FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose adjustment for patients taking strong CYP3A inhibitors In patients taking strong CYP3A inhibitors (see section 4.5), tolvaptan doses have to be reduced as follows:
Danish: Dosisjustering for patienter, der tager stærke CYP3A-hæmmere Hos patienter, der tager stærke CYP3A-hæmmere (se pkt.
English: Acute hepatic failure
Danish: • akut leversvigt
English: • Volume depletion
Danish: • Volumendepletering.
English: Jinarc 60 mg tablets + Jinarc 30 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets.
Danish: Jinarc 60 mg tabletter + Jinarc 30 mg tabletter: blistre med eller uden etui med 14 (7 tabletter i den højeste styrke + 7 tabletter i den laveste styrke), 28 (14 tabletter i den højeste styrke + 14 tabletter i den laveste styrke) eller 56 (28 tabletter i den højeste styrke + 28 tabletter i den laveste styrke) tabletter.
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets EU/1/15/1000/008-010 (blister) EU/1/15/1000/017-019 (blister in wallet card)
Danish: Jinarc 30 mg tabletter + Jinarc 60 mg tabletter EU/1/15/1000/008-010 (blister) EU/1/15/1000/017-019 (blister i etui)
English: 15 mg tablet: blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Danish: 15 mg tablet: blå, trekantet (større akse: 6,58 mm, mindre akse: 6,20 mm), flad, konveks, præget med “OTSUKA” og “15” på den ene side.
English: Jinarc 90 mg tablets + Jinarc 30 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets.
Danish: Jinarc 90 mg tabletter + Jinarc 30 mg tabletter: blistre med eller uden etui med 14 (7 tabletter i den højeste styrke + 7 tabletter i den laveste styrke), 28 (14 tabletter i den højeste styrke + 14 tabletter i den laveste styrke) eller 56 (28 tabletter i den højeste styrke + 28 tabletter i den laveste styrke) tabletter.
English: 7 × 15 mg tablets and 7 × 45 mg tablets 14 × 15 mg tablets and 14 × 45 mg tablets 28 × 15 mg tablets and 28 × 45 mg tablets
Danish: 7 × 15 mg tabletter og 7 × 45 mg tabletter 14 × 15 mg tabletter og 14 × 45 mg tabletter 28 × 15 mg tabletter og 28 × 45 mg tabletter
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets Each 30 mg tablet contains 30 mg of tolvaptan.
Danish: Jinarc 30 mg tabletter + Jinarc 90 mg tabletter Hver 30 mg tablet indeholder 30 mg tolvaptan.
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets Each 30 mg tablet contains 30 mg of tolvaptan.
Danish: Jinarc 30 mg tabletter + Jinarc 60 mg tabletter Hver 30 mg tablet indeholder 30 mg tolvaptan.
English: 60 mg tablet: blue, modified rectangular (major axis 9.9 mm, minor axis 5.6 mm), shallow-convex, debossed with “OTSUKA” and “60” on one side
Danish: 60 mg tablet: blå, modificeret rektangulær (større akse: 9,9 mm, mindre akse: 5,6 mm), flad, konveks, præget med “OTSUKA” og “60” på den ene side.
English: Jinarc 15 mg tablets
Danish: Jinarc 15 mg tabletter
English: Jinarc 15 mg tablets Jinarc 30 mg tablets Jinarc 45 mg tablets Jinarc 60 mg tablets Jinarc 90 mg tablets
Danish: Jinarc 15 mg tabletter Jinarc 30 mg tabletter Jinarc 45 mg tabletter Jinarc 60 mg tabletter Jinarc 90 mg tabletter
English: 90 mg tablet: blue, pentagonal (major axis 9.7 mm, minor axis 9.5 mm), shallow-convex, debossed with “OTSUKA” and “90” on one side
Danish: 90 mg tablet: blå, femkantet (større akse: 9,7 mm, mindre akse: 9,5 mm), flad, konveks, præget med “OTSUKA” og “90” på den ene side.
English: Each 45 mg tablet contains 45 mg of tolvaptan.
