FrancophonIA/ELRC3.0 huggingface dataset:
English: Glimepiride acts mainly by stimulating insulin release from pancreatic beta cells.
Danish: Glimepirid virker hovedsageligt ved at stimulere frigivelse af insulin fra beta-cellerne i pankreas.
English: Extrapancreatic activity
Danish: Ekstrapankreatisk virkning
English: There have been rare reports of elevated liver enzymes and hepatocellular dysfunction during post-marketing experience with pioglitazone and glimepiride (see section 4.8).
Danish: Der har været sjældne rapporter om forhøjede leverenzymer og hepatocellulær funktionssvigt under post marketing-erfaringer med pioglitazon og glimepirid (se pkt.
English: Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Danish: Pioglitazon bør bruges med forsigtighed ved samtidig administration af CYP2C8 hæmmere (f.eks. gemfibrozil) eller inducere (f.eks. rifampicin).
English: The observed excess risk of fractures for women on pioglitazone in this study is therefore 0.5 fractures per 100 patient years of use.
Danish: Den observerede øgede risiko for frakturer hos kvinder i behandling med pioglitazon i dette forsøg er derfor 0,5 frakturer pr. 100 patientårs brug.
English: 1 Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, granulocytopenia, agranulocytosis, haemolytic anaemia and pancyto-penia may occur.
Danish: 1 Moderat til svær trombocytopeni, leukopeni, erytrocytopeni, granulocytopeni, agranulocytose, hæmolytisk anæmi og pancytopeni kan forekomme.
English: The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
Danish: Den observerede overhyppighed af frakturer for pioglitazonbehandlede kvinder i dette datasæt er derfor 0,8 frakturer pr. 100 patientår.
English: Hypoglycaemia (low blood sugar) has been reported uncommonly (may affect up to 1 in 100 people) in patients taking Tandemact.
Danish: Hypoglykæmi (lavt blodsukker) er rapporteret med hyppigheden "ikke almindelig" (kan forekomme hos op til 1 ud af 100 behandlede) hos patienter, som tager Tandemact.
English: Thiazolidinediones act primarily by reducing insulin resistance and sulphonylureas primarily by inducing insulin release from pancreatic beta cells.
Danish: Thiazolidinedionerne virker primært ved at reducere insulinresistens og sulfonylurinstofferne virker primært ved at stimulere insulinfrigivelse fra bugspytkirtlens beta-celler.
English: Do not take Tandemact: - if you are allergic to pioglitazone, glimepiride, other sulphonylureas or sulphonamides, or any of the other ingredients of this medicine (listed in section 6) - if you have heart failure or have had heart failure in the past - if you have liver disease - if you have diabetic ketoacidosis (a complication of diabetes with rapid weight loss, nausea or vomiting) - if you have severe problems with your kidneys - if you have or have ever had bladder cancer - if you have blood in your urine that your doctor has not checked - if you have insulin dependent diabetes (type 1) - if you are in a diabetic coma - if you are pregnant - if you are breast-feeding
Danish: Tag ikke Tandemact: - hvis De er allergisk over for pioglitazon, glimepirid, andre sulfonylurinstoffer eller sulfonamider eller over for et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) - hvis De lider af eller tidligere har lidt af hjertesvigt - hvis De har en leversygdom - hvis De har diabetisk ketoacidose (en komplikation ved diabetes med hurtigt vægttab, kvalme eller opkastning) - hvis De har alvorlige nyreproblemer - hvis De har eller nogensinde har haft blærekræft - hvis De har blod i urinen, og Deres læge ikke har undersøgt årsagen - hvis De har insulinkrævende diabetes (type 1)
English: Do not throw away any medicines via waste water or household waste.
Danish: Af hensyn til miljøet må De ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Proportional increases of the plasma concentration were observed for doses from 2-60 mg.
Danish: Der sås proportionale stigninger i plasmakoncentrationen for doser fra 2-60 mg. Steady-state opnås efter 4-7 dages dosering.
English: 7 A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
Danish: komparatorkontrollerede, dobbeltblinde kliniske forsøg med over 8.100 patienter i den pioglitazon-behandlede gruppe og 7.400 patienter i den komparatorbehandlede gruppe, der blev behandlet i op til 3,5 år.
