FrancophonIA/ELRC3.0 huggingface dataset:
English: Since there is a potential for an increase in doserelated adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Danish: Da der er en risiko for en stigning i dosisrelaterede bivirkninger, kan det være nødvendigt med en nedsættelse af pioglitazon dosis, når gemfibrozil gives samtidigt.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Danish: Denne medicin må ikke anvendes efter den udløbsdato, som er angivet på æsken og blisteren efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: 1 Postmarketing 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: 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, havde en gennemsnitlig reduktion af HbA1c på 0,45% sammenlignet med de patienter, der fortsatte på insulin alene, samtidig sås en reduktion af insulin dosis hos de pioglitazon behandlede.
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 placebo kontrolleret forsøg blev patienter med utilstrækkelig glykæmisk regulering på trods af en tre måneders insulinoptimeringsperiode, randomiseret til pioglitazon eller placebo i 12 måneder.
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: Kontakt lægen hurtigst muligt, hvis du oplever tegn på hjertesvigt såsom usædvanlig åndenød, hurtig vægtstigning eller lokale væskeansamlinger (ødemer).
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 det vigtigste inducerbare cytokrom P450, 1A, 2C8/9 og 3A4.
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: Selvom forsøget ikke kunne påvise dets primære endepunkt, der var en sammensætning af generel dødelighed, ikke letal hjerteinfarkt, apopleksi, akut koronarsyndrom, større benamputation, koronar revaskularisering og revaskularisering i benene, tyder resultaterne på, at der ikke er en langtids kardiovaskulær følgevirkning med hensyn til brug af pioglitazon.
English: In patients with renal impairment, plasma concentrations of pioglitazone and its metabolites are lower than those seen in subjects with normal renal function, but oral clearance of parent substance is similar.
Danish: Hos patienter med nedsat nyrefunktion er plasmakoncentrationerne af pioglitazon og dets metabolitter lavere end dem, der ses hos personer med normal nyrefunktion, men orale clearance af moderstoffet er den samme.
English: Pioglitazone Teva may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Danish: Pioglitazone Teva kan anvendes alene til patienter, som ikke er i stand til at tage metformin, og hos hvem diæt og motion ikke har været i stand til at kontrollere blodsukkeret, eller det kan anvendes som supplement til andre lægemidler (såsom metformin, sulfonylurinstof eller insulin), hvis disse ikke har været i stand til at kontrollere blodsukkeret tilstrækkeligt.
English: - The other ingredients are mannitol, carmellose calcium, hydroxypropylcellulose and magnesium stearate.
Danish: - Øvrige indholdsstoffer: mannitol, carmellosecalcium, hydroxypropylcellulose og magnesiumstearat.
English: In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged ≥65 years compared with those less than 65 years (9.7% compared to 4.0%).
Danish: Hos de patienter, der fik pioglitazon og insulin i dette studie, var procentdelen af patienter med hjertesvigt højere hos patienterne ≥ 65 år end hos patienterne under 65 år (9,7 % sammenlignet med 4,0 %).
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: Lignende ændringer blev observeret for metformin (hæmoglobin 3-4% og hæmatokrit 3,6-4,1% relative reduktioner) og i mindre grad for sulfonylurinstof og insulin (hæmoglobin 1-2% og hæmatokrit 1-3,2% relative reduktioner) hos patienter i kontrollerede sammenlignende undersøgelser med pioglitazon.
English: Adverse reactions reported in excess (> 0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency.
Danish: Bivirkninger, der er rapporteret hyppigere end (> 0,5%) placebo, og som er rapporteret med mere end et isoleret tilfælde hos patienter, der fik pioglitazon i dobbeltblinde forsøg, er anført nedenfor efter MedDRA-terminologien med systemorganklasse og absolut hyppighed.
English: Swensweg 5, 2031 GA Haarlem The Netherlands
Danish: Swensweg 5, 20 GA Haarlem Holland
English: Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when pioglitazone is used in combination with insulin.
