FrancophonIA/ELRC3.0 huggingface dataset:
English: Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Croatian: Aktivirani faktor VIII djeluje kao kofaktor za aktivirani faktor IX, ubrzavajući pretvorbu faktora X u aktivirani faktor X.
English: Recovery, IU/dl per IU/kg
Croatian: Povrat, IU/dl po IU/kg
English: After reconstitution, the solution is drawn back into the syringe.
Croatian: Nakon rekonstitucije, otopinu treba uvući natrag u štrcaljku.
English: Store and transport at 2°C - 8°C.
Croatian: Čuvati i prevoziti na temperaturi od 2C - 8C.
English: The corresponding 90% confidence intervals about the ratios of month 6-to-baseline for the above pharmacokinetic parameters were within the equivalence window of 80% to 125%.
Croatian: Odgovarajući 90%-tni intervali pouzdanosti omjera vrijednosti u 6. mjesecu i na početku za gornje farmakokinetičke parametre bili su unutar raspona ekvivalencije od 80% do 125%.
English: If you stop using ReFacto AF
Croatian: Ako prestanete primjenjivati ReFacto AF
English: Throughout the reconstitution process, it is important to keep the ReFacto AF pre-filled syringe upright (with the white powder above the clear solution) to prevent possible leakage.
Croatian: Tijekom cijelog postupka pripreme lijeka, važno je da ReFacto AF napunjenu štrcaljku držite uspravno (tako da je bijeli prašak iznad bistre otopine) kako biste spriječili eventualno istjecanje.
English: Factor VIII activity is greatly reduced in patients with haemophilia A, and, therefore, replacement therapy is necessary.
Croatian: Aktivnost faktora VIII jako je smanjena u bolesnika s hemofilijom A pa je stoga neophodna nadomjesna terapija.
English: Pfizer Limited Tel: +44 (0)1304 616161
Croatian: United Kingdom Pfizer Limited Tel: +44 (0)1304 616161
English: The product may not be returned to refrigerated storage after storage at room temperature.
Croatian: Lijek se ne smije vratiti u hladnjak nakon čuvanja na sobnoj temperaturi.
English: The table lists adverse reactions reported in the clinical trials with ReFacto or ReFacto AF.
Croatian: Tablica navodi nuspojave prijavljene u kliničkim ispitivanjima s lijekom ReFacto ili ReFacto AF.
English: FVIII inhibition (PTPs)*
Croatian: Inhibicija faktora VIII (PTPs)
English: ReFacto AF can be stored at room temperature (up to 25oC) for a single period up to 3 months.
Croatian: ReFacto AF može se čuvati na sobnoj temperaturi (do 25°C) tijekom jednog razdoblja do 3 mjeseca.
English: Detailed information on this medicine is available on European Medicines Agency website: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: The corresponding 90% confidence intervals about the ratios of ReFacto AF to ReFacto geometric means were within the bioequivalence window of 80% to 125%, demonstrating bioequivalence of ReFacto AF to ReFacto.
Croatian: Odgovarajući 90%-tni intervali pouzdanosti za omjere geometrijskih srednjih vrijednosti za ReFacto AF i ReFacto bili su unutar raspona bioekvivalencije od 80% do 125%, pokazujući da su ReFacto AF i ReFacto bioekvivalentni.
English: Consult with your health care provider before you travel.
Croatian: Potražite savjet svog liječnika prije odlaska na putovanje.
English: Population pharmacokinetic modeling using data from 44 PUPs led to a mean estimated half-life of 8.0 ± 2.2 hours.
Croatian: Modeliranjem populacijske farmakokinetike pomoću podataka prikupljenih u 44 prethodno neliječena bolesnika srednja vrijednost procijenjenog poluvijeka iznosi 8,0 ± 2,2 sati.
English: Safety of ReFacto AF was evaluated in studies that included both previously treated adults and previously treated children and adolescents (n=18, aged 12-16 years in a study and n=49, aged 7-16 years in a supporting study), with a tendency for higher frequencies of adverse reactions in children aged 7-16 years as compared to adults.
Croatian: Sigurnost lijeka ReFacto AF bila je procijenjena tijekom ispitivanja provedenih na prethodno liječenim odraslim osobama te prethodno liječenoj djeci i adolescentima (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) uz tendenciju prema većoj učestalosti nuspojava u djece u dobi od 7 do 16 godina u usporedbi s odraslima.
