FrancophonIA/ELRC3.0 huggingface dataset:
English: Metformin hydrochloride partitions into erythrocytes.
Danish: Metformin fordeler sig i erytrocytter.
English: Non-clinical reproduction studies did not indicate an additive teratogenic effect attributed to the coadministration of linagliptin and metformin.
Danish: Ikke-kliniske reproduktionsstudier indikerede ikke forekomst af en additiv teratogen virkning, der kan tilskrives samtidig administration af linagliptin og metformin.
English: - with meals to lower your chance of an upset stomach.
Danish: - sammen med et måltid for at undgå maveproblemer.
English: Linagliptin glucose-dependently increases insulin secretion and lowers glucagon secretion thus resulting in an overall improvement in the glucose homeostasis.
Danish: Afhængigt af glucoseniveauet øger linagliptin sekretionen af insulin og sænker glucagonsekretionen, hvilket medfører en samlet forbedring i glucosehomøostasen.
English: Linagliptin trough concentrations were also measured in elderly (age ≥ 70 years) with type 2 diabetes in a phase III study of 24 weeks duration.
Danish: Trough værdien af linagliptin blev også målt hos ældre (alder ≥ 70 år) med type 2-diabetes i et 24 ugers fase III studie.
English: isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration.
Danish: isavuconazol) kan reducere metformins elimination i nyrerne og dermed medføre en stigning i plasmakoncentrationen af metformin
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Jentadueto.
Danish: Du skal eventuelt have kontrolleret dit blodsukker eller din nyrefunktion hyppigere, eller lægen kan ændre din dosis af Jentadueto.
English: Placebo Linagliptin 5 mg Once
Danish: Placebo Linagliptin 5 mg én gang dagligt1
English: Patients treated with linagliptin exhibited a significant mean decrease from baseline in body weight compared to a significant weight gain in patients administered glimepiride (-1.39 versus +1.29 kg).
Danish: Patienter behandlet med linagliptin havde en signifikant gennemsnitlig reduktion i kropsvægt i forhold til baseline sammenlignet med en signifikant vægtstigning hos patienter, der fik glimepirid (-1,39 vs +1,29 kg).
English: Clinical experience with Jentadueto in patients with hepatic impairment is lacking.
Danish: Der mangler klinisk erfaring med brug af Jentadueto til patienter med nedsat leverfunktion.
English: Adverse reactions reported in all clinical trials with the linagliptin+metformin combination or the use of the monocomponents (linagliptin or metformin) in clinical trials or from post-marketing experience are shown below according to system organ class.
Danish: Bivirkninger rapporteret i alle kliniske studier med linagliptin+metformin i kombination eller ved brug af monokomponenterne (linagliptin eller metformin) i kliniske studier eller fra erfaringer efter markedsføring er anført nedenfor inddelt i systemorganklasser.
English: An embryofetal development study in pregnant rats did not indicate a teratogenic effect attributed to the co-administration of linagliptin and metformin at AUC exposure levels up to 4 and 30 times human exposure, respectively.
Danish: Et embryo-føtalt udviklingsstudie i drægtige rotter indikerede ingen forekomst af en teratogen virkning, der kan tilskrives samtidig administration af linagliptin og metformin ved AUC-eksponeringsniveauer op til henholdsvis 4 og 30 gange human eksponering.
English: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in cases of fasting, malnutrition or hepatic impairment.
Danish: Alkoholintoksikation er forbundet med en øget risiko for laktatacidose, især i tilfælde af faste, fejlernæring eller leverinsufficiens.
English: It is not an inducer of CYP isozymes.
Danish: Linagliptin inducerer ikke CYP-isozymer.
English: You should not exceed the maximum recommended daily dose of 5 mg linagliptin and 2,000 mg metformin hydrochloride.
Danish: Du bør ikke overskride den maksimalt anbefalede daglige dosis på 5 mg linagliptin og 2.000 mg metformin.
English: Metformin passes into human milk in small amounts.
Danish: Metformin går over i mælken i små mængder.
English: Incretins are secreted at a low basal level throughout the day and levels rise immediately after meal intake.
Danish: Inkretiner udskilles i dagtimerne, hvilket resulterer i et lavt basisniveau, der øges umiddelbart efter et måltid.
