natgillin/translations-raw huggingface dataset:
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. 
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.
Jinarc 30 mg tabletter + Jinarc 60 mg tabletter EU/1/15/1000/008-010 (blister) EU/1/15/1000/017-019 (blister i etui) 
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)
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. 
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.
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. 
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.
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 
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
Jinarc 30 mg tabletter + Jinarc 90 mg tabletter Hver 30 mg tablet indeholder 30 mg tolvaptan. 
Jinarc 30 mg tablets + Jinarc 90 mg tablets Each 30 mg tablet contains 30 mg of tolvaptan.
Jinarc 30 mg tabletter + Jinarc 60 mg tabletter Hver 30 mg tablet indeholder 30 mg tolvaptan. 
Jinarc 30 mg tablets + Jinarc 60 mg tablets Each 30 mg tablet contains 30 mg of tolvaptan.
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. 
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
Jinarc 15 mg tabletter 
Jinarc 15 mg tablets
Jinarc 15 mg tabletter Jinarc 30 mg tabletter Jinarc 45 mg tabletter Jinarc 60 mg tabletter Jinarc 90 mg tabletter 
Jinarc 15 mg tablets Jinarc 30 mg tablets Jinarc 45 mg tablets Jinarc 60 mg tablets Jinarc 90 mg tablets
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. 
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
Hver 45 mg tablet indeholder 45 mg tolvaptan. 
Each 45 mg tablet contains 45 mg of tolvaptan.
• Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt. 
• 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)
Blå, trekantet (større akse: 6,58 mm, mindre akse: 6,20 mm), flad, konveks, præget med “OTSUKA” og “15” på den ene side. 
Blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Tors. 
Sun.
Jinarc 15 mg tabletter Jinarc 45 mg tabletter tolvaptan 
Jinarc 15 mg tablets Jinarc 45 mg tablets tolvaptan
Jinarc 15 mg tabletter + Jinarc 45 mg tabletter 
Jinarc 15 mg tablets + Jinarc 45 mg tablets
Jinarc er indiceret til at bremse progressionen af cysteudvikling og nyreinsufficiens hos voksne med autosomal dominant polycystisk nyresygdom (ADPKD). 
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).
Hver tablet indeholder 15 mg tolvaptan. 
Each tablet contains 15 mg tolvaptan.
Hver 30 mg tablet indeholder 30 mg tolvaptan. 
Each 30 mg tablet contains 30 mg tolvaptan.
Jinarc 15 mg tabletter tolvaptan 
Jinarc 15 mg tablets tolvaptan
30 mg tablet: blå, rund (diameter: 8 mm), flad, konveks, præget med “OTSUKA” og “30” på den ene side. 
30 mg tablet: blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Jinarc 30 mg tabletter tolvaptan 
Jinarc 30 mg tablets tolvaptan
• Amning (se pkt. 
• Breast-feeding (see section 4.6)
eller hvis du er allergisk over for benzazepin eller benzazepinderivater (f.eks. benazepril, 
• 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)
> 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. 
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.
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 
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
Jinarc 30 mg tabletter + Jinarc 60 mg tabletter 
Jinarc 30 mg tablets + Jinarc 60 mg tablets
Jinarc 30 mg tabletter + Jinarc 90 mg tabletter 
Jinarc 30 mg tablets + Jinarc 90 mg tablets
< 60 ml/min/1,73 m 2, men større end 30 ml/min/1,73 m 
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
Jinarc 30 mg tabletter Jinarc 60 mg tabletter tolvaptan 
Jinarc 30 mg tablets Jinarc 60 mg tablets tolvaptan
Hver tablet indeholder 30 mg tolvaptan. 
Each tablet contains 30 mg tolvaptan.
Jinarc 30 mg tabletter Jinarc 90 mg tabletter tolvaptan 
Jinarc 30 mg tablets Jinarc 90 mg tablets tolvaptan
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) 
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)
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) 
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)
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 
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
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 
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
• Hypernatriæmi. 
• Hypernatraemia
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 
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
• åndenød 
• shortness of breath
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) 
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)
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 
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
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) 
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)
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) 
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)
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) 
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)
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 
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
België/Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V. 
België/Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V. Tél/Tel: +31 (0) 20 85 46 555
• vægttab 
• fatigue
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 
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
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 
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
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 
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
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 
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
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 
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
• mavesmerter 
• tiredness
Lægemiddelform Indgivelsesvej 
Strength Pharmaceutical Form Route of Administration Packaging
EU-nummer 
EMEA Number
Dette sammendrag blev sidst ajourført i 07-2017. 
This summary was last updated in 07-2017.
Den fuldstændige EPAR for Clopidogrel TAD findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
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.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel TAD den 23. september 2009. 
The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel TAD on 23 September 2009.
Standarddosen er én tablet a 75 mg én gang dagligt. 
The standard dose is one 75-mg tablet once a day.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel TAD. 
This is a summary of the European public assessment report (EPAR) for Clopidogrel TAD.
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). 
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).
• for nylig har haft myokardieinfarkt (hjertetilfælde). 
• recently had a myocardial infarction (heart attack).
Udvalget anbefalede, at Clopidogrel TAD godkendes til anvendelse i EU. 
The Agency recommended that Clopidogrel TAD be approved for use in the EU.
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. 
This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Det betyder, at Clopidogrel TAD er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union, og som hedder Plavix. 
This means that Clopidogrel TAD is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
• har perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i arterierne) 
• peripheral arterial disease (problems with blood flow in the arteries);
Akut koronarsyndrom er en samlebetegnelse for hjerteproblemer, som omfatter hjerteanfald og ustabil angina (en svær form for brystsmerter). 
Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
• for nylig har haft iskæmisk slagtilfælde (et slagtilfælde forårsaget af manglende blodforsyning til en del af hjernen). 
• recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Ved akut koronarsyndrom indledes behandlingen normalt med en startdosis på fire tabletter. 
In acute coronary syndrome, treatment generally starts with a loading dose of four tablets.
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. 
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.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Clopidogrel TAD? 
What measures are being taken to ensure the safe and effective use of Clopidogrel TAD?
Når blodet koagulerer, skyldes det, at de særlige celler i blodet kaldet blodplader klæber sammen (aggregerer). 
When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Behandling med Clopidogrel TAD kan påbegyndes mellem få dage og indtil 35 dage efter anfaldet 
Clopidogrel TAD can be started between a few days and 35 days after the attack;
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. 
For more information about treatment with Clopidogrel TAD, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
• har en sygdom kaldet "akut koronarsyndrom", hvor det bør gives sammen med aspirin (et andet lægemiddel, som forebygger blodpropper). 
• a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
• har atrieflimren (uregelmæssige hurtige sammentrækninger af de øverste hjertekamre), hvor det bør gives sammen med aspirin. 
• atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Hvad er Clopidogrel TAD, og hvad anvendes det til? 
What is Clopidogrel TAD and what is it used for?
Clopidogrel TAD anvendes til at forebygge problemer forårsaget af blodpropper hos voksne, som: 
Clopidogrel TAD is a medicine used to prevent problems caused by blood clots in adults who have:
Andre oplysninger om Clopidogrel TAD 
Other information about Clopidogrel TAD
Clopidogrel TAD fås som tabletter, der indeholder 75 mg clopidogrel. 
Clopidogrel TAD is available as tablets containing 75 mg clopidogrel.
Nogle af disse patienter kan have fået en stent (et kort rør) anbragt i en arterie for at forhindre denne i at indsnævre sig 
Some of these patients may have had a stent (a short tube) placed in an artery to prevent it from closing up;
Det er ikke en praktisk vejledning i, hvordan Clopidogrel TAD bør anvendes. 
It is not intended to provide practical advice on how to use Clopidogrel TAD.
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. 
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.
Clopidogrel TAD er et "generisk lægemiddel". 
Clopidogrel TAD is a ‘generic medicine'.
Hvilken fordel og risiko er der forbundet med Clopidogrel TAD? 
What are the benefits and risks of Clopidogrel TAD?
Da Clopidogrel TAD er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet. 
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.
Behandling med Clopidogrel TAD kan påbegyndes syv dage efter slagtilfældet og indtil seks måneder efter 
Clopidogrel TAD can be started between seven days and six months after the stroke;
Clopidogrel TAD indeholder det aktive stof clopidogrel. 
Clopidogrel TAD contains the active substance clopidogrel.
Clopidogrel forhindrer blodpladerne i at aggregere ved at forhindre et stof, ADP, i at binde sig til en særlig receptor på blodpladernes overflade. 
Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Clopidogrel TAD udleveres kun efter recept. 
Clopidogrel TAD can only be obtained with a prescription.
Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Plavix. 
Therefore, the Agency's view was that, as for Plavix, the benefit outweighs the identified risk.
Hvis du ønsker praktisk vejledning om anvendelsen af Clopidogrel TAD, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Clopidogrel TAD, patients should read the package leaflet or contact their doctor or pharmacist.
Da Clopidogrel TAD er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix. 
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.
Hvorfor blev Clopidogrel TAD godkendt? 
Why is Clopidogrel TAD approved?
Det aktive stof i Clopidogrel TAD, clopidogrel, er en hæmmer af trombocytaggregation. 
The active substance in Clopidogrel TAD, clopidogrel, is an inhibitor of platelet aggregation.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Clopidogrel TAD. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel TAD have been included in the summary of product characteristics and the package leaflet.
Ved akut koronarsyndrom og atrieflimren anvendes Clopidogrel TAD sammen med aspirin. 
In acute coronary syndrome and atrial fibrillation, Clopidogrel TAD is used together with aspirin, the dose of which should not be higher than 100 mg.
Hvordan blev Clopidogrel TAD undersøgt? 
How has Clopidogrel TAD been studied?
Hvordan anvendes Clopidogrel TAD? 
How is Clopidogrel TAD used?
Hvordan virker Clopidogrel TAD? 
How does Clopidogrel TAD work?
Dette sammendrag blev sidst ajourført i 11-2017. 
This summary was last updated in 11-2017.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Spinraza den 30. maj 2017. 
The European Commission granted a marketing authorisation valid throughout the European Union for Spinraza on 30 May 2017.
Den første dosis skal efterfølges af 3 yderligere doser efter 2, 4 og 9 uger og derefter én dosis hver 4. måned. 
The first dose should be followed by 3 more doses after 2, 4, and 9 weeks and then one dose every 4 months thereafter.
Det erstatter det manglende protein og mindsker derved symptomerne på sygdommen. 
This replaces the missing protein, thereby relieving the symptoms of the disease.
Hos spædbørn kunne nogle bivirkninger ikke vurderes, da de ikke kunne give udtryk for dem. 
In babies some side effects could not be assessed, as they could not communicate them.
I sin vurdering erkendte Det Europæiske Lægemiddelagentur sygdommens alvorlige karakter og det tvingende behov for effektiv behandling. 
In its assessment, the European Medicines Agency recognised the serious nature of the disease and the urgent need for effective treatments.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Spinraza. 
This is a summary of the European public assessment report (EPAR) for Spinraza.