FrancophonIA/ELRC3.0 huggingface dataset:
English: After a single dose of radiolabelled glimepiride, 58% of the radioactivity was recovered in the urine, and 35% in the faeces.
Danish: Efter en enkelt dosis med radioaktivt mærket glimepirid blev 58 % af radioaktiviteten genfundet i urinen og 35 % i fæces.
English: Linearity/non-linearity Single dose studies demonstrate linearity of pharmacokinetics in the therapeutic dose range.
Danish: Linearitet/non-linearitet Forsøg med enkelt dosis viser farmakokinetisk linearitet inden for det terapeutiske dosisområde.
English: Treatment with Tandemact therefore requires regular haematological monitoring (especially leucocytes and platelets).
Danish: Behandling med Tandemact kræver derfor regelmæssig hæmatologisk monitorering (især leukocytter og blodplader).
English: The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Danish: Hyppigheden af ødemer for sammenligningsgrupperne (sulfonylurea, metformin) var 2-5 %.
English: However, the incidence of oedema, weight gain and heart failure were increased.
Danish: Tilfælde med ødemer, vægtstigning og hjerteinsufficiens var dog forøget.
English: There are no adequate data from the use of glimepiride in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af glimepirid til gravide kvinder.
English: Patients should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those with reduced cardiac reserve.
Danish: Patienterne bør observeres med henblik på tegn og symptomer på hjerteinsufficiens, vægtstigning eller ødemer; dette gælder især patienter med nedsat kardiel arbejdskapacitet.
English: This is particularly important in those who have reduced or absent awareness of the warnings of hypoglycaemia or have frequent episodes of hypoglycaemia.
Danish: Dette er særlig vigtigt hos patienter, der slet ikke eller kun i ringe grad er opmærksomme på advarselstegnene på hypoglykæmi, eller patienter der oplever hyppige episoder af hypoglykæmi.
English: Adverse reactions reported in double-blind studies and post marketing experience are listed below as MedDRA preferred term by system organ class and absolute frequency.
Danish: Bivirkninger rapporteret i dobbeltblinde forsøg og post marketing-erfaring er anført herunder efter MedDRA-foretrukken term og systemorganklasser og absolut hyppighed.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Tandemact.
Danish: De følgende oplysninger vedrører de farmakokinetiske forhold af de individuelle aktive stoffer i Tandemact.
English: In the latter (covering embryotoxicity, teratogenicity and developmental toxicity), undesirable effects observed were considered to be secondary to the hypoglycaemic effects induced by the compound in dams and in offspring.
Danish: I det sidste (som dækkede embryotoksicitet, teratogenicitet og udviklings-toksicitet), blev de bivirkninger, som blev observeret, betragtet som værende sekundære til den hypoglykæmiske effekt, som blev induceret af stoffet i moderdyret og i afkommet.
English: Takeda GmbH Production Site Oranienburg Lehnitzstrasse 70 - 98 16515 Oranienburg, Germany
Danish: Takeda GmbH Production Site Oranienburg Lehnitzstrasse 70 - 98 16515 Oranienburg, Tyskland
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Pioglitazone has been shown to be present in the milk of lactating rats.
Danish: Pioglitazon er vist at være til stede i mælken hos rotter.
English: The uptake of glucose from blood into peripheral muscle and fat tissues occurs via a special transport proteins, located in the cells membrane.
Danish: Optagelsen af glukose fra blod i perifere muskel- og fedtvæv foregår via specielle transportproteiner, som findes i cellemembranerne.
English: A higher number of bone fractures was seen in patients, particularly women taking pioglitazone.
Danish: Der blev observeret flere knoglebrud hos patienter, særligt kvinder, som tog pioglitazon.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs; ATC code: A10BD06.
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, kombinationer af orale blodsukkersænkende lægemidler, ATC-kode: A10BD06.
English: When meals are taken at irregular hours or skipped altogether, treatment with Tandemact may lead to hypoglycaemia due to the sulphonylurea component.
Danish: Når måltiderne indtages på uregelmæssige tidspunkter eller helt springes over, kan behandling med Tandemact føre til hypoglykæmi på grund af sulfonylureakomponenten.
