natgillin/translations-raw huggingface dataset:
In other type 2 diabetes studies with canagliflozin, which enrolled a general diabetes population of approximately 5,800 patients, no difference in fracture risk was observed relative to control.
V drugih študijah sladkorne bolezni tipa 2 s kanagliflozinom, v katere je bilo vključenih 5.800 bolnikov iz splošne populacije bolnikov s sladkorno boleznijo, razlik v tveganju za zlom kosti v primerjavi s kontrolno skupino niso opazili.
Significant improvements in body weight and reductions in systolic blood pressure compared to both glimepiride and sitagliptin were also observed.
Poleg tega so opazili tudi pomembno zmanjšanje telesne mase in znižanje sistoličnega krvnega tlaka v primerjavi z glimepiridom in s sitagliptinom.
Insulin and insulin secretagogues, such as sulphonylureas, can cause hypoglycaemia.
Insulin in spodbujevalci izločanja insulina, kot je sulfonilsečnina, lahko povzročijo hipoglikemijo.
This may affect your ability to drive, cycle, and use any tools or machines.
To lahko vpliva tudi na sposobnost vožnje avtomobila ali kolesa ter uporabe naprav in strojev.
Subjects responded to standard treatments while continuing canagliflozin treatment.
Bolniki so se odzvali na običajno zdravljenje in nadaljevali zdravljenje s kanagliflozinom.
• 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, contact a doctor or the nearest hospital straight away.
• 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.
Safety data profiles from individual pivotal studies (including studies in moderately renally impaired patients; older patients [≥ 55 years of age to ≤ 80 years of age]; patients with increased CV-risk) were generally consistent with the adverse reactions identified in this table.
a Profili varnostnih podatkov iz posameznih ključnih študij (vključno s študijami z bolniki z zmerno okvaro ledvic, s starejšimi bolniki [starih od ≥ 50 do ≤ 80 let]; bolnikih s povečanim tveganjem za kardiovaskularne bolezni) so se večinoma ujemali z neželenimi učinki, ki so navedeni v tej preglednici.
Canagliflozin has not been studied in patients with severe hepatic impairment and is not recommended for use in these patients (see section 5.2).
Kanagliflozina niso preučevali pri bolnikih s hudo okvaro jeter, zato uporabe pri teh bolnikih ne priporočamo (glejte poglavje 5.2).
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in previdnostni ukrepi Splošno
Canagliflozin is transported by P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP).
Kanagliflozin se prenaša vezan na P-glikoprotein (P-gp) in membranski transporterski protein (ABCG2 oz. BCRP - Breast Cancer Resistance Protein).
Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Omejeni podatki kliničnih preskušanj kažejo, da se DKA pri bolnikih s sladkorno boleznijo tipa 1, ki so bili zdravljeni z zaviralci SGLT2, pojavi pogosto.
Enzyme inducers (such as St. John's wort [Hypericum perforatum], rifampicin, barbiturates, phenytoin, carbamazepine, ritonavir, efavirenz) may give rise to decreased exposure of canagliflozin.
Induktorji encimov (kot so šentjanževka [Hypericum perforatum], rifampicin, barbiturati, fenitoin, karbamazepin, ritonavir in efavirenz) lahko povzročijo zmanjšano izpostavljenost kanagliflozinu.
In a pooled analysis of clinical data, increases in canagliflozin AUC of 26% were observed in UGT1A9*1/*3 carriers and 18% in UGT2B4*2/*2 carriers.
Pri analizi združenih kliničnih podatkov so opazili povečanja v AUC kanagliflozina pri prenašalcih UGT1A9*1/*3 za 26% in pri prenašalcih UGT2B4*2/*2 za 18%.
In rare instances, phimosis was reported and sometimes circumcision was performed (see section 4.4).
Poročali so o redkih primerih fimoze in v nekaj primerih so izvedli cirkumcizijo (glejte poglavje 4.4).
Invokana is available in PVC/aluminium perforated unit dose blisters.
Zdravilo Invokana je na voljo v pretisnih omotih iz PVC/aluminija, perforiranih na posamezen odmerek.
Hypotension*, Orthostatic hypotension*
Žilne bolezni občasni hipotenzija*, ortostatska hipotenzija*
When pregnancy is detected, treatment with canagliflozin should be discontinued.
V primeru nosečnosti je treba zdravljenje s kanagliflozinom prekiniti.
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).
