FrancophonIA/ELRC3.0 huggingface dataset:
English: Jivi is available in pack sizes of: 1 single pack 1 multipack with 30 single packs Not all pack sizes may be marketed.
Croatian: Jivi je dostupan u veličinama pakiranja: - 1 pojedinačno pakiranje - 1 višestruko pakiranje s 30 pojedinačnih pakiranja.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2.
English: Of the 702 bleeding events treated with Jivi during the main study, 636 (90.6%) were treated with 1 or 2 injections, thereof 81.1% with 1 injection.
Croatian: Od 702 krvarenja liječena lijekom Jivi tijekom glavnog ispitivanja, njih 636 (90,6 %) bilo je liječeno 1 ili 2 injekcijama, od čega 81,1 % jednom injekcijom.
English: Swirl vial gently until all material is dissolved (H).
Croatian: Nježno vrtite bočicu dok se sav sadržaj ne otopi (H).
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Croatian: Bolesnici trebaju biti informirani o ranim znakovima reakcija preosjetljivosti, uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsima, piskanje pri disanju, hipotenziju i anafilaksiju.
English: No triggers or predictors of the immune response to PEG could be identified.
Croatian: Nisu se mogli identificirati okidači niti predisponirajući čimbenici imunološkog odgovora na PEG.
English: Pack sizes 1 single pack.
Croatian: Veličine pakiranja 1 pojedinačno pakiranje.
English: This medicine may be stored at room temperature (up to 25 °C) for up to 6 months when you keep it in its outer carton.
Croatian: Ovaj se lijek može čuvati na sobnoj temperaturi (do 25 °C) najviše 6 mjeseci ako ga držite u vanjskoj kutiji.
English: • a glass vial of powder
Croatian: • staklenu bočicu s praškom
English: This is of importance when monitoring the factor VIII activity of Jivi, and when changing laboratory and/or reagents used in the assay.
Croatian: To je važno za praćenje aktivnosti faktora VIII u lijeku Jivi te kod promjene laboratorija i/ili reagensa koji se primjenjuju u testu.
English: No de novo or confirmed cases of inhibitor against factor VIII occurred.
Croatian: Nije bilo de novo ili potvrđenih slučajeva pojave inhibitora FVIII.
English: This medicine is for single use only.
Croatian: Ovaj je lijek namijenjen samo za jednokratnu primjenu.
English: The table 4 below provides PK parameters based on the population PK model.
Croatian: Tablica 4 u daljnjem tekstu navodi farmakokinetičke parametre temeljene na modelu populacijske farmakokinetike.
English: The PK data (based on chromogenic assay) indicated that Jivi has a reduced clearance (CL), resulting in a terminal half-life that is 1.4-fold longer and a dose normalized AUC which is 1.4-fold higher, as compared to the comparative factor VIII product.
Croatian: Farmakokinetički podaci (temeljeni na kromogenom testu) pokazali su da Jivi ima smanjen klirens što rezultira 1,4 puta duljim terminalnim poluvijekom i 1,4 puta većim AUC-om normaliziranim prema dozi u usporedbi s poredbenim lijekom koji sadrži faktor VIII.
English: When infused into a patient with haemophilia, factor VIII binds to patient's von Willebrand factor.
Croatian: Kada se infuzijom primijeni u bolesnika s hemofilijom, faktor VIII vezuje se s von Willebrandovim faktorom bolesnika.
English: The median (range) dose per injection was 31.7 IU/kg (14; 62).
Croatian: Medijan (raspon) doze po injekciji iznosio je 31,7 IU/kg (14; 62).
English: • chest tightness/general feeling of being unwell
Croatian: • stezanje u prsnom košu/opće loše osjećanje
English: The median dose for all prophylaxis regimens was 46.9 IU/kg/injection.
Croatian: Medijan doze za sve profilaktičke režime bio je 46,9 IU/kg po injekciji.
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 internacionalnim jedinicama (IU) u skladu s važećim standardom Svjetske zdravstvene organizacije za koncentrate za lijekove koji sadrže faktor VIII.
English: Jivi is injected into a vein over 2 to 5 minutes depending on the total volume and your comfort level.
