natgillin/translations-raw huggingface dataset:
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)
Jinarc 15 mg tabletid + Jinarc 45 mg tabletid EU/1/15/1000/005-007 (blister) EU/1/15/1000/014-016 (blister voldikpakendis)
15 mg tablet: blue, triangular, debossed with “OTSUKA” and “15” on one side.
15 mg tablett: sinine, kolmnurkne, ühel küljel pimetrükis „OTSUKA” ja „15”.
Tolvaptan daily split-dose Reduced split-dose 90+30 mg
Tolvaptaani ööpäevane kaheosaline annus Vähendatud kaheosaline annus 90+30 mg
Steady state digoxin concentrations were increased (1.3-fold in maximum observed plasma concentration [Cmax] and 1.2fold in area under the plasma concentration-time curve over the dosing interval [AUCτ]) when coadministered with multiple once daily 60 mg doses of tolvaptan.
Samaaegsel manustamisel tolvaptaani mitme 60 mg annuse manustamisega üks kord ööpäevas suurenesid digoksiini sisaldused püsikontsentratsioonil (maksimaalne täheldatud plasmakontsentratsioon [Cmax] 1,3-kordselt ja plasmakontsentratsiooni ja aja kõver 1,2-kordselt annustamisintervalli [AUCτ] piires).
Each 60 mg tablet contains approximately 16 mg lactose (as monohydrate).
Üks 60 mg tablett sisaldab ligikaudu 16 mg laktoosi (monohüdraadina).
Other side effects:
Muud kõrvaltoimed
Jinarc 15 mg tablets + Jinarc 45 mg tablets Each 15 mg tablet contains 15 mg of tolvaptan.
Jinarc 15 mg tabletid + Jinarc 45 mg tabletid Üks 15 mg tablett sisaldab 15 mg tolvaptaani.
Each 90 mg tablet contains approximately 24 mg lactose (as monohydrate).
Üks 90 mg tablett sisaldab ligikaudu 24 mg laktoosi (monohüdraadina).
Periodic monitoring of plasma osmolality or serum sodium (to calculate plasma osmolarity) and/or body weight should be considered to monitor the risk of dehydration secondary to the aquaretic effects of tolvaptan in case of patient's insufficient water intake.
Kui patsient ei joo piisavalt vett, tuleb tolvapataani vett väljutavast toimest tuleneva dehüdratsiooni ohu tõttu perioodiliselt jälgida plasma osmolaarsust või seerumi naatriumisisaldust (plasma osmolaarsuse arvutamiseks) ja/või kehakaalu.
Each 45 mg tablet contains approximately 12 mg lactose (as monohydrate).
Üks 45 mg tablett sisaldab ligikaudu 12 mg laktoosi (monohüdraadina).
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.
44 ml/min/1,73 m koos eGFR'i vähenemisega >2,0 ml/min/1,73 m 2/aastas vanuses 56...65 aastat, randomiseeriti kas tolvaptaani (n = 683) või platseebo (n = 687) rühma ja neid raviti 12 kuu vältel.
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)
Jinarc 30 mg tabletid + Jinarc 60 mg tabletid EU/1/15/1000/008-010 (blister) EU/1/15/1000/017-019 (blister voldikpakendis)
Patients may down-titrate to lower doses based on tolerability.
Patsiendid võivad taluvusest lähtudes annusetaset vähendada.
30 mg tablet: blue, round, debossed with “OTSUKA” and “30” on one side.
30 mg tablett: sinine, ümmargune, ühel küljel pimetrükis „OTSUKA” ja „30”.
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.
Jinarc 45 mg tabletid + Jinarc 15 mg tabletid: blistrid koos voldikpakendiga või ilma 14 (7 suurema tugevusega tabletti + 7 väiksema tugevusega tabletti), 28 (14 suurema tugevusega tabletti + 14 väiksema tugevusega tabletti) või 56 (28 suurema tugevusega tabletti + 28 väiksema tugevusega tabletti) tabletiga.
Decreased uric acid clearance by the kidney is a known effect of tolvaptan.
Kusihappe kliirensi vähendamine neerudes on tolvaptaani teadaolev toime.
How to store Jinarc
Kuidas Jinarci säilitada
Jinarc 30 mg tablets
Jinarc 30 mg tabletid
Jinarc 30 mg tablets Blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Jinarc 30 mg tabletid Sinine, ümar (diameeter: 8 mm), veidi kumer, ühel küljel on pimetrükk „OTSUKA” ja „30”.