Danish: Hver 45 mg tablet indeholder 45 mg tolvaptan.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to benzazepine or benzazepine derivatives (see section 4.4)
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Danish: Blå, trekantet (større akse: 6,58 mm, mindre akse: 6,20 mm), flad, konveks, præget med “OTSUKA” og “15” på den ene side.
English: Sun.
Danish: Tors.
English: Jinarc 15 mg tablets Jinarc 45 mg tablets tolvaptan
Danish: Jinarc 15 mg tabletter Jinarc 45 mg tabletter tolvaptan
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets
Danish: Jinarc 15 mg tabletter + Jinarc 45 mg tabletter
English: Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease (see section 5.1).
Danish: Jinarc er indiceret til at bremse progressionen af cysteudvikling og nyreinsufficiens hos voksne med autosomal dominant polycystisk nyresygdom (ADPKD).
English: Each tablet contains 15 mg tolvaptan.
Danish: Hver tablet indeholder 15 mg tolvaptan.
English: Each 30 mg tablet contains 30 mg tolvaptan.
Danish: Hver 30 mg tablet indeholder 30 mg tolvaptan.
English: Jinarc 15 mg tablets tolvaptan
Danish: Jinarc 15 mg tabletter tolvaptan
English: 30 mg tablet: blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Danish: 30 mg tablet: blå, rund (diameter: 8 mm), flad, konveks, præget med “OTSUKA” og “30” på den ene side.
English: Jinarc 30 mg tablets tolvaptan
Danish: Jinarc 30 mg tabletter tolvaptan
English: • Breast-feeding (see section 4.6)
Danish: • Amning (se pkt.
English: • if you are allergic to tolvaptan or any of the other ingredients of this medicine (listed in section 6) or if you are allergic to benzazepine or benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine)
Danish: eller hvis du er allergisk over for benzazepin eller benzazepinderivater (f.eks. benazepril,
English: A total of 1,370 patients (age 18-65) with chronic kidney disease (CKD) with an eGFR between 25 and 65 mL/min/1.73 m if younger than age 56; or eGFR between 25 and 44 mL/min/1.73 m 2, plus eGFR decline >2.0 mL/min/1.73 m2/year if between age 56-65 were randomized to either tolvaptan (n = 683) or placebo (n = 687) and were treated for a period of 12 months.
Danish: > 2,0 ml/min/1,73 m2/år (alder 56-65 år) blev randomiseret til enten tolvaptan (n = 683) eller placebo (n = 687) og blev behandlet i en periode på 12 måneder.
English: 7 × 15 mg tablets and 7 × 45 mg tablets in card packaging 14 × 15 mg tablets and 14 × 45 mg tablets in card packaging 28 × 15 mg tablets and 28 × 45 mg tablets in card packaging
Danish: 7 × 15 mg tabletter og 7 × 45 mg tabletter i etui 14 × 15 mg tabletter og 14 × 45 mg tabletter i etui 28 × 15 mg tabletter og 28 × 45 mg tabletter i etui
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets
Danish: Jinarc 30 mg tabletter + Jinarc 60 mg tabletter
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets
Danish: Jinarc 30 mg tabletter + Jinarc 90 mg tabletter
English: Approximately 5 %, 75 % and 20 % had an eGFR 60 mL/min/1.73 m or greater (CKD stage 2), or less than 60 and greater than 30 mL/min/1.73 m
Danish: < 60 ml/min/1,73 m 2, men større end 30 ml/min/1,73 m
English: Jinarc 30 mg tablets Jinarc 60 mg tablets tolvaptan
Danish: Jinarc 30 mg tabletter Jinarc 60 mg tabletter tolvaptan
English: Each tablet contains 30 mg tolvaptan.
Danish: Hver tablet indeholder 30 mg tolvaptan.
