natgillin/translations-raw huggingface dataset:
e 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 O zlomu kosti so poročali pri 0,7% pri 100 mg kanagliflozina, 0,6% pri 300 mg kanagliflozina in 0,3% pri placebu.
Canagliflozin is not recommended for use in patients receiving loop diuretics.
Uporaba kanagliflozina pri bolnikih, ki jemljejo diuretike Henleyeve zanke ni priporočena.
Among male patients taking canagliflozin, 0.9% had more than one infection.
je pri 0,9% prišlo do več kot ene okužbe.
In ongoing, long-term clinical studies of canagliflozin in type 2 diabetes patients with cardiovascular disease (CVD) or at high risk for CVD, an increase in cases of lower limb amputation (primarily of the toe) has been observed in patients treated with canagliflozin.
V dolgoročnih kliničnih študijah kanagliflozina pri bolnikih s sladkorno boleznijo tipa 2 in s srčnožilno boleznijo ali z velikim tveganjem za srčnožilno bolezen, ki še potekajo, so pri bolnikih,
Because of the way canagliflozin works, your urine will test positive for sugar (glucose) while you are taking this medicine.
V času jemanja tega zdravila bo zaradi načina delovanja kanagliflozina izvid preiskave prisotnosti sladkorja (glukoze) v urinu pozitiven.
Canagliflozin showed no effects on fertility and early embryonic development in the rat at exposures up to 19 times the human exposure at the maximum recommended human dose (MRHD).
Pri izpostavljenostih, ki so do 19-krat presegale izpostavljenosti pri ljude, pri največjem priporočenem odmerku (MRHD-Maximum Recommended Human Dose) pri podganah kanagliflozin ni imel učinka na plodnost in zgodnji razvoj zarodka.
Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (area under the curve, AUC) and peak concentration (Cmax) were observed.
Pri sočasni uporabi kanagliflozina z rifampicinom (ki je induktor številnih aktivnih prenašalcev in encimov, ki presnavljajo učinkovine) so opazili zmanjšanje sistemske izpostavljenosti (AUC- Area
Nervous system disorders uncommon
Organski sistem Pogostnost neželen učinek
• blood tests may show changes related to kidney function (increased creatinine or urea) or increased potassium
• koprivnica • krvni testi lahko pokažejo spremembe delovanja ledvic (povečana koncentracija kreatinina ali sečnine) ali povečana koncentracija kalija • krvni testi lahko pokažejo povečano koncentracijo fosfata v krvi
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 once daily, canagliflozin 300 mg once daily, and placebo, respectively (see sections 4.2 and 4.5).
Pri dodajanju zdravila sulfonilsečnini so hipoglikemijo opazili pri 4,1%, bolnikov, ki so prejemali 100 mg kanagliflozina enkrat na dan, pri 12,5% bolnikov, ki so prejemali 300 mg kanagliflozina enkrat na dan, in pri 5,8% bolnikov, ki so prejemali s placebo (glejte poglavji 4.2 in 4.5).
For patients on loop diuretics, the incidences were 3.2% on canagliflozin 100 mg once daily and 8.8% on canagliflozin 300 mg once daily compared to 4.7% in the control group.
Pri bolnikih, ki so jemali diuretike Henleyeve zanke, je bila pogostnost teh neželenih učinkov 3,2% pri uporabi 100 mg kanagliflozina enkrat na dan in 8,8% pri uporabi 300 mg kanagliflozina enkrat na dan v primerjavi s 4,7% v kontrolni skupini.
• Vokanamet 50 mg/1000 mg film-coated tablets (tablets) are beige, capsule-shaped, 21 mm in length, and debossed with “CM” on one side and “551” on the other side.
• Filmsko obložene tablete Vokanamet 50 mg/1000 mg (tablete) so bež barve, v obliki kapsule, dolžine 21 mm in imajo vtisnjeno oznako "CM" na eni strani in "551" na drugi.
There have been no clinical efficacy studies conducted with Vokanamet; however, bioequivalence of Vokanamet to canagliflozin and metformin co-administered as individual tablets was demonstrated in healthy subjects.
Pri zdravih osebah pa so dokazali, da je zdravilo Vokanamet bioekvivalentno kanagliflozinu in metforminu, ki so ju preiskovancem odmerjali sočasno v obliki ločenih tablet.
In patients with evidence of volume depletion, correcting this condition prior to initiation of Vokanamet is recommended (see section 4.4).
Pred začetkom jemanja zdravila Vokanamet je priporočljivo odpraviti hipovolemijo (glejte poglavje 4.4).
Immune system disorders rare
Bolezni imunskega sistema redki anafilaktična reakcija
(E171), iron oxide red (E172) and iron oxide black (E172).
rdeči železov oksid (E172) in črni železov oksid (E172).
