FrancophonIA/ELRC3.0 huggingface dataset:
English: Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Danish: - Pioglitazon er også indiceret til kombinationsbehandling med insulin hos voksne patienter med type 2-diabetes mellitus, der har utilstrækkelig glykæmisk kontrol med insulin, og for hvem metformin er uhensigtsmæssig på grund af kontraindikationer eller intolerans (se pkt.
English: The other side effects that have been experienced by some patients when Pioglitazone Accord is taken with other antidiabetic medicines:
Danish: Andre bivirkninger, der er forekommet hos nogle patienter, når de har taget Pioglitazone Accord sammen med anden medicin mod diabetes:
English: The other side effects that have been experienced by some patients taking Pioglitazone Accord are:
Danish: Andre bivirkninger, der er forekommet hos nogle patienter, når de har taget Pioglitazone Accord:
English: Blurred vision due to swelling (or fluid) at the back of the eye (frequency cannot be estimated from the available data) has also been reported in patients taking Pioglitazone Accord.
Danish: Synsforstyrrelser på grund af hævelse (eller væske) bagest i øjet (hyppigheden kan ikke vurderes ud fra de tilgængelige data) er ligeledes blevet indberettet hos patienter, der tager Pioglitazone Accord.
English: Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Pioglitazone Accord and have also been reported in male patients (frequency cannot be estimated from the available data) taking Pioglitazone Accord.
Danish: Knoglebrud har været almindeligt forekommende (kan påvirke op til 1 ud af 10 behandlede) hos kvindelige patienter, der tager Pioglitazone Accord, og er også rapporteret hos mandlige patienter (hyppigheden kan ikke anslås ud fra de foreliggende oplysninger), der tager Pioglitazone Accord.
English: Pioglitazone Accord 15 mg tablets: 3 years Pioglitazone Accord 30 mg/ 45 mg tablets: 4 years
Danish: Pioglitazone Accord 15 mg tabletter: 3 år Pioglitazone Accord 30 mg/ 45 mg tabletter: 4 år.
English: Pioglitazone Accord 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 Accord-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: Pioglitazone Accord contains pioglitazone.
Danish: Pioglitazone Accord indeholder pioglitazon.
English: The usual starting dose is one tablet of 15 mg or of 30 mg of pioglitazone to be taken once daily.
Danish: Den sædvanlige startdosis er 1 tablet på 15 mg eller 30 mg pioglitazon en gang daglig.
English: Your blood sugar will be checked, and your dose of Pioglitazone Accord may need to be changed.
Danish: De vil få kontrolleret blodsukkeret for at se, om De skal have ændret dosis af Pioglitazone Accord.
English: What Pioglitazone Accord contains
Danish: Pioglitazone Accord indeholder
English: Pioglitazone Accord is available in Aluminium/Aluminium blister packs containing 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.
Danish: Pioglitazone Accord fås i aluminium/aluminium-blisterpakninger a 14, 28, 30, 50, 56, 84, 90, 98, 112 eller 196 tabletter.
English: Also contains lactose monohydrate.
Danish: Indeholder lactosemonohydrat.
English: Accord Healthcare Limited Sage House,
Danish: Accord Healthcare Limited
English: If you forget to take Pioglitazone Accord
Danish: Hvis De har glemt at tage Pioglitazone Accord
English: as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is in appropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
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 som oral kombinationsbehandling, sammen med - metformin hos voksne patienter (specielt overvægtige patienter) med utilstrækkelig glykæmisk kontrol på metformin-monoterapi på trods af maksimalt tolereret metformindosis - sulfonylurinstof hos voksne patienter med utilstrækkelig glykæmisk kontrol på monoterapi med sulfonylurinstof på trods af maksimalt tolereret sulfonylurinstofdosis; dog kun hos patienter, der udviser intolerans over for metformin, eller for hvem metformin er kontraindiceret som trippel oral kombinationsbehandling, sammen med - metformin og sulfonylurinstof hos voksne patienter (specielt overvægtige patienter) med utilstrækkelig glykæmisk kontrol på trods af oral kombinationsbehandling med to præparater.
