FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetics in five non-diabetic patients after bile duct surgery were similar to those in healthy persons.
Danish: Efter galdevejskirurgi hos fem ikke-diabetiske patienter var farmakokinetikken næsten den samme som hos raske.
English: Glimepiride binds with a high exchange rate to a beta cell membrane protein which is associated with the ATP-sensitive potassium channel but which is different from the usual sulphonylurea binding site.
Danish: Glimepirid bindes med høj omsætningshastighed til et membranprotein i beta-cellen, som er knyttet til den ATP-følsomme kaliumkanal, men som adskiller sig fra det sædvanlige bindingssted for sulfonylurinstof.
English: What you need to know before you take Tandemact
Danish: Det skal De vide, før De begynder at tage Tandemact
English: Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema.
Danish: Da insulin og pioglitazon begge er associeret med væskeretention, kan samtidig administration af insulin er og Tandemact øge risikoen for ødemer.
English: Since glimepiride belongs to the chemical class of sulfonylurea medicinal products, caution should be used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered.
Danish: Da glimepirid kemisk set tilhører gruppen af sulfonylurinstoffer, skal der udvises forsigtighed hos patienter med G6PD-mangel, og man bør overveje at anvende et alternativt lægemiddel, der ikke indeholder et sulfonylurinstof.
English: Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia.
Danish: Behandling af patienter, der lider af G6PD-mangel, med lægemidler, der indeholder sulfonylurea, kan medføre hæmolytisk anæmi.
English: If you stop taking Tandemact
Danish: Hvis De holder op med at tage Tandemact
English: Tandemact is indicated as second line treatment of adult patients with type 2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
Danish: Tandemact er indiceret som andetvalgsbehandling af voksne patienter med type 2-diabetes mellitus, der udviser intolerans over for metformin, eller hos hvem metformin er kontraindiceret, og som allerede er behandlet med en kombination af pioglitazon og glimepirid.
English: Glycaemic control should be monitored closely.
Danish: Den glykæmiske kontrol bør monitoreres nøje.
English: In clinical trials with pioglitazone and sulphonylurea monotherapy or in combination there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
Danish: I kliniske forsøg med pioglitazon og sulfonylurea monoterapi eller i kombination var der tegn på dosisrelateret vægtstigning, hvilket kan skyldes fedtakkumulation og i nogle tilfælde væskeophobning.
English: Animal studies have shown reproductive toxicity which was most likely related to the pharmacological action (hypoglycaemia) of glimepiride.
Danish: Dyreforsøg har påvist reproduktionstoksicitet, som sandsynligvis kunne henføres til glimepirids farmakologiske virkning (hypoglykæmi).
English: Risk related to pioglitazone
Danish: Risici i relation til pioglitazon
English: There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9, and 3A4 in man.
Danish: Der sker ingen induktion af de vigtigste inducerbare CYP-isoenzymer, 1A, 2C8/9 og 3A4, hos mennesket.
English: Fluid retention and cardiac failure
Danish: Væskeretention og hjertesvigt
English: To be eligible patients had to have had one or more of the following: myocardial infarction, stroke, percutaneous cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, or peripheral arterial obstructive disease.
Danish: For at kunne deltage i undersøgelsen skulle patienterne have haft en eller flere af følgende lidelser: myokardieinfarkt, slagtilfælde, perkutan koronar intervention eller koronar arterie bypass transplantat, akut koronar syndrom, koronar arterielidelse, obstruerende perifer arteriesygdom.
English: rare rare
Danish: sjælden sjælden
English: If you forget to take Tandemact
Danish: Hvis De har glemt at tage Tandemact
English: 3 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
Danish: 3 Efter markedsføring er der rapporteret om overfølsomhedsreaktioner hos patienter behandlet med pioglitazon.
English: - The other ingredients are cellulose microcrystalline, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate (see section 2 ‘Tandemact contains lactose monohydrate'), magnesium stearate and polysorbate 80.
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, croscarmellosenatrium, hydroxypropylcellulose, lactosemonohydrat (se punkt 2 "Tandemact indeholder lactosemonohydrat"), magnesiumstearat og polysorbat 80.
English: Tandemact should not be used in patients with severe renal function disorders (creatinine clearance < 30 ml/min, see section 4.3).