Canagliflozin was compared to glimepiride as dual therapy with metformin and compared to sitagliptin as triple therapy with metformin and a sulphonylurea (table 5).
Študije nadzorovane z učinkovino Kanagliflozin so primerjali z glimepiridom v okviru dvotirnega zdravljenja z metforminom, s sitagliptinom v okviru trotirnega zdravljenja z metforminom in s sulfonilsečnino (preglednica 5).
GFR mL/min
GFR ml/min metformin kanagliflozin
Vokanamet 150 mg/850 mg film-coated tablets
Vokanamet 150 mg/850 mg filmsko obložene tablete
Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see sections 4.3 and 4.5).
Drugi dejavniki tveganja za laktacidozo so pretirano uživanje alkohola, jetrna insuficienca, neustrezno nadzorovana sladkorna bolezen, ketoacidoza, dolgotrajno postenje in vsa stanja, povezana s hipoksijo,
Canagliflozin was negligibly removed by haemodialysis.
Kanagliflozin se pri hemodializi odstrani v zanemarljivo majhnem obsegu.
Film-coating: - 50 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
filmska obloga: - tablete 50 mg/850 mg: makrogol (3350), polivinilalkohol, smukec, titanov dioksid,
• Vokanamet 150 mg/1000 mg film-coated tablets (tablets) are purple, capsule-shaped, 22 mm in length, and debossed with “CM” on one side and “611” on the other side.
• Filmsko obložene tablete Vokanamet 150 mg/1000 mg (tablete) so vijolične barve, v obliki kapsule, dolžine 22 mm in imajo vtisnjeno oznako "CM" na eni strani in "611" na drugi.
• a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p = 0.017
• statistično značilno zmanjšanje absolutnega tveganja za umrljivost, povezano s sladkorno boleznijo: metformin 7,5 dogodka /1.000 bolnikov-let, samo dieta:
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%).
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%).
- 150 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
- tablete 150 mg/850 mg: makrogol (3350), polivinilalkohol, smukec, titanov dioksid
Vokanamet 50 mg/1000 mg film-coated tablets
Vokanamet 50 mg/1.000 mg filmsko obložene tablete
• 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.
• 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.
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.
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.
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.
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.
Vokanamet 50 mg/850 mg film-coated tablets
Vokanamet 50 mg/850 mg filmsko obložene tablete
d p < 0.001.
-0,1 mmHg).
Not applicable.
niso preučevali.
Dose titration with canagliflozin (added to the optimal dose of metformin) should be considered before the patient is switched to Vokanamet.
Preden bolnik preide na uporabo zdravila Vokanamet, velja razmisliti o prilagajanju odmerka kanagliflozina (kot dodatka k optimalnemu odmerku metformina).
• 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.
• 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.
Vokanamet may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Zdravilo Vokanamet lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza,
Vokanamet 150 mg/1000 mg film-coated tablets
Vokanamet 150 mg/1.000 mg filmsko obložene tablete
Vokanamet has no or negligible influence on the ability to drive, cycle, and use tools or machines.
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.
• vaginal yeast infection.
• glivična okužba nožnice.
Renal failure (mainly in the context of volume depletion)
občasni ledvična odpoved (zaradi izgube tekočine)
• in patients not adequately controlled on their maximally tolerated doses of metformin alone
• pri bolnikih, pri katerih glikemija s samostojno uporabo metformina v največjih odmerkih, ki jih še lahko prenašajo ni dovolj urejena,
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).
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
Skin and subcutaneous tissue disorders very rare
Bolezni kože in podkožja zelo redki rdečina, srbenje, urtikarija
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.
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.
Cationic medicinal products
Kationska zdravila
Nervous system disorders Common
Bolezni živčevja pogosti motnje okušanja
Each 150 mg/850 mg tablet contains 150 mg of canagliflozin and 850 mg of metformin hydrochloride.
Ena tableta 150 mg/850 mg vsebuje 150 mg kanagliflozina in 850 mg metforminijevega klorida.
Each 50 mg/850 mg tablet contains 50 mg of canagliflozin and 850 mg of metformin hydrochloride.
Ena tableta 50 mg/850 mg vsebuje 50 mg kanagliflozina in 850 mg metforminijevega klorida.
Uncommon (may affect up to 1 in 100 people)
Občasni (lahko se pojavijo pri več kot 1 od 100 bolnikov)
• low blood sugar levels (hypoglycaemia) - when taking this medicine with insulin or a sulphonylurea (such as glimepiride or glipizide).
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).
You should notify your doctor immediately if you notice any wounds or discolouration, or if you experience any tenderness or pain in your feet.
Če opazite kakršne koli rane ali spremembo barve kože, imate občutljiva ali boleča stopala, takoj obvestite zdravnika.
