FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), not known (cannot be estimated from the available data).
Croatian: Učestalosti su procijenjene u skladu sa sljedećom konvencijom: vrlo često ( 1/10), često (≥1/100 i < 1/10); manje često (≥1/1000 i < 1/100), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Date of first authorisation: 27 August 1997 Date of latest renewal: 20 July 2012
Croatian: Datum posljednje obnove odobrenja: 20. srpnja 2012.
English: A population pharmacokinetic model was developed using data collected in 73 patients aged 7 months to 60 years.
Croatian: Populacijski farmakokinetički model je razvijen korištenjem podataka prikupljenih od 73 bolesnika u dobi od 7 mjeseci do 60 godina starosti.
English: Repeat infusion every 8 to 24 hours until threat is resolved.
Croatian: Ponavljati infuziju svakih 8 do 24 sata dok ne prestane opasnost.
English: Infants and children had higher clearance, larger volume of distribution, shorter half-life and lower recovery than adolescents and adults.
Croatian: Dojenčad i djeca su imala viši klirens, veći volumen distribucije, kraći poluvijek i niži povrat nego adolescenti i odrasli.
English: If bleeding is not controlled with the recommended dose, contact your doctor.
Croatian: Ako se krvarenje ne može kontrolirati preporučenom dozom, javite se liječniku.
English: Please contact your doctor immediately if you inject more BeneFIX than your doctor recommends.
Croatian: Molimo da se odmah javite liječniku ako injicirate više BeneFIX-a nego što je preporučio liječnik.
English: • Lack of response to treatment (failure to stop or prevent bleeding episodes)
Croatian: • nedostatak odgovora na liječenje (nemogućnost prekidanja ili sprječavanja epizoda krvarenja)
English: - If you suffer from liver or heart disease or if you have recently had surgery, there is an increased risk for blood clotting (coagulation) complications.
Croatian: Ako bolujete od bolesti jetre ili srca ili ste nedavno bili na kirurškom zahvatu, postoji povećan rizik od komplikacija sa zgrušavanjem krvi (koagulacijom).
English: Common to < 1/10
Croatian: Često i <1/10
English: No investigations on carcinogenicity, fertility impairment and foetal development have been conducted.
Croatian: Nisu provedena ispitivanja karcinogenosti, smanjenja plodnosti i fetalnog razvoja.
English: The terminal phase has not been covered unambiguously due to lack of data beyond 24 hours in paediatric subjects < 6 years of age.
Croatian: Završna faza nije jednoznačno obuhvaćena zbog nedostataka podataka nakon 24 sata u pedijatrijskih bolesnika < 6 godina starosti.
English: A summary of pharmacokinetic data is presented in Table 1.
Croatian: Sažetak farmakokinetičkih podataka nalazi se u Tablici 1.
English: Every 24 hours, at least 1 day, until healing is achieved.
Croatian: Svaka 24 sata, najmanje 1 dan, dok ne zacijeli.
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 niti dopustiti da dotakne neku površinu.
English: In each of these situations, the benefit of treatment with BeneFIX should be weighed against the risk of these complications.
Croatian: U tim situacijama potrebno je procijeniti korist od liječenja BeneFIX-om u odnosu na rizik od ovih komplikacija.
English: deep vein thrombosis*; thrombosis*; thrombophlebitis*
Croatian: tromboza dubokih vena*; tromboza*; tromboflebitis*
English: Frequency of doses (hours)/Duration of Therapy (days)
Croatian: Učestalost doza (sati)/trajanje terapije (dani)
English: X reciprocal of observed recovery
Croatian: X recipročna vrijednost opaženog povrata
English: Paediatric population Allergic reactions might be experienced more frequently in children than in adults.
Croatian: Pedijatrijska populacija Alergijske reakcije se mogu pojaviti s većom učestalosti u djece nego u odraslih.
