006 (300 mg - 30 tablets) EU/1/13/884/007 (300 mg - 90 tablets) EU/1/13/884/008 (300 mg - 100 tablets)
EU/1/13/884/001 (100 mg - 10 tableta) EU/1/13/884/002 (100 mg - 30 tableta) EU/1/13/884/003 (100 mg - 90 tableta) EU/1/13/884/004 (100 mg - 100 tableta) EU/1/13/884/005 (300 mg - 10 tableta) EU/1/13/884/006 (300 mg - 30 tableta) EU/1/13/884/007 (300 mg - 90 tableta) EU/1/13/884/008 (300 mg - 100 tableta)
Vulvovaginal candidiasis**, g common
Vulvovaginalna kandidijaza**,g često
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).
Ne preporučuje se primjena kanagliflozina u bolesnika koji uzimaju diuretike Henleove petlje (vidjeti dio 4.5), ili u onih koji imaju depleciju volumena, npr. zbog akutne bolesti (poput gastrointestinalne bolesti).
Haematocrit increase was observed with canagliflozin treatment (see section 4.8); therefore, caution in patients with already elevated haematocrit is warranted.
Tijekom liječenja kanagliflozinom uočeno je povišenje hematokrita (vidjeti dio 4.8); stoga, nalaže se oprez u bolesnika čiji je hematokrit već povišen.
In addition, reductions in body weight and systolic blood pressure relative to placebo were observed.
Dodatno, u odnosu na placebo uočena su smanjenja tjelesne težine i sistoličkog krvnog tlaka.
Balanitis or balanoposthitis occurred primarily in uncircumcised male patients.
Javili su se balanitis ili balanopostitis, naročito u neobrezanih muških bolesnika.
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).
U kontroliranim kliničkim ispitivanjima kanagliflozina, povećanje nuspojava povezanih s deplecijom volumena (npr. posturalna omaglica, ortostatska hipotenzija, hipotenzija) češće je primijećeno uz dozu od 300 mg i češće su zabilježene u prva tri mjeseca (vidjeti dio 4.8).
The tablet is yellow, capsule-shaped, approximately 11 mm in length, immediate-release and film-coated, with “CFZ” on one side and “100” on the other side.
Tableta je žute boje, oblika kapsule, duljine približno 11 mm, s trenutnim oslobađanjem i filmom obložena, s “CFZ” na jednoj strani i “100” na drugoj strani.
Enterohepatic circulation of canagliflozin was negligible.
Enterohepatička cirkulacija kanagliflozina bila je zanemariva.
The effect of canagliflozin on fertility in humans has not been studied.
Djelovanje kanagliflozina na plodnost u ljudi nije ispitano.
Due to its mechanism of action, patients taking canagliflozin will test positive for glucose in their urine.
Zbog mehanizma djelovanja, bolesnici koji uzimaju kanagliflozin imati će pozitivan nalaz glukoze u mokraći.
The pack sizes are cartons of 10 x 1, 30 x 1, 90 x 1, or 100 x 1 tablets.
Veličine pakiranja su kutije s 10 x 1, 30 x 1, 90 x 1 ili 100 x 1 tableta.
• The starting dose of Invokana is one 100 mg tablet each day.
Koliko uzeti • Početna doza lijeka Invokana je jedna tableta od 100 mg svaki dan.
The tablet is white, capsule-shaped, approximately 17 mm in length, immediate-release and film-coated, with “CFZ” on one side and “300” on the other side.
Tableta je bijele boje, oblika kapsule, duljine približno 17 mm, s trenutnim oslobađanjem i filmom obložena, s “CFZ” na jednoj strani i “300” na drugoj strani.
Consistent with the mechanism of sodium glucose co-transporter 2 (SGLT2) inhibition with increased UGE, vulvovaginal candidiasis in females and balanitis or balanoposthitis in males were reported in clinical trials (see section 4.8).
Sukladno mehanizmu inhibicije kotransportera natrij glukoza 2 (SGLT2) s porastom UGE, u kliničkim ispitivanjima prijavljena je vulvovaginalna kandidijaza u žena, a u muškaraca balanitis ili balanopostitis (vidjeti dio 4.8).
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.
Nakon primjene jedne oralne doze od 100 mg i 300 mg, u zdravih ispitanika, kanagliflozin se brzo apsorbirao, uz pojavu vršnih koncentracija (medijan Tmax) 1 sat do 2 sata nakon uzimanja doze.
