natgillin/translations-raw huggingface dataset:
When this happens, sugar (glucose) builds up in the blood. 
(glukoza) se nakuplja u krvi.
Canagliflozin was negligibly removed by haemodialysis. 
Kanagliflozin se zanemarivo uklanjao hemodijalizom.
How to store Invokana 
Kako uzimati lijek Invokana
9.3% versus 1.3%; non-HDL-cholesterol 2.2% and 4.4% versus 0.7%; triglycerides 2.4% and 0.0% versus 7.6%. 
kolesterol 5,7% i 9,3% naspram 1,3%; ne HDL kolesterol 2,2% i 4,4% naspram 0,7%; trigliceride 2,4% i 0,0%
Mean percent increases from baseline for canagliflozin 100 mg and 300 mg versus placebo, respectively, were total cholesterol 3.4% and 5.2% versus 0.9%; HDL-cholesterol 9.4% and 10.3% versus 4.0%; LDL-cholesterol 5.7% and 9.3% versus 1.3%; non-HDL-cholesterol 2.2% and 4.4% versus 0.7%; triglycerides 2.4% and 0.0% versus 7.6%. 
Srednji postotak porasta u odnosu na početnu vrijednost za kanagliflozin od 100 mg odnosno 300 mg naspram placeba, bio je za ukupni kolesterol 3,4% i 5,2% naspram 0,9%; HDL kolesterol 9,4% i 10,3% naspram 4,0%; LDL kolesterol 5,7% i 9,3% naspram 1,3%; ne HDL kolesterol 2,2% i 4,4% naspram 0,7%; trigliceride 2,4% i 0,0%
Vulvovaginal candidiasis includes the terms vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis, 
g Vulvovaginalna kandidijaza uključuje termine vulvovaginalna kandidijaza, vulvovaginalna gljivična infekcija,
Based on AUC exposure, the NOEL of 30 mg/kg/day for pheochromocytomas and renal tubular tumours is approximately 4.5 times the exposure at the daily clinical dose of 300 mg. Based on preclinical and clinical mechanistic studies, Leydig cell tumours, renal tubule tumours, and pheochromocytomas are considered to be rat-specific. 
Temeljeno na izloženosti AUC, NOEL od 30 mg/kg/ dan za feokromocitome i bubrežne tubularne tumore je približno 4,5 puta izloženosti pri dnevnoj kliničkoj dozi od 300 mg.
Body weight Baseline (mean) in kg 
Početna vrijednost (srednja vrijednost) u kg
Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
Slijedom navedenog, nositelj odobrenja će ta izvješća podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom
The frequency of hypoglycaemia was low (approximately 4%) among treatment groups, including placebo, when used as monotherapy or as an add-on to metformin. 
Među liječenim skupinama uključujući placebo, učestalost hipoglikemije bila je niska (priližno 4%), u monoterapiji ili u dodatnoj terapiji uz metformin.
When canagliflozin was added to insulin therapy, hypoglycaemia was observed in 49.3%, 48.2%, and 36.8% of patients treated with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively, and severe hypoglycaemia occurred in 1.8%, 2.7%, and 2.5% of patients treated with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively. 
U slučaju kad je kanagliflozin dodan uz terapiju inzulinom, primijećena je hipoglikemija u 49,3%; 48,2% i 36,8% bolesnika liječenih kanagliflozinom od 100 mg, kanagliflozinom od 300 mg odnosno placebom, a teška hipoglikemija javila se u 1,8%; 2,7% i 2,5% bolesnika liječenih kanagliflozinom od 100 mg, kanagliflozinom od 300 mg odnosno placebom.
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). 