English: METHOD AND ROUTE (S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: If you take more Pioglitazone Accord than you should If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Danish: Hvis De har taget for meget Pioglitazone Accord Kontakt lægen, skadestuen eller apoteket, hvis De ved en fejltagelse har taget for mange tabletter, eller hvis en anden eller et barn tager Deres medicin.
English: common common uncommon macular oedema not known not known not known not known not known
Danish: Øjne synsforstyrrelser2 almindelig almindelig ikke almindelig makulaødem ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
English: Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Danish: Der er rapporteret om hjerteinsufficiens under anvendelse af pioglitazon post-marketing og hyppigere, når pioglitazon bruges i kombinationsbehandling med insulin og hos patienter med tidligere hjerteinsufficiens.
English: Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets
Danish: Pioglitazone Accord 15 mg tabletter Pioglitazone Accord 30 mg tabletter Pioglitazone Accord 45 mg tabletter
English: What you need to know before you take Pioglitazone Accord
Danish: Det skal De vide, før De begynder at tage Pioglitazone Accord
English: If you get any side effects, talk to your doctor, pharmacist.
Danish: Hvis De oplever bivirkninger, bør de tale med Deres læge.
English: Carmellose calcium Hydroxypropyl cellulose Lactose monohydrate Magnesium stearate
Danish: Carmellosecalcium Hydroxypropylcellulose Lactosemonohydrat Magnesiumstearat
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Accord 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 Accord og insulin samtidig.
English: STATEMENT OF ACTIVE SUBSTANCE (S)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
English: common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness
Danish: - let nedsat antal røde blodlegemer (blodmangel) - luftafgang fra tarmen ikke almindelige (kan påvirke op til 1 ud af 100 behandlede) - sukker i urinen, protein i urinen - forhøjede enzymtal - svimmelhed, hvor det føles, som om verden drejer rundt (vertigo) - svedudbrud - træthed - øget appetit
English: Combination with with sulpho with with insulin therapy metformin nylurea metformin and sulphonylurea
Danish: Kombinationsbehandling med metformin med sulfonylurea med metformin og sulfonylurea med insulin
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: Der er rapporter om, at samtidig administration af pioglitazon og rifampicin (en inducer af CYP2C8) har resulteret i en 54% nedsættelse af AUC for pioglitazon.
English: Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking Pioglitazone Accord in combination with insulin.
Danish: Hjertesvigt har været almindeligt forekommende (kan påvirke op til 1 ud af 10 behandlede) hos patienter, der tager Pioglitazone Accord i kombination med insulin.
English: common common common common common blood creatine phosphokinase increased common increased lactic dehydrogenase uncommon alanine aminotransferase increased 7
Danish: almindelig almindelig almindelig almindelig almindelig forhøjet kreatinkinase almindelig forhøjet laktatdehydrogenase ikke almindelig aminotransferase7 ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
English: Your doctor will check whether Pioglitazone Accord is working 3 to 6 months after you start taking it.
Danish: Når De har taget Pioglitazone Accord i 3-6 måneder, vil Deres læge undersøge, om medicinen virker.
English: Localised swelling (oedema) has also been experienced very commonly (may affect more than 1 in 10 people) in patients taking Pioglitazone Accord in combination with insulin.
Danish: Lokale væskeansamlinger (ødemer) har ligeledes været meget almindeligt forekommende (kan påvirke flere end 1 ud af 10 behandlede) hos patienter, der tager Pioglitazone Accord i kombination med insulin.
English: Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Pioglitazone Accord.
Danish: Blærekræft forekommer med hyppigheden "ikke almindelig" (kan påvirke op til 1 ud af 100 behandlede) hos patienter, der tager Pioglitazone Accord.
English: If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.
Danish: Søg hurtigst muligt læge, hvis De oplever nogle af disse bivirkninger, især hvis De er over 65°år.
English: If you have the impression that the effect of Pioglitazone Accord is too weak, talk to your doctor.
Danish: Tal med lægen, hvis De har indtryk af, at effekten af Pioglitazone Accord er for svag.
English: • The other ingredients are lactose monohydrate, carmellose calcium, hydroxypropyl cellulose (E
Danish: Øvrige indholdsstoffer: lactosemonohydrat, carmellosecalcium, hydroxypropylcellulose (E465) og magnesiumstearat (E572).
