What is the translation of " LIJEKA REFACTO " in English?

• refacto

Examples of using Lijeka refacto in Croatian and their translations into English

Naljepnica bočice lijeka refacto af.
Refacto af vial label.

U kliničkom ispitivanju lijeka ReFacto AF u prethodno liječenih bolesnika incidencija inhibitora faktora VIII bila je primarni ishod ispitivanja sigurnosti.
In a clinical study with ReFacto AF in previously treated patients(PTPs), the incidence of factor VIII inhibitors was the primary safety endpoint.

Tijekom liječenja, liječnik može odlučiti promijeniti Vam promijeni dozu lijeka ReFacto AF koju primate.
During your treatment, your doctor may decide to change the dose of ReFacto AF you receive.

Ako primijenite više lijeka ReFacto AF nego što ste trebali.
If you use more ReFacto AF than you should.

Sigurnost lijeka ReFacto AF bila je procijenjena u prethodno liječene djece i adolescenata n=18, u dobi od 12 do 16 godina u jednom ispitivanju i n=49, u dobi od 7 do 16 godina u potpornom ispitivanju.
Safety of ReFacto AF was evaluated in previously treated children and adolescents n=18, age 12-16 years in a study and n=49, age 7-16 years in a supporting study.

To pokazuje da farmakokinetička svojstva lijeka ReFacto AF nisu podložna promjeni tijekom vremena.
This indicates no time-dependent changes in the pharmacokinetic properties of ReFacto AF.

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.
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.

Specifična aktivnost lijeka ReFacto AF je 7600-13 800 IU/mg proteina.
The specific activity of ReFacto AF is 7,600-13,800 IU/mg protein.

Tijekom kliničkih ispitivanja, djeca u dobi manjoj od 6 godina na profilaktičkom režimu uzimala su prosječnu dozu od 50 IU/kg lijeka ReFacto i imala u prosjeku 6, 1 epizoda krvarenja godišnje.
During the clinical trials, children less than 6 years of age on a prophylaxis regimen used an average dose of 50 IU/kg of ReFacto and experienced an average of 6.1 bleeding episodes per year.

Jedna napunjena štrcaljka lijeka ReFacto AF nominalno sadrži 250, 500, 1000, 2000 ili 3000 IU moroktokoga alfa.
Each pre-filled syringe of ReFacto AF contains nominally 250, 500, 1000, 2000, or 3000 IU of moroctocog alfa.

Postupci niže ponuđeni su kao smjernice za pripremu i primjenu lijeka ReFacto AF koji dolazi u napunjenoj štrcaljki.
The procedures below are provided as guidelines for the reconstitution and administration of ReFacto AF provided in a pre-filled syringe.

Zabilježeni izostanak učinka lijeka ReFacto opisan je kao krvarenje u ciljne zglobove, krvarenje u nove zglobove ili subjektivan osjećaj bolesnika da je nastupilo novo krvarenje.
The reported lack of effect with ReFacto has been described as bleeding into target joints, bleeding into new joints or a subjective feeling by the patient of new onset bleeding.

Klinička ispitivanja u kojima se procjenjuje primjena lijeka ReFacto AF u djece u dobi do 6 godina još su u tijeku.
Clinical trials evaluating use of ReFacto AF in children less than 6 years of age are ongoing.

U ispitivanju u kojem su jačina lijeka ReFacto AF, ReFacto i aktivnost FVIII u plazmi bolesnika bile mjerene pomoću testa s kromogenim supstratom, pokazalo se da je ReFacto AF bioekvivalentan lijeku ReFacto..
In a study in which the potency of ReFacto AF, ReFacto and FVIII activity in patient plasma were measured using the chromogenic substrate assay, ReFacto AF was shown to be bioequivalent to ReFacto..

U prethodno neliječenih bolesnika farmakokinetički parametri lijeka ReFacto bili su procijenjeni pomoću kromogenog testa.
In PUPs, pharmacokinetic parameters of ReFacto were evaluated using the chromogenic assay.

Farmakokinetička svojstva lijeka ReFacto, izvedena iz ukriženog ispitivanja lijeka ReFacto i koncentrata FVIII dobivenog iz plazme, pomoću testa kromogenim supstratom(vidjeti dio 4.2), u 18 prethodno liječenih bolesnika navedena su u tablici niže.
Pharmacokinetic properties of ReFacto, derived from a cross-over study of ReFacto and a plasma- derived FVIII concentrate, using the chromogenic substrate assay(see section 4.2), in 18 previously treated patients are listed in the table below.

Napomena: Ako trebate primijeniti više od jedne napunjene štrcaljke lijeka ReFacto AF po infuziji, svaku je štrcaljku potrebno pripremiti prema posebnim uputama.
Note: If you need to use more than one pre-filled syringe of ReFacto AF per infusion, each syringe should be reconstituted according to the specific directions.

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.
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.

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 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 tijeku su klinička ispitivanja s lijekom ReFacto AF u prethodno neliječenih bolesnika.
Clinical trials are ongoing in previously untreated patients(PUPs) with ReFacto AF.

Dok se liječite lijekom ReFacto AF, trebate biti pod nazdorom zbog mogućeg razvoja inhibitora faktora VIII.
While being treated with ReFacto AF, you should be monitored for the development of factor VIII inhibitors.

U kliničkom ispitivanju s lijekom ReFacto, 32 od 101(32%) prethodno neliječena bolesnika(FVIII: C< 2%) razvila su inhibitore.
In a clinical trial with ReFacto, 32 out of 101(32%) PUPs(FVIII: C< 2%) developed inhibitors.

Bolesnici ili njihovi skrbnici mogu davati injekcije s lijekom ReFacto AF, uz uvjet da su dobili prikladnu obuku.
Patients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately.

Kod praćenja razine aktivnosti faktora VIII u bolesnika tijekom liječenja lijekom ReFacto AF, izričito se preporučuje uporaba kromogenog testa.
When monitoring patients' factor VIII activity levels during treatment with ReFacto AF, use of the chromogenic assay is recommended.

Za jedan slučaj ciste u 11-godišnjeg bolesnika i jedan slučaj opisan kao smetenost u 13-godišnjeg bolesnika zabilježeno je da postoji mogućnost povezanosti s liječenjem lijekom ReFacto AF.
One event of cyst in an 11-year old patient and one event described as confusion in a 13-year old patient have been reported as possibly related to ReFacto AF treatment.

U kliničkom ispitivanju prethodno liječenih bolesnika s hemofilijom A(faktor VIII: C ≤2%) koji su išli na veliki kirurški zahvat, u 30 bolesnika koji su primali liječenje lijekom ReFacto AF bio je opažen 1 inhibitor.
In a clinical study of PTPs with haemophilia A(factor VIII: C≤ 2%) undergoing major surgery, 1 inhibitor was observed in 30 patients who received treatment with ReFacto AF.

Devedeset osam(98) od prvobitnih 110 bolesnika nastavilo je liječenje u drugom potpornom ispitivanju i imalo je produženu izloženost lijeku ReFacto AF s medijanom od 169 dodatnih ED raspon 9-425.
Ninety-eight(98) of the original 110 patients continued treatment in a second supportive study and had subsequent extended exposure to ReFacto AF with a median of 169 additional ED range 9-425.

U lijeku ReFacto AF može u tragovima biti prisutan protein hrčka.
Trace amounts of hamster protein may be present in ReFacto AF.

Drugi lijekovi i ReFacto AF.
Other medicines and ReFacto AF.