Overall, 0.5% of male patients discontinued canagliflozin due to candidial balanitis or balanoposthitis.
Općenito, 0,5% muških bolesnika prekinulo je uzimanje kanagliflozina zbog kandidnog balanitisa ili balanopostitisa.
Consistent with the expected increase of hypoglycaemia when a medicinal product not associated with hypoglycaemia is added to insulin and/or sulphonylurea, an increase in hypoglycaemia episodes/events was seen when canagliflozin was added to insulin and/or a sulphonylurea (see section 4.8).
U skladu s očekivanim porastom hipoglikemije kad se lijek koji nije povezan s hipoglikemijom dodaje inzulinu i/ili sulfonilureji, zabilježen je porast epizoda/događaja hipoglikemije kad je kanagliflozin dodan inzulinu i/ili sulfonilureji (vidjet dio 4.8).
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
In addition to the studies presented above, glycaemic efficacy results observed in an 18-week dual therapy sub-study with a sulphonylurea and a 26-week triple therapy study with metformin and pioglitazone were generally comparable with those observed in other studies.
Dodatno uz ispitivanja prikazana iznad, rezultati glikemijske djelotvornosti uočeni u 18-tjednom podispitivanju dvojne terapije sa sulfonilurejom i 26-tjednom ispitivanju trojne terapije s metforminom i pioglitazonom, općenito su bili usporedivi s onima uočenim u drugim ispitivanjima.
Studies have shown no glucose malabsorption with canagliflozin.
Ispitivanja nisu pokazala malapsorpciju glukoze s kanagliflozinom.
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).
Dodatno, u takvih bolesnika prijavljeno je više događaja povišenog kalija i veće povišenje serumskog kreatinina i dušika iz ureje u krvi (BUN)
Canagliflozin-induced renal tubule tumours and pheochromocytomas in rats appear to be caused by carbohydrate malabsorption as a consequence of intestinal SGLT1 inhibitory activity of canagliflozin in the gut of rats; mechanistic clinical studies have not demonstrated carbohydrate malabsorption in humans at canagliflozin doses of up to 2-times the maximum recommended clinical dose.
Čini se da su tumori bubrežnih tubula uzrokovani kanagliflozinom i feokromocitomi u štakora uzrokovani malapsorpcijom ugljikohidrata kao posljedicom inhibitornog djelovanja kanagliflozina na crijevni SGLT1 u crijevima štakora; mehanistička klinička ispitivanja nisu pokazala malapsorpciju ugljikohidrata u ljudi pri dozama kanagliflozina do 2-puta maksimalne preporučene kliničke doze.
Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g., type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Bolesnici koji mogu biti pod većim rizikom od DKA uključuju bolesnike s niskom rezervom funkcije beta-stanica (npr. bolesnici sa šećernom bolešću tipa 2 koji imaju nisku razinu C-peptida ili bolesnici s latentnom autoimunom šećernom bolešću u odraslih (engl. latent autoimmune diabetes in adults, LADA) ili bolesnici s pankreatitisom u anamnezi), bolesnike sa stanjima koja dovode do ograničenog unosa hrane ili teške dehidracije, bolesnike kojima su snižene doze inzulina i bolesnike s povećanim zahtjevima za inzulinom zbog akutne bolesti, kirurškog zahvata ili zlouporabe alkohola.
Invokana contains the active substance canagliflozin which belongs to a group of medicines called “blood-glucose lowering drugs.”
Što je Invokana i za što se koristi Invokana sadrži djelatnu tvar kanagliflozin koja pripada skupini lijekova koji se nazivaju “lijekovi za snižavanje šećera u krvi.”
This leaflet was approved in {month YYYY}.
Ova uputa je zadnji puta revidirana u {mjesec GGGG}.
Simvastatin: The combination of canagliflozin 300 mg once daily for 6 days with a single dose of simvastatin (CYP3A4 substrate) 40 mg resulted in a 12% increase in AUC and a 9% increase in Cmax of simvastatin and an 18% increase in AUC and a 26% increase in Cmax of simvastatin acid.
Simvastatin: Kombinacija kanagliflozina od 300 mg jedanput na dan tijekom 6 dana s jednom dozom simvastatina (supstrat CYP3A4) od 40 mg dovelo je do 12%-tnog povećanja AUC i 9%-tnog povećanja Cmax simvastatina, te 18%-tnog povećanja AUC i 26%-tnog povećanja Cmax kiseline simvastatina.
