FrancophonIA/ELRC3.0 huggingface dataset:
English: When Vokanamet is used as add-on therapy with insulin or an insulin secretagogue (e.g., a sulphonylurea), a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).
Slovenian: Pri uporabi zdravila Vokanamet kot dodatnega zdravila k insulinu ali spodbujevalcu izločanja insulina (na primer sufonilsečnini) je treba za zmanjšanje tveganja za hipoglikemijo razmisliti o zmanjšanju odmerka insulina oziroma spodbujevalca izločanja insulina (glejte poglavji 4.5 in 4.8).
English: Renal impairment Patients with a baseline eGFR < 60 mL/min/1.73 m2 had a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) with incidence rates of 5.3, 5.1, and 3.1 events per 100 patient-years of exposure for canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively (see sections 4.2 and 4.4).
Slovenian: Okvara ledvic Pri bolnikih z izhodiščno vrednostjo eGFR < 60 ml/min/1,73 m2 je bila pojavnost neželenih učinkov, povezanih s hipovolemijo (kot so položajna omotica, ortostatska hipotenzija in hipotenzija) večja, in sicer so bile incidenčne stopnje 5,3, 5,1 in 3,1 dogodkov na 100 bolnikov-let izpostavljenosti pri uporabi 100 mg kanagliflozina, 300 mg kanagliflozina oziroma placeba (glejte poglavji 4.2 in 4.4).
English: HDPE bottle with child-resistant closure, induction seal, and desiccant.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE) z za otroke varno zaporko, indukcijsko zataljeno folijo in sušilnim sredstvom.
English: Canagliflozin dosed with a titration regimen produced clinically and statistically significant (p < 0.001) results relative to placebo in glycaemic control, including HbA1c and change from baseline FPG, and a statistically significant (p < 0.01) improvement in the percentage of patients achieving HbA1c < 7%.
Slovenian: Rezultati pri titriranju odmerkov kanagliflozina v primerjavi s placebom so bili klinično pomembni in statistično značilni (p < 0,001) pri urejanju glikemije, vključno z urejanjem HbA1c in glukoze na tešče od izhodiščne vrednosti ter statistično značilno boljši (p < 0,001) v odstotku bolnikov, ki so dosegli raven HbA1c < 7%.
English: In patients ≥ 75 years of age, the incidence rates were 5.3 on canagliflozin 100 mg and 6.1 on canagliflozin 300 mg compared to 2.4 events per 100 patient-years of exposure in the control group (see sections 4.2 and 4.4).
Slovenian: Pri bolnikih, ki so bili stari ≥ 75 let, je bila incidenčna stopnja teh neželenih učinkov 5,3 pri uporabi 100 mg kanagliflozina in 6,1 pri uporabi 300 mg kanagliflozina v primerjavi z 2,4 dogodka na 100 bolnikov-let izpostavljenosti v kontrolni skupini (glejte poglavji 4.2 in 4.4).
English: What Vokanamet contains
Slovenian: Kaj vsebuje zdravilo Vokanamet
English: These are two medicines that work together in different ways to lower blood glucose (sugar) levels and can help prevent heart disease in adults with type 2 diabetes.
Slovenian: Pri odraslih s sladkorno boleznijo tipa 2 obe učinkovini, vsaka na svoj način, znižujeta koncentracijo glukoze (sladkorja) v krvi in lahko pomagata preprečevati bolezni srca.
English: Each MACE component positively contributed to the overall composite, as shown in Figure 2.
Slovenian: Vsak od neželenih dogodkov v okviru pomembnih kardiovaskularnih neželenih dogodkov je pozitivno prispeval k skupnemu razmerju ogroženosti, kot je prikazano na sliki 2.
English: Table 5: Efficacy results from placebo-controlled clinical study of canagliflozin dosed twice daily
Slovenian: Preglednica 5: Rezultati učinkovitosti kanagliflozina, pri odmerjanju dvakrat na dan v s placebom nadzorovanih kliničnih študijah kanagliflozin placebo (n = 93)
English: Excipient(s) with known effect Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free (see section 6).
Slovenian: Ena tableta vsebuje manj kot 1 mmol natrija (23 mg), kar v bistvu pomeni ‘brez natrija' (glejte poglavje 6).
English: Metformin XR (N = 237)
Slovenian: Parameter učinkovitosti metformin XR (n = 237)
English: Using a mixed-meal challenge, canagliflozin as monotherapy or add-on therapy with one or two oral glucose-lowering medicinal products reduced postprandial glucose from baseline relative to placebo by -1.5 mmol/L to -2.7 mmol/L for canagliflozin 100 mg once daily and -2.1 mmol/L to -3.5 mmol/L for canagliflozin 300 mg once daily, respectively, due to reductions in the pre-meal glucose concentration and reduced postprandial glucose excursions.
