FrancophonIA/ELRC3.0 huggingface dataset:
English: Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Danish: Din vægt bør checkes med jævne mellemrum; hvis din vægt stiger, underret da din læge.
English: Your doctor will tell you the dose to take.
Danish: Din læge vil fortælle dig hvilken dosis, du skal tage.
English: This is the diabetes that usually develops in adulthood.
Danish: Dette er den diabetesform, der normalt udvikler sig i voksenalderen.
English: However if you miss a dose, just carry on with the next dose as normal.
Danish: Hvis du glemmer en dosis, skal du imidlertid bare fortsætte med den næste dosis som normalt.
English: - if you have blood in your urine that your doctor has not checked.
Danish: - hvis du har blod i urinen, og din læge ikke har undersøgt årsagen.
English: Two-year clinical studies have shown maintenance of this effect.
Danish: Kliniske undersøgelser af en varighed på to år har vist at denne effekt bibeholdes.
English: - if you have a problem with your liver or heart.
Danish: - hvis du har problemer med din lever eller dit hjerte.
English: not known not known not known not known not known
Danish: ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
English: Talk to your doctor before stopping this treatment.
Danish: Tal med lægen, før du stopper behandlingen.
English: The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Danish: Den højeste rapporterede dosis på 120 mg/dag i fire dage og derefter 180 mg/dag i syv dage var ikke associeret med nogle symptomer.
English: Balkanpharma Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria
Danish: Balkanpharma Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgarien
English: - if you have liver disease.
Danish: - hvis du har leversygdom.
English: Do not take a double dose to make up for a forgotten tablet.
Danish: Du må ikke tage en dobbeltdosis som erstatning for glemte enkeltdoser.
English: It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Danish: Det anbefales, at du altid medbringer sukkerknalder, slik, kiks eller sød frugtjuice.
English: Although in very rare cases fatal outcome has been reported, causal relationship has not been established.
Danish: Selvom der i meget sjældne tilfælde har været rapporteret tilfælde med letal udgang, er kausal sammenhæng ikke blevet fastslået.
English: Your blood sugar could fall below the normal level and can be increased by taking sugar.
Danish: Blodsukkeret kan derved falde til under det normale niveau og kan bringes til at stige igen ved indtagelse af sukker.
English: Part of the treatment of diabetes is dietary control.
Danish: En del af diabetesbehandlingen er diætkontrol.
English: - if you retain water (fluid retention) or have heart failure problems, in particular if you are over 75 years old.
Danish: - hvis du har vand i kroppen (ødemer) eller har problemer med hjertesvigt, specielt hvis du er over 75 år.
English: The estimated volume of distribution in humans is 0.25 l/kg.
Danish: Det beregnede fordelingsvolumen hos mennesker er 0,25 1/kg.
English: Special population
Danish: Særlige populationer
English: In some cases weight increase may be a symptom of cardiac failure, therefore weight should be closely monitored.
Danish: I nogle tilfælde kan vægtøgning være et symptom på hjertesvigt, så derfor bør vægten monitoreres nøje.
English: Your doctor will advise you to discontinue this medicine.
Danish: Din læge vil råde dig til at stoppe med at tage denne medicin.
English: - if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss,
Danish: - hvis du har haft diabetisk ketoacidose (en komplikation ved diabetes, der giver hurtigt vægttab,
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: This check may be repeated at intervals.
Danish: Denne kontrol skal måske udføres løbende.
English: The relevance of such a mechanism in humans is unclear and pioglitazone should not be used in pregnancy.
Danish: Relevansen af en sådan mekanisme hos mennesker er uklar, og pioglitazon bør ikke anvendes hos gravide.
English: 2031GA Haarlem Netherlands
Danish: 2031GA Haarlem Holland
English: Merckle GmbH Ludwig-Merckle Strasse 3 89143 Blaubeuren Germany
Danish: Merckle GmbH Ludwig-Merckle Strasse 3 89143 Blaubeuren Tyskland
English: Your doctor will take this into account when treating your diabetes.
Danish: Din læge vil tage dette i betragtning ved planlægning af din behandling.
English: Pioglitazone Teva 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: Pioglitazone Teva hjælper med at kontrollere sukkerniveauet i dit blod, hvis du har type 2-diabetes, ved at hjælpe din krop til bedre at udnytte den insulin, kroppen producerer.
English: Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Danish: Pioglitazon og alle aktive metabolitter har en høj bindingsgrad til plasmaprotein (> 99%).
English: The safety and efficacy of pioglitazone in children and adolescents under 18 years of age have not been established.
Danish: Pioglitazons sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Danish: Næsten halvdelen af patienterne havde tidligere haft en hjerteinfarkt, og omkring 20% havde haft et slagtilfælde.