Blood creatinine increased**, k, Blood urea increased**, l, Blood potassium increased**, m, Blood phosphate increasedn
Povišen kreatinin u krvi**,k, povišena urea u krvi**,l, povišen kalij u krvi**,m, povišeni fosfati u krvin
In three studies conducted in special populations (older 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).
U tri ispitivanja koja su provedena s posebnim populacijama (stariji bolesnici, bolesnici s eGFR od 30 mL/min/1,73 m2 do < 50 mL/min/1,73 m2 i bolesnici s kardiovaskularnom bolešću ili sa visokim rizikom za kardiovaskularne bolesti), kanagliflozin je dodan trenutnom stabilnom liječenju dijabetesa kod bolesnika (dijeta, monoterapija ili kombinirano liječenje).
The pharmacokinetics of canagliflozin are essentially similar in healthy subjects and patients with type 2 diabetes.
5.2 Farmakokinetička svojstva Farmakokinetika kanagliflozina je u osnovi slična u zdravih ispitanika i u bolesnika s dijabetesom tipa
Single doses up to 1,600 mg of canagliflozin in healthy subjects and canagliflozin 300 mg twice daily for 12 weeks in patients with type 2 diabetes were generally well-tolerated.
Pojedinačne doze do 1600 mg kanagliflozina u zdravih ispitanika i kanagliflozina od 300 mg dva puta na dan, tijekom 12 tjedana u bolesnika s dijabetesom tipa 2, općenito su bile dobro podonošene.
Persistent renal findings in juvenile rats can most likely be attributed to reduced ability of the developing rat kidney to handle canagliflozin-increased urine volumes, as functional maturation of the rat kidney continues through 6 weeks of age.
Trajni bubrežni nalazi u mladunčadi štakora najvjerojatnije se mogu pripisati smanjenoj sposobnosti bubrega u razvoju štakora koji bi mogao podnijeti kanagliflozinom izazvan porast volumena mokraće, budući da funkcionalno sazrijevanje bubrega u štakora traje tijekom 6 tjedna starosti.
The higher doses of canagliflozin (100 mg/kg) in male and female rats increased the incidence of pheochromocytomas and renal tubular tumours.
Više doze kanagliflozina (100 mg/kg) u mužjaka i ženki štakora povisile su incidenciju feokromocitoma i bubrežnih tubularnih tumora.
The safety of canagliflozin was evaluated in 10,285 patients with type 2 diabetes, including 3,139 patients treated with canagliflozin 100 mg and 3,506 patients treated with canagliflozin 300 mg, who received medicinal product in nine double-blind, controlled phase 3 clinical studies.
Sigurnost kanagliflozina bila je procijenjena u 10 285 bolesnika s dijabetesom tipa 2, s uključenih 3139 bolesnika liječenih kanagliflozinom od 100 mg i 3506 bolesnika liječenih kanagliflozinom od 300 mg, koji su primili lijek u devet dvostruko slijepih, kontroliranih ispitivanja faze 3.
In an embryo-foetal development study in rats, ossification delays of metatarsal bones were observed at systemic exposures 73 times and 19 times higher than the clinical exposures at the 100 mg and 300 mg doses.
U embrio-fetalnim razvojnim ispitivanjima u štakora, uočene su zakašnjele osifikacije metatarzalnih kostiju pri sistemskim izloženostima koja su bila 73 puta i 19 puta viša u odnosu na kliničke izloženosti pri dozama od 100 mg i 300 mg.
Canagliflozin should also not be used in patients with end stage renal disease (ESRD) or in patients on dialysis as it is not expected to be effective in such populations (see sections 4.4 and 5.2).
Kanagliflozin također ne smiju uzimati bolesnici sa završnim stadijem bubrežne bolesti ili bolesnici na dijalizi, jer se ne očekuje da će biti učinkovit u toj populaciji (vidjeti dijelove 4.4 i 5.2).
Care should be taken when increasing the dose in patients ≥ 75 years of age, patients with known cardiovascular disease, or other patients for whom the initial canagliflozin-induced diuresis poses a risk (see section 4.4).
Potreban je oprez u slučaju povećanja doze u bolesnika starosti ≥ 75 godina, u bolesnika s poznatom kardiovaskularnom bolešću ili u drugih bolesnika za koje početna kanagliflozinom izazvana diureza predstavlja rizik (vidjeti dio 4.4).
Add-on therapy with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5, and 5.1 for available data on different add-on therapies).
