FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived coagulation factor IX.
Croatian: Liječnik Vam može predložiti da razmotrite cijepljenje protiv hepatitisa A i B ako redovito/ponavljano primate faktor zgrušavanja IX dobiven iz ljudske plazme.
English: EU/1/01/186/002 (1000 IU)
Croatian: EU/1/01/186/001 (500 IU) EU/1/01/186/002 (1000 IU)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Date of first authorisation: 03 July 2001
Croatian: Datum prvog odobrenja: 3. srpnja 2001.
English: In theory, therefore, the use of Nonafact could generate antibodies to mouse protein.
Croatian: Stoga primjena lijeka Nonafact teoretski može pokrenuti stvaranje protutijela na mišje proteine.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Croatian: Pri pripremi lijekova od ljudske plazme ili krvi, poduzimaju se određene mjere za sprečavanje prijenosa infekcije na bolesnike.
English: Plasma coagulation factor IX is a normal constituent of human plasma.
Croatian: Plazmatski faktor zgrušavanja IX je normalni sastojak ljudske plazme.
English: In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
Croatian: U slučaju niže navedenih krvarenja, aktivnost faktora IX ne bi smjela pasti ispod navedene razine aktivnosti u plazmi (u % u odnosu na normalno ili IU/dl) u odgovarajućem vremenskom razdoblju.
English: - The other ingredients are sodium chloride, sucrose, histidine and water for injections.
Croatian: - Pomoćne tvari su natrijev klorid, saharoza, histidin i voda za injekcije.
English: Nonafact has no influence on the ability to drive and use machines.
Croatian: Nonafact ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Remove the plastic cap from the vials.
Croatian: Uklonite plastični zatvarač s bočica.
English: Single dose administration only.
Croatian: Samo za jednokratnu primjenu.
English: Swirl the vial gently to completely dissolve the powder within 5 minutes.
Croatian: Lagano okrećite bočicu tijekom 5 minuta kako bi se prašak u potpunosti otopio.
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of plasma-derived factor IX products.
Croatian: Potrebno je razmotriti odgovarajuće cijepljenje (hepatitis A i B) za bolesnike koji redovito/ponavljano primaju lijekove s faktorom IX dobivenim iz plazme.
English: Nonafact can be administered to prevent and treat bleeding in patients suffering from haemophilia B (a congenital lack of active factor IX).
Croatian: Nonafact se može primijeniti za sprečavanje i liječenje krvarenja u bolesnika koji boluju od hemofilije B (urođeni nedostatak aktivnog faktora IX).
English: Hypersensitivity to the active substance or to any of the excipients: sodium chloride, sucrose, histidine.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari: natrijev klorid, saharozu, histidin.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not use if the solution is not totally clear or if the powder is not totally reconstituted.
Croatian: Ne primijeniti ako otopina nije potpuno bistra ili ako prašak nije potpuno otopljen.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped viruses such as hepatitis A and parvovirus B19.
Croatian: Poduzete mjere smatraju se učinkovitim za viruse s ovojnicom poput virusa humane imunodeficijencije (HIV), virusa hepatitisa B (HBV) i virusa hepatitisa C (HCV) te za viruse koji nemaju ovojnicu kao što su virus hepatitisa A i parvovirus B19.
English: During the course of treatment it is advised that the concentrations of factor IX in your blood are checked regularly.
Croatian: Tijekom trajanja liječenja savjetuje se da se koncentracija faktora IX u Vašoj krvi redovito kontrolira.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Croatian: Standardne mjere za sprečavanje infekcija koje nastaju uslijed korištenja lijekova pripremljenih od ljudske krvi ili plazme uključuju selekciju darivatelja, probir pojedinačnih darivanja i sakupljene plazme na specifične pokazatelje infekcije i uključivanje učinkovitih koraka proizvodnje za deaktivaciju/uklanjanje virusa.
English: Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Croatian: Hemofilija B je spolno vezani nasljedni poremećaj zgrušavanja krvi uslijed smanjene razine faktora IX i očituje se obilnim krvarenjima u zglobove, mišiće, unutarnje organe, koji nastaju spontano ili kao posljedica nesreće ili kirurškog zahvata.
