FrancophonIA/ELRC3.0 huggingface dataset:
English: 180 film-coated tablets
Danish: 180 filmovertrukne tabletter
English: In addition the pharmacokinetic characteristics of linagliptin were found to be similar in dedicated phase I studies in Japanese, Chinese and Caucasian healthy subjects and African American type 2 diabetes patients.
Danish: Desuden fandt man i fase I-studier, at linagliptins farmakokinetiske karakteristika var ens hos japanske, kinesiske og kaukasiske raske frivillige og afroamerikanske type 2-diabetes-patienter.
English: Co-administration with 5 mg linagliptin did not alter the steady-state pharmacokinetics of levonorgestrel or ethinylestradiol.
Danish: Samtidig administration af 5 mg linagliptin ændrede ikke steady state-farmakokinetikken for levonorgestrel eller ethinylestradiol.
English: PHARMACEUTICAL FORM AND CONTENTS 60 x 1 film-coated tablets.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 60 x 1 filmovertrukne tabletter.
English: It is not known whether linagliptin passes into human milk.
Danish: Det vides ikke, om linagliptin går over i mælken.
English: Furthermore GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output.
Danish: Desuden sænker GLP-1 glucagonsekretionen fra bugspytkirtlens alfaceller, hvilket medfører, at leverens glucoseproduktion reduceres.
English: High overdose of metformin hydrochloride or concomitant risks may lead to lactic acidosis.
Danish: En stor overdosis af metformin eller samtidige risici kan føre til laktatacidose.
English: For the entire treatment period (median time on treatment 5.9 years) the rate of patients with moderate or severe hypoglycaemia was 6.5% on linagliptin versus 30.9% on glimepiride, severe hypoglycaemia occurred in 0.3% of patients on linagliptin versus 2.2% on glimepiride.
Danish: I hele behandlingsperioden (mediantid i behandling 5,9 år) var hyppigheden af patienter med moderat eller svær hypoglykæmi 6,5 % for linagliptin versus 30,9 % for glimepirid.
English: Table 1:
Danish: Tabel 1:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING TIL BLISTER
English: The overall incidence of adverse events and serious adverse events in patients receiving linagliptin was similar to that in patients receiving placebo.
Danish: Den samlede forekomst af uønskede hændelser og alvorlige uønskede hændelser hos patienter, der fik linagliptin, svarede til forekomsten hos patienter, der fik placebo.
English: Acute pancreatitis has been observed in patients taking linagliptin.
Danish: Der er blevet observeret akut pankreatitis hos patienter, der tog linagliptin.
English: When linagliptin and metformin were administered in combination with insulin, hypoglycaemia was the most frequently reported adverse event, but occurred at comparable rate when placebo and metformin were combined with insulin (linagliptin plus metformin plus insulin 29.5% and 30.9% in the placebo plus metformin plus insulin group) with a low rate of severe (requiring assistance) episodes (1.5% and 0.9%).
Danish: Når linagliptin og metformin blev givet i kombination med insulin, var hypoglykæmi den hyppigst rapporterede bivirkning, men forekom med lignende hyppighed, når placebo og metformin blev kombineret med insulin (linagliptin plus metformin plus insulin 29,5 %, placebo plus metformin plus insulin 30,9 %) med lav hyppighed for alvorlige hændelser (der kræver hjælp) (1,5 % og 0,9 %).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
English: Red iron oxide (E172)
Danish: Rød jernoxid (E172)
English: In placebocontrolled studies, more than 1800 patients were treated with the therapeutic dose of either 2.5 mg linagliptin twice daily (or its bioequivalent of 5 mg linagliptin once daily) in combination with metformin for ≥ 12/24 weeks.
Danish: I placebokontrollerede studier blev mere end 1.800 patienter behandlet med den terapeutiske dosis på 2,5 mg linagliptin 2 gange dagligt (eller det bioækvivalente 5 mg linagliptin én gang dagligt) i kombination med metformin i ≥ 12/24 uger.
English: Talk to your doctor if you want to breast-feed while taking this medicine.
Danish: Tal med din læge, hvis du ønsker at amme.
English: Among patients who were using insulin at baseline, the incidence of severe hypoglycaemia was 4.4% in linagliptin-treated patients and 4.9% in placebo treated patients.
Danish: Blandt patienterne, som brugte insulin ved baseline, var forekomsten af svær hypoglykæmi 4,4 % hos patienter, der blev behandlet med linagliptin, og 4,9 % hos patienter, der fik placebo.
English: Metformin is excreted in human milk in small amounts.
Danish: Metformin udskilles i små mængder i human mælk.