English: coumarin derivatives such as warfarin (to treat heart or blood problems) - allopurinol, probenecid, sulfinpyrazone (to treat gout) - cyclophosphamide, ifosfamide, trofosfamide (to treat cancer) - fenfluramine (to reduce weight) - tritoqualine (to treat allergies)
Danish: coumarin-derivater som f.eks. warfarin (til behandling af hjerte- eller blodproblemer) - allopurinol, probenecid, sulfinpyrazon (til behandling af gigt) - cyclophosphamid, ifosfamid, trofosfamid (til behandling af kræft) - fenfluramin (til vægtreduktion) - tritoqualin (til behandling af allergier)
English: Renal and urinary disorders glycosuria uncommon proteinuria uncommon
Danish: Nyrer og urinveje glukosuri ikke almindelig proteinuri ikke almindelig
English: In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
Danish: 10 I kliniske forsøg med pioglitazon var hyppigheden af forhøjelser i ALT større end tre gange den øvre grænse for normal lig med placebo men mindre end det observerede i sammenligningsgrupperne med metformin og sulfonylurinstof.
English: - if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye), talk to your doctor if you notice any change to your vision.
Danish: - hvis De har en særlig type af diabetisk øjensygdom kaldet makulært ødem (hævelse i det bagerste af øjet).
English: There was no tumourigenic response in mice of either sex. Hyperplasia of the urinary bladder was not seen in dogs or monkeys treated with pioglitazone for up to 12 months.
Danish: Der sås ikke hyperplasi af urinblæren hos hunde eller aber, der var blevet med pioglitazon behandlet i op til 12 måneder.
English: Your doctor will check whether Tandemact is working 3 to 6 months after you start taking it.
Danish: Når De har taget Tandemact i 3-6 måneder, vil Deres læge undersøge, om medicinen virker.
English: Ask your doctor or pharmacist for more information if you are not sure how to recognise this.
Danish: Bed Deres læge eller apoteket om yderligere information, hvis De ikke er sikker på, at De kan genkende disse symptomer.
English: 8 Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
Danish: 8 I kontrollerede kliniske forsøg blev der rapporteret ødemer hos 6-9 % af de patienter, der blev behandlet med pioglitazon i mere end ét år.
English: What Tandemact contains - The active substances are pioglitazone and glimepiride.
Danish: Tandemact indeholder: - Aktive stoffer: pioglitazon og glimepirid.
English: 4.7 Effects on ability to drive and use machines Tandemact has minor influence on the ability to drive and use machines.
Danish: Tandemact påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Tandemact 30 mg/2 mg tablets
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Tandemact 30 mg/2 mg tabletter
English: The following medicines may decrease the blood sugar lowering effect of Tandemact.
Danish: Følgende lægemidler kan nedsætte den blodsukkersænkende virkning af Tandemact.
English: Two metabolites - most probably resulting from hepatic metabolism (major enzyme is CYP2C9) - were identified both in urine and faeces: the hydroxy derivative and the carboxy derivative.
Danish: To metabolitter, hydroxyderivatet og carboxyderivatet, som formentlig er fremkommet under levermetabolismen (hovedenzymet er CYP2C9), blev identificeret både i urin og fæces.
English: Musculoskeletal and connective tissue disorders bone fracture7
Danish: Knogler, led, muskler og bindevæv knoglefraktur7
English: Mean levels of liver enzymes decreased with treatment with pioglitazone.
Danish: Leverenzymernes middelniveauer faldt ved behandling med pioglitazon.
English: Rare changes in haematology have been observed with glimepiride treatment (see section 4.8).
Danish: Der er i behandlingen med glimepirid observeret sjældne hæmatologiske ændringer (se pkt.
English: - headache - inflammation of the sinuses (sinusitis) - vertigo - abnormal vision - sweating - tiredness - difficulty sleeping (insomnia) - decreased blood sugar - sugar in urine - proteins in urine - increased appetite - increase of an enzyme called lactic dehydrogenase (LDH)
Danish: Ikke almindelige: (kan påvirke op til 1 ud af 100 behandlede) - hovedpine - bihulebetændelse (sinuitis) - svimmelhed - abnormt syn (synsforstyrrelser) - svedudbrud - træthed - problemer med at falde i søvn (søvnløshed) - nedsat blodsukker - sukker i urinen - proteiner i urinen - øget appetit - forhøjelse af et enzym kaldet laktisk dehydrogenase (LDH)
English: In the 3.5 year PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
Danish: I PROactive-forsøget, som forløb over 3,5 år, fik 44/870 (5,1 %; 1,0 frakturer pr. 100 patientår) af de pioglitazon-behandlede kvindelige patienter frakturer.
