FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.
Danish: Inden distribution af ordineringsvejledning i hvert medlemsland skal indehaveren af markedsføringstilladelsen sammen med den nationale lægemiddelmyndighed godkende indhold og format af uddannelsesmaterialet sammen med en kommunikationsplan.
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, ciclosporin, calciumkanalblokkere og HMGCoA reduktasehæmmere, kan ikke forventes.
English: If ALT levels remain > 3 times the upper limit of normal, therapy should be discontinued.
Danish: Hvis ALAT-niveauer forbliver >3 X den øvre normale grænse, bør behandlingen seponeres.
English: Blister packs (OPA/Al/PVC-Al foil): 14, 28, 30, 56, 60, 90 and 98 tablets in a box.
Danish: Blisterpakninger (OPA/Al/PVC-Al-folie): 14, 28, 30, 56, 60, 90 og 98 tabletter i en æske.
English: There may be an increased possibility of your becoming pregnant because you may ovulate again when you take Pioglitazone Krka.
Danish: Der kan være større sandsynlighed for at du bliver gravid, fordi du kan få ægløsning igen, når du tager Pioglitazone Krka.
English: Use in children and adolescents Use in children under 18 years is not recommended.
Danish: Brug til børn og unge Brug til børn under 18 år frarådes.
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: Dette studie viste et øget antal rapporter om hjertesvigt, men det medførte imidlertid ikke til en øget dødelighed i studiet.
English: - The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
Danish: - Uddannelsesmaterialet til lægerne skal indeholde: produktresuméet, indlægssedlen og en ordinationsvejledning.
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: If you take Pioglitazone Krka 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 Krka sammen med anden diabetesmedicin, er der en større risiko for, at dit blodsukker falder til under det normale niveau (hypoglykæmi).
English: The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone.
Danish: Indehaveren af markedsføringstilladelsen skal sørge for undervisningsmateriale til alle læger, som forventes at ordinere/anvende pioglitazon.
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 graviditet.
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: If ALT levels are increased to 3 times the 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: If you are following a diabetic diet, you should continue with this while you are taking Pioglitazone Krka.
Danish: Hvis du følger en diabetesdiæt, skal du fortsætte med denne, mens du tager Pioglitazone Krka.
English: A 24month mechanistic study in male rats demonstrated that administration of pioglitazone resulted in an increased incidence of hyperplastic changes in the bladder.
Danish: Et 24-måneders mekanistisk forsøg med hanrotter viste, at administration af pioglitazon medførte en øget incidens af hyperplastiske forandringer i blæren.
English: - if you have heart failure or have had heart failure in the past.
Danish: - hvis du lider af hjertesvigt eller tidligere har haft hjertesvigt.
English: If you stop using Pioglitazone Krka tablets, your blood sugar may go up.
Danish: Hvis du holder op med at tage Pioglitazone Krka tabletter, kan dit blodsukker stige.
English: very common (may affect more than 1 in 10 people) - decreased blood sugar (hypoglycaemia)
Danish: meget almindelige (kan påvirke flere end 1 ud af 10 personer) - lavt blodsukker (hypoglykæmi)
English: Approximately one third of patients were receiving insulin in combination with metformin and/or a sulphonylurea.
Danish: Omkring en tredjedel af patienterne fik insulin i kombination med metformin og/eller et sulfonylurinstof.
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: Before you start taking Pioglitazone Krka you will have a blood sample taken to check your liver function.
Danish: Før du begynder at tage Pioglitazone Krka, vil du få taget en blodprøve til kontrol af leverfunktionen.
English: Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Krka.
Danish: Din læge vil bede dig om at få taget blodprøver periodevis, mens du er i behandling med Pioglitazone Krka.
English: Oedema was reported in 6 - 9% of patients treated with pioglitazone over one year in controlled clinical trials.
Danish: Der blev rapporteret ødemer hos 6-9% af patienterne, der blev behandlet i et år med pioglitazon i kontrollerede kliniske undersøgelser.
English: However if you miss a dose, just carry on with the next dose as normal.Do not take a double dose to make up for a forgotten tablet.
Danish: Hvis du glemmer en dosis, skal du imidlertid bare fortsætte med den næste dosis som normalt.
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, ACE-hæmmere, angiotensin II-antagonister, calciumantagonister, nitrater, diuretika, acetylsalicylsyre, statiner og fibrater).
English: Pioglitazone has no or negligible influence on the ability to drive and use machines.
Danish: Pioglitazon påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
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 cytochrom P450, 1A, 2C8/9 og 3A4.
English: When Pioglitazone Krka 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 Krka 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: The tablets are available in boxes of 14, 28, 30, 56, 60, 90 and 98 tablets in blisters.
