FrancophonIA/ELRC3.0 huggingface dataset:
English: Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Danish: Begrænsede data fra kliniske studier tyder på, at diabetisk ketoacidose optræder med hyppigheden ”almindelig”, når patienter med type 1-diabetes behandles med SGLT2-hæmmere.
English: g Vulvovaginal candidiasis includes the terms vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis,
Danish: g Vulvovaginal candidiasis omfatter termerne vulvovaginal candidiasis, vulvovaginal svampeinfektion, vulvovaginitis,
English: • iodinated contrast agents (medicines used during an X-ray).
Danish: ● jodholdige kontrastmidler (medicin til brug i forbindelse med røntgenundersøgelser).
English: Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Danish: De rapporterede tilfælde af laktatacidose hos patienter, der fik metformin, forekom især hos patienter med diabetes og signifikant nyresvigt.
English: • if you have ever had serious heart disease or if you have had a stroke
Danish: ● hvis du nogensinde har haft en alvorlig hjertesygdom eller et slagtilfælde
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and only if normal renal function has been established.
Danish: Behandlingen må først genoptages 48 timer efter indgrebet eller efter overgang til oral ernæring, og kun hvis nyrefunktionen er fundet normal.
English: Lactic acidosis (very rare, may affect up to 1 in 10,000 people)
Danish: Laktatacidose (meget sjælden - kan berøre op til 1 ud af 10.000 personer)
English: Physicians should alert the patients on the risk and on the symptoms of lactic acidosis.
Danish: Læger bør advare patienterne om risikoen for laktatacidose og om symptomer derpå.
English: 300 mg, respectively, compared to 2.7% for placebo.
Danish: 300 mg sammenlignet med 2,7 % for placebo.
English: ● Acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock;
Danish: ● Akut eller kronisk sygdom, der kan give vævshypoksi, såsom hjerteinsufficiens, nyresvigt, nyligt myokardieinfarkt, shock
English: There is an increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition, or hepatic impairment) due to the metformin active substance of Vokanamet (see section 4.4).
Danish: Ved akut alkoholforgiftning ses en øget risiko for laktatacidose (især i forbindelse med faste, fejlernæring eller nedsat leverfunktion) på grund af det aktive stof metformin i Vokanamet (se pkt.
English: Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): 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.
Danish: Søg læge med det samme, hvis du får en af følgende bivirkninger: Diabetisk ketoacidose (sjælden - kan berøre op til 1 ud af 1.000 personer) Symptomerne på diabetisk ketoacidose (se også afsnit 2, Advarsler og forholdsregler) er: forhøjet niveau af “ketonstoffer” i urinen eller blodet hurtigt vægttab kvalme eller opkastning mavesmerter voldsom tørst hurtig og dyb vejrtrækning forvirring usædvanlig søvnighed eller træthed dine ånde lugter sødligt, du har en sødlig eller metallisk smag i munden eller din urin eller sved lugter anderledes
English: Therefore, Vokanamet must be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.4).
Danish: Vokanamet skal derfor seponeres før eller på tidspunktet for testen og må ikke genoptages, før der er gået 48 timer efter testen, og først når nyrefunktionen atter er blevet evalueret og fundet normal (se pkt.
English: • low blood sugar levels (hypoglycaemia) - when taking this medicine with insulin or a sulphonylurea (such as glimepiride or glipizide).
Danish: ● lavt blodsukker - hvis du tager dette lægemiddel sammen med insulin eller et sulfonylurinstof (såsom glimepirid eller glipizid).
English: This is more likely if you are already fasting, have malnutrition, or liver problems.
Danish: Risikoen øges, hvis du er fastende, fejlernæret eller har leverproblemer.
English: • cimetidine (medicine used to treat stomach problems)
Danish: ● cimetidin (medicin mod mavebesvær)
English: Nervous system disorders common
Danish: Nervesystemet Almindelig
English: • cholestyramine (medicine used to reduce cholesterol levels in the blood).
Danish: ● colestyramin (middel til at nedsætte blodets indhold af kolesterol).
