natgillin/translations-raw huggingface dataset:
The phase 3, multi-centre, international, randomized-withdrawal, placebo-controlled, double-blind trial 156-13-210 compared the efficacy and safety of tolvaptan (45 to 120 mg/day) to placebo in patients able to tolerate tolvaptan during a five-week titration and run-in period on tolvaptan.
Z multicentričnim, mednarodnim, z odtegnitvijo randomiziranim, s placebom nadzorovanim, dvojno slepim preskušanjem 3. faze št. 156-13-210 so primerjali učinkovitost in varnost tolvaptana (45
Jinarc is to be administered twice daily in split dose regimens of 45 mg + 15 mg, 60 mg + 30 mg or 90 mg + 30 mg.
Zdravilo Jinarc se daje dvakrat na dan po režimu razdeljenega odmerka 45 mg + 15 mg, 60 mg + 30 mg ali 90 mg + 30 mg. Jutranji odmerek je treba vzeti vsaj 30 minut pred jutranjim obrokom.
• pain in the abdomen
• bolečina v trebuhu
The active substance is tolvaptan.
Učinkovina je tolvaptan.
Jinarc 15 mg tablets: blisters with 7 or 28 tablets
Jinarc 15-mg tablete: pretisni omoti s 7 ali 28 tabletami
2) medically significant kidney pain (defined as requiring prescribed leave, last-resort analgesics,
2) medicinsko značilna bolečina ledvic (opredeljena kot bolečina, zaradi katere se predpiše bolniški stalež, analgetiki zadnjega izhoda, narkotiki in proti-nociceptivna zdravila, radiološki ali kirurški posegi)
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 15 mg tablete + Jinarc 45 mg tablete Jinarc 30 mg tablete + Jinarc 60 mg tablete Jinarc 30 mg tablete + Jinarc 90 mg tablete
Fri.
• izpuščaj
1,692 mL (height adjusted 972 mL/m).
(CKD-EPI), pri čemer jih je imelo 79 % hipertenzijo in povprečni TKV 1.692 ml (prilagojeno za višino 972 ml/m).
• itching of your skin
• srbenje kože
CYP3A inhibitors
Zaviralci CYP3A
Jinarc contains lactose as an excipient.
Zdravilo Jinarc vsebuje laktozo kot pomožno snov.
What Jinarc contains
Kaj vsebuje zdravilo Jinarc
Jinarc 15 mg tablets + Jinarc 45 mg tablets Each 15 mg tablet contains 15 mg of tolvaptan.
Jinarc 15 mg tablete + Jinarc 45 mg tablete Ena 15-mg tableta vsebuje 15 mg tolvaptana.
Jinarc 30 mg tablets: blisters with 7 or 28 tablets
Jinarc 30-mg tablete: pretisni omoti s 7 ali 28 tabletami
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 tablete + Jinarc 45 mg tablete EU/1/15/1000/005-007 (pretisni omot) EU/1/15/1000/014-016 (pretisni omot in zgibanka)
• ADRs associated with long term use of Jinarc
• resnih neželenih učinkih, povezanih z dolgotrajno uporabo zdravila Jinarc
The expiry date refers to the last day of that month.
zgibanki in pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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
Na izhodišču so imeli bolniki povprečno ocenjeno stopnjo glomerularne filtracije (eGFR) 82 ml/min/1,73 m
• 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)
• Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1,
• Volume depletion
• splošna oslabelost
Abdominal pain, Abdominal distension, Constipation, Dyspepsia,
Bolezni prebavil driska, suha usta bolečina v trebuhu, trebušna distenzija, konstipacija, dispepsija, gastroezofagealna refluksna bolezen
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 tablete + Jinarc 90 mg tablete EU/1/15/1000/011-013 (pretisni omot) EU/1/15/1000/020-022 (pretisni omot in zgibanka)
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 tablete + Jinarc 60 mg tablete EU/1/15/1000/008-010 (pretisni omot) EU/1/15/1000/017-019 (pretisni omot in zgibanka)
Serum sodium abnormalities
Nenormalnosti natrija v serumu
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.
