FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: After 24 weeks of treatment, the primary endpoint of mean change from baseline in HbA1c was -1.83% in the combination group versus -0.96% in the pioglitazone group (p< 0.0001) and -0.99% in the metformin group (p< 0.0001).
Danish: Efter 24 ugers behandling var det primære endepunkt, middelændring i HbA1c fra baseline, -1,83 % i kombinationsgruppen versus -0,96 % i pioglitazon-gruppen (p < 0,0001) og-0,99 % i metformin-gruppen (p < 0,0001).
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Competact.
Danish: Du skal eventuelt have kontrollere dit blodsukker eller din nyrefunktion hyppigere, eller lægen kan ændre din dosis af Competact.
English: Competact is indicated as second line treatment of type 2 diabetes mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Danish: Competact er indiceret som andetvalgsbehandling af type 2-diabetes mellitus hos voksne patienter, særligt hos overvægtige patienter, som ikke kan opnå tilstrækkelig glykæmisk kontrol ved deres maksimalt tolererede dosis af oral metformin alene.
English: Blurred vision due to swelling (or fluid) at the back of the eye (macular oedema) has been reported (frequency cannot be estimated from available data).
Danish: Uskarpt syn på grund af hævelser (eller væske) bagest i øjet (makulaødem) (hyppigheden kan ikke vurderes ud fra tilgængelige data).
English: Contents of the pack and other information What Competact contains
Danish: Pakningsstørrelser og yderligere oplysninger Competact indeholder
English: Liver enzymes should be checked prior to the initiation of therapy with Competact in all patients.
Danish: Leverenzymer bør checkes forud for igangsættelse af behandling med Competact hos alle patienter.
English: Dose titration with pioglitazone (added to the optimal dose of metformin) should be considered before the patient is switched to Competact.
Danish: Dosistitrering med pioglitazon (som tillægsbehandling til den optimale dosis metformin) skal overvejes, før patienten skifter til Competact.
English: - The other ingredients are microcrystalline cellulose, povidone (K30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide (E171).
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, povidon (K 30), croscaramellosenatrium, magnesiumstearat, hypromellose, macrogol 8000, talcum og titandioxid (E171).
English: Stop taking Competact and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Danish: Stop med at tage Competact og kontakt omgående læge eller nærmeste hospital, hvis du får et eller flere af nedenstående symptomer på laktatacidose, da denne tilstand kan føre til koma.
English: Maximum daily dose is 45 mg
Danish: Maksimal daglig dosis er 45 mg
English: If you need to have major surgery you must stop taking Competact during and for some time after the procedure.
Danish: Hvis du skal have en større operation, skal du stoppe med at tage Competact under indgrebet og i nogen tid herefter.
English: Small clinical trials have not revealed metformin to have malformative effects.
Danish: Små kliniske undersøgelser har ikke afsløret, at metformin skulle give anledning til misdannelser.
English: Concomitant use not recommended Alcohol
Danish: Samtidig brug frarådes Alkohol
English: common common alanine aminotransferase increased9
Danish: almindelig almindelig forhøjet alanin-aminotransferase8
English: Multipack: 196 (2 packs of 98) film-coated tablets.
Danish: Multipakning: 196 (2 pakninger á 98) filmovertrukne tabletter.
English: If you forget to take Competact
Danish: Hvis De har glemt at tage Competact
English: 60 x 1 tablets
Danish: 60 x 1 tabletter
English: As Competact contains metformin hydrochloride,it must be discontinued at the time of surgery under general, spinal or epidural anesthesia.
Danish: Da Competact indeholder metforminhydrochlorid, skal det seponeres på operationstidspunktet i forbindelse med generel, rygmarvs- eller epiduralbedøvelse.
English: Therapy with Competact 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 Competact bør ikke igangsættes hos patienter med forhøjede leverenzymer (ALAT > 2,5 x øvre normal grænse) eller hos patienter med tegn på leversygdom.
English: The recommended dose of Competact is 30 mg/day pioglitazone plus 1,700 mg/day of metformin hydrochloride (this dose is achievable with one tablet of Competact 15 mg/850 mg, taken twice a day).
Danish: Den anbefalede dosis af Competact er 30 mg pioglitazon dagligt plus 1.700 mg metforminhydrochlorid dagligt (denne dosis opnås med én Competact tablet med 15 mg/850 mg 2 gange dagligt).
English: They are supplied in aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, multipacks of 196 (2 packs of 98) tablets or in aluminium/aluminium perforated unit dose blisters in packs of 60 x 1 tablets.
Danish: De leveres i aluminium/aluminium-blisterpakninger med 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, multipakninger med 196 (2 pakninger med 98) tabletter eller i aluminium/aluminium perforerede enkeltdosisblistere i pakninger med 60 x 1 tabletter.