Each 50 mg/1000 mg tablet contains 50 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Ena tableta 50 mg/1.000 mg vsebuje 50 mg kanagliflozina in 1000 mg metforminijevega klorida.
There was no change in metformin AUC; however, mean peak plasma concentration of metformin was decreased by 16% when administered with food.
povprečna najvišja koncentracija metformina pa se je znižala za 16%.
Each 150 mg/1000 mg tablet contains 150 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Ena tableta 150 mg/1.000 mg vsebuje 150 mg kanagliflozina in 1000 mg metforminijevega klorida.
Vokanamet contains two different active substances, canagliflozin and metformin.
Kaj je zdravilo Vokanamet in za kaj ga uporabljamo Zdravilo Vokanamet vsebuje dve različni učinkovini: kanagliflozin in metformin.
Vokanamet should not be used to treat this condition.
Vokanamet ne sme uporabljati.
Triple therapy with metformin and sulphonylurea (26 weeks) Canagliflozin + metformin and sulphonylurea
Dvotirno zdravljenje z metforminom (26 tednov) kanagliflozin + metformin placebo + metformin (n = 183)
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.
GFR od 30 ml/min do < 60 ml/min in pri bolnikih, ki so bili stari ≥ 75 let.
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 diuretike Henleyeve zanke (glejte poglavje 4.5)
Iron oxide black (E172)
rdeči železov oksid (E172) črni železov oksid (E172)
6.5 Nature and contents of container HDPE bottle with child-resistant closure, induction seal, and desiccant.
Plastenka iz polietilena visoke gostote (HDPE) z za otroke varno zaporko, indukcijsko zataljeno folijo in sušilnim sredstvom.
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.
-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.
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.
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
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.
za 100 mg kanagliflozina in 18,0% za 300 mg kanagliflozina v primerjavi z 2,7% za placebo.
Your kidneys will be tested by a blood test before you start taking and during treatment with Vokanamet.
Pred in med zdravljenjem z zdravilom Vokanamet bo zdravnik preverjal delovanje vaših ledvic s krvno preiskavo.
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)
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)
Your blood sugar levels may rise if you stop taking this medicine.
Če prenehate jemati to zdravilo, se vam koncentracije sladkorja v krvi lahko povečajo.
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)
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)
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).
(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).
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:
Če se pri vas pojavi kateri od naslednjih resnih neželenih učinkov, prenehajte jemati zdravilo Vokanamet in takoj poiščite zdravnika ali pojdite v najbližjo bolnišnico:
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.
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.
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)
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)
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.
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.
Lactic acidosis
metformin in sulfonilsečnina
These are two medicines that work together in different ways to lower blood glucose (sugar) levels in adults with type 2 diabetes.
Pri odraslih s sladkorno boleznijo tipa 2 obe učinkovini, vsaka na svoj način, znižujeta koncentracijo glukoze (sladkorja) v krvi.
Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 850 mg metformin hydrochloride.
Ena filmsko obložena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 150 mg kanagliflozina, in 850 mg metforminijevega klorida.
Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 1000 mg metformin hydrochloride.
Ena filmsko obložena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 150 mg kanagliflozina, in 1.000 mg metforminijevega klorida.
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.
m Povprečni odstotek spremembe koncentracije kalija v krvi je bil 0,5% za 100 mg kanagliflozina in 1,0% za
Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Ena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 50 mg kanagliflozina, in 850 mg metforminijevega klorida.
Elimination Following administration of a single oral [14C]canagliflozin dose to healthy subjects, 41.5%, 7.0%, and
Po odmerjanju enkratnega s [14C] označenega peroralnega odmerka kanagliflozina zdravim osebam so
Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 1000 mg metformin hydrochloride.
Ena filmsko obložena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 50 mg kanagliflozina, in 1.000 mg metforminijevega klorida.
Effects of canagliflozin on other medicinal products Digoxin
Vpliv kanagliflozina na druge učinkovine
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,
Pri bolnikih, starih ≥ 75 let, so opazili večjo pogostnost neželenih učinkov, povezanih s hipovolemijo (kot so položajna omotica, ortostatska hipotenzija in hipotenzija).
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).
48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno (glejte poglavji 4.2 in 4.5).
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%).
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%).
Hypoglycaemia in combination with insulin or sulphonylurea uncommon
Hipoglikemija in dodajanje zdravila insulinu ali spodbujevalcu izločanja insulina
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.
pri katerih glikemija ni bila zadovoljivo urejena kljub zdravljenju z metforminom v monoterapiji ali v kombinaciji z drugimi antihiperglikemičnimi zdravili.
Vokanamet 150 mg/1000 mg film-coated tablets Macrogol (3350)
Vokanamet 150 mg/1.000 mg filmsko obložene tablete makrogol 3350 polivinilalkohol smukec titanov dioksid (E171)
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.
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