Danish: Patienterne bør observeres for på tegn og symptomer på hjerteinsufficiens, vægtøgning og ødem, når pioglitazon bruges i kombination med insulin.
English: - The tablets are supplied in blisters in packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets.
Danish: Tabletterne leveres i blister a 14, 28, 30, 50, 56, 84, 90, 98, 112 eller 196 tabletter.
English: There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Danish: Der er været sjældne rapporter vedrørende hepatocellulær funktionssvigt under post-marketing undersøgelser (se pkt.
English: Liver enzymes should be checked prior to the initiation of therapy with pioglitazone in all patients.
Danish: Leverenzymer bør checkes forud for igangsættelse af behandling med pioglitazon hos alle patienter.
English: Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets
Danish: Aluminium/aluminium-blisterpakninger, pakninger a 14, 28, 30, 50, 56, 84, 90, 98, 112 og 196 tabletter.
English: Therapy with pioglitazone 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 pioglitazon bør ikke igangsættes hos patienter med forhøjede leverenzymer (ALAT > 2,5 X øvre normal grænse) eller hos patienter med tegn på leversygdom.
English: It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.
Danish: Selvom det er uklart, om der er en direkte sammenhæng mellem pioglitazon og makulaødem, tilrådes læger at være opmærksomme på muligheden for makulaødem i tilfælde, hvor patienter rapporterer forstyrrelser i synsskarpheden.
English: If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked.
Danish: Hvis en patient udvikler symptomer, der tyder på leverfunktionssvigt (disse kan omfatte uforklarlig kvalme, opkastninger, mavesmerter, træthed, anoreksi og/eller mørk urin), så bør leverenzymer checkes.
English: In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and preexisting 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: Allergic reactions have been reported (frequency cannot be estimated from the available data) in patients taking pioglitazone.
Danish: Der er rapporteret om allergiske reaktioner (hyppighed kan ikke vurderes ud fra de tilgængelige data) hos patienter, der tager pioglitazon.
English: This is similar to that seen in a sulphonylurea active comparator group.
Danish: Lignende blev observeret i den sammenlignende gruppe, der fik sulfonylurinstof.
English: Symptomatic and general supportive measures should be taken in case of overdose.
Danish: Tilfælde af overdosering bør behandles symptomatisk med almindelig, understøttende behandling.
English: Pioglitazone should be discontinued if any deterioration in cardiac status occurs.
Danish: Pioglitazon bør seponeres, hvis der opstår en forværring i hjertestatus.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERKORT
English: • The risk of bladder cancer risk and relevant risk minimisation advice.
Danish: • Risikoen for blærecancer og relevant rådgivning om risikominimering.
English: Close monitoring of glycaemic control should be considered (see section 4.4).
Danish: Nøje monitorering af den glykæmiske regulering bør overvejes (se pkt.
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: En kardiovaskulær endepunktsstudie med pioglitazon er udført hos patienter under 75 år med type 2diabetes mellitus og betydende makrovaskulær sygdom.
English: Fertility In animal fertility studies there was no effect on copulation, impregnation or fertility index.
Danish: I dyreforsøg fandt man ingen effekt på kopulation, befrugtning eller fertilitetsindeks.
English: very common fatigue uncommon
Danish: meget almindelig træthed ikke almindelig
English: Therefore, pioglitazone should not be administered to breast-feeding women.
Danish: Pioglitazon bør derfor ikke indgives til ammende kvinder.
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: Dette skyldtes, at pioglitazon mindskede den maternelle hyperinsulinæmi og øgede insulinresistensen, som optræder under graviditet og derved reducerer tilgængeligheden af metaboliske substrater til fostervækst.
English: In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys.
Danish: I toksikologiske forsøg sås plasmavolumenforøgelse med fortynding af blodet, anæmi og reversibel, excentrisk hypertrofi af hjertet, konsistent efter gentagen dosering til mus, rotter, hunde og aber.
English: There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
Danish: Der var en lille reduktion i middel-hæmoglobin (4% relativ reduktion) og hæmatokrit (4,1% relativ reduktion) under behandling med pioglitazon, foreneligt med blodfortynding.