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
7 × 15 mg tabletti ja 7 × 45 mg tabletti 14 × 15 mg tabletti ja 14 × 45 mg tabletti 28 × 15 mg tabletti ja 28 × 45 mg tabletti
In post-marketing experience with tolvaptan in ADPKD, acute liver failure requiring liver transplantation has been reported.
Tolvaptaani turuletulekujärgsel kasutamisel autosoom-dominantse polütsüstilise neeruhaiguse raviks on kirjeldatud maksasiirdamiseni viivat ägedat maksapuudulikkust.
Pharmacotherapeutic group: Diuretics, vasopressin antagonists, ATC code: C03XA01.
Farmakoterapeutiline rühm: diureetikumid, vasopressiini antagonistid.
The pharmacodynamic effects of tolvaptan have been determined in healthy subjects and subjects with ADPKD across CKD stages 1 to 4.
Tolvaptaani farmakodünaamilisi toimeid on määratud kindlaks tervetel uuringus osalejatel ja autosoom-dominantse polütsüstilise neeruhaigusega uuringus osalejatel kroonilise neeruhaiguse 1. kuni 4. astmekorral.
Each 15 mg tablet contains 15 mg tolvaptan.
Üks 15 mg tablett sisaldab 15 mg tolvaptaani.
Jinarc 15 mg tablets Jinarc 30 mg tablets Jinarc 45 mg tablets Jinarc 60 mg tablets Jinarc 90 mg tablets
Jinarc 15 mg tabletid Jinarc 30 mg tabletid Jinarc 45 mg tabletid Jinarc 60 mg tabletid Jinarc 90 mg tabletid
In addition, increased use of allopurinol and other medicinal products used to manage gout were observed in the double-blind, placebo-controlled trial.
Peale selle täheldati topeltpimedas platseebo-kontrolliga uuringus allopurinooli ja teiste podagraravimite suurenenud kasutamist.
Jinarc 30 mg tablets + Jinarc 60 mg tablets Each 30 mg tablet contains 30 mg of tolvaptan.
Jinarc 30 mg tabletid + Jinarc 60 mg tabletid Üks 30 mg tablett sisaldab 30 mg tolvaptaani.
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
Patsientidel oli ravi algul hinnanguline keskmine glomeerulite filtratsioonikiirus (eGFR) 82 ml/min/1,73 m
Nocturia, Pollakiuria, Polyuria
Noktuuria Pollakisuuria Polüuuria
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 60 mg tabletid + Jinarc 30 mg tabletid: blistrid koos voldikpakendiga või ilma 14 (7 suurema tugevusega tabletti + 7 väiksema tugevusega tabletti), 28 (14 suurema tugevusega tabletti + 14 väiksema tugevusega tabletti) või 56 (28 suurema tugevusega tabletti + 28 väiksema tugevusega tabletti) tabletiga.
Each Jinarc 60 mg tablet contains 60 mg tolvaptan.
Üks Jinarc 60 mg tablett sisaldab 60 mg tolvaptaani.
2) medically significant kidney pain (defined as requiring prescribed leave, last-resort analgesics,
1) neerufunktsiooni halvenemine (mida määratleti seerumi kreatiniinitaseme pöördväärtuse püsiva
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.
Jinarc 90 mg tabletid + Jinarc 30 mg tabletid: blistrid koos voldikpakendiga või ilma 14 (7 suurema tugevusega tabletti + 7 väiksema tugevusega tabletti), 28 (14 suurema tugevusega tabletti + 14 väiksema tugevusega tabletti) või 56 (28 suurema tugevusega tabletti + 28 väiksema tugevusega tabletti) tabletiga.
The treatment difference in eGFR change observed in this trial is 1.27 mL/min/1.73 m 2, representing a
Selles uuringus täheldatud eGFR-i muutuse erinevus on 1,27 ml/min/1,73 m2, moodustades 35%-lise vähenemise muutuse vähimruutude meetodil (LS) eGFR-is -2,34 ml/min/1,73 m2 tolvaptaani rühmas võrreldes
Jinarc 30 mg tablets + Jinarc 90 mg tablets Each 30 mg tablet contains 30 mg of tolvaptan.
Jinarc 30 mg tabletid + Jinarc 90 mg tabletid Üks 30 mg tablett sisaldab 30 mg tolvaptaani.
Each Jinarc 30 mg tablet contains 30 mg tolvaptan.
Üks Jinarc 30 mg tablett sisaldab 30 mg tolvaptaani.
Each Jinarc 15 mg tablet contains 15 mg tolvaptan.