English: Jinarc 30 mg tablets Jinarc 90 mg tablets tolvaptan
Danish: Jinarc 30 mg tabletter Jinarc 90 mg tabletter tolvaptan
English: EU/1/15/1000/005 14 tablets (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tablets (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tablets (28 × 15 mg + 28 × 45 mg)
Danish: EU/1/15/1000/005 14 tabletter (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tabletter (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tabletter (28 × 15 mg + 28 × 45 mg)
English: EU/1/15/1000/014 14 tablets (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tablets (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tablets (28 × 15 mg + 28 × 45 mg)
Danish: EU/1/15/1000/014 14 tabletter (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tabletter (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tabletter (28 × 15 mg + 28 × 45 mg)
English: 7 × 30 mg tablets and 7 × 90 mg tablets 14 × 30 mg tablets and 14 × 90 mg tablets 28 × 30 mg tablets and 28 × 90 mg tablets
Danish: 7 × 30 mg tabletter og 7 × 90 mg tabletter 14 × 30 mg tabletter og 14 × 90 mg tabletter 28 × 30 mg tabletter og 28 × 90 mg tabletter
English: 7 × 30 mg tablets and 7 × 60 mg tablets 14 × 30 mg tablets and 14 × 60 mg tablets 28 × 30 mg tablets and 28 × 60 mg tablets
Danish: 7 × 30 mg tabletter og 7 × 60 mg tabletter 14 × 30 mg tabletter og 14 × 60 mg tabletter 28 × 30 mg tabletter og 28 × 60 mg tabletter
English: • Hypernatraemia
Danish: • Hypernatriæmi.
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 15 mg and 7 × 45 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets
Danish: 14 tabletter i 1 PVC/aluminiumsfolieblister i etui med 7 × 15 mg og 7 × 45 mg tabletter 28 tabletter i 2 PVC/aluminiumsfolieblistre i etui med 7 × 15 mg og 7 × 45 mg tabletter 56 tabletter i 4 PVC/aluminiumsfolieblistre i etui med 7 × 15 mg og 7 × 45 mg tabletter
English: • shortness of breath
Danish: • åndenød
English: EU/1/15/1000/008 14 tablets (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tablets (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tablets (28 × 30 mg + 28 × 60 mg)
Danish: EU/1/15/1000/008 14 tabletter (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tabletter (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tabletter (28 × 30 mg + 28 × 60 mg)
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 15 mg and 7 × 45 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets
Danish: 14 tabletter i 1 PVC/aluminiumsfolieblister med 7 × 15 mg og 7 × 45 mg tabletter 28 tabletter i 2 PVC/aluminiumsfolieblistre med 7 × 15 mg og 7 × 45 mg tabletter 56 tabletter i 4 PVC/aluminiumsfolieblistre med 7 × 15 mg og 7 × 45 mg tabletter
English: Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Danish: Tél/Tel: +31 (0) 20 85 46 555
English: EU/1/15/1000/020 14 tablets (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tablets (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tablets (28 × 30 mg + 28 × 90 mg)
Danish: EU/1/15/1000/020 14 tabletter (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tabletter (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tabletter (28 × 30 mg + 28 × 90 mg)
English: EU/1/15/1000/011 14 tablets (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tablets (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tablets (28 × 30 mg + 28 × 90 mg)
Danish: EU/1/15/1000/011 14 tabletter (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tabletter (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tabletter (28 × 30 mg + 28 × 90 mg)
English: Otsuka Pharmaceutical Netherlands B.V. Teл: +31 (0) 20 85 46 555
Danish: Teл: +31 (0) 20 85 46 555
English: EU/1/15/1000/017 14 tablets (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tablets (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tablets (28 × 30 mg + 28 × 60 mg)
Danish: EU/1/15/1000/017 14 tabletter (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tabletter (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tabletter (28 × 30 mg + 28 × 60 mg)
English: 7 × 30 mg tablets and 7 × 60 mg tablets in card packaging 14 × 30 mg tablets and 14 × 60 mg tablets in card packaging 28 × 30 mg tablets and 28 × 60 mg tablets in card packaging
Danish: 7 × 30 mg tabletter og 7 × 60 mg tabletter i etui 14 × 30 mg tabletter og 14 × 60 mg tabletter i etui 28 × 30 mg tabletter og 28 × 60 mg tabletter i etui
English: België/Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V. Tél/Tel: +31 (0) 20 85 46 555
Danish: België/Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V.
