FrancophonIA/ELRC3.0 huggingface dataset:
English: A lower proportion of patients treated with canagliflozin 100 mg once daily (5.6%) and canagliflozin 300 mg once daily (4.9%) experienced at least one episode/event of hypoglycaemia over 52 weeks of treatment compared to the group treated with glimepiride (34.2%).
Slovenian: Do najmanj ene hipoglikemije v 52 tednih zdravljenja je prišlo pri manjšem deležu bolnikov, ki so prejemali 100 mg kanagliflozina enkrat na dan (5,6%) oziroma 300 mg kanagliflozina enkrat na dan (4,9%), kot pri zdravljenju z glimepiridom (34,2%).
English: - 150 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Slovenian: - tablete 150 mg/850 mg: makrogol (3350), polivinilalkohol, smukec, titanov dioksid
English: Vokanamet 50 mg/1000 mg film-coated tablets
Slovenian: Vokanamet 50 mg/1.000 mg filmsko obložene tablete
English: • Vokanamet 50 mg/850 mg film-coated tablets (tablets) are pink, capsule-shaped, 20 mm in length, and debossed with “CM” on one side and “358” on the other side.
Slovenian: • Filmsko obložene tablete Vokanamet 50 mg/850 mg (tablete) so roza barve, v obliki kapsule, dolžine 20 mm in imajo vtisnjeno oznako "CM" na eni strani in "358" na drugi.
English: This has been shown at therapeutic doses in controlled, medium-term, or long-term clinical studies: metformin reduces total cholesterol, LDL-C, and triglyceride levels.
Slovenian: Metformin znižuje koncentracije skupnega holesterola, LDL holesterola in trigliceridov, kar so dokazali v nadzorovanih srednje dolgih oziroma dolgotrajnih kliničnih študijah pri uporabi terapevtskih odmerkov metformina.
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: Vokanamet 50 mg/850 mg film-coated tablets
Slovenian: Vokanamet 50 mg/850 mg filmsko obložene tablete
English: d p < 0.001.
Slovenian: -0,1 mmHg).
English: Not applicable.
Slovenian: niso preučevali.
English: Dose titration with canagliflozin (added to the optimal dose of metformin) should be considered before the patient is switched to Vokanamet.
Slovenian: Preden bolnik preide na uporabo zdravila Vokanamet, velja razmisliti o prilagajanju odmerka kanagliflozina (kot dodatka k optimalnemu odmerku metformina).
English: • Vokanamet 150 mg/850 mg film-coated tablets (tablets) are light yellow, capsule-shaped, 21 mm in length, and debossed with “CM” on one side and “418” on the other side.
Slovenian: • Filmsko obložene tablete Vokanamet 150 mg/850 mg (tablete) so svetlo rumene barve, v obliki kapsule, dolžine 21 mm in imajo vtisnjeno oznako "CM" na eni strani in "418" na drugi.
English: Vokanamet may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Slovenian: Zdravilo Vokanamet lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza,
English: Vokanamet 150 mg/1000 mg film-coated tablets
Slovenian: Vokanamet 150 mg/1.000 mg filmsko obložene tablete
English: Vokanamet has no or negligible influence on the ability to drive, cycle, and use tools or machines.
Slovenian: Zdravilo Vokanamet nima vpliva oziroma ima zanemarljiv vpliv na sposobnost vožnje, kolesarjenja in upravljanja z napravami ali s stroji, vendar so poročali o omotičnosti oziroma začasni stemnitvi pred očmi, kar bi lahko vplivalo na sposobnost vožnje, kolesarjenja in upravljanja z napravami ali s stroji.
English: • vaginal yeast infection.
Slovenian: • glivična okužba nožnice.
English: Renal failure (mainly in the context of volume depletion)
Slovenian: občasni ledvična odpoved (zaradi izgube tekočine)
English: • in patients not adequately 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: 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
English: Skin and subcutaneous tissue disorders very rare
Slovenian: Bolezni kože in podkožja zelo redki rdečina, srbenje, urtikarija
English: n 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: n V primerjavi s placebom je bil povprečni odstotek spremembe koncentracije fosfata v serumu, glede na začetno vrednost 3,6% za 100 mg kanagliflozina in 5,1% za 300 mg kanagliflozina.
English: Cationic medicinal products
Slovenian: Kationska zdravila
English: Nervous system disorders Common
Slovenian: Bolezni živčevja pogosti motnje okušanja
English: Each 150 mg/850 mg tablet contains 150 mg of canagliflozin and 850 mg of metformin hydrochloride.
Slovenian: Ena tableta 150 mg/850 mg vsebuje 150 mg kanagliflozina in 850 mg metforminijevega klorida.
English: Each 50 mg/850 mg tablet contains 50 mg of canagliflozin and 850 mg of metformin hydrochloride.
