FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 5 mg tablets Olanzapine
Croatian: NAZIV LIJEKA Olanzapin Glenmark 5 mg tablete olanzapin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/587/001
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 15 mg tablets Olanzapine
Croatian: NAZIV LIJEKA Olanzapin Glenmark 15 mg tablete olanzapin
English: See package leaflet for further information
Croatian: Vidjeti Uputu o lijeku za dodatne informacije.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg olanzapine Excipient with known effect: Each tablet contains 0.92 mg of aspartame For the full list of excipients, see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: svaka tableta sadrži 0,92 mg aspartama.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/007
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/587/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/587/004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/587/004
English: Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) 11
Croatian: povišene razine kolesterola2,3 povišene razine glukoze4 povišene razine triglicerida2,5 glikozurija pojačan apetit razvoj ili egzacerbacija dijabetesa, ponekad povezana s ketoacidozom ili komom, uključujući i neke slučajeve sa smrtnim ishodom (vidjeti dio 4.4)11
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 7.5 mg olanzapine.
Croatian: Svaka tableta sadrži 7,5 mg olanzapina.
English: If you stop taking Olanzapine Glenmark
Croatian: Nemojte uzimati lijek Olanzapine Glenmark
English: SE-11276 Stockholm Sweden
Croatian: SE-11276 Stockholm Švedska
English: If you have not used it within 3 hours, throw it away.
Croatian: Ako je ne primijenite u roku od 3 sata, bacite je.
English: Repeat every 12-24 hours.
Croatian: Ponoviti svakih 12-24 sata.
English: Additional Instructions:
Croatian: Dodatne upute:
English: The required dose is determined using the following formula:
Croatian: Potrebna doza određuje se pomoću sljedeće formule:
English: This is of importance particularly when changing the laboratory and/or reagents used.
Croatian: To je posebice važno prilikom promjene laboratorija i/ili korištenog reagensa.
English: It is important that the recommendations in section 6.3 be followed closely.
Croatian: Važno je pažljivo slijediti preporuke u dijelu 6.3.
English: No long-term outcome is available.
Croatian: Nisu dostupni podaci o dugoročnom ishodu.
English: Date removed from the refrigerator:
Croatian: Datum uklanjanja iz hladnjaka:
English: (pre- and post-operative)
Croatian: (prije i poslije operacije)
English: PK parameter
Croatian: PK parametar
English: Always wash your hands before performing the following procedures.
Croatian: Uvijek operite ruke prije provođenja sljedećih postupaka.
English: SD Median
Croatian: SD Medijan
English: Do not attempt self-infusion unless properly trained.
Croatian: Nemojte pokušavati sami sebi dati infuziju ako niste primili ispravnu obuku.
English: Every 24 hours, at least 1 day, until healing is achieved.
Croatian: Svaka 24 sata, najmanje 1 dan, do izlječenja.
English: Clinical studies did not include subjects aged 65 and over.
Croatian: Klinička ispitivanja nisu uključila ispitanike starije od 65 godina i više.
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju šoka, potrebno je primijeniti standardno medicinsko liječenje šoka.
English: Do not stop using ReFacto AF without consulting your doctor.
Croatian: Nemojte prestati primjenjivati ReFacto AF bez savjetovanja s Vašim liječnikom.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25°C.
Croatian: Dokazana je kemijska i fizikalna stabilnost tijekom 3 sata na temperaturi do 25
English: • dizziness and loss of consciousness
Croatian: • omaglica i gubitak svijesti
English: Consumption and efficacy results in paediatric population
Croatian: Rezultati upotrebe i djelotvornosti u pedijatrijskoj populaciji
English: Therefore, factor VIII should be used during pregnancy and breast-feeding only if clearly indicated.
Croatian: Stoga se faktor VIII smije primjenjivati tijekom trudnoće i dojenja samo ako je to jasno indicirano.
English: - if you are allergic to moroctocog alfa or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na moroktokog alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Thrombin then converts fibrinogen into fibrin, and a clot is formed.
Croatian: Trombin potom pretvara fibrinogen u fibrin i nastaje ugrušak.
English: Pack size of 1.
Croatian: Veličina pakiranja od 1.
English: Other in-use storage times and conditions are the responsibility of the user.
Croatian: Drugačije vrijeme i uvjeti čuvanja odgovornost su korisnika.