English: Other risk factors for lactic acidosis are excessive alcohol intake, hepatic impairment, 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).
Danish: Andre risikofaktorer for laktatacidose omfatter stort alkoholforbrug, leverinsufficiens, utilstrækkeligt kontrolleret diabetes, ketose, langvarig faste og enhver tilstand forbundet med hypoksi samt samtidig brug af lægemidler, der kan forårsage laktatacidose (se pkt.
English: STOP taking Jentadueto and contact a doctor immediately if you notice any of the following serious side effects: - Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas
Danish: STOP med at tage Jentadueto og kontakt din læge med det samme, hvis du bemærker en eller flere af følgende alvorlige bivirkninger: - Svære og vedvarende smerter i maven, som kan stråle ud til ryggen, samt kvalme og opkastning,
English: Steady-state predictions for AUC of linagliptin in patients with ESRD indicated comparable exposure to that of patients with moderate or severe renal impairment.
Danish: Estimeret AUC ved steady state for linagliptin hos patienter med ESRD var sammenlignelig med patienter med moderat eller svært nedsat nyrefunktion.
English: The steady-state pharmacokinetics of 5 mg linagliptin were not changed by concomitant administration of a single 1.75 mg dose glibenclamide (glyburide).
Danish: Farmakokinetikken for linagliptin 5 mg ved steady state blev ikke påvirket af samtidig administration af en enkelt dosis af glibenclamid (glyburid) på 1,75 mg.
English: • Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin.
Danish: • induktorer af OCT1 (f.eks. rifampicin) kan øge absorptionen i mave-tarm-kanalen og virkningen af metformin
English: Effects of other medicinal products on linagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by coadministered medicinal products is low.
Danish: De kliniske data, som er beskrevet nedenfor, tyder på, at risikoen for klinisk relevante interaktioner ved administration sammen med andre lægemidler er lav.
English: Pack sizes of 14, 60 and 180 film-coated tablets.
Danish: Pakningsstørrelser på 14, 60 og 180 filmovertrukne tabletter.
English: Number of Subjects
Danish: Antal personer
English: Concomitant use not recommended
Danish: Samtidig brug frarådes
English: The use of linagliptin has not been studied in pregnant women.
Danish: Der findes ingen kliniske data fra anvendelse af linagliptin til gravide kvinder.
English: Factors that may increase the risk of lactic acidosis (see 4.4) should be reviewed before considering initiation of metformin in patients with GFR<60 ml/min.
Danish: 4.4), skal gennemgås, inden påbegyndelse af metforminbehandling overvejes hos patienter med GFR < 60 ml/min.
English: Metformin hydrochloride stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Danish: Metformin stimulerer intracellulær glykogensyntese ved at indvirke på glycogensyntase.
English: If you take more Jentadueto tablets than you should have, you may experience lactic acidosis.
Danish: Hvis du har taget for mange Jentadueto tabletter, kan du få laktatacidose.
English: Administration of iodinated contrast agent
Danish: Administration af iodholdige kontrastmidler
English: When linagliptin and metformin were administered in combination with a sulphonylurea, hypoglycaemia was the most frequently reported adverse event (linagliptin plus metformin plus sulphonylurea 23.9% and 16.0% in placebo plus metformin plus sulphonylurea).
Danish: Når linagliptin og metformin blev givet i kombination med et sulfonylurinstof, var hypoglykæmi den hyppigst rapporterede bivirkning (linagliptin plus metformin plus sulfonylurinstof 23,9 %, placebo plus metformin plus sulfonylurinstof 16,0 %).
English: Exposure in T2DM patients with severe RI was increased by about 1.4 fold compared to T2DM patients with normal renal function.
Danish: Eksponeringen hos type 2-diabetes-patienter med svært nedsat nyrefunktion var ca. 1,4 gange højere sammenlignet med type 2-diabetes-patienter med normal nyrefunktion.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: Sulphonylureas:
Danish: Sulfonylurinstoffer:
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale pakning for at beskytte mod fugt.
English: Linagliptin 5 mg once daily and 2.5 mg twice daily provided comparable (CI: -0.07; 0.19) significant HbA1c reductions of -0.80% (from baseline 7.98%), and -0.74% (from baseline 7.96%) compared to placebo.
Danish: Behandling med linagliptin 5 mg én gang dagligt og 2,5 mg 2 gange dagligt medførte sammenlignelige (CI: -0,07; 0,19), signifikante HbA1c -reduktioner på henholdsvis -0,80 % (i forhold til baseline 7,98 %) og -0,74 % (i forhold til baseline 7,96 %) sammenlignet med placebo.
