FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those with reduced cardiac reserve.
Danish: Patienterne bør observeres med henblik på tegn og symptomer på hjerteinsufficiens, vægtøgning og ødem; dette gælder især patienter med nedsat kardiel arbejdskapacitet.
English: If you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor.
Danish: Hvis De tager antiinflammatoriske (betændelseshæmmende) lægemidler, som også kan forårsage væskeophobning og hævelse, skal De også fortælle det til lægen.
English: However, in the case of metformin, in the fed state the mean AUC and Cmax were lower (13% and 28% respectively).
Danish: Hvad angår metformin, nedsatte fødeindtagelse imidlertid middel-AUC og Cmax (henholdsvis 13 % og 28 %).
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes mellitus.
Danish: Den prospektive randomiserede undersøgelse (UKPDS) har påvist langtidsfordele af intensiv blodsukkerkontrol ved type 2-diabetes mellitus.
English: Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered.
Danish: Derfor skal en tæt monitorering af glykæmisk kontrol, dosisjustering inden for den anbefalede dosering og ændringer i diabetesbehandlingen overvejes ved samtidig indgivelse af kationiske lægemidler, der elimineres via tubulær sekretion i nyrerne.
English: In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.
Danish: I kliniske forsøg, der løb over et år, gav Pioglitazon konsekvent en statistisk signifikant reduktion i albumin/kreatinin-forholdet sammenlignet med baseline.
English: After 24 weeks of treatment, the primary endpoint of mean change from baseline in HbA1c was -1.83% in the combination group versus -0.96% in the pioglitazone group (p< 0.0001) and -0.99% in the metformin group (p< 0.0001).
Danish: Efter 24 ugers behandling var det primære endepunkt, middelændring i HbA1c fra baseline, -1,83 % i kombinationsgruppen versus -0,96 % i pioglitazon-gruppen (p < 0,0001) og -0,99 % i metformin-gruppen (p < 0,0001).
English: Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and which can lead to diabetic pre-coma.
Danish: Ketoacidose er en tilstand, hvor såkaldte ketonstoffer ophobes i blodet, hvilket kan føre til diabetisk prækoma.
English: Metformin is contra-indicated
Danish: Metformin er kontraindiceret.
English: The rate of deterioration of HbA1c during the second year was less with pioglitazone than with gliclazide.
Danish: Hastigheden, hvormed forringelsen af HbA1c skete i løbet af det andet år, var lavere med pioglitazon end med gliclazid.
English: If you have reduced kidney function, your doctor may prescribe a lower dose, which may need to be given as separate tablets of pioglitazone and metformin.
Danish: Hvis du har nedsat nyrefunktion, vil lægen eventuelt ordinere en lavere dosis, som eventuelt skal gives som separate tabletter med pioglitazon og metformin.
English: The formation and presence of urinary calculi with subsequent irritation and hyperplasia was postulated as the mechanistic basis for the observed tumourigenic response in the male rat.
Danish: Dannelse og forekomst af nyresten med efterfølgende irritation og hyperplasi blev angivet som det mekanistiske grundlag for det observerede tumorfremkaldende respons hos hanrotter.
English: Pioglitazone effects may be mediated by a reduction of insulin resistance.
Danish: Pioglitazons virkninger kan medieres af en reduktion af insulinresistensen.
English: If ALT levels are increased to 3 x upper limit of normal during Glubrava therapy, liver enzyme levels should be reassessed as soon as possible.
Danish: Hvis ALAT-niveauer øges til 3 x den øvre, normale grænse under Glubrava-behandling, bør leverenzymniveauerne vurderes igen så hurtigt som muligt.
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: Der forventes ikke interaktioner med substanser, der metaboliseres af disse enzymer, f.eks. orale kontraceptiva, ciclosporin, calciumblokkere og HMG-CoA-reduktasehæmmere.
English: Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.
Danish: Fertiliteten hos han- eller hunrotter blev ikke påvirket af metformin ved doser på op til 600 mg pr. kg daglig, hvilket er omkring tre gange den maksimalt anbefalede daglige dosis til mennesker, baseret på sammenligninger af legemsoverflade.
English: The RMP has been updated in accordance.
Danish: Risikostyringsplanen er blevet opdateret i overensstemmelse med dette.
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (> 5 mmol/L) and an increased anion gap and lactate/pyruvate ratio.
