FrancophonIA/ELRC3.0 huggingface dataset:
English: On the basis of the scientific conclusions for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone is unchanged subject to the proposed changes to the product information.
Danish: Begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne å baggrund af de videnskabelige konklusioner for glimepirid / pioglitazonhydrochlorid, metformin / pioglitazon, pioglitazon er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder glimepirid / pioglitazonhydrochlorid, metformin / pioglitazon, pioglitazon, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: 1 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
Danish: Efter markedsføring er der rapporteret om overfølsomhedsreaktioner hos patienter behandlet med pioglitazon.
English: This can lead to a risk of hyperglycaemia (high blood sugar level): - rifampicin (to treat tuberculosis and other infections) - glucocorticoids (to treat allergies and inflammation) - beta-2-agonists (to treat asthma) - medicines which increase urine production (diuretics, to treat high blood pressure)
Danish: Dette kan medføre en risiko for hyperglykæmi (højt blodsukker): - rifampicin (til behandling af tuberkulose og andre infektioner) - glukokortikoider (til behandling af allergier og inflammation) - beta-2-agonister (til behandling af astma) - vanddrivende lægemidler (diuretika, til behandling af højt blodtryk)
English: The decision whether to continue the patient on therapy with Glubrava should be guided by clinical judgement pending laboratory evaluations.
Danish: Beslutningen om, hvorvidt patienten skal fortsætte med behandlingen med Glubrava, bør støtte sig til en løbende klinisk bedømmelse af laboratorieværdierne.
English: The risk of fractures should be considered in the long term care of patients treated with pioglitazone (see section 4.8).
Danish: Man skal være opmærksom på risikoen for frakturer ved den langsigtede pleje af patienter, som har fået behandling med pioglitazon (se pkt.
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 De oplever tegn på hjertesvigt såsom usædvanlig åndenød, hurtig vægtstigning eller lokale væskeansamlinger (ødemer).
English: De uts chland Takeda GmbH Tel: 0800 825 3325 medinfo@takeda.de
Danish: Deutschland Takeda GmbH Tel: 0800 825 3325 medinfo@takeda.de
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD05.
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, kombinationspræparater, ATC-kode: A10BD05.
English: Glubrava is not recommended in women of childbearing potential not using contraception.
Danish: Glubrava må ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: Physicians should start treatment with the lowest available dose and increase the dose gradually, particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and cardiac failure).
Danish: Lægen bør starte behandlingen med den laveste dosis og øge dosis gradvist, særligt når pioglitazon anvendes i kombination med insulin (se pkt.
English: Any macroscopic haematuria should be investigated before starting pioglitazone therapy.
Danish: Enhver form for makroskopisk hæmaturi bør undersøges før opstart af behandling med pioglitazon.
English: The other ingredients are microcrystalline cellulose, povidone (K30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide (E171).
Danish: magnesiumstearat, hypromellose, macrogol 8000, talcum og titandioxid (E171).
English: This can lead to a risk of hypoglycaemia (low blood sugar): - gemfibrozil (to lower high cholesterol level) - angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists (to treat high blood pressure) - cimetidine (to reduce stomach acid)
Danish: Dette kan medføre en risiko for hypoglykæmi (lavt blodsukker): - gemfibrozil (til at sænke et højt kolesterolniveau) - angiotensin-konverterende enzym (ACE)-hæmmere og angiotensin II-receptorantagonister (til behandling af for højt blodtryk) - cimetidin (til behandling af for meget mavesyre)
English: The improved glycaemic control is associated with a reduction in both fasting and postprandial plasma insulin concentrations.
Danish: Den forbedrede blodsukkerregulering er associeret med en reduktion af både fastende og postprandiale insulinkoncentrationer i plasma.
English: 2 Long term treatment of metformin has been associated with a decrease of vitamin B12 absorption with decrease of serum levels.
Danish: 2Langtidsbehandling med metformin har været forbundet med nedsat absorption af cyanocobalamin med nedsatte serumniveauer.
English: If you have any further questions, ask your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller på apoteket.
English: Localised swelling (oedema) has also been experienced commonly (may affect up to 1 in 10 people) in patients taking Glubrava in combination with insulin.
Danish: Lokal hævelse (ødem) er også forekommet almindeligt (kan ramme op til 1 ud af 10 behandlede) hos patienter, der tager Glubrava sammen med insulin.