English: Linagliptin in combination with metformin and insulin A 24-week placebo-controlled study was conducted to evaluate the efficacy and safety of linagliptin (5 mg once daily) added to insulin with or without metformin.
Danish: Linagliptin i kombination med metformin og insulin Et 24-ugers placebokontrolleret studie blev udført for at vurdere linagliptins (5 mg én gang dagligt) effekt og sikkerhed med eller uden metformin som supplement til insulin.
English: Lactic acidosis is a medical emergency and must be treated in hospital.
Danish: Laktatacidose er en alvorlig medicinsk tilstand og kræver behandling på hospital.
English: 90 x 1 film-coated tablets.
Danish: 90 x 1 filmovertrukne tabletter.
English: Liver, kidneys and gastrointestinal tract are the principal target organs of toxicity in mice and rats at repeat doses of linagliptin of more than 300 times the human exposure.
Danish: Lever, nyrer og mave-tarm-kanalen var de primære målorganer for toksisk påvirkning hos mus og rotter efter gentagne doser af linagliptin på mere end 300 gange den humane eksponering.
English: As metformin is excreted by the kidney, Jentadueto should be used with caution as age increases.
Danish: Da metformin udskilles renalt, bør øget alder hos patienterne ligeledes følges af en øget forsigtighed i brugen af Jentadueto.
English: - bronchodilators (β-sympathomimetics) for the treatment of bronchial asthma.
Danish: astma og gigt (kortikosteroider) - Bronkodilatorer (β-sympatomimetika), der bruges til behandling af bronkial astma - Medicin, der indeholder alkohol.
English: Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Danish: Kombinationsbehandling, hvor forholdsregler skal iagttages Glukokortikoider (givet systemisk og lokalt), beta-2-agonister og diuretika har en selvstændig hyperglykæmisk virkning.
English: However, such studies have been conducted with the individual active substances, i.e. linagliptin and metformin.
Danish: Der er ikke foretaget interaktionsstudier, men sådanne studier er dog udført med de enkelte aktive stoffer, dvs. linagliptin og metformin.
English: No adverse effects of linagliptin on fertility were observed in male or female rats (see section 5.3).
Danish: Der blev ikke observeret bivirkninger fra linagliptin på fertiliteten hos han- og hunrotter (se punkt 5.3).
English: If this happens you must stop taking Jentadueto and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Danish: Hvis dette sker for dig, skal du omgående stoppe med at tage Jentadueto og kontakte læge eller nærmeste hospital, da laktatacidose kan føre til koma.
English: When linagliptin was added to a sulphonylurea on a background of metformin, the incidence of hypoglycaemia was increased over that of placebo.
Danish: Når linagliptin blev givet i supplement til et sulfonylurinstof med metformin som basisbehandling, sås en øget forekomst af hypoglykæmi sammenlignet med placebo.
English: 100 x 1 film-coated tablets.
Danish: 100 x 1 filmovertrukne tabletter.
English: Linagliptin cardiovascular safety study (CAROLINA) CAROLINA was a randomized study in 6033 patients with early type 2 diabetes and increased CV risk or established complications who were treated with linagliptin 5 mg (3023) or glimepiride 1-4mg (3010) added to standard of care (including background therapy with metformin in 83% of patients) targeting regional standards for HbA1c and CV risk factors.
Danish: Linagliptin studie af kardiovaskulær sikkerhed (CAROLINA) CAROLINA var et randomiseret studie hos 6033 patienter med tidlig type 2-diabetes med en øget kardiovaskulær risiko eller fastlagte komplikationer, som blev behandlet med linagliptin 5 mg (3023) eller glimepirid 1-4 mg (3010), tilføjet til deres standardbehandling (herunder baggrundsbehandling med metformin hos 83 % af patienter) rettet mod regionale standarder for HbA1c og kardiovaskulære risikofaktorer.
English: Symptoms of lactic acidosis are non-specific such as feeling or being very sick, vomiting, stomach ache with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing.
Danish: Symptomer på laktatacidose er uspecifikke, f.eks. kvalme eller opkastning, mavesmerter med muskelkramper, generel utilpashed med voldsom træthed samt vejrtrækningsbesvær.
English: • Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efficacy and renal elimination of metformin.
Danish: • hæmmere af både OCT1 og OCT2 (f.eks. crizotinib, olaparib) kan ændre virkningen af metformin og dens elimination i nyrerne.
English: Linagliptin concentrations in this study were within the range of values previously observed in younger type 2 diabetes patients.
Danish: Plasmakoncentrationen af linagliptin var inden for samme interval, som tidligere set hos yngre type 2-diabetikere.