Razlika v spremembi eGFR pri zdravljenju, opažena v enem letu tega preskušanja, je 1,27 ml/min/1,73 m2, kar predstavlja 35-% zmanjšanje mediane najmanjših kvadratov pri spremembi eGFR -2,34 ml/min/1,73 m v skupini, ki je prejemala tolvaptan, v primerjavi z -3,61 ml/min/1,73 m v skupini, ki je prejemala placebo.
Each 15 mg tablet contains approximately 35 mg lactose (as monohydrate).
Ena 15-mg tableta vsebuje približno 35 mg laktoze (v obliki monohidrata).
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 tableta: modra, kvadratna (6,8 mm na stran, večja os: 8,2 mm), plitko konveksna z vtisnjenim napisom "OTSUKA" in "45" na eni strani.
How to store Jinarc
Shranjevanje zdravila Jinarc
30 mg tablet: blue, round, debossed with “OTSUKA” and “30” on one side.
30-mg tableta: modra, okrogla z vtisnjenim napisom "OTSUKA" in "30" na eni strani.
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 tablete + Jinarc 15-mg tablete: pretisni omoti z zgibanko ali brez nje s 14 (7 tablet večje jakosti + 7 tablet manjše jakosti), 28 (14 tablet večje jakosti + 14 tablet manjše jakosti) ali 56 (28 tablet večje jakosti + 28 tablet manjše jakosti) tabletami.
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 tableta: modra, trikotna (večja os: 6,58 mm, manjša os: 6,20 mm), plitko konveksna z vtisnjenim napisom "OTSUKA" in "15" na eni strani.
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 tableta: modra, peterokotna (večja os: 9,7 mm, manjša os: 9,5 mm), plitko konveksna z vtisnjenim napisom "OTSUKA" in "90" na eni strani.
• nausea
• bruhanje
Cardiac disorders
Srčne bolezni palpitacije
Each 45 mg tablet contains 45 mg tolvaptan.
Ena 45-mg tableta vsebuje 45 mg tolvaptana.
Each 60 mg tablet contains 60 mg tolvaptan.
Ena 60-mg tableta vsebuje 60 mg tolvaptana.
Each 45 mg tablet contains approximately 12 mg lactose (as monohydrate).
Ena 45-mg tableta vsebuje približno 12 mg laktoze (v obliki monohidrata).
Each 30 mg tablet contains 30 mg tolvaptan.
Ena 30-mg tableta vsebuje 30 mg tolvaptana.
Each 60 mg tablet contains approximately 16 mg lactose (as monohydrate).
Ena 60-mg tableta vsebuje približno 16 mg laktoze (v obliki monohidrata).
Each 15 mg tablet contains 15 mg tolvaptan.
Ena 15-mg tableta vsebuje 15 mg tolvaptana.
• vomiting
• zasoplost
Each 90 mg tablet contains 90 mg tolvaptan.
Ena 90-mg tableta vsebuje 90 mg tolvaptana.
Blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Modra, trikotna (večja os: 6,58 mm, manjša os: 6,20 mm), plitko konveksna z vtisnjenim napisom "OTSUKA" in "15" na eni strani.
Jinarc 30 mg tablets + Jinarc 60 mg tablets Each 30 mg tablet contains 30 mg of tolvaptan.
Jinarc 30 mg tablete + Jinarc 60 mg tablete Ena 30-mg tableta vsebuje 30 mg tolvaptana.
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 tablete + Jinarc 30-mg tablete: pretisni omoti z zgibanko ali brez nje s 14 (7 tablet večje jakosti + 7 tablet manjše jakosti), 28 (14 tablet večje jakosti + 14 tablet manjše jakosti) ali 56 (28 tablet večje jakosti + 28 tablet manjše jakosti) tabletami.