English: If glimepiride is taken simultaneously with certain other medicinal products, both undesired increases and decreases in the hypoglycaemic action of glimepiride can occur.
Danish: Hvis glimepirid tages samtidig med visse andre lægemidler kan der optræde uønskede stigninger såvel som reduktioner i den glimepirids hypoglykæmiske virkning.
English: This may affect your ability to drive or use machines.
Danish: Dette kan påvirke Deres evne til at køre bil og betjene maskiner.
English: Before you start taking Tandemact you will have a blood sample taken to check your liver function.
Danish: Inden De begynder at tage Tandemact, får De taget en blodprøve for at tjekke leverfunktionen.
English: At two years, glycaemic control (defined as HbA1c < 8.0%) was sustained in 69% of patients treated with pioglitazone, compared with 50% of patients on gliclazide.
Danish: Efter to år var den glykæmiske kontrol (defineret som HbA1c < 8,0 %) opretholdt hos 69 % af patienterne behandlet med pioglitazon sammenlignet med 50 % af patienterne behandlet med gliclazid.
English: If ALT levels are increased to 3 x upper limit of normal during Tandemact therapy, liver enzyme levels should be reassessed as soon as possible.
Danish: Hvis ALT-niveauerne øges til 3 x den øvre, normale grænse under Tandemact-behandlingen, bør leverenzymniveauerne revurderes igen så hurtigt som muligt.
English: MAO-inhibitors quinolone antibiotics probenecid miconazole pentoxyfylline (high dose parenteral) tritoqualine fluconazole
Danish: MAO-hæmmere quinolon-antibiotika probenecid miconazol pentoxifyllin (højdosis parenteral) tritoqualin fluconazol
English: Some patients experienced the following side effects whilst taking pioglitazone and sulphonylureas, including glimepiride:
Danish: Nogle patienter har oplevet følgende bivirkninger, mens De tog pioglitazon og sulfonylurinstoffer, herunder glimepirid:
English: You may also experience a reduction in blood count (anaemia).
Danish: De vil muligvis opleve et nedsat antal blodceller (anæmi).
English: The safety and efficacy of Tandemact in children and adolescents under 18 years of age have not been established.
Danish: Tandemacts sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Treatment with Tandemact requires regular monitoring of glycaemic control.
Danish: Behandling med Tandemact kræver regelmæssig monitorering af den glykæmiske kontrol.
English: If large quantities have been ingested, gastric lavage is indicated, followed by activated charcoal and sodium-sulphate.
Danish: Hvis der er indtaget store mængder, er maveudskylning indiceret efterfulgt af aktivt kul og natriumsulfat.
English: There are no adequate data from the use of pioglitazone in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af pioglitazon til gravide kvinder.
English: Rare (may affect up to 1 in 1,000 people) - noticeable changes in blood
Danish: Sjældne: (Kan forekomme hos op til 1 ud af 1.000 behandlede) - væsentlige forandringer i blodet
English: The tablets are supplied in aluminium/aluminium blister packs containing either 14, 28, 30, 50, 90 or 98 tablets.
Danish: Tabletterne leveres i aluminium/aluminium-blisterpakninger med enten 14, 28, 30, 50, 90 eller 98 tabletter.
English: If patients are receiving pioglitazone in combination with a sulphonylurea other than glimepiride, patients should be stabilised with concomitant pioglitazone and glimepiride before switching to Tandemact.
Danish: Hvis patienterne får pioglitazon i kombination med et andet sulfonylurinstof end glimepirid, bør patienterne stabiliseres på samtidig indtagelse af pioglitazon og glimepirid, inden de skifter over til Tandemact.
English: If patients report hypoglycaemia, the dose of Tandemact should be reduced or free combination therapy should be considered.
Danish: Hvis patienterne rapporterer om hypoglykæmi, bør Tandemact-dosis reduceres eller kombinationsterapi med fri dosering overvejes.
English: Allergic reactions have been reported with frequency not known (cannot be estimated from the available data) in patients taking Tandemact.