English: Nausea common
Danish: Kvalme almindelig
English: - if you have a severe infection such as an infection affecting your lung or bronchial system or your kidney.
Danish: - hvis du på noget tidspunkt har været ramt af diabetisk koma - hvis du har en sværinfektion som f.eks. en infektion, der påvirker dine lunger, bronkier eller nyrer.
English: In a cardiovascular and renal safety study (CARMELINA) with median observation period of 2.2 years, adjudicated acute pancreatitis was reported in 0.3% of patients treated with linagliptin and in 0.1% of patients treated with placebo.
Danish: I et studie af kardiovaskulær og renal sikkerhed (CARMELINA) med en median observationsperiode på 2,2 år, blev der rapporteret adjudikeret akut pankreatitis hos 0,3 % af patienterne i behandling med linagliptin, og hos 0,1 % af patienterne, der fik placebo.
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Danish: Nedsat B12-vitaminabsorption, der i meget sjældne tilfælde kan resultere i klinisk relevant B12-vitamin-mangel (f.eks. megaloblastisk anæmi), er set ved langvarig metforminbehandling.
English: Number of patients Primary CV composite (Cardiovascular death, non-fatal MI, non-fatal stroke)
Danish: Antal patienter Primært sammensat kardiovaskulært (kardiovaskulær mortalitet, ikke dødeligt MI, ikke-dødelig apopleksi) Mortalitet uanset årsag
English: How Jentadueto works
Danish: Sådan virker Jentadueto
English: Pruritus uncommon
Danish: Pruritus ikke almindelig
English: The NOAEL for maternal-, embryo-fetal-, and offspring toxicity in rats was 49 times human exposure.
Danish: NOAEL for toksicitet i moderdyret, embryo-føtal toksicitet og toksicitet i afkommet hos rotter var 49 gange den humane eksponering.
English: Therefore, linagliptin is not an inhibitor of P-glycoprotein-mediated transport in vivo.
Danish: Linagliptin er derfor ikke en in vivo-hæmmer af P-glykoproteinmedieret transport.
English: Linagliptin also showed significant improvements in patients achieving a target HbA1c of < 7.0% (31.2% on linagliptin versus 9.2% on placebo), and also for fasting plasma glucose (FPG) with -12.7 mg/dl reduction compared to placebo.
Danish: Linagliptin medførte desuden signifikante forbedringer hos patienterne, der opnåede en mål-HbA1c på < 7,0 % (31,2 % på linagliptin vs 9,2 % på placebo), og også i patienternes faste-plasma-glucose (FPG) med en reduktion på -12,7 mg/dl sammenlignet med placebo.
English: Among patients who were using sulfonylurea at baseline, the incidence of severe hypoglycaemia was 2.0% in linagliptin-treated patients and 1.7% in placebo treated patients.
Danish: Blandt patienterne, som brugte sulfonylurinstof ved baseline, var forekomsten af svær hypoglykæmi 2,0 % hos patienter, der blev behandlet med linagliptin, og 1,7 % hos patienter, der fik placebo.
English: Linagliptin cardiovascular and renal safety study (CARMELINA) The CARMELINA study evaluated the cardiovascular and renal safety of linagliptin versus placebo in patients with type 2 diabetes and with increased CV risk evidenced by a history of established macrovascular or renal disease (see section 5.1).
Danish: Linagliptin studie af kardiovaskulær og renal sikkerhed (CARMELINA) CARMELINA-studiet evaluerede den kardiovaskulære og renale sikkerhed af linagliptin vs placebo hos patienter med type 2-diabetes, og med en øget kardiovaskulær risiko, vist ved en anamnese med fastlagt makrovaskulær eller renal sygdom (se pkt.
English: If this happens to you, you may need immediate hospital treatment, as lactic acidosis can lead to coma.
Danish: Hvis du får nogen af disse symptomer, kan du have brug for omgående behandling på et hospital, da laktatacidose kan føre til koma.
English: In the pooled analysis of the seven placebo-controlled trials, the overall incidence of adverse events in patients treated with placebo and metformin was comparable to that seen with linagliptin 2.5 mg and metformin (54.3 and 49.0%).
Danish: I en puljet analyse af de syv placebokontrollerede studier var den samlede incidens af bivirkninger i gruppen, der fik placebo og metformin, sammenlignelig med incidensen af bivirkninger i gruppen, der fik linagliptin 2,5 mg og metformin (54,3 % og 49,0 %).