English: 319 Pinner Road, North Harrow,
Danish: Sage House, 319 Pinner Road, North Harrow, HA1 4HF, Middlesex Storbritannien
English: - hypersensitivity to the active substance or to any of the excipients listed in 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
Danish: hjerteinsufficiens eller hjerteinsufficiens i anamnesen (NYHA-klasse I til IV) nedsat leverfunktion diabetisk ketoacidose blærecancer i anamnesen ikke udredt makroskopisk hæmaturi
English: How to take Pioglitazone Accord
Danish: Sådan skal De tage Pioglitazone Accord
English: EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister)
Danish: EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 tabletter i alu/alu-blister) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 tabletter i alu/alu-blister) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 tabletter i alu/alu-blister)
English: Pioglitazone Accord 45 mg tablets
Danish: Pioglitazone Accord 45 mg tabletter
English: Each tablet contains 74.46 mg of lactose monohydrate (see section 4.4).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 74,46 mg lactosemonohydrat (se pkt.
English: Pioglitazone Accord 30 mg tablets
Danish: Pioglitazone Accord 30 mg tabletter
English: Pioglitazone Accord 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Danish: Pioglitazone Accord 15 mg tabletter Hver tablet indeholder 15 mg pioglitazon (som hydrochlorid).
English: Pioglitazone Accord 15 mg tablets
Danish: Pioglitazone Accord 15 mg tabletter
English: Each tablet contains 111.70 mg of lactose monohydrate (see section 4.4).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 111,70 mg lactosemonohydrat (se pkt.
English: • Pioglitazone Accord 15 mg tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P' on one side and ‘15' on other side.
Danish: Pioglitazone Accord 15 mg tabletter er hvide til offwhite, runde, bikonvekse tabletter uden overtræk, mærket med ‘P' på den ene side og ‘15' på den anden side.
English: • Pioglitazone Accord 45 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘45' on the other side.
Danish: Pioglitazone Accord 45 mg tabletter er er hvide til offwhite, flade, runde tabletter uden overtræk, præget med ‘PIO' på den ene side og ‘45' på den anden side.
English: Pioglitazone Accord 30 mg tablets Pioglitazone
Danish: Pioglitazone Accord 30 mg tabletter Pioglitazon
English: NAME OF THE MEDICINAL PRODUCT Pioglitazone Accord 45 mg tablets
Danish: LÆGEMIDLETS NAVN Pioglitazone Accord 45 mg tabletter Pioglitazon
English: NAME OF THE MEDICINAL PRODUCT Pioglitazone Accord 15 mg tablets
Danish: LÆGEMIDLETS NAVN Pioglitazone Accord 15 mg tabletter Pioglitazon
English: • Pioglitazone Accord 30 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘30' on the other side.
Danish: Pioglitazone Accord 30 mg tabletter er hvide til offwhite, flade, runde tabletter uden overtræk, præget med ‘PIO' på den ene side og ‘30' på den anden side.
English: The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘45' on the other side.
Danish: Tabletterne er hvide til offwhite, flade, runde tabletter uden overtræk, præget med ‘PIO' på den ene side og ‘45' på den anden side.
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet ødemer5
English: • The active substance in Pioglitazone Accord is pioglitazone.
Danish: Aktivt stof: pioglitazon.
English: The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘30' on the other side.
Danish: Tabletterne er hvide til offwhite, flade, runde tabletter uden overtræk, præget med ‘PIO' på den ene side og ‘30' på den anden side.
English: • Each Pioglitazone Accord 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Danish: Hver Pioglitazone Accord 30 mg tablet indeholder 30 mg pioglitazon (som hydrochlorid).
English: The tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P' on one side and ‘15' on other side.
Danish: Tabletterne er hvide til offwhite, runde, bikonvekse, uden overtræk, præget med ‘P' på den ene side og ‘15' på den anden side.
English: Each tablet contains 37.24 mg of lactose monohydrate (see section 4.4).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 37,24 mg lactosemonohydrat (se pkt.