English: Ne de rland Takeda Nederland bv Tel: +31 23 56 68 777
Danish: Nederland Takeda Nederland bv Tel: +31 23 56 68 777
English: Unite d Kingdom Takeda UK Ltd Tel: +44 (0)1628 537 900
Danish: United Kingdom Takeda UK Ltd Tel: +44 (0)1628 537 900
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, 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, ACE-hæmmere, angiotensin II-receptorantagonister og diuretika, især loop-diuretika.
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: The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
Danish: Risikoen for at udvikle laktatacidose er også forhøjet ved dårligt kontrolleret diabetes, alvorlige infektioner, længerevarende faste eller alkoholindtagelse, dehydrering (væskemangel - se yderligere oplysninger nedenfor), leverproblemer og enhver tilstand med nedsat iltforsyning til en legemsdel (såsom akut alvorlig hjertesygdom).
English: if you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see section “Risk of lactic acidosis”) or ketoacidosis.
Danish: - hvis du har dårligt kontrolleret diabetes, der eksempelvis er ledsaget af alvorlig hyperglykæmi (højt blodsukker), kvalme, opkastning, diarré, hurtigt vægttab, laktatacidose (se afsnittet ”Risiko for laktatacidose”) eller ketoacidose.
English: Hypoglycae mia
Danish: Hypoglykæmi
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 glucoseproduktion og forøger den perifere deponering af glucose i tilfælde af insulinresistens.
English: This medicine has been prescribed for you only.
Danish: - Lægen har ordineret dette lægemiddel til Dem personligt.
English: In case of dehydration (severe diarrhoea or vomiting, fever, heat, reduced fluid intake), Glubrava 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 Glubrava behandlingen afbrydes midlertidigt, og at det anbefales, at de kontakter en læge.
English: Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Danish: Det bør overvejes at dosisjustere pioglitazon inden for det anbefalede område eller at ændre diabetesbehandlingen (se pkt.
English: Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Glubrava and have also been reported in male patients (frequency cannot be estimated from the available data) taking Glubrava.
Danish: Knoglebrud er rapporteret som almindelige (kan ramme op til 1 ud af 10 behandlede) hos kvindelige patienter, der tager Glubrava, og er ligeledes indberettet hos mandlige patienter (hyppighed kan ikke vurderes ud fra de tilgængelige data).
English: 5 Isolated reports: liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.
Danish: Isolerede rapporter: Anormale leverfunktionstest eller hepatitis, der forsvinder ved seponering af metformin.
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Danish: Der er efter markedsføringen blevet rapporteret om nye udbrud eller forværring af diabetisk makulært ødem med nedsat synsevne med thiazolidinedioner, herunder pioglitazon.
English: Takeda GmbH Podružnica Slovenija Tel:+ 386 (0) 59 082 480
Danish: Takeda GmbH Podružnica Slovenija Te:.+ 386 (0) 59 082 480
English: Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Danish: Pioglitazon skal bruges med forsigtighed ved samtidig administration af CYP2C8-hæmmere (f.eks. gemfibrozil) eller -induktorer (f.eks. rifampicin).
English: The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
Danish: Den observerede overhyppighed af frakturer hos pioglitazonbehandlede kvinder i dette datasæt er derfor 0,8 frakturer pr. 100 patientår.
English: Bladder cancer
Danish: Blærecancer
English: Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see sections 4.3 and 4.5).
Danish: Andre risikofaktorer for laktatacidose omfatter stort alkoholforbrug, leverinsufficiens, utilstrækkeligt kontrolleret diabetes, ketose, langvarig faste og enhver tilstand forbundet med hypoksi samt samtidig brug af lægemidler, der kan forårsage laktatacidose (se pkt.
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, der var blevet behandlet med pioglitazon i op til 2 år.
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 leverenzymerne kontrolleres.
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 non-steroide antiinflammatoriske lægemidler, inklusive selektive COX-2-hæmmere.
English: Studies of pioglitazone in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg med pioglitazon har påvist reproduktionstoksicitet (se pkt.
English: The observed excess risk of fractures for women on pioglitazone in this study is therefore 0.5 fractures per 100 patient years of use.
Danish: Den observerede øgede risiko for frakturer hos kvinder, som fik pioglitazon i dette forsøg, er derfor 0,5 frakturer pr. 100 patientårs brug.
