FrancophonIA/ELRC3.0 huggingface dataset:
English: AFSTYLA works by replacing the missing factor VIII in haemophilia A patients to enable their blood to clot normally.
Croatian: AFSTYLA djeluje tako da zamjenjuje faktor VIII koji nedostaje u bolesnika s hemofilijom A kako bi omogućio normalno zgrušavanje njihove krvi.
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: Kada se upotrebljava in vitro jednostupanjski test koagulacije na temelju tromboplastinskog vremena (aPTT) za određivanje aktivnosti faktora VIII u uzorcima krvi bolesnika, na rezultate aktivnosti faktora VIII u plazmi mogu značajno utjecati vrsta aPTT reagensa i referentni standard koji se upotrebljava u testu.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: U tablici u nastavku prikazuju se nuspojave prema MedDRA klasifikaciji organskih sustava (klasifikacija organskog sustava i preporučeni pojam).
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, te tako ubrzava pretvorbu faktora X u aktivirani faktor X.
English: Prophylaxis: 146 subjects were assigned to a prophylaxis regimen (median ABR, 1.14 (interquartile range: 0.0, 4.2)), 79 (54%) were assigned a 3-times per week regimen and 47 (32%) a 2-times per week regimen.
Croatian: Profilaksa: Režimu profilakse bilo je dodijeljeno 146 ispitanika (medijan godišnje stope krvarenja, 1,14 (interkvartilni raspon: 0,0; 4,2)), 79 (54 %) ih je bilo dodijeljeno režimu primjene lijeka 3 puta tjedno i 47 (32 %) režimu primjene lijeka 2 puta tjedno.
English: • you notice that the medicine stops working properly (bleeding is not stopped) For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Croatian: Za djecu koja nisu ranije primala terapiju s faktorom VIII, inhibitorna antitijela (pogledajte dio 2) mogu se stvarati vrlo često (više od 1 na 10 bolesnika); međutim za bolesnike koji su primali raniju terapiju s faktorom VIII (više od 150 dana liječenja) rizik je manje čest (manje od 1 na 100 bolesnika).
English: The pharmacokinetics (PK) of AFSTYLA was evaluated in 81 previously treated adult subjects who had been diagnosed with severe haemophilia A with <1% factor VIII and with age from 1860 years old, following an intravenous injection of 50 IU/kg.
Croatian: Farmakokinetika lijeka AFSTYLA procijenjena je na 81 prethodno liječenom odraslom ispitaniku koji su imali dijagnozu teške hemofilije A s <1 % faktora VIII i u dobi od 18 do 60 godina, nakon intravenske injekcije od 50 IU/kg.
English: The recommended starting regimen is 20 to 50 IU/kg of AFSTYLA administered 2 to 3 times weekly.
Croatian: Preporučeni je početni režim od 20 do 50 IU/kg lijeka AFSTYLA koji se primjenjuje od 2 do 3 puta tjedno.
English: If this happens, you should stop using the medicine immediately and contact your doctor.
Croatian: Ako se to dogodi, morate odmah prestati primjenjivati lijek i obratiti se liječniku.
English: Also there can be significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the chromogenic assay according to Ph. Eur.
Croatian: Također mogu postojati značajna odstupanja između rezultata testa koji se dobiju jednostupanjskim testom koagulacije na temelju aPPT-a i kromogenim testom prema Europskoj farmakopeji.
English: Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Croatian: Pažljivo uklonite blister pakiranje s kompleta Mix2Vial držeći ga za rub i povlačeći ga okomito prema gore.
English: • If the reconstituted product is not administered immediately, storage times and conditions prior to use are in the responsibility of the user.
Croatian: • Ako se rekonstituirani lijek ne primijeni odmah, trajanje i uvjeti čuvanja do primjene lijeka odgovornost su korisnika.
English: The reconstituted solution should be clear to slightly opalescent, yellow to colourless i.e., it might sparkle when held up to the light but must not contain any obvious particles.