English: If you forget to take Jentadueto
Danish: Hvis du har glemt at tage Jentadueto
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 2 packs, each containing 60 x 1 film-coated tablets Multipack comprising 2 packs, each containing 90 x 1 film-coated tablets Multipack comprising 2 packs, each containing 100 x 1 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning bestående af 2 pakker - hver indeholder 60 x 1 filmovertrukne tabletter Multipakning bestående af 2 pakker - hver indeholder 90 x 1 filmovertrukne tabletter Multipakning bestående af 2 pakker - hver indeholder 100 x 1 filmovertrukne tabletter
English: A dose reduction of the sulphonylurea or insulin may be considered (see section 4.2).
Danish: Det kan overvejes at reducere dosis af sulfonylurinstof eller insulin (se pkt.
English: The most frequently reported adverse reaction for linagliptin plus metformin was diarrhoea (1.6%) with a comparable rate on metformin plus placebo (2.4%).
Danish: Den hyppigst rapporterede bivirkning for linagliptin plus metformin var diarré (1,6 %) med en sammenlignelig hyppighed for metformin plus placebo (2,4 %).
English: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before taking Jentadueto.
Danish: Hvis du er usikker på, om noget af ovenstående passer på dig, skal du kontakte lægen, apoteket eller sundhedspersonalet, før du tager Jentadueto.
English: (1) reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis, (2) in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilisation,
Danish: (1) reduktion af hepatisk glucoseproduktion gennem hæmning af glukoneogenese og glycogenolyse, (2) i musklerne, ved øgning af insulinfølsomheden, ved forbedring af den perifere glucoseoptagelse og udnyttelse af glucose, (3) og forsinkelse af den intestinale glucoseabsorption.
English: Change in clinical status of patients with previously controlled type 2 diabetes As Jentadueto contains metformin, a patient with previously well controlled type 2 diabetes on Jentadueto who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Danish: Ændring i klinisk status hos patienter med tidligere velbehandlet type 2-diabetes Da Jentadueto indeholder metformin, skal en patient med type 2-diabetes, der tidligere har været velbehandlet på Jentadueto, men som udvikler unormale laboratorieværdier eller klinisk sygdom (især uklar og dårligt defineret sygdom), straks vurderes for tegn på ketoacidose eller laktatacidose.
English: Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly (see sections 4.3 and 4.4).
Danish: Nyrefunktionen skal monitoreres med henblik på at hindre metforminassocieret laktatacidose, specielt hos ældre (se pkt.
English: Overweight patients should continue their energy-restricted diet.
Danish: Overvægtige patienter bør fortsætte på lavenergi-diæt.
English: The most effective method to remove lactate and metformin hydrochloride is haemodialysis.
Danish: Den mest effektive metode til fjernelse af laktat og metformin er hæmodialyse.
English: Linagliptin binds selectively to DPP-4 and exhibits a > 10,000 fold selectivity versus DPP-8 or DPP-9 activity in vitro.
Danish: Linagliptin binder in vitro selektivt til DPP-4 og udviser en > 10.000 gange større selektivitet for dette enzym end for DPP-8 eller DPP-9.
English: If bullous pemphigoid is suspected, Jentadueto should be discontinued.
Danish: Hvis der er mistanke om bulløs pemfigoid, skal Jentadueto seponeres.
English: Glycaemic parameters at final visit (24-week study) for linagliptin and metformin, alone and in combination in patients with type 2 diabetes mellitus inadequately controlled on diet and exercise
Danish: Glykæmiske parametre ved afsluttende besøg (24-ugers studie) for linagliptin og metformin, alene og i kombination, hos patienter, der har type 2-diabetes mellitus og er utilstrækkeligt kontrolleret på diæt og motion.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG DEN INDRE EMBALLAGE
English: After a median follow up of 6.25 years, linagliptin, when added to standard of care, did not increase the risk of major adverse cardiovascular events (table 5) as compared to glimepiride.
Danish: Efter en median opfølgning på 6,25 år, når linagliptin blev tilføjet til standardbehandling, øgede linagliptin ikke risikoen for større kardiovaskulære hændelser (se tabel 5), sammenlignet med glimepirid.
English: After a median follow up of 2.2 years, linagliptin, when added to standard of care, did not increase the risk of major adverse cardiovascular events or renal outcome events.
Danish: Efter en median opfølgning på 2,2 år øgede linagliptin, når det blev tilføjet til standardbehandling, ikke risikoen for større uønskede kardiovaskulære eller renale hændelser.
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 14 filmovertrukne tabletter
English: In patients with stable chronic heart failure, Jentadueto may be used with a regular monitoring of cardiac and renal function.