Danish: Tandemact bør ikke anvendes til patienter med svære nyrelidelser (kreatininclearance < 30 ml/min, se pkt.
English: If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing stop taking this medicine and talk to your doctor immediately.
Danish: Hvis du får en alvorlig allergisk reaktion, herunder nældefeber og hævelse af ansigtet, læber, tunge eller svælg, der kan forårsage vejrtrækningseller synkebesvær, skal du afbryde behandlingen og kontakte en læge øjeblikkeligt.
English: Tell your doctor or pharmacist if you are taking any of these.
Danish: Fortæl lægen eller på apoteket, hvis du tager et eller flere af disse lægemidler.
English: Closing the potassium channel induces depolarisation of the beta cell and results - by opening of calcium channels - in an increased influx of calcium into the cell.
Danish: Lukning af kaliumkanalerne inducerer depolarisation af beta-cellen og fører til en åbning af calciumkanalerne og dermed til en øget calciumtransport til cellen.
English: Following oral administration, pioglitazone is rapidly absorbed, and peak plasma concentrations of unchanged pioglitazone are usually achieved 2 hours after administration.
Danish: Pioglitazon absorberes hurtigt efter oral indgivelse, og de maksimale plasmakoncentrationer af uomdannet pioglitazon opnås som regel 2 timer efter indgivelse.
English: If a patient wishes to become pregnant, treatment with Tandemact should be discontinued.
Danish: Hvis en patient ønsker at blive gravid, skal Tandemact seponeres.
English: The extrapancreatic effects are for example an improvement of the sensitivity of the peripheral tissue for insulin and a decrease of the insulin uptake by the liver.
Danish: Den ekstrapankreatiske virkning kan for eksempel være øget insulinfølsomhed i de perifere væv og et fald i leverens insulinoptagelse.
English: A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Danish: Et studie med pioglitazon med kardiovaskulært endepunkt er udført hos patienter under 75 år med type 2-diabetes mellitus og betydende makrovaskulær sygdom.
English: In animal fertility studies with pioglitazone, there was no effect on copulation, impregnation or fertility index.
Danish: I dyrefertilitetsstudier med pioglitazon var der ingen virkning på indekser for kopulation, befrugtning eller fertilitet.
English: Tandemact combines two antihyperglycaemic active substances with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: pioglitazone, a member of the thiazolidinedione class and glimepiride, a member of the sulphonylurea class.
Danish: Tandemact kombinerer to antidiabetiske aktive stoffer med komplementære virkningsmekanismer til forbedring af den glykæmiske kontrol hos patienter med type 2-diabetes mellitus: pioglitazon, der hører til thiazolidinedionerne og glimepirid, der hører til gruppen af sulfonylurinstoffer.
English: There is no clinical trial experience of other oral anti-hyperglycaemic medicinal products added to treatment with Tandemact or concomitantly administered glimepiride and pioglitazone.
Danish: Der er ingen erfaring fra kliniske forsøg vedrørende tilføjelse af andre orale antihyperglykæmiske lægemidler til behandlingen med Tandemact eller samtidigt administreret glimepirid og pioglitazon.
English: During therapy with pioglitazone there was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction), consistent with haemodilution.
Danish: Under behandlingen med pioglitazon var der en lille reduktion i middel-hæmoglobin (4 % relativ reduktion) og hæmatokrit (4,1 % relativ reduktion) svarende til hæmodilution.
English: Hepatobiliary disorders6 hepatitis very rare very rare impairment of liver function (with cholestasis and jaundice)
Danish: Lever og galdeveje6 hepatitis meget sjælden meget sjælden nedsat leverfunktion (med kolestase og gulsot)
English: Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Danish: Det bør overvejes at foretage en dosisjustering af pioglitazon inden for det anbefalede dosisområde eller at ændre diabetesbehandlingen (se pkt.
English: In diabetic patients, good metabolic control over 24 hours can be achieved with a single daily dose.
Danish: Med en enkelt dosis om dagen opnår patienter med diabetes god metabolisk kontrol i 24 timer.
English: Takeda Farmacéutica España S.A. Tel: +34 917 14 99 00 spain@takeda.com
Danish: Takeda Farmaéutica España S.A. Tel: +34 917 14 99 00 spain@takeda.com
English: Pioglitazone did not cause statistically significant increases in LDL-cholesterol levels compared with placebo, whilst reductions were observed with metformin and gliclazide.