English: • low blood pressure, pain and redness of veins associated with a blood clot, flushing
Croatian: • nizak krvni tlak, bol i crvenilo vena povezani s krvnim ugruškom, navale crvenila
English: It is recommended to record the lot number from the ReFacto AF pre-filled syringe label every time you use ReFacto AF.
Croatian: Preporučuje se zabilježiti broj serije na naljepnici ReFacto AF napunjene štrcaljke svaki put kad primjenjujete ReFacto AF.
English: The number of units of factor VIII administered is expressed in International Units (IUs), which are related to the current WHO standard for factor VIII products.
Croatian: Broj jedinica primijenjenog faktora VIII izražen je u međunarodnim jedinicama (IU), koje se odnose na standard SZO-a za lijekove s faktorom VIII.
English: Do not use ReFacto AF
Croatian: Nemojte primjenjivati ReFacto AF
English: Note: If you use more than one vial of ReFacto AF per infusion, each vial should be reconstituted as per the previous instructions.
Croatian: Napomena: Ako primjenjujete više od jedne bočice ReFacto AF po infuziji, svaku bočicu trebate pripremiti prema prethodnim uputama.
English: Pfizer Tél: +33 (0)1 58 07 34 40
Croatian: Tél: +33 (0)1 58 07 34 40
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Croatian: Bolesnike treba obavijestiti o ranim znakovima reakcija preosjetljivosti, uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsištu, piskanje pri disanju, hipotenziju i anafilaksiju.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia A.
Croatian: Liječenje treba započeti pod nadzorom liječnika s iskustvom u liječenju hemofilije A.
English: Contains 4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection
Croatian: Sadrži 4 ml otopine natrijevog klorida 9 mg/ml (0,9%) za injekciju
English: Connect a sterile 10 cc or larger luer lock syringe to one opening (port) in the syringe connector and the ReFacto AF pre-filled syringe to the remaining open port on the opposite end.
Croatian: Spojite sterilnu štrcaljku od 10 cc ili veću štrcaljku s luer lock-om na jedan otvor (tzv. port) na konektoru za štrcaljku, a ReFacto AF napunjenu štrcaljku na preostali otvoreni port na suprotnoj strani.
English: 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.
Croatian: 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.
English: FVIII inhibition (PUPs)*
Croatian: Inhibicija faktora VIII (PUPs)
English: Remove the luer-to-luer syringe connector from its package (luer-to-luer syringe connectors are not provided).
Croatian: Izvadite luer-na-luer konektor za štrcaljku iz pakiranja (luer-na-luer konektori za štrcaljke nisu priloženi).
English: 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.
Croatian: 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.
English: Remove the protective blue vented sterile cap from its packaging.
Croatian: Izvadite zaštitni propusni plavi zatvarač iz pakiranja.
English: When using an in vitro thromboplastin time (aPTT)-based one-stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
Croatian: Prilikom primjene in vitro jednofaznog testa zgrušavanja na temelju tromboplastinskog vremena (aPTT) za određivanje aktivnosti faktora VIII u uzorcima krvi bolesnika, na rezultate aktivnosti faktora VIII u plazmi mogu znatno utjecati i vrsta aPTT reagensa i referentni standard koji se koristi u testu.
English: Remove the protective needle cover and insert the butterfly needle of the infusion set tubing into your vein, as instructed by your doctor or other healthcare professional.
Croatian: Uklonite zaštitni poklopac s igle i uvedite iglu s krilcima (tzv. “leptirić”) na infuzijskoj cijevi u venu, prema uputama liječnika ili drugog zdravstvenog radnika.
English: Dose by weight (IU/kg) per prophylaxis infusion a median (min, max)
Croatian: Doza prema težini (IU/kg) po profilaktičkoj infuziji medijan (minimum, maksimum)
English: During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Croatian: Savjetuje se odgovarajuće određivanje razina faktora VIII tijekom liječenja kako bi se vodilo određivanje doze koja se primjenjuje i učestalost ponavljanja infuzija.
English: Gently and slowly advance the plunger rod by pushing until the two plungers inside the pre-filled syringe meet, and all of the solvent is transferred to the top chamber containing the ReFacto AF powder.
Croatian: Nježno i polako uvedite klip i utiskujte ga sve dok se dva klipa unutar napunjene štrcaljke ne dodirnu i otapalo potpuno ne prijeđe u gornju komoru koja sadrži ReFacto AF prašak.
English: As part of the pivotal trial with ReFacto in PUPs, ITI data from 25 patients were reviewed (15 with high titres, 10 with low titres).