Üks Jinarc 15 mg tablett sisaldab 15 mg tolvaptaani.
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
45 mg tablett: sinine, nelinurkne (üks külg 6,8 mm, pikem külg 8,2 mm), veidi kumer, ühel küljel on pimetrükk „OTSUKA” ja „45”.
Tolvaptan may cause hyperglycaemia (see section 4.8).
Tolvaptaan võib kutsuda esile hüperglükeemia (vt lõik 4.8).
Jinarc 15 mg tablets
Jinarc 15 mg tabletid
Each Jinarc 45 mg tablet contains 45 mg tolvaptan.
Üks Jinarc 45 mg tablett sisaldab 45 mg tolvaptaani.
Each Jinarc 90 mg tablet contains 90 mg tolvaptan.
Üks Jinarc 90 mg tablett sisaldab 90 mg tolvaptaani.
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
60 mg tablett: sinine, modifitseeritud ristküliku kujuline (pikem külg 9,9 mm, lühem külg 5,6 mm), veidi kumer, ühel küljel on pimetrükk „OTSUKA” ja „60”.
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
90 mg tablett: sinine, viisnurkne (pikem külg 9,7 mm, lühem külg 9,5 mm), veidi kumer, ühel küljel on pimetrükk „OTSUKA” ja „90”.
Acute reductions in mean total kidney volume were also observed following 3 weeks of therapy in all CKD stages, ranging from -4.6 % for CKD stage 1 to -1.9 % for CKD stage 4.
−4,6 %-st kroonilise neeruhaiguse 1. astmel kuni −1,9 %-ni 4. astmel.
Each 60 mg tablet contains 60 mg tolvaptan.
Üks 60 mg tablett sisaldab 60 mg tolvaptaani.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.
Farmakoloogilise ohutuse, korduvtoksilisuse, genotoksilisuse ja kartsinogeensuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
Each 30 mg tablet contains 30 mg tolvaptan.
Üks 30 mg tablett sisaldab 30 mg tolvaptaani.
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.
3,61 ml/min/1,73 m platseeborühmas, mida täheldati ühe aasta jooksul.
Blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Sinine, kolmnurkne (pikem külg: 6,58 mm, lühem külg: 6,20 mm), veidi kumer, ühel küljel on pimetrükk „OTSUKA” ja „15”.
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.
15 mg tablett: sinine, kolmnurkne (pikem külg 6,58 mm, lühem külg 6,20 mm), veidi kumer, ühel küljel on pimetrükk „OTSUKA” ja „15”.
Each 45 mg tablet contains 45 mg of tolvaptan.
Üks 45 mg tablett sisaldab 45 mg tolvaptaani.
Jinarc 15 mg tablets + Jinarc 45 mg tablets
Jinarc 15 mg tabletid + Jinarc 45 mg tabletid
The no observed adverse effect level (NOAEL) for effects on reproduction in females (100 mg/kg/day) was about 8-times the maximum human recommended dose of 120 mg/day on a mg/m basis.
Emasloomade reproduktsioonile avalduvate kõrvaltoimeteta tase (100 mg/kg ööpäevas) oli ligikaudu
Each 90 mg tablet contains 90 mg of tolvaptan.
Üks 90 mg tablett sisaldab 90 mg tolvaptaani.
Jinarc 15 mg tablets Jinarc 45 mg tablets tolvaptan
Jinarc 15 mg tabletid Jinarc 45 mg tabletid
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/1/15/1000/005 14 tabletti (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tabletti (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tabletti (28 × 15 mg + 28 × 45 mg)
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
7 × 15 mg tabletti ja 7 × 45 mg tabletti voldikpakendis 14 × 15 mg tabletti ja 14 × 45 mg tabletti voldikpakendis 28 × 15 mg tabletti ja 28 × 45 mg tabletti voldikpakendis
Tolvaptan is not recommended in the paediatric age group.
Tolvaptaani kasutamine laste vanuserühmas ei ole soovitatav.
Very common Common
• üldine nõrkustunne
Tolvaptan has not been extensively studied in ADPKD in combination with diuretics.
Tolvaptaani kasutamist autosoom-dominantse polütsüstilise neeruhaiguse raviks koos diureetikumidega ei ole ulatuslikult uuritud.