Croatian: Jivi se daje injekcijom u venu tijekom 2 do 5 minuta, ovisno o ukupnom volumenu i razini ugodnosti.
English: PK was also evaluated in 22 subjects (≥12 yrs) and in 16 of these subjects after 6 months of prophylaxis treatment in the Phase II/III study.
Croatian: Farmakokinetika je također ocijenjena u 22 ispitanika (u dobi ≥ 12 godina) te u 16-ero tih ispitanika nakon 6 mjeseci profilaktičkog primanja lijeka u ispitivanju faze II/III.
English: Dose proportional increases were observed between the doses of 25 and 60 IU/kg indicating dose linearity between 25 IU/kg and 60 IU/kg.
Croatian: Između doza od 25 i 60 IU/kg uočena su povećanja proporcionalna dozi, što upućuje na linearnost u rasponu doza između 25 IU/kg i 60 IU/kg.
English: Wipe the rubber stopper on the vial with an alcohol swab and allow the stopper to air dry before use.
Croatian: Obrišite gumeni čep jastučićem natopljenim alkoholom i pustite ga da se osuši prije sljedećeg koraka.
English: Perioperative haemostatic efficacy was rated as good or excellent during all major surgeries.
Croatian: Perioperativna hemostatska djelotvornost tijekom svih velikih kirurških zahvata ocijenjena je kao dobra ili odlična.
English: Eleven patients in the every 7 days arm increased frequency.
Croatian: Jedanaest bolesnika u skupini koja je primala lijek svakih 7 dana povećalo je učestalost primanja lijeka.
English: A total of 20 major surgical procedures were performed and assessed in 17 patients.
Croatian: Ukupno je provedeno i procijenjeno 20 velikih kirurških zahvata u 17 bolesnika.
English: Degree of haemorrhage/Type of surgical procedure
Croatian: Stupanj krvarenja / vrsta kirurškog zahvata
English: Table 2: Frequency of adverse drug reactions in clinical trials
Croatian: Tablica 2: Učestalost nuspojava lijeka u kliničkim ispitivanjima
English: • allergic reactions (may present as hives, generalized urticaria, tightness of the chest, wheezing,
Croatian: • alergijske reakcije (mogu biti u obliku koprivnjače, generalizirane urtikarije, stezanja u prsima,
English: A clinical immune response associated with anti-PEG antibodies, manifested as symptoms of acute hypersensitivity and/or loss of drug effect has been observed primarily within the first 4 exposure days.
Croatian: Zabilježen je klinički imunološki odgovor povezan s protutijelima na PEG (anti-PEG) koji se manifestira simptomima akutne preosjetljivosti i/ili gubitka učinka lijeka, naročito unutar prva 4 dana izloženosti.
English: Inject the solution into a vein over 2 to 5 minutes, keeping an eye on the position of the needle.
Croatian: Ubrizgavajte otopinu u venu tijekom 2 do 5 minuta, pazeći cijelo vrijeme na položaj igle.
English: Table 3 summarizes the PK parameters after single dose of 60 IU/kg from the Phase II/III study where PK was evaluated in 22 subjects.
Croatian: Tablica 3 sažeto prikazuje farmakokinetičke parametre nakon jednokratne doze od 60 IU/kg iz ispitivanja faze II/III u kojem je farmakokinetika procijenjena u 22 ispitanika.
English: Jivi is not indicated in previously untreated patients and in patients less than 12 years of age.
Croatian: Jivi nije indiciran u prethodno neliječenih bolesnika te u bolesnika mlađih od 12 godina.
English: • 45-60 IU per kg body weight every 5 days or
Croatian: • 45-60 IU po kg tjelesne težine svakih 5 dana ili
English: Antibodies to PEG disappeared after discontinuation of Jivi.
Croatian: Protutijela na PEG nestala su nakon prekida primjene lijeka Jivi.
English: Each vial of Jivi contains nominally 250 or 500 or 1000 or 2000 or 3000 IU damoctocog alfa pegol.
Croatian: Svaka bočica lijeka Jivi sadrži nominalno 250, 500, 1000, 2000 ili 3000 IU damoktokog alfa pegola.