Danish: Diagnostiske laboratoriefund er nedsat pH i blodet (< 7,35), forhøjet laktatniveau i blodet (> 5 mmol/l) samt øget anion-gap og laktat/pyruvat-ratio.
English: There are limited amount of data from the use of metformin in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af metformin til gravide kvinder.
English: If 3 to 6 months after starting Glubrava your sugar control is not improved, the medicine should be discontinued.
Danish: Hvis kontrollen med dit blodsukker ikke er forbedret 3-6 måneder efter påbegyndt behandling med Glubrava, skal behandlingen afbrydes.
English: Talk to your doctor for further instructions.
Danish: Kontakt lægen for at få yderligere rådgivning.
English: The following side effects have been experienced by some patients taking Glubrava
Danish: Følgende bivirkninger er forekommet hos patienter, der tog Glubrava
English: However, the incidence of oedema, weight gain and heart failure were increased.
Danish: Forekomsten af ødem, vægtøgning og hjertesvigt var dog øget.
English: Intrinsic clearance is therefore reduced, coupled with a higher unbound fraction of pioglitazone.
Danish: Intrinsic clearance reduceres derfor kombineret med en større ubundet fraktion af pioglitazon.
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: A 24-month 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: Non-clinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Danish: Ikke-kliniske data for metformin viser ingen særlig fare for mennesker på basis af traditionelle studier af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogenicitet og toksicitet i forbindelse med reproduktion.
English: Glubrava is indicated as second line treatment of type 2 diabetes mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Danish: Glubrava er indiceret som andetvalgsbehandling af type 2-diabetes mellitus hos voksne patienter, særligt hos overvægtige patienter, som ikke kan opnå tilstrækkelig glykæmisk kontrol ved deres maksimalt tolererede dosis af oral metformin alene.
English: Pioglitazone and metformin combination
Danish: Kombination af pioglitazon og metformin
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Glubrava before or at the time of the injection.
Danish: Hvis du skal have sprøjtet et kontrastmiddel, som indeholder jod, ind i dit blod, for eksempel i forbindelse med en røntgenundersøgelse eller scanning, skal du stoppe med at tage Glubrava forud for eller på tidspunktet for injektionen.
English: If necessary, the dose of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Danish: Hvis påkrævet, bør dosis af det antidiabetiske lægemiddel justeres under behandling med andre lægemidler og ved denne behandlings ophør.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Glubrava in all subsets of the paediatric population in type 2 diabetes mellitus.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlægge resultaterne af studier med Glubrava i alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Danish: Glukokortikoider (indgivet systemisk og lokalt), beta-2-agonister og diuretika har intern hyperglykæmisk aktivitet.
English: if you have liver disease.
Danish: - hvis De har en leversygdom.
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, symptomgivende koronararteriesygdom eller ældre patienter), bør lægen starte med den laveste dosis, som derefter øges gradvist.
English: As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
Danish: Som en konsekvens af forøget insulinvirkning kan behandling med pioglitazon hos patienter med polycystisk ovariesyndrom måske resultere i fornyet ovulation.
English: Signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate.
Danish: Tegn og symptomer omfatter blod i urinen, smerter ved vandladning eller en pludselig vandladningstrang.
English: Very common (may affect more than 1 in 10 people) - stomach ache - feeling sick (nausea) - vomiting - diarrhoea - loss of appetite
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 behandlede) - mavepine - kvalme - opkastning - diarre - appetitløshed
English: Food had no effect on the AUC and Cmax of pioglitazone when Glubrava was administered to healthy volunteers.
Danish: Fødeindtagelse påvirkede ikke AUC og Cmax for pioglitazon, når Glubrava blev givet til raske frivillige.
English: A large overdose of metformin (or coexisting risks of lactic acidosis) may lead to lactic acidosis which is a medical emergency and must be treated in hospital.
Danish: En stor overdosis metformin (eller samtidig eksisterende risikofaktorer for udvikling af laktacidose) kan føre til laktacidose, som er en kritisk tilstand og skal behandles på hospitalet.
English: Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals.
Danish: Pioglitazon synes at virke via aktivering af specifikke kernereceptorer (peroxisom proliferator-aktiveret receptor gamma), der medfører forøget insulinfølsomhed i lever-, fedt- og skeletmuskelceller hos dyr.
