FrancophonIA/ELRC3.0 huggingface dataset:
English: Multipack containing 180 (3 x 60) film-coated tablets.
Danish: Multipakning indeholdende 180 (3 x 60) filmovertrukne tabletter
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, dehydration, and syncope) was 1.2% for canagliflozin 100 mg once daily, 1.3% for canagliflozin 300 mg once daily, and 1.1% for placebo.
Danish: I den puljede analyse af de fire 26-ugers placebokontrollerede studier var incidensen af alle bivirkninger relateret til volumendepletering (f.eks. postural svimmelhed, ortostatisk hypotension, hypotension, dehydrering og synkope) 1,2 % for canagliflozin 100 mg en gang dagligt, 1,3 % for canagliflozin 300 mg en gang dagligt og 1,1 % for placebo.
English: In a second cardiovascular study (CANVAS-R) of 5,807 treated subjects with established or at least two risk factors for cardiovascular disease, the incidence rates of all adjudicated bone fracture were 1.1 and 1.3 events per 100 patient-years of follow-up to canagliflozin and placebo, respectively.
Danish: I et andet kardiovaskulært studie (CANVAS-R) med 5.807 behandlede forsøgspersoner med etableret eller minimum to risikofaktorer for kardiovaskulær sygdom var incidensraterne for alle konstaterede knoglebrud henholdsvis 1,1 og 1,3 hændelser pr. 100 patientårs opfølgning på canagliflozin og placebo.
English: The majority of patients with a baseline eGFR 45 mL/min/1.73 m 2 to < 60 mL/min/1.73 m 2 were on insulin and/or a sulphonylurea (85% [614/721]).
Danish: Størstedelen af patienterne med eGFR 45 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 ved baseline blev behandlet med insulin og/eller et sulfonylurinstof (85 % [614/721]).
English: Phimosis was reported at a rate of 0.39 and 0.07 events per 100 patient-years on canagliflozin and placebo, respectively.
Danish: Phimosis blev rapporteret med en rate på henholdsvis 0,39 og 0,07 hændelser pr. 100 patientår med canagliflozin og placebo.
English: In long-term clinical studies of canagliflozin in type 2 diabetes patients with established cardiovascular disease (CVD) or at least 2 risk factors for CVD, an approximately 2-fold increased risk of lower limb amputation (primarily of the toe and midfoot), has been observed in patients treated with canagliflozin (see section 4.8).
Danish: I kliniske langtidsstudier med canagliflozin hos patienter med type 2-diabetes og etableret kardiovaskulær sygdom eller mindst to risikofaktorer for kardiovaskulær sygdom har der været observeret ca. en fordobling af risikoen for amputation af en underekstremitet (primært tå og mellemfod) hos patienter, der fik canagliflozin (se pkt.
English: 20 film-coated tablets 60 film-coated tablets
Danish: 20 filmovertrukne tabletter 60 filmovertrukne tabletter
English: At the last post-baseline value, incidence rates of such decreases were 3.3 for patients treated with canagliflozin 100 mg, 2.7 for canagliflozin 300 mg, and 3.7 events per 100 patient-years of exposure for placebo (see section 4.4).
Danish: Ved den sidste post-baseline-værdi var incidensraterne for sådanne fald 3,3 for patienter, der fik canagliflozin 100 mg, 2,7 for canagliflozin 300 mg og 3,7 hændelser pr. 100 patientårs eksponering for placebo (se pkt.
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 incidence rates of 5.3, 6.1 and 2.4 events per 100 patient-years of exposure for canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, and in the control group, respectively.
Danish: Patienter ≥ 75 år havde en højere frekvens af bivirkninger relateret til volumendepletering (såsom postural svimmelhed, ortostatisk hypotension, hypotension) med incidensrater på 5,3, 6,1 og 2,4 hændelser pr. 100 patientårs eksponering for henholdsvis canagliflozin 100 mg en gang dagligt, canagliflozin 300 mg en gang dagligt og kontrolgruppen.
English: Canagliflozin + metformin and sitagliptin (N = 107)
Danish: Canagliflozin + metformin og sitagliptin (N = 107)
English: Vulvovaginal candidiasis (including vulvovaginitis and vulvovaginal mycotic infection) was reported in 10.4% and 11.4% of female patients treated with canagliflozin 100 mg once daily and canagliflozin
Danish: Vulvovaginal candidiasis (inklusive vulvovaginitis og vulvovaginal svampeinfektion) blev rapporteret hos 10,4 % og 11,4 % af de kvindelige patienter, der blev behandlet med henholdsvis canagliflozin 100 mg en gang dagligt og canagliflozin 300 mg en gang dagligt, sammenlignet med 3,2 % af kvinderne i placebo-armen.