English: Many of these patients reported concurrent peripheral oedema.
Danish: Mange af disse patienter rapporterede samtidigt perifere ødemer.
English: The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Danish: De rapporterede ødemer var generelt milde til moderate og krævede sædvanligvis ikke seponering af behandlingen.
English: It is not known whether pioglitazone is secreted in human milk.
Danish: Det vides ikke, om pioglitazon udskilles i human mælk.
English: There are no adequate human data to determine the safety of pioglitazone during pregnancy.
Danish: Der foreligger ikke tilstrækkelige data for mennesker til at bedømme sikkerheden af pioglitazon under en graviditet.
English: If ALT levels remain > 3 X the upper limit of normal, therapy should be discontinued.
Danish: Hvis ALAT-niveauer forbliver > 3 X den øvre normale grænse, bør behandlingen seponeres.
English: Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:
Danish: Pioglitazon er indiceret som andet- eller tredjevalgsbehandling af type 2-diabetes mellitus som beskrevet nedenfor:
English: Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Danish: Steady-state-farmakokinetik er ens hos patienter på 65 år og derover og unge personer.
English: If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.
Danish: Hvis dette er relevant for dig, skal du anvende sikker prævention, så du undgår uønsket graviditet.
English: Pioglitazone Teva with food and drink
Danish: Brug af Pioglitazone Teva sammen med mad og drikke
English: Patients should be advised to adhere strictly to a calorie-controlled diet.
Danish: Patienterne bør rådgives med hensyn til nøje at overholde en kaloriekontrolleret diæt.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger via det nationale rapporteringssystem anført i Appendiks V*.
English: Take Pioglitazone Teva daily as prescribed.
Danish: Tag Pioglitazone Teva dagligt som foreskrevet.
English: These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Danish: Disse fund blev observeret i forskellige dyrearter ved plasmakoncentrationer ≤ 4 gange den kliniske udsættelse.
English: Environmental Risk Assessment (ERA): No environmental impact is anticipated from the clinical use of pioglitazone.
Danish: Miljørisikovurdering: Der forventes ingen virkninger på miljøet fra klinisk anvendelse af pioglitazon.
English: - if you have or have ever had bladder cancer.
Danish: kvalme eller opkastning) - hvis du har eller nogensinde har haft blærekræft.
English: This study showed an increase in reports of heart failure, however this did not lead to an increase in mortality in this study.
Danish: Denne studie viste et øget antal rapporter om hjertesvigt, men det førte ikke til en øget dødelighed i studien.
English: You should swallow the tablets with a glass of water.
Danish: Du skal tage tabletterne med et glas vand.
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: Interaktion med præparater, der metaboliseres af disse enzymer, f.eks. orale kontraceptiva, cyclosporin, calciumkanalblokkere og HMGCoA reduktasehæmmere, kan ikke forventes.
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure)
Danish: • Forsigtighed ved brug hos ældre i lyset af aldersbetingede risici (især blærecancer, knoglebrud og hjerteinsufficiens).
English: Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Danish: Efter oral indgivelse af radioaktivt mærket pioglitazon hos mennesker genfandtes den mærkede del hovedsagelig i fæces (55%) og i en mindre mængde i urin (45%).
English: - if you have cysts on your ovaries (polycystic ovary syndrome).
Danish: - hvis du har cyster på æggestokkene (polycystisk ovariesyndrom).
English: Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
Danish: Inden for hver enkelt systemorganklasse er bivirkningerne opstillet efter faldende hyppighed efterfulgt af faldende alvorlighed.
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Teva.
Danish: Der kan være større sandsynlighed for at blive gravid, fordi du kan få ægløsning igen, når du tager Pioglitazone Teva.
English: When Pioglitazone Teva is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Danish: Når Pioglitazone Teva tages sammen med andre lægemidler, der anvendes til behandling af sukkersyge (f.eks. insulin, chlorpropamid, glibenclamid, gliclazid, tolbutamid), vil din læge give dig besked på, om du skal tage en mindre dosis af lægemidlerne.
English: If you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor.
Danish: Hvis du tager antiinflammatoriske (betændelseshæmmende) lægemidler, som også kan forårsage væskeophobning og hævelse, skal du også fortælle det til lægen.
English: Talk to your doctor or pharmacist before taking Pioglitazone Teva (also see section 4)
Danish: Kontakt lægen eller apotekspersonalet, før du tager Pioglitazone Teva (se også punkt 4)
English: not known (frequency cannot be estimated from the available data) - increase in liver enzymes - allergic reactions
Danish: ikke kendt (hyppigheden kan ikke bedømmes ud fra de forhåndenværende data) - forhøjede leverenzymer - allergiske reaktioner
English: Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12506 patients, 0.15%) than in control groups (7 cases from 10212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029).
