FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with a minor contribution by CYP2C9.
Danish: In vitro-studier har vist, at rosiglitazon primært metaboliseres af CYP2C8 og i mindre omfang af CYP2C9.
English: Rosiglitazone with metformin and sulphonylurea
Danish: Rosiglitazon med metformin og sulfonylurinstof
English: An adjusted mean reduction in HbA1c of 0.24% was seen for patients taking rosiglitazone added to sulphonylurea, versus a reduction in HbA1c of 0.10% for patients taking metformin added to sulphonylurea, (p=0.0083 for treatment difference).
Danish: Hos de patienter, der fik rosiglitazon lagt oven i SU, sås en justeret gennemsnitsreduktion i HbA1c på 0,24 % over for en reduktion i HbA1c på 0,10 % hos de patienter, der fik metformin lagt oven i SU (p = 0,0083 mht. forskel i behandling).
English: Sodium starch glycollate Hypromellose (E464) Microcrystalline cellulose (E460)
Danish: Natriumstivelsesglycolat Hypromellose (E464) Mikrokrystallinsk cellulose (E460) Lactosemonohydrat Povidon (E1201)
English: Packs of 14, 28, 56, 112 (2x56), 168 (3x56) and 180 tablets.
Danish: Pakninger med 14, 28, 56, 112 (2x56), 168 eller 180 tabletter.
English: POSSIBLE SIDE EFFECTS
Danish: Bivirkning
English: In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone.
Danish: I forlængelse af bivirkningsdata, der blev fundet i kliniske undersøgelser, er de data, der blev fundet efter markedsføring af rosiglitazon listet i tabellen nedenfor.
English: The adjudicated primary endpoint was cardiovascular hospitalisation (which included hospitalisations for heart failure) or cardiovascular death.
Danish: Det vigtigste primære endepunkt var kardiovaskulær indlæggelse (herunder med hjerteinsufficiens) og kardiovaskulær død.
English: Î Tell your doctor as soon as possible if you get any of these symptoms.
Danish: Fortæl det til lægen så hurtigt så muligt, hvis du får nogen af disse symptomer.
English: When clinically appropriate, direct change from metformin monotherapy to AVANDAMET may be considered.
Danish: Et direkte skift fra monoterapi med metformin til AVANDAMET kan overvejes, hvis det vurderes klinisk passende.
English: • collapse.
Danish: • kollaps.
English: AVANDAMET dose adjustment within the recommended posology or changes in diabetic treatment should be considered.
Danish: Justering af AVANDAMETdosis inden for den anbefalede dosering eller ændringer i diabetisk behandling bør overvejes (se afsnit 4.5).
English: The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors such as poorly controlled diabetes, ketosis,
Danish: Forekomsten af lactacidose kan og bør reduceres ved også at bedømme andre relaterede risikofaktorer såsom dårligt reguleret diabetes, ketose, længerevarende faste, overdrevet alkoholindtag, leverinsufficiens samt enhver tilstand forbundet med hypoxi.
English: Skin and subcutaneous tissue disorders (see Immune system disorders) angioedema
Danish: Hud og subkutane væv (se Immunsystemet) Angiødem
English: Renal function
Danish: Nyrefunktion
English: Within each system organ class, adverse reactions are presented in the table by decreasing frequency for the rosiglitazone monotherapy treatment regimen.
Danish: Inden for hver organklasse er bivirkninger ved rosiglitazon i monoterapi stillet op efter faldende frekvens.
English: tell your doctor before you take Avandamet.
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE AVANDAMET
English: Î Tell your doctor or pharmacist if any of the side effects listed gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som
English: Your doctor will advise you to stop taking Avandamet before the X-ray and for 48 hours after it.
Danish: Din læge vil vejlede dig til ikke at tage Avandamet i mindst 48 timer før og efter.
English: Tablet core:
Danish: Tabletkerne:
English: • allergic reactions
Danish: • hurtig vægtøgning
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/258/016
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/258/016
English: Eye disorders
Danish: Øjne Maculaødem
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 3 packs, each containing 112 film-coated tablets.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Multipakning omfattende 3 pakninger, hver indeholdende 112 filmovertrukne tabletter.