Pri zgoraj navedenih bolnikih, ki so nagnjeni k bolj obsežnemu zmanjšanju znotrajžilnega volumna, so včasih opazili tudi bolj obsežno zmanjšanje ocenjene glomerulne filtracije (za > 30%), kar se je sčasoma popravilo, v redkih primerih je bila potrebna prekinitev zdravljenja s kanagliflozinom (glejte poglavje 4.8).
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).
Uporaba kanagliflozina ni priporočena pri bolnikih, ki jemljejo diutetike Henleyeve zanke (glejte poglavje 4.5) ali pri bolnikih s hipovolemijo, npr. zaradi akutne bolezni (kot so gastrointestinalne bolezni).
Haematocrit increase was observed with canagliflozin treatment (see section 4.8); therefore, caution in patients with already elevated haematocrit is warranted.
Pri zdravljenju s kanagliflozinom so opazili povečan hematokrit (glejte poglavje 4.8), zato pri bolnikih s predhodno povečanim hematokritom svetujemo previdnost.
Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
Če se pojavijo ti simptomi, je treba takoj preveriti, ali gre za ketoacidozo, ne glede na koncentracijo glukoze v krvi.
Adverse reactions in table 1 are based on the pooled analysis of the four 26-week placebo-controlled studies (n=2,313) described above.
Podatki o neželenih učinkih v preglednici 1 izhajajo iz zgoraj opisane analize združenih podatkov štirih 26-tedenskih, s placebom nadzorovanih študij (n = 2.313).
In addition, reductions in body weight and systolic blood pressure relative to placebo were observed.
Poleg tega so pri bolnikih opazili zmanjšanje telesne mase in znižanje sistoličnega krvnega tlaka v primerjavi z uporabo placeba.
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).
Pri povečevanju odmerka je potrebna previdnost pri bolnikih, ki so stari ≥ 75 let, bolnikih z znano srčnožilno boleznijo in drugih bolnikih, pri katerih začetna, s kanagliflozinom povzročena diureza predstavlja nevarnost (glejte poglavje 4.4).
Moderate increases (generally < 400 mL to 500 mL) in daily urine volume were seen that attenuated over several days of dosing.
Opazili so zmerno povečanje volumna dnevno izločenega urina (večinoma za < 400 ml do 500 ml), ki pa se je v nekaj dneh po odmerjanju zmanjšalo.
Patients with hepatic impairment For patients with mild or moderate hepatic impairment, no dose adjustment is required.
Bolniki z okvaro jeter Pri bolnikih z blago ali zmerno okvaro jeter prilagajanje odmerjanja ni potrebno.
For further detail, it may be advisable to contact the specific manufacturer of the 1,5-AG assay.
Priporočamo, da se za dodatne podatke obrnete na izdelovalca testa 1,5-AG.
Cholestyramine may potentially reduce canagliflozin exposure.
Holestiramin lahko zmanjša izpostavljenost kanagliflozinu.
The increases in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Povečanje izpostavljenosti simvastatinu oziroma simvastatinski kislini ni klinično pomembno.
For patients receiving canagliflozin, in case of intercurrent conditions that may lead to volume depletion (such as a gastrointestinal illness), careful monitoring of volume status (e.g., physical examination, blood pressure measurements, laboratory tests including renal function tests), and serum electrolytes is recommended.
Če pri bolnikih, ki prejemajo kanagliflozin, pride do sočasnih težav, ki lahko povzročijo hipovolemijo (na primer nekatere gastrointestinalne bolezni), je priporočeno skrbno spremljanje volumskega statusa (na primer s telesnim pregledom, z meritvami krvnega tlaka, z laboratorijskimi preiskavami vključno s testi delovanja ledvic) in določanje koncentracije elektrolitov v serumu.
Among female patients taking canagliflozin, 2.3% experienced more than one infection.
Med bolnicami, ki so jemale kanagliflozin, je pri 2,3% prišlo do več kot ene okužbe.
• if you have type 1 diabetes (your body does not produce any insulin).
• če imate sladkorno bolezen tipa 1 (vaše telo sploh ne tvori insulina) - za zdravljenje te bolezni se zdravila Invokana ne sme uporabljati
Manufacturer Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy
Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italija
Use in patients at risk for adverse reactions related to volume depletion
Uporaba pri bolnikih s tveganjem za neželene učinke, povezane s hipovolemijo
For oral use
Za peroralno uporabo
Lactose anhydrous Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate
Jedro tablete brezvodna laktoza mikrokristalna celuloza hidroksipropilceluloza premrežen natrijev karmelozat magnezijev stearat
The mean steady-state volume of distribution of canagliflozin following a single intravenous infusion in healthy subjects was 119 litres, suggesting extensive tissue distribution.
