FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with renal impairment (eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min) Patients with a baseline eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min had a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) with incidences of 4.7%, 8.1%, and 1.5% on canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively (see sections 4.2 and 4.4).
Danish: Patienter med nedsat nyrefunktion (eGFR < 60 ml/min/1,73 m2 eller CrCl < 60 ml/min) Patienter med eGFR < 60 ml/min/1,73 m2 eller CrCl < 60 ml/min ved baseline havde en større bivirkningsincidens associeret med volumendepletering (f.eks. postural svimmelhed, ortostatisk hypotension, hypotension), idet incidensen var 4,7 %, 8,1 % og 1,5 % for henholdsvis canagliflozin 100 mg, canagliflozin 300 mg og placebo (se pkt.
English: When canagliflozin was added to insulin therapy, hypoglycaemia was observed in 49.3%, 48.2%, and 36.8% of patients treated with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively, and severe hypoglycaemia occurred in 1.8%, 2.7%, and 2.5% of patients treated with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively.
Danish: Når canagliflozin blev givet som tillæg til insulinbehandling, forekom hypoglykæmi hos 49,3 %, 48,2 % og 36,8 % af patienter, der fik henholdsvis canagliflozin 100 mg, canagliflozin 300 mg og placebo, og der blev observeret svær hypoglykæmi hos 1,8 %, 2,7 % og 2,5 % af de patienter, der fik henholdsvis canagliflozin 100 mg, canagliflozin 300 mg og placebo.
English: For patients on loop diuretics, the incidences were 3.2% on canagliflozin 100 mg and 8.8% on canagliflozin 300 mg compared to 4.7% in the control group.
Danish: Hos patienter, der fik loop-diuretika, var incidensen 3,2 % med canagliflozin 100 mg og 8,8 % med canagliflozin 300 mg sammenlignet med 4,7 % i kontrolgruppen.
English: Patients (%) achieving HbA1c < 7% Body weight Baseline (mean) in kg % change from baseline (adjusted mean)
Danish: Patienter (%) der opnåede HbA1c < 7 % 53,6 Legemsvægt Baseline (gennemsnit) i kg Ændring i % fra baseline (justeret gennemsnitsændring) Forskel ift.
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 (PPG) from baseline relative to placebo by -1.5 mmol/L to -2.7 mmol/L for canagliflozin 100 mg and -2.1 mmol/L to -3.5 mmol/L for 300 mg, respectively, due to reductions in the pre-meal glucose concentration and reduced postprandial glucose excursions.
Danish: Under provokation med et blandet måltid reducerede canagliflozin som monoterapi eller tillægsbehandling til et eller to orale glucosesænkende lægemidler postprandial glucose (PPG) fra baseline-værdien i forhold til placebo med henholdsvis -1,5 mmol/l til -2,7 mmol/l for canagliflozin 100 mg og -2,1 mmol/l til -3,5 mmol/l for 300 mg som følge af reduktioner i glucosekoncentrationen før måltidet samt reducerede udsving i postprandial glucose.
English: The overall incidence of elevated serum potassium was higher in patients with moderate renal impairment with incidences of 7.5%, 12.3%, and 8.1% on canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively.
Danish: Den samlede incidens af forhøjet serumkalium var større hos patienter med moderat nedsat nyrefunktion og var henholdsvis 7,5 %, 12,3 % og 8,1 % for canagliflozin 100 mg, canagliflozin 300 mg og placebo.
English: In a study comparing canagliflozin 300 mg to sitagliptin 100 mg in triple therapy with metformin and a sulphonylurea, canagliflozin demonstrated non-inferior (p < 0.05) and superior (p < 0.05) reduction in HbA1c relative to sitagliptin.
Danish: I et studie, der sammenlignede canagliflozin 300 mg med sitagliptin 100 mg i trippelbehandling med metformin og sulfonylurinstof, udviste canagliflozin ikke-inferiør (p < 0,05) og overlegen (p < 0,05) reduktion af HbA1c i forhold til sitagliptin.
English: Vascular disorders uncommon
Danish: Vaskuære sygdomme Ikke almindelig
English: Improvement in homeostasis model assessment for beta-cell function (HOMA beta-cell) and improved beta-cell insulin secretion response to a mixed-meal challenge has been observed in clinical studies with canagliflozin.
Danish: I kliniske studier med canagliflozin er der set en forbedret model til vurdering af homøostase for ß-cellefunktion (HOMA ß-celle) og forbedret respons af ß-cellernes insulinsekretion ved udsættelse for et blandet måltid.