English: 4 Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic medicinal products.
Danish: Disse er relateret til ændringer i blodsukkeret på grund af forbigående ændringer i linsens turgiditet og refraktionsindeks, som det også ses ved andre hypoglykæmiske lægemidler.
English: There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Danish: Der har været post marketing-tilfælde af hjerteinsufficiens, hvor pioglitazon har været anvendt i kombination med insulin eller hos patienter med hjerteinsufficiens i anamnesen.
English: Glimepiride has a very low distribution volume (approximately 8.8 litres) which is roughly equal to the albumin distribution space, high protein binding (> 99%), and a low clearance (approximately 48 mL/min).
Danish: Desuden har glimepirid høj proteinbinding (> 99 %) og lav clearance (cirka 48 ml/min).
English: Skin and subcutaneous tissue disorders sweating uncommon hypersensitivity to light very rare very rare urticaria2
Danish: Hud og subkutane væv svedudbrud ikke almindelig lysoverfølsomhed meget sjælden meget sjælden nældefeber2
English: 6 Elevation of liver enzymes may occur.
Danish: 6 Der kan forekomme forhøjede leverenzymer.
English: This can lead to a risk of hypoglycaemia (low blood sugar): - gemfibrozil and fibrates (to lower high cholesterol level) - insulin, metformin or other medicines to treat diabetes mellitus - phenylbutazone, azapropazone, oxyphenbutazone, aspirin-like medicines (to treat pain and inflammation) - long acting sulphonamides, tetracyclines, chloramphenicol, fluconazole, miconazole,
Danish: Dette kan medføre en risiko for hypoglykæmi (lavt blodsukker): - gemfibrozil og fibrater (for at sænke højt kolesteroltal) - insulin, metformin eller andre lægemidler til behandling af diabetes mellitus - phenylbutazon, azopropazon, oxyphenbutazon, aspirin-lignende lægemidler (til behandling af smerter og inflammation) - langtidsvirkende sulfonamider, tetracykliner, chloramphenicol, fluconazol, miconazol,
English: Talk to your doctor or pharmacist before taking Tandemact (see also section 4) - if you have a problem with your heart.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før De tager Tandemact (se også punkt 4),
English: The symptoms may include cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea.
Danish: Symptomerne kan omfatte koldsved, træthed, hovedpine, hurtige hjerteslag, stik af sult, irritabilitet, nervøsitet eller kvalme.
English: The following medicines can increase the blood sugar lowering effect of Tandemact.
Danish: Følgende lægemidler kan øge den blodsukkersænkende virkning af Tandemact.
English: Passage of the blood brain barrier is low.
Danish: Glimepirid passerer kun blod-hjernebarrieren i ringe grad.
English: Clinical trials have been conducted with co-administered pioglitazone and glimepiride (see section 5.1).
Danish: Der er udført kliniske forsøg med samtidig administration af pioglitazon og glimepirid (se pkt.
English: Localised swelling (oedema) has also been experienced commonly (may affect up to 1 in 10 people) in patients taking Tandemact in combination with insulin.
Danish: Lokal hævelse (ødem) er også observeret med hyppigheden "almindelig" (kan forekomme hos op til 1 ud af 10 behandlede hos patienter, som får Tandemact i kombination med insulin.
English: An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions reports of bone fracture from randomised, controlled, double blind clinical trials (see section 4.8).
Danish: I en poolet analyse af bivirkningsrapporter om knoglefrakturer fra randomiserede, kontrollerede, dobbeltblindede kliniske forsøg blev der set en forøget incidens af frakturer hos kvinder (se pkt.
English: Hypersensitivity reactions of the skin may occur as itching, rash, and urticaria.
Danish: Overfølsomhedsreaktioner i huden kan optræde som kløe, udslæt og nældefeber.
English: Infections and infestations upper respiratory tract infection common common sinusitis uncommon uncommon
Danish: Infektioner og parasitære sygdomme øvre luftvejsinfektion almindelig almindelig bihulebetændelse ikke almindelig ikke almindelig
English: oestrogens and progestagens, saluretics, thiazide diuretics, thyroid stimulating agents, glucocorticoids, phenothiazine derivatives, chlorpromazine, adrenaline and sympathicomimetics, nicotinic acid (high doses) and nicotinic acid derivatives, laxatives (long-term use), phenytoin, diazoxide, glucagon, barbiturates and rifampicin.