English: Remove the protective sheath from one end of a transfer needle and pierce the stopper of the vial containing water for injections.
Croatian: Uklonite zaštitni omot na jednom kraju igle za prijenos i probodite čep bočice koja sadrži vodu za injekcije.
English: Individuals with haemophilia B who receive factor IX preparations, should be monitored for the development of neutralising antibodies against factor IX (inhibitors) (see Possible side effects).
Croatian: Pojedince s hemofilijom B koji primaju pripravke faktora IX potrebno je pratiti zbog razvoja neutralizirajućih protutijela protiv faktora IX (inhibitora) (vidjeti Moguće nuspojave).
English: • If you have further questions, ask your doctor or pharmacist or nurse.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: By replacement therapy the plasma level of factor IX is increased, thereby enabling a temporary correction of the factor IX deficiency and correction of the bleeding tendencies.
Croatian: Nadomjesnom terapijom povećava se razina faktora IX u plazmi što privremeno ispravlja nedostatak faktora IX i sklonost krvarenju.
English: Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway.
Croatian: Faktor IX aktivira se pomoću faktora XIa u unutrašnjem putu zgrušavanja krvi te pomoću kompleksa faktor VII/tkivni faktor u vanjskom putu.
English: For long-term prophylaxis against bleeding in patients with severe haemophilia B, the usual doses are 20 to 40 IU of factor IX per kilogram of body weight at intervals of 3 to 4 days.
Croatian: Za dugoročnu profilaksu protiv krvarenja u bolesnika s teškom hemofilijom B, uobičajene doze su od 20 do 40 IU faktora IX po kilogramu tjelesne težine u razmacima od 3 do 4 dana.
English: The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism.
Croatian: Primjena pripravaka niske čistoće faktora IX povezana je s pojavom infarkta miokarda, diseminirane intravaskularne koagulacije, venske tromboze i plućne embolije.
English: Minor surgery including tooth extraction
Croatian: Kirurški zahvati Manji kirurški zahvati uključujući vađenje zuba
English: The safety and efficacy of Nonafact in children 0 to 6 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Nonafact u djece od 0 do 6 godina nije još ustanovljena.
English: As with all medicinal products derived from human blood, the use of Nonafact can cause allergic reactions which may include swelling of the larynx, burning and stinging at the infusion site, chills, flushing, hives, itching and rash, headache, tiredness, nausea, restlessness, fast heartbeat, chest tightness, tingling, vomiting, wheezing.
Croatian: Kao i svi ostali lijekovi dobiveni iz ljudske krvi, primjena lijeka Nonafact može prouzročiti alergijske reakcije koje mogu uključivati oticanje grla, pečenje i žarenje na mjestu infuzije, zimicu, navale crvenila, koprivnjaču, svrbež i osip, glavobolju, umor, mučninu, nemir, ubrzane otkucaje srca, stezanje u prsištu, trnce, povraćanje, piskanje pri disanju.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Croatian: Ako je potreban uređaj za pristup središnjoj veni (CVAD), moguća je pojava komplikacija povezanih s uređajem CVAD poput lokalnih infekcija, bakteremije i tromboze na mjestu umetanja katetera.
English: If you forget to use Nonafact
Croatian: Ako ste zaboraviti primijeniti Nonafact
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: There is a very slight risk that Nonafact will cause clots to form in blood vessels, resulting in thrombosis.
Croatian: Prisutan je i vrlo mali rizik da će Nonafact prouzročiti stvaranje ugrušaka u krvnim žilama, što uzrokuje trombozu.
English: The product must not be used if any cloudiness, lumps or particulate matter are visible.
Croatian: Lijek se ne smije primijeniti ako se vide zamućenja, grudice ili čestice.
English: Remove the protective sheath from the other end of the transfer needle.
Croatian: Uklonite zaštitni omot s drugog kraja igle za prijenos.
English: Swirl the vial gently to completely dissolve the powder.
Croatian: Lagano okrećite bočicu kako bi se prašak u potpunosti otopio.
English: If, after administration, you develop hypersensitive reactions like hives, itching and rash, chest tightness, wheezing and light headedness contact your physician immediately.