English: Temporary interruption of treatment with canagliflozin may be considered for patients who develop volume depletion while on canagliflozin therapy until the condition is corrected.
Danish: Hos patienter, der får volumendepletering under behandling med canagliflozin, kan behandlingen midlertidigt afbrydes, indtil dette er korrigeret.
English: Additional safety analyses (including long-term data) from data across the entire canagliflozin programme (placebo- and active-controlled studies) were conducted to assess reported adverse reactions in order to identify adverse reactions (see table 1) (see sections 4.2 and 4.4).
Danish: For at vurdere de indberettede bivirkinger og derigennem identificere bivirkninger (se tabel 1) blev der udført supplerende sikkerhedsanalyser af data inklusive langtidsdata fra hele canagliflozin-programmet (placebokontrollerede og aktivt kontrollerede studier) (se pkt.
English: Dual therapy with metformin (26 weeks) Canagliflozin + metformin
Danish: Behandling med to lægemidler: + metformin (26 uger) Canagliflozin + metformin
English: Each tablet contains 117.78 mg lactose.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på En tablet indeholder 117,78 mg lactose.
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, respectively, compared to the combination of glimepiride and metformin (1.0%) and -2.5% for canagliflozin 300 mg in combination with metformin and a sulphonylurea compared to sitagliptin in combination with metformin and a sulphonylurea (0.3%).
Danish: I to 52-ugers aktivt kontrollerede studier, hvor canagliflozin blev sammenlignet med glimepirid og sitagliptin, var de vedvarende og statistisk signifikante gennemsnitsreduktioner i legemsvægt udtrykt i procent for canagliflozin som tillægsbehandling til metformin -4,2 % og -4,7 % for henholdsvis canagliflozin 100 mg og 300 mg sammenlignet med kombinationen af glimepirid og metformin (1,0 %) og -2,5 % for canagliflozin 300 mg i kombination med metformin og et sulfonylurinstof sammenlignet med sitagliptin i kombination med metformin og et sulfonylurinstof
English: Due to its mechanism of action, canagliflozin, by increasing urinary glucose excretion (UGE) induces an osmotic diuresis, which may reduce intravascular volume and decrease blood pressure (see section 5.1).
Danish: Anvendelse til patienter med risiko for bivirkninger, der er forbundet med volumendepletering På grund af dets virkningsmekanisme, som øger udskillelse af glucose i urin (UGE), inducerer canagliflozin osmotisk diurese, hvilket kan reducere det intravaskulære volumen og sænke blodtrykket (se pkt.
English: In rare instances, phimosis was reported and sometimes circumcision was performed (see section 4.4).
Danish: Der rapporteredes sjældne tilfælde af phimosis, der somme tider endte med omskæring (se pkt.
English: Enterohepatic circulation of canagliflozin was negligible.
Danish: Der sås kun ubetydelig enterohepatisk cirkulation of canagliflozin.
English: Monitoring of renal function is recommended as follows: - Prior to initiation of canagliflozin and at least annually, thereafter (see sections 4.2, 4.8, 5.1, and
Danish: Det anbefales at monitorere nyrefunktionen som følger: - Før initiering af behandling med canagliflozin og derefter mindst én gang om året (se pkt.
English: Canagliflozin has been observed to inhibit P-gp in vitro.
Danish: Der er observeret in vitro-hæmning af P-gp.
English: Canagliflozin was negligibly removed by haemodialysis.
Danish: Canagliflozin blev kun fjernet i ubetydelig grad ved hæmodialyse.
English: The hazard ratio for the composite primary endpoint (time to event of cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, and unstable angina requiring hospitalisation) for canagliflozin (both doses pooled) versus combined active and placebo comparators was 0.91 (95% CI: 0.68; 1.22); therefore, there was no evidence of an increase in cardiovascular risk with canagliflozin relative to comparators.
Danish: Hazard ratio for det samlede primære endepunkt (tid til en af følgende hændelser: kardiovaskulær død, ikke-fatal apopleksi, ikke-fatal myokardieinfarkt og ustabil angina pectoris, der kræver hospitalsindlæggelse) for canagliflozin (med pooling af begge doser) versus kombineret aktive og placebo-komparatorer var 0,91 (95 % CI: 0,68; 1,22).
English: Age had no clinically meaningful effect on the pharmacokinetics of canagliflozin based on a population pharmacokinetic analysis (see sections 4.2, 4.4, and 4.8).
Danish: Alder har ikke en klinisk relevant virkning på canagliflozins farmakokinetik ud fra en farmakokinetisk analyse af population (se pkt.