Slovenian: Ena tableta 50 mg/850 mg vsebuje 50 mg kanagliflozina in 850 mg metforminijevega klorida.
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (lahko se pojavijo pri več kot 1 od 100 bolnikov)
English: • low blood sugar levels (hypoglycaemia) - when taking this medicine with insulin or a sulphonylurea (such as glimepiride or glipizide).
Slovenian: Hipoglikemija (zelo pogosti; pojavijo se lahko pri več kot 1 od 10 bolnikov) • nizka koncentracija sladkorja v krvi (hipoglikemija) - pri jemanju tega zdravila skupaj z insulinom ali sulfonilsečnino (na primer z glimepiridom ali glipizidom).
English: You should notify your doctor immediately if you notice any wounds or discolouration, or if you experience any tenderness or pain in your feet.
Slovenian: Če opazite kakršne koli rane ali spremembo barve kože, imate občutljiva ali boleča stopala, takoj obvestite zdravnika.
English: Each 50 mg/1000 mg tablet contains 50 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Slovenian: Ena tableta 50 mg/1.000 mg vsebuje 50 mg kanagliflozina in 1000 mg metforminijevega klorida.
English: There was no change in metformin AUC; however, mean peak plasma concentration of metformin was decreased by 16% when administered with food.
Slovenian: povprečna najvišja koncentracija metformina pa se je znižala za 16%.
English: Each 150 mg/1000 mg tablet contains 150 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Slovenian: Ena tableta 150 mg/1.000 mg vsebuje 150 mg kanagliflozina in 1000 mg metforminijevega klorida.
English: Vokanamet contains two different active substances, canagliflozin and metformin.
Slovenian: Kaj je zdravilo Vokanamet in za kaj ga uporabljamo Zdravilo Vokanamet vsebuje dve različni učinkovini: kanagliflozin in metformin.
English: Vokanamet should not be used to treat this condition.
Slovenian: Vokanamet ne sme uporabljati.
English: Triple therapy with metformin and sulphonylurea (26 weeks) Canagliflozin + metformin and sulphonylurea
Slovenian: Dvotirno zdravljenje z metforminom (26 tednov) kanagliflozin + metformin placebo + metformin (n = 183)
English: In this pooled analysis, patients on loop diuretics, patients with a baseline GFR 30 mL/min to < 60 mL/min, and patients ≥ 75 years of age had generally higher incidences of these adverse reactions.
Slovenian: GFR od 30 ml/min do < 60 ml/min in pri bolnikih, ki so bili stari ≥ 75 let.
English: 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).
Slovenian: Uporaba kanagliflozina ni priporočena pri bolnikih, ki jemljejo diuretike Henleyeve zanke (glejte poglavje 4.5)
English: Iron oxide black (E172)
Slovenian: rdeči železov oksid (E172) črni železov oksid (E172)
English: 6.5 Nature and contents of container 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: 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: -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: Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Slovenian: Kombinacije, pri katerih so potrebni previdnostni ukrepi Nekatera zdravila lahko škodljivo vplivajo na delovanje ledvic, kar lahko poveča tveganje za laktacidozo, npr. nesteriodna protivnetna zdravila, vključno s selektivnimi zaviralci ciklooksigenaze
English: l 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: za 100 mg kanagliflozina in 18,0% za 300 mg kanagliflozina v primerjavi z 2,7% za placebo.
English: Your kidneys will be tested by a blood test before you start taking and during treatment with Vokanamet.
Slovenian: Pred in med zdravljenjem z zdravilom Vokanamet bo zdravnik preverjal delovanje vaših ledvic s krvno preiskavo.
English: Vokanamet 150 mg/850 mg film-coated tablets EU/1/14/918/007 (20 tablets) EU/1/14/918/008 (60 tablets) EU/1/14/918/009 (180 tablets)
Slovenian: Vokanamet 150 mg/850 mg filmsko obložene tablete EU/1/14/918/007 (20 tablet) EU/1/14/918/008 (60 tablet) EU/1/14/918/009 (180 tablet)
English: Your blood sugar levels may rise if you stop taking this medicine.
Slovenian: Če prenehate jemati to zdravilo, se vam koncentracije sladkorja v krvi lahko povečajo.
English: Vokanamet 50 mg/1000 mg film-coated tablets EU/1/14/918/004 (20 tablets) EU/1/14/918/005 (60 tablets) EU/1/14/918/006 (180 tablets)
Slovenian: Vokanamet 50 mg/1.000 mg filmsko obložene tablete EU/1/14/918/004 (20 tablet) EU/1/14/918/005 (60 tablet) EU/1/14/918/006 (180 tablet)
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: (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: Stop taking Vokanamet immediately and contact a doctor or go to the nearest hospital straight away if you have any of the following serious side effects:
Slovenian: Če se pri vas pojavi kateri od naslednjih resnih neželenih učinkov, prenehajte jemati zdravilo Vokanamet in takoj poiščite zdravnika ali pojdite v najbližjo bolnišnico:
English: The reductions in RTG led to increased UGE in subjects with type 2 diabetes treated with either 100 mg or 300 mg once daily 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.