Danish: Der er rapporteret om allergiske reaktioner med ukendt hyppighed (kan ikke vurderes ud fra tilgængelige data) hos patienter, der tager Tandemact.
English: This is similar to that seen in a sulphonylurea active comparator group.
Danish: Dette ligner det, der ses i en gruppe med et sulfonylurinstof som aktiv komparator.
English: When treating patients who have at least one risk factor for development of congestive heart failure (e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start with the lowest available dose of pioglitazone and increase the dose gradually.
Danish: Når patienter med mindst én risikofaktor for kongestivt hjerteinsufficiens (dvs. tidligere myokardieinfarkt eller symptomatisk karsygdom eller ældre patienter) behandles, bør lægen begynde med den lavest mulige dosis pioglitazon og derefter gradvist forøge dosis.
English: acetozolamide
Danish: acetozolamid
English: Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Danish: Skønt undersøgelsen mislykkedes mht. dens primære slutmål, der var en sammensætning af alle dødelighedsårsager, ikke dødelig myokardieinfarkt, slagtilfælde, akut koronar syndrom, større benamputationer, koronar revaskulari, og benrevaskulari, så pegede resultaterne på, at der ikke på længere sigt findes nogle kardiovaskulære bekymringer med hensyn til brugen af pioglitazon.
English: Tandemact helps control the level of sugar in your blood when you have type 2 diabetes by increasing the amount of insulin available and helping your body make better use of it.
Danish: Når De har type 2-diabetes hjælper Tandemact med til at regulere niveauet af sukker i Deres blod ved at øge mængden af tilgængelig insulin og hjælpe kroppen med at udnytte den bedre.
English: Glimepiride is transferred to the placenta.
Danish: Glimepirid passerer placenta.
English: Investigations weight increased9
Danish: Undersøgelser vægtstigning9
English: common common common increased lactic dehydrogenase uncommon decrease in sodium serum concentrations very rare very rare alanine aminotransferase increase10
Danish: almindelig almindelig almindelig øget laktisk dehydrogenase ikke almindelig fald i natriumkoncentration i serum meget sjælden meget sjælden stigning i alaninamino-transferase 10
English: Tandemact is contraindicated during pregnancy (see section 4.3).
Danish: Tandemact er kontraindiceret under graviditet (se pkt.
English: Risk related to glimepiride
Danish: Risici i relation til glimepirid
English: In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Danish: I lyset af de potentielle risici ved længerevarende behandling bør den ordinerende læge ved efterfølgende rutinemæssige kontroller bekræfte at den kliniske fordel ved pioglitazon opretholdes (se pkt.
English: H2 antagonists, betablockers, clonidine and reserpine may lead to either potentiation or weakening of the blood glucose lowering effect.
Danish: H2-antagonister, betablokkere, clonidin og reserpin kan føre til enten forstærkning eller svækkelse af den blodsukkersænkende effekt.
English: Studies in human volunteers have shown Tandemact to be bioequivalent to the administration of pioglitazone and glimepiride given as separate tablets.
Danish: Undersøgelser med frivillige forsøgspersoner har vist, at Tandemact er bioækvivalent med administration af pioglitazon og glimepirid givet som separate tabletter.
English: Preclinical effects observed occurred at exposures sufficiently in excess of the maximum human exposure as to indicate little relevance to clinical use, or were due to the pharmacodynamic action (hypoglycaemia) of the compound.
Danish: De prækliniske virkninger, der blev observeret ved eksponeringer, der i tilstrækkelig grad overskred den maksimale humane eksponering, således at de kun indikerede ringe relevans i forbindelse med klinisk brug eller skyldtes den farmakodynamiske virkning (hypoglykæmi) af produktet.
English: Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Danish: Fortæl lægen hurtigst muligt, hvis De oplever tegn på hjertesvigt som f.eks. unormal åndenød eller hurtig vægtstigning eller lokal hævelse (ødem).
English: Decrease in blood platelets (which increases risk of bleeding or bruising), red blood cells (which makes the skin pale and cause weakness or breathlessness) and white blood cells(which makes infections more likely) have been reported in patients taking Tandemact rarely (may affect up to 1 in 1,000 people).
