FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma coagulation factor IX is a normal constituent of human plasma.
Slovenian: Plazemski koagulacijski faktor IX je normalna sestavina človeške plazme.
English: The powder dissolves within 5 minutes to produce a clear, colourless to light-yellow solution.
Slovenian: Prašek se v 5 minutah raztopi v bistro, brezbarvno do svetlo rumeno raztopino.
English: Swirl the vial gently to completely dissolve the powder.
Slovenian: Nežno vrtite vialo, da popolnoma raztopite prašek.
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).
Slovenian: Ponovite infuzijo vsakih 8 do 24 ur, do zadostnega celjenja rane, zatem zdraviti vsaj še naslednjih 7 dni za vzdrževanje aktivnosti faktorja IX od 30 % do 60 % (i.e./dl).
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.
Slovenian: Običajni ukrepi za preprečevanje okužb povezanih z uporabo zdravil, pripravljenih iz človeške krvi ali plazme, vključujejo izbiro dajalcev, presejanje posameznih donacij in zbirov plazme na vsebnost točno določenih označevalcev okužb ter postopke pri izdelavi, namenjene inaktivaciji ali odstranjevanju virusov.
English: One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of human plasma.
Slovenian: Ena mednarodna enota (i.e.) aktivnosti faktorja IX je enaka količini faktorja IX v enem mililitru človeške plazme.
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).
Slovenian: Aktivnost faktorja IX v plazmi izražamo kot odstotek (relativno glede na normalno človeško plazmo) ali v mednarodnih enotah (relativno glede na mednarodni standard za faktor IX v plazmi).
English: Administer immediately.
Slovenian: Takoj injicirajte.
English: 60-100 Repeat infusion every 8 to 24 hours until threat is resolved.
Slovenian: 60-100 Ponovite infuzijo vsakih 8 do 24 ur, dokler grožnja ne mine.
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.
Slovenian: Zaradi možne nevarnosti za trombotične zaplete moramo uvesti klinični nadzor za morebitni pojav zgodnjih znakov trombotične ali porabne koagulopatije z ustreznim biološkim testiranjem ob dajanju tega zdravila bolnikom z obolenjem jeter, bolnikom po operaciji, novorojenčkom ali bolnikom s tveganjem za trombotske pojave ali DIK.
English: Animal reproduction studies have not been conducted with factor IX.
Slovenian: Reproduktivnih študij pri živalih s faktorjem IX niso opravili.
English: Before administration, check that the solution is clear or slightly opalescent.
Slovenian: Pred dajanjem preverite, ali je raztopina bistra ali rahlo opalescentna.
English: Immediately before administration, the solution should be inspected: the solution should be clear or slightly opalescent.
Slovenian: Neposredno pred dajanjem je treba pregledati videz raztopine: raztopina mora biti bistra ali rahlo opalescentna.
English: 30-60 Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved.
Slovenian: 30-60 Ponovite infuzijo vsakih 24 ur od 3 do 4 dni ali več, dokler bolečina in akutna nezmožnost ne izzvenita.
English: 30-60 Every 24 hours, at least 1 day, until healing is achieved.
Slovenian: 30-60 Vsakih 24 ur, vsaj 1 dan, dokler ni doseženo celjenje.
English: A deficiency of factor IX causes blood coagulation problems, which may lead to bleeding in joints, muscles or internal organs.
Slovenian: Pomanjkanje faktorja IX povzroči težave pri strjevanju krvi, ki lahko vodijo v krvavitev v sklepih, mišicah ali notranjih organih.
English: Your body may develop antibodies (inhibitors) against factor IX, which will inactivate Nonafact.
Slovenian: Vaše telo lahko razvije protitelesa (inhibitorje) proti faktorju IX, kar bo onemogočilo delovanje zdravila Nonafact.
English: Do not use Nonafact:
Slovenian: Ne uporabljajte zdravila Nonafact:
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, tj. dejansko »brez natrija«.
English: What Nonafact is and what it is used for What you need to know before you use Nonafact How to use Nonafact
Slovenian: Kaj je zdravilo Nonafact in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Nonafact Kako uporabljati zdravilo Nonafact Možni neželeni učinki
English: Catheter-related complications
Slovenian: Zapleti, povezani s katetrom
English: The potency (IU) is determined using the European Pharmacopoeia one stage clotting test..
Slovenian: Jakost (i.e.) je določena z uporabo enostopenjskega testa strjevanja krvi po Evropski farmakopeji.
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.
Slovenian: Med zdravljenjem svetujemo ustrezno spremljanje ravni faktorja IX za določanje višine danega odmerka in pogostnosti ponavljanih infuzij.
English: Paediatric population There are insufficient data to recommend the use of Nonafact in children less than 6 years of age.
Slovenian: Pediatrična populacija Ni zadostnih podatkov, da bi lahko priporočali uporabo zdravila Nonafact pri otrocih, mlajših od 6 let.
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.