Pri zdravih osebah je bil povprečen volumen porazdelitve kanagliflozina v stanju dinamičnega ravnovesja po enkratni intravenski infuziji 119 litrov, kar kaže na obsežno porazdelitev v tkivih.
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).
Pri teh bolnikih so poročali tudi o več dogodkih z zvišano koncentracijo kalija ter o večjem zvišanju koncentracije kreatinina v serumu in dušika sečnine v krvi (BUN - Blood Urea Nitrogen) (glejte poglavje 4.8).
Investigations common
Preiskave pogosti
To assess risk factors for these adverse reactions, a larger pooled analysis (N=9,439) of patients from eight controlled phase 3 studies including both doses of canagliflozin was conducted.
Za oceno dejavnikov tveganja za navedene neželene učinke so izvedli večjo analizo združenih podatkov bolnikov (n = 9.439) iz osmih nadzorovanih študij faze III z obema odmerkoma kanagliflozina.
O-glucuronidation is the major metabolic elimination pathway for canagliflozin, which is mainly glucuronidated by UGT1A9 and UGT2B4 to two inactive O-glucuronide metabolites.
O-glukuronidacija je glavna presnovna pot izločanja kanagliflozina, in sicer večinoma poteka z encimoma UGT1A9 in UGT2B4, pri čemer nastaneta dva neaktivna O-glukuronidna presnovka.
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 v odmerku 300 mg enkrat na dan, 6 dni, z enkratnim odmerkom 40 mg simvastatina (ki je substrat CYP3A4) je povzročila povečanje AUC simvastatina za 12% in zvišanje njegove Cmax za 9% ter povečanje AUC simvastatinske kisline za 18% in zvišanje njene Cmax za 26%.
Among male patients taking canagliflozin, 0.9% had more than one infection.
Med bolniki, ki so jemali kanagliflozin, je pri 0,9% prišlo do več kot ene okužbe.
Canagliflozin is a low-clearance substance, with a mean systemic clearance of approximately 192 mL/min in healthy subjects following intravenous administration.
Kanagliflozin je učinkovina z majhnim očistkom, saj je njegov povprečni sistemski očistek pri zdravih osebah po intravenskem odmerjanju približno 192 ml/min.
Due to volume depletion, generally small mean decreases in eGFR were seen within the first 6 weeks of treatment initiation with canagliflozin.
Zaradi hipotenzije so večinoma opazili majhno povprečno znižanje ocenjene glomerulne filtracije v prvih 6 tednih po začetku zdravljenja s kanagliflozinom.
A single-dose, open-label study evaluated the pharmacokinetics of canagliflozin 200 mg in subjects with varying degrees of renal impairment (classified using CrCl based on the Cockroft-Gault equation) compared to healthy subjects.
V odprti študiji s posameznimi odmerki so ocenjevali farmakokinetične lastnosti kanagliflozina v odmerku 200 mg pri osebah z različnimi stopnjami okvare ledvic (po klasifikaciji glede na CrCl po Cockroft-Gaultovi enačbi) v primerjavi z zdravimi osebami.
Invokana can be used by itself or along with other medicines you may be using to treat your type 2 diabetes (such as metformin, insulin, a DPP-4 inhibitor [such as sitagliptin, saxagliptin, or linagliptin], a sulphonylurea [such as glimepiride or glipizide], or pioglitazone) that lower blood sugar levels.
Zdravilo Invokana je mogoče uporabljati samostojno ali pa skupaj z drugimi zdravili, ki jih morda že uporabljate pri zdravljenju sladkorne bolezni tipa 2 (kot so metformin, insulin, zaviralci encima DPP-4 [na primer sitagliptin, saksagliptin in linagliptin], sulfonilsečnine [na primer glimepirid ali glipizid] ali pioglitazon) in znižujejo koncentracijo sladkorja v krvi.
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.
V študiji embrio-fetalnega razvoja pri podganah, so pri sistemskih izpostavljenostih, ki so bile 73-krat in 19-krat večje od kliničnih pri odmerkih 100 mg in 300 mg, opazili zakasnitev osifikacije metatarzalnih kosti.
Canagliflozin has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Kanagliflozin nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Pharmacotherapeutic group: Drugs used in diabetes, other blood glucose lowering drugs, excluding insulins.
Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, drugi antidiabetiki razen insulinov.
In the dedicated cardiovascular study and the larger pooled analysis, discontinuations due to adverse reactions related to volume depletion and serious adverse reactions related to volume depletion were not increased with canagliflozin.