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.
Danish: I et kardiovaskulært studie (CANVAS) med 4.327 behandlede forsøgspersoner med etableret eller minimum to risikofaktorer for kardiovaskulær sygdom var incidensraterne for alle konstaterede knoglebrud henholdsvis 1,6, 1,8 og 1,1 pr. 100 patientårs opfølgning på canagliflozin 100 mg, canagliflozin 300 mg og placebo, hvor den skæve fordeling af brud opstod i løbet af de første 26 ugers behandling.
English: The incidence rates for larger decreases in eGFR (> 30%) at any time during treatment were 7.3, 8.1, and 6.5 events per 100 patient-years of exposure for canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively.
Danish: Incidensraterne for større fald i eGFR (> 30 %) uanset tidspunktet i løbet af behandlingen var henholdsvis 7,3, 8,1 og 6,5 hændelser pr. 100 patientårs eksponering for canagliflozin 100 mg, canagliflozin 300 mg og placebo.
English: In CANVAS, subjects were randomly assigned 1:1:1 to canagliflozin 100 mg, canagliflozin 300 mg, or matching placebo.
Danish: I CANVAS blev forsøgspersonerne vilkårligt tildelt canagliflozin 100 mg, canagliflozin 300 mg eller matchende placebo 1:1:1.
English: Sitagliptin 100 mg + metformin and sulphonylurea (N = 378)
Danish: Sitagliptin 100 mg + metformin og sulfonylurinstof (N = 378)
English: Placebo + metformin and sitagliptin (N = 106)
Danish: Placebo + metformin og sitagliptin (N = 106)
English: The overall incidence rate of elevated serum potassium was higher in patients with moderate renal impairment with incidence rates of 4.9, 6.1, and 5.4 events per 100 patient-years of exposure for canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively.
Danish: Den samlede incidensrate af forhøjet serumkalium var større hos patienter med moderat nedsat nyrefunktion med incidensrater på henholdsvis 4,9, 6,1 og 5,4 hændelser pr. 100 patientårs eksponering for canagliflozin 100 mg, canagliflozin 300 mg og placebo.
English: In the combined canagliflozin group, the HR for all-cause mortality versus placebo was 0.87 (0.74,
Danish: I den kombinerede canagliflozin-gruppe var HR for død af en hvilken som helst årsag versus placebo
English: 1 x 60 film-coated tablets
Danish: 1 x 60 filmovertrukne tabletter
English: Bone fracture
Danish: Knoglefraktur
English: Circumcision was performed at rates of 0.31 and 0.09 events per 100 patient-years on canagliflozin and placebo, respectively (see section 4.4).
Danish: Omskæring blev foretaget med rater på henholdsvis 0,31 og 0,09 hændelser pr. 100 patientår med canagliflozin og placebo (se pkt.
English: , Blood urea increased b, p
Danish: , forhøjet urat i blodet b, p
English: • The active substances are canagliflozin and metformin hydrochloride.
Danish: Vokanamet indeholder: • Aktive stoffer: canagliflozin og metforminhydrochlorid.
English: , Blood potassium increased b, q
Danish: , forhøjet kalium i blodet b, q
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) EU/1/14/918/003 (50 mg/850 mg - 180 film-coated tablets) 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) EU/1/14/918/006 (50 mg/1000 mg - 180 film-coated tablets) 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) EU/1/14/918/009 (150 mg/850 mg - 180 film-coated tablets) 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) EU/1/14/918/012 (150 mg/1000 mg - 180 film-coated tablets)
Danish: EU/1/14/918/001 (50 mg/850 mg - 20 filmovertrukne tabletter) EU/1/14/918/002 (50 mg/850 mg - 60 filmovertrukne tabletter) EU/1/14/918/003 (50 mg/850 mg - 180 filmovertrukne tabletter) EU/1/14/918/004 (50 mg/1000 mg - 20 filmovertrukne tabletter) EU/1/14/918/005 (50 mg/1000 mg - 60 filmovertrukne tabletter) EU/1/14/918/006 (50 mg/1000 mg - 180 filmovertrukne tabletter) EU/1/14/918/007 (150 mg/850 mg - 20 filmovertrukne tabletter) EU/1/14/918/008 (150 mg/850 mg - 60 filmovertrukne tabletter) EU/1/14/918/009 (150 mg/850 mg - 180 filmovertrukne tabletter EU/1/14/918/010 (150 mg/1000 mg - 20 filmovertrukne tabletter) EU/1/14/918/011 (150 mg/1000 mg - 60 filmovertrukne tabletter) EU/1/14/918/012 (150 mg/1000 mg - 180 filmovertrukne tabletter)
English: Consistent with the mechanism of sodium glucose co-transporter 2 (SGLT2) inhibition with increased UGE, vulvovaginal candidiasis in females and balanitis or balanoposthitis in males were reported in clinical studies with canagliflozin (see section 4.8).