English: Repeat infusion every 8-24 hours until threat is resolved.
Croatian: Ponoviti infuziju svakih 8-24 sata do prestanka prijetnje.
English: The amount of drug product left in the infusion set will not affect your treatment.
Croatian: Količina lijeka koja preostane u priboru za infuziju neće utjecati na Vaše liječenje.
English: Minor surgery including tooth extraction
Croatian: Manji kirurški postupak uključujući vađenje zuba
English: This dose and duration will depend upon your individual needs for replacement factor VIII therapy.
Croatian: Ta doza i trajanje ovisit će o Vašim individualnim potrebama za nadomjesnom terapijom faktorom VIII.
English: • swelling of lips and tongue
Croatian: • oticanje usana i jezika
English: Grasp the plunger rod as shown in the following diagram.
Croatian: Uhvatite klip kako je prikazano na sljedećoj slici.
English: • severe allergic reaction
Croatian: • teška alergijska reakcija
English: What ReFacto AF is and what it is used for
Croatian: Što je ReFacto AF i za što se koristi
English: Talk to your doctor or pharmacist before using ReFacto AF - if you experience allergic reactions.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite ReFacto AF - ako dobijete alergijsku reakciju.
English: • increased liver enzymes, increased bilirubin
Croatian: • povišeni jetreni enzimi, povišen bilirubin
English: Doses administered should be titrated to the patient's clinical response.
Croatian: Primijenjene doze treba titrirati prema kliničkom odgovoru bolesnika.
English: Do not use this medicine if you notice that it is cloudy or contains visible particles.
Croatian: Nemojte primijeniti ovaj lijek ako primijetite da je zamućen ili sadrži vidljive čestice.
English: After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.
Croatian: Nakon čišćenja, nemojte dodirivati gumeni čep rukama i pazite da ne dodirne neku drugu površinu.
English: Check with your doctor or pharmacist.
Croatian: Provjerite s Vašim liječnikom ili ljekarnikom.
English: Immune Tolerance Induction
Croatian: Izazivanje imunološke tolerancije
English: Animal reproduction studies have not been conducted with factor VIII, therefore no data are available on fertility.
Croatian: Nisu provedena ispitivanja reprodukcije na životinjama s faktorom VIII, stoga nema dostupnih podataka o utjecaju na plodnost.
English: In the presence of an inhibitor, higher doses or appropriate specific treatment may be required.
Croatian: Ako je prisutan inhibitor, mogu biti potrebne više doze ili odgovarajuće specifično liječenje.
English: The specific activity of ReFacto AF is 7,600-13,800 IU/mg protein.
Croatian: Specifična aktivnost lijeka ReFacto AF je 7600-13 800 IU/mg proteina.
English: Date of first authorisation: 13 April 1999 Date of latest renewal: 15 April 2014
Croatian: Datum posljednje obnove odobrenja: 15. travnja 2014.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Croatian: Sljedeća tablica može poslužiti kao smjernica za doziranje kod epizoda krvarenja i kirurških zahvata:
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Croatian: Učestalosti su procijenjene u skladu sa sljedećom konvencijom: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10) i manje često (≥ 1/1000 i < 1/100).
English: In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.
Croatian: U nekim slučajevima, osobito kod mlađih bolesnika, mogu biti potrebni kraći vremenski razmaci između doza ili više doze.
English: • slight increase in heart enzymes
Croatian: • blagi porast srčanih enzima
English: Inform your doctor if you are on a controlled sodium diet.
Croatian: Obavijestite svog liječnika ako ste na dijeti s ograničenim unosom natrija.
English: Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.
Croatian: Teški simptomi, uključujući otežano disanje i (skoru) nesvjesticu zahtijevaju hitno liječenje.
English: In general, dose selection for an elderly patient should be individualised.
Croatian: Općenito, odabir doze za starijeg bolesnika treba se temeljiti na individualnom pristupu.
English: What ReFacto AF looks like and contents of the pack
Croatian: Kako ReFacto AF izgleda i sadržaj pakiranja
English: ** Human coagulation factor VIII produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Croatian: ** Ljudski faktor koagulacije VIII proizveden tehnologijom rekombinantne DNK u stanicama jajnika kineskog hrčka (CHO).
English: ReFacto AF is appropriate for use in adults and children of all ages, including newborns.
Croatian: ReFacto AF je pogodan za primjenu u odraslih i djece svih dobi, uključujući novorođenčad.
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Croatian: Ponoviti infuziju svakih 8-24 sata do odgovarajućeg cijeljenja rane, a potom terapija još najmanje 7 dana da bi se aktivnost faktora VIII održala na 30% do 60% (IU/dl).
English: Repeat infusion every 12-24 hours for 3-4 days or more until pain and acute disability are resolved.
Croatian: Ponoviti infuziju svakih 12-24 sata tijekom 3-4 dana ili više do prestanka bola i akutne onesposobljenosti.
English: No investigations on carcinogenic potential or toxicity to reproduction have been conducted.
Croatian: Nisu provedena ispitivanja kancerogenosti i reproduktivne toksičnosti.
English: AUCinf, IU∙h/mLb t½, hb
Croatian: AUCinf, IU∙h/ml t½, h
English: At least 1 day until the bleeding episode as indicated by pain is resolved or healing is achieved.
Croatian: Najmanje 1 dan do prestanka epizode krvarenja praćenog bolom ili do izlječenja.
English: Patients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately.
Croatian: Bolesnici ili njihovi skrbnici mogu davati injekcije s lijekom ReFacto AF, uz uvjet da su dobili odgovarajuću obuku.
English: It is a glycoprotein with an approximate molecular mass of 170,000 Da consisting of 1438 amino acids.
Croatian: To je glikoprotein približne molekularne mase od 170 000 Da koji se sastoji od 1438 aminokiselina.
English: White to off-white cake/powder
Croatian: Bijeli do gotovo bijeli kolačić/prašak
English: Тел.
Croatian: Tel.
English: Aged <6 years Aged 6 to <12 years Cmax, IU/mLb
Croatian: U dobi < 6 godina U dobi od 6 do < 12 godina Cmax, IU/ml
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, including other infusion solutions.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima, uključujući druge otopine za infuziju.
English: Your doctor or other healthcare professional should teach you how to infuse ReFacto AF.
Croatian: Vaš liječnik ili drugi zdravstveni radnik mora Vas obučiti kako primijeniti ReFacto AF infuzijom.
English: In case of severe allergic reactions, alternative therapy must be considered.
Croatian: U slučaju teških alergijskih reakcija, mora se razmotriti druga mogućnost liječenja.
English: Your doctor may change your recommended infusion rate to make the infusion more comfortable.
Croatian: Liječnik Vam može promijeniti preporučenu brzinu infuzije kako bi infuzija bila ugodnija.
English: This vented cap has tiny holes that allow air to escape in order to prevent pressure build-up.
Croatian: Taj propusni zatvarač ima sitne rupice koje omogućuju izlazak zraka kako bi se spriječio porast tlaka.
English: ReFacto AF does not contain von Willebrand factor, and hence is not indicated in von Willebrand's disease.
Croatian: ReFacto AF ne sadrži von Willebrandov faktor pa stoga nije indiciran u von Willebrandovoj bolesti.
English: • weakness, injection site reactions including pain
Croatian: • slabost, reakcije na mjestu primjene injekcije uključujući bol
English: Abbreviations: ABR = annualised bleeding rate
Croatian: ABR = anualizirana stopa krvarenja (engl. annualized bleed rate)
English: This is to be considered during the preparation and administration of the product, including storage time elapsed in a PVC container following reconstitution.
Croatian: To treba uzeti u obzir tijekom pripreme i primjene lijeka, uključujući proteklo vrijeme čuvanja u PVC spremniku nakon rekonstitucije.
English: Always wash your hands before performing the following reconstitution and administration procedures.
Croatian: Uvijek operite ruke prije sljedećih postupaka pripreme i primjene.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Tablica prikazana u nastavku u skladu je s MedDRA klasifikacijom organskih sustava (SOC i razina preporučenog pojma).
English: Frequency of doses (hours)/ Duration of therapy (days)
Croatian: Učestalost doziranja (sati)/ Trajanje terapije (dani)
English: Other medicines and ReFacto AF
Croatian: Drugi lijekovi i ReFacto AF
English: If you use more ReFacto AF than you should
Croatian: Ako primijenite više lijeka ReFacto AF nego što ste trebali
English: During your treatment, your doctor may decide to change the dose of ReFacto AF you receive.
Croatian: Tijekom liječenja, liječnik može odlučiti promijeniti dozu lijeka ReFacto AF koju primate.
English: Factor VIII is necessary for the blood to form clots and stop bleedings.
Croatian: Faktor VIII je potreban za zgrušavanje krvi i zaustavljanje krvarenja.
English: Of these 25 patients, 20 had a decrease in inhibitor titres to < 0.6 BU/mL, of whom initially 11 of 15 had high titres (≥ 5 BU/mL) and 9 of 10 had low titres.
Croatian: Od tih 25 bolesnika, 20 ih je imalo smanjenje titra inhibitora na < 0,6 BU/ml, od njih je inicijalno 11 od 15 imalo visoki titar (≥5 BU/ml), a 9 od 10 niski titar.
English: Out of 6 patients who developed low titre inhibitors but did not receive ITI, 5 had similar titre decreases.
Croatian: bolesnika koji su razvili niski titar inhibitora, ali nisu primili ITI, 5 ih je imalo slično snižavanje titra.
English: Reports of lack of effect
Croatian: Prijave izostanka učinka
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Croatian: Količinu koja će se primijeniti i učestalost primjene uvijek treba odrediti prema kliničkoj učinkovitosti u pojedinom slučaju.
English: Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Croatian: Važno je napomenuti da anualizirana stopa krvarenja nije usporediva između različitih koncentrata faktora i između različitih kliničkih ispitivanja.
English: Typically, one-stage clotting assay results are 20-50% lower than the chromogenic substrate assay results.
Croatian: Obično su rezultati jednofaznog testa zgrušavanja krvi 20-50% niži od rezultata testa s kromogenim supstratom.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently for ReFacto, and may in some cases progress to severe anaphylaxis including shock (see section 4.4).
Croatian: Preosjetljivost ili alergijske reakcije (koje mogu uključivati angioedem, žarenje i peckanje na mjestu infuzije, zimice, navale crvenila, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje, piskanje pri disanju) nisu opažene često uz ReFacto, no u nekim slučajevima mogu napredovati do teške anafilaksije uključujući šok (vidjeti dio 4.4).
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII; ATC code: B02BD02.
Croatian: Farmakoterapijska skupina: antihemoragici, koagulacijski faktor VIII, ATK oznaka: B02BD02.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Croatian: Ako se pojave simptomi preosjetljivosti, bolesnicima treba savjetovati da odmah prestanu uzimati lijek i obrate se svom liječniku.
English: What ReFacto AF is and what it is used for What you need to know before you use ReFacto AF How to use ReFacto AF
Croatian: Što je ReFacto AF i za što se koristi Što morate znati prije nego počnete primjenjivati ReFacto AF Kako primjenjivati ReFacto AF Moguće nuspojave
English: You should bring enough of your factor VIII product for anticipated treatment when travelling.
Croatian: Trebate ponijeti dovoljno lijeka s faktorom VIII za predviđeno liječenje dok ste na putu.
English: • numbness, sleepiness, altered taste
Croatian: • utrnulost, pospanost, promijenjen okus
English: Reconstituted ReFacto AF must not be administered in the same tubing or container with other medicinal products.
Croatian: Pripremljeni ReFacto AF ne smije se primijeniti u istoj cijevi ili spremniku s drugim lijekovima.
English: Severe, sudden allergic (anaphylactic) reactions are uncommon (may affect up to 1 in 100 people).
Croatian: Teške, iznenadne alergijske (anafilaktičke) reakcije su manje česte (mogu se javiti u do 1 na 100 osoba).
English: The ReFacto AF laboratory standard can be used to correct for this discrepancy (see section 5.2).
Croatian: Da bi se korigiralo ovo nepodudaranje, može se uporabiti laboratorijski standard za ReFacto AF (vidjeti dio 5.2).
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Croatian: Pojedini bolesnici mogu varirati u svom odgovoru na faktor VIII iskazujući različite poluvijekove i razine povrata.
English: ReFacto AF has functional characteristics comparable to those of endogenous factor VIII.
Croatian: ReFacto AF ima funkcionalne značajke usporedive s onima endogenog faktora VIII.
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: These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors.
Croatian: Ti inhibitori, posebno kada su u visokim razinama, zaustavljaju ispravno djelovanje liječenja, pa ćete Vi ili Vaše dijete biti pod pažljivim praćenjem zbog mogućeg razvoja tih inhibitora.