V posebni kardiovaskularni študiji in po podatkih združene analize pogostnost prekinitve zdravljenja zaradi neželenega učinka, povezanega s hipovolemijo, in pogostnost resnih neželenih učinkov, povezanih s hipovolemijjo, nista bili povečani zaradi zdravljenja s kanagliflozinom.
Due to its mechanism of action, patients taking canagliflozin will test positive for glucose in their urine.
Pri bolnikih, ki jemljejo kanagliflozin je, zaradi njegovega mehanizma delovanja, rezultat testa prisotnosti glukoze v urinu pozitiven.
Effects of other medicinal products on canagliflozin The metabolism of canagliflozin is primarily via glucuronide conjugation mediated by UDP glucuronosyl transferase 1A9 (UGT1A9) and 2B4 (UGT2B4).
Metabolizem kanagliflozina poteka predvsem s konjugacijo v glukuronide s posredovanjem UDP glukuronozil transferaze 1A9 (UGT1A9) in 2B4 (UGT2B4).
b Thirst includes the terms thirst, dry mouth, and polydipsia.
b Izraz žeja vključuje žejo, suha usta in polidipsijo.
The pack sizes are cartons of 10 x 1, 30 x 1, 90 x 1, or 100 x 1 tablets.
Na voljo so naslednje velikosti pakiranj: škatla z 10 x 1, s 30 x 1, z 90 x 1 ali s 100 x 1 tableto.
• The active substance is canagliflozin.
• Zdravilna učinkovina je kanagliflozin.
Protein binding is independent of canagliflozin plasma concentrations.
Vezava na beljakovine ni odvisna od koncentracije kanagliflozina v plazmi.
Renal clearance of canagliflozin 100 mg and 300 mg doses ranged from 1.30 mL/min to 1.55 mL/min.
Ledvični očistek pri odmerkih 100 mg in 300 mg je znašal od 1,30 ml/min do 1,55 ml/min.
Genital mycotic infections
Genitalne glivične okužbe
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).
V treh študijah, ki so jih izvajali pri posebnih skupinah bolnikov (pri starejših bolnikih, pri bolnikih z ocenjeno glomerulno filtracijo od 30 ml/min/1,73 m2 do < 50 ml/min/1,73 m2 in pri bolnikih s tveganjem oziroma s povečanim tveganjem za kardiovaskularne bolezni), so kanagliflozin dodali k stabilni shemi zdravljenja sladkorne bolezni posameznega bolnika (dieti, monoterapiji ali kombinaciji zdravil).
Overall, 0.5% of male patients discontinued canagliflozin due to candidial balanitis or balanoposthitis.
Skupno je 0,5% vseh bolnikov moškega spola prekinilo zdravljenje s kanagliflozinom zaradi kandidoznega balanitisa oziroma balanopostitisa.
After 104 weeks of treatment, canagliflozin did not adversely affect bone mineral density.
Po 104 tednih zdravljenja ni bilo negativnega vpliva kanagliflozina na kostno gostoto.
Age had no clinically meaningful effect on the pharmacokinetics of canagliflozin based on a population pharmacokinetic analysis (see sections 4.2, 4.4, and 4.8).
Po podatkih populacijske farmakokinetične analize starost ni klinično pomembno vplivala na farmakokinetiko kanagliflozina (glejte poglavja 4.2, 4.4 in 4.8).
Thirst includes the terms thirst, dry mouth, and polydipsia.
Izraz žeja vključuje žejo, suha usta in polidipsijo.
Canagliflozin's action to increase UGE directly lowering plasma glucose is independent of insulin.
Delovanje kanagliflozina na povečanje izločanja glukoze z urinom, s čimer neposredno zniža koncentracijo glukoze v plazmi, je neodvisno od insulina.
Talk to your doctor about the best way to discontinue Invokana and control your blood sugar as soon as you know that you are pregnant.
Takoj, ko izveste, da ste noseči, se s svojim zdravnikom pogovorite o najboljšem načinu prenehanja jemanja zdravila Invokana in urejanja sladkorja v krvi med nosečnostjo.
This leaflet was approved in {month YYYY}.
Navodilo je bilo nazadnje revidirano dne {mesec LLLL}.
Common (may affect up to 1 in 10 people)
Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov)
What Invokana looks like and contents of the pack
Izgled zdravila Invokana in vsebina pakiranja
< 60 mL/min taking canagliflozin 100 mg who are receiving concurrent therapy with a UGT enzyme inducer and who require additional glycaemic control, other glucose-lowering therapies should be considered (see sections 4.2 and 4.4).