Danish: Fald i antallet af blodplader (hvilket øger risikoen for blødning eller blodudtrædning), røde blodlegemer (hvilket gør huden bleg og forårsager svaghed eller åndenød) og hvide blodlegemer (hvilket øger risikoen for infektioner) er rapporteret hos patienter, som får Tandemact med hyppigheden "sjælden" (kan forekomme hos op til 1 ud af 1.000 behandlede).
English: Blood glucose should be closely monitored.
Danish: Blodsukkeret bør monitoreres nøje.
English: General disorders and administration site conditions oedema8
Danish: Almene symptomer og reaktioner på administrationsstedet ødem8
English: Alcohol intake may potentiate or weaken the hypoglycaemic action of glimepiride in an unpredictable fashion.
Danish: Alkoholindtagelse kan forstærke eller svække glimepirids hypoglykæmiske virkning på uforudsigelig måde.
English: In a placebo controlled trial, patients with inadequate glycaemic control despite a three month insulin optimisation period were randomised to pioglitazone or placebo for 12 months.
Danish: I et kontrolleret forsøg med placebo, indgik patienter med utilstrækkelig glycemisk kontrol på trods af en tre-måneders optimeringsperiode, i et randomiseret forsøg med brug af pioglitazon eller placebo i 12 måneder.
English: In animals, glimepiride is excreted in milk.
Danish: Hos dyr udskilles glimepirid i mælk.
English: As with other sulphonylureas this effect is based on an increase of responsiveness of the pancreatic beta cells to the physiological glucose stimulus.
Danish: Lige som for andre sulfonylurinstoffer skyldes denne virkning en øget følsomhed i beta-cellerne over for den fysiologiske glukosestimulation.
English: Therapy with Tandemact should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease.
Danish: Behandling med Tandemact bør ikke igangsættes hos patienter med forhøjede leverenzymer (ALT > 2,5 x øvre normal grænse) eller hos patienter med andre tegn på leversygdom.
English: Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following active substances is taken, for example:
Danish: Forstærkning af den blodsukkersænkende effekt, hvorfor der i nogle tilfælde kan optræde hypoglykæmi, når ét af de følgende aktive stoffer tages, for eksempel:
English: In very rare cases, impairment of liver function (e.g. with cholestasis and jaundice) may develop, as well as hepatitis which may progress to liver failure.
Danish: I meget sjældne tilfælde kan det udvikle sig til nedsat leverfunktion (f.eks. med kolestase og gulsot) og hepatitis, der kan udvikle sig til leversvigt.
English: Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
Danish: Pioglitazon gennemgår en omfattende metabolisme i leveren gennem hydroxylering af alifatiske methylengrupper.
English: Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity.
Danish: Lignende ændringer i kroppens fedtdistribution ved behandling med pioglitazon har været fulgt af en forbedret insulinfølsomhed.
English: Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Danish: Der blev observeret lignende ændringer med metformin (hæmoglobin 3-4 % og hæmatokrit 3,6-4,1 % relative reduktioner) og i mindre grad sulfonylurea og insulin (hæmoglobin 1-2 % og hæmatokrit 1-3,2 % relative reduktioner) hos patienter i kontrollerede, sammenlignende undersøgelser med pioglitazon.
English: 5 Gastro-intestinal complaints are very rare and seldom lead to discontinuation of therapy.
Danish: 5 Gastrointestinale gener er meget sjældne og fører sjældent til seponering af behandlingen.
English: Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
Danish: Samtidig administration af pioglitazon og sulfonylurinstoffer synes ikke at påvirke farmakokinetikken af sulfonylurea.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4).
Danish: Andre reaktioner som f.eks. knoglefraktur, vægtstigning og ødem kan forekommer som almindelige bivirkninger (≥ 1/100 til < 1/10) (se punkt 4.4).
English: There is a linear relationship between dose and both Cmax and AUC (area under the time/concentration curve).
Danish: Linearitet/non-linearitet Der er lineær relation mellem dosis og såvel Cmax som AUC (areal under tid/koncentration-kurven).
English: The transport of glucose in these tissues is the rate limiting step in the use of glucose.