U placebo-kontroliranim ispitivanjima, liječenje kanagliflozinom od 100 mg i 300 mg dovelo je do smanjenja srednjih vrijednosti sistoličkog krvnog tlaka od -3,9 mmHg odnosno -5,3 mmHg, u usporedbi s placebom (-0,1 mmHg) i manjeg učinka na dijastolički krvni tlak sa promjene srednjih vrijednosti uz kanagliflozin od 100 mg i 300 mg od -2,1 mmHg odnosno -2,5 mmHg, u usporedbi s placebom (-0,3 mmHg).
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). 
Međutim, kad se kanagliflozin uzima kao dodatna terapija uz inzulin ili inzulinski sekretagog, bolesnike treba upozoriti na rizik pojave hipoglikemije i na povišeni rizik za pojavu nuspojava povezanih s deplecijom volumena, poput posturalne omaglice (vidjeti dijelove 4.2, 4.4 i 4.8).
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). 
U slučaju kad je kanagliflozin dodan uz terapiju sulfonilurejom, hipoglikemija je primijećena u 4,1%; 12,5% i 5,8% bolesnika liječenih kanagliflozinom od 100 mg, kanagliflozinom od 300 mg, odnosno placebom (vidjeti dijelove 4.2 i 4.5).
• St. John's wort (an herbal medicine to treat depression) 
• gospinu travu (biljni lijek za liječenje depresije)
In this pooled analysis, patients on loop diuretics, patients with a baseline eGFR 30 mL/min/1.73 m2 to 
U ovoj udruženoj analizi, bolesnici na diureticima Henleove petlje, bolesnici s početnom vrijednosti eGFR 30 mL/min/1,73 m2
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. 
Kanagliflozin od 100 mg kao dvojna terapija s metforminom izazvao je slična smanjenja HbA1c od početne vrijednosti, a 300 mg je izazvao superiorna (p < 0,05) smanjenja HbA1c u usporedbi s glimepiridom, te prema tome pokazao neinferiornost.
How to take Invokana 
Kako čuvati lijek Invokana
Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3% for placebo. 
e Fraktura kostiju bila je prijavljena u 0,7% i 0,6% za kanagliflozin od 100 mg odnosno 300 mg, u usporedbi s 0,3% za placebo.
In four placebo-controlled studies, treatment with canagliflozin as monotherapy or add-on therapy with one or two oral glucose-lowering medicinal products resulted in mean changes from baseline relative to placebo in FPG of -1.2 mmol/L to -1.9 mmol/L for canagliflozin 100 mg and -1.9 mmol/L to -2.4 mmol/L for canagliflozin 300 mg, respectively. 
U četri placebo-kontrolirana ispitivanja, liječenje kanagliflozinom kao monoterapijom ili dodatnom terapijom s jednim ili dva oralna lijeka koji snižavaju glukozu rezultiralo je promjenom srednje vrijednosti FPG od početne vrijednosti u odnosu na placebo, od -1,2 mmol/L do -1,9 mmol/L za kanagliflozin od 100 mg odnosno -1,9 mmol/L do -2,4 mmol/L za kanagliflozin od 300 mg.
The majority of patients with a baseline eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 were on insulin and/or a sulphonylurea (85% [614/721]). 
Većina bolesnika s početnom vrijednošću eGFR 45 mL/min/1,73 m2 do < 60 mL/min/1,73 m2 bili su na inzulinu i/ili sulfonilureji (85% [614/721]).
The proportion of patients with larger decreases in eGFR (> 30%) at any time during treatment was 9.3%, 12.2%, and 4.9% with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively. 
Udio bolesnika s većim smanjenjima eGFR (> 30%) u bilo kojem trenutku tijekom liječenja kanagliflozinom od 100 mg, kanagliflozinom od 300 mg, odnosno placebom bio je 9,3%; 12,2% i 4,9%.
Canagliflozin should not be initiated in patients with an eGFR < 60 mL/min/1.73 m2 or 
Kanagliflozin ne smiju započinjati uzimati bolesnici s eGFR < 60 mL/min/1,73 m2 ili CrCl < 60 mL/min.