< 60 ml/min, ki jemljejo kanagliflozin 100 mg in sočasno induktorje encimov UGT in potrebujejo dodaten nadzor nad glikemijo, je treba razmisliti o drugem antihiperglikemičnem zdravljenju (glejte poglavji 4.2 in 4.4).
In a single-dose study in patients with type 2 diabetes, treatment with 300 mg before a mixed meal delayed intestinal glucose absorption and reduced postprandial glucose through both a renal and a non-renal mechanism.
V študiji enkratnih odmerkov pri bolnikih s sladkorno boleznijo tipa 2 je odmerek 300 mg pred mešanim obrokom zakasnil absorpcijo glukoze v črevesju in znižal koncentracijo glukoze v krvi po obroku tako s pomočjo ledvičnega kot neledvičnega mehanizma delovanja.
In interaction studies, canagliflozin at steady-state had no clinically relevant effect on the pharmacokinetics of metformin, oral contraceptives (ethinyl estradiol and levonorgestrol), glibenclamide, paracetamol, hydrochlorothiazide, or warfarin.
V študijah medsebojnih delovanj kanagliflozin v stanju dinamičnega ravnovesja ni imel klinično pomembnega učinka na farmakokinetiko metformina, peroralnih kontraceptivov (etanilestradiol in levonorgestrol), glibenklamida, paracetamola, hidroklortiazida in varfarina.
In addition, in such patients greater decreases in eGFR were reported (see sections 4.2 and 4.8).
Poleg tega so pri teh bolnikih poročali tudi o večjem zmanjšanju ocenjene glomerulne filtracije (glejte poglavji 4.2 in 4.8).
Adverse reactions listed below are classified according to frequency and system organ class (SOC).
Neželeni učinki so razvrščeni po pogostnosti in po organskih sistemih.
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).
V skladu z mehanizmom zaviranja prenašalca SGLT2 (sodium glucose co-transporter 2) in povečanjem izločanja glukoze z urinom so v kliničnih študijah poročali o vulvovaginalni kandidozi pri ženskah in o balanitisu ter balanopostitisu pri moških (glejte poglavje 4.8).
Pharmacodynamic interactions
Farmakodinamične interakcije
Dabigatran: The effect of concomitant administration of canagliflozin (a weak P-gp inhibitor) on dabigatran etexilate (a P-gp substrate) has not been studied.
Dabigatran: učinka sočasne uporabe kanagliflozina (šibek zaviralec P-gp) na dabigatran eteksilat
Enterohepatic circulation of canagliflozin was negligible.
Obseg enterohepatične cirkulacije kanagliflozina je zanemarljiv.
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).
Kadar z drugimi zdravili, ki znižujejo koncentracijo glukoze, vključno z insulinom, skupaj z dieto in s telesno dejavnostjo, glikemija ni zadostno urejena (za razpoložljive podatke o različnih načinih dodatnega zdravljenja glejte poglavja 4.4, 4.5 in 5.1).
Do not use Invokana if the packaging is damaged or shows signs of tampering.
Zdravila Invokana ne uporabljajte, če opazite, da je ovojnina poškodovana ali da je bila že odprta.
Elderly (≥ 65 years old) Renal function and risk of volume depletion should be taken into account (see section 4.4).
Starostniki (≥ 65 let) Upoštevati je treba stanje ledvic in tveganje za pojav hipovolemije (glejte poglavje 4.4).
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.
Zdrave osebe so večinoma dobro prenašale enkratne odmerke do 1.600 mg kanagliflozina, bolniki s sladkorno boleznijo tipa 2 pa odmerke 300 mg dvakrat na dan v obdobju 12 tednov.
Additional safety analyses (including long-term data) from data across the entire canagliflozin programme (placebo- and active-controlled studies) were conducted to assess reported adverse reactions in order to identify adverse reactions (see table 1) (see sections 4.2 and 4.4).
Za ugotavljanje neželenih učinkov so izvedli dodatno analizo podatkov o varnosti zdravila (vključno s podatki pri dolgotrajni uporabi) v kateri so ocenili neželene učinke, poročane v celotnem programu študij s kanagliflozinom (s placebom in aktivno nadzorovanih študij) (glejte preglednico 1) (glejte poglavji 4.2 in 4.4).
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 tablet) EU/1/13/884/002 (100 mg - 30 tablet) EU/1/13/884/003 (100 mg - 90 tablet) EU/1/13/884/004 (100 mg - 100 tablet) EU/1/13/884/005 (300 mg - 10 tablet) EU/1/13/884/006 (300 mg - 30 tablet) EU/1/13/884/007 (300 mg - 90 tablet) EU/1/13/884/008 (300 mg - 100 tablet)