English: Pruritis
Danish: Knoglelidelser
English: These may affect more than 1 in 10 people:
Danish: Meget almindelige bivirkninger Disse kan påvirke mere end 1 ud af 10 patienter:
English: Hepatobiliary disorders hepatic dysfunction, primarily evidenced by elevated hepatic enzymes5
Danish: Nedsat leverfunktion, primært kommet til udtryk ved forhøjede leverenzymer5
English: Metabolism and nutrition disorders hypercholesterolaemia1 Common hypertriglyceridaemia Common Hyperlipaemia weight increase increased appetite
Danish: Metabolisme og ernæring Hypercholesterolæmi 1
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/258/015
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/258/015
English: These may affect up to 1 in 1,000 people:
Danish: Sjældne bivirkninger Disse kan påvirke op til 1 ud af 1.000 patienter:
English: Iron oxide yellow (E172).
Danish: Gul jernoxid (E172).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ETIKET (MED BLÅ BOKS)
English: Women who are infertile due to a condition affecting their ovaries (such as Polycystic Ovarian Syndrome), may start ovulating again when they start taking Avandamet.
Danish: Kvinder, som er infertile på grund af polycystisk ovariesyndrom, skal være opmærksomme på, at ægløsningen kan blive genebtableret under behandling med Avandamet.
English: The frequency of adverse reactions identified from clinical trial data with rosiglitazone Adverse reaction
Danish: Frekvens af bivirkninger identificeret under kliniske undersøgelser med rosiglitazon Bivirkning
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (56 TABLETS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MELLEMLIGGENDE KARTON (UDEN BLÅ BOKS) KUN MULTIPAKNING (56 TABLETTER)
English: Î Check with your doctor, as Avandamet may not be suitable for you.
Danish: Det er ikke sikkert, at Avandamet er den rigtige behandling til dig.
English: Metformin should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards and only after renal function has been re-evaluated and found to be normal.
Danish: Metformin bør seponeres inden, eller på tidspunktet for undersøgelsen, og ikke genoptages før 48 timer efter.
English: Metformin may act via three mechanisms: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation - by delaying intestinal glucose absorption.
Danish: Metformin kan virke via tre mekanismer: - ved at reducere den hepatiske glucoseproduktion ved hæmning af gluconeogenese og
English: Avandamet 4 mg/1000 mg tablets are pink, marked "gsk" on one side and "4/1000" on the other.
Danish: Avandamet 4 mg/1000 mg tabletter er pink og mærket ”gsk” på den ene side og ”4/1000” på den anden.
English: Packs of 28, 56, 112, 336 (3x112) and 360 tablets.
Danish: Pakninger med 28, 56, 112, 336 eller 360 tabletter.
English: Administration of iodinated contrast agent
Danish: Indgivelse af jodholdigt kontrastmiddel
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (MED BLÅ BOKS) (EKSKLUSIVE MULTIPAKNINGER)
English: INFORMATION IN BRAILLE avandamet 4 mg/1000 mg
Danish: INFORMATION I BRAILLE-SKRIFT avandamet 4 mg/1000 mg
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du vil have yderligere oplysninger om Avandamet, skal du henvende dig til den lokale repræsentant:
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Danish: ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR
English: EU/1/03/258/018, 56 tablets, component of a 168 tablet multipack.
Danish: EU/1/03/258/018, 56 tabletter, del af multipakning med 168 tabletter.
English: INFORMATION IN BRAILLE avandamet 1 mg/500 mg
Danish: INFORMATION I BRAILLE-SKRIFT avandamet 1 mg/500 mg
English: EU/1/03/258/017, 56 tablets, component of a 168 tablet multipack.
Danish: EU/1/03/258/017, 56 tabletter, del af multipakning med 168 tabletter.
English: Taking AVANDAMET with or just after food may reduce gastrointestinal symptoms associated with metformin.
Danish: De gastrointestinale bivirkninger forbundet med metformin kan reduceres, hvis AVANDAMET tages med, eller umiddelbart efter, et måltid.
English: Pink film-coated tablets marked "gsk" on one side and "4/1000" on the other.
Danish: Pink filmovertrukne tabletter mærker ”gsk” på den ene side og ”4/1000” på den anden.
English: Avandamet 2 mg/500 mg tablets are pale pink, marked "gsk" on one side and "2/500" on the other.
Danish: Avandamet 2 mg/500 mg tabletter er lys pink og mærket ”gsk” på den ene side og ”2/500” på den anden.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (3x112 TABLETS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ETIKET (MED BLÅ BOKS) KUN MULTIPAKNING (3X112 TABLETTER)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (112 TABLETS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MELLEMLIGGENDE KARTON (UDEN BLÅ BOKS) KUN MULTIPAKNINGER (112 TABLETTER)
English: Excipients:
Danish: Ældre:
English: What Avandamet contains
Danish: Avandamet indeholder
English: Avandamet 2 mg/1000 mg tablets are yellow, marked "gsk" on one side and "2/1000" on the other.