Danish: Transporten af glukose i disse væv er det hastighedsbegrænsende trin i glukoseomsætningen.
English: Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Danish: Patienter, der fik pioglitazon opnåede en middelreducering i HbA1c på 0,45 %, sammenlignet med de patienter, der fortsatte med insulin alene, og der opnåedes en reduktion af insulinforbruget i gruppen, der blev behandlet med pioglitazon.
English: Via Crosa 86, 28065 Cerano (NO) Italy
Danish: 28065 Cerano (NO) Italien
English: In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included in insulin.
Danish: I en resultatundersøgelse af patienter med præ-eksisterende større makrovaskulære lidelser, var tilfælde af alvorlige hjerteinsufficiens 1,6 % højere med pioglitazon end med placebo, når den blev tilføjet behandling, der inkluderede insulin.
English: Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.
Danish: Der kan ikke forventes interaktion med præparater, der metaboliseres af disse enzymer, f.eks. orale kontraceptiva, ciclosporin, calciumblokkere og HMGCoA reduktasehæmmere.
English: In addition, glimepiride seems to have pronounced extrapancreatic effects also postulated for other sulphonylureas.
Danish: Glimepirid synes tillige at have en udtalt ekstrapankreatisk virkning, hvilket også menes at være tilfældet for andre sulfonylurinstoffer.
English: The hypoglycaemia may in general be accompanied by neurological symptoms like restlessness, tremor, visual disturbances, coordination problems, sleepiness, coma and convulsions.
Danish: Hypoglykæmien kan generelt være ledsaget af neurologiske symptomer som rastløshed, tremor, synsforstyrrelser, koordinationsproblemer, søvnighed, koma og krampetrækninger.
English: Liver enzymes should be checked prior to the initiation of therapy with Tandemact in all patients.
Danish: Leverenzymerne bør tjekkes forud for igangsættelse af behandling med Tandemact hos alle patienter.
English: The tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption.
Danish: Tabletterne indeholder lactose monohydrat og bør derfor ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: It is known from other sulphonylureas that, despite initially successful countermeasures, hypoglycaemia may recur.
Danish: Det kendes fra andre sulfonylurinstoffer, at hypoglykæmi kan forekomme gentagne gange, selv om modforholdsreglerne i første omgang var vellykkede.
English: Treatment of overdose of Tandemact primarily consists of preventing absorption of glimepiride by inducing vomiting and then drinking water or lemonade with activated charcoal (adsorbent) and sodium-sulphate (laxative).
Danish: Behandling af en overdosis Tandemact består primært i at forhindre absorption af glimepirid ved først at få patienten til at kaste op og derefter at få patienten til at drikke vand eller limonade med aktivt kul (absorberende) og natriumsulfat (afførende).
English: The decision whether to continue the patient on therapy with Tandemact should be guided by clinical judgement pending laboratory evaluations.
Danish: Beslutningen om, hvorvidt patienten skal fortsætte med behandlingen med Tandemact bør støtte sig til en løbende klinisk bedømmelse, indtil laboratorieværdierne foreligger.
English: Take Tandemact daily as prescribed.
Danish: De skal tage Deres Tandemact-tabletter dagligt som foreskrevet.
English: Close monitoring of glycaemic control should be considered (see section 4.4).
Danish: Nøje monitorering af den glykæmiske kontrol bør overvejes (se pkt.
English: Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.
Danish: Hvis De allerede har sløret syn, og symptomet forværres, skal De hurtigst muligt kontakte Deres læge.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin together experienced the development of heart failure.
Danish: Nogle patienter med langvarig type 2-diabetes mellitus og hjertesygdom eller tidligere slagtilfælde, som blev behandlet med pioglitazon og insulin samtidig, oplevede udvikling af hjertesvigt.
English: The pioglitazone dose may need to be increased when rifampicin is concomitantly administered.
Danish: Det er muligt, at pioglitazon dosis skal øges, når rifampicin gives samtidig.
English: In some cases weight increase may be a symptom of cardiac failure therefore weight should be closely monitored.
Danish: I nogle tilfælde kan vægtstigning være symptom på hjerteinsufficiens.