English: EU/1/07/421/001 14 tablets EU/1/07/421/002 28 tablets EU/1/07/421/003 30 tablets EU/1/07/421/004 50 tablets EU/1/07/421/005 56 tablets EU/1/07/421/006 60 tablets EU/1/07/421/007 90 tablets EU/1/07/421/008 98 tablets EU/1/07/421/009 180 tablets
Danish: EU/1/07/421/001 14 tabletter EU/1/07/421/002 28 tabletter EU/1/07/421/003 30 tabletter EU/1/07/421/004 50 tabletter EU/1/07/421/005 56 tabletter EU/1/07/421/006 60 tabletter EU/1/07/421/007 90 tabletter EU/1/07/421/008 98 tabletter EU/1/07/421/009 180 tabletter
English: The most effective method to remove lactate and metformin is haemodialysis.
Danish: Den mest effektive metode til at fjerne laktat og metformin er hæmodialyse.
English: Given the accumulation of data since the implementation of the additional risk minimisation measures, the PRAC agreed with the MAH's proposal to remove the additional risk minimisation measures.
Danish: Som følge af akkumuleringen af data siden gennemførelsen af de yderligere risikominimeringsforanstaltninger tilsluttede PRAC sig forslaget fra indehaveren af markedsføringstilladelsen om at fjerne de yderligere risikominimeringsforanstaltninger.
English: Allergic reactions have been reported with frequency not known (cannot be estimated from the available data) in patients taking Glubrava.
Danish: Der er rapporteret om allergiske reaktioner med ukendt hyppighed (hyppigheden kan ikke vurderes ud fra de tilgængelige data) hos patienter, der tager Glubrava.
English: You may take your tablets with or just after food to reduce the chance of an upset stomach.
Danish: De bør tage tabletterne i forbindelse med et måltid eller umiddelbart efter et måltid for at nedsætte risikoen for maveproblemer.
English: Metabolism and nutrition disorders Vitamin B12 absorption decreased2
Danish: Metabolisme og ernæring nedsat absorption af B12-vitamin2
English: Metformin is excreted unchanged in the urine.
Danish: Biotransformation Metformin udskilles uændret i urinen.
English: Reproductive system and breast disorders erectile dysfunction common
Danish: Det reproduktive system og mammae erektil dysfunktion almindelig
English: Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
Danish: Symptomerne omfatter mavesmerter, hurtig og dyb vejrtrækning og søvnighed, og din ånde kan få en usædvanlig frugtagtig lugt.
English: Kaplan-Meier analysis showed shorter time to treatment failure in patients treated with gliclazide, compared with pioglitazone.
Danish: Kaplan-Meier chanalyse viste kortere tid til behandlingssvigt hos patienter behandlet med gliclazid sammenlignet med pioglitazon.
English: Stop taking Glubrava and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Danish: Stop med at tage Glubrava og kontakt omgående læge eller nærmeste hospital, hvis du får et eller flere af nedenstående symptomer på laktatacidose, da denne tilstand kan føre til koma.
English: 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 genotoksicitetsstudier in vivo og in vitro.
English: Stop taking Glubrava for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Danish: Stop med at tage Glubrava i en kort periode, hvis du har en tilstand, som kan være forbundet med dehydrering (betydeligt tab af kropsvæsker), såsom alvorlig opkastning, diarré, feber, udsættelse for varme eller indtagelse af mindre væske end normalt.
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.
English: Polycystic ovarian syndrome
Danish: Polycystisk ovariesyndrom
English: Dose titration with pioglitazone (added to the optimal dose of metformin) should be considered before the patient is switched to Glubrava.
Danish: Dosistitrering med pioglitazon (som tillægsbehandling til den optimale dosis metformin) skal overvejes, før patienten skifter til Glubrava.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR´erne for glimepirid / pioglitazonhydrochlorid, metformin / pioglitazon, pioglitazon er CHMP nået frem til følgende videnskabelige konklusioner:
English: Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Danish: Efter indgivelse af en dosis på 850 mg sås en 40 % lavere maksimal plasmakoncentration, en 25 % mindskelse i AUC og en forlængelse af tiden, før den maksimale plasmakoncentration opnåedes, på 35 min.
English: Since insulin and pioglitazone are both associated with fluid retention, concomitant administration of insulin and Glubrava may increase the risk of oedema.
Danish: Da insulin og pioglitazon er begge associeret med væskeretention, kan samtidig indgivelse af insulin og Glubrava øge risikoen for ødemer.