English: If you take more BeneFIX than you should
Croatian: Ako primjenite više BeneFIX-a nego što ste trebali
English: Do not use this medicine if you notice the solution is not clear or colourless.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da otopina nije bistra ili bezbojna.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Croatian: Količina koju treba primijeniti i učestalost primjene uvijek trebaju biti usmjereni prema kliničkoj učinkovitosti u pojedinačnom slučaju.
English: - Allergic reactions are possible.
Croatian: - Moguće su alergijske reakcije.
English: To minimize the possibility of agglutination, it is important to limit the amount of blood entering the tubing.
Croatian: Da bi se mogućnost aglutinacije svela na najmanju moguću mjeru, važno je ograničiti količinu krvi koja ulazi u cjevčice.
English: No MedDRA 17.1 PT was retrieved.
Croatian: Nema preporučenog pojma u MedDRA 17.1.
English: Therefore, if you experience allergic reactions such as those described above, you should be tested for the presence of an inhibitor.
Croatian: Stoga, ako osjetite alergijske reakcije kao što su one opisane gore, trebate se testirati na prisutnost inhibitora.
English: This should be considered during the preparation and administration of BeneFIX.
Croatian: To treba uzeti u obzir tijekom pripreme i primjene BeneFIX-a.
English: Do not freeze in order to prevent damage to the pre-filled syringe.
Croatian: Ne zamrzavati, kako bi se spriječilo oštećenje napunjene štrcaljke.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should only take BeneFIX upon specific instructions from your doctor.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, smijete uzimati BeneFIX samo nakon posebnih uputa koje Vam je dao liječnik.
English: Adults 18 to 60
Croatian: Odrasli 18 do 60
English: In the case of shock, the current medical standards for treatment of shock should be observed.
Croatian: U slučaju šoka, potrebno je pridržavati se važećih medicinskih standarda za liječenje šoka.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Croatian: Sljedeća tablica može se upotrijebiti kao vodič za doziranje kod epizoda krvarenja i kirurških zahvata:
English: • Development of neutralising antibodies (inhibitors)
Croatian: • razvoj neutralizirajućih protutijela (inhibitora)
English: In most of the cases, an infusion rate of up to 4 mL per minute has been used.
Croatian: U većini se slučajeva infuzija primjenjivala brzinom do 4 ml po minuti.
English: The solution should appear clear and colourless.
Croatian: Otopina treba izgledati bistra i bezbojna.
English: Your doctor will decide the dose of BeneFIX you will receive.
Croatian: Liječnik će odlučiti koliku dozu BeneFIX-a ćete primati.
English: The reconstituted product does not contain a preservative and should be used immediately, but no longer than 3 hours after reconstitution.
Croatian: Rekonstituirani lijek ne sadrži konzervanse i mora se odmah primijeniti, najkasnije 3 sata od rekonstitucije.
English: Pharmacotherapeutic group: Antihaemorrhagics, blood coagulation factor IX; ATC code: B02BD04
Croatian: Farmakoterapijska skupina: antihemoragici, faktor zgrušavanja krvi IX; ATK oznaka: B02BD04
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor IX activity of 30% to 60% (IU/dL)
Croatian: Ponavljati infuziju svakih 8 do 24 sata do odgovarajućeg cijeljenja rane, a potom terapija još najmanje dodatnih 7 dana da se održi aktivnost faktora IX od 30% do 60% (IU/dl)
English: Mean  SD Pharmacokinetic Parameters Based on Individual Bayes Estimates from Population Pharmacokinetic Analysis
Croatian: Tablica 2. Srednja vrijednost  SD farmakokinetičkih parametara temeljena na individualnoj Bayesovoj procjeni iz populacijske farmakokinetičke analize
English: Clinical studies of BeneFIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Croatian: Klinička ispitivanja BeneFIX-a nisu uključivala dovoljan broj ispitanika u dobi od 65 godina ili starijih da bi se odredilo reagiraju li drugačije od mlađih ispitanika.
English: BeneFIX can be used for all age groups.