Age Clearance of tolvaptan is not significantly affected by age.
Starost Starost nima značilnega vpliva na očistek tolvaptana.
Jinarc 15 mg tablets + Jinarc 45 mg tablets
Jinarc 15 mg tablete + Jinarc 45 mg tablete
Each 30 mg tablet contains approximately 70 mg lactose (as monohydrate).
Ena 30-mg tableta vsebuje približno 70 mg laktoze (v obliki monohidrata).
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 tableta: modra, modificiran pravokotnik (večja os: 9,9 mm, manjša os: 5,6 mm), plitko konveksna z vtisnjenim napisom "OTSUKA" in "60" na eni strani.
Each 90 mg tablet contains approximately 24 mg lactose (as monohydrate).
Ena 90-mg tableta vsebuje približno 24 mg laktoze (v obliki monohidrata).
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 tablete + Jinarc 30-mg tablete: pretisni omoti z zgibanko ali brez nje s 14 (7 tablet večje jakosti + 7 tablet manjše jakosti), 28 (14 tablet večje jakosti + 14 tablet manjše jakosti) ali 56 (28 tablet večje jakosti + 28 tablet manjše jakosti) tabletami.
Jinarc 30 mg tablets + Jinarc 90 mg tablets Each 30 mg tablet contains 30 mg of tolvaptan.
Jinarc 30 mg tablete + Jinarc 90 mg tablete Ena 30-mg tableta vsebuje 30 mg tolvaptana.
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 tablete in 7 × 45 mg tablete 14 × 15 mg tabletein 14 × 45 mg tablete 28 × 15 mg tablete in 28 × 45 mg tablete
30 but greater than 15 mL/min/1.73 m
3b 45 % (eGFR 30-45 ml/min/1,73 m
WALLET CARD
ZUNANJA ŠKATLA
• weight loss
• izguba telesne mase
• constipation
• utrujenost
Each tablet contains 15 mg tolvaptan.
Ena tableta vsebuje 15 mg tolvaptana.
• Hypernatraemia
• hipernatriemija.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj, pruritus
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 tablete in 7 × 45 mg tablete v zgibanka 14 × 15 mg tablete in 14 × 45 mg tablete v zgibanka 28 × 15 mg tablete in 28 × 45 mg tablete v zgibanka
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 tablet (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tablet (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tablet (28 × 15 mg + 28 × 45 mg)
• Obligation to conduct post-authorisation measures
• Obveznosti izvajanja ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okvirju izvesti naslednje ukrepe:
Each tablet contains 30 mg tolvaptan.
Ena tableta vsebuje 30 mg tolvaptana.
Each Jinarc 15 mg tablet contains 15 mg tolvaptan.
Ena 15-mg tableta zdravila Jinarc vsebuje 15 mg tolvaptana.
Each Jinarc 30 mg tablet contains 30 mg tolvaptan.
Ena 30-mg tableta zdravila Jinarc vsebuje 30 mg tolvaptana.
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 tablet (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tablet (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tablet (28 × 15 mg + 28 × 45 mg)
15 mg tablet: blue, triangular, debossed with “OTSUKA” and “15” on one side.
45-mg tableta: modra, kvadratna z vtisnjenim napisom "OTSUKA" in "45" na eni strani.
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 tablete in 7 × 90 mg tablete 14 × 30 mg tablete in 14 × 90 mg tablete 28 × 30 mg tablete in 28 × 90 mg tablete
Each Jinarc 45 mg tablet contains 45 mg tolvaptan.
Ena 45-mg tableta zdravila Jinarc vsebuje 45 mg tolvaptana.
Each Jinarc 60 mg tablet contains 60 mg tolvaptan.
Ena 60-mg tableta zdravila Jinarc vsebuje 60 mg tolvaptana.