English: Known allergic reaction to hamster protein.
Croatian: Poznata alergijska reakcija na protein hrčka.
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 50 exposure days but continues throughout life although the risk is uncommon.
Croatian: Rizik od razvijanja inhibitora u korelaciji je s težinom bolesti, kao i s izloženošću faktoru VIII, a najveći je unutar prvih 50 dana izloženosti, ali nastavlja se tijekom života iako je manje čest.
English: The reported lack of effect with ReFacto has been described as bleeding into target joints, bleeding into new joints or a subjective feeling by the patient of new onset bleeding.
Croatian: Zabilježeni izostanak učinka lijeka ReFacto opisan je kao krvarenje u ciljne zglobove, krvarenje u nove zglobove ili subjektivan osjećaj bolesnika da je nastupilo novo krvarenje.
English: In a study of ReFacto, twenty of 113 (18%) previously treated patients (PTPs) had an increase in anti-CHO antibody titre, without any apparent clinical effect.
Croatian: U ispitivanju lijeka ReFacto, dvadeset od 113 (18%) prethodno liječenih bolesnika imalo je povišen titar anti-CHO protutijela, bez ikakvog vidljivog kliničkog učinka.
English: Remove the empty ReFacto AF pre-filled syringe and repeat procedures 3 and 4 above for any additional reconstituted syringes.
Croatian: Uklonite ispražnjenu ReFacto AF napunjenu štrcaljku i ponovite postupke br. 3 i 4 gore s dodatnim pripremljenim štrcaljkama.
English: Remove the contents of the ReFacto AF pre-filled syringe kit and place on a clean surface, making sure you have all the supplies you will need.
Croatian: Izvadite sadržaj kompleta ReFacto AF s napunjenom štrcaljkom i postavite ga na čistu površinu, pazeći da imate sav pribor koji će Vam biti potreban.
English: Very rarely, development of antibodies to hamster protein has been observed, but there were no clinical sequelae.
Croatian: Razvoj protutijela na protein hrčka opažen je vrlo rijetko, ali nije bilo kliničkih posljedica.
English: If you are unsure about this, ask your doctor.
Croatian: Ako niste sigurni u vezi s ovime, obratite se svom liječniku.
English: ReFacto AF is used for the treatment and prevention of bleeding (prophylaxis) in adults and children of all ages (including newborns) with haemophilia A.
Croatian: ReFacto AF se primjenjuje za liječenje i sprječavanje krvarenja (profilaksu) u odraslih i djece svih dobi (uključujući novorođenčad) s hemofilijom A.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Croatian: Posebice u slučaju većih kirurških intervencija neizostavno je precizno praćenje nadomjesne terapije putem testova koagulacije (aktivnost plazmatskog faktora VIII).
English: If any of these signs occur, stop the infusion immediately and contact a doctor or seek immediate emergency care.
Croatian: Ako nastupi neki od ovih znakova, odmah prekinite infuziju i obratite se liječniku ili odmah potražite hitnu medicinsku pomoć.
English: Dose adjustment for patients with renal or hepatic impairment has not been studied in clinical trials.
Croatian: Prilagodba doze za bolesnike s oštećenjem bubrega ili jetre nije ispitana u kliničkim ispitivanjima.
English: Moroctocog alfa is a glycoprotein with 1438 amino acids with a sequence that is comparable to the 90 + 80 kDa form of factor VIII (i.e. B-domain deleted) and similar post-translational modifications to those of the plasma-derived molecule.
Croatian: Moroktokog alfa je glikoprotein od 1438 aminokiselina čiji je slijed usporediv s oblikom 90 + 80 kDa faktora VIII (tj. delecijom B-domene) i s postranslacijskim promjenama koje su slične onima kod molekule dobivene iz plazme.
English: Except in cases where inhibitors were detected, the mean recovery was stable over time (6 visits during a 2-year period) and individual values ranged from 0 (in presence of inhibitor) to 2.7 IU/dl per IU/kg.
Croatian: Osim u slučajevima u kojima su otkriveni inhibitori, srednja vrijednost povrata bila je stabilna tijekom vremena (6 kontrola u razdoblju od 2 godine), a pojedinačne vrijednosti kretale su se u rasponu od 0 (u prisutnosti inhibitora) do 2,7 IU/dl po IU/kg.