natgillin/translations-raw huggingface dataset:
Jinarc 30 mg tabletter: blistre med 7 eller 28 tabletter
Jinarc 30 mg tablets: blisters with 7 or 28 tablets
Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at tage Jinarc Sådan skal du tage Jinarc Bivirkninger
What Jinarc is and what it is used for What you need to know before you take Jinarc How to take Jinarc
Indlægsseddel Information til patienten
Package leaflet: Information for the patient
79 % havde hypertension og et gennemsnitligt TKV på 1.692 ml (højdejusteret 972 ml/m).
1,692 mL (height adjusted 972 mL/m).
Serum-natriumabnormiteter
Serum sodium abnormalities
Jinarc 15 mg tabletter EU/1/15/1000/001-002 (blister)
Jinarc 15 mg tablets EU/1/15/1000/001-002 (blister)
2) medicinsk signifikante nyresmerter (defineres som krævende ordineret sygeorlov, last-resort analgetika, narkotika og antinociceptive, radiologiske eller kirurgiske interventioner) 3) forværret hypertension
narcotic and anti-nociceptive, radiologic or surgical interventions) 3) worsening hypertension
Incidensen af bivirkninger forbundet med tolvaptan-behandling er angivet i tabellen nedenfor.
The incidences of the Adverse Drug Reactions (ADRs) associated with tolvaptan therapy are tabulated below.
Sådan skal du tage Jinarc
How to take Jinarc
Ved baseline havde patienter en gennemsnitlig estimeret glomerulær filtrationsrate (eGFR) på 82 ml/min/1,73 m
At baseline, patients had average estimated glomerular filtration rate (eGFR) of 82 mL/min/1.73 m2 (CKD-EPI) with 79 % having hypertension and a mean TKV of
Nyrer og urinveje Nykturi, Pollakisuri,
Nocturia, Pollakiuria, Polyuria
Generaliseret udslæt
Generalised rash
Patientadvarselskortet skal indeholde følgende væsentlige elementer:
The Patient Alert Card shall contain the following key messages:
14 metabolitter er blevet identificeret i plasma, urin og fæces.
Fourteen metabolites have been identified in plasma, urine and faeces; all but one were also metabolised by CYP3A.
Jinarc 30 mg tabletter EU/1/15/1000/003-004 (blister)
Jinarc 30 mg tablets EU/1/15/1000/003-004 (blister)
Jinarc 15 mg tabletter 7 eller 28 tabletter i PVC/aluminiumsfolieblister
Jinarc 15 mg tablets 7 or 28 tablets in PVC/aluminium foil blister
Jinarc 30 mg tabletter 7 eller 28 tabletter i PVC/aluminiumsfolieblister
Jinarc 30 mg tablets 7 or 28 tablets in PVC/aluminium foil blister
• Information til patienten
• The Patient information leaflet
• Informationspakke til patienter
• Patient information pack
Den behandlingsforskel med hensyn til eGFR-ændring, der blev observeret i dette studie, er 1,27 ml/min/1,73 m2, hvilket svarer til en reduktion på 35 % i mindste kvadraters middelværdier for eGFR (-2,34 ml/min/1,73 m for tolvaptan-gruppen vs. -3,61 ml/min/1,73 m for placebogruppen) i løbet af et år.
35 % reduction in the LS means of change in eGFR of -2.34 mL/min/1.73 m in tolvaptan group relative to a -3.61 mL/min/1.73 m in placebo group observed over the course of one year.
Jinarc 15 mg tabletter + Jinarc 45 mg tabletter Hver 15 mg tablet indeholder 15 mg tolvaptan.
Jinarc 15 mg tablets + Jinarc 45 mg tablets Each 15 mg tablet contains 15 mg of tolvaptan.
15 mm tablet: blå, trekantet, præget med “OTSUKA” og “15” på den ene side.
15 mg tablet: blue, triangular, debossed with “OTSUKA” and “15” on one side.
Jinarc 15 mg tabletter + Jinarc 45 mg tabletter Jinarc 30 mg tabletter + Jinarc 60 mg tabletter Jinarc 30 mg tabletter + Jinarc 90 mg tabletter
Jinarc 15 mg tablets + Jinarc 45 mg tablets Jinarc 30 mg tablets + Jinarc 60 mg tablets Jinarc 30 mg tablets + Jinarc 90 mg tablets
Jinarc 30 mg tabletter Blå, rund (diameter: 8 mm), flad, konveks, præget med “OTSUKA” og “30” på den ene side.
Jinarc 30 mg tablets Blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Hver 60 mg tablet indeholder ca. 16 mg laktose (som monohydrat).
Each 60 mg tablet contains approximately 16 mg lactose (as monohydrate).
Hver 45 mg tablet indeholder ca. 12 mg laktose (som monohydrat).
Each 45 mg tablet contains approximately 12 mg lactose (as monohydrate).
45 mg tablet: blå, firkantet (6,8 mm på den ene side, større akse 8,2 mm), flad, konveks, præget med “OTSUKA” and “45” på den ene side.
45 mg tablet: blue, square (6.8 mm on a side, major axis 8.2 mm), shallow-convex, debossed with “OTSUKA” and “45” on one side
Hver 90 mg tablet indeholder ca. 24 mg laktose (som monohydrat).
Each 90 mg tablet contains approximately 24 mg lactose (as monohydrate).
Jinarc 15 mg tabletter + Jinarc 45 mg tabletter EU/1/15/1000/005-007 (blister) EU/1/15/1000/014-016 (blister i etui)
Jinarc 15 mg tablets + Jinarc 45 mg tablets EU/1/15/1000/005-007 (blister) EU/1/15/1000/014-016 (blister in wallet card)
30 mm tablet: blå, rund, præget med “OTSUKA” og “30” på den ene side.
30 mg tablet: blue, round, debossed with “OTSUKA” and “30” on one side.
Jinarc 45 mg tabletter + Jinarc 15 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 45 mg tablets + Jinarc 15 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.
Hver 15 mg tablet indeholder 15 mg tolvaptan.
Each 15 mg tablet contains 15 mg tolvaptan.
Denne type reaktion indtraf efter den første administration af tolvaptan.Patienterne skal overvåges omhyggeligt under behandlingen.
This type of reaction occurred after the first administration of tolvaptan.
Hver 90 mg tablet indeholder 90 mg tolvaptan.
Each 90 mg tablet contains 90 mg tolvaptan.
Hver 60 mg tablet indeholder 60 mg tolvaptan.
Each 60 mg tablet contains 60 mg tolvaptan.
Jinarc 30 mg tabletter
Jinarc 30 mg tablets
Jinarc 30 mg tabletter + Jinarc 90 mg tabletter EU/1/15/1000/011-013 (blister) EU/1/15/1000/020-022 (blister i etui)
Jinarc 30 mg tablets + Jinarc 90 mg tablets EU/1/15/1000/011-013 (blister) EU/1/15/1000/020-022 (blister in wallet card)
Dosisjustering for patienter, der tager stærke CYP3A-hæmmere Hos patienter, der tager stærke CYP3A-hæmmere (se pkt.
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:
• akut leversvigt
Acute hepatic failure
• Volumendepletering.
• Volume depletion
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;