English: • tightness in the chest, fall in blood pressure (often shown by feeling dizzy when getting up quickly), itchy nettle-rash, wheezing, feeling sick or faint.
Croatian: • imate stezanje u prsnom košu, pad krvnog tlaka (koji se često osjeti kao omaglica, osobito pri naglom ustajanju), koprivnjaču praćenu svrbežom, piskanje pri disanju, mučninu ili nesvjesticu.
English: During the main study period subjects were assigned to prophylaxis 2x/week (n=24), or randomized to every 5 days (n=43) or every 7 days (n=43) or received on-demand treatment (n=20) with Jivi.
Croatian: Tijekom razdoblja glavnog ispitivanja, ispitanici su bili raspoređeni u skupinu koja je primala profilaksu 2x tjedno (n=24) ili randomizirani da je primaju svakih 5 dana (n=43) ili svakih 7 dana (n=43) ili su lijek Jivi primali kao liječenje kod krvarenja (n=20).
English: This effect may be related to a developmental change in immunity, and although it is difficult to define a clear cut-off age for the change in risk, this phenomenon predominantly occurs in young children with haemophilia.
Croatian: Iako je teško definirati točnu dob u kojoj dolazi do promjene rizika, ova se pojava pretežno javlja u male djece s hemofilijom.
English: No long-term studies in animals to evaluate the carcinogenic potential of Jivi, or studies to determine the effects of Jivi on reproduction have been conducted.
Croatian: Nisu provedena dugotrajna ispitivanja lijeka Jivi kako bi se procijenio kancerogeni potencijal niti ispitivanja kojima bi se odredio utjecaj lijeka Jivi na reprodukciju.
English: One hundred and thirty four male PTPs received at least one injection of Jivi (including 13 subjects aged 12 to 17 years of age) for prophylaxis (n=114) or on-demand treatment (n=20) for a period of 36 weeks.
Croatian: U razdoblju od 36 tjedana sto trideset i četiri prethodno liječena muška bolesnika primila su najmanje jednu injekciju lijeka Jivi (uključujući 13 ispitanika u dobi od 12 do 17 godina) za profilaksu (n=114) ili za liječenje kod krvarenja (n=20).
English: Phase III (Paediatric): Pharmacokinetics, safety, and efficacy of Jivi for three prophylaxis regimens (twice weekly, every 5 and every 7 days) and treatment of breakthrough bleeds were evaluated in a multi-national, uncontrolled, open-label trial in 73 paediatric patients (<12 years of age) during a period of 50 EDs and at least 6 months.
Croatian: Faza III (Pedijatrijska): Farmakokinetika, sigurnost i djelotvornost lijeka Jivi u tri profilaktička režima (dvaput tjedno, svakih 5 i svakih 7 dana) i u liječenju probojnih krvarenja ocijenjene su u multinacionalnom, nekontroliranom, otvorenom ispitivanju u 73 pedijatrijska bolesnika (u dobi < 12 godina) tijekom razdoblja od najmanje 50 ED i minimalno 6 mjeseci.
English: The end date of the 6 month storage period at a temperature up to 25 °C should be recorded on the product carton.
Croatian: Datum isteka šestomjesečnog razdoblja čuvanja lijeka na temperaturi do 25 °C treba zabilježiti na pakiranju lijeka.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION Water for injections METHOD OF ADMINISTRATION EXPIRY DATE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA ŠTRCALJKA NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA, AKO JE POTREBNO Voda za injekcije NAČIN PRIMJENE LIJEKA ROK VALJANOSTI
English: Low post-injection factor VIII levels in the absence of detectable factor VIII inhibitors indicate that loss of drug effect is likely due to anti-PEG antibodies; in such cases Jivi should be discontinued and patients switched to a previously effective factor VIII product.
Croatian: Niske razine FVIII poslije injekcije, a u odsutnosti mjerljivih inhibitora FVIII, pokazuju da je do smanjenja učinka lijeka došlo vjerojatno zbog protutijela anti-PEG; u takvim slučajevima treba prekinuti primjenu lijeka Jivi i bolesnike vratiti na prethodno djelotvoran lijek s FVIII.