Danish: Tilfælde af blærecancer blev rapporteret oftere i en metaanalyse af kontrollerede kliniske studier med pioglitazon (19 tilfælde hos 12.506 patienter, 0,15 %) end i kontrolgruppen (7 tilfælde hos 10.212 patienter, 0,07 %), HR=2,64 (95 % CI 1,11-6,31; p=0,029).
English: Glycaemic control should be monitored closely.
Danish: Omhyggelig glykæmisk kontrol er nødvendig.
English: You may also experience a reduction in blood count (anaemia).
Danish: Du kan også få blodmangel (anæmi).
English: In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
Danish: I en dyremodel af familiær adenomatøs polyposis (FAP) behandlet med to andre thiazolidindioner øgedes tumormangfoldigheden i kolon.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: България Тева Фармасютикълс България ЕООД
Danish: Тева Фармасютикълс България ЕООД Teл.
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 and increase the dose gradually.
Danish: Ved behandling af patienter, der har mindst én risikofaktor for udvikling af hjerteinsufficiens (f.eks. tidligere hjerteinfarkt eller symptomgivende koronar arteriel sygdom eller hos ældre), bør lægen starte med den lavest tilgængelige dosis, som derefter øges gradvist.
English: Pioglitazone tablets are taken orally once daily with or without food.
Danish: Pioglitazon-tabletter indtages per os en gang dagligt alene eller i forbindelse med et måltid.
English: Pioglitazone Teva has no or negligible influence on the ability to drive and use machines.
Danish: Pioglitazone Teva påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: No information is available from dialysed patients therefore pioglitazone should not be used in such patients.
Danish: Der er ingen tilgængelige data fra dialysepatienter, og derfor bør pioglitazon ikke anvendes til denne patientkategori.
English: HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity.
Danish: En HOMA analyse viste, at pioglitazon forbedrer beta-cellefunktionen samt øger insulinfølsomheden.
English: Kaplan-Meier analysis showed shorter time to treatment failure in patients treated with gliclazide, compared with pioglitazone.
Danish: Kaplan-Meier analyse viste kortere tid til behandlingssvigt hos patienter behandlet med gliclazid sammenlignet med pioglitazon.
English: If patients report hypoglycaemia, the dose of insulin should be decreased.
Danish: Hvis patienter oplever hypoglykæmi, bør insulin dosis nedsættes.
English: Pioglitazone
Danish: Pioglitazon
English: If ALT levels are increased to 3 X upper limit of normal during pioglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Danish: Hvis ALAT-niveauer øges til 3 X den øvre normale grænse under pioglitazonbehandling, bør leverenzymniveauer vurderes igen så hurtigt som muligt.
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 glykæmisk kontrol (defineret som HbA1c < 8,0%) opretholdt hos 69% af patienterne behandlet med pioglitazon sammenlignet med 50% af patienterne behandlet med gliclazid.
English: The European Medicines Agency has waived the obligation to submit the results of studies with pioglitazone in all subsets of the paediatric population in Type 2 Diabetes Mellitus.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med pioglitazon hos alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: Package leaflet: Information for the user Pioglitazone Teva 15 mg tablets
Danish: Indlægsseddel: Information til brugeren Pioglitazone Teva 15 mg tabletter
English: Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Teva.
Danish: Din læge vil bede dig om at få taget blodprøver periodevis, mens du er i behandling med Pioglitazone Teva.
English: If you take Pioglitazone Teva with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Danish: Hvis du tager Pioglitazone Teva sammen med anden diabetesmedicin, er der en større risiko for, at dit blodsukker falder til under det normale niveau (hypoglykæmi).
English: The rate of deterioration of HbA1c during the second year was less with pioglitazone than with gliclazide.
Danish: Hastigheden, hvorved forringelsen af HbA1c i løbet af det andet år skete, var lavere med pioglitazon end med gliclazid.
English: The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Danish: Hyppigheden af ødemer i de sammenlignende grupper (sulfonylurinstof, metformin) var 2-5%.
English: Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Danish: Dosisjustering af pioglitazon inden for det anbefalede område eller ændringer i diabetesbehandlingen bør overvejes (se pkt.
English: No increase in mortality from heart failure was observed.
Danish: Der sås ingen øgning i dødeligheden som følge af hjertesvigt.
English: The other side effects that have been experienced by some patients taking pioglitazone are:
Danish: Andre bivirkninger, der forekommet hos nogle patienter, der tog pioglitazon, er:
English: Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily.
Danish: Behandling med pioglitazon kan initieres med 15 mg eller 30 mg én gang dagligt.
English: It is an anti-diabetic medicine used to treat type 2 (noninsulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work adequately.