English: Candidal balanitis or balanoposthitis was reported in 4.2% and 3.7% of male patients treated with canagliflozin 100 mg and canagliflozin 300 mg, respectively, compared to 0.6% in placebo-treated male patients.
Danish: Balanitis eller balanopostitis, der skyldes en Candida-infektion, blev rapporteret hos 4,2 % og 3,7 % af de mandlige patienter, der blev behandlet med henholdsvis canagliflozin 100 mg og canagliflozin 300 mg sammenlignet med 0,6 % af dem, der fik placebo.
English: If an inducer of these UGT enzymes must be co-administered with canagliflozin, increasing the dose to 300 mg once daily may be considered if patients are currently tolerating canagliflozin 100 mg once daily, have an eGFR ≥ 60 mL/min/1.73 m2 or CrCl ≥ 60 mL/min, and require additional glycaemic control.
Danish: Hvis en induktor af disse UGT-enzymer skal administreres samtidig med canagliflozin, kan det overvejes at øge dosis til 300 mg en gang dagligt, hvis patienterne får canagliflozin 100 mg en gang dagligt og tåler dette godt, har eGFR ≥ 60 ml/min/1,73 m2 eller
English: The incidence with canagliflozin treatment in the two active-controlled studies was similar to comparators.
Danish: I de to aktivt kontrollerede studier sås overensstemmende incidens for behandling med canagliflozin og komparatorerne.
English: In a cardiovascular study of 4,327 patients with known or at high risk for cardiovascular disease, the incidence rates of bone fracture were 1.6, 1.6, and 1.1 per 100 patient years of exposure 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 med 4.327 patienter med kendt eller høj risiko for kardiovaskulær sygdom var incidensen af knoglebrud hhv. 1,6, 1,6 og 1,1 pr. 100 patientårs eksponering for canagliflozin 100 mg, canagliflozin 300 mg og placebo.
English: Pharmacotherapeutic group: Drugs used in diabetes, other blood glucose lowering drugs, excluding insulins.
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, blodglucosesænkende midler ekskl.
English: The majority of patients with a baseline eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 were on insulin and/or a sulphonylurea (85% [614/721]).
Danish: De fleste patienter med eGFR 45 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 ved baseline fik insulin og/eller et sulfonylurinstof (85 % [614/721]).
English: Canagliflozin 300 mg + metformin and sulphonylurea (N = 377)
Danish: Canagliflozin 300 mg + metformin og sulfonylurinstof (N = 377)
English: Canagliflozin should not be initiated in patients with an eGFR < 60 mL/min/1.73 m2 or
Danish: Canagliflozin bør ikke initieres hos patienter med eGFR < 60 ml/min/1,73 m2 eller CrCl < 60 ml/min.
English: Difference from placebo (adjusted mean) (97.5% CI)
Danish: placebo (justeret gennemsnitstal) [97,5% CI]
English: Each tablet contains 39.2 mg lactose.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på En tablet indeholder 39,2 mg lactose.
English: When canagliflozin is used as add-on therapy with insulin or an insulin secretagogue (e.g., 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).
Danish: Når canagliflozin anvendes som tillæg til insulin eller et ß-cellestimulerende middel (f.eks. et sulfonylurinstof), kan det overvejes at give en lavere dosis af insulinet eller det ß-cellestimulerende middel for at reducere risikoen for hypoglykæmi (se pkt.
English: Film-coating
Danish: Filmovertræk
English: At study endpoint, 3.0% of patients treated with canagliflozin 100 mg, 4.0% with canagliflozin 300 mg, and 3.3% with placebo had such decreases (see section 4.4).
Danish: Ved studiets endepunkt forekom sådanne fald hos 3,0 % af de patienter, der fik canagliflozin 100 mg, 4,0 % af dem, der fik canagliflozin 300 mg, og 3,3 % af dem, der fik placebo (se pkt.
English: When canagliflozin was added to a sulphonylurea therapy, hypoglycaemia was observed in 4.1%, 12.5%, and 5.8% of patients treated with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively (see sections 4.2 and 4.5).
Danish: Når canagliflozin blev gives som tillæg til behandling sulfonylurinstoffer, blev der observeret hypoglykæmi i 4,1 %, 12,5 % og 5,8 % af de patienter, der blev behandlet med henholdsvis canagliflozin 100 mg, canagliflozin 300 mg og placebo (se pkt.
English: In patients ≥ 75 years of age, the incidences were 4.9% on canagliflozin 100 mg and 8.7% on canagliflozin 300 mg compared to 2.6% in the control group (see sections 4.2 and 4.4).