English: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation - by delaying intestinal glucose absorption.
Danish: - ved at reducere den hepatiske glucoseproduktion ved hæmning af gluconeogenese og glycogenolyse - i muskler, ved forøgelse af insulinfølsomheden, forbedring af perifer glucoseoptagelse og-udnyttelse - ved at forsinke den intestinale glucoseabsorption.
English: Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Danish: De prækliniske data for metformin viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogenicitet og toksicitet i forbindelse med reproduktion.
English: - if you have liver disease.
Danish: - hvis De har en leversygdom.
English: Women of childbearing potential / Contraception in males and females Competact is not recommended in women of childbearing potential not using contraception.
Danish: Kvinder i den fertile alder / kontraception hos mænd og kvinder Competact må ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: Bioequivalence studies in healthy volunteers have shown Competact to be bioequivalent to the administration of pioglitazone and metformin given as separate tablets.
Danish: Bioækvivalensundersøgelser med raske frivillige har vist, at Competact er bioækvivalent med indgivelse af pioglitazon og metformin givet som separate tabletter.
English: If a patient wishes to become pregnant, treatment with Competact should be discontinued.
Danish: Hvis en patient ønsker at blive gravid, skal behandlingen med Competact seponeres.
English: EU/1/06/354/001 14 tablets EU/1/06/354/002 28 tablets EU/1/06/354/003 30 tablets EU/1/06/354/004 50 tablets EU/1/06/354/005 56 tablets EU/1/06/354/006 60 tablets EU/1/06/354/007 90 tablets EU/1/06/354/008 98 tablets EU/1/06/354/010 112 tablets EU/1/06/354/009 180 tablets EU/1/06/354/012 60 x 1 tablets
Danish: EU/1/06/354/001 14 tabletter EU/1/06/354/002 28 tabletter EU/1/06/354/003 30 tabletter EU/1/06/354/004 50 tabletter EU/1/06/354/005 56 tabletter EU/1/06/354/006 60 tabletter EU/1/06/354/007 90 tabletter EU/1/06/354/008 98 tabletter EU/1/06/354/010 112 tabletter EU/1/06/354/009 180 tabletter EU/1/06/354/012 60 x 1 tabletter
English: Multipack of 196 (2 packs of 98) tablets and aluminium/aluminium perforated unit dose blisters in pack of 60 x 1 tablets.
Danish: Multipakning med 196 (2 pakninger med 98) tabletter og aluminium/aluminium perforerede enkeltdosis-blistere i pakninger med 60 x 1 tabletter.
English: Following initiation of therapy with Competact, it is recommended that liver enzymes be monitored periodically according to clinical judgement.
Danish: Efter igangsættelse af behandling med Competact anbefales det, at leverenzymerne monitoreres med jævne mellemrum i henhold til en klinisk vurdering.
English: It is recommended, therefore, that patients treated with Competact undergo periodic monitoring of liver enzymes.
Danish: Det anbefales derfor, at patienter, der er i behandling med Competact, med regelmæssige mellemrum får foretaget monitorering af leverenzymer.
English: Talk to your doctor or pharmacist before taking Competact (see also section 4).
Danish: Kontakt lægen eller apotekspersonalet, før De tager Competact (se også punkt 4) - hvis De har problemer med hjertet.
English: It is an anti-diabetic medicine used in adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin alone is not sufficient.
Danish: Det er medicin mod sukkersyge og anvendes til behandling af type 2 (ikke-insulinkrævende) diabetes mellitus hos voksne, hvor behandling med metformin alene ikke er tilstrækkelig.
English: Eye disorders visual disturbance3
Danish: Synsforstyrrelser3
English: - if you have a severe infection or are dehydrated.
Danish: - hvis De har en alvorlig infektion eller lider af væskemangel.
English: Other medicines and Competact
Danish: Brug af anden medicin sammen med Competact
English: FOR CALENDARISED PACKS: 7 Tablet blister
Danish: FORKORTELSER FOR UGEDAGE TIL KALENDERPAKNINGER: Blister med 7 tabletter
English: If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart-beating, vision disorders or difficulty in concentration, you should take some sugar to increase your blood sugar level again.
Danish: Hvis de får symptomer på hypoglykæmi som f.eks. svaghed, svimmelhed, øget svedproduktion, hurtigere puls, synsforstyrrelser eller problemer med koncentrationsevnen, skal De indtage lidt sukker for at få blodsukkerniveauet til at stige igen.