Croatian: U sklopu pivotalnog ispitivanja s ReFactom u prethodno neliječenih bolesnika pregledani su podaci o izazivanju imunološke tolerancije u 25 bolesnika (15 s visokim titrom, 10 s niskim titrom.
English: Powder and solvent for solution for injection in pre-filled syringe White to off-white cake/powder in top chamber of the pre-filled syringe Clear, colourless solvent in bottom chamber of the pre-filled syringe
Croatian: Prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Bijeli do gotovo bijeli kolačić/prašak u gornjoj komori napunjene štrcaljke Bistro, bezbojno otapalo u donjoj komori napunjene štrcaljke
English: More extensive haemarthrosis, muscle bleeding or haematoma
Croatian: Opsežnija hemartroza, krvarenje u mišiće ili hematom
English: • inhibitor development for patients who have never been previously treated with factor VIII
Croatian: • razvoj inhibitora u bolesnika koji prethodno nikad nisu bili liječeni lijekovima s faktorom VIII
English: No symptoms of overdose have been reported with recombinant coagulation factor VIII products.
Croatian: Nije zabilježen nijedan simptom predoziranja s lijekovima s rekombinantnim koagulacijskim faktorom VIII.
English: Mean ± SD FVIII Pharmacokinetic Parameters after Single 50 IU/kg Dose in Paediatric PTPs
Croatian: Srednja vrijednost  SD za farmakokinetičke parametre FVIII nakon pojedinačne doze od 50 IU/kg u prethodno liječenih pedijatrijskih bolesnika
English: Total ABR all subjects b median (min, max)
Croatian: Ukupni ABR svih ispitanika medijan (minimum, maksimum)
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).
English: Do not freeze, in order to prevent damage to the pre-filled syringe.
Croatian: Ne zamrzavati, kako ne bi došlo do oštećenja napunjene štrcaljke.
English: Patients should be advised to consult with their healthcare provider prior to travel.
Croatian: Bolesnicima također treba savjetovati da prije putovanja potraže savjet svog liječnika.
English: Abbreviations: Cmax = maximum observed plasma concentration; CV = coefficient of variation; AUCinf = area under the plasma concentration-time profile from time zero extrapolated to infinite time; t½ = terminal half-life; CL = clearance; Vss = steady-state volume of distribution.
Croatian: Kratice: Cmax, maksimalna zabilježena koncentracija u plazmi; CV, koeficijent varijacije; AUCinf, površina ispod krivulje za koncentraciju u plazmi - vremenski profil ekstrapoliran od nule do beskonačnog vremena; t½, terminalni poluvijek; CL, klirens; Vss, volumen distribucije u stanju dinamičke ravnoteže.
English: Do not touch the inside of the cap or the syringe tip.
Croatian: Nemojte dodirivati unutrašnjost zatvarača ili vršak štrcaljke.
English: Powder and solvent for solution for injection in pre-filled syringe FuseNGo
Croatian: Prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki FuseNGo
English: Whilst continuing to hold the ReFacto AF pre-filled syringe upright, remove the grey rubber tip cap and replace it with the protective blue vented cap.
Croatian: I dalje držeći ReFacto AF napunjenu štrcaljku uspravno, uklonite sivi gumeni zaštitni zatvarač na vrhu i zamijenite ga zaštitnim plavim propusnim zatvaračem.
English: Holding the pre-filled syringe upright, remove the white tamper-evident seal by bending the seal right to left (or a gentle rocking motion) to break the perforation of the cap and expose the grey rubber tip cap of the ReFacto AF pre-filled syringe.
Croatian: Držeći napunjenu štrcaljku uspravno, uklonite bijeli zatvarač za zaštitu tako što ćete ga savijati lijevo-desno (ili nježnim svijajućim pokretima) kako biste prelomili zatvarač duž perforacije i izložili sivi gumeni čep na ReFacto AF napunjenoj štrcaljki.
English: Screw the plunger rod firmly into the opening in the finger rest of the ReFacto AF pre-filled syringe by pushing and turning clockwise firmly until resistance is felt (approximately 2 turns).
Croatian: Čvrsto utisnite klip u otvor na označenom mjestu za prst na ReFacto AF napunjenoj štrcaljki tako što ćete ga pritisnuti i čvrsto zakrenuti u smjeru kazaljke na satu sve dok ne osjetite otpor (približno 2 zakretaja).
English: Use only the pre-filled syringe provided in the box for reconstitution.
Croatian: Za pripremu upotrijebite samo napunjenu štrcaljku priloženu u kutiji.
