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Issuing CEFTA Economy
Serbia
BTI Reference
1840/17
Validity Start Date
19/01/2017
Validity End Date
19/01/2020
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 liofilizovanog praha, upakovanog u staklenu bocicu, koja se uz uputstvo za upotrebu isporucuje u kartonskoj kutiji sa naštampanom proizvodackom deklaracijom. Proizvod sadrži infliksimab (himerno monoklonsko antitelo) 100 mg, kao aktivnu komponentu, i pomocne supstance: polisorbat 80, saharozu, natrijum dihidrogenfosfat, monohidrat i dinatrijum fosfat, dihidrat. Nakon rekonstitucije, 1 ml rastvora sadrži 10 mg infliksimaba. Primenjuje se putem intravenske infuzije, nakon rekonstitucije dodatkom vode za injekcije, u lecenju reumatoidnog i psorijaticnog artritisa, ankilozirajuceg spondilitisa i psorijaze, kod odraslih osoba, kao i u lecenju Kronove bolesti i ulceroznog kolitisa, kod odraslih i dece starosti 6 godina i više. Terapeutsko dejstvo leka (pripada grupi „TNF blokatora“) se zasniva na sprecavanju delovanja proteina TNFa, koji ucestvuje u zapaljenskim procesima u organizmu.
National keywords
Imunološki proizvod (lek)
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