Musculoskeletal and connective tissue disorders uncommon 
Angioedemd Poremećaji mišićno-koštanog sustava i vezivnog tkiva manje često
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. 
Za bolesnike na diureticima Henleove petlje, incidencije su bile 3,2% uz kanagliflozin od 100 mg i 8,8% uz kanagliflozin od 300 mg u usporedbi s 4,7% u kontrolnoj skupini.
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. 
Uz mještoviti obrok kao poticaj, kanagliflozin kao monoterapija ili dodatna terapija s jednim ili dva oralna lijeka koji snižavaju glukozu, je smanjila postprandijalnu glukozu (PPG) od početne vrijednosti u odnosu na placebo za -1,5 mmol/L do -2,7 mmol/L za kanagliflozin od 100 mg, odnosno -2,1 mmol/L do -3,5 mmol/L za lijek od 300 mg, zbog smanjenja koncentracija glukoze prije jela i smanjene ekskurzije postprandijalne glukoze.
Add-on therapy with insulind (18 weeks) Canagliflozin + insulin 
Dodatna terapija s inzulinomd (18 tjedana) Kanagliflozin + inzulin
LIST OF EXCIPIENTS Contains lactose. 
Invokana sadrži laktozu
Placebo + metformin and sulphonylurea (N = 156) 
Placebo + metformin i sulfonilureja (N = 156)
Bone fracture 
Frakture kostiju
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) 
Prestanite uzimati lijek Invokana i što je prije moguće posjetite liječnika ako imate bilo koju od sljedećih ozbiljnih nuspojava:
The increased UGE with SGLT2 inhibition also translates to an osmotic diuresis, with the diuretic effect leading to a reduction in systolic blood pressure; the increase in UGE results in a loss of calories and therefore a reduction in body weight, as has been demonstrated in studies of patients with type 2 diabetes. 
povišenje UGE rezultira gubitkom kalorija i zbog toga sa smanjenjem tjelesne težine, kako je bilo pokazano u ispitivanjima s bolesnicima s dijabetesom tipa 2.
i Mean percent increases from baseline for canagliflozin 100 mg and 300 mg versus placebo, respectively, were total cholesterol 3.4% and 5.2% versus 0.9%; HDL-cholesterol 9.4% and 10.3% versus 4.0%; LDL-cholesterol 5.7% and 
i Srednji postotak porasta u odnosu na početnu vrijednost za kanagliflozin od 100 mg odnosno 300 mg naspram placeba, bio je za ukupni kolesterol 3,4% i 5,2% naspram 0,9%; HDL kolesterol 9,4% i 10,3% naspram 4,0%; LDL
Your blood sugar levels may rise if you stop taking this medicine. 
Ako prestanete uzimati lijek Invokana Ako prestanete uzimati ovaj lijek, može Vam porasti razina šećera u krvi.
3.2% of the administered radioactive dose was recovered in faeces as canagliflozin, a hydroxylated metabolite, and an O-glucuronide metabolite, respectively. 
primijenjene radioaktivne doze se ponovno našlo u stolici, kao hidroksilirani odnosno O-glukuronidni metabolit.
Very common 
manje često
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal products subject to medical prescription 
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
Sitagliptin 100 mg + metformin and sulphonylurea (N = 378) 
Sitagliptin 100 mg + metformin i sulfonilureja (N = 378)
Canagliflozin 300 mg + metformin and sulphonylurea (N=377) 
Kanagliflozin od 300 mg + metformin i sulfonilureja (N = 377)
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. 
l Srednje vrijednosti postotka promjene urea nitrata u krvi u odnosu na početnu bila je 17,1% i 18,0% za kanagliflozin od 100 mg odnosno 300 mg naspram 2,7% za placebo.
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. 
Nakon pojedinačnih i višestrukih oralnih doza kanagliflozina, kod bolesnika s dijabetesom tipa 2,
Canagliflozin should not be used during breast-feeding. 