Danish: østrogener og progestagener, saluretika, tiaziddiuretika, thyroidstimulerende midler, glukokortikoider, phenotiazinderivater, chlorpromazin, adrenalin og sympatomimetika, nicotinsyre (høje doser) og nicotinsyrederivater afføringsmidler (langtidsbrug),
English: The symptoms may include cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness, nausea, coma or convulsion.
Danish: Symptomerne kan omfatte koldsved, træthed, hovedpine, hurtige hjerteslag, stik af sult, irritabilitet, nervøsitet, kvalme, koma eller krampeanfald.
English: Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Tandemact.
Danish: Blærekræft forekommer med hyppigheden "ikke almindelig" (kan forekomme hos op til 1 ud af 100 behandlede) hos patienter, der tager Tandemact.
English: How to take Tandemact
Danish: Sådan skal De tage Tandemact
English: In patients with low creatinine clearance, there was a tendency for glimepiride clearance to increase and for average serum concentrations to decrease, most probably resulting from a more rapid elimination because of lower protein binding.
Danish: Hos patienter med lav kreatininclearance sås en tendens til stigende clearance af glimepirid og faldende gennemsnitlige serumkoncentrationer.
English: not known not known rash2
Danish: ikke kendt ikke kendt kløe2
English: HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Danish: Der var mindre, men ikke klinisk signifikante stigninger i LDL-kolesterolniveauer.
English: In vitro studies have shown no inhibition of any subtype of cytochrome P450.
Danish: In vitro-undersøgelser har ikke vist hæmning af nogen CYP-undertyper.
English: Tandemact 45 mg/4 mg tablets
Danish: Tandemact 45 mg/4 mg tabletter
English: Tandemact is contra-indicated during breast-feeding (see section 4.3).
Danish: Tandemact er kontraindiceret under amning (se pkt.
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or other sulphonylureas or sulphonamides - Cardiac failure or history of cardiac failure (NYHA stages I to IV) - Current bladder cancer or a history of bladder cancer - Uninvestigated macroscopic haematuria - Hepatic impairment - Type 1 diabetes mellitus - Diabetic coma - Diabetic ketoacidosis - Severe renal function disorders (creatinine clearance < 30 ml/min) - Pregnancy - Breast-feeding (see section 4.6)
Danish: 6.1, eller over for andre sulfonylurinstoffer eller sulfonamider - svigtende hjertefunktion eller en anamnese med hjertesvigt (NYHA grad I til IV) - aktuel blærecancer eller blærecancer i anamnesen - ikke udredt makroskopisk hæmaturi - nedsat leverfunktion - type 1-diabetes mellitus - diabetisk koma - diabetisk ketoacidose - svære nyrelidelser (kreatininclearance < 30 ml/min) - graviditet - amning (se pkt.
English: - anabolic steroids (supporting muscle build up) or male sex hormone replacement therapy - fluoxetine, MAO-inhibitors (to treat depression) - angiotensin-converting enzyme (ACE) inhibitors, sympatholytics, disopyramide, pentoxifylline,
Danish: quinoloner, clarithromycin (til behandling af bakterie- og svampeinfektioner) - anabolske steroider (til muskelopbygning) eller erstatningsbehandling med mandlige kønshormoner - fluoxetin, MAO-hæmmere (til behandling af depression) - angiotensinkonverterende enzym (ACE)-hæmmere, sympatolytika, disopyramid, pentoxifyllin,
English: Women of childbearing potential / Contraception in males and females Tandemact is not recommended in women of childbearing potential not using contraception.
Danish: Tandemact bør ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: common fatigue uncommon
Danish: almindelig træthed ikke almindelig
English: Tandemact 30 mg/2 mg tablets Tandemact 30 mg/4 mg tablets Tandemact 45 mg/4 mg tablets pioglitazone/glimepiride
Danish: Tandemact 30 mg/2 mg tabletter Tandemact 30 mg/4 mg tabletter Tandemact 45 mg/4 mg tabletter pioglitazon/glimepirid
English: Marketing authorisation holder Takeda Pharma A/S Dybendal Alle 10
Danish: Indehaver af markedsføringstilladelsen Takeda Pharma A/S
English: Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone.
Danish: Der er rapporter om, at samtidig administration af pioglitazon og gemfibrozil (en hæmmer af CYP2C8) har resulteret i en 3-dobbelt stigning i AUC for pioglitazon.