English: If you stop taking Glubrava
Danish: Hvis De holder op med at tage Glubrava
English: Glubrava may cause a very rare (may affect up to 1 in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Danish: Glubrava kan forårsage en meget sjælden (kan forekomme hos op til 1 ud af 10.000 brugere), men meget alvorlig bivirkning, der kaldes laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler”).
English: Cationic medicinal products that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Danish: Kationiske lægemidler, som elimineres via tubulær sekretion i nyrerne (f.eks. cimetidin) kan interagere med metformin ved at konkurrere om fælles tubulære transportsystemer i nyrerne.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om Glubrava, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs)) should be initiated with caution in metformin treated patients.
Danish: Lægemidler, som kan medføre akut nedsættelse af nyrefunktionen (såsom antihypertensiva, diuretika og non-steroide antiinflammatoriske lægemidler (NSAID'er)), bør opstartes med forsigtighed hos patienter i behandling med metformin.
English: If jaundice is observed, the medicinal product should be discontinued.
Danish: Hvis der observeres gulsot, bør lægemidlet seponeres.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Glubrava.
Danish: De følgende oplysninger vedrører de farmakokinetiske forhold af de individuelle aktive stoffer i Glubrava.
English: Post-marketing, bone fractures have been reported in both male and female patients (see section 4.4).
Danish: Der er efter markedsføring indberettet knoglefrakturer hos både mandlige og kvindelige patienter (se pkt.
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, acetylsalicylic acid, statins, fibrates).
Danish: Næsten alle patienterne (95 %) var i behandling med kardiovaskulære lægemidler (beta-blokkere, ACE-hæmmere, angiotensin II-antagonister, calciumantagonister, nitrater, diuretika, acetylsalisylsyre, statiner og fibrater).
English: Children and adolescents Use in children and adolescents under 18 years is not recommended.
Danish: Børn og unge Børn og unge under 18 år må normalt ikke få Glubrava.
English: If a patient wishes to become pregnant, treatment with Glubrava should be discontinued.
Danish: Hvis en patient ønsker at blive gravid, skal behandlingen med Glubrava seponeres.
English: As Glubrava contains metformin hydrochloride, it must be discontinued at the time of surgery under general, spinal or epidural anesthesia.
Danish: Da Glubrava indeholder metforminhydrochlorid, skal det seponeres på operationstidspunktet i forbindelse med generel, rygmarvs- eller epiduralbedøvelse.
English: Metformin is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.
Danish: Metformin er kontraindiceret hos patienter med GFR < 30 ml/min, og behandlingen skal afbrydes midlertidigt ved tilstedeværelse af tilstande, der påvirker nyrefunktionen (se pkt.
English: You may also experience a reduction in blood count (anaemia).
Danish: De kan også få blodmangel (anæmi).
English: In animal fertility studies with pioglitazone, there was no effect on copulation, impregnation or fertility index.
Danish: I fertilitetsstudier med pioglitazon hos dyr fandt man ingen effekt på kopulation, befrugtning eller fertilitetsindeks.
English: Glycaemic control should be monitored closely.
Danish: Tæt glykæmisk kontrol er nødvendig.
English: Foetal growth restriction was apparent in animal studies with pioglitazone.
Danish: Forsinket fostervækst var tydelig i dyreforsøg med pioglitazon.
English: Liver enzymes should be checked prior to the initiation of therapy with Glubrava in all patients.
Danish: Leverenzymer bør checkes forud for igangsættelse af behandling med Glubrava hos alle patienter.
English: Patients receiving pioglitazone in dual oral therapy with a sulphonylurea may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea may be necessary.
Danish: Patienter, der er i behandling med pioglitazon i kombination med sulfonylurinstof, kan have risiko for dosisrelateret hypoglykæmi, og det kan være nødvendigt at reducere dosis af sulfonylurinstof.
English: If you need to have major surgery you must stop taking Glubrava during and for some time after the procedure.
Danish: Hvis du skal have en større operation, skal du stoppe med at tage Glubrava under indgrebet og i nogen tid herefter.
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 in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity.
Danish: Lignende ændringer i fedtdistributionen ved behandling med pioglitazon har været fulgt af en forbedret insulinfølsomhed.
English: Microcrystalline cellulose Povidone (K30) Croscarmellose sodium Magnesium stearate
Danish: Mikrokrystallinsk cellulose Povidon (K30) Croscarmellosenatrium Magnesiumstearat
English: Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
Danish: Pioglitazon gennemgår en omfattende metabolisme i leveren ved hydroxylering af alifatiske methylengrupper.