English: Table 4: PK parameters (geometric mean [%CV]) based on population PK model, using chromogenic assay.
Croatian: Tablica 4: Farmakokinetički parametri (geometrijska srednja vrijednost [%CV]) temeljena na modelu populacijske farmakokinetike, određeno kromogenim testom.
English: Only the components provided in the package should be used for reconstitution and injection because treatment failure can occur as a consequence of factor VIII adsorption to the internal surfaces of some injection equipment.
Croatian: Za rekonstituciju i injiciranje smije se koristiti samo pribor priložen u pakiranju jer zbog adsorpcije faktora VIII na unutrašnje površine određene opreme za injiciranje liječenje može biti neuspješno.
English: During the extension, 942 bleeds were treated with Jivi and 92.3% were controlled with 1 or 2 injections, thereof 83% with 1 injection.
Croatian: Tijekom nastavka ispitivanja, lijekom Jivi liječena su 942 krvarenja i njih 92,3 % bilo je zaustavljeno 1 ili 2 injekcijama, od čega 83 % jednom injekcijom.
English: The potency International Unit (IU) is determined using the European Pharmacopoeia chromogenic assay.
Croatian: Potentnost (IU) određena je pomoću kromogenog testa prema Europskoj farmakopeji.
English: These items are not included in the Jivi package.
Croatian: Ovi proizvodi nisu dio pakiranja lijeka Jivi.
English: Injection site reactions **, Pyrexia common * Frequency is based on studies with all factor VIII products which included patients with severe haemophilia A. PTPs = previously-treated patients” **includes injection site pruritus, injection site rash and vessel puncture site pruritus ***includes erythema and erythema multiforme ****includes rash and rash papular
Croatian: *Učestalost se temelji na ispitivanjima sa svim lijekovima s FVIII koja su uključivala bolesnike s teškom hemofilijom A. PTP = prethodno liječeni bolesnici (engl. previously-treated patients) **uključuje svrbež na mjestu injekcije, osip na mjestu injekcije i svrbež na mjestu uboda u krvnu žilu ***uključuje eritem i multiformni eritem ****uključuje osip i papularni osip
English: A field study has indicated that the factor VIII activity of Jivi can be accurately measured in plasma using either a validated chromogenic substrate (CS) assay or a one-stage (OS) clotting assay using specific reagents.
Croatian: Terensko ispitivanje pokazalo je da se aktivnost faktora VIII u lijeku Jivi može precizno mjeriti u plazmi pomoću validiranog testa određivanja s kromogenim supstratom (engl. chromogenic substrate, CS) ili jednostupanjskog testa koagulacije (engl. one-stage, OS) pomoću specifičnih reagensa
English: Table 3: Pharmacokinetic parameters (geometric mean (%CV) and arithmetic mean (SD)) for Jivi following a single 60 IU/kg dose based on chromogenic assay.
Croatian: Tablica 3: Farmakokinetički parametri (geometrijska srednja vrijednost (%CV) i aritmetička srednja vrijednost (SD)) za Jivi nakon jednokratne doze od 60 IU/kg temeljeni na kromogenom testu
English: Jivi is used to treat and prevent bleeding in previously treated adults and adolescents aged from 12 years with haemophilia A (hereditary factor VIII deficiency).
Croatian: Jivi se koristi za liječenje i sprječavanje krvarenja u prethodno liječenih odraslih i adolescenata od navršenih 12 godina koji imaju hemofiliju A (nasljedni nedostatak faktora VIII).
English: Anti¬PEG antibodies
Croatian: Protutijela na PEG
English: Do not use this medicine if you notice any particles or the solution is cloudy.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive čestice u otopini ili ako je otopina zamućena.
English: Attach the syringe to the venipuncture set (J).
Croatian: Pričvrstite štrcaljku na pribor za venepunkciju (J).
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Sljedeća tablica prikazana je prema MedDRA klasifikaciji organskih sustava (organski sustavi i preporučeni pojmovi za nuspojave).
English: May be stored at temperatures up to 25 °C for up to 6 months within the expiry date indicated on the label.
