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Issuing CEFTA Economy
Serbia
BTI Reference
2080/17
Validity Start Date
31/08/2017
Validity End Date
31/08/2020
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 tecnosti, u staklenom špricu sa iglom, zapremine 0,8 ml. Isporucuje se u kartonskoj kutiji sa naštampanom proizvodackom deklaracijom, koja sadrži dva šprica, dva pojedinacno upakovana tufera natopljena alkoholom i uputstvo za upotrebu. Proizvod sadrži adalimumab (humano monoklonsko antitelo) 40 mg, kao aktivnu komponentu, i pomocne supstance: manitol, limunsku kiselinu monohidrat, natrijum citrat, natrijum dihidrogenfosfat dihidrat, natrijum hlorid, polisorbat 80, natrijum hidroksid i vodu za injekcije. Primenjuje se supkutano, kod odraslih za lecenje reumatoidnog artritisa, ankilozirajuceg spondilitisa i aksijalnog spondiloartritisa bez radiografskog dokaza AS, psorijaznog artritisa, psorijaze i ulceronzog kolitisa, a kod dece i adolescenata za lecenje poliartikularnog juvenilnog idiopatskog artritisa. Koristi se, takode, za lecenje Kronove bolesti kod dece i odraslih.
National keywords
Imunološki proizvod (lek), pripremljen u pakovanju za prodaju na malo.
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