Slovenian: 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 enkrat na dan in za -2,1 mmol/l do -3,5 mmol/l pri 300 mg kanagliflozina enkrat na dan. Kanagliflozin je znižal koncentracijo glukoze pred obrokom in zmanjšal obseg nihanj koncentracij glukoze po obroku.
English: Triple therapy with metformin and sulphonylurea (26 weeks) Canagliflozin + metformin and sulphonylurea
Slovenian: Trotirno zdravljenje z metforminom in s sulfonilsečnino (26 tednov) kanagliflozin + metformin in sulfonilsečnina placebo + metformin in sulfonilsečnina (n = 156)
English: This effect at the 300 mg dose of canagliflozin may, in part, be due to local inhibition of intestinal SGLT1 (an important intestinal glucose transporter) related to transient high concentrations of canagliflozin in the intestinal lumen prior to medicinal product absorption (canagliflozin is a low potency inhibitor of the SGLT1 transporter).
Slovenian: V študijah faze III je odmerek 300 mg kanagliflozina pred obrokom enkrat na dan omogočil bolj obsežno zmanjšanje nihanja koncentracije glukoze v krvi po obroku kot odmerek 100 mg enkrat na dan. Do takega delovanja odmerka 300 mg kanagliflozina lahko pride deloma zaradi lokalnega zaviranja prenašalca SGLT1 v črevesju (pomembnega črevesnega prenašalca glukoze), ki je povezano s prehodno visoko koncentracijo kanagliflozina v svetlini črevesa, preden se zdravilo absorbira (kanagliflozin je šibak zaviralec prenašalca SGLT1).
English: Canagliflozin + metformin and sitagliptin (N = 107)
Slovenian: kanagliflozin + metformin in sitaglipin (n = 107)
English: Canagliflozin 300 mg (N = 238)
Slovenian: kanagliflozin 300 mg (n = 238)
English: 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.
Slovenian: Če se pojavijo nespecifični simptomi, kot so navzea, bruhanje, anoreksija, bolečine v trebuhu, huda žeja, težave z dihanjem, zmedenost, nenavadna utrujenost ali zaspanost, je treba upoštevati možnost, da gre za diabetično ketoacidozo.
English: Canagliflozin 100 mg (N = 237)
Slovenian: kanagliflozin 100 mg (n = 237)
English: • if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat,talk to a doctor or go to the nearest hospital immediately.
Slovenian: • če ste hitro izgubili telesno maso, vam je slabo ali bruhate, imate bolečine v trebuhu, ste hudo žejni, hitro in globoko dihate, ste zmedeni, neobičajno zaspani ali utrujeni, imate sladkast zadah,
English: In a cardiovascular study (CANVAS) of 4,327 treated subjects with established or at least two risk factors for cardiovascular disease, the incidence rates of all adjudicated bone fracture were 1.6, 1.8, and 1.1 per 100 patient-years of follow-up to canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively, with the fracture imbalance initially occurring within the first 26 weeks of therapy.
Slovenian: V študiji srčnožilnih učinkov (študiji CANVAS) pri 4.327 zdravljenih preiskovancih z ugotovljeno srčnožilno boleznijo ali s prisotnima najmanj dvema dejavnikoma tveganja zanjo je bila incidenčna stopnja vseh domnevnih zlomov kosti 1,6 oziroma 1,8 na 100 bolnikov-let spremljanja pri bolnikih, ki so jemali 100 mg ali 300 mg kanagliflozina, in 1,1 pri bolnikih, ki so jemali placebo.
English: The tablet is light yellow, capsule-shaped, 21 mm in length, film-coated, and debossed with “CM” on one side and “418” on the other side.
Slovenian: Tableta je svetlo rumena, ovalna, dolga 21 mm, filmsko obložena z vtisnjeno oznako "CM" na eni in "418" na drugi strani.
English: The tablet is beige, capsule-shaped, 21 mm in length, film-coated, and debossed with “CM” on one side and “551” on the other side.
Slovenian: Tableta je bež, ovalna, dolga 21 mm, filmsko obložena z vtisnjeno oznako "CM" na eni in "551" na drugi strani.
English: The tablet is pink, capsule-shaped, 20 mm in length, film-coated, and debossed with “CM” on one side and “358” on the other side.