English: • if you have a diabetic pre-coma
Danish: ● hvis du har et insulintilfælde med diabetisk prækoma
English: ● by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis
Danish: ● ved reduktion af glucoseproduktion i leveren gennem hæmning af glukoneogenese og glykogenolyse
English: • an operation under general, spinal, or peridural anaesthetic.
Danish: ● opereres under fuld, spinal eller epidural bedøvelse.
English: The primary assessment of safety and tolerability was conducted in a pooled analysis (N = 2,313) of four 26-week placebo-controlled clinical studies (monotherapy and add-on therapy with metformin, metformin and a sulphonylurea, and metformin and pioglitazone).
Danish: Den primære vurdering af sikkerhed og tolerabilitet blev udført som en poolet analyse (N=2.313) af fire 26-ugers placebokontrollerede kliniske studier (som monoterapi og som tillægsbehandling til metformin, metformin og et sulfonylurinstof samt metformin og pioglitazon).
English: Table 1: Tabulated list of adverse reactions (MedDRA) from placebo-controlled studiesa and from postmarketing experience System organ class Frequency
Danish: Tabel 1: Bivirkninger (MedDRA) opstillet i tabelform på baggrund af placebokontrollerede studiera og erfaringer efter markedsføringen Systemorganklasse
English: A subset of patients (N = 208) from the active-controlled dual therapy study with metformin who underwent dual energy X-ray densitometry (DXA) and abdominal computed tomography (CT) scans for evaluation of body composition demonstrated that approximately two-thirds of the weight loss with canagliflozin was due to loss of fat mass with similar amounts of visceral and abdominal subcutaneous fat being lost.
Danish: Hos en delmængde af patienterne (N=208) fra det aktivt kontrollerede studie med dualbehandling med metformin, som fik udført DXA-scanning (dual-energy x-ray absorptiometry) og abdominal CTscanning (computertomografi) til evaluering af kroppens vævssammensætning, blev det påvist, at ca. to tredjedele af vægttabet med canagliflozin skyldtes tab af fedtmasse med lige store tab af visceralt og abdominalt subkutant fedt.
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).
Danish: Generelt opnåede canagliflozin klinisk og statistisk signifikante (p<0,001) resultater i forhold til placebo, hvad angår glykæmisk kontrol inklusive glykeret hæmoglobin (HbA1c), procentdelen af patienter, der opnåede HbA1c < 7 %, ændringer fra baseline i fastende plasmaglucose (FPG) samt postprandial glucose (PPG) efter 2 timer.
English: If you experience some of the signs of lactic acidosis which include feeling sick (nausea) or being sick (vomiting), stomach ache, severe weakness, muscle cramps, unexplained weight loss, rapid breathing, or feeling cold or uncomfortable, stop taking Vokanamet immediately and contact a doctor or go to the nearest hospital straight away.
Danish: Hvis du oplever nogle af tegnene på laktatacidose, der omfatter kvalme og opkastning, mavesmerter, alvorlig svaghedsfølelse, muskelkramper, uventet vægttab, hurtig vejrtrækning eller kuldefornemmelse eller ubehag, skal du straks stoppe med at tage Vokanamet og kontakte en læge eller tage direkte hen på nærmeste hospital.
English: Metformin is excreted unchanged in the urine.
Danish: Biotransformation Metformin udskilles uomdannet i urinen.
English: • feeling thirsty
Danish: ● tørst
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Tablet core
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Tabletkerne
English: Drug/laboratory test interference
Danish: Interferens mellem lægemidlet og laboratorieprøver
English: Your kidneys will be tested by a blood test before you start taking and while you are taking this medicine.
Danish: Du vil få undersøgt din nyrefunktion ved hjælp af en blodprøve, før du begynder at tage Vokanamet og under behandlingen.
English: In a study comparing canagliflozin 300 mg once daily 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 en gang dagligt med sitagliptin 100 mg i trippelbehandling med metformin og et sulfonylurinstof, udviste canagliflozin ikke-inferior (p<0,05) og superior (p<0,05) reduktion af HbA1c i forhold til sitagliptin.
English: • an X-ray where you will be injected with a dye.
Danish: ● røntgenfotograferes og have indsprøjtet et kontrastmiddel.