Croatian: Rekonstituirana otopina treba biti bistra do blago opalescentna, žuta do bezbojna, tj. može se sjajiti kad se drži prema svjetlu, ali ne smije sadržavati nikakve vidljive čestice.
English: IR and Cmax were baseline corrected while the remaining parameters were not baseline corrected.
Croatian: Vrijednosti IR i Cmax korigirane su za početne vrijednosti, dok ostali parametri nisu korigirani za početne vrijednosti.
English: The potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Croatian: Potentnost (IU) se određuje pomoću kromogenog testa prema Europskoj farmakopeji.
English: Place the powder vial on an even and firm surface.
Croatian: Stavite bočicu s praškom na ravnu i čvrstu površinu.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Croatian: Ako je potreban centralni venski kateter, treba uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom, uključujući lokalne infekcije, bakterijemiju i trombozu na mjestu kateterizacije.
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 injections.
Croatian: Tijekom liječenja savjetuje se odgovarajuće određivanje razine faktora VIII da bi se mogla odrediti doza koju treba primijeniti i učestalost ponavljanja injekcija.
English: AFSTYLA 250, 500 and 1000 IU (2.5 ml solvent) Each vial contains 17.5 mg (0.76 mmol) of sodium.
Croatian: AFSTYLA 250, 500 i 1000 IU (2,5 ml otapala) Svaka bočica sadrži 17,5 mg (0,76 mmol) natrija.
English: IR = incremental recovery recorded at 30 minutes after injection for subjects 12 to < 18 years and at 60 minutes after injection for subjects 1 to < 12 years; Cmax = maximum concentration, AUC = area under the factor VIII activity time curve extrapolated to infinity; t1/2 = half-life; MRT = mean residence time; CL = body weight adjusted clearance; Vss = body weight adjusted volume of distribution at steady-state.
Croatian: IR (engl. incremental recovery)= prirast po jedinici doze zabilježen 30 minuta nakon injekcije za ispitanike dobi 12 do <18 godina i 60 minuta nakon injekcije za ispitanike dobi 1 do <12 godina; Cmax = maksimalna koncentracija, AUC0-inf = područje ispod krivulje aktivnosti faktora VIII u vremenu ekstrapolirano do beskonačnosti; t1/2 = poluvijek; MRT (engl. mean residence time) = srednje vrijeme zadržavanja; CL = klirens prilagođen tjelesnoj težini; Vss = volumen distribucije prilagođen tjelesnoj težini u stanju dinamičke ravnoteže.
English: Individualised prophylaxis: Of the 81 patients on prophylaxis (median ABR 3.69 (interquartile range: 0.00, 7.20)), 43 (53%) were assigned to a 2-times weekly regimen and 25 (31%) to a 3-times per week regimen.
Croatian: Individualizirana profilaksa: Od 81 bolesnika na profilaksi (medijan godišnje stope krvarenja 3,69 (interkvartilni raspon: 0,00; 7,20)), 43 (53 %) bilo je dodijeljeno režimu 2 puta tjedno, a 25 (31 %) režimu 3 puta tjedno.
English: Potency assignment is determined using a chromogenic substrate assay.
Croatian: Potentnost se određuje upotrebom testa s kromogenim supstratom.
English: AFSTYLA may be stored at room temperature, not to exceed 25 °C, for a single period of up to 3 months, within the expiration date printed on the carton and vial labels.
Croatian: AFSTYLA se može čuvati na sobnoj temperaturi koja ne smije premašiti 25 °C u jednokratnom razdoblju od najviše 3 mjeseca, unutar roka valjanosti otisnutoga na kutiji i naljepnicama bočica.
English: • you notice symptoms of allergic reactions Allergic reactions may include the following symptoms: hives, generalised urticaria (itchy rash), tightness of the chest, difficulty in breathing, wheezing, low blood pressure, dizziness, and anaphylaxis.
