FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of (severe) overdose hospitalisation in an intensive care department is indicated.
Danish: I tilfælde af en (svær) overdosis er hospitalisering på intensiv afdeling indiceret.
English: - if you are already taking other medicines for the treatment of diabetes.
Danish: - hvis De allerede tager anden medicin til behandling af diabetes.
English: These are in general reversible upon discontinuation of treatment.
Danish: Disse er generelt reversible ved seponering af behandlingen.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Danish: Dette kan udgøre en risiko i situationer, hvor disse evner er af særlig stor vigtighed (f.eks. i forbindelse med at køre bil og betjene maskiner).
English: After high doses, slightly longer half-lives were noted.
Danish: Efter høje doser sås lidt længere halveringstider.
English: There was no significant difference in effect regardless of whether glimepiride was given 30 minutes or immediately before a meal.
Danish: Der var ingen signifikant forskel i virkningen, hvad enten glimepirid blev givet 30 minutter før eller umiddelbart før et måltid.
English: Talk to your doctor before stopping this treatment.
Danish: Tal med Deres læge, inden De ophører med denne behandling.
English: Tandemact should be used every day to work properly.
Danish: Tandemact skal tages hver dag for at virke ordentligt.
English: very rare very rare
Danish: meget sjælden meget sjælden
English: Take care if you experience abnormal vision.
Danish: De skal udvise forsigtighed, hvis De oplever unormalt syn.
English: Children and adolescents Use in children and adolescents under 18 years is not recommended.
Danish: Børn og unge Anvendelse hos børn og unge under 18 år anbefales ikke.
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Tandemact.
Danish: Der kan være en øget sandsynlighed for at blive gravid, da De muligvis får ægløsning igen, når De tager Tandemact.
English: In healthy persons, the minimum effective oral dose is approximately 0.6 mg.
Danish: Hos raske personer er den mindste effektive orale dosis cirka 0,6 mg.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter "EXP".
English: Renal elimination of the two metabolites was impaired.
Danish: Den renale elimination af de to metabolitter var nedsat.
English: Symptoms may not be present for up to 24 hours after ingestion.
Danish: Symptomerne vil muligvis ikke optræde før op til 24 timer efter indtagelsen.
English: If you are following a special diet for diabetes, you should continue with this while you are taking Tandemact.
Danish: Hvis De følger en speciel diabetesdiæt, skal De fortsætte med denne, mens De tager Tandemact.
English: For this reason, other medicinal products should only be taken with Tandemact with the knowledge (or at the prescription) of the doctor.
Danish: Derfor bør andre lægemidler kun tages sammen med Tandemact med lægens viden (eller efter ordinering fra lægen).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 January 2007
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 08. januar 2007 Dato for seneste fornyelse: 09. september 2016
English: Based on the experience with glimepiride and with other sulphonylureas the following interactions have to be mentioned.
Danish: Baseret på erfaringen med glimepirid og med andre sulfonylurinstoffer, skal følgende interaktioner nævnes.
English: Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Danish: Næsten halvdelen af patienterne havde tidligere haft en myokardieinfarkt og omkring 20 % havde haft et slagtilfælde.
English: However if you miss a dose, skip the missed dose and just carry on with the next dose as normal.
Danish: Hvis De glemmer en dosis, skal De imidlertid springe den glemte dosis over og bare fortsætte med den næste dosis som normalt.
English: - if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old.
Danish: - hvis De ophober væske (væskeretention) eller har problemer med hjertesvigt, især hvis De er over 75 år.
English: These findings were observed across species at plasma concentrations  4 times the clinical exposure.
Danish: Disse fund blev observeret i forskellige dyrearter ved plasmakoncentrationer  4 gange den kliniske eksponering.
English: Immune system disorders allergic shock2
Danish: Immunsystemet allergisk shock2
English: Insulin release
Danish: Frigivelse af insulin
English: Do not use Tandemact if you are pregnant.
Danish: De bør ikke tage Tandemact, hvis De er gravid.
English: There have been no formal interaction studies for Tandemact, however, the concomitant use of the active substances in patients in clinical use has not resulted in any unexpected interactions.
Danish: Der er ikke udført formelle interaktionsundersøgelser med Tandemact, men samtidig brug af de aktive stoffer hos patienter i klinisk brug har ikke resulteret i uventede interaktioner.