Dodatna terapija uz druge lijekove koji snižavaju glukozu uključujući inzulin, kada oni zajedno s dijetom i tjelovježbom nisu dostatni za primjerenu regulaciju glikemije (za dostupne podatke o različitim vrstama dodatnih terapija vidjeti dijelove 4.4, 4.5, i 5.1).
Canagliflozin is a low-clearance substance, with a mean systemic clearance of approximately 192 mL/min in healthy subjects following intravenous administration.
Kanagliflozin je tvar niskog klirensa, uz srednju vrijednost sistemskog klirensa od približno 192 mL/min u zdravih ispitanika nakon intravenske primjene.
Keep out of the sight and reach of children.
DJECE Čuvati izvan pogleda i dohvata djece.
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.
Ispitivanje je uključilo 8 ispitanika s normalnom funkcijom bubrega (CrCl ≥ 80 mL/min), 8 ispitanika s blagim oštećenjem bubrega (CrCl 50 mL/min do < 80 mL/min), 8 ispitanika s umjerenim oštećenjem bubrega (CrCl 30 mL/min do < 50 mL/min),
In patients ≥ 75 years of age, a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) was reported.
U bolesnika starosti ≥ 75 godina, prijavljena je veća incidencija nuspojava povezanih s deplecijom volumena (npr. posturalna omaglica, ortostatska hipotenzija, hipotenzija).
vaginal infection, vulvitis, and genital infection fungal.
vulvovaginitis, vaginalna infekcija, vulvitis i genitalna gljivična infekcija.
Compared to healthy subjects, plasma AUC of canagliflozin was increased by approximately 17%, 63%, and 50% in subjects with mild, moderate, and severe renal impairment, respectively, but was similar for ESRD subjects and healthy subjects.
U usporedbi sa zdravim ispitanicima, AUC kanagliflozina u plazmi bio je povišen za približno 17%, 63% odnosno 50% u bolesnika s blagim, umjerenim odnosno teškim zatajenjem bubrega, ali bio je sličan za ispitanike u završnom stadiju bubrežne bolesti i zdrave ispitanike.
The tablets contain lactose.
Tablete sadrže laktozu.
• changes in urination (including urinating more frequently or in larger amounts, urgent need to urinate, need to urinate at night)
• infekcije mokraćnog sustava • promjene vezane uz mokrenje (uključujući češće mokrenje, veću količinu mokraće, osjećaj potrebe za žurnim mokrenjem, potreba mokrenja noću) • zatvor
Pack sizes of 10 x 1, 30 x 1, 90 x 1, and 100 x 1 film-coated tablets.
Veličine pakiranja od 10 x 1, 30 x 1, 90 x 1 i 100 x 1 filmom obloženih tableta.
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).
Primjena u bolesnika s rizikom pojave nuspojava povezanih s deplecijom volumena Zbog svog mehanizma djelovanja, kanagliflozin, povećavajući ekskreciju glukoze urinom (UGE) inducira osmotsku diurezu, što može reducirati intravaskularni volumen i smanjiti krvni tlak (vidjeti dio 5.1).
N/Ac a Intent-to-treat population using last observation in study prior to glycaemic rescue therapy.
N/Pc a „Intent to treat“ populacija (planirana za liječenje) koristeći posljednje zapažanje u ispitivanju prije hitnog liječenja glikemije drugim lijekovima.
“CFZ” on one side and “300” on the other side.
17 mm, s “CFZ” na jednoj strani i “300” na drugoj strani.
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.
Podskup bolesnika (N = 208) iz dvojne terapije ispitivanja s aktivnim usporednim lijekom s metforminom u kojem su bili podvrgnuti denzitometriji X-zrakama dualne energije (DXA) i kompjuteriziranoj tomografiji (CT) abdomena za procjenu sastava tijela, pokazao je da se oko dvije trećine gubitka težine s kanagliflozinom dogodio zbog gubitka mase masnoće uz sličan gubitak visceralne i abdominalne supkutane masnoće.
“CFZ” on one side and “100” on the other side.
11 mm, s “CFZ” na jednoj strani i “100” na drugoj strani.
Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with canagliflozin (see sections 4.2 and 4.8).
Stoga, može biti potrebna niža doza inzulina i inzulinskih sekretagoga, kako bi se smanjio rizik za pojavu hipoglikemije kada se primjenjuju u kombinaciji s kanagliflozinom (vidjeti dijelove 4.2 i 4.8).