Croatian: • primijetite simptome alergijskih reakcija Alergijske reakcije mogu uključivati sljedeće simptome: koprivnjaču, generaliziranu urtikariju (osip koji svrbi), stezanje u prsištu, otežano disanje, piskanje pri disanju, nizak krvni tlak, omaglicu i anafilaksiju.
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Croatian: Liječenje treba izvoditi pod nadzorom liječnika s iskustvom u liječenju hemofilije.
English: White or slightly yellow powder or friable mass and clear, colourless solvent for solution for injection.
Croatian: Bijeli ili žućkasti prašak ili drobljiva masa i bistro, bezbojno otapalo za otopinu za injekciju.
English: • If you need a central venous access device (CVAD for injection of AFSTYLA), the risk of complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.
Croatian: • Ako je potreban centralni venski kateter (za ubrizgavanje lijeka AFSTYLA), Vaš liječnik treba uzeti u obzir rizik od komplikacija uključujući lokalne infekcije, bakterije u krvi (bakterijemiju) i stvaranje krvnih ugrušaka u krvnim žilama (tromboza) na mjestu uvođenja katetera.
English: No age-specific differences in adverse reactions were observed between children, adolescents and adult subjects.
Croatian: Nuspojave u djece i adolescenata Nisu primijećene razlike prema dobi u nuspojavama između djece, adolescenata i odraslih ispitanika.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton administration set (inner box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Kutija sa setom za primjenu (unutarnja kutija)
English: AFSTYLA 1500, 2000, 2500 and 3000 IU (5 ml solvent) Each vial contains 35 mg (1.52 mmol) of sodium.
Croatian: AFSTYLA 1500, 2000, 2500 i 3000 IU (5 ml otapala) Svaka bočica sadrži 35 mg (1,52 mmol) natrija.
English: Do not use AFSTYLA
Croatian: Nemojte primjenjivati lijek AFSTYLA
English: IR = incremental recovery recorded at 30 minutes after injection; Cmax = maximum concentration, AUC0-inf = area under the factor VIII activity time curve extrapolated to infinity; t1/2 = half-life; MRT = mean residence time; CL = body weight adjusted clearance with N = 80; Vss = body weight adjusted volume of distribution at steady-state.
Croatian: IR (engl. incremental recovery) = prirast po jedinici doze zabilježen 30 minuta nakon injekcije; Cmax = maksimalna koncentracija, AUC0-inf = područje ispod krivulje aktivnosti faktora VIII u vremenu ekstrapolirano do beskonačnosti; t1/2 = poluvijek; MRT (engl. mean residence time) = srednje vrijeme zadržavanja; CL = klirens prilagođen tjelesnoj težini sa N = 80; Vss = volumen distribucije prilagođen tjelesnoj težini u stanju dinamičke ravnoteže.
English: PK Parameters rVIII-SingleChain 50 IU/kg (N=81) Mean (CV%) Median (Min,Max)
Croatian: Farmakokinetički parametri jednolančani faktor rVIII 50 IU/kg (N=81) Srednja vrijednost (KV %) Medijan (min., maks.)
English: More extensive haemarthrosis, muscle bleeding or haematoma
Croatian: Intenzivnija hemartroza, krvarenje u mišiću ili hematom
English: Comparison of Pharmacokinetic Parameters by Age Category following a Single Injection of 50 IU/kg of AFSTYLA - Chromogenic Assay:
Croatian: Usporedba farmakokinetičkih parametara prema dobnoj kategoriji nakon jedne injekcije od 50 IU/kg lijeka AFSTYLA - kromogeni test:
English: Patients on prophylaxis 2- and 3-times per week were assigned median doses of 35 and 30 IU/kg per injection respectively with a median annual consumption across all prophylaxis regimens of 4,283 IU/kg year.
Croatian: Bolesnicima na profilaksi režimima 2 i 3 puta tjedno bili su dodijeljeni medijani doze od 35 odnosno 30 IU/kg po injekciji, sa medijanom godišnje potrošnje u svim režimima profilakse od 4283 IU/kg godišnje.