Danish: Pioglitazon forøgede ikke LDL-kolesterolniveauer statistisk signifikant sammenlignet med placebo, mens der blev set reduktioner med metformin og gliclazid.
English: The following statements reflect the information available on the individual active substances (pioglitazone and glimepiride).
Danish: De efterfølgende oplysninger afspejler de tilgængelige data, som findes for de enkelte aktive stoffer (pioglitazon og glimepirid).
English: If you experience symptoms of hypoglycaemia such as cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea, you should take some sugar to increase your blood sugar level again.
Danish: Hvis De får symptomer på hypoglykæmi som f.eks. koldsved, træthed, hovedpine, hurtige hjerteslag, stik af sult, irritabilitet, nervøsitet eller kvalme, skal De indtage lidt sukker for at få blodsukkerniveauet til at stige igen.
English: Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked.
Danish: Fortæl lægen hurtigst muligt, hvis De udvikler symptomer, som kunne tyde på et problem med leveren (f.eks. kvalme uden nogen forklaring, opkastning, mavesmerter, træthed, tab af appetit og/eller mørk urin), da Deres leverfunktion i så fald skal tjekkes.
English: A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of therapy).
Danish: Et klinisk forsøg, hvor pioglitazon blev sammenlignet med gliclazid, begge som monoterapi, blev forlænget til en varighed af to år for at undersøge, hvornår behandlingen svigter (defineret som forekomst af HbA1c  8,0 % efter de første seks måneders behandling).
English: Glimepiride increases the activity of the glycosyl-phosphatidylinositol-specific phospholipase C which may be correlated with the induced lipogenesis and glycogenesis in isolated fat and muscle cells.
Danish: Glimepirid øger aktiviteten af glycosylphosphatidylinositol-specifikt phospholipase C, som kan være korreleret med den inducerede lipogenese og glykogenese i isolerede fedt- og muskelceller.
English: Glimepiride increases very rapidly the number of active glucose transport molecules in the plasma membranes of muscle and fat cells, resulting in stimulated glucose uptake.
Danish: Glimepirid øger meget hurtigt antallet af aktive glukosetransportmolekyler i muskel- og fedtcellers plasmamembraner, hvilket resulterer i en stimuleret glukoseoptagelse.
English: The following data are findings in studies performed with pioglitazone or glimepiride individually.
Danish: De følgende data er baseret på forsøg med pioglitazon eller glimepirid individuelt.
English: Not known (frequency can not be estimated from the available data) - increase in liver enzymes - itchy skin - raised and itchy rash (hives)
Danish: Ikke kendt (hyppighed kan ikke beregnes ud fra de foreliggende data) - forhøjelse af leverenzymer - hudkløe - hævet og kløende udslæt (nældefeber)
English: Avoid alcohol while taking Tandemact since alcohol may increase or decrease the blood sugar lowering action of Tandemact in an unpredictable way.
Danish: Undgå at indtage alkohol under behandlingen med Tandemact, da alkohol uforudsigeligt kan øge eller nedsætte den blodsukkersænkende virkning af Tandemact.
English: Blurred vision due to swelling (or fluid) at the back of the eye (macular oedema) has also been reported in patients taking Tandemact (frequency cannot be estimated from the available data).
Danish: Sløret syn på grund af hævelse (eller væske) bagest i øjet (makulaødem) er også rapporteret hos patienter, som får Tandemact (hyppigheden kan ikke vurderes ud fra tilgængelige data).
English: It is recommended, therefore, that patients treated with Tandemact undergo periodic monitoring of liver enzymes.
Danish: Det anbefales derfor, at patienter, der er i behandling med Tandemact, med regelmæssige mellemrum får foretaget monitorering af leverenzymerne.
English: A decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Danish: Det kan være nødvendigt at reducere pioglitazondosis, når gemfibrozil gives samtidig.
English: Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur when one of the following active substances is taken, for example:
Danish: Der kan forekomme svækkelse af den blodsukkersænkende effekt og derved forhøjede blodsukkerniveauer, hvis ét af følgende aktive stoffer tages, for eksempel:
English: Sulphonylureas regulate insulin secretion by closing the ATP-sensitive potassium channel in the beta cell membrane.