Croatian: BeneFIX se može primjenjivati u svim dobnim skupinama.
English: • one plaster
Croatian: • jedan flaster
English: In addition, pharmacokinetic parameters were followed up in 23 of the same patients after repeated administration of BeneFIX for six months and found to be unchanged compared with those obtained at the initial evaluation.
Croatian: Osim toga, farmakokinetički parametri praćeni su u 23 ista bolesnika nakon ponovljene primjene BeneFIX-a u razdoblju od šest mjeseci i bili su nepromijenjeni u odnosu na one dobivene u početnoj procjeni.
English: 1, 28700 San Sebastian de los Reyes, Madrid Spain
Croatian: A-1, Km. 23. Desvio Algete, Km. 1, 28700 San Sebastian de los Reyes, Madrid Španjolska
English: The safety and efficacy of using BeneFIX for immune tolerance induction has not been established.
Croatian: Sigurnost i djelotvornost primjene BeneFIX-a za indukciju imunološke tolerancije nije ustanovljena.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Croatian: Stoga bolesnicima koji imaju alergijske reakcije treba procijeniti prisutnost inhibitora.
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Croatian: Najmanje 1 dan, sve dok epizoda krvarenja, na koju ukazuje bol, ne prestane ili se ne postigne cijeljenje.
English: Your doctor may advise you to stop treatment with BeneFIX if you are breast-feeding or become pregnant.
Croatian: Liječnik Vam može savjetovati da prekinete liječenje BeneFIX-om ako dojite ili zatrudnite.
English: • Thrombotic events (abnormal blood clots)
Croatian: • trombotički događaji (abnormalni krvni ugrušci)
English: This dose and duration will depend upon your individual needs for replacement factor IX therapy and how quickly your body uses up factor IX, which will be checked regularly.
Croatian: Ta doza i trajanje liječenja ovisit će o Vašim individualnim potrebama za nadomjesnom terapijom faktora IX i koliko brzo Vaše tijelo troši faktor IX, što će se redovito provjeravati.
English: • two alcohol swabs
Croatian: • dvije vatice natopljene alkoholom
English: Abbreviations: AUC∞ = area under the plasma concentration-time curve from time zero to infinity; Cmax = peak concentration; t1/2 = plasma elimination half-life; CL = clearance; SD = standard deviation.
Croatian: Skraćenice: AUC∞ = površina ispod krivulje koncentracija u plazmi-vrijeme od nultog vremena do beskonačnosti; Cmax = vršna koncentracija; t1/2 = poluvijek eliminacije iz plazme; CL = klirens; SD = standardna devijacija.
English: Two patients underwent surgical procedures (circumcision and port-a-catheter insertion).
Croatian: Dva bolesnika podvrgnuta su kirurškim zahvatima (obrezivanje i uvođenje katetera).
English: Do not take BeneFIX:
Croatian: Nemojte primjenjivati BeneFIX:
English: BeneFIX 1000 BeneFIX 1500 BeneFIX 2000 BeneFIX 3000
Croatian: BeneFIX 250 BeneFIX 500 BeneFIX 1000 BeneFIX 1500 BeneFIX 2000 BeneFIX 3000
English: Note: If you use more than one vial of BeneFIX per infusion, each vial should be reconstituted as per the previous instructions.
Croatian: Napomena: Ako primjenjujete više od jedne bočice BeneFIX-a po infuziji, svaku bočicu trebate pripremiti prema prethodnim uputama.
English: • Dizziness, altered taste
Croatian: • omaglica, promijenjeni osjet okusa
English: Therefore if you are known to have such a mutation your doctor may monitor you more closely for signs of an allergic reaction particularly when you first start to take BeneFIX.
Croatian: Stoga, ako se zna da imate takvu mutaciju, liječnik Vas može pažljivije pratiti zbog znakova alergijske reakcije, osobito na početku prve primjene BeneFIX-a.