Danish: Hos patienter ≥ 75 år var incidensen 4,9 % med canagliflozin 100 mg og 8,7 % med canagliflozin 300 mg sammenlignet med 2,6 % i kontrolgruppen (se pkt.
English: Musculoskeletal and connective tissue disorders uncommon
Danish: Knogler, led, muskler og bindevæv Ikke almindelig
English: Canagliflozin-induced renal tubule tumours and pheochromocytomas in rats appear to be caused by carbohydrate malabsorption as a consequence of intestinal SGLT1 inhibitory activity of canagliflozin in the gut of rats; mechanistic clinical studies have not demonstrated carbohydrate malabsorption in humans at canagliflozin doses of up to 2-times the maximum recommended clinical dose.
Danish: Canagliflozin-inducerede tumorer i nyretubuli og fæokromocytomer hos rotter synes at være forårsaget af malabsorption af kulhydrater som følge af canagliflozins SGLT1-hæmmende aktivitet i tarmsystemet hos rotter.
English: Invokana 100 mg film-coated tablets Invokana 300 mg film-coated tablets canagliflozin
Danish: Invokana 100 mg filmovertrukne tabletter Invokana 300 mg filmovertrukne tabletter canagliflozin
English: Patients with hepatic impairment For patients with mild or moderate hepatic impairment, no dose adjustment is required.
Danish: Patienter med nedsat leverfunktion Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat leverfunktion.
English: NAME OF THE MEDICINAL PRODUCT Invokana 100 mg tablets Invokana 300 mg tablets canagliflozin
Danish: LÆGEMIDLETS NAVN Invokana 100 mg tabletter Invokana 300 mg tabletter canagliflozin
English: NAME OF THE MEDICINAL PRODUCT Invokana 100 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Invokana 100 mg filmovertrukne tabletter
English: Patients with a baseline eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 treated with canagliflozin 100 mg and
Danish: Patienter med eGFR 45 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 ved baseline, som fik canagliflozin 100 mg og
English: Placebo + metformin and sulphonylurea (N = 156)
Danish: Placebo + metformin og sulfonylurinstof (N = 156)
English: Sitagliptin 100 mg + metformin and sulphonylurea (N=378)
Danish: Sitagliptin 100 mg + metformin og sulfonylurinstof (N = 378)
English: Baseline (mean) in kg % change from baseline (adjusted mean)
Danish: Baseline (gennemsnit) i kg Ændring i % fra baseline (justeret gennemsnitsændring) Forskel ift.
English: N/Ac Compared to sitagliptin as triple therapy with metformin and sulphonylurea (52 weeks)
Danish: Sammenlignet med sitagliptin som trippelbehandling med metformin og sulfonylurinstof (52 uger)
English: NAME OF THE MEDICINAL PRODUCT Invokana 300 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Invokana 300 mg filmovertrukne tabletter
English: Canagliflozin should not be used during breast-feeding.
Danish: Canagliflozin må ikke anvendes under amning.
English: Patients (%) achieving HbA1c < 7% 47.6 Body weight
Danish: Patienter (%) der opnåede HbA1c < 7% Legemsvægt
English: Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3% for placebo.
Danish: e Knoglebrud blev rapporteret hos hhv. 0,7 % og 0,6 % af patienterne med canagliflozin 100 mg og 300 mg sammenlignet med hos 0,3 % af patienterne med placebo.
English: Canagliflozin has not been studied in severe renal impairment (eGFR < 30 mL/min/1.73 m2 or CrCl < 30 mL/min) or ESRD.
Danish: Canagliflozin er ikke undersøgt hos patienter med svært nedsat nyrefunktion nyresygdom (eGFR < 30 ml/min/1,73 m2 eller CrCl
English: Canagliflozin 100 mg as dual therapy with metformin produced similar reductions in HbA1c from baseline and 300 mg produced superior (p < 0.05) reductions in HbA1c compared to glimepiride, thus demonstrating non-inferiority.
Danish: I dobbeltbehandlingen med metformin gav canagliflozin 100 mg omtrent samme reduktioner i HbA1c fra baseline, og canagliflozin 300 mg gav reduktioner, i HbA1c, som var resultaterne for glimepirid overlegne (p < 0,05), hvilket påviste Invokanas non-inferiority.
English: Difference from placebo (adjusted mean) (95% CI)
Danish: placebo (justeret gennemsnitstal) [95% CI]
English: • bone fracture
Danish: • knoglebrud
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: n Gennemsnitsændringerne (%) fra baseline i serumphosphat var 3,6 % og 5,1 %med canagliflozin 100 mg og 300 mg sammenlignet med 1,5 % med placebo.