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 tabletti ja 7 × 90 mg tabletti 14 × 30 mg tabletti ja 14 × 90 mg tabletti 28 × 30 mg tabletti ja 28 × 90 mg tabletti
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)
EU/1/15/1000/014 14 tabletti (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tabletti (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tabletti (28 × 15 mg + 28 × 45 mg)
Talk to your doctor before taking Jinarc
Enne Jinarci võtmist pidage nõu oma arstiga:
Jinarc 30 mg tablets + Jinarc 60 mg tablets
Jinarc 30 mg tabletid + Jinarc 60 mg tabletid
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
7 × 30 mg tabletti ja 7 × 60 mg tabletti 14 × 30 mg tabletti ja 14 × 60 mg tabletti 28 × 30 mg tabletti ja 28 × 60 mg tabletti
Each tablet contains 15 mg tolvaptan.
Üks tablett sisaldab 15 mg tolvaptaani.
Jinarc 30 mg tablets + Jinarc 90 mg tablets
Jinarc 30 mg tabletid + Jinarc 90 mg tabletid
Jinarc may cause your liver not to work properly.
Jinarc võib põhjustada maksa talitlushäireid.
See leaflet for further information.
Täpsem teave on esitatud pakendi infolehel.
Each tablet contains 30 mg tolvaptan.
Üks tablett sisaldab 30 mg tolvaptaani.
Diabetes mellitus
Lihasspasmid
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
14 tabletti 1 PVC/alumiiniumfooliumist blistris 7 × 15 mg ja 7 × 45 mg tabletiga 28 tabletti 2 PVC/alumiiniumfooliumist blistris 7 × 15 mg ja 7 × 45 mg tabletiga 56 tabletti 4 PVC/alumiiniumfooliumist blistris 7 × 15 mg ja 7 × 45 mg tabletiga
• itching
• isutus
Anaphylaxis
Imendumine
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)
EU/1/15/1000/008 14 tabletti (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tabletti (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tabletti (28 × 30 mg + 28 × 60 mg)
Jinarc 30 mg tablets Jinarc 60 mg tablets tolvaptan
Jinarc 30 mg tabletid Jinarc 60 mg tabletid
Jinarc 30 mg tablets Jinarc 90 mg tablets tolvaptan
Jinarc 30 mg tabletid Jinarc 90 mg tabletid
Each 15 mg tablet contains approximately 35 mg lactose (as monohydrate).
Teadaolevat toimet omav(ad) abiaine(d) Üks 15 mg tablett sisaldab ligikaudu 35 mg laktoosi (monohüdraadina).
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Tél/Tel: +31 (0) 20 85 46 555
Serum sodium abnormalities
Seerumi naatriumisisalduse kõrvalekalded
A reversible reduction in GFR has been observed in ADPKD trials at the initiation of tolvaptan treatment.
Autosoom-dominantse polütsüstilise neeruhaiguse uuringutes on täheldatud ravi alustamisel tolvaptaaniga glomeerulite filtratsioonikiiruse pöörduvat vähenemist.
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/1/15/1000/020 14 tabletti (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tabletti (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tabletti (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/1/15/1000/011 14 tabletti (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tabletti (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tabletti (28 × 30 mg + 28 × 90 mg
Otsuka Pharmaceutical Netherlands B.V. Teл: +31 (0) 20 85 46 555
Teл: +31 (0) 20 85 46 555
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)
EU/1/15/1000/017 14 tabletti (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tabletti (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tabletti (28 × 30 mg + 28 × 60 mg)
• gout
• lööve
The active substance is tolvaptan.
Mida Jinarc sisaldab Toimeaine on tolvaptaan.
België/Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V. Tél/Tel: +31 (0) 20 85 46 555
België/Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V.
• nausea
• nahakihelus
• fatigue
• unehäired
Abdominal pain, Abdominal distension, Constipation, Dyspepsia,
Farmakodünaamiliselt prognoositavad ja kõige sagedamini esinevad kõrvaltoimed on janu, polüuuria,
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
7 × 30 mg tabletti ja 7 × 90 mg tabletti voldikpakendis 14 × 30 mg tabletti ja 14 × 90 mg tabletti voldikpakendis 28 × 30 mg tabletti ja 28 × 90 mg tabletti voldikpakendis
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 tabletti 1 PVC/alumiiniumfooliumist blistris 7 × 30 mg ja 7 × 90 mg tabletiga 28 tabletti 2 PVC/alumiiniumfooliumist blistris 7 × 30 mg ja 7 × 90 mg tabletiga 56 tabletti 4 PVC/alumiiniumfooliumist blistris 7 × 30 mg ja 7 × 90 mg tabletiga
Each 30 mg tablet contains approximately 70 mg lactose (as monohydrate).