Kanagliflozin se ne bi trebao primjenjivati tijekom dojenja.
% change from baseline (adjusted mean) 
Promjena od početne vrijednosti (prilagođena srednja vrijednost)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 100 mg kanagliflozina.
If renal function falls persistently below eGFR 45 mL/min/1.73 m2 or CrCl < 45 mL/min, 
Ako bubrežna funkcija padne trajno ispod eGFR 45 mL/min/1,73 m2 ili
Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post-marketing in patients treated with SGLT2 inhibitors, including canagliflozin. 
inhibitorima, uključujući kanagliflozin, prijavljeni su rijetki slučajevi dijabetičke ketoacidoze (DKA), uključujući i slučajeve opasne po život.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 300 mg kanagliflozina.
300 mg, respectively, compared to 2.7% for placebo. 
100 mg odnosno 300 mg naspram 0,6% za placebo.
Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): increased levels of “ketone bodies” in your urine or blood rapid weight loss feeling sick or being sick stomach pain excessive thirst fast and deep breathing confusion unusual sleepiness or tiredness a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat. 
povišene razine “ketonskih tijela” u mokraći ili krvi nagli gubitak tjelesne težine mučnina ili povraćanje bol u trbuhu prekomjerna žeđ ubrzano i duboko disanje smetenost neuobičajena pospanost ili umor zadah slatkog mirisa, slatki ili metalni okus u ustima ili drugačiji miris mokraće ili znoja.
NAME OF THE MEDICINAL PRODUCT Invokana 100 mg film-coated tablets 
NAZIV LIJEKA Invokana 100 mg filmom obložene tablete
NAME OF THE MEDICINAL PRODUCT Invokana 100 mg tablets Invokana 300 mg tablets canagliflozin 
NAZIV LIJEKA Invokana 100 mg tablete Invokana 300 mg tablete kanagliflozin
Latvija Janssen-Cilag Polska Sp. z o.o. 
Latvija Janssen-Cilag Polska Sp. z o.o. filiāle Latvijā
• Invokana 100 mg film-coated tablets (tablets) are yellow, capsule-shaped, 11 mm long, with 
Kako Invokana izgleda i sadržaj pakiranja - Invokana 100 mg filmom obložene tablete (tablete) su žute, oblikovane poput kapsule, dužine
Table 2: Efficacy results from placebo-controlled clinical studiesa 
Tablica 2: Rezultati djelotvornosti iz placebo-kontroliranih kliničkih ispitivanjaa Monoterapija (26 tjedana) Kanagliflozin
Triple therapy with metformin and sulphonylurea (26 weeks) Canagliflozin + metformin and sulphonylurea 
Trojna terapija s metforminom i sulfonilurejom (26 tjedana) Kanagliflozin + metformin i sulfonilureja
• bone fracture 
Fraktura kostijue
The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. 
U slučaju pojave nespecifičnih simptoma poput mučnine, povraćanja, anoreksije, boli u abdomenu,
Steady-state was reached after 4 days to 5 days of once-daily dosing with canagliflozin 100 mg to 300 mg. Canagliflozin does not exhibit time-dependent pharmacokinetics, and accumulated in plasma up to 36% following multiple doses of 100 mg and 300 mg. 
Kanagliflozin ne pokazuje farmakokinetiku ovisnu o vremenu, te se akumulirao u plazmi do 36% nakon višekratnih doza od 100 mg i 300 mg.
Invokana 100 mg film-coated tablets Invokana 300 mg film-coated tablets canagliflozin 
Invokana 100 mg filmom obložene tablete Invokana 300 mg filmom obložene tablete kanagliflozin
NAME OF THE MEDICINAL PRODUCT Invokana 300 mg film-coated tablets 
NAZIV LIJEKA Invokana 300 mg filmom obložene tablete
In patients tolerating canagliflozin whose eGFR falls persistently below 60 mL/min/1.73 m2 or CrCl 60 mL/min, the dose of canagliflozin should be adjusted to or maintained at 100 mg once daily. 