English: No unchanged substance was detected in the urine.
Danish: Der blev ikke påvist uomdannet stof i urinen.
English: Your doctor will advise you to discontinue this medicine.
Danish: Deres læge vil råde dem til at ophøre med at tage dette lægemiddel.
English: - if you have a problem with your liver.
Danish: - hvis De har problemer med hjertet.
English: Your blood sugar level can be increased by taking sugar.
Danish: Dit blodsukkerniveau kan øges ved indtagelse af sukker.
English: The tablets should be swallowed with a glass of water.
Danish: Tabletterne bør synkes med et glas vand.
English: The tablets are taken orally shortly before or with the first main meal.
Danish: Tabletterne skal tages oralt kort tid inden eller sammen med det første hovedmåltid.
English: These problems generally get better after you stop taking Tandemact.
Danish: Disse problemer fortager sig som regel, når De ophører med at tage Tandemact.
English: On this basis M-IV contribution to efficacy is approximately three-fold that of pioglitazone, whilst the relative efficacy of M-II is minimal.
Danish: På dette grundlag er M-IV's bidrag til effekten omkring tre gange pioglitazons, mens den relative effekt af M II er minimal.
English: Pharmacokinetics were similar in males and females, as well as in young and elderly (above 65 years) patients.
Danish: Farmakokinetikken var cirka den samme hos mænd og kvinder samt hos unge og ældre (over 65 år) patienter.
English: It is important to know what symptoms to expect when hypoglycaemia (low blood sugar) occurs.
Danish: Det er vigtigt at vide hvilke symptomer, man kan forvente i tilfælde af hypoglykæmi (lavt blodsukker).
English: 2 In very rare cases mild hypersensitivity reactions may develop into serious reactions with dyspnoea, fall in blood pressure and sometimes shock.
Danish: 2 I meget sjældne tilfælde kan milde overfølsomhedsreaktioner udvikle sig til alvorlige reaktioner med dyspnø, blodtryksfald og sommetider shock.
English: Your blood sugar will be checked, and your dose of Tandemact may need to be changed.
Danish: Deres blodsukker vil blive tjekket, og det vil muligvis være nødvendigt at ændre Deres dosis af Tandemact.
English: The recommended dose of Tandemact is one tablet taken once daily.
Danish: Den anbefalede dosis af Tandemact er én tablet én gang dagligt.
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Danish: Deltagernes gennemsnitsalder var 62 år og de havde i gennemsnit haft diabetes i 9,5 år.
English: These can also hide the signs of hypoglycaemia, so special care is needed when taking these medicines
Danish: Disse kan også skjule tegnene på hypoglykæmi, så der skal udvises forsigtighed ved indtagelse af disse lægemidler
English: In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Danish: I kliniske forsøg har patienter taget pioglitazon i højere doser end den anbefalede maksimale dosis på 45 mg daglig.
English: Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Danish: Patienter skal rådes til at tage forholdsregler til at undgå hypoglykæmi, mens de kører bil.
English: This type 2 diabetes usually develops in adulthood where the body either does not produce enough insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it produces.
Danish: Denne type 2-diabetes udvikler sig som regel i voksenalderen, hvor kroppen enten ikke producerer nok insulin (et hormon, som kontrollerer blodsukkerniveauet) eller ikke kan udnytte den insulin, som den producerer, effektivt.
English: Severe hypoglycaemia or prolonged hypoglycaemia, only temporarily controlled by the usual amounts of sugar, require immediate medical treatment and occasionally hospitalisation.
Danish: Svær hypoglykæmi eller længere tids varende hypoglykæmi, der kun midlertidigt er kontrolleret ved den normale mængde sukker, kræver omgående lægebehandling og til tider hospitalsindlæggelse.
English: Cross allergenicity with sulphonylureas, sulphonamides or related substances is possible.
Danish: Krydsallergi med sulfonylurinstoffer, sulfonamider eller beslægtede stoffer er mulig.
English: After ingestion of an overdose of glimepiride, hypoglycaemia may occur, lasting from 12 to 72 hours, and may recur after initial recovery.
Danish: Efter indtagelse af en overdosis glimepirid kan der indtræde hypoglykæmi, der kan vare fra 12 til 72 timer, og som kan vende tilbage efter den første bedring.