Teadaolevat toimet omav(ad) abiaine(d) Üks 30 mg tablett sisaldab ligikaudu 70 mg laktoosi (monohüdraadina).
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
14 tabletti 1 PVC/alumiiniumfooliumist blistris 7 × 30 mg ja 7 × 60 mg tabletiga 28 tabletti 2 PVC/alumiiniumfooliumist blistris 7 × 30 mg ja 7 × 60 mg tabletiga 56 tabletti 4 PVC/alumiiniumfooliumist blistris 7 × 30 mg ja 7 × 60 mg tabletiga
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 tabletti 1 PVC/alumiiniumfooliumist blistris voldikpakendis 7 × 30 mg ja 7 × 90 mg tabletiga 28 tabletti 2 PVC/alumiiniumfooliumist blistris voldikpakendis 7 × 30 mg ja 7 × 90 mg tabletiga 56 tabletti 4 PVC/alumiiniumfooliumist blistris voldikpakendis 7 × 30 mg ja 7 × 90 mg tabletiga
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
7 × 30 mg tabletti ja 7 × 60 mg tabletti voldikpakendis 14 × 30 mg tabletti ja 14 × 60 mg tabletti voldikpakendis 28 × 30 mg tabletti ja 28 × 60 mg tabletti voldikpakendis
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)
Jinarc 30 mg tabletid + Jinarc 90 mg tabletid EU/1/15/1000/011-013
General disorders and administration site conditions
Üldised häired ja manustamisko ha reaktsioonid
Otsuka Pharmaceutical Netherlands B.V. Thλ: +31 (0) 20 85 46 555
Thλ: +31 (0) 20 85 46 555
The key secondary composite endpoint (ADPKD progression) was time to multiple clinical progression events of: 1) worsening kidney function (defined as a persistent [reproduced over at least 2 weeks] 25 %
Põhiline teisene liittulemusnäitaja (autosoom-dominantse polütsüstilise neeruhaiguse progresseerumine) oli mitme kliinilise progresseerumise nähu tekkimiseni kulunud aeg:
Name
Tugevus
Strength Pharmaceutical Form Route of Administration Packaging
Ravimvorm Manustamistee
This summary was last updated in 07-2017.
Kokkuvõtte viimane uuendus: 07-2017.
The standard dose is one 75-mg tablet once a day.
Standardannus on üks 75 mg tablett üks kord ööpäevas.
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.
Euroopa avaliku hindamisaruande täistekst ravimi Clopidogrel TAD kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Clopidogrel TAD?
Mis meetmed võetakse, et tagada ravimi Clopidogrel TAD ohutu ja efektiivne kasutamine?
clopidogrel
klopidogreel
The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel TAD on 23 September 2009.
Euroopa Komisjon andis ravimi Clopidogrel TAD müügiloa, mis kehtib kogu Euroopa Liidus, 23. septembril 2009.
In acute coronary syndrome, treatment generally starts with a loading dose of four tablets.
Ägeda koronaarsündroomi korral algab ravi üldiselt küllastusannusega 4 tabletti.
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).
Seejärel jätkatakse standardannusega 75 mg ööpäevas vähemalt 4 nädalat (ST-segmendi elevatsiooniga infarkti korral) või kuni 12 kuud (ebastabiilse stenokardia või Q-sakita südameinfarkti korral).
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.
Ravim on näidustatud patsientidele, kellel on vähemalt üks vaskulaarhäirete, näiteks südameinfarkti või insuldi riskitegur, kes ei saa võtta K-vitamiini antagoniste (samuti antikoagulandid) ja kellel on väike verejooksurisk.
The Agency recommended that Clopidogrel TAD be approved for use in the EU.
Ravimiamet soovitas ravimi Clopidogrel TAD kasutamise Euroopa Liidus heaks kiita.
• peripheral arterial disease (problems with blood flow in the arteries);
• Perifeersete arterite haigus (arteriaalsed verevarustushäired).
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.
Ägeda koronaarsündroomi ja kodade virvenduse korral võetakse ravimit Clopidogrel TAD koos aspiriiniga, mille annus ei tohi ületada 100 mg.
Clopidogrel TAD is available as tablets containing 75 mg clopidogrel.
Ravimit Clopidogrel TAD turustatakse tablettidena, mis sisaldavad 75 mg klopidogreeli.
What is Clopidogrel TAD and what is it used for?
Mis on Clopidogrel TAD ja milleks seda kasutatakse?
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.
Ravimi Clopidogrel TAD ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.