Slovenian: V vseh študijah faze I je pri bolnikih s sladkorno boleznijo tipa 2, ki so prejemali kanagliflozin bodisi v odmerku 100 mg ali 300 mg enkrat na dan, znižanje praga za izločanje glukoze povzročilo povečano izločanje glukoze z urinom, ki je znašalo od 77 g/dan do 119 g/dan.
English: Vokanamet 50 mg/850 mg film-coated tablets EU/1/14/918/001 (20 tablets) EU/1/14/918/002 (60 tablets) EU/1/14/918/003 (180 tablets)
Slovenian: Vokanamet 50 mg/850 mg filmsko obložene tablete EU/1/14/918/001 (20 tablet) EU/1/14/918/002 (60 tablet) EU/1/14/918/003 (180 tablet)
English: Candidal balanitis or balanoposthitis was reported in 4.2% and 3.7% of male patients treated with canagliflozin 100 mg once daily and canagliflozin 300 mg once daily, respectively, compared to 0.6% in placebo-treated male patients.
Slovenian: bolnikov s 100 mg kanagliflozina enkrat na dan in pri 3,7% bolnikov s 300 mg kanagliflozina enkrat na dan v primerjavi z 0,6% bolnikov, ki so prejemali placebo.
English: Lactic acidosis
Slovenian: metformin in sulfonilsečnina
English: These are two medicines that work together in different ways to lower blood glucose (sugar) levels 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.
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 850 mg metformin hydrochloride.
Slovenian: Ena filmsko obložena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 150 mg kanagliflozina, in 850 mg metforminijevega klorida.
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 1000 mg metformin hydrochloride.
Slovenian: Ena filmsko obložena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 150 mg kanagliflozina, in 1.000 mg metforminijevega klorida.
English: m 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: m Povprečni odstotek spremembe koncentracije kalija v krvi je bil 0,5% za 100 mg kanagliflozina in 1,0% za
English: Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Slovenian: Ena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 50 mg kanagliflozina, in 850 mg metforminijevega klorida.
English: Elimination Following administration of a single oral [14C]canagliflozin dose to healthy subjects, 41.5%, 7.0%, and
Slovenian: Po odmerjanju enkratnega s [14C] označenega peroralnega odmerka kanagliflozina zdravim osebam so
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 1000 mg metformin hydrochloride.
Slovenian: Ena filmsko obložena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 50 mg kanagliflozina, in 1.000 mg metforminijevega klorida.
English: Effects of canagliflozin on other medicinal products Digoxin
Slovenian: Vpliv kanagliflozina na druge učinkovine
English: In the pooled analysis of the four 26-week, placebo-controlled studies, the incidence of all adverse reactions related to volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension,
Slovenian: Pri bolnikih, starih ≥ 75 let, so opazili večjo pogostnost neželenih učinkov, povezanih s hipovolemijo (kot so položajna omotica, ortostatska hipotenzija in hipotenzija).
English: Vokanamet should be discontinued prior to, or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and 4.5).
Slovenian: 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno (glejte poglavji 4.2 in 4.5).
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: 300 mg kanagliflozina enkrat na dan v kombinaciji z metforminom in s sulfonilsečnino je v povprečju spremenilo telesno maso za -2,5% v primerjavi s sitagliptinom v kombinaciji z metforminom in s sulfonilsečnino (za 0,3%).
English: Hypoglycaemia in combination with insulin or sulphonylurea uncommon
Slovenian: Hipoglikemija in dodajanje zdravila insulinu ali spodbujevalcu izločanja insulina
English: The co-administration of canagliflozin and metformin has been studied in patients with type 2 diabetes inadequately controlled on metformin either alone or in combination with other glucose-lowering medicinal products.
Slovenian: pri katerih glikemija ni bila zadovoljivo urejena kljub zdravljenju z metforminom v monoterapiji ali v kombinaciji z drugimi antihiperglikemičnimi zdravili.
English: Vokanamet 150 mg/1000 mg film-coated tablets Macrogol (3350)
Slovenian: Vokanamet 150 mg/1.000 mg filmsko obložene tablete makrogol 3350 polivinilalkohol smukec titanov dioksid (E171)
English: For patients with a baseline GFR 30 mL/min to < 60 mL/min or CrCl 30 to < 60 mL/min, the incidences were 4.8% on canagliflozin 100 mg once daily and 8.1% on canagliflozin 300 mg once daily compared to 2.6% in the control group.