Slovenian: Tableta je roza, ovalna, dolga 20 mm, filmsko obložena z vtisnjeno oznako "CM" na eni in "358" na drugi strani.
English: The tablet is purple, capsule-shaped, 22 mm in length, film-coated, and debossed with “CM” on one side and “611” on the other side.
Slovenian: Tableta je vijolična, ovalna, dolga 22 mm, filmsko obložena z vtisnjeno oznako "CM" na eni in "611" na drugi strani.
English: In general, canagliflozin produced clinically and statistically significant (p < 0.001) results relative to placebo in glycaemic control, including glycosylated haemoglobin (HbA1c), the percentage of patients achieving HbA1c < 7%, change from baseline fasting plasma glucose (FPG), and 2-hour postprandial glucose (PPG).
Slovenian: Rezultati pri uporabi kanagliflozina v primerjavi z uporabo placeba so bili večinoma klinično in statistično značilni (p < 0,001) pri urejanju glikemije, vključno z urejanjem odstotka glikoziliranega hemoglobina (HbA1c,) z odstotkom bolnikov, ki so dosegli raven HbA1c < 7%, s spremembo koncentracije glukoze na tešče od izhodiščne vrednosti in spremembo koncentracije glukoze v plazmi 2 uri po obroku.
English: Canagliflozin 300 mg + metformin XR (N = 237)
Slovenian: kanagliflozin 300 mg + metformin XR (n = 237)
English: Canagliflozin 100 mg + metformin XR (N = 237)
Slovenian: kanagliflozin 100 mg + metformin XR (n = 237)
English: Canagliflozin as initial combination therapy with metformin
Slovenian: Začetno kombinirano zdravljenje kanagliflozina in metformina
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with Vokanamet (see sections 4.2 and 4.8).
Slovenian: Zato je za zmanjševanje tveganja za hipoglikemijo pri sočasnem zdravljenju z zdravilom Vokanamet v nekaterih primerih potrebno zmanjšati odmerek insulina oziroma spodbujevalca izločanja insulina (glejte poglavji 4.2 in 4.8).
English: Figure 1: Time to first occurrence of MACE
Slovenian: Čas do prvega pojava pomembnega kardiovaskularnega neželenega dogodka
English: Vokanamet should not be used during breast-feeding.
Slovenian: Med dojenjem se zdravila Vokanamet ne sme uporabljati.
English: • Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell.
Slovenian: • Če se pri vas pojavi kombinacija simptomov, ki vključujejo bolečino, občutljivost, rdečico ali otekanje spolovil ali predele med spolovili in zadnjikom, skupaj s povišano telesno temperaturo ali splošnim slabim počutjem, se takoj posvetujte z zdravnikom.
English: Liver function test abnormal, Hepatitis
Slovenian: Bolezni jeter, žolčnika in žolčevodov zelo redki patološke vrednosti jetrnih testov, hepatitis
English: For patients on loop diuretics, the incidence rates were 5.0 on canagliflozin 100 mg and 5.7 on canagliflozin 300 mg compared to 4.1 events per 100 patient-years of exposure in the control group.
Slovenian: Pri bolnikih, ki so jemali diuretike Henleyeve zanke, je bila incidenčna stopnja teh neželenih učinkov 5,0 pri uporabi 100 mg kanagliflozina in 5,7 pri uporabi 300 mg kanagliflozina v primerjavi s 4,1 dogodka na 100 bolnikov-let izpostavljenosti v kontrolni skupini.
English: 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.
Slovenian: Povprečni odstotek spremembe koncentracije dušika iz sečnine v krvi (BUN) glede na začetno vrednost je bil 17,1% za 100 mg kanagliflozina in 18,0% za 300 mg kanagliflozina v primerjavi z 2,7% za placebo.
English: Canagliflozin 100 mg once daily 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.
Slovenian: 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.
English: 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 once daily, respectively, compared to the combination of glimepiride and metformin (1.0%) and -2.5% for canagliflozin 300 mg once daily in combination with metformin and a sulphonylurea compared to sitagliptin in combination with metformin and a sulphonylurea (0.3%).
Slovenian: V dveh 52-tedenskih aktivno nadzorovanih študijah, v katerih so kanagliflozin primerjali z glimepiridom oziroma s sitagliptinom, je 100 mg oziroma 300 mg kanagliflozina enkrat na dan 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%).