English: Table 3: Efficacy results from placebo-controlled clinical studiesa
Danish: Tabel 3: Effektresultater i placebokontrollerede kliniske studiera
English: The most commonly reported adverse reactions during treatment were hypoglycaemia in combination with insulin or a sulphonylurea, vulvovaginal candidiasis, urinary tract infection, and polyuria or pollakiuria (i.e., urinary frequency).
Danish: Under behandlingen var de hyppigst indberettede bivirkninger hypoglykæmi i kombination med insulin eller sulfonylurinstoffer, vulvovaginal candidiasis, urinvejsinfektion og polyuri eller pollakisuri
English: Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin
Danish: Sammenlignet med glimepirid som dualbehandling med metformin (52 uger) Canagliflozin + metformin
English: a Intent-to-treat population using last observation in study prior to glycaemic rescue therapy.
Danish: Ikke relevantc a Intent-to-treat-population under anvendelse af den sidste observation i studiet før glykæmisk nødmedicin.
English: Lactic acidosis is a medical emergency and must be treated in a hospital.
Danish: Laktatacidose er en kritisk tilstand, der skal behandles på hospitalet.
English: ● and delay of intestinal glucose absorption.
Danish: ● ved at forhale intestinal absorption af glucose
English: Glimepiride (titrated) + metformin (N = 482)
Danish: Glimepirid (titreret) + metformin (N=482)
English: Administration of iodinated contrast agent
Danish: Administration af iodholdigt kontraststof
English: Safety data profiles from individual pivotal studies (including studies in moderately renally impaired patients; older patients [≥ 55 years of age to ≤ 80 years of age]; patients with increased CV-risk) were generally consistent with the adverse reactions identified in this table.
Danish: a Sikkerhedsdataprofiler fra individuelle pivotale studier (herunder studier med patienter med moderat nedsat nyrefunktion, ældre patienter [i alderen ≥ 55 år til ≤ 80 år], patienter med øget risiko for kardiovaskulær sygdom)
English: Your doctor will decide whether you need any other treatment to control your blood sugar while you have stopped taking Vokanamet.
Danish: Din læge vil tage stilling til, om du har behov for anden behandling til at kontrollere blodsukkeret,
English: Vokanamet must not be used in patients with moderate or severe renal impairment (eGFR < 60 mL/min/1.73m2 or CrCl < 60 mL/min) due to the active substance metformin (see sections 4.3, 4.4 and 5.2).
Danish: Vokanamet må ikke anvendes til patienter med moderat til svært nedsat nyrefunktion (eGFR < 60 ml/min/1,73m2 eller CrCl < 60 ml/min) på grund af det aktive stof metformin (se pkt.
English: b p < 0.001 compared to placebo.
Danish: b p<0,001 sammenlignet med placebo.
English: ● Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock (see section 4.4);
Danish: ● Akutte lidelser, der kan påvirke nyrefunktionen, såsom dehydrering, svær infektion, shock (se pkt.
English: • too much lactic acid in your blood (lactic acidosis).
Danish: ● for meget mælkesyre i blodet.
English: d p = 0.013 compared to placebo.
Danish: d p=0,013 sammenlignet med placebo.
English: CrCl < 60 mL/min), (see sections 4.2 and 4.4);
Danish: CrCl < 60 ml/min) (se pkt.
English: Statistically significant (p < 0.001) changes from baseline HbA1c relative to placebo of -0.57% and -0.70% were observed for 100 mg once daily and 300 mg once daily, respectively (see sections 4.2 and 4.8).
Danish: Der observeredes statistisk signifikante (p<0,001) ændringer fra baseline HbA1c i forhold til placebo på -0,57 % og -0,70 % for henholdsvis 100 mg en gang dagligt og 300 mg en gang dagligt (se pkt.