Danish: I kliniske studier med canagliflozin blev der i overensstemmelse med mekanismen bag hæmning af natriumglucose-co-transportør 2 (SGLT2), der øger glucoseudskillelse i urinen, rapporteret om vulvovaginal candidiasis hos kvinder og balanitis eller balanopostitis hos mænd (se pkt.
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).
Danish: Nedsat nyrefunktion Patienter med eGFR < 60 ml/min/1,73 m2 ved baseline havde en større incidens af bivirkninger associeret med volumendepletering (f.eks. postural svimmelhed, ortostatisk hypotension, hypotension) med incidensrater på henholdsvis 5,3, 5,1 og 3,1 hændelser pr. 100 patientårs eksponering for canagliflozin 100 mg, canagliflozin 300 mg og placebo (se pkt.
English: • Severe renal failure (eGFR < 30 mL/min) (see sections 4.2 and 4.4);
Danish: • Svær nyreinsufficiens (eGFR < 30 ml/min) (se pkt.
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
Danish: 4.4), skal gennemgås, inden påbegyndelse af metforminbehandling overvejes hos patienter med eGFR < 60 ml/min/1,73 m
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.
Danish: En beige, kapselformet tablet, 21 mm lang, filmovertrukket og præget med “CM” på den ene side og “551” på den anden side.
English: Triple therapy with metformin and sulphonylurea (26 weeks) Canagliflozin + metformin and sulphonylurea
Danish: Ikke relevant Behandling med tre lægemidler: + metformin og sulfonylurinstof (26 uger) Canagliflozin + metformin og sulfonylurinstof
English: All-cause mortality
Danish: Død af en hvilken som helst årsag
English: N = 4,344
Danish: 4.2, 4.4 og
English: Add-on therapy with insulin d (18 weeks)
Danish: Tillægsbehandling med insulin d (18 uger) Canagliflozin + insulin
English: Difference from canagliflozin 300 mg (adjusted mean) (95% CI)
Danish: canagliflozin 300 mg (justeret gennemsnitstal) (95 % CI) Forskel ift.
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.
Danish: Hos patienter, der fik loop-diuretika, var incidensraterne 5,0 med canagliflozin 100 mg og 5,7 med canagliflozin 300 mg sammenlignet med 4,1 hændelser pr. 100 patientårs eksponering i kontrolgruppen.
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide black (E172)
Danish: Titandioxid (E171) Rød jernoxid (E172) Sort jernoxid (E172)
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).
Danish: Hos patienter ≥ 75 år var incidensraterne 5,3 med canagliflozin 100 mg og 6,1 med canagliflozin 300 mg sammenlignet med 2,4 hændelser pr. 100 patientårs eksponering i kontrolgruppen (se pkt.
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.
Danish: En lyserød, kapselformet tablet, 20 mm lang, filmovertrukket og præget med “CM” på den ene side og “358” på den anden side.
English: Hypoglycaemia in add-on therapy with insulin or insulin secretagogues
Danish: Hypoglykæmi ved tillægsbehandling til insulin eller ß-cellestimulerende midler
English: Maximum daily dose is 3000 mg Dose reduction may be considered in relation to declining renal function.
Danish: Dosisreduktion kan overvejes i forbindelse med tiltagende nedsættelse af nyrefunktionen.
English: Vokanamet 150 mg/850 mg film-coated tablets
Danish: Vokanamet 150 mg/850 mg filmovertrukne tabletter
English: For patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2, the incidence rates were 5.2 on canagliflozin 100 mg and 5.4 on canagliflozin 300 mg compared to 3.1 events per 100 patient-years of exposure in the control group.
Danish: < 60 ml/min/1,73 m2 ved baseline var incidensraterne 5,2 med canagliflozin 100 mg og 5,4 med canagliflozin 300 mg sammenlignet med 3,1 hændelser pr. 100 patientårs eksponering i kontrolgruppen.
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.
Danish: En lilla, kapselformet tablet, 22 mm lang, filmovertrukket og præget med “CM” på den ene side og “611” på den anden side.
English: Table 4: Efficacy results from placebo-controlled clinical studies Dual therapy with metformin (26 weeks)
Danish: Tabel 4: Effektresultater i placebokontrollerede kliniske studier Behandling med to lægemidler: + metformin (26 uger) Canagliflozin + metformin
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.