Danish: Sulfonylurinstoffer regulerer insulinsekretion ved at lukke de ATP-følsomme kaliumkanaler i beta-cellemembranen.
English: In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
Danish: I kontrollerede kliniske forsøg blev hyppigheden af hjerteinsufficiens ved behandling med pioglitazon rapporteret som værende den samme som ved placebobehandling, metformin og sulphonylurea behandlingsgruppen, men hyppigheden var forøget når pioglitazon blev brugt i kombinationsbehandling med insulin.
English: Overall no additional risk of accumulation is to be assumed in such patients.
Danish: Der forventes generelt ikke øget risiko for akkumulering hos patienter med nedsat nyrefunktion.
English: Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Tandemact and have also been reported in male patients (frequency cannot be estimated from the available data) taking Tandemact.
Danish: Knoglebrud har været almindeligt forekommende (kan påvirke op til 1 ud af 10 behandlede) hos kvindelige patienter, der tager Tandemact, og er ligeledes indberettet hos mandlige patienter (hyppighed kan ikke vurderes ud fra de tilgængelige data).
English: Tandemact should be discontinued if any deterioration in cardiac state occurs.
Danish: Behandling med Tandemact bør ophøre, hvis der indtræder hjerteforringelser.
English: Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, granulocytopenia, agranulocytosis, haemolytic anaemia and pancytopenia may occur rarely (≥ 1/10,000 to < 1/1,000) (see section 4.4).
Danish: Moderat til svær trombocytopeni, leukopeni, erytrocytopeni, granulocytopeni, agranulocytose, hæmolytisk anæmi og pancytopeni kan forekomme i sjældne tilfælde (≥ 1/10.000 til < 1/1.000) (se pkt.
English: Sulphonylurea-derivatives like glimepiride pass into the breast milk.
Danish: Sulfonylurinstofderivater som glimepirid udskilles i mælk.
English: In combination trials pioglitazone added to a sulphonylurea resulted in a mean weight increase over one year of 2.8 kg.
Danish: I undersøgelser med kombinationsbehandling medførte pioglitazon, når det blev givet som tillæg til et sulfonylurinstof, en gennemsnitlig vægtstigning på 2,8 kg i løbet af et år.
English: This is a serious reaction which may occur uncommonly (≥ 1/1,000 to < 1/100) (see section 4.4).
Danish: Dette er en alvorlig bivirkning, som kan forekomme som ikke-almindelig bivirkning (≥ 1/1.000 til < 1/100) (se punkt.
English: Nausea, vomiting and epigastric pain may occur.
Danish: Der kan forekomme kvalme, opkastning samt epigastrisk smerte.
English: Under the influence of sympatholytic active substances such as betablockers, clonidine, guanethidine and reserpine, the signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent.
Danish: Under behandling med sympatolytika såsom betablokkere, clonidin, guanethidin og reserpin kan tegn på adrenerg modregulering til hypoglykæmi være reduceret eller mangle helt.
English: If a pregnancy occurs, treatment with Tandemact should be discontinued.
Danish: I tilfælde af graviditet skal behandlingen med Tandemact seponeres.
English: 9 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 - 3 kg over one year.
Danish: 9 I kontrollerede kliniske forsøg med aktive stoffer som sammenligning var den gennemsnitlige vægtstigning med pioglitazon som monoterapi 2-3 kg i løbet af et år.
English: Following initiation of therapy with Tandemact, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Danish: Efter igangsættelse af behandling med Tandemact anbefales det, at leverenzymerne monitoreres med jævne mellemrum i henhold til en klinisk vurdering.
English: phenylbutazone, azapropazone and oxyfenbutazone insulin and oral antidiabetic products metformin salicylates and p-amino-salicylic acid anabolic steroids and male sex hormones chloramphenicol clarithromycin coumarin anticoagulants disopyramide fenfluramine fibrates angiotensin-converting enzyme (ACE) inhibitors fluoxetine allopurinol sympatholytics cyclo-, tro- and iphosphamides sulphinpyrazone certain long-acting sulphonamides tetracyclines
Danish: phenylbutazon, azapropazon og oxyphenbutazon insulin og orale antidiabetika metformin salicylater og p-aminosalicylsyre anabolske steroider og mandlige kønshormoner chloramphenicol clarithromycin coumarin-antikoagulantia disopyramid fenfluramin fibrater angiotensinkonverterende enzym (ACE)-hæmmere fluoxetin allopurinol sympatolytika cyclo-, tro- og iphosphamider sulfinpyrazon visse langtidsvirkende sulfonamider tetracykliner
English: Elderly Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Danish: Ældre Steady-state farmakokinetikken hos patienter på 65 år og derover ligner den der ses hos unge personer.