Jinarc 30 mg tablets + Jinarc 90 mg tablets
Jinarc 30 mg tablete + Jinarc 90 mg tablete
30 mg tablet: blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
30-mg tableta: modra, okrogla (premer: 8 mm), plitko konveksna z vtisnjenim napisom "OTSUKA" in "30" na eni strani.
Each Jinarc 90 mg tablet contains 90 mg tolvaptan.
Ena 90-mg tableta zdravila Jinarc vsebuje 90 mg tolvaptana.
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 tablete in 7 × 60 mg tablete 14 × 30 mg tablete in 14 × 60 mg tablete 28 × 30 mg tablete in 28 × 60 mg tablete
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
14 tablet v 1 pretisnem omotu PVC/aluminijasta folija v zgibanki s 7 × 15 mg in 7 × 45 mg tabletami 28 tablet v 2 pretisnih omotih PVC/aluminijasta folija v zgibanki s 7 × 15 mg in 7 × 45 mg tabletami 56 tablet v 4 pretisnih omotih PVC/aluminijasta folija v zgibanki s 7 × 15 mg in 7 × 45 mg tabletami
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 tablet (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tablet (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tablet (28 × 30 mg + 28 × 60 mg)
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 tablet v 1 pretisnem omotu PVC/aluminijasta folija s 7 × 15 mg in 7 × 45 mg tabletami 28 tablet v 2 pretisnih omotih PVC/aluminijasta folija s 7 × 15 mg in 7 × 45 mg tabletami 56 tablet v 4 pretisnih omotih PVC/aluminijasta folija s 7 × 15 mg in 7 × 45 mg tabletami
Anaphylactic shock,
Bolezni imunskega sistema anafilaktični šok, generalizirani izpuščaj
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 tablete in 7 × 90 mg tablete v zgibanka 14 × 30 mg tablete in 14 × 90 mg tablete v zgibanka 28 × 30 mg tablete in 28 × 90 mg tablete v zgibanka
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 tablet (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tablet (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tablet (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 tablet (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tablet (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tablet (28 × 30 mg + 28 × 90 mg)
• heartburn
• srbečica
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 tablete in 7 × 60 mg tablete v zgibanka 14 × 30 mg tablete in 14 × 60 mg tablete v zgibanka 28 × 30 mg tablete in 28 × 60 mg tablete v zgibanka
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 tablet (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tablet (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tablet (28 × 30 mg + 28 × 60 mg)
Jinarc 15 mg tablets EU/1/15/1000/001-002 (blister)
Jinarc 15 mg tablete EU/1/15/1000/001-002 (pretisni omot) Jinarc 30 mg tablete EU/1/15/1000/001-004 (pretisni omot)
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 tablet v 1 pretisnem omotu PVC/aluminijasta folija v zgibanki s 7 × 30 mg in 7 × 60 mg tabletami 28 tablet v 2 pretisnih omotih PVC/aluminijasta folija v zgibanki s 7 × 30 mg in 7 × 60 mg tabletami 56 tablet v 4 pretisnih omotih PVC/aluminijasta folija v zgibanki s 7 × 30 mg in 7 × 60 mg tabletami
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 tablet v 1 pretisnem omotu PVC/aluminijasta folija v zgibanki s 7 × 30 mg in 7 × 90 mg tabletami 28 tablet v 2 pretisnih omotih PVC/aluminijasta folija v zgibanki s 7 × 30 mg in 7 × 90 mg tabletami 56 tablet v 4 pretisnih omotih PVC/aluminijasta folija v zgibanki s 7 × 30 mg in 7 × 90 mg tabletami
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 tablet v 1 pretisnem omotu PVC/aluminijasta folija s 7 × 30 mg in 7 × 90 mg tabletami 28 tablet v 2 pretisnih omotih PVC/aluminijasta folija s 7 × 30 mg in 7 × 90 mg tabletami 56 tablet v 4 pretisnih omotih PVC/aluminijasta folija s 7 × 30 mg in 7 × 90 mg tabletami
• find it difficult to urinate.