Danish: Middelændringer fra baseline i hæmatokrit var 2,4 % og 2,5 % for henholdsvis canagliflozin 100 mg og 300 mg sammenlignet med 0,0 % for placebo.
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.
Danish: Middelændringer (%) fra baseline i blod-carbamid var henholdsvis 17,1 % og 18,0 % for canagliflozin 100 mg og 300 mg sammenlignet med 2,7 % for placebo.
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.
Danish: Middelændringer (%) fra baseline i serumphosphat var henholdsvis 3,6 % og 5,1 % for canagliflozin 100 mg og 300 mg sammenlignet med 1,5 % for placebo.
English: Vokanamet 50 mg/850 mg film-coated tablets
Danish: Vokanamet 50 mg/850 mg filmovertrukne tabletter
English: Mean baseline eGFR was 62.5, 64.7, and 63.5 mL/min/1.73 m2 for canagliflozin 100 mg, canagliflozin 300 mg, and the control group, respectively (see sections 4.2 and
Danish: 63,5 ml/min/1,73 m 2 for canagliflozin 100 mg, canagliflozin 300 mg og kontrolgruppen (se pkt.
English: Canagliflozin 100 mg titrated to 300 mg p < 0.01 compared to placebo
Danish: Canagliflozin 100 mg titreret til 300 mg p < 0,01 sammenlignet med placebo 90,7 % af forsøgspersonerne i canagliflozingruppen optitreret til 300 mg
English: Vokanamet 50 mg/850 mg film-coated tablets Vokanamet 50 mg/1000 mg film-coated tablets Vokanamet 150 mg/850 mg film-coated tablets Vokanamet 150 mg/1000 mg film-coated tablets canagliflozin/metformin hydrochloride
Danish: Vokanamet 50 mg/850 mg filmovertrukne tabletter Vokanamet 50 mg/1000 mg filmovertrukne tabletter Vokanamet 150 mg/850 mg filmovertrukne tabletter Vokanamet 150 mg/1000 mg filmovertrukne tabletter canagliflozin/metforminhydrochlorid
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.
Danish: En lysegul, kapselformet tablet, 21 mm lang, filmovertrukket og præget med “CM” på den ene side og “418” på den anden side.
English: Vokanamet 50 mg/1000 mg film-coated tablets
Danish: Vokanamet 50 mg/1.000 mg filmovertrukne tabletter
English: • constipation
Danish: • forvirring
English: Vokanamet 150 mg/1000 mg film-coated tablets
Danish: Vokanamet 150 mg/1.000 mg filmovertrukne tabletter
English: In the CANVAS Program, for time to first adjudicated nephropathy event (doubling of serum creatinine, need for renal-replacement therapy, and renal death), the HR was 0.53 (95% CI: 0.33, 0.84) for canagliflozin (0.15 events per 100 patient-years) versus placebo (0.28 events per 100 patient-years).
Danish: I CANVAS-programmet var HR 0,53 (95 % CI: 0,33; 0,84) for canagliflozin (0,15 hændelser pr. 100 patientår) kontra placebo (0,28 hændelser pr. 100 patientår) for tid til første konstaterede nefropatiske hændelse (fordobling af serumkreatinin, behov for dialyse og død som følge af nyresygdom).
English: Dehydration rare
Danish: Dehydrering
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172)
Danish: Titandioxid (E171) Rød jernoxid (E172) Gul jernoxid (E172)
English: In this pooled analysis, patients on loop diuretics, patients with a baseline eGFR 30 mL/min/1.73 m2 to
Danish: I denne puljede analyse sås generelt en større incidens af disse bivirkninger hos patienter, der fik loop-diuretika, patienter med eGFR 30 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 ved baseline og patienter ≥ 75 år.
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Danish: Titandioxid (E171) Gul jernoxid (E172)
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.
Danish: Middelændringer (%) fra baseline i kreatinin var 2,8 % og 4,0 % for henholdsvis canagliflozin 100 mg og 300 mg sammenlignet med 1,5 % for placebo.
English: - 150 mg/850 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), and iron oxide yellow (E172).
Danish: - 150 mg/850 mg tabletter: macrogol 3350, poly(vinylalkohol), talcum, titandioxid
English: The apparent terminal half-life (t1/2) (expressed as mean ± standard deviation) was 10.6 ± 2.13 hours and 13.1 ± 3.28 hours for the 100 mg and 300 mg doses, respectively.