Croatian: Ako nakon primjene razvijete reakcije preosjetljivosti poput koprivnjače, svrbeža i osipa, stezanja u prsištu, piskanja pri disanju i blage ošamućenosti odmah se obratite svome liječniku.
English: What you need to know before you use Nonafact
Croatian: Što morate znati prije nego počnete primjenjivati Nonafact
English: Nonafact contains trace amounts (< 0.1 ng mouse IgG/IU of factor IX) of the murine monoclonal antibody used in its purification.
Croatian: Nonafact sadrži mišje monoklonsko protutijelo u tragovima (< 0,1 ng mišjeg IgG/IU faktora IX), koje se koristi u pročišćavanju lijeka.
English: There are insufficient data to recommend the use of Nonafact in children less than 6 years of age.
Croatian: Nema dovoljno podataka za preporuku primjene lijeka Nonafact u djece u dobi mlađoj od 6 godina.
English: BOX VIAL OF POWDER 500 IU BOX VIAL OF POWDER 1000 IU
Croatian: KUTIJA ZA BOČICE S PRAŠKOM 500 IU KUTIJA ZA BOČICE S PRAŠKOM 1000 IU
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11.
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/186/001 EU/1/01/186/002 13.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/186/001
English: Contains: sodium chloride, histidine and sucrose.
Croatian: Sadrži: natrijev klorid, histidin i saharozu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU (100 IU/ml after reconstitution) 1000 IU (100 IU/ml after reconstitution)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 500 IU(100 IU/mL nakon pripreme)
English: No interactions of human coagulation factor IX products with other medicinal products have been reported.
Croatian: Nisu zabilježene interakcije lijekova s ljudskim koagulacijskim faktorom IX s drugim lijekovima.
English: Nephrotic syndrome has been reported following attempted immune tolerance induction on haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Croatian: Opisan je slučaj pojave nefrotskog sindroma nakon pokušaja indukcije imunološke tolerancije u bolesnika s hemofilijom B s prisutnim inhibitorima faktora IX i alergijskim reakcijama u anamnezi.
English: 30-60 Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved.
Croatian: 30 - 60 Ponavljati infuziju svaka 24 sata tijekom 3 - 4 dana ili duže sve do prestanka boli i akutne onesposobljenosti.
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Croatian: Zbog potencijalnog rizika trombotskih komplikacija potrebno je odgovarajućim biološkim testovima provesti kliničko praćenje ranih znakova trombotske i potrošne koagulopatije u slučajevima primjene ovog lijeka u bolesnika s jetrenom bolešću, bolesnika nakon operacije, novorođenčadi ili bolesnika s rizikom od trombotskih pojava ili diseminirane intravaskularne koagulacije (DIK).
English: It is a vitamin K-dependent coagulation factor and is synthesised in the liver.
Croatian: K ovisan faktor zgrušavanja koji se sintetizira u jetri.
English: 1000 IU: one vial (glass type I) of powder + one vial (glass type I) of 10 ml solvent with stoppers (bromobutyl).
Croatian: 1000 IU: jedna bočica (staklo tipa I) s praškom + jedna bočica (staklo tipa I) s 10 ml otapala sa čepovima (bromobutil)
English: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Croatian: Liječenje i profilaksa krvarenja kod bolesnika s hemofilijom B (urođeni nedostatak faktora IX).
English: 500 IU: one vial (glass type I) of powder + one vial (glass type I) of 5 ml solvent with stoppers (bromobutyl).
Croatian: 500 IU: jedna bočica (staklo tipa I) s praškom + jedna bočica (staklo tipa I) s 5 ml otapala sa čepovima (bromobutil)
English: It is strongly recommended that every time that Nonafact 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: Izrazito se preporučuje da se svaki put kod primjene lijeka Nonafact bolesniku, zabilježi naziv i broj serije lijeka kako bi se očuvala poveznica između bolesnika i serije lijeka.
English: It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Croatian: Treba naglasiti da u bolesnika s prisutnim inhibitorima faktora IX može postojati povećan rizik od anafilaksije uz svaku sljedeću primjenu faktora IX.