English: What BeneFIX is and what it is used for What you need to know before you take BeneFIX How to take BeneFIX
Croatian: Što je BeneFIX i za što se koristi Što morate znati prije nego počnete primjenjivati BeneFIX Kako primjenjivati BeneFIX
English: • Vision impairment (including blurred vision, appearance of spots/lights)
Croatian: • oštećenje vida (uključujući zamagljen vid, pojavu točaka/svjetla)
English: BeneFIX can cause harm to an unborn baby when given to pregnant women.
Croatian: Nije poznato može li BeneFIX naškoditi nerođenom djetetu kad se daje trudnicama.
English: Month 6 n = 23 Mean ± SD
Croatian: 6. mjesec n = 23 Srednja vrijednost ± SD
English: = body weight (in kg) X desired factor IX increase (%) or (IU/dL)
Croatian: = tjelesna težina (u kg) X željeno povećanje faktora IX (%) ili (IU/dl)
English: What BeneFIX is and what it is used for
Croatian: Što je BeneFIX i za što se koristi
English: The cap may need to be replaced (if not administering reconstituted BeneFIX immediately), so set it aside by placing it on its top.
Croatian: Možda ćete morati vratiti poklopac na štrcaljku (ako pripremljeni BeneFIX ne primijenite odmah) pa ga odložite sa strane tako što ćete ga postaviti vrhom dolje.
English: BeneFIX may increase the risk of thrombosis (abnormal blood clots) in your body if you have risk factors for developing blood clots, including an indwelling venous catheter.
Croatian: BeneFIX može povećati rizik od tromboze (nenormalni krvni ugrušci) u Vašem tijelu ako imate faktore rizika za razvoj krvnih ugrušaka, uključujući stalni venski kateter.
English: Your doctor may decide to change the dose of BeneFIX you receive during your treatment.
Croatian: Liječnik može odlučiti promijeniti dozu BeneFIX-a koju primate tijekom Vašeg liječenja.
English: BeneFIX has no influence on the ability to drive or use machines.
Croatian: BeneFIX ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: METHOD OF ADMINISTRATION Use the entire contents.
Croatian: Upotrijebite sav sadržaj.
English: Your doctor may want to monitor you for inhibitor development (see “Warnings and precautions”).
Croatian: Liječnik Vas može htjeti pratiti zbog razvoja inhibitora (vidjeti “Upozorenja i mjere opreza”).
English: The treatment required depends on the nature and severity of side-effects (see also “Warnings and precautions”).
Croatian: Potrebno liječenje ovisi o prirodi i težini nuspojava (vidjeti također “Upozorenja i mjere opreza”).
English: Please dispose of all unused solution, empty vials and used needles and syringes in an appropriate container for throwing away waste as it may hurt others if not handled properly.
Croatian: Molimo da bacite svu neiskorištenu otopinu, prazne bočice i uporabljene igle i štrcaljke u odgovarajući spremnik za bacanje otpada da se druge osobe, zbog neispravnog rukovanja materijalom, ne bi ozlijedile.
English: Only the provided infusion set should be used.
Croatian: Smije se upotrijebiti samo priloženi set za infuziju.
English: What BeneFIX looks like and contents of the pack
Croatian: Kako BeneFIX izgleda i sadržaj pakiranja
English: Wipe the top of the vial with an alcohol swab provided, or use another antiseptic solution and allow to dry.
Croatian: Obrišite vrh bočice priloženom vaticom natopljenom alkoholom ili uporabite drugu antiseptičku otopinu i ostavite da se osuši.
English: In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity levels (in % of normal or in IU/dL) in the corresponding period.
Croatian: U slučaju sljedećih događaja krvarenja, aktivnost faktora IX ne bi smjela pasti ispod navedenih razina aktivnosti u plazmi (u % normale ili u IU/dl) u određenom razdoblju.
English: Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved.
Croatian: Ponavljati infuziju svaka 24 sata tijekom 34 dana ili dulje dok bol i akutna onesposobljenost ne prestanu.