Danish: Den tilsyneladende terminale halveringstid (t1/2) (udtrykt som middelværdi ± standardafvigelse) var 10,6 ± 2,13 timer og 13,1 ± 3,28 timer for henholdsvis 100 mg og 300 mg. Steady state blev nået efter 4-5 dage ved daglig administration af canagliflozin 100300 mg. Canagliflozin udviser ikke tidsafhængig farmakokinetik, og op til 36 % akkumuleres i plasma efter gentagne doser på 100 mg og 300 mg.
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)
Danish: EU/1/14/918/003 (50 mg/850 mg - 180 filmovertrukne tabletter) EU/1/14/918/006 (50 mg/1000 mg - 180 filmovertrukne tabletter) EU/1/14/918/009 (150 mg/850 mg - 180 filmovertrukne tabletter) EU/1/14/918/012 (150 mg/1000 mg - 180 filmovertrukne tabletter)
English: % change from baseline (adjusted mean)
Danish: Baseline (middelværdi) Ændring fra baseline (justeret middelværdi)
English: Each 150 mg/850 mg tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin and 850 mg of metformin hydrochloride.
Danish: Hver 150 mg/850 mg tablet indeholder canagliflozinhemihydrat svarende til 150 mg canagliflozin og 850 mg metforminhydrochlorid.
English: Body weight Baseline (mean) in kg % change from baseline (adjusted mean) -2.1 Difference from metformin XR (adjusted mean) (95% CI)
Danish: Legemsvægt Baseline (gennemsnit) i kg % ændring fra baseline (justeret gennemsnitsændring) Forskel ift.
English: Each 50 mg/850 mg tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin and 850 mg of metformin hydrochloride.
Danish: Hver 50 mg/850 mg tablet indeholder canagliflozinhemihydrat svarende til 50 mg canagliflozin og 850 mg metforminhydrochlorid.
English: Haematocrit increase was observed with canagliflozin treatment (see section 4.8); therefore, careful monitoring in patients with already elevated haematocrit is warranted.
Danish: 4.8), og nøje overvågning tilrådes hos patienter, der allerede har forhøjet hæmatokrit.
English: Film-coating: - 50 mg/850 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), iron oxide red (E172) and iron oxide black (E172).
Danish: Filmovertræk - 50 mg/850 mg tabletter: macrogol 3350, poly(vinylalkohol), talcum, titandioxid
English: Each 50 mg/1000 mg tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Danish: Hver 50 mg/1.000 mg tablet indeholder canagliflozinhemihydrat svarende til 50 mg canagliflozin og 1.000 mg metforminhydrochlorid.
English: Mundipharma Pharmaceuticals B.V. Leusderend 24
Danish: Mundipharma Pharmaceuticals B.V.
English: Each 150 mg/1000 mg tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Danish: Hver 150 mg/1.000 mg tablet indeholder canagliflozinhemihydrat svarende til 150 mg canagliflozin og 1.000 mg metforminhydrochlorid.
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)
Danish: EU/1/14/918/010 (20 filmovertrukne tabletter) EU/1/14/918/011 (60 filmovertrukne tabletter) EU/1/14/918/012 (180 filmovertrukne tabletter)
English: In the clinical development programme, 1,085 patients with a baseline eGFR 30 mL/min/1.73 m2 to
Danish: Hos patienter med eGFR 30 ml/min/1,73 m2 til
English: • rash or red skin - this may be itchy and include raised bumps, oozing fluid or blisters.
Danish: • udslæt eller hudrødme, som kan være ledsaget af kløe og omfatte hævede områder i huden,
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.
Danish: Middelændringer (%) fra baseline i serumkalium var henholdsvis 0,5 % og 1,0 % for canagliflozin 100 mg og 300 mg sammenlignet med 0,6 % for placebo.
English: recent myocardial infarction, shock;
Danish: Kardiovaskulær død Ikkedødeligt myokardieinfarkt pkt.
English: Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 850 mg metformin hydrochloride.
Danish: Hver tablet indeholder canagliflozinhemihydrat svarende til 50 mg canagliflozin og 850 mg metforminhydrochlorid.
English: Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 850 mg metformin hydrochloride.
Danish: Hver tablet indeholder canagliflozinhemihydrat svarende til 150 mg canagliflozin og 850 mg metforminhydrochlorid.
English: EU/1/14/918/007 (20 film-coated tablets) EU/1/14/918/008 (60 film-coated tablets) EU/1/14/918/009 (180 film-coated tablets)
Danish: EU/1/14/918/007 (20 filmovertrukne tabletter) EU/1/14/918/008 (60 filmovertrukne tabletter) EU/1/14/918/009 (180 filmovertrukne tabletter)