English: One pack with 1500, 2000, 2500 or 3000 IU containing: 1 vial with powder
Croatian: Jedno pakiranje s 1500, 2000, 2500 ili 3000 IU sadrži: 1 bočicu s praškom
English: Do not use the solution if it is visibly cloudy or if it contains flakes or particles.
Croatian: Nemojte primijeniti otopinu koja je vidno zamućena ili sadrži pahuljice ili čestice.
English: The median dose used to treat a bleeding event was 27.6 IU/kg
Croatian: Medijan doze za liječenje događaja krvarenja bio je 27,6 IU/kg.
English: L-Histidine, polysorbate 80, calcium chloride dihydrate, sodium chloride (see last paragraph of section 2), sucrose.
Croatian: L-histidin, polisorbat 80, kalcijev klorid dihidrat, natrijev klorid (pogledajte posljednji odjeljak 2. dijela), saharoza.
English: Patients on prophylaxis 2- and 3-times per week were assigned median doses of 35 and 32 IU/kg per injection respectively with a median annual consumption across all prophylaxis regimens of 4,109 IU/kg year.
Croatian: Bolesnicima na profilaksi režimima 2 i 3 puta tjedno dodijeljeni su medijani doze od 35 odnosno 32 IU/kg po injekciji, sa medijanom godišnje potrošnje u svim režimima profilakse od 4109 IU/kg godišnje.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava Omaglica često
English: AFSTYLA is presented as white or slightly yellow powder or friable mass and clear, colourless solvent for solution for injection.
Croatian: AFSTYLA izgleda kao bijeli ili žućkasti prašak ili drobljiva masa i bistro, bezbojno otapalo za otopinu za injekciju.
English: 1 disposable 10 ml syringe
Croatian: 1 jednokratnu štrcaljku od 10 ml
English: The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO concentrate standard for factor VIII products.
Croatian: Broj primijenjenih jedinica faktora VIII izražava se u međunarodnim jedinicama (IU), koje su u skladu s važećim standardom koncentrata Svjetske zdravstvene organizacije (SZO) za lijekove koji sadrže faktor VIII.
English: AFSTYLA has demonstrated a higher VWF affinity relative to full-length rFVIII.
Croatian: Lijek AFSTYLA pokazao je viši afinitet za von Willebrandov faktor (VWF) u odnosu na rFVIII pune duljine.
English: One pack with 250, 500 or 1000 IU containing: 1 vial with powder
Croatian: Jedno pakiranje s 250, 500 ili 1000 IU sadrži: 1 bočicu s praškom
English: AFSTYLA is used to treat and prevent bleeding episodes in patients with haemophilia A (inborn factor VIII deficiency).
Croatian: AFSTYLA se koristi za liječenje i sprječavanje epizoda krvarenja u bolesnika sa hemofilijom A (urođenim nedostatkom faktora VIII).
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 se mora upoznati s ranim znakovima reakcija preosjetljivosti, uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsištu, piskanje pri disanju, hipotenziju i anafilaksiju.
English: 2 alcohol swabs
Croatian: 2 blazinice natopljene alkoholom
English: With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully counterclockwise into two pieces.
Croatian: Jednom rukom uhvatite dio kompleta Mix2Vial s lijekom, a drugom rukom dio s otapalom pa pažljivo odvijte komplet u smjeru suprotnom od kazaljke na satu tako da se komplet razdvoji u dva dijela.
English: Place the solvent vial on an even, clean surface and hold the vial tight.
Croatian: Stavite bočicu otapala na ravnu, čistu površinu i čvrsto je uhvatite.
English: Please record the date from when you start to store AFSTYLA at room temperature on the product carton.
Croatian: Na kutiji lijeka zabilježite datum kada ste počeli čuvati lijek na sobnoj temperaturi.