Danish: Avandamet 2 mg/1000 mg tabletter er gule og mærket ”gsk” på den ene side og ”2/1000” på den anden.
English: INFORMATION IN BRAILLE avandamet 2 mg/500 mg
Danish: INFORMATION I BRAILLE-SKRIFT avandamet 2 mg/500 mg
English: These may affect up to 1 in 10 people:
Danish: Almindelige bivirkninger Disse kan påvirke op til 1 ud af 10 patienter:
English: INFORMATION IN BRAILLE avandamet 2 mg/1000 mg
Danish: INFORMATION I BRAILLE-SKRIFT avandamet 2 mg/1000 mg
English: In their entirety, the available data on the risk of cardiac ischaemia are inconclusive.
Danish: Alt i alt kan der ikke drages nogen konklusion ud fra de foreliggende oplysninger om risikoen for myokardieiskæmi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg of rosiglitazone (as rosiglitazone maleate) and 1000 mg of metformin hydrochloride (corresponding to metformin free base 780 mg).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 4 mg rosiglitazon (som rosiglitazonmealeat) og 1000 mg metforminhydrochlorid (svarende til 780 mg fri metforminbase).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of rosiglitazone (as rosiglitazone maleate) and 500 mg of metformin hydrochloride (corresponding to metformin free base 390 mg).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 2 mg rosiglitazon (som rosiglitazonmealeat) og 500 mg metforminhydrochlorid (svarende til 390 mg fri metforminbase).
English: Skin and subcutaneous disorders urticaria
Danish: Hud og subkutane væv Nældefeber
English: Metformin (background sulphonylurea)
Danish: Metformin (får i forvejen SU)
English: Myocardial Ischaemia
Danish: Myokardieiskæmi
English: ГлаксоСмитКлайн ЕООД Teл.
Danish: България ГлаксоСмитКлайн ЕООД
English: Component of a multipack comprising 3 packs, each containing 112 film-coated tablets.
Danish: Del af multipakning omfattende 3 pakninger, hver indeholdende 112 filmovertrukne tabletter.
English: Česká republika GlaxoSmithKline s.r.o.
Danish: GlaxoSmithKline s.r.o.
English: Use only as directed by your doctor.
Danish: Følg altid lægens anvisninger.
English: Yellow film-coated tablets marked "gsk" on one side and "1/500" on the other.
Danish: Gule filmovertrukne tabletter mærket ”gsk” på den ene side og ”1/500” på den anden.
English: Take special care with Avandamet
Danish: Vær ekstra forsigtig med at tage Avandamet
English: Therefore, due to the metformin active substance, AVANDAMET should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Danish: På grund af indholdet af metformin bør behandlingen med AVANDAMET afbrydes inden, eller på tidspunktet for undersøgelsen, og ikke genoptages før 48 timer efter.
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN AVANDAMET 4 mg/1000 mg filmovertrukne tabletter
English: In addition, an updated RMP should be submitted:
Danish: Yderligere skal en opdateret RMP indsendes: - når ny information, som kan have indflydelse på den gældende sikkerhedsspecifikation,
English: Pale pink film-coated tablets marked "gsk" on one side and "2/500" on the other.
Danish: Svagt pink filmovertrukne tabletter mærker ”gsk” på den ene side og ”2/500” på den anden.
English: Yellow film-coated tablets marked "gsk" on one side and "2/1000" on the other.
Danish: Gule filmovertrukne tabletter mærket ”gsk” på den ene side og ”2/1000” på den anden.
English: • liver doesn't function as well as it should (increase in liver enzymes).
Danish: • nedsat leverfunktion (forhøjede leverenzymer).
English: The most effective method to remove lactate and metformin is haemodialysis, however rosiglitazone is highly protein bound and is not cleared by haemodialysis.
Danish: Den mest effektive behandlingsform er, at fjerne laktat og metformin ved hæmodialyse.
English: Don't stop taking Avandamet
Danish: Hvis du holder op med at tage Avandamet
English: Your kidneys should be checked at least once a year - more often if you are over 65, or if your kidney function is close to abnormal.
Danish: Hvis du er over 65 år, eller hvis din nyrefunktion ikke er helt optimal, skal det gøres oftere.
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN AVANDAMET 1 mg/500 mg filmovertrukne tabletter
English: These may affect up to 1 in 10,000 people:
Danish: Meget sjældne bivirkninger Disse kan påvirke op til 1 ud af 10.000 patienter:
English: • heart failure
Danish: Hjerte Hjerteinsufficiens2
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/500 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN AVANDAMET 2 mg/500 mg filmovertrukne tabletter
English: EU/1/03/258/010 14 tablets EU/1/03/258/011 28 tablets EU/1/03/258/012 56 tablets EU/1/03/258/022 180 tablets
Danish: EU/1/03/258/010 14 tabletter EU/1/03/258/011 28 tabletter EU/1/03/258/012 56 tabletter EU/1/03/258/022 180 tabletter
English: 3 In a retrospective analysis of data from 42 pooled short-term clinical studies, the overall incidence of events typically associated with cardiac ischaemia was higher for rosiglitazone containing regimens, 2.00% versus combined active and placebo comparators, 1.53% [hazard ratio (HR) 1.30 (95% confidence interval (CI) 1.004 - 1.69)].
Danish: Forekomsten var hhv. 2,00 % for rosiglitazon over for 1,53 % for komparatorerne [hazard ratio (HR) 1,30 (95 % konfidensinterval (CI) 1,004 - 1,69)].
English: GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
Danish: KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/1000 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN AVANDAMET 2 mg/1000 mg filmovertrukne tabletter
English: Multipack comprising 3 packs, each containing 56 film-coated tablets.
Danish: Multipakning bestående af 3 pakninger, som hver indeholder 56 filmovertrukne tabletter.
English: - Patients on metformin and sulphonylurea: when appropriate AVANDAMET may be initiated at 4 mg/day rosiglitazone with the dose of metformin substituting that already being taken.
Danish: Oral tripel-kombinationsbehandling (rosiglitazon, metformin og sulfonylurinstof) (se afsnit 4.4) - Patienter, der hidtil har fået metformin og sulfonylurinstof: Hvor det er hensigtsmæssigt kan AVANDAMET-behandlingen påbegyndes med en dosis af rosiglitazon på 4 mg pr. dag og en dosis metformin, som erstatter den dosis, som allerede indtages.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg of rosiglitazone (as maleate) and 500 mg of metformin hydrochloride.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 2 mg rosiglitazon (som maleat) og 500 mg metforminhydrochlorid.
English: EU/1/03/258/007 14 tablets EU/1/03/258/008 28 tablets EU/1/03/258/009 56 tablets EU/1/03/258/021 180 tablets
Danish: EU/1/03/258/007 14 tabletter EU/1/03/258/008 28 tabletter EU/1/03/258/009 56 tabletter EU/1/03/258/021 180 tabletter
English: EU/1/03/258/004 28 tablets EU/1/03/258/005 56 tablets EU/1/03/258/006 112 tablets EU/1/03/258/020 360 tablets
Danish: EU/1/03/258/004 28 tabletter EU/1/03/258/005 56 tabletter EU/1/03/258/006 112 tabletter EU/1/03/258/020 360 tabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 4 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 4 mg rosiglitazon (som maleat) og 1000 mg metforminhydrochlorid.
English: - hypersensitivity to rosiglitazone, to metformin hydrochloride or to any of the excipients - cardiac failure or history of cardiac failure (New York Heart Association (NYHA) stages I to IV) - an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4) - acute or chronic disease which may cause tissue hypoxia such as: - cardiac or respiratory failure - recent myocardial infarction - shock - hepatic impairment - acute alcohol intoxication, alcoholism (see section 4.4) - diabetic ketoacidosis or diabetic pre-coma - renal failure or renal dysfunction e.g. serum creatinine levels > 135 µmol/l in males and > 110 µmol/l in females and/or creatinine clearance < 70 ml/min (see section 4.4) - acute conditions with the potential to alter renal function such as: - dehydration - severe infection - shock - intravascular administration of iodinated contrast agents (see section 4.4) - lactation.
Danish: - nedsat leverfunktion - akut alkoholforgiftning, alkoholisme (se afsnit 4.4) - diabetisk ketoacidose eller diabetisk prækoma - nyresvigt eller nedsat nyrefunktion f.eks. serumkreatinin niveau > 135 µmol/l hos mænd og
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg tablets rosiglitazone/metformin HCl
Danish: LÆGEMIDLETS NAVN AVANDAMET 4 mg/1000 mg tabletter rosiglitazon/metformin HCl
English: General disorders and administration site conditions Oedema
Danish: Almene symptomer og reaktioner på administrationsstedet Ødem
English: Component of a multipack comprising 2 packs, each containing 56 film-coated tablets.
Danish: Del af multipakning omfattende 2 pakninger, hver indeholdende 56 filmovertrukne tabletter.
English: EU/1/03/258/001 28 tablets EU/1/03/258/002 56 tablets EU/1/03/258/003 112 tablets EU/1/03/258/019 360 tablets
Danish: EU/1/03/258/001 28 tabletter EU/1/03/258/002 56 tabletter EU/1/03/258/003 112 tabletter EU/1/03/258/019 360 tabletter
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 1 mg/500 mg tablets rosiglitazone/metformin HCl
Danish: LÆGEMIDLETS NAVN AVANDAMET 1 mg/500 mg tabletter rosiglitazon/metformin HCl
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1 mg of rosiglitazone (as maleate) and 500 mg of metformin hydrochloride.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 1 mg rosiglitazon (som maleat) og 500 mg metforminhydrochlorid.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 2 mg rosiglitazon (som maleat) og 1000 mg metforminhydrochlorid.
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/500 mg tablets rosiglitazone/metformin HCl
Danish: LÆGEMIDLETS NAVN AVANDAMET 2 mg/500 mg tabletter rosiglitazon/metformin HCl
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/1000 mg tablets rosiglitazone/metformin HCl
Danish: LÆGEMIDLETS NAVN AVANDAMET 2 mg/1000 mg tabletter rosiglitazon/metformin HCl
English: Component of a multipack comprising 3 packs, each containing 56 film-coated tablets.
Danish: Del af multipakning omfattende 3 pakninger, hver indeholdende 56 filmovertrukne tabletter.
English: Each tablet contains 1 mg of rosiglitazone (as rosiglitazone maleate) and 500 mg of metformin hydrochloride (corresponding to metformin free base 390 mg).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 1 mg rosiglitazon (som rosiglitazonmaleat) og 500 mg metforminhydrochlorid (svarende til 390 mg fri metforminbase).
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Danish: Hvis du får bivirkninger Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre eller du får
English: PHARMACEUTICAL FORM
Danish: LÆGEMIDLETS NAVN
English: Each tablet contains 2 mg of rosiglitazone (as rosiglitazone maleate) and 1000 mg of metformin hydrochloride (corresponding to metformin free base 780 mg).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 2 mg rosiglitazon (som rosiglitazonmaleat) og 1000 mg metforminhydrochlorid (svarende til 780 mg fri metforminbase).
English: Sulphonylurea (background metformin) Glimepiride*
Danish: SU glimepirid* (får i forvejen metformin)
English: Hepatobiliary disorders liver function disorders
Danish: Lever og galdeveje Nedsat leverfunktion
English: EU/1/03/258/013, 56 tablets, component of a 112 tablet multipack.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/258/013, 56 tabletter, del af multipakning med 112 tabletter.
English: • raised and itchy rash (hives)
Danish: • hævet og kløende udslæt (nældefeber)
English: EU/1/03/258/014, 56 tablets, component of a 112 tablet multipack.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/258/014, 56 tabletter, del af multipakning med 112 tabletter.
English: Very rare skin reactions (e.g. urticaria, pruritis, rash)
Danish: Hudreaktioner (for eksempel nældefeber, kløe, udslæt)
English: What Avandamet looks like and contents of the pack Avandamet 1 mg/500 mg tablets are yellow and marked "gsk" on one side and "1/500" on the other.
Danish: Avandamet 1 mg/500 mg tabletter er gule og mærket ”gsk” på den ene side og ”1/500” på den anden.
English: BEFORE YOU TAKE AVANDAMET
Danish: Hvis du har glemt at tage Avandamet
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Danish: Tel: + 39 (0)45 9218 111
English: cardiac ischaemia3*
Danish: Hjerteiskæmi3*
English: • dizziness
Danish: • knoglebrud
English: Table 3 presents adverse reactions by system organ class and by frequency category.
Danish: Data fra kliniske undersøgelser og post-marketingdata I Tabel 3 er bivirkninger listet under organklasser og absolutte frekvenser.
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 4 mg/1000 mg film-coated tablets rosiglitazone/metformin HCl
Danish: AVANDAMET 4 mg/1000 mg filmovertrukne tabletter rosiglitazon/metformin HCl
English: Content (concentration)
Danish: Indhold (koncentration)
English: MA (EU) number
Danish: MF (EU)nummer
English: 1 vial + 1 syringe + 1 needle + 1 adaptor + 2 alcohol pads
Danish: 1 hætteglas + 1 injektionssprøjte + 1 kanyle + 1 adaptor + 2 spritservietter
English: EU/1/19/1356/001 IDACIO 40 mg/0.8 ml
Danish: 40 mg/0,8 ml
English: Strength Pharmaceutical Form
Danish: (Særnavn) navn Styrke Lægemiddelform Administration Emballage
English: Solution for injection
Danish: Injektionsvæske, opløsning