English: Hypoglycaemia may occur in combination with sulphonylureas or insulin.
Danish: Hypoglykæmi kan forekomme i kombination med sulfonylurinstoffer eller insulin.
English: - Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Danish: - Pioglitazon er også indiceret til kombinationsbehandling med insulin hos voksne patienter med type 2-diabetes mellitus, der har utilstrækkelig glykæmisk kontrol med insulin, og for hvem metformin er uhensigtsmæssig på grund af kontraindikationer eller intolerans (se pkt.
English: Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
Danish: Samtidig indgivelse af pioglitazon og sulfonylurinstoffer synes ikke at påvirke sulfonylurinstoffers farmakokinetik.
English: No dose adjustment is necessary for elderly patients (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis hos ældre patienter (se pkt.
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 effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Danish: Effekten af pioglitazon (45 mg monoterapi versus placebo) er blevet undersøgt i et mindre 18 ugers klinisk forsøg hos type 2-diabetikere.
English: common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness - increased appetite
Danish: almindelige (forekommer hos op til 1 ud af 10 patienter) - hovedpine - svimmelhed - ledsmerter - impotens - rygsmerter - kortåndethed - mindre fald i de røde blodlegemer (blodmangel) - luftafgang fra tarmen ikke almindelige (forekommer hos op til 1 ud af 100 patienter) - sukker i urinen, protein i urinen - forhøjede enzymtal - svimmelhed, hvor verden drejer rundt (vertigo) - svedudbrud - træthed
English: In vitro studies have shown no inhibition of any subtype of cytochrome P450.
Danish: In vitro-undersøgelser har ikke vist hæmning af nogen undertype af cytokrom P450.
English: In a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced post prandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised triglycerides.
Danish: I et 20-ugers forsøg reducerede pioglitazon såvel faste triglycerider som postprandial hypertriglyceridæmi gennem en effekt på både absorberede og leversyntetiserede triglycerider.
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: Pioglitazone has been shown to be present in the milk of lactating rats.
Danish: Tilstedeværelse af pioglitazon i mælken hos diegivende rotter er påvist.
English: Blurred vision due to swelling (or fluid) at the back of the eye (frequency cannot be estimated from the available data) has also been reported in patients taking pioglitazone.
Danish: Synsforstyrrelser på grund af hævelse (eller væske) bagest i øjet (hyppigheden kan ikke vurderes ud fra de tilgængelige data) er ligeledes blevet indberettet hos patienter, der tager pioglitazon.
English: In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those ≥65 years compared to 4.0% in patients less than 65 years.
Danish: Hos de patienter, der fik insulin uden pioglitazon, var incidensen af hjertesvigt 8,2 % hos patienter ≥ 65 år og 4,0 % hos patienter under 65 år.
English: Following initiation of therapy with pioglitazone, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Danish: Efter igangsættelse af behandling med pioglitazon anbefales det, at leverenzymer monitoreres med jævne mellemrum baseret på en klinisk vurdering.
English: Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance.
Danish: Det er påvist, at behandling med pioglitazon reducerer leverens glukoseproduktion og forøger den perifere deponering af glukose i tilfælde af insulinresistens.
English: 3 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: 3 I kontrollerede kliniske undersøgelser er hyppigheden af rapporteret hjerteinsufficiens ved pioglitazonbehandling den samme som for placebo-, metformin- og sulfonylurinstof-grupperne, men var forøget ved kombinationsbehandling med insulin.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIGE FOR BATCHFRIGIVELSE
English: Ear and labyrinth disorders vertigo uncommon
Danish: Øre og labyrint vertigo ikke almindelig
English: It is recommended, therefore, that patients treated with pioglitazone undergo periodic monitoring of liver enzymes.
Danish: Det anbefales derfor, at patienter behandlet med pioglitazon med regelmæssige mellemrum får foretaget monitorering af leverenzymer.