Danish: Jentadueto kan gives til patienter med stabil kronisk hjerteinsufficiens, forudsat at hjerte- og nyrefunktionen monitoreres regelmæssigt.
English: Animal studies with metformin do not indicate harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier med metformin indikerer ikke skadelige virkninger, hvad angår reproduktionstoksicitet (se pkt.
English: As a result of tissue binding, the mean apparent volume of distribution at steady-state following a single 5 mg intravenous dose of linagliptin to healthy subjects is approximately 1110 litres, indicating that linagliptin extensively distributes to the tissues.
Danish: På grund af vævsbinding var det gennemsnitlige fordelingsvolumen ved steady state efter en enkelt intravenøs dosis på 5 mg linagliptin hos raske frivillige ca. 1.110 liter, hvilket antyder, at linagliptin har en udtalt vævsfordeling.
English: Cardiovascular and renal outcomes by treatment group in the CARMELINA study Linagliptin 5mg
Danish: Tabel 4 Kardiovaskulære og renale endepunkter pr. behandlingsgruppe i CARMELINA-studiet Linagliptin 5 mg
English: Therefore, linagliptin is not an inhibitor of OCT-mediated transport.
Danish: Linagliptin er derfor ikke en OCT-medieret transporthæmmer.
English: In case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake), metformin should be temporarily discontinued and contact with a health care professional is recommended.
Danish: Patienterne skal informeres om, at i tilfælde af dehydrering (alvorlig diarré eller opkastning, feber eller nedsat væskeindtagelse) skal metforminbehandlingen afbrydes midlertidigt, og at det anbefales, at de kontakter en læge.
English: Adverse reactions reported in patients who received linagliptin+metformin alone (as mono-components or in combination) or as add-on to other anti-diabetic therapies in clinical trial and from post-marketing experience
Danish: Bivirkninger indberettet for patienter, der fik linagliptin+metformin alene (som monokomponenter eller i kombination) eller som supplement til andre antidiabetiske behandlinger i kliniske studier, og fra erfaringer efter markedsføring.
English: Erythema very rare
Danish: Erytem meget sjælden
English: Some patients have had the following side effects while taking Jentadueto: - Common (may affect up to 1 in 10 people): diarrhoea, blood enzyme increase (lipase increase),
Danish: Nogle patienter har oplevet følgende bivirkninger: - Almindelige (kan forekomme hos op til 1 ud af 10 personer): diarré, stigning i blodenzymer
English: Multiple daily doses of linagliptin had a minimal effect on the steady-state pharmacokinetics of simvastatin, a sensitive CYP3A4 substrate, in healthy subjects.
Danish: Daglige doser af linagliptin havde hos raske frivillige en minimal indvirkning på steady state-farmakokinetikken for simvastatin, et sensitivt CYP3A4-substrat.
English: Maximum daily dose is 2000 mg The starting dose is at most half of the maximum dose.
Danish: Den maksimale daglige dosis er 2.000 mg Startdosis er højst halvdelen af den maksimale dosis.
English: The two active substances work together to control blood sugar levels in adult patients with a form of diabetes called ‘type 2 diabetes mellitus'.
Danish: De 2 aktive stoffer supplerer hinanden med at kontrollere blodsukkeret hos voksne patienter med type 2-diabetes mellitus.
English: After once daily dosing of 5 mg linagliptin, steady-state plasma concentrations are reached by the third dose.
Danish: Efter administration af 5 mg linagliptin én gang dagligt opnåedes steady state-plasmakoncentration efter tredje dosis.
English: In moderate renal impairment, a moderate increase in exposure of about 1.7 fold was observed compared with control.
Danish: Hos patienter med moderat nedsat nyrefunktion sås en moderat øget eksponering på ca. 1,7 gange sammenlignet med kontrolgruppen.
English: • in patients inadequately controlled on their maximally tolerated dose of metformin alone
Danish: • hos patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt tolererede dosis metformin alene
English: * Based on lipase elevations >3xULN observed in clinical trials # Based on Linagliptin cardiovascular and renal safety study (CARMELINA), see also below Adverse reactions reported in patients who received metformin as monotherapy and that were not observed in patients receiving Jentadueto.
Danish: * Baseret på lipase-stigninger på > 3 x den øvre normalgrænse set i kliniske forsøg Baseret på Linagliptin studie af kardiovaskulær og renal sikkerhed (CARMELINA), se også nedenfor Bivirkninger rapporteret hos patienter, der fik metformin som monoterapi, og som ikke blev observeret hos patienter, der fik Jentadueto.