Croatian: Može se čuvati na temperaturi do 25 °C najviše 6 mjeseci unutar razdoblja roka valjanosti navedenog na naljepnici.
English: The median (Q1; Q3) recovery was 2.6 (2.3; 3.0) by chromogenic assay.
Croatian: Medijan (Q1; Q3) oporavka iznosio je 2,6 (2,3;3,0) prema kromogenom testu.
English: When using an in vitro activated partial 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, which can result in over- or under-estimation of factor VIII activity.
Croatian: Kad se za određivanje aktivnosti faktora VIII u uzorcima krvi bolesnika koristi in vitro jednostupanjski test koagulacije temeljen na aktiviranom parcijalnom tromboplastinskom vremenu (aPTV), na rezultate aktivnosti faktora VIII u plazmi mogu značajno utjecati i vrsta aPTV reagensa i referentni standard primijenjen u testu, što može dovesti do procjenjivanja aktivnosti faktora VIII kao previsoke ili preniske.
English: In addition 4 weeks toxicity studies with the PEG moiety of Jivi were conducted in two species.
Croatian: Dodatno su provedena ispitivanja toksičnosti na dvije životinjske vrste s PEG dijelom lijeka Jivi koja su trajala 4 tjedna.
English: The median dose for prophylaxis was 47.7 IU/kg.
Croatian: Medijan doze za profilaksu iznosio je 47,7 IU/kg.
English: • Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.
Croatian: • Bočicu i napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Stop injecting the product immediately and get medical help at once if this occurs.
Croatian: U tom slučaju odmah prestanite ubrizgavati lijek i zatražite hitnu liječničku pomoć.
English: A total of 221 patients constituted the safety population from three pivotal Phase I and III studies [PROTECT VIII].
Croatian: Populacija za procjenu sigurnosti u tri pivotalna ispitivanja faze I i III [PROTECT VIII] sastojala se od ukupno 221 bolesnika.
English: Data show that in the affected subjects, following discontinuation of Jivi, the anti-PEG IgM antibodies decreased in titre and became undetectable over time .
Croatian: Podaci pokazuju da se nakon prekida primjene lijeka Jivi u zahvaćenih ispitanika titar IgM protutijela na PEG smanjivao te s vremenom postao nemjerljiv.
English: Treatment and prophylaxis of bleeding in previously treated patients ≥ 12 years of age with haemophilia A (congenital factor VIII deficiency).
Croatian: Liječenje i profilaksa krvarenja u prethodno liječenih bolesnika u dobi od ≥ 12 godina s hemofilijom A (nasljedni nedostatak faktora VIII).
English: Finally, apply a small pressure dressing to the injection site and consider if a plaster is necessary.
Croatian: Na kraju lagano pritisnite mjesto ubrizgavanja zavojem te stavite flaster, ako je potrebno.
English: Abdominal pain, Nausea, Vomiting common Skin and subcutaneous tissue disorders Erythema***, Rash**** common Pruritus uncommon
Croatian: Poremećaji kože i potkožnog tkiva eritem***, osip****
English: The overall median (Q1; Q3) total ABR was 1.17 (0.0; 4.3) and 0.6 (0.0: 3.2) for spontaneous bleeds in the combined prophylaxis groups and total ABR was 33.0 in the on-demand group.
Croatian: Cjelokupni medijan (Q1; Q3) ukupnog ABR-a bio je 1,17 (0,0; 4,3) i 0,6 (0,0; 3,2) za spontana krvarenja u kombiniranoj profilaktičkoj skupini, a ukupni ABR bio je 33,0 u skupini koja je primala lijek kod liječenja krvarenja.
English: Perioperative Management
Croatian: Perioperativno zbrinjavanje
English: Holding the syringe by the barrel, snap the syringe cap off the tip (D).
Croatian: Držeći štrcaljku za tijelo, odvojite zatvarač štrcaljke s vrha (D).
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
English: 1 vial with powder, 1 pre-filled syringe with 2.5 mL water for injections, 1 vial adapter and 1 venipuncture set.
Croatian: 1 bočica s praškom, 1 napunjena štrcaljka s 2,5 ml vode za injekcije, 1 nastavak za bočicu i 1 pribor za venepunkciju.