English: What Pioglitazone Accord is and what it is used for What you need to know before you take Pioglitazone Accord How to take Pioglitazone Accord Possible side effects
Danish: Det skal De vide, før De begynder at tage Pioglitazone Accord Sådan skal De tage Pioglitazone Accord Bivirkninger
English: • Each Pioglitazone Accord 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Danish: Hver Pioglitazone Accord 45 mg tablet indeholder 45 mg pioglitazon (som hydrochlorid).
English: EU/1/11/722/021 14 tablets EU/1/11/722/022 28 tablets EU/1/11/722/023 30 tablets EU/1/11/722/024 50 tablets EU/1/11/722/025 56 tablets EU/1/11/722/026 84 tablets EU/1/11/722/027 90 tablets EU/1/11/722/028 98 tablets EU/1/11/722/029 112 tablets EU/1/11/722/030 196 tablets
Danish: EU/1/11/722/021 14 tabletter EU/1/11/722/022 28 tabletter EU/1/11/722/023 30 tabletter EU/1/11/722/024 50 tabletter EU/1/11/722/025 56 tabletter EU/1/11/722/026 84 tabletter EU/1/11/722/027 90 tabletter EU/1/11/722/028 98 tabletter EU/1/11/722/029 112 tabletter EU/1/11/722/030 196 tabletter
English: EU/1/11/722/001 14 tablets EU/1/11/722/002 28 tablets EU/1/11/722/003 30 tablets EU/1/11/722/004 50 tablets EU/1/11/722/005 56 tablets EU/1/11/722/006 84 tablets EU/1/11/722/007 90 tablets EU/1/11/722/008 98 tablets EU/1/11/722/009 112 tablets EU/1/11/722/010 196 tablets
Danish: EU/1/11/722/001 14 tabletter EU/1/11/722/002 28 tabletter EU/1/11/722/003 30 tabletter EU/1/11/722/004 50 tabletter EU/1/11/722/005 56 tabletter EU/1/11/722/006 84 tabletter EU/1/11/722/007 90 tabletter EU/1/11/722/008 98 tabletter EU/1/11/722/009 112 tabletter EU/1/11/722/010 196 tabletter
English: Tell your doctor or pharmacist if you are taking,have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: - Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: EU/1/11/722/011 14 tablets EU/1/11/722/012 28 tablets EU/1/11/722/013 30 tablets EU/1/11/722/014 50 tablets EU/1/11/722/015 56 tablets EU/1/11/722/016 84 tablets EU/1/11/722/017 90 tablets EU/1/11/722/018 98 tablets EU/1/11/722/019 112 tablets EU/1/11/722/020 196 tablets
Danish: EU/1/11/722/011 14 tabletter EU/1/11/722/012 28 tabletter EU/1/11/722/013 30 tabletter EU/1/11/722/014 50 tabletter EU/1/11/722/015 56 tabletter EU/1/11/722/016 84 tabletter EU/1/11/722/017 90 tabletter EU/1/11/722/018 98 tabletter EU/1/11/722/019 112 tabletter EU/1/11/722/020 196 tabletter
English: • Each Pioglitazone Accord 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Danish: Hver Pioglitazone Accord 15 mg tablet indeholder 15 mg pioglitazon (som hydrochlorid).
English: Pioglitazone Accord contains lactose monohydrate If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Pioglitazone Accord.
Danish: Kontakt lægen, før De tager denne medicin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: Your doctor will give you Ivozall once every day for 5 days.
Danish: Din læge vil give dig Ivozall en gang daglig i 5 dage.
English: Estimates based on other analysis
Danish: Estimater baseret på anden analyse
English: Patients who met each of the following criteria:
Danish: Patienter, som overholder alle de følgende kriterier:
English: If you (or your child) weigh less than 20 kg, the infusion time may be longer.
Danish: Hvis du (eller dit barn) vejer under 20 kg, kan infusionstiden være længere.
English: > 24 hours
Danish: > 24 timer
English: This is usually reversible and appears to be dose-dependent.
Danish: Denne er normalt reversibel og synes at være dosisafhængig.
English: Best Response
Danish: Bedste respons
English: Talk to your doctor about contraception.
Danish: Tal med din læge om prævention.