English: - After reconstitution with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution], the prepared solution for injection contains either 62.5, 125, 250, 500 or 750 IU of moroctocog alfa per ml, respectively (based on the strength of moroctocog alfa, i.e., 250, 500, 1000, 2000, or 3000 IU).
Croatian: - Nakon pripreme s priloženim otapalom [otopinom natrijevog klorida 9 mg/ml (0,9%)], pripremljena otopina za injekciju sadrži 62,5, 125, 250, 500 odnosno 750 IU moroktokoga alfa po ml (na temelju jačine moroktokoga alfa, tj., 250, 500, 1000, 2000 ili 3000 IU).
English: ReFacto AF is provided as a powder for injection in a glass vial and a solvent is provided in a prefilled syringe.
Croatian: ReFacto AF se isporučuje kao prašak za injekciju u staklenoj bočici, a otapalo se nalazi u napunjenoj štrcaljki.
English: ReFacto AF is given by injection into a vein lasting several minutes.
Croatian: ReFacto AF se daje injekcijom u venu u trajanju od nekoliko minuta.
English: Note: If the solution is not to be used immediately, the syringe cap is to be carefully replaced.
Croatian: Napomena: Ako nećete odmah primijeniti otopinu, trebate pažljivo vratiti zatvarač na štrcaljku.
English: c Subjects in the PTP study reported their FVIII treatment modality (prophylaxis or on demand) at baseline and were not required to maintain this modality as a condition of study participation.
Croatian: Ispitanici uključeni u ispitivanje provedeno na prethodno liječenim bolesnicima prijavili su na početku modalitet svog liječenja faktorom VIII (profilaktičkog ili prema potrebi) i nisu morali održavati taj modalitet kao uvjet sudjelovanja u ispitivanju.
English: Use immediately or within 3 hours of reconstitution.
Croatian: Primijeniti odmah ili u roku od 3 sata nakon pripreme otopine.
English: Do not remove the adapter from the package.
Croatian: Nemojte vaditi nastavak iz pakiranja.
English: Remove the protective blue vented cap and firmly attach the intravenous infusion set provided onto the ReFacto AF pre-filled syringe.
Croatian: Uklonite zaštitni propusni plavi zatvarač i čvrsto spojite priloženi komplet za intravensku infuziju na ReFacto AF napunjenu štrcaljku.
English: The reconstituted solution may be stored at room temperature for up to 3 hours.
Croatian: Pripremljena otopina može se čuvati na sobnoj temperaturi najdulje 3 sata.
English: After reconstitution this medicinal product contains 1.23 mmol (29 mg) sodium per vial or pre-filled syringe, to be taken into consideration by patients on a controlled sodium diet.
Croatian: Nakon rekonstitucije ovaj lijek sadrži 1,23 mmol (29 mg) natrija po bočici ili napunjenoj štrcaljki, što treba uzeti u obzir kod bolesnika na dijeti s ograničenim unosom natrija.
English: CL, mL/h/kgb
Croatian: CL, ml/h/kg Vss, ml/kg a
English: A solvent [sodium chloride 9 mg/ml (0.9%) solution for injection] is included within the ReFacto AF pre-filled syringe for reconstituting moroctocog alfa.
Croatian: Otapalo [otopina za injekciju natrijevog klorida od 9 mg/ml [0,9%]) priloženo je unutar ReFacto AF napunjene štrcaljke za pripremu otopine moroktokoga alfa.
English: This indicates no time-dependent changes in the pharmacokinetic properties of ReFacto AF.
Croatian: To pokazuje da farmakokinetička svojstva lijeka ReFacto AF nisu podložna promjeni tijekom vremena.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ReFacto AF.
Croatian: Do razvoja neutralizirajućih antitijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući lijekom ReFacto AF.
English: 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.
Croatian: 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.
English: Trace amounts of hamster protein may be present in ReFacto AF.
Croatian: U lijeku ReFacto AF može u tragovima biti prisutan protein hrčka.
English: Remove the luer-to-luer syringe connector from the 10 cc or larger luer lock syringe and attach the infusion set, as described above in the directions for administration of the pre-filled syringe [see Administration (Intravenous Infusion)].
Croatian: Uklonite luer-na-luer konektor za štrcaljku sa štrcaljke od 10 cc ili veće štrcaljke s luer lock-om i pripojite komplet za infuziju, kako je opisano gore u uputama za primjenu napunjene štrcaljke [pogledajte Primjena (intravenska infuzija)].
English: Lift the package away from the adapter and discard the package.
Croatian: Pakiranje odvojite od nastavka i bacite ga.