English: Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Danish: Studier hos mennesker tyder ikke på induktion af de vigtigste inducerbare CYP1A, CYP2C8/9 og CYP3A4.
English: Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked.
Danish: Kontakt lægen hurtigst muligt, hvis De får symptomer, som kan tyde på leverproblemer (såsom uforklarlig kvalme, opkastning, mavepine, træthed, appetitløshed og/eller mørk urin), da Deres leverfunktion bør tjekkes.
English: In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included insulin.
Danish: I et outcome-forsøg med patienter med betydende makrovaskulær sygdom var hyppigheden af alvorlig hjerteinsufficiens ved kombinationsbehandling med insulin 1,6 % højere med pioglitazon end med placebo.
English: if you have a problem with your liver.
Danish: - hvis De har leverproblemer.
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.
English: Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with GFR < 60 mL/min.
Danish: 4.4), skal gennemgås, inden påbegyndelse af metforminbehandling overvejes hos patienter med GFR < 60 ml/min.
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: I 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: Dietary acidification significantly decreased but did not abolish the incidence of tumours.
Danish: Tilsætning af syre til kosten reducerede tumorincidensen signifikant, men eliminerede ikke tumordannelse helt.
English: Glubrava 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 Glubrava Deres krop med bedre at udnytte den insulin, kroppen producerer.
English: There was no tumourigenic response in mice of either sex. Hyperplasia of the urinary bladder was not seen in dogs or monkeys treated with pioglitazone for up to 12 months.
Danish: Hyperplasi af urinblæren sås ikke hos hunde eller aber, der var blevet behandlet med pioglitazon i op til 12 måneder.
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: The recommended dose of Glubrava is 30 mg/day pioglitazone plus 1,700 mg/day of metformin hydrochloride (this dose is achievable with one tablet of Glubrava 15 mg/850 mg, taken twice a day).
Danish: Voksne med normal nyrefunktion (GFR ≥ 90 ml/min) Den anbefalede dosis af Glubrava er 30 mg pioglitazon dagligt plus 1.700 mg metforminhydrochlorid dagligt (denne dosis opnås med én Glubrava tablet med 15 mg/850 mg 2 gange dagligt).
English: If you experience this side effect, talk to your doctor as soon as possible.
Danish: Hvis De oplever denne bivirkning, skal De tale med Deres læge så hurtigt, som muligt.
English: No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Danish: Der sås ingen øget hyppighed af frakturer hos mænd, der blev behandlet med pioglitazon (1,7 %) sammenlignet med komparator (2,1 %).
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting treatment with a NSAID.
Danish: Eksempler på sådanne situationer er, når der indledes antihypertensiv behandling eller diuretisk behandling, og ved opstart af behandling med en NSAID.
English: No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Danish: Der sås ingen øget hyppighed af frakturer hos mænd, der blev behandlet med pioglitazon (1,3 %) sammenlignet med komparator (1,5 %).
English: Takeda Pharma A/S Tlf: +45 46 77 11 11
Danish: Danmark Takeda Pharma A/S Tlf: +45 46 77 11 11
English: Luxe mbourg/Luxemburg Takeda Belgium Tél/Tel: +32 2 464 06 11 Takeda-belgium@takeda.com
Danish: Luxembourg/Luxemburg Takeda Belgium Tél/Tel: +32 2 464 06 11 takeda-belgium@takeda.com
English: Nervous system disorders hypo-aesthesia common common insomnia uncommon uncommon headache common taste disturbance common common
Danish: Nervesystemet hypæstesi almindelig almindelig insomni ikke almindelig ikke almindelig hovedpine almindelig smagsforstyrelser almindelig almindelig
English: Slove nská re publika Takeda Pharmaceuticals Slovakia s.r.o.
Danish: Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o.
English: There have been rare reports of elevated liver enzymes and hepatocellular dysfunction during post-marketing experience with pioglitazone (see section 4.8).
Danish: Der har været sjældne rapporter om forhøjede leverenzymer og hepatocellulær dysfunktion af pioglitazon post marketing (se pkt.
English: The relevance to humans of the tumourigenic findings in the male rat cannot be excluded.
Danish: Det kan ikke udelukkes, at påvisning af tumordannelse hos hanrotter har relevans for mennesker.