English: Glimepiride inhibits the glucose production in the liver by increasing the intracellular concentration of fructose-2,6-bisphosphate, which in turn inhibits the gluconeogenesis.
Danish: Glimepirid hæmmer leverens glukosedannelse ved at øge intracellulær koncentration affruktose-2,6-biphosphat, som igen hæmmer glukoneogenesen.
English: Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure (see section 4.4).
Danish: Hjerteinsufficiens er rapporteret i markedsføringen af brugen af pioglitazon, og oftere når pioglitazon blev brugt i kombination med insulin eller på patienter med en historie om hjerteinsufficiens (se pkt.
English: The risk of fractures should be considered in the long term care of patients treated with pioglitazone (see section 4.8).
Danish: Man bør være opmærksom på risikoen for frakturer ved langtidsbehandling af patienter, som har fået behandling med pioglitazon (se pkt.
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Danish: Der er efter markedsføringen blevet rapporteret om nyudbrud eller forværring af diabetisk makulært ødem med nedsat synsevne med thiazolidinedioner, herunder pioglitazon.
English: The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Danish: Hos dyr kan der kun påvises en lille mængde uomdannet pioglitazon i enten urin eller fæces Hos mennesker er den gennemsnitlige plasmahalveringstid for uomdannet pioglitazon 5-6 timer og for dets samlede, aktive metabolitter 16-23 timer.
English: Nervous system disorders dizziness common hypo-aesthesia common common headache uncommon insomnia uncommon uncommon
Danish: Nervesystemet svimmelhed almindelig hypoæstesi almindelig almindelig hovedpine ikke almindelig søvnløshed ikke almindelig ikke almindelig
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, acetylsalicylic acid, statins, fibrates).
Danish: Næsten alle deltagere (95 %) modtog kardiovaskulære lægemidler (betablokkere, ACE-hæmmere, angiotensin II hæmmere, Kalcium kanalhæmmere, nitrater, vanddrivende midler, acetylsalicylsyre, statiner, fibrater).
English: common uncommon macular oedema not known not known
Danish: almindelig ikke almindelig makulært ødem ikke kendt ikke kendt
English: In PROactive, a cardiovascular outcome study, 5,238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
Danish: I PROaktiv, en kardiovaskulær resultatundersøgelse, indgik 5.238 patienter med type-2 diabetes mellitus og præeksisterende større makrovaskulær lidelse i en randomiseret undersøgelse, hvor de fik henholdsvis pioglazone eller placebo sideløbende med eksisterende antidiabetisk og kardiovaskulær behandling.
English: If you experience this symptom for the first time, talk to your doctor as soon as possible.
Danish: Hvis De oplever dette symptom for første gang, skal De hurtigst muligt kontakte Deres læge.
English: Frequency of adverse reactions Pioglitazone Glimepiride Tandemact
Danish: Hyppighed af bivirkninger Pioglitazon Glimepirid Tandemact
English: 6.5 Nature and contents of container Aluminium/aluminium blisters; packs of 14, 28, 30, 50, 90 or 98 tablets.
Danish: 6.5 Emballagetype og pakningsstørrelser Aluminium/ aluminium blisterpakninger: pakninger med 14, 28, 30, 50, 90, og 98 tabletter.
English: Metabolism and nutrition disorders hypoglycaemia uncommon appetite increased uncommon
Danish: Metabolisme og ernæring hypoglykæmi ikke almindelig øget appetit ikke almindelig
English: Gastrointestinal disorders5 flatulence common vomiting very rare very rare diarrhoea very rare very rare nausea very rare very rare abdominal pain very rare very rare abdominal pressure very rare very rare
Danish: Mave-tarm-kanalen5 flatulens almindelig opkastning meget sjælden meget sjælden diarré meget sjælden meget sjælden kvalme meget sjælden meget sjælden mavesmerter meget sjælden meget sjælden trykken i maven meget sjælden meget sjælden oppustethed i maven meget sjælden meget sjælden