English: Patients should follow the specific venipuncture procedures provided by their doctor.
Croatian: Bolesnici trebaju slijediti posebne postupke za venepunkciju koje im je dao njihov liječnik.
English: The procedures below are provided as guidelines for the reconstitution and administration of BeneFIX.
Croatian: Niže opisani postupci nude smjernice za pripremu i primjenu BeneFIX-a.
English: It is strongly recommended that every time BeneFIX is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Croatian: Strogo se preporučuje, svaki put kada se BeneFIX primijeni bolesniku, zabilježiti ime i broj serije lijeka kako bi se sačuvala veza između bolesnika i serije lijeka.
English: The effect of BeneFIX on fertility has not been established.
Croatian: Učinak BeneFIX-a na plodnost nije ustanovljen.
English: However, the half-life of the product (see section 5.2) and the limited pharmacokinetic study data for the once-weekly regimen do not allow recommending this regimen in general for long-term prophylaxis in severe haemophilia B patients.
Croatian: No, zbog poluvijeka lijeka (vidjeti dio 5.2) i ograničenih farmakokinetičkih podataka za režim doziranja jednom tjedno, takav se režim ne može općenito preporučiti za dugoročnu profilaksu u bolesnika s teškom hemofilijom B.
English: One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one mL of normal human plasma.
Croatian: Jedna međunarodna jedinica (IU) aktivnosti faktora IX ekvivalentna je količini faktora IX u jednom mililitru normalne ljudske plazme.
English: As with any patient receiving BeneFIX, dose selection for an elderly patient should be individualised.
Croatian: Kao i sa svakim bolesnikom koji prima BeneFIX, odabir doze za starijeg bolesnika treba prilagoditi pojedinačnim potrebama.
English: FIX consumption for routine prophylaxis in 22 evaluable patients was 4607 ( 1849) IU/kg per year and 378 ( 152) IU/kg per month.
Croatian: Potrošnja BeneFIX-a u rutinskoj profilaksi u 22 ocjenjiva bolesnika bila je 4607 ( 1849) IU/kg godišnje i 378 ( 152) IU/kg mjesečno.
English: The safety and efficacy of BeneFIX administration by continuous infusion have not been established (see also sections 4.2 and 4.8).
Croatian: Sigurnost i djelotvornost primjene BeneFIX-a kontinuiranom infuzijom nisu ustanovljene (vidjeti također dijelove 4.2 i 4.8).
English: Number of factor IX IU required
Croatian: Potreban broj IU faktora IX
English: Dose and duration of the substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of bleeding, and on the patient's clinical condition.
Croatian: Doza i trajanje nadomjesne terapije ovisi o težini nedostatka faktora IX, mjestu i opsegu krvarenja i kliničkom stanju bolesnika.
English: Other medicines and BeneFIX
Croatian: Drugi lijekovi i BeneFIX
English: The calculation of the required dose of BeneFIX can be based on the finding that one unit of factor IX activity per kg body weight is expected to increase the circulating level of factor IX, an average of 0.8 IU/dL (range from 0.4 to 1.4 IU/dL) in patients  12 years (further information in section 5.2).
Croatian: Izračun potrebne doze BeneFIX-a može se temeljiti na nalazu da jedna jedinica aktivnosti faktora IX po kg tjelesne težine očekivano poveća cirkulirajuću razinu faktora IX za prosječno 0,8 IU/dl (raspon od 0,4 do 1,4 IU/dl) u bolesnika  12 godina (za dodatne informacije vidjeti dio 5.2).
English: People who are born with haemophilia B (Christmas disease) lack sufficient factor IX to control bleeding.
Croatian: Osobe koje su rođene s hemofilijom B (Christmasova bolest) nemaju dovoljno faktora IX za kontrolu krvarenja.