English: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021)
Danish: - en signifikant reduktion i den absolutte risiko for enhver diabetes-relateret komplikation i metformingruppen (28,9 tilfælde/1.000 patientår) versus diæt alene (43,3 tilfælde/1.000 patientår), p = 0,0023, og versus de kombinerede monoterapigrupper med sulfonylurinstof og insulin (40,1 tilfælde/1.000 patientår), p = 0,0034 - en signifikant reduktion i den absolutte risiko for diabetes-relateret mortalitet: metformin (7,5 tilfælde/1.000 patientår), diæt alene (12,7 tilfælde/1.000 patientår), p = 0,017 - en signifikant reduktion i den absolutte risiko for overordnet mortalitet: metformin (13,5 tilfælde/1.000 patientår) versus diæt alene (20,6 tilfælde/1.000 patientår), p = 0,011, og versus de kombinerede monoterapigrupper med sulfonylurinstof og insulin (18,9 tilfælde/1.000 patientår), p = 0,021 - en signifikant reduktion i den absolutte risiko for myocardieinfarkt: metformin (11 tilfælde/1.000 patientår), diæt alene (18 tilfælde/1.000 patientår), p = 0,01.
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 patienterne (95 %) var i behandling med kardiovaskulære lægemidler (beta-blokkere, ACE-hæmmere, angiotensin II-antagonister, calciumantagonister, nitrater, diuretika, acetylsalicylsyre, statiner og fibrater).
English: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Competact should have their renal function monitored regularly (see sections 4.3 and 4.4).
Danish: Da metformin udskilles via nyrerne, og ældre patienter har en tendens til nedsat nyrefunktion, bør ældre patienter, som behandles med Competact, have nyrefunktionen monitoreret regelmæssigt (se pkt.
English: The decision whether to continue the patient on therapy with Competact should be guided by clinical judgement pending laboratory evaluations.
Danish: Beslutningen om, hvorvidt patienten skal fortsætte med behandlingen med Competact, bør støtte sig til en løbende klinisk bedømmelse af laboratorieværdierne.
English: 1 Post-marketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
Danish: 1 Efter markedsføring er der rapporteret om overfølsomhedsreaktioner hos patienter behandlet med pioglitazon.
English: Competact may cause a very rare (may affect up to 1 in 10,000), but very serious side effect called lactic acidosis (see section “Risk of lactic acidosis”).
Danish: Competact kan forårsage en meget sjælden (kan forekomme hos op til 1 ud af 10.000 brugere), men meget alvorlig bivirkning, der kaldes laktatacidose (se afsnittet ”Risiko for laktatacidose”).
English: Both pioglitazone and metformin have been shown to be present in the milk of lactating rats.
Danish: Tilstedeværelse af både pioglitazon og metformin i mælken hos diegivende rotter er påvist.
English: 5 Isolated reports: liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.
Danish: 5Isolerede rapporter: Anormale leverfunktionstest eller hepatitis, der forsvinder ved seponering af metformin.
English: Competact contains pioglitazone and metformin.
Danish: Competact indeholder pioglitazon og metformin.
English: Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Danish: Lignende ændringer blev observeret for metformin (hæmoglobin 3-4 % og hæmatokrit 3,6-4,1 % relative reduktioner) hos patienter i kontrollerede sammenlignende undersøgelser med pioglitazon.
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 PROactive, et kardiovaskulært outcome -forsøg, med 5.238 patienter med type 2-diabetes mellitus og betydende makrovaskulær sygdom, som blev randomiseret til pioglitazon eller placebo i tillæg til eksisterende antidiabetika og kardiovaskulær behandling i op til 3,5 år.
English: If this happens you must stop taking Competact and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Danish: Hvis dette sker for dig, skal du omgående stoppe med at tage Competact og kontakte læge eller nærmeste hospital, da laktatacidose kan føre til koma.
English: Since there is a potential for an increase in dose-related adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Danish: Da der er risiko for stigning i dosis-relaterede bivirkninger, kan det være nødvendigt at nedsætte pioglitazon-dosis, når gemfibrozil gives samtidigt.
English: Use in children and adolescents under 18 years is not recommended.
Danish: Børn og unge under 18 år må normalt ikke få Competact.
English: Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Competact.
Danish: Blærekræft forekommer med hyppigheden "ikke almindelig" (kan ramme op til 1 ud af 100 behandlede) hos patienter, der tager Competact.
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: 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 straks kontakte en læge.
English: Some medicinal products that can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDS, including selective cyclo-oxygenase (COX) II inhibitors, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Danish: Visse lægemidler kan påvirke nyrefunktionen negativt, hvilket kan øge risikoen for laktatacidose, f.eks. NSAID'er, herunder selektive cyklooxygenase (COX) II-hæmmere, angiotensinkonverterende enzym (ACE)-hæmmere, angiotensin II-receptorantagonister og diuretika, især loop-diuretika.