English: When monitoring patients' factor VIII activity levels during treatment with ReFacto AF, use of the chromogenic assay is recommended.
Croatian: Kod praćenja razine aktivnosti faktora VIII u bolesnika tijekom liječenja lijekom ReFacto AF, izričito se preporučuje uporaba kromogenog testa.
English: After reconstitution, the solution will be clear or slightly opalescent and colourless.
Croatian: Nakon rekonstitucije, otopina će biti bistra ili blago opalescentna i bezbojna.
English: ReFacto AF contains the active substance moroctocog alfa, human coagulation factor VIII.
Croatian: ReFacto AF sadrži djelatnu tvar moroktokog alfa, ljudski koagulacijski faktor VIII.
English: • difficulty in breathing, wheezing, tightness in the chest
Croatian: • otežano disanje, piskanje pri disanju, stezanje u prsnom košu
English: Common to < 1/10
Croatian: Često ≥ 1/100 i < 1/10
English: The pre-filled syringe consists of 2 chambers, one chamber contains the ReFacto AF lyophilised powder and the other chamber contains the solvent [sodium chloride 9 mg/ml (0.9%) solution].
Croatian: Napunjena štrcaljka sastoji se od dvije komore: jedna komora sadrži liofilizirani prašak ReFacto AF, a druga komora sadrži otapalo [otopinu natrijevog klorida od 9 mg/ml (0,9%)].
English: Allergic type hypersensitivity reactions have been observed with ReFacto AF.
Croatian: S lijekom Refacto AF opažene su reakcije preosjetljivosti alergijskog tipa.
English: Tabulated list of adverse reactions
Croatian: Tabelirani popis nuspojava
English: • rash, hives, wheals, generalised itching
Croatian: • osip, koprivnjača, generalizirani svrbež
English: Remove the plastic flip-top cap from the ReFacto AF vial to expose the central portion of the rubber stopper.
Croatian: Uklonite plastični poklopac s bočice ReFacto AF kako biste izložili središnji dio gumenog čepa.
English: Vss, mL/kgb a Geometric mean (geometric CV%) for all, except for arithmetic mean ±SD for incremental recovery and t½.
Croatian: Geometrijska srednja vrijednost (geometrijski CV%) za sve, osim za aritmetičku sredinu ± SD za prirast po jedinici doze i t½.
English: Solvent for ReFacto AF
Croatian: Otapalo za ReFacto AF
English: MRT (h) recovery (IU/dl increase in FVIII:C per IU/kg FVIII given) Abbreviations: AUCt = area under the plasma concentration-time curve from zero to the last measurable concentration; t½ = half-life; CL = clearance; FVIII:C = FVIII activity; MRT = mean residence time
Croatian: Kratice: AUCt = površina ispod krivulje koncentracije u plazmi tijekom vremena od nule do posljednje mjerljive koncentracije; t½ = poluvijek; CL = klirens; FVIII:C = FVIII aktivnost; MRT = srednja vrijednost vremena zadržavanja
English: You can use the peel-off label found on the ReFacto AF pre-filled syringe to record the lot number.
Croatian: Možete uporabiti samoljepivu naljepnicu koja se nalazi na ReFacto AF napunjenoj štrcaljki kako biste zabilježili broj serije.
English: Place the vial on a flat surface.
Croatian: Postavite bočicu na ravnu površinu.
English: Use immediately or within 3 hours of reconstitution or after removing the grey rubber tip cap from the syringe
Croatian: Primijeniti odmah ili u roku od 3 sata nakon pripreme otopine ili nakon uklanjanja sivog gumenog zatvarača vrha štrcaljke.
English: With the ReFacto AF pre-filled syringe on top, slowly depress the plunger rod until the contents empty into the 10 cc or larger luer lock syringe.
Croatian: ReFacto AF napunjena štrcaljka mora biti gore; polako potiskujte klip sve dok potpuno ne ispraznite sadržaj u štrcaljku od 10 cc ili veću štrcaljku s luer-lock-om.
English: The procedures below are provided as guidelines for the reconstitution and administration of ReFacto AF provided in a pre-filled syringe.
Croatian: Postupci niže ponuđeni su kao smjernice za pripremu i primjenu lijeka ReFacto AF koji dolazi u napunjenoj štrcaljki.
English: 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.
Croatian: Izričito se preporučuje zabilježiti naziv na kutiji i broj serije lijeka svaki put kad se bolesniku primjenjuje ReFacto AF kako bi se vodila evidencija o brojevima serije lijeka primijenjenog pojedinom bolesniku.