60 mL/min/1,73 m2 ili CrCl 60 mL/min, doza kanagliflozina mora se prilagoditi ili održavati na 100 mg jedanput dnevno.
NO-1325-Lysaker Tlf: +47 24 12 65 00 
Janssen-Cilag AS Drammensveien 288 Postboks 144 NO-1325-Lysaker Tlf: +47 24 12 65 00
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. 
U drugim ispitivanjima dijabetesa tipa 2 s kanagliflozinom, koja su uključila opću populaciju s dijabetesom od oko
SK-821 08 Bratislava Tel: +421 232 408 400 
SK-821 08 Bratislava
Reporting of side effects 
Prijavljivanje nuspojave
Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 1.5% for placebo. 
k Srednje vrijednosti postotka promjene kreatinina u odnosu na početnu bila je 2,8% i 4,0% za kanagliflozin od 100 mg odnosno 300 mg naspram 1,5% za placebo.
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 
U bolesnika s eGFR 60 mL/min/1,73 m2 do < 90 mL/min/1,73 m2 ili s CrCl 60 mL/min do
In the clinical development programme, 1,085 patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 were evaluated. 
1085 bolesnika s početnom vrijednosti eGFR 30 mL/min/1,73 m2 do < 60 mL/min/1,73 m2.
respectively, compared to 0.6% for placebo. 
odnosno 4,3%) u usporedbi s 4,0% s placebom.
NAME OF THE MEDICINAL PRODUCT Invokana 100 mg film-coated tablets Invokana 300 mg film-coated tablets canagliflozin 
Uputa o lijeku: Informacija za bolesnika Invokana 100 mg filmom obložene tablete Invokana 300 mg filmom obložene tablete kanagliflozin
Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin. 
Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 100 mg kanagliflozina.
Baseline (mean) in kg % change from baseline (adjusted mean) Difference from glimepiride (adjusted mean) (95% CI) 
Početna vrijednost (srednja vrijednost) u kg % promjene u odnosu na početnu vrijednost (prilagođena srednja vrijednost) Razlika u odnosu na glimepirid
Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.0% for placebo. 
Srednje vrijednosti promjene hematokrita u odnosu na početnu bila je 2.4% i 2,5% za kanagliflozin od 100 mg odnosno 300 mg naspram 0,0% za placebo.
In patients with an eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 or CrCl 45 mL/min to 
Bolesnici s eGFR 45 mL/min/1,73 m2 do < 60 mL/min/1,73 m2
Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin. 
Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 300 mg kanagliflozina.
When pregnancy is detected, treatment with canagliflozin should be discontinued. 
Liječenje kanagliflozinom mora se prekinuti ako se ustanovi trudnoća.
• nausea 
• koprivnjača
Iron oxide yellow (E172) 
Filmska ovojnica polivinilni alkohol titanijev dioksid (E171)
CrCl < 60 mL/min. 
476 kcal/dan.
Urinary tract infections 
Infekcije mokraćnog sustava
Patients (%) achieving HbA1c < 7% 19.8b 
Bolesnici (%) koji su postigli HbA1c
Difference from placebo (adjusted mean) (95% CI) 
(prilagođena srednja vrijednost) (95% CI)
EU/1/13/884/001 (10 tablets) EU/1/13/884/002 (30 tablets) EU/1/13/884/003 (90 tablets) EU/1/13/884/004 (100 tablets) 
EU/1/13/884/003 (90 tableta)
Tell your doctor as soon as possible if you get any of the signs of low blood sugar. 
Što je prije moguće recite svom liječniku ako imate bilo koju od slijedećih nuspojava:
Urinary tract infections were more frequently reported for canagliflozin 100 mg and 300 mg (5.9% versus 4.3%, respectively) compared to 4.0% with placebo. 