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 poolede 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: Table 2: The frequency of metformin adverse reactions identified from clinical trial and postmarketing data
Danish: Tabel 2: Hyppigheden af metformins bivirkninger som angivet i kliniske studier og efter markedsføring af lægemidlet Systemorganklasse Hyppighed
English: Sitagliptin 100 mg + metformin and sulfonylurea (N=378)
Danish: Sitagliptin 100 mg + metformin og sulfonylurinstof (N=378)
English: • urinary tract infections
Danish: ● urinvejsinfektioner
English: Decreases in eGFR (-3.6% and -5.2%) were reported with canagliflozin 100 mg and canagliflozin 300 mg, respectively, compared to the control group (-3.0%) (see sections 4.2 and 4.4).
Danish: Der blev observeret fald i eGFR (-3,6 %, henholdsvis -5,2 %) for canagliflozin 100 mg og 300 mg sammenlignet med kontrolgruppen (-3,0 %) (se pkt.
English: • if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat, contact a doctor or the nearest hospital straight away.
Danish: ● hvis du taber dig meget hurtigt, får kvalme eller kaster op, får mavesmerter, er voldsomt tørstig, trækker vejret hurtigt og dybt, er forvirret, er usædvanligt søvnig eller træt, dine ånde lugter sødligt, du har en sødlig eller metallisk smag i munden eller din urin eller sved lugter anderledes.
English: Possible signs of lactic acidosis are: - feeling sick (nausea) or being sick (vomiting) - stomach ache - severe weakness - muscle cramps - unexplained weight loss - rapid breathing - feeling cold or uncomfortable.
Danish: Mulige tegn på laktatacidose: - kvalme eller opkastning - mavesmerter - alvorlig svaghedsfølelse - muskelkramper - uventet vægttab - hurtig vejrtrækning - kuldefornemmelse eller ubehag
English: Environmental Risk Assessment: no environmental impact is anticipated from the clinical use of either of the active substances canagliflozin or metformin in Vokanamet.
Danish: Der forventes ingen miljøpåvirkning fra klinisk anvendelse af de to aktive stoffer canagliflozin og metformin i Vokanamet.
English: In four placebo-controlled studies, treatment with canagliflozin as monotherapy or add-on therapy with one or two oral glucose-lowering medicinal products resulted in mean changes from baseline relative to placebo in FPG of -1.2 mmol/L to -1.9 mmol/L for canagliflozin 100 mg once daily and -1.9 mmol/L to -2.4 mmol/L for canagliflozin 300 mg once daily, respectively.
Danish: I fire placebokontrollerede studier førte behandling med canagliflozin som monoterapi eller som tillægsbehandling til et eller to orale glucosesænkende lægemidler til gennemsnitlige ændringer i FPG fra baseline i forhold til placebo på -1,2 mmol/l til -1,9 mmol/l for canagliflozin 100 mg en gang dagligt og -1.9 mmol/l til -2.4 mmol/l for canagliflozin 300 mg en gang dagligt.
English: Caution should be exercised in patients for whom a canagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension, patients on diuretics, or elderly patients (≥ 65 years of age) (see sections 4.2 and 4.8).
Danish: Forsigtighed tilrådes hos patienter, hos hvem et blodtryksfald udløst af canagliflozin kunne være risikabelt, f.eks. patienter med kendt kardiovaskulær sygdom, patienter i behandling med antihypertensiva eller med hypotension i anamnesen, patienter, der får diuretika, eller ældre patienter
English: compared to 0.0% for placebo.
Danish: 0,3 % for placebo.
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 med relation til volumendepletering På grund af dets virkningsmekanisme, som medfører øget udskillelse af glucose i urinen (UGE), inducerer canagliflozin osmotisk diurese, hvilket kan reducere det intravaskulære volumen og sænke blodtrykket (se pkt.
English: ● Hepatic impairment, acute alcohol intoxication, alcoholism (see sections 4.2 and 4.5).
Danish: ● Nedsat leverfunktion, akut alkoholforgiftning, alkoholisme (se pkt.
English: • rash or redness of the penis or foreskin (yeast infection)
Danish: ● udslæt eller rødme på penis eller forhuden (svampeinfektion)
English: ● 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
Danish: ● en signifikant reduktion i den absolutte risiko for enhver diabetes-relateret mortalitet: metformin 7,5 hændelser/1.000 patientår, diæt alene 12,7 hændelser/1.000 patientår, p=0,017
English: • in patients on their maximally tolerated doses of metformin along with other glucose-lowering medicinal products including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5, and 5.1 for available data on different add-on therapies)
Danish: ● hos patienter, der får den maksimale tolererede dosis metformin sammen med andre glucosesænkende lægemidler inklusive insulin, når disse ikke giver tilstrækkelig glykæmisk kontrol (se pkt.