Danish: Tabletterne leveres i blisterpakninger med à 14, 28, 30, 56, 60, 90 og 98 tabletter.
English: There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Danish: Der har været sjældne rapporter vedrørende hepatocellulær funktionssvigt under post-marketing undersøgelser (se pkt.
English: - Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).
Danish: - Forsigtighed ved anvendelse til ældre set i lyset af aldersrelaterede risici (især blærecancer,
English: Allergic reactions have been reported (frequency not known) in patients taking Pioglitazone Krka.
Danish: Der er rapporteret om allergiske reaktioner (hyppighed ikke kendt) hos patienter, der tager Pioglitazone Krka.
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 tegn og symptomer på hjerteinsufficiens, vægtøgning og ødemer, når pioglitazon bruges i kombination med insulin.
English: The safety and efficacy of pioglitazone in children and adolescents under 18 years of age have not been established.
Danish: Pioglitazon sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
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: 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 cytochrom P450.
English: Pioglitazone tablets are taken orally once daily with or without food.
Danish: Pioglitazon-tabletter indtages per os én gang dagligt alene eller i forbindelse med et måltid.
English: Pioglitazone Krka 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 sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Danish: Pioglitazone Krka 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 sulfonylurinstof eller insulin), hvis disse ikke har været i stand til at kontrollere blodsukkeret tilstrækkeligt.
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: Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 times the 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: What Pioglitazone Krka contains - The active substance is pioglitazone.
Danish: Pioglitazone Krka indeholder: - Aktivt stof: pioglitazon.
English: Blurred vision due to swelling (or fluid) at the back of the eye (frequency not known) has also been reported in patients taking Pioglitazone Krka.
Danish: Synsforstyrrelser på grund af hævelse (eller væske) bagest i øjet (hyppigheden er ukendt) er ligeledes blevet indberettet hos patienter, der tager Pioglitazone Krka.
English: It is an anti-diabetic medicine used to treat type 2 (noninsulin dependent) diabetes mellitus, when metformin is not suitable or has failed to work adequately.
Danish: Det er medicin mod sukkersyge og anvendes til behandling af type 2-diabetes mellitus (ikke-insulinkrævende sukkersyge), når metformin ikke er egnet eller ikke har haft tilstrækkelig virkning.
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: In animal fertility studies there was no effect on copulation, impregnation or fertility index.
Danish: I dyreforsøg dyr fandt man ingen effekt på kopulation, befrugtning eller fertilitetsindeks.
English: - The risk bladder cancer and relevant risk minimisation advice.
Danish: - Risikoen for blærecancer og relevante anvisninger for risikominimering.
English: - The risk of heart failure and relevant risk minimisation advice.
Danish: - Risikoen for hjertesvigt og relevante anvisninger for risikominimering.
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 cytochrom P450.
English: Date of first authorisation: 21 March 2012 Date of latest renewal: DD month YYYY
Danish: Dato for første markedsføringstilladelse: 21/3/2012 Dato for seneste fornyelse:
English: Frequencies are defined as: - Very common ( 1/10) - Common ( 1/100 to < 1/10) - Uncommon ( 1/1,000 to < 1/100) - Rare ( 1/10,000 to < 1/1,000) - Very rare (< 1/10,000) - Not known (cannot be estimated from the available data)
Danish: Hyppighederne er defineret som: Hyppighederne er defineret som: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
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 langtidskardiovaskulære følgevirkninger med hensyn til brug af pioglitazon.
English: This leaflet was last revised in <MM/YYYY>
Danish: Denne indlægsseddel blev senest ændret { MM/ÅÅÅÅ }
English: Take Pioglitazone Krka tablets daily as prescribed.
Danish: Tag Pioglitazone Krka dagligt som foreskrevet.
English: Pioglitazone Krka tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
Danish: Pioglitazone Krka-tabletter indeholder lactosemonohydrat og bør derfor ikke anvendes til patienter med arvelig fructoseintolerans, galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
English: You can usually continue to take other medicines whilst you are being treated with Pioglitazone Krka.
Danish: Du kan normalt fortsætte med at tage anden medicin, mens du får Pioglitazone Krka.
English: The other side effects that have been experienced by some patients when Pioglitazone Krka is taken with other antidiabetic medicines are:
Danish: Andre bivirkninger, der er forekommet hos nogle patienter, når de har taget Pioglitazone Krka sammen med anden medicin mod diabetes:
English: Pioglitazone Krka contains pioglitazone.
Danish: Pioglitazone Krka indeholder pioglitazon.
English: Pioglitazone Krka with food and drink You may take your tablets with or without food.