• težko odvajate vodo
• shortness of breath
• razbijanje srca
Aspartate aminotransferase increased,
Preiskave zvišana raven alanin aminotransferaz, zvišana raven aspartat aminotransferaz, zmanjšana telesna masa zvišana raven bilirubina
The treatment difference in eGFR change observed in this trial is 1.27 mL/min/1.73 m 2, representing a
Zmanjšanje eGFRCKD-EPI od 72,2 do 9,79 (ml/min/1,73 m2) je bilo povezano z
• muscle spasms
• suha usta
Strength Pharmaceutical Form Route of Administration Packaging
ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
EMEA Number
številka EU
This summary was last updated in 07-2017.
Povzetek je bil nazadnje posodobljen 07-2017.
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.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Klopidogrel TAD je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel TAD on 23 September 2009.
Evropska komisija je dovoljenje za promet z zdravilom Klopidogrel TAD, veljavno po vsej Evropski uniji, izdala 23. septembra 2009.
The standard dose is one 75-mg tablet once a day.
Običajni odmerek zdravila je ena 75-miligramska tableta enkrat na dan.
• recently had a myocardial infarction (heart attack).
• so nedavno doživeli miokardni infarkt (srčni napad).
Clopidogrel TAD
Klopidogrel TAD
What measures are being taken to ensure the safe and effective use of Clopidogrel TAD?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Klopidogrel TAD?
This is a summary of the European public assessment report (EPAR) for Clopidogrel TAD.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Klopidogrel TAD.
• peripheral arterial disease (problems with blood flow in the arteries);
• imajo periferno arterijsko bolezen (težave s pretokom krvi v arterijah);
This means that Clopidogrel TAD is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
What are the benefits and risks of Clopidogrel TAD?
Kakšne so koristi in tveganja, povezani z zdravilom Klopidogrel TAD?
This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
To preprečuje, da bi trombociti postali „lepljivi“, ter tako zmanjšuje tveganje za nastanek krvnih strdkov in prispeva k preprečitvi novega srčnega napada ali kapi.
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.
Pri akutnem koronarnem sindromu in atrijski fibrilaciji se zdravilo Klopidogrel TAD uporablja skupaj z aspirinom, katerega odmerek ne sme biti višji od 100 mg.
Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Akutni koronarni sindrom je skupina obolenj srca, ki zajema tudi srčni napad in nestabilno angino pektoris (hudo obliko bolečine v prsih).
What is Clopidogrel TAD and what is it used for?
Kaj je zdravilo Klopidogrel TAD in za kaj se uporablja?
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).
Temu sledi običajni 75-miligramski odmerek enkrat na dan v trajanju najmanj štirih tednov (pri miokardnem infarktu z dvigom spojnice ST) ali največ 12 mesecev (pri nestabilni angini pektoris ali pri miokardnem infarktu brez zobca Q).
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.
Uporablja se pri tistih bolnikih, ki imajo vsaj en dejavnik tveganja za vaskularne dogodke, kot so srčni napad ali možganska kap, ter tistih, ki ne smejo jemati antagonistov vitamina K (drugega zdravila, ki preprečuje krvne strdke) in pri katerih je tveganje za krvavitve majhno.
For more information about treatment with Clopidogrel TAD, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Klopidogrel TAD preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Klopidogrel TAD upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
In acute coronary syndrome, treatment generally starts with a loading dose of four tablets.
Pri akutnem koronarnem sindromu se zdravljenje načeloma uvede z začetnim odmerkom štirih tablet.
Clopidogrel TAD can be started between a few days and 35 days after the attack;
Zdravilo Klopidogrel TAD se lahko začne jemati od nekaj dni po napadu do 35 dni po njem;
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.
Ker je zdravilo Klopidogrel TAD generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Clopidogrel TAD is a medicine used to prevent problems caused by blood clots in adults who have:
Zdravilo Klopidogrel TAD se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki pri odraslih, ki: