FrancophonIA/ELRC3.0 huggingface dataset:
English: How does Insuman work?
Croatian: Kako djeluje Insuman?
English: Strength Pharmaceutical Form
Croatian: EMA broj postupka (Zaštićeno)ime Doza Farmaceutski oblik
English: This is particularly important if you are having major surgery.
Croatian: To je osobito važno ako ćete imati veći kirurški zahvat.
English: The required dose is determined using the following formula:
Croatian: Potrebna doza se određuje korištenjem sljedeće formule:
English: Data show that immune tolerance may be achieved.
Croatian: Podaci pokazuju da je moguće postići imunološku toleranciju.
English: Date of latest renewal: 20 December 2013
Croatian: Datum posljednje obnove odobrenja: 20. prosinca 2013.
English: Important note:
Croatian: Važna napomena:
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at 25 °C.
Croatian: Međutim, kemijska i fizikalna stabilnost tijekom primjene dokazana je tijekom 3 sata na temperaturi od 25 °C.
English: ATC code: B02BD02.
Croatian: ATK oznaka: B02BD02.
English: Therefore, factor VIII should be used during pregnancy and breastfeeding only if clearly indicated.
Croatian: Stoga se faktor VIII smije primjenjivati tijekom trudnoće i dojenja samo ako je to jasno indicirano.
English: The product dissolves rapidly (usually in less than 1 minute).
Croatian: Lijek se brzo otapa (obično za manje od 1 minute).
English: Do not throw away any medicines via waste water or household waste.
Croatian: Nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: The product is provided in one of the following configurations:
Croatian: Lijek dolazi u jednoj od sljedećih konfiguracija:
English: Wash your hands thoroughly using soap and warm water.
Croatian: Temeljito operite ruke koristeći sapun i toplu vodu.
English: Do not remove the blue cap until instructed in a later step.
Croatian: Ne uklanjajte plavi zatvarač dok ne dobijete upute u kasnijem koraku.
English: Do not use if packaging is opened or damaged.
Croatian: Ne koristiti ako je pakiranje otvoreno ili oštećeno.
English: Rarely, inhibitors may develop after the first 100 exposure days.
Croatian: U rijetkim slučajevima se inhibitori mogu razviti nakon prvih 100 dana izloženosti.
English: Parameter (mean ± standard deviation)
Croatian: Parametar (srednja vrijednost ± standardna devijacija)
English: Additional side effects in children
Croatian: Dodatne nuspojave u djece
English: What ADVATE is and what it is used for
Croatian: Što je ADVATE i za što se koristi
English: Including tooth extraction.
Croatian: Uključujući vađenje zuba.
English: Inject intravenously.
Croatian: Injicirajte intravenski.
English: The data from this study demonstrate that the two prophylactic dosing regimens are comparable in terms of reduction of bleeding rate.
Croatian: Podaci iz navedene studije pokazuju da su dva profilaktična režima doziranja usporediva što se tiče smanjenja stope krvarenja.
English: ADVATE is indicated in all age groups.
Croatian: ADVATE je indiciran u svim dobnim skupinama.
English: (pre- and postoperative)
Croatian: (prije i nakon operacije)
English: Do not draw air into the syringe.
Croatian: Ne smijete uvući zrak u štrcaljku.
English: Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, acute toxicology, repeated dose toxicity, local toxicity and genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, akutne toksičnosti, toksičnosti ponovljenih doza, lokalne toksičnosti i genotoksičnosti.
English: Should a significant increase occur, reducing the rate of administration or temporarily interrupting the injection usually allows the symptoms to disappear promptly (see sections 4.4 and 4.8).
Croatian: Ako dođe do značajnijeg povećanja pulsa, smanjenjem brzine primjene ili privremenim prekidom injiciranja simptomi obično brzo nestaju (vidjeti dijelove 4.4 i 4.8).
English: Talk to your doctor before using ADVATE.
Croatian: Obratite se svom liječniku prije nego primijenite ADVATE.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanjerizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: If severe, sudden allergic reactions (anaphylactic) occur, the injection must be stopped immediately.
Croatian: Ako se jave teške, iznenadne alergijske reakcije (anafilaktičke), injekcija se mora odmah prekinuti.
English: Do not tilt the system until the transfer is complete.
Croatian: Ne nagibajte sustav sve do završetka prijenosa.
English: Do not remove the device from the package.
Croatian: Ne vadite uređaj iz pakiranja.
English: Under certain circumstances (e.g. presence of a low-titre inhibitor), doses larger than those calculated using the formula may be necessary.
Croatian: U određenim uvjetima (npr. kod prisutnosti niskog titra inhibitora) može biti potrebno primijeniti i doze veće od onih izračunatih korištenjem formule.
English: Proceed with the next injection as scheduled and continue as advised by your doctor.
Croatian: Nastavite sa sljedećom injekcijom prema rasporedu i nastavite uzimati lijek kako Vam je savjetovao liječnik.
English: Baxalta Manufacturing Sàrl Route de Pierre-à-Bot 111 CH-2000 Neuchâtel Switzerland
Croatian: Baxalta Manufacturing Sàrl Route de Pierre-à-Bot 111 CH-2000 Neuchâtel Švicarska
English: Baxter AG Industriestrasse 67 A-1221 Vienna Austria
Croatian: Baxter AG Industriestrasse 67 A-1221 Beč Austrija
English: ADVATE should be administered via the intravenous route.
Croatian: ADVATE treba primijeniti intravenskim putem.
English: ADVATE is prepared without the addition of any human- or animal-derived protein in the entire manufacturing process.
Croatian: ADVATE je proizveden bez dodataka proteina ljudskog ili životinjskog podrijetla tijekom cijelog postupka proizvodnje.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: You should tell your doctor if you have been previously treated with Factor VIII products, especially if you developed inhibitors, since there might be a higher risk that it happens again.
Croatian: Trebate obavijestiti svog liječnika ako ste prethodno bili liječeni lijekovima koji sadrže faktor VIII, osobito ako su se u Vas razvili inhibitori, budući da ste onda izloženi većem riziku da se u Vas ponovno pojave inhibitori.
English: It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Croatian: Proizveden je tehnologijom rekombinantne DNK u stanicama jajnika kineskog hrčka (CHO - Chinese hamster ovary).
English: The analysis of plasma samples was conducted in a central laboratory using a one-stage clotting assay.
Croatian: Analiza uzoraka plazme provedena je u središnjem laboratoriju korištenjem jednostupanjskog ispitivanja zgrušavanja.
English: The safety and haemostatic efficacy of ADVATE in the paediatric population are similar to that of adult patients.
Croatian: Sigurnost i hemostatska djelotvornost lijeka ADVATE u pedijatrijskoj populaciji slične su kao u odraslih bolesnika.
English: The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay.
Croatian: Potentnost (međunarodne jedinice) se određuje korištenjem kromogenog ispitivanja Europske farmakopeje.
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su prikazane prema sljedećim kategorijama učestalosti: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) te nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The factor VIII/von Willebrand Factor complex consists of two molecules (factor VIII and von Willebrand Factor) with different physiological functions.
Croatian: Kompleks faktor VIII/von Willebrandov faktor sastoji se od dvije molekule (faktora VIII i von Willebrandovog faktora) koje imaju različite fiziološke funkcije.
English: However, no correlating adverse histopathological changes could be observed indicating a transient nature of this finding.
Croatian: Međutim, nisu primijećene povezane nepoželjne histopatološke promjene, što ukazuje na prolaznost te pojave.
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PRILOG II. A. PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation.
Croatian: Proizveden je bez dodavanja bilo kakvih (egzogenih) proteina ljudskog ili životinjskog podrijetla tijekom postupka kultiviranja stanica, pročišćavanja ili konačne formulacije.
English: What ADVATE is and what it is used for What you need to know before you use ADVATE How to use ADVATE
Croatian: Što je ADVATE i za što se koristi Što morate znati prije nego počnete primjenjivati ADVATE Kako primjenjivati ADVATE
English: Catheter-related complications in treatment
Croatian: Komplikacije u liječenju vezane za kateter
English: A non-interventional prospective registry (PASS-INT-004) documented ITI in 44 paediatric and adult subjects of whom 36 completed ITI therapy.
Croatian: U neintervencijskom prospektivnom registru (PASS-INT-004) zabilježeno je liječenje metodom imunotolerancije u 44 pedijatrijska i odrasla bolesnika, od kojih je 36 završilo liječenje metodom imunotolerancije.
English: Do not use ADVATE - if you are allergic to octocog alfa or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to mouse or hamster proteins
Croatian: Nemojte primjenjivati ADVATE - ako ste alergični na djelatnu tvar ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako ste alergični na proteine miša ili hrčka.
English: The table is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Tablica je u skladu s klasifikacijom organskih sustava prema MedDRA (SOC i razina preporučenog pojma).
English: Specific activity: approx. 4,000 - 10,000 IU/mg protein
Croatian: Specifična aktivnost: približno 4000 - 10 000 IU/mg proteina
English: Pharmacokinetic data with ADVATE on previously untreated patients are currently not available.
Croatian: Farmakokinetički podaci za ADVATE u bolesnika koji prethodno nisu bili liječeni, trenutno nisu dostupni.
English: Usually, the replacement therapy with ADVATE is a life-long treatment.
Croatian: Nadomjesno liječenje lijekom ADVATE obično je doživotno.
English: If this happens your or your child's medicines may stop working properly and you or your child may experience persistent bleeding.
Croatian: U tom slučaju Vaš lijek ili lijek Vašeg djeteta može prestati ispravno djelovati, a kod Vas ili Vašeg djeteta može se javiti krvarenje koje ne prestaje.
English: If this happens, you should contact your doctor immediately.
Croatian: Ako se to dogodi, odmah se obratite liječniku.
English: However, in some cases, especially in younger patients, more frequent injections or higher doses may be necessary.
Croatian: Ipak, u nekim slučajevima, osobito u mlađih bolesnika, mogu biti potrebni kraći vremenski razmaci uzimanja ili više doze.
English: Detailed instructions for self-administration are given at the end of this package leaflet.
Croatian: Detaljne upute za samostalno davanje nalaze se na kraju ove Upute o lijeku.
English: Do not use solutions that are cloudy or have deposits.
Croatian: Nemojte koristiti otopine koje su mutne ili imaju naslage.
English: If any of these symptoms occur, stop the injection immediately and contact your doctor.
Croatian: Ako se u Vas pojavi bilo koji od ovih simptoma, odmah prekinite injekciju te obavijestite svog liječnika.
English: The specific activity of ADVATE is approximately 4,000-10,000 IU/mg protein.
Croatian: Specifična aktivnost lijeka ADVATE iznosi približno 4000-10 000 IU/mg proteina.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Croatian: Trombin potom pretvara fibrinogen u fibrin što dovodi do stvaranja krvnog ugruška.
English: Uncommon (PTPs)
Croatian: manje često (PTPs)
English: • Do not try to administer the injection unless you have received special training from your doctor or nurse.
Croatian: • Ne smijete sami sebi dati injekciju, ako Vas liječnik ili medicinska sestra nisu posebno obučili za to.
English: Use immediately or within 3 hours of reconstitution.
Croatian: Primijeniti odmah, ili u roku od 3 sata nakon pripreme otopine.
English: Common side effects (may affect up to 1 in 10 people) headache and fever.
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) glavobolja i vrućica.
English: Your doctor will calculate your dose of ADVATE (in international units or IU) depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding.
Croatian: Doza lijeka ADVATE (izražena u međunarodnim jedinicama ili IU) koju će izračunati liječnik ovisiti će o Vašem stanju i tjelesnoj težini, kao i o tome hoćete li lijek uzimati za prevenciju ili liječenje krvarenja.
English: Children and adolescents The listed warnings and precautions apply to both adults and children (from 0 to 18 years of age).
Croatian: Djeca i adolescenti Navedena upozorenja i mjere opreza isti su u odraslih kao i za djecu (u dobi od 0 do 18 godina).
English: Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Croatian: Bolesnici mogu različito reagirati na faktor VIII, postizanjem različitih vrijednosti povrata in vivo i pokazujući različite poluvijeke.
English: Only a clear and colourless solution should be used.
Croatian: Smije se upotrijebiti samo bistra i bezbojna otopina.
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Croatian: Ako se ne postignu očekivane razine aktivnosti faktora VIII u plazmi ili ako se krvarenje ne može kontrolirati primjenom odgovarajuće doze, potrebno je napraviti ispitivanje na prisutnost inhibitora faktora VIII.
English: The dose of octocog alfa is calculated depending on your body weight and the factor VIII levels to be achieved.
Croatian: Doza oktokoga alfa izračunava se ovisno o Vašoj tjelesnoj težini i razini faktora VIII koja se želi postići.
English: Within a sub-study of PUP-study 060103, ITI-treatments in 11 PUPs were documented.
Croatian: U okviru podstudije u PUP studiji 060103, zabilježeno je liječenje metodom imunotolerancije u 11 prethodno neliječenih bolesnika.
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre inhibitors which are transiently present or remain consistently low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Croatian: Klinički značaj razvoja inhibitora ovisit će o titru inhibitora, pri čemu inhibitori s niskim titrom koji su prolazno prisutni ili ostaju stalno niskog titra, predstavljaju manji rizik za pojavu nedovoljnog kliničkog odgovora u odnosu na inhibitore s visokim titrom.
English: No symptoms of overdose with recombinant coagulation factor VIII have been reported.
Croatian: Nisu prijavljeni simptomi predoziranja s rekombinantnim koagulacijskim faktorom VIII.
English: Swirl gently until all material is dissolved.
Croatian: Nježno okrećite bočicu dok se sav materijal ne otopi.
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju šoka, potrebno je primijeniti uobičajene medicinske mjere za liječenje takvog stanja.
English: The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 20 exposure days.
Croatian: Rizik od razvijanja inhibitora u korelaciji je s težinom bolesti, kao i s izloženošću faktoru VIII, a najveći je unutar prvih 20 dana izloženosti.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse or hamster proteins.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili proteine miša ili hrčka.
English: Clinical studies with ADVATE included 418 subjects with at least one exposure to ADVATE reporting in total 93 adverse drug reactions (ADRs).
Croatian: Klinička ispitivanja lijeka ADVATE uključivala su 418 ispitanika s najmanje jednom izloženosti lijeku ADVATE, a prijavljeno je ukupno 93 nuspojava.
English: Boulevard René Branquart 80 B-7860 Lessines Belgium
Croatian: Boulevard René Branquart 80 B-7860 Lessines Belgija
English: - Aseptic Technique should be used
Croatian: - Treba koristiti aseptičku tehniku
English: b) The unexpected decrease in coagulation factor VIII levels occurred in one patient during continuous infusion of ADVATE following surgery (postoperative days 10-14).
Croatian: Neočekivano sniženje razine koagulacijskog faktora VIII pojavilo se u jednog bolesnika tijekom kontinuirane infuzije lijeka ADVATE nakon kirurškog zahvata (tijekom 10-14 dana nakon kirurškog zahvata).
English: In study 060201 two long-term prophylaxis treatment schemes have been compared in 53 PTPs: an individualized pharmacokinetic guided dosing regimen (within a range of 20 to 80 IU of factor VIII per kg body weight at intervals of 72 ± 6 hours, n=23) with a standard prophylactic dosing regimen (20 to 40 IU/kg every 48 ±6 hours, n=30).
Croatian: U studiji 060201, dvije sheme dugotrajnog profilaktičnog liječenja uspoređene su u 53 prethodno liječenih bolesnika: individualiziran režim doziranja na temelju farmakokinetike (u rasponu od 20 do 80 IU faktora VIII po kg tjelesne težine u razmacima od 72 ± 6 sati, n=23) sa standardnim profilaktičnim režimom doziranja (20 do 40 IU/kg svakih 48 ± 6 sati, n=30).
English: After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3.
Croatian: Otopina je nakon rekonstitucije bistra, bezbojna, bez vidljivih čestica i pH otopine iznosi između 6,7 i 7,3.
English: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.
Croatian: Jedna međunarodna jedinica (IU) aktivnosti faktora VIII jednaka je količini faktora VIII u jednom ml normalne ljudske plazme.
English: If you forget to use ADVATE
Croatian: Ako ste zaboravili primijeniti ADVATE
English: If you have the impression that the effect of ADVATE is insufficient, talk to your doctor.
Croatian: Ako imate dojam da je učinak lijeka ADVATE nedostatan, obratite se svom liječniku.
English: Development of antibodies to mouse and/or hamster protein with related hypersensitivity reactions may be observed.
Croatian: Može se opaziti stvaranje antitijela na proteine miša i/ili hrčka s povezanim reakcijama preosjetljivosti.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima ili otapalima.
English: End of 6 month period, if stored at room temperature: Do not use after the expiry date.
Croatian: Kraj šestomjesečnog razdoblja, ako se čuva na sobnoj temperaturi: Lijek se ne smije upotrijebiti nakon isteka roka valjanosti.
English: Be sure that the ADVATE powder is completely dissolved, otherwise not all reconstituted solution will pass through the device filter.
Croatian: Budite sigurni da je prašak ADVATE u potpunosti otopljen, inače sva rekonstituirana otopina neće proći kroz filtar uređaja.
English: Do not use this medicine after the expiry date, which is stated on the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake EXP.
English: In patients with haemophilia A (inborn lack of factor VIII), it is missing or not working properly.
Croatian: U bolesnika s hemofilijom A (urođeni nedostatak faktora VIII) njega nedostaje ili ne djeluje pravilno.
English: Disconnect the syringe.
Croatian: Odvojite štrcaljku.
English: These symptoms can constitute an early symptom of an anaphylactic shock, manifestations of which may additionally include extreme dizziness, loss of consciousness, and extreme difficulty in breathing.
Croatian: Ovi simptomi mogu sačinjavati rane simptome anafilaktičkog šoka, čiji dodatni pokazatelji mogu biti omaglica, gubitak svijesti te iznimno teške poteškoće u disanju.
English: - Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: - Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Adjusted recovery and terminal half-life (t½) was approximately 20% lower in young children (less than 6 years of age) than in adults, which may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
Croatian: Prilagođena vrijednost povrata i poluvijek (t½) bili su za približno 20% manje u mlađe djece (mlađe od 6 godina života) u odnosu na odrasle bolesnike, što je za očekivati s obzirom na poznatu činjenicu da je volumen plazme po kilogramu tjelesne težine veći u mlađih bolesnika.
English: Reconstitution with the BAXJECT III system - Do not use if the lid is not completely sealed on the blister
Croatian: Rekonstitucija pomoću sustava BAXJECT III - Ne upotrebljavajte ako pokrov na blisteru nije u potpunosti zatvoren.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dl.
Croatian: Izračun potrebne doze faktora VIII temelji se na empirijskim saznanjima da 1 IU faktora VIII po kg tjelesne težine povećava aktivnost faktora VIII u plazmi za 2 IU/dl.
English: The pharmacokinetic guided dosing regimen (according to a specific formula) was targeted to maintain factor VIII trough levels ≥ 1% at the inter-dosing interval of 72 hours.
Croatian: Režim doziranja na temelju farmakokinetike (prema posebnoj formuli) bio je usmjeren održavanju najniže vrijednosti faktora VIII na razinama ≥ 1% u razdoblju od 72 sati između doza.
English: Procedural site reaction a) Calculated based on total number of patients who received ADVATE (418).
Croatian: Izračunato temeljem ukupnog broja bolesnika koji su primali ADVATE (418).
English: Required units (IU) = body weight (kg) x desired factor VIII rise (%) x 0.5
Croatian: Potrebne jedinice (IU) = tjelesna težina (kg) x željeni porast faktora VIII (%) x 0,5