Danish: Brug af Pioglitazone Krka sammen med mad og drikke Du kan tage dine tabletter i forbindelse med et måltid, men det er ikke nødvendigt.
English: Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator.
Danish: Der blev observeret frakturer hos 2,6% af de kvinder, der blev behandlet med pioglitazon, sammenlignet med 1,7% af de kvinder, der blev behandlet med komparator.
English: Localised swelling (oedema) has also been experienced very commonly in patients taking Pioglitazone Krka in combination with insulin.
Danish: Lokale væskeansamlinger (ødemer) har ligeledes været meget almindeligt forekommende hos patienter, der tager Pioglitazone Krka i kombination med insulin.
English: Your blood sugar will be checked, and your dose of Pioglitazone Krka may need to be changed.
Danish: Du vil få kontrolleret blodsukkeret og det kan være, at du skal have ændret din dosis af Pioglitazone Krka.
English: Do not take Pioglitazone Krka: - if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Pioglitazone Krka - hvis du er allergisk over for pioglitazon eller et af de øvrige indholdsstoffer i Pioglitazone Krka.
English: Frequency of adverse reactions of pioglitazone by treatment regimen
Danish: Bivirkninger Hyppighed af pioglitazons bivirkninger ved forskellige behandlinger
English: A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Danish: Et studie med pioglitazon med kardiovaskulær endepunkt er udført hos patienter under 75 år med type 2diabetes mellitus og betydende makrovaskulær sygdom.
English: Proportional increases of the plasma concentration were observed for doses from 2 - 60 mg.
Danish: Proportionale stigninger i plasmakoncentrationen sås for doser fra 2-60 mg. Steady-state opnås efter 4-7 dages dosering.
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: as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;
Danish: som monoterapi: - hos voksne patienter (specielt overvægtige patienter), der er utilstrækkeligt reguleret via diæt og motion, og for hvem metformin ikke er velegnet på grund af kontraindikationer eller intolerans.
English: Lactose monohydrate Hydroxypropylcellulose (E463) Croscarmellose sodium Magnesium stearate (E572)
Danish: Lactosemonohydrat Hydroxypropylcellulose (E463) Croscarmellosenatrium Magnesiumstearat (E572)
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 findes på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Excipient with known effect: Each tablet contains 88.83 mg of lactose (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 88,83 mg lactose (se pkt.
English: - Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in 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: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Danish: Brug ikke Pioglitazone Krka efter den udløbsdato, der står på blisterpakningen og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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: Excipient with known effect: Each tablet contains 176.46 mg of lactose (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 176,46 mg lactose (se pkt.
English: Management Symptomatic and general supportive measures should be taken in case of overdose.
Danish: Behandling Tilfælde af overdosering bør behandles symptomatisk med almindelig understøttende behandling.
English: Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon
Danish: Nervesystemet hypoæstesi almindelig almindelig almindelig almindelig almindelig hovedpine almindelig ikke almindelig svimmelhed almindelig insomni ikke almindelig ikke almindelig ikke almindelig ikke almindelig ikke almindelig
English: - Very common ( 1/10) - Common ( 1/100 to < 1/10) - Uncommon ( 1/1,000 to < 1/100) - Rare ( 1/10,000 to < 1/1,000) - Very rare (< 1/10,000) - Not known (cannot be estimated from the available data)
Danish: Hyppighederne er defineret som: meget almindelig (≥1/10); - almindelig (≥1/100 til <1/10); - ikke almindelig (≥1/1.000 til <1/100); - sjælden (≥1/10.000 til <1/1.000); - meget sjælden (<1/10.000); - ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Krka and insulin experienced the development of heart failure.
Danish: Nogle patienter, som har haft type 2-diabetes i mange år og samtidig har hjertesygdom, eller som har haft et slagtilfælde, har udviklet hjertesvigt, når de blev behandlet med Pioglitazone Krka og insulin samtidig.
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 i HbA1c på 0,45% sammenlignet med de patienter, der fortsatte med insulin alene, samtidig sås en reduktion af insulin dosis hos de pioglitazon behandlede.
English: One tablet should be taken once daily.
Danish: Den sædvanlige dosis er 1 tablet én gang daglig.
English: Combination with sulphonylurea with metformin and sulphonylurea with insulin
Danish: Kombinationsbehandling med sulfonylurea med metformin og sulfonylurea med insulin
English: Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking Pioglitazone Krka in combination with insulin.
Danish: Hjertesvigt har været almindeligt forekommende (kan påvirke op til 1 ud af 10 personer) hos patienter, der tager Pioglitazone Krka i kombination med insulin.
English: Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
Danish: Samtidig inddgivelse af pioglitazon og sulfonylurinstoffer synes ikke at påvirke sulfonylurinstoffers farmakokinetik.