English: Reconstitution and administration
Croatian: Rekonstitucija i primjena
English: AFSTYLA 500 IU powder and solvent for solution for injection AFSTYLA 1000 IU powder and solvent for solution for injection AFSTYLA 1500 IU powder and solvent for solution for injection AFSTYLA 2000 IU powder and solvent for solution for injection AFSTYLA 2500 IU powder and solvent for solution for injection AFSTYLA 3000 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant, single-chain coagulation factor VIII)
Croatian: AFSTYLA 250 IU prašak i otapalo za otopinu za injekciju AFSTYLA 500 IU prašak i otapalo za otopinu za injekciju AFSTYLA 1000 IU prašak i otapalo za otopinu za injekciju AFSTYLA 1500 IU prašak i otapalo za otopinu za injekciju AFSTYLA 2000 IU prašak i otapalo za otopinu za injekciju AFSTYLA 2500 IU prašak i otapalo za otopinu za injekciju AFSTYLA 3000 IU prašak i otapalo za otopinu za injekciju lonoktokog alfa (rekombinantni, jednolančani koagulacijski faktor VIII)
English: If the one-stage clotting assay is used, multiply the result by a conversion factor of 2 to determine the patient's factor VIII activity level (see section 4.2).
Croatian: Ako se upotrijebi jednostupanjski test koagulacije, pomnožite rezultat faktorom konverzije 2 kako biste odredili razinu aktivnosti faktora VIII bolesnika (vidjeti dio 4.2).
English: Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
Croatian: Uzmite Mix2Vial zajedno s blister pakiranjem i gurnite šiljak plavog kraja nastavka ravno prema dolje kroz čep bočice s otapalom.
English: Pharmacokinetic Parameters following a Single Injection of 50 IU/kg of AFSTYLAChromogenic Substrate Assay:
Croatian: Farmakokinetički parametri nakon jedne injekcije od 50 IU/kg lijeka AFSTYLA - test s kromogenim supstratom:
English: No age-specific differences in adverse reactions were observed between paediatric and adult subjects.
Croatian: Pedijatrijska populacija Nisu primijećene razlike prema dobi u nuspojavama između pedijatrijskih i odraslih ispitanika.
English: 1 disposable 5 ml syringe
Croatian: 1 jednokratnu štrcaljku od 5 ml
English: Powder: L-Histidine, Polysorbate 80, Calcium chloride dihydrate, Sodium chloride, Sucrose
Croatian: Prašak: L-histidin, polisorbat 80, kalcijev klorid dihidrat, natrijev klorid, saharoza
English: Immediate containers
Croatian: Unutarnji spremnici
English: Bring the solvent to room temperature.
Croatian: Otapalo treba postići sobnu temperaturu.
English: The active substance in AFSTYLA is lonoctocog alfa.
Croatian: Djelatna tvar u lijeku AFSTYLA je lonoktokog alfa.
English: Other ingredients: L-Histidine, Polysorbate 80, Calcium chloride dihydrate, Sodium chloride, Sucrose
Croatian: Ostali sastojci: L-histidin, polisorbat 80, kalcijev klorid dihidrat, natrijev klorid, saharoza
English: Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counterclockwise.
Croatian: Kad se otopina prenese u štrcaljku, čvrsto uhvatite tijelo štrcaljke (dok je klip štrcaljke okrenut prema dolje) i odvojite prozirni nastavak Mix2Vial od štrcaljke odvijanjem u smjeru suprotnom od kazaljke na satu.
English: 1 vial with 5 ml water for injections 1 filter transfer device 20/20
Croatian: 1 bočicu s 5 ml vode za injekcije 1 napravu za prijenos s filtrom 20/20
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Croatian: Ti su inhibitori obično IgG imunoglobulini koji djeluju protiv prokoagulacijske aktivnosti faktora VIII, a njihova količina određuje se u Bethesda jedinicama (BU) po ml plazme pomoću modificiranog testa.
English: If you or your child´s bleeding is not being controlled with AFSTYLA, tell your doctor immediately.
Croatian: Vašeg djeteta ne može kontrolirati pomoću lijeka AFSTYLA, odmah se obratite liječniku.