Slovenian: Pri bolnikih z izhodiščno vrednostjo GFR od 30 ml/min do < 60 ml oziroma z očistkom kreatinina od 30 do < 60 ml/min je bila pogostnost teh neželenih učinkov 4,8% pri uporabi
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: (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: Baseline (mean) in kg % change from baseline (adjusted mean)
Slovenian: 57,1b telesna masa izhodiščna (povprečna) vrednost v kg sprememba od izhodiščne vrednosti v % (prilagojena povprečna vrednost)
English: k 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: k Povprečni odstotek spremembe glede na začetno vrednost kreatinina je bil 2,8% za 100 mg kanagliflozina in 4,0%
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, lahko se pojavi pri največ 1 od 1.000 bolnikov) Znaki diabetične ketoacidoze so (glejte tudi poglavje 2, Opozorila in previdnostni ukrepi): povečane koncentracije “ketonskih teles” v urinu in 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: Patients (%) achieving HbA1c < 7% 53.6 Body weight
Slovenian: N/Ac bolniki (%), ki so dosegli HbA1c < 7% 53,6 telesna masa izhodiščna (povprečna) vrednost v kg sprememba od izhodiščne vrednosti v % (prilagojena povprečna vrednost)
English: d p = 0.013 compared to placebo.
Slovenian: 300 mgkanagliflozina v primerjavi z 0,6% za placebo.
English: Patients ≥ 75 years of age had a higher incidence of adverse reactions related to volume depletion (such as postural dizziness, orthostatic hypotension, hypotension) with incidences of 4.9%, 8.7% and 2.6% on canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, and in the control group, respectively.
Slovenian: V analizi združenih podatkov štirih 26-tedenskih s placebom nadzorovanih študij je bila pogostnost vseh neželenih učinkov, ki so povezani s hipovolemijo (na primer položajne omotice, ortostatske hipotenzije, hipotenzije, dehidracije in sinkope) 1,2% pri uporabi 100 mg kanagliflozina enkrat na dan, 1,3% pri uporabi 300 mg kanagliflozina enkrat na dan in 1,1% pri uporabi placeba.
English: b p < 0.001 compared to placebo.
Slovenian: razlika v primerjavi s placebom
English: Vokanamet 50 mg/1000 mg film-coated tablets Macrogol (3350)
Slovenian: Vokanamet 50 mg/1.000 mg filmsko obložene tablete makrogol 3350 polivinilalkohol smukec titanov dioksid (E171)
English: j 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: j Povprečna sprememba hematokrita glede na začetno vrednost je bila 2,4% za 100 mg kanagliflozina in 2,5% za
English: How to store Vokanamet
Slovenian: Shranjevanje zdravila Vokanamet
English: Polyvinyl alcohol
Slovenian: Zdravilo VOKANAMET
English: 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 a daily dose of 300 mg canaliflozin and occurred most frequently in the first three months (see section 4.8).
Slovenian: V nadzorovanih kliničnih študijah s kanagliflozinom so pri uporabi 300 mg odmerka opazili povečano pogostnost neželenih učinkov, povezanih s hipovolemijo (na primer položajne omotice, ortostatske hipotenzije ali hipotenzije).
English: VOKANAMET
Slovenian: Odmerjanje
English: Patients (%) achieving HbA1c < 7% Body weight
Slovenian: N/Ac bolniki (%), ki so dosegli raven HbA1c telesna masa izhodiščna (povprečna) vrednost v kg sprememba od izhodiščne vrednosti v % (prilagojena povprečna vrednost)
English: 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.
Slovenian: (Cmax) in njegova AUC sta se povečevali sorazmerno z odmerkom v okviru odmerjanja od 50 mg do 300 mg. Navidezni končni razpolovni čas (t1/2) (izražen kot povprečna vrednost ± standardna deviacija) je bil 10,6 ± 2,13 ure oziroma 13,1 ± 3,28 ure pri odmerku 100 mg oziroma 300 mg. Do stanja dinamičnega ravnovesja je prišlo po 4 do 5 dneh odmerjanja 100 mg do 300 mg kanagliflozina enkrat na dan. Farmakokinetika kanagliflozina ni odvisna od časa odmerjanja, po večkratnih odmerkih 100 mg in 300 mg pa je prišlo do kopičenja kanagliflozina v plazmi v obsegu do 36%.
English: Interim and final results will be submitted in accordance with the protocol.
Slovenian: Vmesni in končni rezultati bodo posredovani skladno s protokolom.
English: - There is visible evidence of contamination, such as change in appearance.
Slovenian: - Obstajajo vidni znaki kontaminacije, na primer sprememba videza.
English: Adults and elderly:
Slovenian: Odrasli in starejši:
English: Initiation of the study by July
Slovenian: Začetek študije bo v juliju 2010.
English: Dispose of in accordance with local regulations.
Slovenian: Odstranite v skladu z lokalnimi predpisi.