English: When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.
Danish: Til patienter, som ikke bør behandles med metformin på grund af intolerans eller kontraindikationer, når der ikke opnås tilstrækkelig glykæmisk kontrol alene med kostomlægning og motion.
English: Possible side effects
Danish: “Bivirkninger”
English: Canagliflozin should be discontinued when eGFR is persistently below 45 mL/min/1.73 m2 or CrCl persistently below 45 mL/min (see sections 4.4, 4.8, 5.1, and 5.2).
Danish: Canagliflozin bør seponeres ved vedvarende eGFR under 45 ml/min/1,73 m2 eller vedvarende CrCl under 45 ml/min (se pkt.
English: The increased UGE with SGLT2 inhibition also translates to an osmotic diuresis, with the diuretic effect leading to a reduction in systolic blood pressure; the increase in UGE results in a loss of calories and therefore a reduction in body weight, as has been demonstrated in studies of patients with type 2 diabetes.
Danish: UGE-forhøjelsen resulterer i kalorietab og dermed til tab af legemsvægt, hvilket er påvist i studier af patienter med type 2-diabetes.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En tablet indeholder canagliflozinhemihydrat svarende til 300 mg canagliflozin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En tablet indeholder canagliflozinhemihydrat svarende til 100 mg canagliflozin.
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin.
Danish: Hver filmovertrukket tablet indeholder canagliflozinhemihydrat svarende til 300 mg canagliflozin.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal products subject to medical prescription
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
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: k Gennemsnitsændringerne (%) fra baseline in kreatinin var 2,8 % og 4,0 % med henholdsvis canagliflozin 100 mg og 300 mg sammenlignet med 1,5 % med placebo.
English: 3.2% of the administered radioactive dose was recovered in faeces as canagliflozin, a hydroxylated metabolite, and an O-glucuronide metabolite, respectively.
Danish: 41,5 %, 7,0 %, og 3,2 % af den administrerede radioaktive dosis genfundet i fæces som henholdsvis canagliflozin, en hydroxyleret metabolit og en O-glucuronidmetabolit.
English: In this pooled analysis, patients on loop diuretics, patients with a baseline eGFR 30 mL/min/1.73 m2 to
Danish: I denne poolede analyse sås generelt en større incidens af disse bivirkninger hos patienter, der fik loopdiuretika, patienter med eGFR 30 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 ved baseline og patienter
English: NAME OF THE MEDICINAL PRODUCT Invokana 100 mg film-coated tablets Invokana 300 mg film-coated tablets canagliflozin
Danish: LÆGEMIDLETS NAVN Invokana 100 mg filmovertrukne tabletter Invokana 300 mg filmovertrukne tabletter canagliflozin
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: l Gennemsnitsændringerne (%) fra baseline i P-karbamid var henholdsvis 17,1 % og 18,0 % med canagliflozin 100 mg og 300 mg sammenlignet med 2,7 % med placebo.
English: In the clinical development programme, 1,085 patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 were evaluated.
Danish: 1.085 patienter med eGFR 30 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 ved baseline blev evalueret i det kliniske udviklingsprogram.
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.
Danish: Hver filmovertrukket tablet indeholder canagliflozinhemihydrat svarende til 100 mg canagliflozin.
English: Patients with renal impairment For patients with an eGFR 60 mL/min/1.73 m2 to < 90 mL/min/1.73 m2 or CrCl 60 mL/min to
Danish: Det er ikke nødvendigt at justere dosis hos patienter med eGFR 60 ml/min/1,73 m2 til < 90 ml/min/1,73 m2 eller CrCl 60 ml/min til < 90 ml/min.
English: What Invokana looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Triple therapy with metformin and sulphonylurea (26 weeks) Canagliflozin + metformin and sulphonylurea
Danish: Intet svarc Behandling med tre lægemidler: + metformin og sulfonylurinstof (26 uger) Canagliflozin + metformin og sulfonylurinstof
English: What Invokana contains
Danish: Invokana indholder:
English: Contact a doctor or the nearest hospital straight away if you have any of the following side effects:
Danish: - Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis en bivirkning bliver værre,
English: < 90 mL/min, no dose adjustment is needed.
Danish: CrCl ≥ 60 ml/min og har behov for supplerende glykæmisk kontrol.
English: Add-on therapy with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5, and 5.1 for available data on different add-on therapies).
Danish: Tillægsbehandling med andre glucosesænkende lægemidler inklusive insulin, når disse kombineret med diæt og motion ikke er i stand til at kontrollere blodsukkeret (se pkt.