Examples of using Refacto in English and their translations into Croatian
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Due to the difference in methods used to assign product potency of XYNTHA and ReFacto AF, 1 IU of the XYNTHA product(one-stage assay calibrated) is approximately equivalent to 1.38 IU of the ReFacto AF product chromogenic assay calibrated.
If you are not going to use the ReFacto AF solution immediately, you should store
Ako nećete odmah primijeniti ReFacto AF otopinu, štrcaljku trebate čuvati u uspravnom položaju,In a study in which the potency of ReFacto AF, ReFacto
U ispitivanju u kojem su jačina lijeka ReFacto AF, In a cross-over pharmacokinetic study, the pharmacokinetic parameters for ReFacto AF were determined at baseline and followed up in 25 previously treated patients(≥ 12 years) after repeated administration of ReFacto AF for six months.
U ukriženom farmakokinetičkom ispitivanju, farmakokinetički parametri za ReFacto AF bili su određeni na početku u 25 prethodno liječenih bolesnika(≥ 12 godina) i praćeni nakon ponavljane primjene lijeka ReFacto AF tijekom šest mjeseci.Safety of ReFacto AF was evaluated in previously treated children
Sigurnost lijeka ReFacto AF bila je procijenjena u prethodno liječene djeceC≤ 2%) undergoing major surgery, 1 inhibitor was observed in 30 patients who received treatment with ReFacto AF.
koji su išli na veliki kirurški zahvat, u 30 bolesnika koji su primali liječenje lijekom ReFacto AF bio je opažen 1 inhibitor.expose the grey rubber tip cap of the ReFacto AF pre-filled syringe.
izložili sivi gumeni čep na ReFacto AF napunjenoj štrcaljki.It is strongly recommended that every time ReFacto AF is administered to a patient, the name on the carton and batch number of the product are recorded in order to maintain a link between the patient and the batch number of the medicinal product.
Izričito se preporučuje se zabilježiti naziv na kutiji i broj serije lijeka svaki put kad se bolesniku primjenjuje ReFacto AF kako bi se vodila evidencija o primijenjenim brojevima serije lijeka svakom bolesniku.The manufacturing process for ReFacto was modified to eliminate any exogenous human- or animal-derived protein in the cell culture process, purification, or final formulation; and at the same time the invented name was changed to ReFacto AF.
Proces proizvodnje lijeka ReFacto izmijenjen je kako bi se tijekom postupka kultivacije stanica, pročišćavanja i konačne formulacije uklonili svi egzogeni proteini ljudskog ili životinjskog porijekla; te je istovremeno zaštićeni naziv promijenjen u ReFacto AF.had subsequent extended exposure to ReFacto AF with a median of 169 additional ED range 9-425.
drugom potpornom ispitivanju i imalo je produženu izloženost lijeku ReFacto AF s medijanom od 169 dodatnih ED raspon 9-425.In a supporting study of ReFacto AF, 1 de novo and 2 recurrent inhibitors(all low-titre, central laboratory determination) were observed in 110 patients; median exposure of 58 ED(range 5-140) and 98 patients had at least 50 ED to ReFacto AF.
U potpornom ispitivanju lijeka ReFacto AF, 1 de novo i 2 ponovne pojave inhibitora(svi u niskom titru, određeni u središnjem laboratoriju) bile su opažene u 110 bolesnika; medijan izloženosti bio je 58 ED(raspon 5-140) i 98 bolesnika imalo je najmanje 50 ED za ReFacto AF.In the same study, in which the drug potency of ReFacto AF and a full-length recombinant factor VIII( FLrFVIII) comparator, and the FVIII activity measured in patient plasma samples were all determined using the same one-stage clotting assay at a central laboratory, ReFacto AF was shown to be pharmacokinetically equivalent to FLrFVIII in 30 previously treated patients(≥ 12 years) using the standard bioequivalence approach.
U istom ispitivanju u kojem su jačina lijeka ReFacto AF i komparatora pune duljine za rekombinantni faktor VIII( FLrFVIII) te aktivnost FVIII u uzorcima plazme bolesnika bili određeni pomoću istog testa zgrušavanja krvi u jednom koraku u središnjem laboratoriju, pokazalo se da je ReFacto AF farmakokinetički ekvivalentan FLrFVIII u 30 prethodno liječenih bolesnika( ≥ 12 godina) korištenjem standardnog bioekvivalencijskog pristupa.ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 3000 IU prašakReFacto AF contains sodium.
ReFacto AF sadrži natrij.Other medicines and ReFacto AF.
Drugi lijekovi i ReFacto AF.How to store ReFacto AF.
Kako čuvati ReFacto AF.How to use ReFacto AF.
Kako primjenjivati ReFacto AF.What ReFacto AF looks like
Kako ReFacto AF izgledaAllergic type hypersensitivity reactions have been observed with ReFacto AF.
S lijekom Refacto AF opažene su reakcije preosjetljivosti alergijskog tipa.ReFacto AF must be used within 3 hours of reconstitution.
ReFacto AF se mora primijeniti unutar 3 sata nakon pripreme.