Infekcije mokraćnog sustava bile su češće prijavljene za kanagliflozin od 100 mg i 300 mg (5,9%
Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular. 
Osip uključuje pojmove eritemni osip, generalizirani osip, makularni osip, makulopapularni osip, papularni osip,
Urine glucose 
Glukoza u mokraći
Change from baseline (adjusted mean) Difference from glimepiride (adjusted mean) (95% CI) 
% promjene u odnosu na početnu vrijednost (prilagođena srednja vrijednost) Razlika u odnosu na glimepirid
< 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). 
U bolesnika s eGFR 45 mL/min/1,73 m2 do < 60 mL/min/1,73 m2 ili CrCl 45 mL/min do < 60 mL/min koji uzimaju kanagliflozin od 100 mg, koji istovremeno primaju terapiju induktorima UGT enzima i koji zahtjevaju dodatnu regulaciju glikemije, u obzir treba uzeti druge lijekove za snižavanje glukoze (vidjeti dijelove 4.2 i 4.4).
Patients (%) achieving HbA1c < 7% 53.6 Body weight 
Bolesnici (%) koji su postigli HbA1c Tjelesna težina
Janssen-Cilag Polska Sp. z o.o. 
Janssen-Cilag Polska Sp. z o.o. Eesti filiaal Lõõtsa 2
For patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2, the incidences were 4.8% on canagliflozin 100 mg and 8.1% on canagliflozin 300 mg compared to 2.6% in the control group. 
Bolesnici s početnom vrijednosti eGFR 45 mL/min/1,73 m2 do < 60 mL/min/1,73 m2 koji su liječeni kanagliflozinom od 100 mg i 300 mg pokazali su poboljšanja srednje vrijednosti postotka promjene tjelesne težine u odnosu na placebo od -1,8% odnosno -2,0%.
respectively, compared to 1.5% for placebo. 
100 mg odnosno 300 mg naspram 1,5% za placebo.
The overall incidence of elevated serum potassium was higher in patients with moderate renal impairment with incidences of 7.5%, 12.3%, and 8.1% on canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively. 
Ukupna incidencija povišenog kalija u serumu bila je viša u bolesnika s umjerenim oštećenjem bubrega uz kanagliflozin od 100 mg, kanagliflozin od 300 mg, odnosno placebo s incidencijama od
Canagliflozin + insulin 
Primijećeno je da kanagliflozin inhibira
• 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) 
• druge antidijabetike - ili inzulin ili sulfonilureju (poput glimepirida ili glipizida) - liječenik će
canagliflozin treatment should be discontinued. 
Liječenje kanagliflozinom mora se prekinuti u slučaju da je eGFR
Johnson & Johnson România SRL Str. Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5 013714 Bucureşti, ROMÂNIA Tel: +40 21 207 1800 
Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5
Change from baseline (adjusted mean) Difference from sitagliptin (adjusted mean) (95% CI) 
% promjene u odnosu na početnu vrijednost (prilagođena srednja vrijednost) Razlika u odnosu na sitagliptin
Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg, compared to 1.5% for placebo. 
Srednje vrijednosti postotka promjene kalija u krvi u odnosu na početnu bila je 0,5% i 1,0% za kanagliflozin od 100 mg odnosno 300 mg naspram 0,6% za placebo.
h 
m
j Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively, 
j Srednje vrijednosti promjene hematokrita u odnosu na početnu bila je 2.4% i 2,5% za kanagliflozin od 100 mg odnosno 300 mg naspram 0,0% za placebo.
Adverse reaction 
Peroralna primjena
STATEMENT OF ACTIVE SUBSTANCE(S) 
Početna vrijednost (srednja vrijednost)
d Based on postmarketing experience with canagliflozin. 
pruritički osip, pustularni osip i vezikularni osip. d Temeljeno na iskustvu nakon stavljanja kanagliflozina u promet.