English: Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years.
Danish: Pioglitazon eller placebo blev inddraget i eksisterende antidiabetisk og kardiovaskulær behandling i op til 3,5 år.
English: The bioavailability of glimepiride after oral administration is complete.
Danish: Biotilgængeligheden af glimepirid efter oral indgift er fuldstændig.
English: After oral administration of glimepiride, the terminal half-lives of those metabolites were 3 to 6 and 5 to 6 hours respectively.
Danish: Efter oral indgift af glimepirid var den terminale halveringstid af disse metabolitter henholdsvis 3-6 og 5-6 timer.
English: Your doctor will tell you the dose to take or if necessary to change to a different dose.
Danish: Deres læge vil ordinere den dosis medicin, som De skal tage eller om nødvendigt ordinere Dem en anden dosis.
English: Symptoms can almost always be promptly controlled by immediate intake of carbohydrates (sugar).
Danish: Symptomerne kan næsten altid kontrolleres med det samme ved øjeblikkelig indtagelse af kulhydrater (sukker).
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If you have the impression that the effect of Tandemact is too weak, talk to your doctor.
Danish: Hvis De fornemmer, at virkningen af Tandemact er for svag, skal De tale med Deres læge om det.
English: Start the administration of glucose as soon as possible, if necessary by a bolus intravenous injection of 50 ml of a 50% solution, followed by an infusion of a 10% solution with strict monitoring of blood glucose.
Danish: Påbegynd indgivelse af glukose så hurtigt som muligt, om nødvendigt ved intravenøs bolusinjektion af en 50 ml 50 % opløsning efterfulgt af en infusion af en 10 % opløsning med nøje monitorering af blodsukkeret.
English: In light of age-related risks (especially bladder cancer, fractures and heart failure), the balance of benefits and risks should be considered carefully both before and during treatment in the elderly.
Danish: I lyset af aldersrelaterede risici (især blærecancer, knoglebrud og hjerteinsufficiens) bør forholdet mellem fordele og risici overvejes nøje både før og under behandlingen hos ældre.
English: If you stop using Tandemact, your blood sugar may go up.
Danish: Hvis De stopper med at tage Tandemact, kan blodsukkeret stige.
English: Your doctor may take blood tests to monitor your blood cell levels and liver function.
Danish: Deres læge kan tage blodprøver for at overvåge antallet af blodceller og leverfunktionen.
English: You must tell your doctor if you are, you think you may be pregnant or are planning to have a baby.
Danish: Fortæl lægen, hvis De er gravid, har mistanke om, at De er gravid eller planlægger at blive gravid.
English: The recommended dose is one tablet taken once daily shortly before or with the first main meal.
Danish: Den anbefalede dosis er én tablet taget én gang daglig kort tid inden eller sammen med det første hovedmåltid.
English: If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Danish: Hvis De ved en fejltagelse tager for mange tabletter, eller hvis en anden eller et barn tager Deres medicin, skal De omgående kontakte en læge eller en farmaceut.
English: Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
Danish: Inden for hver systemorganklasse er bivirkningerne opstillet efter faldende incidens efterfulgt af faldende alvorlighed.
English: Approximately one third of patients were receiving insulin in combination with metformin and/or a sulphonylurea.
Danish: Omkring en tredjedel af patienterne modtog insulin i kombination med metformin og sulphonylurea.
English: Your blood sugar could fall below the normal level.
Danish: Deres blodsukkerniveau kan falde til under det normale niveau.
English: No increase in mortality from heart failure was observed.
Danish: Der blev ikke observeret nogen stigning i dødelighed i forbindelse med hjerteinsufficiens.
English: very rare very rare allergic vasculitis2
Danish: meget sjælden meget sjælden allergisk vasculitis2
English: The effect of glimepiride is dose-dependent and reproducible.
Danish: Virkningen af glimepirid er dosisafhængig og reproducerbar.
English: This check should be repeated at intervals.
Danish: Denne test kan gentages med mellemrum.
English: If ALT levels remain > 3 x the upper limit of normal, therapy should be discontinued.
Danish: Hvis ALT-niveauerne forbliver > 3 x den øvre, normale grænse, bør behandlingen seponeres.