English: INFORMATION IN BRAILLE Tandemact 45 mg/4 mg
Danish: INFORMATION I BRAILLESKRIFT Tandemact 45 mg/4 mg
English: - Tandemact 45 mg/4 mg tablets are white to off-white, round, flat and debossed ‘4833 G' on one face and ‘45/4' on the other.
Danish: - Tandemact 45 mg/4 mg tabletterne er hvide til off-white, runde og flade og præget ‘4833 G' på den ene side og ‘45/4' på den anden side.
English: If you experience this side effect, talk to your doctor as soon as possible.
Danish: Hvis De oplever denne bivirkning, skal De hurtigst muligt kontakte Deres læge.
English: EU/1/06/366/005 EU/1/06/366/006 EU/1/06/366/007 EU/1/06/366/008 EU/1/06/366/009 EU/1/06/366/010 EU/1/06/366/011 EU/1/06/366/012 EU/1/06/366/013 EU/1/06/366/014 EU/1/06/366/015 EU/1/06/366/016 EU/1/06/366/017
Danish: EU/1/06/366/005 EU/1/06/366/006 EU/1/06/366/007 EU/1/06/366/008 EU/1/06/366/009 EU/1/06/366/010 EU/1/06/366/011 EU/1/06/366/012 EU/1/06/366/013 EU/1/06/366/014 EU/1/06/366/015 EU/1/06/366/016 EU/1/06/366/017 EU/1/06/366/018 EU/1/06/366/019 EU/1/06/366/020 EU/1/06/366/021 EU/1/06/366/022
English: - allergic reactions including allergic shock - feeling sick (nausea), vomiting and diarrhoea - stomach ache - abdominal pressure - feeling of fullness in the stomach - sensitivity to light - decrease in salt (sodium) concentrations in the blood
Danish: Meget sjældne (Kan forekomme hos op til 1 ud af 10.000 behandlede) - leversygdom - allergiske reaktioner herunder allergisk shock - kvalme (nausea), opkastning og diarre - mavesmerter - trykken i maven - oppustethed i maven - øget følsomhed for lys - nedsat indhold af salt (natrium) i blodet
English: INFORMATION IN BRAILLE Tandemact 30 mg/2 mg
Danish: INFORMATION I BRAILLESKRIFT Tandemact 30 mg/2 mg
English: Tandemact 30 mg/4 mg tablets
Danish: Tandemact 30 mg/4 mg tabletter
English: Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Danish: Hvis Deres vægt stiger, skal De kontakte Deres læge.
English: This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth.
Danish: Den forsinkede fostervækst skyldtes, at pioglitazon mindskede den maternale hyperinsulinæmi og en øget insulinresistens, som optræder under drægtighed.
English: Hepatic impairment Tandemact should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Danish: Nedsat leverfunktion Tandemact bør ikke anvendes til patienter med nedsat leverfunktion (se pkt.
English: Pioglitazone was devoid of genotoxic potential in a comprehensive battery of in vivo and in vitro genotoxicity assays.
Danish: I en bred vifte af genotoksicitetsundersøgelser in vivo og in vitro var pioglitazon uden genotoksisk potentiale.
English: INFORMATION IN BRAILLE Tandemact 30 mg/4 mg
Danish: INFORMATION I BRAILLESKRIFT Tandemact 30 mg/4 mg
English: Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5).
Danish: Der er set henholdsvis en øgning eller en nedsættelse af plasmakoncentrationen af pioglitazon ved samtidig administration af pioglitazon og gemfibrozil (en hæmmer af CYP2C8) eller rifampicin (en inducer af CYP2C8) (se pkt.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Tandemact Fortæl altid lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: Each Tandemact 45 mg/4 mg tablet contains 45 mg pioglitazone (as hydrochloride) and 4 mg glimepiride.
Danish: Hver Tandemact 45 mg/4 mg tablet indeholder 45 mg pioglitazon (som hydrochlorid) og 4 mg glimepirid.
English: The following medicines can increase or decrease the blood sugar lowering effect of Tandemact: - H2 antagonists (to treat stomach ulcers) - beta-blockers, clonidine, guanethidine and reserpine (to treat high blood pressure or heart failure).
Danish: - H2-antagonister (til behandling af mavesår) - betablokkere, clonidin, guanethidin og reserpin (til behandling af højt blodtryk eller hjertesvigt)