English: PR = Partial remission
Danish: PR = Partiel remission
English: Concentrate (ml)*
Danish: Koncentrat (ml)*
English: Estimates based on noncompartmental analysis (n = 14 / n = 14)
Danish: Estimater baseret på nonkompartmental analyse (n = 14 / n = 14)
English: (There are no exposure data in rabbits.)
Danish: (Der forligger ingen data efter eksponering af kaniner).
English: Ivozall contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU.
Danish: Ivozall indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i EU.
English: Other exfoliative conditions have also been reported.
Danish: Andre eksfoliative tilstande er også blevet indberettet.
English: Because of the way this medicine works, it will affect your blood and other organs.
Danish: På grund af lægemidlets virkemåde påvirker det blodet og andre organer.
English: However, there are no known clinically significant interactions with other medicinal products or laboratory tests.
Danish: Der er dog ikke kendskab til klinisk betydningsfulde interaktioner med andre lægemidler eller laboratorieundersøgelser.
English: Ivozall may harm both male and female reproductive organs.
Danish: Ivozall kan skade både mandlige og kvindelige kønsorganer.
English: The liver is a potential target organ for toxicity.
Danish: Leveren er et muligt organ for toksicitet.
English: 5.2 hours
Danish: 5,2 timer
English: Therefore, Ivozall should not be used during pregnancy, especially not during the first trimester, unless clearly necessary (i.e. only if the potential benefit to the mother outweighs the risk to the foetus).
Danish: Ivozall bør derfor ikke anvendes under graviditet, og især ikke i løbet af det første trimester, med mindre det er klart nødvendigt (dvs. kun hvis den potentielle fordel for moderen opvejer den potentielle risiko for fostret).
English: Frequency not known: C. difficile colitis
Danish: Ikke kendt: C. difficile colitis
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør lægemidlet bruges med det samme.
English: The infusion will be given over 2 hours.
Danish: Infusionen varer 2 timer.
English: * = see below **All adverse reactions occurring at least twice (i.e., 2 or more reactions (1.7%)) are included in this table
Danish: * = se nedenfor **Alle bivirkninger forekom mindst to gange (dvs. 2 eller flere reaktioner (1,7 %)) er medtaget i denne tabel
English: Individual duration remission and survival data for patients who achieved CR or CRp
Danish: Individuel varighed af remission og overlevelsesdata for patienter, der opnåede CR eller CRp
English: As a result, it is not expected to affect the metabolism of active substances which are known substrates for these enzymes.
Danish: Følgelig forventes stoffet ikke at påvirke metabolismen af aktive stoffer, som er kendte substrater for disse enzymer.
English: See the section ‘Pregnancy and breast-feeding' below.
Danish: Se afsnittet ‘Graviditet og amning' nedenfor.
English: After 24 hours, about 60% of the dose is excreted unchanged in the urine.
Danish: Efter 24 timer er omkring 60 % udskilt uomdannet med urinen.
English: Volume of distribution (steady state)
Danish: Fordeling: Fordelingsvolumen (steady-state)
English: The reference medicine for Ivozall has been authorised under ‘exceptional circumstances'.
Danish: Referencelægemidlet for Ivozall er godkendt under "særlige vilkår".”.
English: No specific antidotal therapy exists.
Danish: Der findes intet specifikt antidot.
English: Grade 3 or 4 elevated creatinine occurred in 8% of patients.
Danish: Forhøjet kreatinin grad 3 eller 4 opstod hos 8 % af patienterne.
English: Adults (> 21 and < 65 years old)
Danish: Voksne (> 21 og < 65 år)
English: Overall remission (CR + CRp)
Danish: Total remission (CR + CRp)
English: CR = Complete remission
Danish: CR = Komplet remission
English: Acute lymphoblastic leukaemia is caused by abnormal growth of some types of white blood cells.
Danish: Akut lymfoid leukæmi skyldes abnorm vækst af visse typer hvide blodlegemer.
English: Adverse reactions reported during the post-marketing period are also included in the table under the frequency category “not known” (cannot be estimated from the available data).
Danish: Bivirkninger, der er indberettet i tiden efter markedsføring af produktet, er inkluderet i tabellen med hyppigheden “ikke kendt” (kan ikke estimeres ud fra forhåndenværende data).