English: 1 vial with 2.5 ml water for injections 1 filter transfer device 20/20
Croatian: 1 bočicu s 2,5 ml vode za injekcije 1 napravu za prijenos s filtrom 20/20
English: How to store AFSTYLA
Croatian: Kako primjenjivati lijek AFSTYLA
English: The PK parameters were based on plasma factor VIII activity measured by the chromogenic substrate assay (for discrepancy in the factor VIII activity determined with one-stage clotting assay, please see Section 4.2).
Croatian: Farmakokinetički parametri temelje se na aktivnosti faktora VIII u plazmi koja je mjerena testom s kromogenim supstratom (za odstupanja u aktivnosti faktora VIII koja se određuje jednostupanjskim testom koagulacije, vidjeti dio 4.2).
English: Plasma factor VIII activity in patients receiving AFSTYLA using either the chromogenic assay or the one-stage clotting assay should be monitored to guide the dose administered and the frequency of repeat injections.
Croatian: U bolesnika koji primaju lijek AFSTYLA potrebno je nadzirati aktivnost faktora VIII u plazmi pomoću kromogenog testa ili jednostupanjskog testa koagulacije kako bi se odredila doza koju treba primijeniti i učestalost ponavljanja injekcija.
English: Plasma factor VIII levels can be monitored using either a chromogenic substrate assay or a onestage clotting assay.
Croatian: Razine faktora VIII u plazmi mogu se nadzirati upotrebom testa s kromogenim supstratom ili jednostupanjskog testa koagulacije.
English: CSL Behring GmbH
Croatian: Latvija CSL Behring GmbH
English: While the product vial is upright, connect the syringe to the Mix2Vial's Luer Lock fitting by screwing clockwise.
Croatian: Dok je bočica s lijekom u uspravnom položaju, spojite štrcaljku na navojni spoj (luer lock) nastavka Mix2Vial navijanjem u smjeru kazaljke na satu.
English: Lonoctocog alfa 2000 IU
Croatian: lonoktokog alfa 2000 IU
English: If the one-stage clotting assay is used, multiply the result by a conversion factor of 2 to determine the patient's factor VIII activity level.
Croatian: Ako se upotrijebi jednostupanjski test koagulacije, pomnožite rezultat faktorom konverzije 2 kako biste odredili razinu aktivnosti faktora VIII bolesnika.
English: Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved.
Croatian: Lagano vrtite bočicu s lijekom s pričvršćenim prozirnim nastavkom sve dok se prašak potpuno ne otopi.
English: Open the Mix2Vial by peeling off the lid. Do not remove the Mix2Vial from the blister package!
Croatian: Nemojte vaditi Mix2Vial iz blister pakiranja!
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial label 2.5 ml and 5 ml
Croatian: Naljepnica na bočici s otapalom 2,5 ml i 5 ml
English: 12 to <18 years (N=10) Mean (CV%) Median (Min,Max)
Croatian: Od 12 do <18 godina (N=10) Srednja vrijednost (KV %) Medijan (min., maks.)
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: To se mora uzeti u obzir kod bolesnika s prehranom s ograničenim unosom natrija.
English: Lonoctocog alfa 3000 IU
Croatian: lonoktokog alfa 3000 IU
English: 6 to <12 years (N=19) Mean (CV%) Median (Min,Max)
Croatian: Od 6 do <12 godina (N=19) Srednja vrijednost (KV %) Medijan (min., maks.)
English: Allergic type hypersensitivity reactions are possible with AFSTYLA.
Croatian: Kod primjene lijeka AFSTYLA moguća je pojava reakcija preosjetljivosti alergijskog tipa.
English: 1 disposable 5 ml syringe 1 venipuncture set
Croatian: 1 jednokratnu štrcaljku od 5 ml 1 set za venepunkciju
English: AFSTYLA contains sodium
Croatian: AFSTYLA sadrži natrij
English: Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding
Croatian: Ranija hemartroza, krvarenje u mišiću ili krvarenje u usnoj šupljini