English: Biotransformation Following a [
Danish: Biotransformation Efter en oral [
English: Linagliptin cardiovascular and renal safety study (CARMELINA) CARMELINA was a randomized study in 6979 patients with type 2 diabetes with increased CV risk evidenced by a history of established macrovascular or renal disease who were treated with linagliptin 5 mg (3494) or placebo (3485) added to standard of care targeting regional standards for HbA1c, CV risk factors and renal disease.
Danish: Linagliptin studie af kardiovaskulær og renal sikkerhed (CARMELINA) CARMELINA var et randomiseret studie hos 6979 patienter med type 2-diabetes med en øget kardiovaskulær risiko, vist ved en anamnese af fastlagt makrovaskulær eller renal sygdom, som blev behandlet med linagliptin 5 mg (3494) eller placebo (3485), tilføjet til deres standardbehandling rettet mod regionale standarder for HbA1c, kardiovaskulære risikofaktorer og nyresygdom.
English: The NOAEL for fertility, early embryonic development and teratogenicity in rats was set at > 900 times the human exposure.
Danish: NOAEL (no observed adverse effect level) for fertilitet, tidlig fosterudvikling og teratogenicitet i rotter blev sat til > 900 gange den humane eksponering.
English: The observed incidence of hypoglycaemia in patients treated with linagliptin was similar to placebo.
Danish: Den observerede forekomst af hypoglykæmi hos patienter behandlet med linagliptin, svarede til forekomsten ved placebo.
English: Patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin
Danish: Patienter, der ikke er tilstrækkeligt kontrolleret på dual kombinationsbehandling med insulin og maksimal, tolereret metformindosis
English: Lactic acidosis is a medical emergency and must be treated in a hospital.
Danish: Laktatacidose er en alvorlig tilstand, der skal behandles på et hospital.
English: In the treated population, severe hypoglycaemic events (requiring assistance) were reported in 3.0% of patients on linagliptin and in 3.1% on placebo.
Danish: I den behandlede population blev der rapporteret svære hypoglykæmiske hændelser (der krævede hjælp) hos 3,0 % af patienterne, der fik linagliptin, og hos 3,1 %, der fik placebo.
English: The dose of Jentadueto should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Danish: Jentadueto bør doseres således, at der tages linagliptin 2,5 mg 2 gange dagligt (5 mg i alt pr. dag) og en metformindosis, der svarer til den dosis, der allerede tages.
English: Co-administration of multiple oral doses of 5 mg linagliptin and a single oral dose of 1.75 mg glibenclamide (glyburide) resulted in clinically not relevant reduction of 14% of both AUC and Cmax of glibenclamide.
Danish: Administration af en enkelt oral dosis på 1,75 mg glibenclamid (glyburid) og gentagne orale doser på 5 mg linagliptin medførte en klinisk ikke relevant reduktion på af både AUC og Cmax for glibenclamid 14 %.
English: INFORMATION IN BRAILLE Jentadueto 2.5 mg/850 mg
Danish: INFORMATION I BRAILLESKRIFT Jentadueto 2,5 mg/850 mg
English: Co-administration of a single 5 mg oral dose of linagliptin and multiple 200 mg oral doses of ritonavir, a potent inhibitor of P-glycoprotein and CYP3A4, increased the AUC and Cmax of linagliptin approximately twofold and threefold, respectively.
Danish: Administration af en enkelt oral dosis på 5 mg linagliptin og gentagne orale doser på 200 mg ritonavir, en potent P-glykoprotein- og CYP3A4-hæmmer, gav en stigning i linagliptins AUC og Cmax på henholdsvis ca. to og tre gange.
English: Posology for renally impaired patients GFR ml/min Metformin
Danish: Dosering til patienter med nedsat nyrefunktion GFR ml/min Metformin
English: Respiratory, thoracic and mediastinal disorders Cough uncommon
Danish: Luftveje, thorax og mediastinum Hoste ikke almindelig
English: System organ class Adverse reaction
Danish: Systemorganklasse Bivirkning
English: When linagliptin plus metformin hydrochloride is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4).
Danish: Når linagliptin plus metforminhydrochlorid anvendes i kombination med insulin, kan en lavere insulindosis være nødvendig for at nedsætte risikoen for hypoglykæmi (se pkt.
English: If you have symptoms of acute pancreatitis, like persistent, severe abdominal pain, you should consult your doctor.
Danish: Hvis du har vedvarende, svære mavesmerter, kan det være symptomer på akut pankreatitis, og du skal kontakte din læge.
English: common
Danish: almindelig
English: INFORMATION IN BRAILLE Jentadueto 2.5 mg/1,000 mg
Danish: INFORMATION I BRAILLESKRIFT Jentadueto 2,5 mg/1.000 mg