English: The median (Q1; Q3) ABR during prophylaxis was 2.09 (0.0; 6.1) for all bleeds and 0.0 (0;0 4.2) for spontaneous bleeds as compared to 23.4 (18; 37) total bleeds in the on-demand group.
Croatian: Medijan (Q1; Q3) ABR-a tijekom profilakse bio je 2,09 (0,0; 6,1) za sva krvarenja te 0,0 (0,0; 4,2) za spontana krvarenja u usporedbi s 23,4 (18; 37) za ukupna krvarenja u skupini koja je primala lijek kao liječenje kod krvarenja.
English: A total of 73 previously treated pediatric patients (44 subjects < 6 years and 29 subjects 6 to <12 years) received prophylaxis treatment twice weekly, every 5 days or every 7 days in the phase III study.
Croatian: U ispitivanju faze III, ukupno su 73 prethodno liječena pedijatrijska bolesnika (44 ispitanika u dobi < 6 godina i 29 ispitanika u dobi od 6 do < 12 godina) profilaktički primala lijek dvaput tjedno, svakih 5 dana ili svakih 7 dana.
English: The active substance, damoctocog alfa pegol, is a site specifically PEGylated B-domain deleted recombinant human coagulation factor VIII, produced in baby hamster kidney cells (BHK), with a 60 kDa branched polyethylene-glycol (two 30 kDa PEG) moiety.
Croatian: Djelatna tvar, damoktokog alfa pegol, rekombinantni je ljudski koagulacijski faktor VIII s uklonjenom B-domenom pegiliran na specifičnom položaju, proizveden u stanicama bubrega mladog hrčka (engl. baby hamster kidney, BHK), s razgranatim polietilenglikolnim (PEG) dijelom od 60 kDa (dva PEG-a od 30 kDa).
English: Holding the adapter housing, place over the product vial and firmly press down (B).
Croatian: Držeći plastično pakiranje nastavka, namjestite ga iznad bočice s lijekom i čvrsto pritisnite prema dolje (B).
English: The pharmacokinetics (PK) of Jivi was compared to that of factor VIII in a crossover Phase I study.
Croatian: Farmakokinetika lijeka Jivi uspoređena je s farmakokinetikom faktora VIII u ukriženom (engl. crossover) ispitivanju faze I.
English: Jivi powder should only be reconstituted with the supplied solvent (2.5 mL water for injections) in the prefilled-syringe and the vial adapter.
Croatian: Jivi prašak smije se rekonstituirati samo otapalom (2,5 ml vode za injekcije) priloženim u napunjenoj štrcaljki i pomoću nastavka za bočicu.
English: How to store Jivi
Croatian: Kako čuvati Jivi
English: Jivi 250 IU powder and solvent for solution for injection
Croatian: Jivi 250 IU prašak i otapalo za otopinu za injekciju
English: If you stop using Jivi Do not stop using this medicine without checking with your doctor.
Croatian: Nemojte prestati uzimati ovaj lijek bez dogovora s liječnikom.
English: • allergic to mouse or hamster proteins.
Croatian: • alergični na bjelančevine miša ili hrčka.
English: All patients could be successfully treated with their previous factor VIII products.
Croatian: Svi su se bolesnici mogli uspješno liječiti lijekovima s FVIII koje su prethodno primali.
English: Each single pack of Jivi contains
Croatian: Svako pojedinačno pakiranje lijeka Jivi sadrži
English: Jivi contains sodium
Croatian: Jivi sadrži natrij
English: AUC (IU*h/dL) AUC, norm (h*kg/dL) Cmax (IU/dL) t½ (h)
Croatian: AUC (IU*h/dl) AUCnorm (h*kg/dl) Cmaks (IU/dl) t½ (h)
English: This medicine contains less than 1 mmol (23 mg) sodium per dose, and is therefore considered to be essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: The median (range) dose was 37.3 (18; 66) IU/kg/injection.
Croatian: Medijan (raspon) doze iznosio je 37,3 IU/kg (18; 66) po injekciji.
English: Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.
Croatian: Bočicu i napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.