English: Following administration of a supratherapeutic dose of 10 mg linagliptin concomitantly with 40 mg of simvastatin daily for 6 days, the plasma AUC of simvastatin was increased by 34%, and the plasma Cmax by 10%.
Danish: Efter samtidig administration af en daglig supraterapeutisk dosis på 10 mg linagliptin og 40 mg simvastatin i 6 dage var simvastatins plasma-AUC øget med 34 %, og plasma-Cmax var øget med 10 %.
English: Stop taking Jentadueto and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Danish: Stop med at tage Jentadueto og kontakt omgående læge eller nærmeste hospital, hvis du får et eller flere af nedenstående symptomer på laktatacidose, da denne tilstand kan føre til koma.
English: Тел: +359 2 958 79 98
Danish: КГ Тел: +359 2 958 79 98
English: • Diabetic pre-coma.
Danish: • Diabetisk prækoma
English: Due to the metformin component, Jentadueto may cause a very rare, but very serious complication called lactic acidosis, particularly if your kidneys are not working properly.
Danish: På grund af metformin-indholdet kan Jentadueto give en meget sjælden, men meget alvorlig bivirkning, der kaldes laktatacidose (mælkesyreforgiftning), især hvis du har nedsat nyrefunktion.
English: It is not known whether linagliptin is excreted into human milk.
Danish: Det er ukendt, om linagliptin udskilles i human mælk.
English: In rats, effects on reproductive organs, thyroid and the lymphoid organs were seen at more than 1500 times human exposure.
Danish: I rotter blev der set påvirkning af reproduktive organer, thyroidea og lymfoide organer ved en eksponering på mere end 1.500 gange den humane eksponering.
English: Hypoglycaemia is not identified as adverse reaction for linagliptin, metformin, or linagliptin plus metformin.
Danish: Hypoglykæmi er ikke identificeret som en bivirkning for linagliptin, metformin eller linagliptin plus metformin.
English: The mean HbA1c at baseline was 8.0%.
Danish: Den gennemsnitlige HbA1c ved baseline var 8,0 %.
English: Gastrointestinal disorders Decreased appetite uncommon
Danish: Mave-tarm-kanalen Nedsat appetit ikke almindelig
English: Infections and infestations Nasopharyngitis uncommon
Danish: Infektioner og parasitære sygdomme Nasofaryngitis ikke almindelig
English: Avoid excessive alcohol intake while taking Jentadueto since this may increase the risk of lactic acidosis (see section ‘Warnings and precautions').
Danish: Du skal undgå at indtage store mængder alkohol, mens du er i behandling med Jentadueto, da det kan øge risikoen for laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler”).
English: - The other ingredients are: - Tablet core: arginine, copovidone, magnesium stearate, maize starch, silica, colloidal anhydrous.
Danish: - Øvrige indholdsstoffer: Tabletkerne: Arginin, copovidon, magnesiumstearat, majsstivelse, kolloid vandfri silica.
English: When Jentadueto is used with a sulphonylurea medicine or with insulin, low blood sugar can occur and your doctor may reduce the dose of your sulphonylurea or insulin.
Danish: Når Jentadueto tages sammen med et sulfonylurinstof eller med insulin, kan lavt blodsukker forekomme, og lægen vil måske nedsætte dosis af sulfonylurinstof eller insulin.
English: The European Medicines Agency has waived the obligation to submit the results of the studies with Jentadueto in all subsets of the paediatric population in type 2 diabetes (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Jentadueto i en eller flere undergrupper af den pædiatriske population med type 2-diabetes (se pkt.
English: Liver, kidneys, stomach, reproductive organs, thymus, spleen, and lymph nodes were target organs of toxicity in Cynomolgus monkeys at more than 450 times human exposure.
Danish: Lever, nyrer, mave, reproduktive organer, thymus, milt og lymfeknuder var målorganer for toksicitet i cynomolgusaber ved en eksponering på mere end 450 gange den humane eksponering.
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Danish: Er du i tvivl, så spørg lægen eller på apoteket, før du tager dette lægemiddel.
English: In one study linagliptin was given as add-on to metformin plus sulphonylurea.
Danish: I et studie blev linagliptin givet som supplement til metformin plus sulfonylurinstof.
English: Lactic acidosis is characterised by acidotic dyspnea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma.
Danish: Laktatacidose er kendetegnet ved acidotisk dyspnø, abdominalsmerter, muskelkramper, asteni og hypotermi efterfulgt af koma.