English: common common uncommon macular oedema not known not known not known not known not known
Danish: Synsforstyrrelser2 almindelig almindelig ikke almindelig makulaødem ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
English: - metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Danish: - metformin og sulfonylurinstof hos voksne patienter (specielt overvægtige patienter) med utilstrækkelig glykæmisk kontrol på trods af oral kombinationsbehandling med to præparater.
English: Investigations weight increased6 common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon alanine aminotransferase increased7
Danish: almindelig almindelig almindelig almindelig almindelig forhøjet kreatinkinase almindelig forhøjet laktatdehydrogenase ikke almindelig forhøjet alaninaminotransferase7
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 med pioglitazon (se pkt.
English: In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450.
Danish: In vitro-undersøgelser har ikke vist holdepunkter for, at pioglitazon hæmmer nogen undertype af cytokrom P450.
English: The decision whether to continue the patient on therapy with pioglitazone should be guided by clinical judgement pending laboratory evaluations.
Danish: Beslutningen om, hvorvidt patienten skal fortsætte med behandlingen med pioglitazon bør støtte sig til løbende klinisk bedømmelse af laboratorieværdier.
English: Respiratory, thoracic and mediastinal disorders dyspnoea common
Danish: Luftveje, thorax og mediastinum dyspnø almindelig
English: The dose may be increased in increments up to 45 mg once daily.
Danish: Dosis kan øges gradvist op til 45 mg dagligt.
English: - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea as triple oral therapy in combination with
Danish: - metformin hos voksne patienter (specielt overvægtige patienter) med utilstrækkelig glykæmisk kontrol på metformin-monoterapi på trods af maksimalt tolereret metformindosis - sulfonylurinstof hos voksne patienter med utilstrækkelig glykæmisk kontrol på monoterapi med sulfonylurinstof på trods af maksimalt tolereret sulfonylurinstofdosis; dog kun hos patienter, der udviser intolerans over for metformin, eller for hvem metformin er kontraindiceret som trippel oral kombinationsbehandling, sammen med
English: In clinical trials of up to two years duration, pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL cholesterol levels, compared with placebo, metformin or gliclazide.
Danish: I kliniske forsøg af en varighed på op til to år reducerede pioglitazon total plasma triglycerider og frie fedtsyrer og forøgede HDL-kolesterolniveauer sammenlignet med placebo, metformin eller gliclazid.
English: Post marketing cases of peripheral oedema and cardiac failure have also been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors.
Danish: Efter markedsføringen er der også rapporteret om perifere ødemer og hjertesvigt hos patienter, der fik samtidig behandling med pioglitazon og nonsteroide antiinflammatoriske lægemidler, inklusive selektive COX-2-hæmmere.
English: Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking pioglitazone and have also been reported in male patients (frequency cannot be estimated from the available data) taking pioglitazone.
Danish: Knoglebrud har været almindeligt forekommende (forekommer hos op til 1 ud af 10 patienter) hos kvindelige patienter, der tager pioglitazon, og er ligeledes indberettet hos mandlige patienter (hyppighed kan ikke vurderes ud fra de tilgængelige data).
English: You can usually continue to take other medicines whilst you are being treated with Pioglitazone Teva.
Danish: Du kan normalt blive ved med at tage anden medicin, mens du får Pioglitazone Teva.
English: If you experience any of these, talk to your doctor as soon as possible.
Danish: Hvis du oplever nogen af disse symptomer, skal du hurtigst muligt kontakte din læge.
English: Frequency of adverse reactions of pioglitazone by treatment regimen
Danish: Bivirkning Hyppighed af pioglitazons bivirkninger ved forskellige behandlinger
English: This medicine will not affect your ability to drive or use machines but take care if you experience abnormal vision.
Danish: Dette lægemiddel vil ikke påvirke din evne til at køre bil eller arbejde med maskiner.
English: An increased incidence of hyperplasia (males and females) and tumours (males) of the urinary bladder epithelium was apparent in rats treated with pioglitazone for up to 2 years.
Danish: Der sås øget incidens af hyperplasi (hos hanner og hunner) og tumorer (hos hanner) i urinblærens epitel hos rotter behandlet med pioglitazon i op til 2 år.