English: Tandemact with alcohol
Danish: Brug af Tandemact sammen med alkohol
English: This study showed an increase in reports of heart failure; however this did not lead to an increase in mortality in this study.
Danish: Denne undersøgelse viste en forøget rapportering af hjerteinsufficiens, hvilket dog ikke medførte en forøgelse af dødeligheden i denne undersøgelse.
English: Part of the treatment of diabetes is dietary control.
Danish: En del af behandlingen af diabetes er kostmæssig styring.
English: Blood and lymphatic system disorders changes in haematology1
Danish: Blod- og lymfesystem ændringer i hæmatologi1
English: common common
Danish: almindelig almindelig
English: Comparison of single and multiple once-daily dosing revealed no significant differences in pharmacokinetics, and the intra-individual variability was very low.
Danish: Ved sammenligning af en enkelt dosis og multiple doser én gang daglig blev der ikke fundet signifikante forskelle i farmakokinetikken, og den intraindividuelle variation var meget lav.
English: It is used in adults when metformin is not suitable to treat type 2 (non-insulin dependent) diabetes mellitus.
Danish: Det bruges hos voksne, når metformin ikke er egnet til behandling af type 2-diabetes mellitus (ikke-insulinkrævende).
English: 14 tablets 28 tablets 30 tablets 50 tablets 90 tablets 98 tablets
Danish: 14 tabletter 28 tabletter 30 tabletter 50 tabletter 90 tabletter 98 tabletter
English: Tandemact contains pioglitazone and glimepiride which are anti-diabetic medicines, used to control blood sugar level.
Danish: Tandemact indeholder pioglitazon og glimepirid, som er antidiabetiske lægemidler, der anvendes til at kontrollere blodsukkerniveauet.
English: When you take Tandemact, your blood sugar could fall below the normal level (hypoglycaemia).
Danish: Når De tager Tandemact, kan Deres blodsukker falde til under det normale niveau (hypoglykæmi).
English: Patients should be advised to adhere strictly to a calorie-controlled diet.
Danish: Patienterne bør rådgives til at følge en kaloriekontrolleret diæt nøje.
English: Your doctor will ask you to have blood tests periodically during treatment with Tandemact.
Danish: Deres læge vil bede Dem om at de i perioder får foretaget forskellige blodprøver, mens de behandles med Tandemact.
English: Mean dominant serum half-life, which is of relevance for the serum concentrations under multiple-dose conditions, is about 5 to 8 hours.
Danish: Den gennemsnitlige dominante halveringstid i serum, som er relevant for serum-koncentrationerne under behandling med multiple doser, er ca. 5-8 timer.
English: Repeated dosing does not result in accumulation of the compound or metabolites.
Danish: Gentagen dosering resulterer ikke i akkumulation af dette stof eller af metabolitter.
English: Ask your doctor or pharmacist for more information if you are not sure how to recognise this and what you should do if you experience the symptoms.
Danish: Bed Deres læge eller apotek om yderligere oplysninger, hvis De ikke er sikker på, hvordan De skal genkende symptomerne, og hvad De skal gøre, hvis De oplever disse symptomer.
English: Tandemact may either increase or weaken the effects of the following medicines: - coumarin derivatives such as warfarin (to slow down or stop blood clotting)
Danish: Tandemact kan enten øge eller svække virkningerne af følgende lægemidler: - coumarin-derivater som f.eks. warfarin (bruges til at sinke eller stoppe blodpropdannelse)
English: This leads to insulin release through exocytosis.
Danish: Dette fører til frigivelse af insulin gennem eksocytose.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovrvågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: The physiological response to acute physical exercise, reduction of insulin secretion, is still present under glimepiride.
Danish: Det fysiologiske respons på akut fysisk aktivitet, dvs. reduktion af insulinsekretion, er stadig tilstede under glimepirid-behandlingen.
English: very rare very rare hypersensitivity and allergic reactions3
Danish: meget sjælden meget sjælden overfølsomhed og allergiske reaktioner3
English: - if you have problems with your enzyme called Glucose-6-phosphodehydrogenase since it can decrease your red cells.
Danish: - hvis De har problemer med et enzym kaldet glukose-6-fosfat-dehydrogenase, da det kan forårsage et fald i antallet af røde blodlegemer.