English: e Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3%
Danish: e .Knoglefraktur rapporteredes hos henholdsvis 0,7 % og 0,6 % for canagliflozin 100 mg og 300 mg sammenlignet med
English: ● a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Danish: ● en signifikant reduktion af den absolutte risiko for myokardieinfarkt: metformin 11 hændelser/1.000 patientår, diæt alene 18 hændelser/1.000 patientår, (p=0,01)
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 once daily, canagliflozin 300 mg once daily, and placebo, respectively (see sections 4.2 and 4.5).
Danish: Når canagliflozin blev gives som tillæg til et sulfonylurinstof, blev der observeret hypoglykæmi hos 4,1 %, 12,5 % og 5,8 % af de patienter, der blev behandlet med henholdsvis canagliflozin 100 mg en gang dagligt, canagliflozin 300 mg en gang dagligt og placebo (se pkt.
English: In an analysis of four 26-week, placebo-controlled studies (N = 2,313), treatment with canagliflozin 100 mg and 300 mg once daily resulted in mean reductions in systolic blood pressure of -3.9 mmHg and -5.3 mmHg, respectively, compared to placebo (-0.1 mmHg) and a smaller effect on diastolic blood pressure with mean changes for canagliflozin 100 mg once daily and 300 mg once daily of -2.1 mmHg and -2.5 mmHg, respectively, compared to placebo (-0.3 mmHg).
Danish: I en analyse af fire 26-ugers placebokontrollerede studier (N=2.313) resulterede behandling med canagliflozin 100 mg og 300 mg en gang dagligt i gennemsnitlige reduktioner i systolisk blodtryk på henholdsvis -3,9 mmHg og -5,3 mmHg sammenlignet med placebo (-0,1 mmHg) og en mindre virkning på diastolisk blodtryk med gennemsnitlige ændringer for canagliflozin 100 mg en gang dagligt og 300 mg en gang dagligt på henholdsvis -2,1 mmHg og -2,5 mmHg sammenlignet med placebo (-0,3 mmHg).
English: • corticosteroids (used to treat a variety of conditions, such as severe inﬂammation of the skin or in asthma) that are given by mouth, as an injection, or inhaled • beta-2 agonists (such as salbutamol or terbutaline) used to treat asthma.
Danish: ● kortikosteroider (bruges ved en lang række tilstande som f.eks. svære betændelseslignende tilstande i huden eller astma), der indtages gennem munden, gives som injektion eller inhaleres
English: l Mean percent changes from baseline in blood urea nitrogen were 17.1% and 18.0% for canagliflozin 100 mg and
Danish: l Middelændringer (%) fra baseline i blod-carbamid var henholdsvis 17,1 % og 18,0 % for canagliflozin 100 mg og
English: For patients with an estimated glomerular filtration rate (eGFR) 60 mL/min/1.73 m2 to < 90 mL/min/1.73m2 or creatinine clearance (CrCl) of 60 mL/min to < 90 mL/min, no dose adjustment is needed.
Danish: Dosisjustering er ikke nødvendig hos patienter med en estimeret glomerulær filtrationshastighed (eGFR) på 60 ml/min/1,73 m2 til < 90 ml/min/1,73 m2 eller kreatininclearance (CrCl) på 60 ml/min til
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g., type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Danish: (LADA) eller patienter med pancreatitis i anamnesen), patienter med tilstande, der medfører lavt fødeindtagelse eller svær dehydrering, patienter, hvis insulindosis er blevet nedsat, samt patienter med øget insulinbehov på grund af akut sygdom, kirurgi eller alkoholmisbrug.
English: • 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.
Danish: ● Vokanamet 50 mg/1.000 mg filmovertrukne tabletter er beige, kapselformede, 21 mm lange tabletter præget med “CM” på den ene side og “551” på den anden side