English: Bioequivalence studies in healthy subjects demonstrated that the Jentadueto (linagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of linagliptin and metformin hydrochloride as individual tablets.
Danish: Bioækvivalensstudier hos raske frivillige viste, at Jentadueto-kombinationstabletterne (linagliptin/metformin) er bioækvivalente med samtidig administration af linagliptin og metformin som separate tabletter.
English: A statistically significant greater proportion of patients with a baseline HbA1c ≥7.0% and treated with linagliptin 5 mg achieved a target HbA1c of <7% compared to placebo.
Danish: En statistisk signifikant større andel af patienter med baseline-HbA1c ≥ 7,0 % og behandlet med linagliptin 5 mg opnåede mål-HbA1c < 7 % sammenholdt med placebo.
English: The safety of linagliptin 2.5 mg twice daily (or its bioequivalent of 5 mg once daily) in combination with metformin has been evaluated in over 6800 patients with type 2 diabetes mellitus.
Danish: Sikkerheden af linagliptin 2,5 mg 2 gange dagligt (eller det bioækvivalente 5 mg én gang dagligt) i kombination med metformin er blevet undersøgt hos mere end 6.800 patienter med type 2-diabetes mellitus.
English: Jentadueto combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Danish: Jentadueto er en kombination af to antihyperglykæmiske lægemidler med komplementære virkningsmekanismer til forbedring af glykæmisk kontrol hos patienter med type 2-diabetes: linagliptin, en dipeptidylpeptidase-4-hæmmer (DPP-4), og metformin, der tilhører biguanidklassen.
English: The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration(see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
Danish: Der er også øget risiko for at udvikle laktatacidose ved ukontrolleret diabetes, alvorlige infektioner, langvarig faste eller alkoholindtagelse, dehydrering (væskemangel - se yderligere oplysninger nedenfor), leverproblemer og enhver tilstand med nedsat iltforsyning til en legemsdel (såsom akut alvorlig hjertesygdom).
English: It contains two different active substances linagliptin and metformin.
Danish: Jentadueto indeholder to forskellige aktive stoffer, linagliptin og metformin.
English: Linagliptin is a P-glycoprotein substrate, and inhibits P-glycoprotein mediated transport of digoxin with low potency.
Danish: Linagliptin er substrat for P-glykoprotein og hæmmer af P-glykoproteinmedieret transport af digoxin med lav potens.
English: 1,000 mg Twice Daily
Danish: 1.000 mg to gange dagligt
English: 500 mg Twice Daily
Danish: 500 mg to gange dagligt
English: Some patients have experienced inflammation of the pancreas (pancreatitis; frequency rare, may affect up to 1 in 1000 people).
Danish: Betændelse i bugspytkirtlen (pankreatitis) er set hos nogle patienter (hyppighed sjælden, kan forekomme hos op til 1 ud af 1.000 personer).
English: Titanium dioxide (E171) Talc
Danish: Titandioxid (E171)
English: Some patients experienced rash (frequency uncommon), hives (urticaria; frequency rare), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema; frequency rare).
Danish: Nogle patienter fik udslæt (hyppighed; ikke almindelig), nældefeber (urticaria; hyppighed sjælden) samt hævelse af ansigt, læber, tunge og svælg, hvilket kan forårsage problemer med at trække vejret eller synke (angioødem; hyppighed sjælden).
English: Some patients have experienced allergic reactions (frequency rare), which may be serious, including wheezing and shortness of breath (bronchial hyperreactivity; frequency uncommon (may affect up to 1 in 100 people)).
Danish: Nogle patienter har haft overfølsomhedsreaktioner (hyppighed; sjælden, herunder hvæsende vejrtrækning og åndenød (bronkial hyperreaktivitet; hyppighed ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter)).
English: • Inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin.
Danish: • hæmmere af OCT1 (f.eks. verapamil) kan nedsætte virkningen af metformin
English: In patients with mild moderate and severe hepatic impairment (according to the Child-Pugh classification), mean AUC and Cmax of linagliptin were similar to healthy matched controls following administration of multiple 5 mg doses of linagliptin.
Danish: Hos patienter med let, moderat og svært nedsat leverfunktion (i henhold til Child-Pugh-klassifikationen), var den gennemsnitlige AUC og Cmax sammenlignelig med raske, matchende kontrolpersoner efter indgivelse af multiple doser af linagliptin 5 mg.
English: Bottles contain 14, 60 or 180 film-coated tablets.
Danish: Beholderne indeholder 14, 60 eller 180 filmovertrukne tabletter.