English: Table 4: Efficacy results from placebo-controlled clinical studies Dual therapy with metformin (26 weeks)
Slovenian: Preglednica 4: Rezultati učinkovitosti iz s placebom nadzorovanih kliničnih študij Dvotirno zdravljenje z metforminom (26 tednov) kanagliflozin + metformin placebo + metformin (n = 183)
English: EU/1/14/918/003 (50 mg/850 mg - 180 film-coated tablets) EU/1/14/918/006 (50 mg/1000 mg - 180 film-coated tablets) EU/1/14/918/009 (150 mg/850 mg - 180 film-coated tablets) EU/1/14/918/012 (150 mg/1000 mg - 180 film-coated tablets)
Slovenian: EU/1/14/918/003 (50 mg/850 mg - 180 filmsko obloženih tablet) EU/1/14/918/006 (50 mg/1000 mg - 180 filmsko obloženih tablet) EU/1/14/918/009 (150 mg/850 mg - 180 filmsko obloženih tablet) EU/1/14/918/012 (150 mg/1000 mg - 180 filmsko obloženih tablet)
English: • in patients insufficiently controlled on their maximally tolerated doses of metformin alone
Slovenian: • pri bolnikih, pri katerih glikemija s samostojno uporabo metformina v največjih odmerkih, ki jih še lahko prenašajo, ni dovolj urejena,
English: Patients should be advised to seek medical attention if they experience a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise.
Slovenian: Bolnikom s simptomi, ki vključujejo bolečino, eritem ali otekanje v genitalnem predelu ali predelu presredka, skupaj s povišano telesno temperaturo in slabim počutjem, je treba svetovati, naj poiščejo zdravniško pomoč.
English: Furthermore, canagliflozin was studied as triple therapy with metformin and sitagliptin and dosed with a titration regimen, using a starting dose of 100 mg and titrated to 300 mg as early as week 6 in patients requiring additional glycaemic control who had appropriate eGFR and were tolerating canagliflozin 100 mg (table 4).
Slovenian: Začeli so s 100 mg odmerkom in ga pri bolnikih, ki so potrebovali dodaten nadzor glikemije, imeli primerno glomerulno filtracijo in dobro prenašali 100 mg odmerek kanagliflozina, titrirali do 300 mg v začetku 6. tedna (Preglednica 4).
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide black (E172)
Slovenian: makrogol 3350 polivinilalkohol smukec titanov dioksid (E171) rdeči železov oksid (E172) črni železov oksid (E172)
English: Mean percent changes from baseline in blood potassium were 0.5% and 1.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.6% for placebo.
Slovenian: Povprečni odstotek spremembe koncentracije kalija v krvi je bil 0,5% za 100 mg kanagliflozina in 1,0% za 300 mgkanagliflozina v primerjavi z 0,6% za placebo.
English: Difference from canagliflozin 300 mg (adjusted mean) (95% CI)
Slovenian: 100 mg kanagliflozina (prilagojena povprečna vrednost) (95-odstotni IZ) razlika v primerjavi s
English: EU/1/14/918/010 (150 mg/1000 mg - 20 film-coated tablets) EU/1/14/918/011 (150 mg/1000 mg - 60 film-coated tablets)
Slovenian: EU/1/14/918/010 (150 mg/1000 mg - 20 filmsko obloženih tablet) EU/1/14/918/011 (150 mg/1000 mg - 60 filmsko obloženih tablet)
English: 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.
Slovenian: Povprečni odstotek spremembe glede na začetno vrednost kreatinina je bil 2,8% za 100 mg kanagliflozina in 4,0% 300 mg kanagliflozina v primerjavi z 1,5% za placebo.
English: 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.
Slovenian: Povprečna sprememba hematokrita glede na začetno vrednost je bila 2,4% za 100 mg kanagliflozina in 2,5% za 300 mg kanagliflozina v primerjavi z 0,0% za placebo.
English: Risk factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with eGFR < 60 mL/min/1.73 m
Slovenian: Pri bolnikih z eGFR < 60 ml/min/1,73 m2 je treba pred uvedbo metformina pregledati dejavnike tveganja, ki lahko povečajo tveganje za laktacidozo (glejte poglavje 4.4).
English: Intent-to-treat population using last observation in study prior to glycaemic rescue therapy.
Slovenian: populacija z namenom zdravljenja (intention-to-treat) z uporabo zadnje meritve v študiji pred prejemom nujnih zdravil v primeru hipoglikemije p < 0,05
English: 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.
Slovenian: 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 (NOELNo Observed Effect Level).
English: Each 50 mg/850 mg tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin and 850 mg of metformin hydrochloride.
Slovenian: Ena tableta 50 mg/850 mg vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 50 mg kanagliflozina, in 850 mg metforminijevega klorida.