English: What you need to know before you take BeneFIX
Croatian: Što morate znati prije nego počnete primjenjivati BeneFIX
English: Efficacy analysis in study 3090A1-301-WW was based on 22 evaluable paediatric subjects on prophylaxis regimen including 4 on-demand patients who shortly changed to prophylaxis.
Croatian: Analiza djelotvornosti u studiji 3090A1-301-WW temeljila se na 22 ocjenjiva pedijatrijska bolesnika na režimu profilakse uključujući 4 bolesnika na liječenju kod pojave krvarenja koji su ubrzo prešli na profilaksu.
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, bolesnike treba savjetovati da odmah prekinu primjenu lijeka i da se obrate svom liječniku.
English: A clinically relevant, low responding inhibitor was detected in 1 out of 65 BeneFIX patients (including 9 patients participating only in the surgery study) who had previously received plasmaderived products.
Croatian: Klinički značajan inhibitor niskog odgovora otkrio se u 1 od 65 bolesnika liječenih BeneFIX-om (uključujući 9 bolesnika koji su sudjelovali samo u ispitivanju primjene kod kirurških zahvata) koji su prethodno primali lijekove dobivene iz plazme.
English: Lot Pfizer Europe MA EEIG
Croatian: Pfizer Europe MA EEIG
English: The product may contain traces of hamster proteins (see Do not take BeneFIX).
Croatian: Lijek može sadržavati proteine hrčka u tragovima (vidjeti Nemojte primjenjivati BeneFIX).
English: BeneFIX must be stored below 30°C and must be used by the expiry date on the label.
Croatian: BeneFIX se mora čuvati na temperaturi ispod 30°C i mora se primijeniti prije isteka roka valjanosti navedenog na naljepnici.
English: This patient was able to continue treatment with BeneFIX with no anamnestic rise in inhibitor or anaphylaxis (see section 4.4).
Croatian: Taj je bolesnik mogao nastaviti liječenje BeneFIX-om bez anamnestičkog porasta inhibitora ili anafilaksije (vidjeti dio 4.4).
English: If you stop taking BeneFIX
Croatian: Ako prestanete primjenjivati BeneFIX
English: Animal reproduction studies have not been conducted with factor IX.
Croatian: Nisu provedena ispitivanja reprodukcije s faktorom IX na životinjama.
English: - Even in the absence of factor IX inhibitor, higher doses of BeneFIX may be needed than required for other plasma-derived factor IX products that you may have taken previously.
Croatian: - Čak i u odsutnosti inhibitora faktora IX možda će Vam biti potrebne više doze BeneFIX-a nego drugih lijekova s faktorom IX dobivenih iz plazme koje ste možda prethodno uzimali.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Croatian: Osobito u slučaju velikih kirurških zahvata prijeko je potrebno precizno pratiti nadomjesnu terapiju uz pomoć analize koagulacije (aktivnosti faktora IX u plazmi).
English: Degree of haemorrhage/Type of surgical procedure
Croatian: Stupanj krvarenja/vrsta kirurškog postupka
English: Mean dosage ( standard deviation) for prophylaxis was 63.7 ( 19.1) IU/kg at intervals of 3 to 7 days.
Croatian: Srednja vrijednost doze ( standardna devijacija) za profilaksu bila je 63,7 ( 19,1) IU/kg u intervalima od 3 do 7 dana.
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Croatian: Vrlo rijetko je zabilježen razvoj protutijela na proteine hrčka s povezanim reakcijama preosjetljivosti.
English: Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Croatian: Pojedini bolesnici mogu imati različiti odgovor na faktor IX, pokazujući različite poluvijekove i razine povrata.
English: Hypersensitivity/allergic reactions
Croatian: Preosjetljivost/alergijske reakcije
English: In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also section 4.4).
Croatian: U nekim su slučajevima ove reakcije napredovale do teške anafilaksije i pojavile su se u bliskoj vremenskoj povezanosti s razvojem inhibitora faktora IX (također vidjeti dio 4.4).