English: Very rare - decrease in amount of vitamin B12 in the blood - redness of the skin - itchy skin - raised and itchy rash (hives)
Danish: Meget sjældne - nedsat indhold af cyanocobalamin (vitamin B12) i blodet - hudrødme - hudkløe - hævet og kløende udslæt (nældefeber)
English: This type 2 diabetes usually develops in adulthood particularly as a result of the person being overweight and where the body either does not produce enough insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it produces.
Danish: Kroppen producerer ikke tilstrækkeligt insulin (et hormon, som kontrollerer blodsukkerniveauet), eller kroppen udnytter ikke den insulin, den producerer, tilstrækkeligt effektivt.
English: Single dose studies demonstrate linearity of pharmacokinetics in the therapeutic dose range.
Danish: Linearitet/non-linearitet Enkeldosisforsøg har påvist linearitet af farmakokinetikken i det terapeutiske dosisinterval.
English: Common weight gain headache respiratory infection abnormal vision joint pain impotence blood in urine reduction in blood count (anaemia) numbness taste disturbance
Danish: Almindelige - vægtstigning - hovedpine - infektion i luftvejene - synsforstyrrelser - ledsmerter - impotens - blod i urinen - blodmangel (anæmi) - følelsesløshed - smagsforstyrrelser
English: If a pregnancy occurs, treatment with Glubrava should be discontinued.
Danish: Hvis en patient bliver gravid, skal behandlingen med Glubrava seponeres.
English: When clinically appropriate, direct change from metformin monotherapy to Glubrava may be considered.
Danish: Et direkte skift fra metformin monoterapi til Glubrava kan overvejes, hvis det vurderes klinisk hensigtsmæssigt.
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 Deres evne til at køre bil eller arbejde med maskiner.
English: Clinical trials have been conducted with Glubrava tablets and co-administered pioglitazone and metformin (see section 5.1).
Danish: Der er udført kliniske forsøg med både Glubravatabletter og samtidig administration af pioglitazon og metformin (se pkt.
English: In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450.
Danish: In vitro-studier har ikke vist holdepunkter for, at pioglitazon hæmmer nogen CYP-undertyper.
English: Mean levels of liver enzymes decreased with treatment with pioglitazone.
Danish: De gennemsnitlige niveauer af leverenzymer faldt ved behandling med pioglitazon.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin together experienced the development of heart failure.
Danish: Nogle patienter, som har haft type 2-diabetes mellitus i mange år og samtidig har hjertesygdom eller har haft et slagtilfælde, har udviklet hjertesvigt, når de blev behandlet med pioglitazon og insulin samtidig.
English: If you wish to become pregnant, your doctor will advise you to discontinue this medicine.
Danish: Deres læge vil råde Dem til at stoppe med at tage dette lægemiddel, hvis De bliver gravid.
English: Symptoms of lactic acidosis include: vomiting stomach ache (abdominal pain) muscle cramps a general feeling of not being well with severe tiredness difficulty in breathing reduced body temperature and heartbeat
Danish: Symptomerne på laktatacidose omfatter: - opkastning - mavesmerter - muskelkramper - almen utilpashed med udpræget træthed - vejrtrækningsbesvær - nedsat kropstemperatur og langsommere puls
English: The following medicines can increase the blood sugar lowering effect of Glubrava.
Danish: Følgende typer medicin kan forstærke Glubravas blodsukkersænkende effekt.
English: 56 tablets
Danish: 56 tabletter
English: Not known - inflammation of the liver (hepatitis) - liver does not work as well as it should (changes in liver enzymes)
Danish: Ikke kendt - leverbetændelse (hepatitis) - nedsat leverfunktion (ændringer i leverenzymværdier)
English: 45-59 Maximum daily dose is 2,000 mg The starting dose is at most half of the maximum dose.
Danish: Den maksimale daglige dosis er 2.000 mg Startdosis er højst halvdelen af den maksimale dosis.
English: The following medicines may decrease the blood sugar lowering effect of Glubrava.
Danish: Følgende typer medicin kan svække Glubravas blodsukkersænkende effekt.
English: Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Danish: Samtidig administration af pioglitazon og rifampicin (en CYP2C8-induktor) er rapporteret at resultere i en nedsættelse af AUC for pioglitazon på 54 %.
English: Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Danish: Hvis vægten stiger, skal De underrette Deres læge.