English: Effects of canagliflozin on other medicinal products
Slovenian: Vpliv kanagliflozina na druge učinkovine
English: Consideration may also be given to stopping treatment with Vokanamet in patients who develop events which may precede amputation such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene.
Slovenian: Pri bolnikih, pri katerih pride do dogodkov, ki vodijo do amputacije, kot so razjede na koži spodnjih okončin, okužba, osteomielitis ali gangrena, bo morda treba razmisliti tudi o ukinitvi zdravljenja z zdravilom Vokanamet.
English: Each 150 mg/850 mg tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin and 850 mg of metformin hydrochloride.
Slovenian: Ena tableta 150 mg/850 mg vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 150 mg kanagliflozina, in 850 mg metforminijevega klorida.
English: Mundipharma Pharmaceuticals B.V. Leusderend 24
Slovenian: Mundipharma Pharmaceuticals B.V.
English: Each 50 mg/1000 mg tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Slovenian: Ena tableta 50 mg/1.000 mg vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 50 mg kanagliflozina, in 1000 mg metforminijevega klorida.
English: EU/1/14/918/004 (50 mg/1000 mg - 20 film-coated tablets) EU/1/14/918/005 (50 mg/1000 mg - 60 film-coated tablets)
Slovenian: EU/1/14/918/004 (50 mg/1000 mg - 20 filmsko obloženih tablet) EU/1/14/918/005 (50 mg/1000 mg - 60 filmsko obloženih tablet)
English: Each 150 mg/1000 mg tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Slovenian: Ena tableta 150 mg/1.000 mg vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 150 mg kanagliflozina, in 1000 mg metforminijevega klorida.
English: 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.
Slovenian: Diabetična ketoacidoza (redko, pojavi se lahko pri največ 1 od 1.000 bolnikov) Znaki diabetične ketoacidoze so (glejte tudi poglavje 2): - povečane koncentracije “ketonskih teles” v urinu ali krvi - hitra izguba telesne mase - slabost ali bruhanje - bolečine v trebuhu - huda žeja - hitro in globoko dihanje - zmedenost - neobičajna zaspanost ali utrujenost - sladkast zadah, sladek ali kovinski okus v ustih ali spremenjen vonj seča ali znoja
English: 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.
Slovenian: 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.
English: EU/1/14/918/007 (150 mg/850 mg - 20 film-coated tablets) EU/1/14/918/008 (150 mg/850 mg - 60 film-coated tablets)
Slovenian: EU/1/14/918/007 (150 mg/850 mg - 20 filmsko obloženih tablet) EU/1/14/918/008 (150 mg/850 mg - 60 filmsko obloženih tablet)
English: EU/1/14/918/010 (20 film-coated tablets) EU/1/14/918/011 (60 film-coated tablets) EU/1/14/918/012 (180 film-coated tablets)
Slovenian: EU/1/14/918/010 (20 filmsko obloženih tablet) EU/1/14/918/011 (60 filmsko obloženih tablet) EU/1/14/918/012 (180 filmsko obloženih tablet)
English: EU/1/14/918/001 (50 mg/850 mg - 20 film-coated tablets) EU/1/14/918/002 (50 mg/850 mg - 60 film-coated tablets)
Slovenian: EU/1/14/918/001 (50 mg/850 mg - 20 filmsko obloženih tablet) EU/1/14/918/002 (50 mg/850 mg - 60 filmsko obloženih tablet)
English: For patients inadequately controlled on maximal tolerated dose of metformin
Slovenian: Bolniki, pri katerih glikemija ni dovolj urejena z uporabo metformina v največjih odmerkih, ki jih še lahko prenašajo
English: Adjusted p < 0.01
Slovenian: N/A: navedba ni smiselna p < 0,001
English: Difference from glimepiride (adjusted mean) (95% CI)
Slovenian: razlika v primerjavi z metforminom XL (prilagojena povprečna vrednost) (95-odstotni IZ)
English: Difference from metformin XR (adjusted mean) (95% CI) Percent of patients achieving HbA1c
Slovenian: 300 mg kanagliflozina (prilagojena povprečna vrednost) (95-odstotni IZ) razlika v primerjavi z metforminom XL (prilagojena povprečna vrednost) (95-odstotni IZ) bolniki (%), ki so dosegli raven
English: Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular.
Slovenian: Izraz izpuščaj vključuje eritematozni izpuščaj, generaliziran izpuščaj, makulozen izpuščaj, makulopapularen izpuščaj, papulozen izpuščaj, srbeč izpuščaj, pustulozen izpuščaj in vezikulozen izpuščaj.