English: Not known (frequency can not be estimated from the available data) - inflammation of the liver (hepatitis) - liver does not work as well as it should (changes in liver enzymes)
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængeligedata) - leverbetændelse (hepatitis) - nedsat leverfunktion (ændringer i leverenzymværdier)
English: Hepatobiliary disorders hepatitis5
Danish: Lever og galdeveje hepatitis5
English: The following data are findings in studies performed with pioglitazone or metformin individually.
Danish: De følgende data er baseret på baggrund af forsøg med pioglitazon og metformin individuelt.
English: Competact 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 metformin hydrochloride, a member of the biguanide class.
Danish: Competact kombinerer to antidiabetiske stoffer med komplementære virkningsmekanismer til forbedring af den glykæmiske kontrol hos patienter med type 2-diabetes mellitus: pioglitazon, der hører til thiazolidinedionerne og metforminhydrochlorid, der hører til biguaniderne.
English: In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg.
Danish: I undersøgelser med kombinationsbehandling medførte pioglitazon som tillæg til metformin en gennemsnitlig vægtøgning på 1,5 kg i løbet af et år.
English: The improved glycaemic control is associated with a reduction in both fasting and postprandial plasma insulin concentrations.
Danish: Den forbedrede blodglucoseregulering er associeret med en reduktion af både fastende og postprandiale insulinkoncentrationer i plasma.
English: Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Danish: Undersøgelser hos mennesker tyder ikke på induktion af de vigtigste inducerbare CYP1A, 2C8/9 og 3A4.
English: Individual cartons not to be sold separately.
Danish: Æskerne må ikke sælges stykvis.
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 pioglitazonbehandlede kvinder frakturer sammenlignet med 23/905 (2,5 %, 0,5 frakturer pr. 100 patientår) af de kvinder, som fik komparator.
English: Avoid excessive alcohol intake while taking Competact since this may increase the risk of lactic acidosis (see section “Risk of lactic acidosis”).
Danish: Du skal undgå at indtage store mængder alkohol, mens du er i behandling med Competact, da det kan øge risikoen for laktatacidose (se afsnittet ” Risiko for laktatacidose ”).
English: - The active substances are pioglitazone and metformin hydrochloride.
Danish: - Aktive stoffer: pioglitazon og metforminhydrochlorid.
English: In case of dehydration (severe diarrhoea or vomiting, fever, heat, reduced fluid intake), Competact should be temporarily discontinued and contact with a health care professional is recommended.
Danish: Patienterne skal informeres om, at i tilfælde af dehydrering (alvorlig diarré eller opkastning, feber eller nedsat væskeindtagelse) skal Competactbehandlingen afbrydes midlertidigt, og at det anbefales, at de kontakter en læge.
English: Frequency of adverse reactions Pioglitazone Metformin Competact
Danish: Hyppighed Pioglitazone Metformin Competact
English: Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
Danish: hurtig og dyb vejrtrækning og søvnighed, og din ånde kan få en usædvanlig frugtagtig lugt.
English: Competact must therefore not be used in women who are breast-feeding (see section 4.3).
Danish: Competact må derfor ikke anvendes af ammende kvinder (se pkt.
English: common common arthralgia common
Danish: Artralgi almindelig
English: Animal studies have not shown teratogenic effects but have shown foetotoxicity related to the pharmacologic action (see section 5.3).
Danish: Derimod har dyreforsøg påvist fostertoksicitet, der er relateret til den farmakologiske virkning (se pkt.
English: If you have taken more Competact that you should have, you may experience lactic acidosis (see section “Risk of lactic acidosis”).
Danish: Hvis De har taget for mange Competact, kan De få laktacidose (se afsnittet ”Risiko for laktatacidose”).
English: 9 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: 9I kliniske forsøg med pioglitazon var hyppigheden af ALAT-forhøjelse tre gange over den øverste normalgrænse den samme som for placebo, men mindre end den, der blev set i komparatorgrupperne med metformin og sulfonylurinstof.
English: Competact helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Danish: Når De har type 2-diabetes, hjælper Competact Deres krop med bedre at udnytte den insulin, kroppen producerer.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Danish: Hos mennesker har metformin, uafhængigt af stoffets virkning på blodglucosen, en gunstig virkning på lipidmetabolismen.
English: The tablets are white to off-white, oblong, film-coated, embossed ‘15 / 850' on one face and ‘4833M' on the other.
Danish: Tabletterne er hvide til offwhite, aflange, filmovertrukne og mærket med ‘15 / 850' på den ene side og ʽ4833M' på den anden side.
English: If you experience these symptoms for the first time talk to your doctor as soon as possible.
Danish: Hvis De oplever dette for første gang, skal De kontakte Deres læge så hurtigt som muligt.