Danish: Det er en antidiabetisk medicin, der anvendes til behandling af type 2-diabetes mellitus (ikke-insulinkrævende sukkersyge) hos voksne, når metformin ikke er egnet eller ikke har haft tilstrækkelig virkning.
English: However, certain medicines are especially likely to affect the amount of sugar in your blood: - gemfibrozil (used to lower cholesterol) - rifampicin (used to treat tuberculosis and other infections) Tell your doctor or pharmacist if you are taking any of these.
Danish: Visse typer medicin er dog særlig tilbøjelige til at påvirke mængden af pioglitazon i blodet: - gemfibrozil (til at sænke kolesteroltallet) - rifampicin (mod tuberkulose og andre infektioner) Fortæl det til lægen eller på apoteket, hvis du får et af disse lægemidler.
English: Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin.
Danish: Interaktionsundersøgelser har vist, at pioglitazon ikke har nogen relevant effekt på hverken farmakokinetik eller farmakodynamik af digoxin, warfarin, phenprocoumon og metformin.
English: Pioglitazone was devoid of genotoxic potential in a comprehensive battery of in vivo and in vitro genotoxicity assays.
Danish: Pioglitazon var uden genotoksisk potentiale ved et omfattende batteri af genotoksicitetsundersøgelser in vivo og in vitro.
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 as soon as possible.
Danish: Hvis du får en alvorlig allergisk reaktion, herunder nældefeber og hævelse af ansigtet, læber, tunge eller svælg, der kan forårsage vejrtræknings- eller synkebesvær, skal du afbryde behandlingen og kontakte en læge så hurtigt som muligt.
English: Before you start taking Pioglitazone Teva you will have a blood sample taken to check your liver function.
Danish: Før du begynder at tage Pioglitazone Teva, vil du få taget en blodprøve til kontrol af leverfunktionen.
English: - if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).
Danish: - hvis du lider af en særlig diabetisk øjenlidelse, som hedder makulaødem (væskeansamling i det bagerste af øjet).
English: Your doctor may increase the dose to a maximum of 45 mg once a day.
Danish: Din læge kan øge dosis til maksimalt 45 mg en gang daglig.
English: Brampton Road, Hampden Park, Eastbourne, East Sussex - BN22 9AG United Kingdom
Danish: Brampton Road, Hampden Park, Eastbourne East Sussex - BN22 9AG Storbritannien
English: This medicine does not require any special storage precautions.
Danish: Denne medicin kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: If you are following a special diet for diabetes, you should continue with this while you are taking Pioglitazone Teva.
Danish: Hvis du følger en særlig diæt på grund af din diabetes, skal du fortsætte med denne diæt, mens du tager Pioglitazone Teva.
English: Carmellose calcium Hydroxypropylcellulose Magnesium stearate
Danish: Carmellosecalcium Hydroxypropylcellulose Magnesiumstearat
English: - The active substance is pioglitazone.
Danish: - Aktivt stof: pioglitazon.
English: No dose adjustment is necessary in patients with impaired renal function (creatinine clearance > 4 ml/min) (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion (kreatininclearance > 4 ml/min) (se pkt.
English: 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets 112 tablets 196 tablets
Danish: 14 tabletter 28 tabletter 30 tabletter 50 tabletter 56 tabletter 84 tabletter 90 tabletter 98 tabletter 112 tabletter 196 tabletter
English: 5 Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
Danish: 5 Der blev rapporteret ødemer hos 6-9% af patienterne, der blev behandlet i et år med pioglitazon i kontrollerede kliniske studier.
English: In combination with insulin, the current insulin dose can be continued upon initiation of pioglitazone therapy.
Danish: I kombination med insulin kan den aktuelle insulindosis fortsættes efter pioglitazonbehandlingen er påbegyndt.
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 P450-isoenzymer 1A, 2C8/9 og 3A4 hos mennesket.
English: Symptoms are unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Danish: Symptomerne er usædvanlig åndenød, hurtig vægtstigning eller lokale væskeansamlinger (ødemer).
English: If you stop using Pioglitazone Teva, your blood sugar may go up.
Danish: Hvis du holder op med at tage Pioglitazone Teva, kan dit blodsukker stige.
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Danish: Næsten alle patienterne (95%) var i behandling med lægemidler for kardiovaskulær sygdom (betablokkere, ACEhæmmere, angiotensin II-antagonister, calciumantagonister, nitrater, diuretika, acetylsalisylsyre, statiner og fibrater).
English: However, the incidences of oedema, weight gain and heart failure were increased.
Danish: Forekomsten af ødem, vægtøgning og hjertesvigt var dog øget.
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 indgift måske øge risikoen for ødemer.
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 samtidigt.