English: Do not use Tandemact if you are breastfeeding or are planning to breast-feed (see section “Do not take Tandemact”).
Danish: De bør ikke tage Tandemact, hvis De ammer eller planlægger at amme (se punkt ”Tag ikke Tandemact”).
English: Eye disorders visual disturbance4
Danish: Øjne synsforstyrrelser4
English: Patients who experience visual disturbance should be cautious when driving or using machines.
Danish: Patienter, som oplever synsforstyrrelser, skal udvise forsigtighed, når de fører motorkøretøj og betjener maskiner.
English: It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Danish: Det anbefales, at De altid medbringer et par sukkerknalder, lidt slik, kiks eller sukkerholdig frugtjuice.
English: Pioglitazone was associated with significant weight gain.
Danish: Pioglitazon blev associeret med en signifikant vægtstigning.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Tandemact in all subsets of the paediatric population in type 2 diabetes mellitus.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Tandemact i alle undergrupper af den pædiatriske population med type 2-diabetes mellitus (se pkt.
English: Approximately half of the study population had at least two of the cardiovascular history entry criteria.
Danish: Omkring halvdelen af forsøgspersonerne havde haft mindst to af de kardiovaskulære tilfælde, der udgjorde Kriterierne for at deltage.
English: Glimepiride may either potentiate or weaken the effects of coumarin derivatives.
Danish: Glimepirid kan enten forstærke eller svække effekten af coumarin derivater.
English: Although the hydroxy metabolite of glimepiride caused a small but significant decrease in serum glucose in healthy persons, it accounts for only a minor part of the total effect.
Danish: Selvom glimepirids hydroxymetabolit gav et lille, men signifikant fald i serumglukose hos raske personer, står denne metabolit kun bag en mindre del af den totale virkning.
English: This finding is based on conventional safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, and reproduction toxicity studies.
Danish: Denne observation er baseret på konventionelle studier af sikkerhedsfarmakologi, gentagen dosis-toksicitet, genotoksicitet, carcinogenicitet og reproduktionstoksicitet.
English: No animal studies have been conducted with the combined products of Tandemact.
Danish: Der er ikke udført dyreforsøg med kombinationen af stoffer i Tandemact.
English: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland Delpharm Novara S.r.l., Via Crosa, 86, 28065 Cerano (NO), Italy Takeda GmbH, Production Site Oranienburg, Lehnitzstrasse 70 - 98, 16515 Oranienburg, Germany
Danish: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Irland Delpharm Novara S.r.l., Via Crosa, 86, 28065 Cerano (NO), Italien Takeda GmbH, Production Site Oranienburg,Lehnitzstrasse 70 - 98, 16515 Oranienburg, Tyskland
English: Hypoglycaemic reactions mostly occur immediately due to the sulphonylurea component of Tandemact.
Danish: Hypoglykæmiske reaktioner forekommer oftest øjeblikkeligt på grund af sulphonylurea-komponenten i Tandemact.
English: This is because some medicines can weaken or strengthen the effect of Tandemact on the level of sugar in your blood.
Danish: Det skyldes, at nogle lægemidler kan svække eller forstærke den virkning, Tandemact har på niveauet af sukker i Deres blod.
English: In particular when treating hypoglycaemia due to accidental intake of Tandemact in infants and young children, the dose of glucose given must be carefully controlled to avoid the possibility of producing dangerous hyperglycaemia.
Danish: Især i forbindelse med behandling af hypoglykæmi på grund af utilsigtet indtagelse af Tandemact hos spædbørn og mindre børn skal den administrerede dosis af glukosen kontrolleres omhyggeligt for at undgå risikoen for at fremkalde farlig hyperglykæmi.
English: Food intake has no relevant influence on absorption, only absorption rate is slightly diminished.
Danish: Fødeindtagelse påvirker ikke absorptionen i relevant grad, men absorptionshastigheden nedsættes dog lidt.
English: Maximum serum concentrations (Cmax) are reached approximately 2.5 hours after oral intake (mean 0.3 µg/mL during multiple dosing of 4 mg daily).
Danish: De maksimale serumkoncentrationer (Cmax) nås cirka 2,5 timer efter oral indtagelse (gennemsnitligt 0,3 µg/ml ved gentagen dosering af 4 mg daglig).