English: For long-term prevention of bleeding in individuals with severe haemophilia B, the usual doses of 20 to 40 IU of factor IX per kilogram body weight should be given at intervals of 3 to 4 days.
Croatian: Za dugoročno sprječavanje krvarenja u osoba s teškom hemofilijom B mogu se davati uobičajene doze od 20 do 40 IU faktora IX po kilogramu tjelesne težine u razmacima od 3 do 4 dana.
English: Special warnings and precautions for use
Croatian: Posebna upozorenja i mjere opreza pri uporabi
English: 60-100 Repeat infusion every 8 to 24 hours until threat is resolved.
Croatian: 60 - 100 Ponavljati infuziju svakih 8 do 24 sata sve do otklanjanja životne opasnosti.
English: During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Croatian: Tijekom liječenja savjetuje se odgovarajuće određivanje razina faktora IX kao smjernica za dozu koju treba primijeniti i učestalost ponavljanja infuzija.
English: Intravenous use.
Croatian: Primjena u venu.
English: The use of Nonafact may also produce an increase in body temperature in rare cases.
Croatian: Primjena lijeka Nonafact u rijetkim slučajevima može dovesti do porasta tjelesne temperature.
English: If you use more Nonafact than you should
Croatian: Ako primijenite više lijeka Nonafact nego što je potrebno
English: Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breastfeeding is not available.
Croatian: S obzirom na rijetku pojave hemofilije B u žena, nisu dostupna iskustva u svezi s primjenom faktora IX tijekom trudnoće i dojenja.
English: It is strongly recommended that every time you receive a dose of Nonafact the name and batch number of the product are recorded in order to maintain a record of the batches used.
Croatian: Izrazito se preporučuje da se svaki put kad primite dozu lijeka Nonafact zabilježi naziv i broj serije lijeka kako bi se sačuvao zapis korištenih serija lijeka.
English: There is a potential risk that higher doses of Nonafact will cause clots to form in blood vessels, resulting in thrombosis.
Croatian: Prisutan je potencijalni rizik pri višim dozama lijeka Nonafact za stvaranje ugrušaka u krvnim žilama koji uzrokuju trombozu.
English: The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
Croatian: Broj primijenjenih jedinica faktora IX izražava se u međunarodnim jedinicama (IU), koje su u skladu s važećim standardom Svjetske zdravstvene organizacije (SZO) za lijekove s faktorom IX.
English: Nonafact contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Croatian: Nonafact sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: Method of administration Intravenous use.
Croatian: Način primjene Intravenska primjena.
English: No symptoms of overdose with human coagulation factor IX have been reported.
Croatian: Nisu prijavljeni simptomi predoziranja ljudskim koagulacijskim faktorom IX.
English: Nonafact 100 IU/ml powder and solvent for solution for injection Human coagulation factor IX
Croatian: Nonafact 100 IU/ml prašak i otapalo za otopinu za injekciju ljudski koagulacijski faktor IX
English: Nonafact 100 IU/ml powder for solution for injection Human coagulation factor IX for intravenous use
Croatian: Nonafact 100 IU/ml prašak za otopinu za injekciju ljudski koagulacijski faktor IX za primjenu u venu
English: Reconstitute with 5 ml of water for injections.
Croatian: Pripremite za primjenu s 5 ml vode za injekcije.
English: 500 IU human coagulation factor IX (100 IU/ml after reconstitution).
Croatian: 500 IU ljudskog koagulacijskog faktora IX (100 IU/ml nakon pripreme).
English: 1000 IU human coagulation factor IX (100 IU/ml after reconstitution).
Croatian: 1000 IU ljudskog koagulacijskog faktora IX (100 IU/ml nakon pripreme).
English: Pharmacotherapeutic group: antihemorrhagics, blood coagulation factor IX.
Croatian: Farmakoterapijska skupina: antihemoragici, faktor koagulacije krvi IX. ATK oznaka: B02BD04.
English: The in vivo increase in factor IX levels obtained with Nonafact is 1.1 IU/dl per IU administered per kg body weight, which corresponds to an in vivo recovery of 49 %.
Croatian: In vivo porast razine faktora IX dobiven pomoću lijeka Nonafact je 1,1 IU/dl po IU primijenjenoj po kg tjelesne težine, što odgovara in vivo povratu od 49%.Poluvijek lijeka Nonafact je oko 19 (17 - 21) sati.
English: for intravenous use
Croatian: za primjenu u venu
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Croatian: Unatoč tome, kod primjene lijekova dobivenih od ljudske krvi ili plazme nije moguće potpuno isključiti mogućnost prijenosa infektivnih uzročnika.
English: Reconstitute with 10 ml of water for injections.
Croatian: Pripremite za primjenu s 10 ml vode za injekcije.
English: Invert the solvent vial and pierce the stopper of the vial containing the powder.
Croatian: Preokrenite bočicu s otapalom i probodite čep bočice koja sadrži prašak.
English: Solvent: Water for injections.
Croatian: Otapalo: Voda za injekcije.
English: NAME OF THE MEDICINAL PRODUCT Nonafact 100 IU/ml powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA Nonafact 100 IU/ml prašak i otapalo za otopinu za injekciju.
English: BATCH NUMBER Lot: {number} 14.
Croatian: 13. BROJ SERIJE Broj serije: {broj}
English: Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin.
Croatian: Aktivirani faktor IX, zajedno s aktiviranim faktorom VIII, aktivira faktor X.
English: How to use Nonafact
Croatian: Kako primjenjivati Nonafact
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains nominally 500 IU or 1000 IU of human coagulation factor IX.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka bočica sadrži nominalno 500 IU ili 1000 IU ljudskog koagulacijskog faktora IX. Nonafact sadrži približno 500 ili 1000 IU (100 IU/ml) ljudskog koagulacijskog faktora IX nakon rekonstitucije.
English: Solvent: water for injections
Croatian: Otapalo: voda za injekcije
English: MedDRA system organ class (SOC)
Croatian: MedDRA - klasifikacija organskih sustava
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 15.
Croatian: 14. NAČIN IZDAVANJA LIJEKA Lijek se izdaje na recept.
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Croatian: Unatoč navedenim mjerama, kod primjene lijekova dobivenih od ljudske krvi ili plazme nije moguće potpuno isključiti mogućnost prijenosa infektivnih uzročnika.
English: VIAL OF POWDER 500 IU VIAL OF POWDER 1000 IU
Croatian: BOČICA S PRAŠKOM 500 IU BOČICA S PRAŠKOM 1000 IU
English: Treatment monitoring
Croatian: Praćenje liječenja
English: INFORMATION IN BRAIILE 17.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU
English: Keep the container in the outer carton, in order to protect from light.
Croatian: Spremnik čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Nonafact is presented as a powder and a solvent for solution for injection (vial of 5 ml or 10 ml)
Croatian: Nonafact je prašak i otapalo za otopinu za injekciju (bočica od 5 ml ili 10 ml) Nonafact se sastoji od pakiranja koje sadrži:
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Prije uzimanja bilo kojeg lijeka upitajte za savjet svog liječnika ili ljekarnika.
English: Reconstituted products should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Rekonstituirane lijekove prije primjene treba vizualno pregledati na prisutnost čestica ili promjenu boje.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: A PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Conventional animal toxicity studies and mutagenicity studies with plasma coagulation factor IX were not carried out.
Croatian: Faktor IX u ovom lijeku se stoga ponaša kao endogeni faktor IX. Konvencionalna ispitivanja toksičnosti i mutagenosti na životinjama s plazmatskim faktorom zgrušavanja IX nisu provedena.
English: Contact your doctor immediately if you suspect that the product is becoming progressively less effective.
Croatian: Ako sumnjate da lijek postupno postaje sve manje učinkovit, odmah se obratite svom liječniku.
English: Thrombosis
Croatian: Tromboza
English: How to store Nonafact
Croatian: Kako čuvati Nonafact
English: Keep the vials in the outer carton, in order to protect from light.
Croatian: Bočice čuvajte u vanjskom pakiranju radi zaštite od svjetlosti.
English: Overdose
Croatian: Predoziranje
English: Animal reproduction studies have not been conducted with factor IX.
Croatian: Nisu provedena ispitivanja utjecaja faktora IX na reproduktivnu sposobnost životinja.