Canagliflozin has not been studied in patients with severe hepatic impairment and is not recommended for use in these patients (see section 5.2).
Kanagliflozin nije ispitan u bolesnika s teškim oštećenjem jetre, te se njegova primjena u tih bolesnika ne preporučuje (vidjeti dio 5.2).
** See section 4.4.
(vidjeti dio 4.2).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
Invokana has no or negligible influence on the ability to drive, cycle, and use tools or machines.
Invokana ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima, biciklom i upotrebe alata ili strojeva.
Canagliflozin should not be used during pregnancy.
Kanagliflozin se ne smije primjenjivati tijekom trudnoće.
Ossification delays were also observed for the combination of canagliflozin and metformin, which were more prominent than for metformin alone at canagliflozin exposures 43 times and 12 times higher than clinical exposures at 100 mg and 300 mg doses.
Za kombinaciju kanagliflozina i metformina također su primijećene zakašnjele osifikacije koje su bile više izražene nego za sam metformin pri izloženostima kanagliflozinu 43 puta i 12 puta višim od kliničkih izloženosti pri dozama od 100 mg i 300 mg.
In phase 3 studies, pre-meal administration of canagliflozin 300 mg provided a greater reduction in postprandial glucose excursion than observed with the 100 mg dose.
U ispitivanjima faze 3, primjena kanagliflozina od 300 mg prije jela, dovela je do većeg smanjenja ekskurzije postprandijalne glukoze, nego što je primijećeno s dozom od 100 mg.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza Rok valjanosti.
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).
Primarna procjena sigurnosti i podnošljivosti provedena analizom udruženih podataka (n = 2313) iz četiri 26-tjedna placebo kontrolirana klinička ispitivanja (monoterapija i dodatna terapija s metforminom, metforminom i sulfonilurejom, i metforminom i pioglitazonom).
The reductions in RTG led to increased UGE in subjects with type 2 diabetes treated with either 100 mg or 300 mg of canagliflozin ranging from 77 g/day to 119 g/day across the phase 1 studies; the UGE observed translates to a loss of 308 kcal/day to 476 kcal/day.
Smanjenja RTG dovela su do povišenog UGE u ispitanika s dijabetesom tipa 2 liječenih bilo sa 100 mg ili 300 mg kanagliflozina u rasponu od 77 g/dan do 119 g/ dan kroz ispitivanja faze 1; uočen UGE prevodi se na gubitak 308 kcal/dan do 476 kcal/dan.
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.
Cmax kanagliflozina bio je umjereno povišen za 13%, 29% i 29% u bolesnika s blagim, umjerenim odnosno teškim zatajenjem bubrega, ali ne i u ispitanika na hemodijalizi.
Polyvinyl chloride/Aluminum (PVC/Alu) perforated unit dose blister.
Polivinilklorid/aluminij (PVC/Alu) perforirani blister djeljiv na jedinične doze.
Possible signs of dehydration are: feeling light-headed or dizzy passing out (fainting) or feeling dizzy or faint when you stand up very dry or sticky mouth, feeling very thirsty feeling very weak or tired passing little or no urine fast heartbeat.
Mogući znakovi dehidracije su: osjećaj ošamućenosti ili omaglice nesvjestica ili osjećaj omaglice ili gubitak svijesti pri ustajanju vrlo suha ili ljepljiva usta, snažan osjećaj žeđi osjećaj jake slabosti ili umora oslabljeno ili odsutno mokrenje brzi otkucaji srca.
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.
No Observed Effect Level) pri izloženostima 2,4 puta i 0,6 puta kliničke izloženosti pri dozama od 100 mg odnosno 300 mg, te se nije u potpunosti povratila tijekom otprilike 1-mjesečnog razdoblja oporavka.
Interaction studies suggest that the pharmacokinetics of canagliflozin are not altered by metformin, hydrochlorothiazide, oral contraceptives (ethinyl estradiol and levonorgestrol), ciclosporin, and/or probenecid.
Ispitivanja interakcija pokazuju da metformin ne mijenja farmakokinetiku kanagliflozina, hidrolortiazida, oralnih kontraceptiva (etinilestradiol i levonorgestrol), ciklosporina, i/ili probenecida.
Signs include blurred vision, tingling lips, trembling, sweating, pale looking, a change in mood, or feeling anxious or confused.
Znakovi uključuju zamagljen vid, trnce usana, drhtanje, znojenje, bljedoću, promjene raspoloženja, osjećaj tjeskobe ili smetenosti.