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Issuing CEFTA Economy
Serbia
BTI Reference
1925/17
Validity Start Date
16/03/2017
Validity End Date
16/03/2020
Nomenclature code
3002150000
Justification
Language
Српски језик
Issuing place
Beograd
Issuing date
Goods description
Imunološki proizvod (lek), pripremljen u pakovanju za prodaju na malo. Predmetna roba je u vidu praha, upakovanog u staklenu bocicu, koja se uz uputstvo za upotrebu isporucuje u kartonskoj kutiji sa naštampanom proizvodackom deklaracijom. Proizvod sadrži vedolizumab (monoklonsko antitelo) 300 mg, kao aktivnu komponentu, i pomocne supstance: L-histidin, L-histidin hidrohlorid, L-arginin hidrohlorid, saharozu i polisorbat 80. Nakon rekonstitucije, 1 ml rastvora sadrži 60 mg vedolizumaba. Primenjuje se putem intravenske infuzije, nakon rekonstitucije dodatkom vode za injekcije, u lecenju Kronove bolesti i ulceroznog kolitisa, kod odraslih kod kojih nije postignut zadovoljavajuci odgovor, ili je odgovor postao neadekvatan, bilo na standardnu terapiju ili na antagoniste faktora nekroze tumora alfa (TNFa), kao i kod onih koji takvu terapiju nisu podnosili.
National keywords
imunološki proizvod
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