English: • fatigue
Danish: • vægttab
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 60 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets
Danish: 14 tabletter i 1 PVC/aluminiumsfolieblister med 7 × 30 mg og 7 × 60 mg tabletter 28 tabletter i 2 PVC/aluminiumsfolieblistre med 7 × 30 mg og 7 × 60 mg tabletter 56 tabletter i 4 PVC/aluminiumsfolieblistre med 7 × 30 mg og 7 × 60 mg tabletter
English: 7 × 30 mg tablets and 7 × 90 mg tablets in card packaging 14 × 30 mg tablets and 14 × 90 mg tablets in card packaging 28 × 30 mg tablets and 28 × 90 mg tablets in card packaging
Danish: 7 × 30 mg tabletter og 7 × 90 mg tabletter i etui 14 × 30 mg tabletter og 14 × 90 mg tabletter i etui 28 × 30 mg tabletter og 28 × 90 mg tabletter i etui
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 90 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets
Danish: 14 tabletter i 1 PVC/aluminiumsfolieblister i etui med 7 × 30 mg og 7 × 90 mg tabletter 28 tabletter i 2 PVC/aluminiumsfolieblistre i etui med 7 × 30 mg og 7 × 90 mg tabletter 56 tabletter i 4 PVC/aluminiumsfolieblistre i etui med 7 × 30 mg og 7 × 90 mg tabletter
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 30 mg and 7 × 90 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 90 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 90 mg tablets
Danish: 14 tabletter i 1 PVC/aluminiumsfolieblister med 7 × 30 mg og 7 × 90 mg tabletter 28 tabletter i 2 PVC/aluminiumsfolieblistre med 7 × 30 mg og 7 × 90 mg tabletter 56 tabletter i 4 PVC/aluminiumsfolieblistre med 7 × 30 mg og 7 × 90 mg tabletter
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 30 mg and 7 × 60 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 60 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 60 mg tablets
Danish: 14 tabletter i 1 PVC/aluminiumsfolieblister i etui med 7 × 30 mg og 7 × 60 mg tabletter 28 tabletter i 2 PVC/aluminiumsfolieblistre i etui med 7 × 30 mg og 7 × 60 mg tabletter 56 tabletter i 4 PVC/aluminiumsfolieblistre i etui med 7 × 30 mg og 7 × 60 mg tabletter
English: • tiredness
Danish: • mavesmerter
English: Otsuka Pharmaceutical Netherlands B.V. Thλ: +31 (0) 20 85 46 555
Danish: Thλ: +31 (0) 20 85 46 555
English: Strength Pharmaceutical Form Route of Administration Packaging
Danish: Lægemiddelform Indgivelsesvej
English: EMEA Number
Danish: EU-nummer
English: This summary was last updated in 07-2017.
Danish: Dette sammendrag blev sidst ajourført i 07-2017.
English: The full EPAR for Clopidogrel TAD can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Clopidogrel TAD findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel TAD on 23 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel TAD den 23. september 2009.
English: The standard dose is one 75-mg tablet once a day.
Danish: Standarddosen er én tablet a 75 mg én gang dagligt.
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel TAD.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel TAD.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST segment elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Danish: Dette efterfølges så af en standarddosis på 75 mg én gang dagligt i mindst fire uger (ved myokardieinfarkt med ST-segment-elevation) eller i op til 12 måneder (ved ustabil angina eller non-Q-takmyokardieinfarkt).
English: • recently had a myocardial infarction (heart attack).
Danish: • for nylig har haft myokardieinfarkt (hjertetilfælde).
English: The Agency recommended that Clopidogrel TAD be approved for use in the EU.
Danish: Udvalget anbefalede, at Clopidogrel TAD godkendes til anvendelse i EU.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Danish: Dette forhindrer dem i at blive "klæbrige" og mindsker således risikoen for, at der dannes blodpropper, og hjælper med til at forhindre et nyt hjerte- eller slagtilfælde.
English: This means that Clopidogrel TAD is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel TAD er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union, og som hedder Plavix.
English: • peripheral arterial disease (problems with blood flow in the arteries);
Danish: • har perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i arterierne)
English: Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Danish: Akut koronarsyndrom er en samlebetegnelse for hjerteproblemer, som omfatter hjerteanfald og ustabil angina (en svær form for brystsmerter).
English: • recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Danish: • for nylig har haft iskæmisk slagtilfælde (et slagtilfælde forårsaget af manglende blodforsyning til en del af hjernen).
English: In acute coronary syndrome, treatment generally starts with a loading dose of four tablets.
Danish: Ved akut koronarsyndrom indledes behandlingen normalt med en startdosis på fire tabletter.
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Danish: Det anvendes til patienter, som har mindst én risikofaktor for vaskulære hændelser såsom hjerteanfald eller slagtilfælde, og som ikke kan tage vitamin Kantagonister (andre lægemidler, der forebygger blodpropper), og som har en lav blødningsrisiko.
English: What measures are being taken to ensure the safe and effective use of Clopidogrel TAD?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Clopidogrel TAD?
English: When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Danish: Når blodet koagulerer, skyldes det, at de særlige celler i blodet kaldet blodplader klæber sammen (aggregerer).
English: Clopidogrel TAD can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel TAD kan påbegyndes mellem få dage og indtil 35 dage efter anfaldet
English: For more information about treatment with Clopidogrel TAD, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel TAD, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Danish: • har en sygdom kaldet "akut koronarsyndrom", hvor det bør gives sammen med aspirin (et andet lægemiddel, som forebygger blodpropper).
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Danish: • har atrieflimren (uregelmæssige hurtige sammentrækninger af de øverste hjertekamre), hvor det bør gives sammen med aspirin.
English: What is Clopidogrel TAD and what is it used for?
Danish: Hvad er Clopidogrel TAD, og hvad anvendes det til?
English: Clopidogrel TAD is a medicine used to prevent problems caused by blood clots in adults who have:
Danish: Clopidogrel TAD anvendes til at forebygge problemer forårsaget af blodpropper hos voksne, som:
English: Other information about Clopidogrel TAD
Danish: Andre oplysninger om Clopidogrel TAD
English: Clopidogrel TAD is available as tablets containing 75 mg clopidogrel.
Danish: Clopidogrel TAD fås som tabletter, der indeholder 75 mg clopidogrel.
English: Some of these patients may have had a stent (a short tube) placed in an artery to prevent it from closing up;
Danish: Nogle af disse patienter kan have fået en stent (et kort rør) anbragt i en arterie for at forhindre denne i at indsnævre sig
English: It is not intended to provide practical advice on how to use Clopidogrel TAD.
Danish: Det er ikke en praktisk vejledning i, hvordan Clopidogrel TAD bør anvendes.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel TAD has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Clopidogrel TAD er af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: Clopidogrel TAD is a ‘generic medicine'.
Danish: Clopidogrel TAD er et "generisk lægemiddel".
English: What are the benefits and risks of Clopidogrel TAD?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel TAD?
English: Because Clopidogrel TAD is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Clopidogrel TAD er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Clopidogrel TAD can be started between seven days and six months after the stroke;
Danish: Behandling med Clopidogrel TAD kan påbegyndes syv dage efter slagtilfældet og indtil seks måneder efter
English: Clopidogrel TAD contains the active substance clopidogrel.
Danish: Clopidogrel TAD indeholder det aktive stof clopidogrel.
English: Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Danish: Clopidogrel forhindrer blodpladerne i at aggregere ved at forhindre et stof, ADP, i at binde sig til en særlig receptor på blodpladernes overflade.
English: Clopidogrel TAD can only be obtained with a prescription.
Danish: Clopidogrel TAD udleveres kun efter recept.
English: Therefore, the Agency's view was that, as for Plavix, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Plavix.
English: For practical information about using Clopidogrel TAD, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Clopidogrel TAD, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Because Clopidogrel TAD is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel TAD er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: Why is Clopidogrel TAD approved?
Danish: Hvorfor blev Clopidogrel TAD godkendt?