Slovenian: Hemofilija B je spolno vezana dedna motnja strjevanja krvi zaradi znižanih ravni faktorja IX in povzroča obsežne krvavitve v sklepe, mišice ali notranje organe, bodisi spontano, bodisi kot posledico nezgodne ali kirurške travme.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Slovenian: Pri izdelavi zdravil iz človeške krvi ali plazme se z določenimi ukrepi poskuša preprečiti prenos okužb na bolnike.
English: Your doctor will determine the dose of Nonafact you need and how frequently you should use it depending on the situation.
Slovenian: Vaš zdravnik bo glede na situacijo določil odmerek zdravila Nonafact, ki ga potrebujete, in kako pogosto ga boste uporabljali.
English: Conventional animal toxicity studies and mutagenicity studies with plasma coagulation factor IX were not carried out.
Slovenian: Običajnih študij toksičnosti pri živalih ter študij mutagenosti s plazemskim koagulacijskim faktorjem IX niso izvajali.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Slovenian: Naslednjo preglednico lahko uporabimo za smernice pri odmerjanju ob krvavitvah in operacijskih posegih:
English: Nonafact consists of a carton containing:
Slovenian: Zdravilo Nonafact je sestavljeno iz ovojnine, ki vsebuje:
English: What is Nonafact and what it is used for
Slovenian: Kaj je zdravilo Nonafact in za kaj ga uporabljamo
English: Store in a refrigerator (at 2°C - 8°C ).
Slovenian: Shranjujte v hladilniku (pri temperaturi med 2 °C in 8 °C).
English: Because of the risk of allergic reactions with factor IX products, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Slovenian: Zaradi nevarnosti alergijskih reakcij pri dajanju izdelkov s faktorjem IX morate na začetku faktor IX dati, glede na presojo lečečega zdravnika, pod zdravstvenim nadzorom in kjer lahko omogočite ustrezno zdravstveno oskrbo alergijskih reakcij.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (at 2C - 8C).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (pri temperaturi med 2 °C in 8 °C).
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.
Slovenian: Privzeti ukrepi se štejejo za učinkovite proti virusom z ovojnico, kakršni so virus človeške imunske pomanjkljivosti (HIV), virus hepatitisa B (HBV) in virus hepatitisa C (HCV), ter proti virusom brez ovojnice, kakršna sta virus hepatitisa A in parvovirus B19.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROSTITEV SERIJE
English: Remove the protective sheath from the other end of the transfer needle.
Slovenian: Snemite zaščitni tulec z drugega konca igle za prenos.
English: Nonafact has no influence on the ability to drive and use machines.
Slovenian: Zdravilo Nonafact nima vpliva na sposobnost vožnje in upravljanja s stroji.
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 %.
Slovenian: In vivo povišanje ravni faktorja IX, ki ga dosežemo z zdravilom Nonafact, je 1,1 i.e./dl na število i.e., ki jih damo na kg telesne mase, kar ustreza in vivo nadomeščanju 49 %.
English: Nonafact has no known effects on the ability to drive and to use machines.
Slovenian: Zdravilo Nonafact nima znanih učinkov na sposobnost vožnje in upravljanja s stroji.
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 1.1 % of normal activity.
Slovenian: Izračun potrebnega odmerka faktorja IX temelji na empiričnih izsledkih, da 1 mednarodna enota (i.e.) faktorja IX na kg telesne mase poviša aktivnost plazemskega faktorja IX za 1,1 % normalne aktivnosti.
English: Treatment monitoring
Slovenian: Nadzor zdravljenja
English: EU/1/01/186/002 (1000 IU)
Slovenian: EU/1/01/186/002
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.
Slovenian: Uporabo manj prečiščenih zdravil s faktorjem IX so povezovali s primeri miokardnega infarkta, diseminirane intravaskularne koagulacije, venske tromboze in pljučne embolije.
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.
Slovenian: Kot pri vseh zdravilih, izdelanih iz človeške krvi, lahko uporaba zdravila Nonafact povzroči alergijske reakcije, ki lahko vključujejo oteklino grla, pekoče bolečine in zbadanje na mestu infundiranja, mrazenje, oblivanja vročine, koprivnico, srbenje in izpuščaj, glavobol, utrujenost, siljenje na bruhanje, nemir, hitro bitje srca, občutek tiščanja v prsnem košu, mravljinčenje, bruhanje, piskajoče in sopihajoče dihanje.
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.
Slovenian: Število enot danega faktorja IX izražamo v mednarodnih enotah (i.e.), ki so povezane z veljavnim standardom organizacije SZO za zdravila s faktorjem IX.
English: The safety and efficacy of Nonafact in children 0 to 6 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Nonafact pri otrocih v starosti od 0 do 6 let nista bili dokazani.
English: What you need to know before you use Nonafact
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Nonafact
English: Reconstitute with 5 ml of water for injections.
Slovenian: Rekonstituirajte s 5 ml vode za injekcije.
English: Other medicines and Nonafact
Slovenian: Druga zdravila in zdravilo Nonafact
English: In case of shock, standard medical treatment for shock should be implemented.
Slovenian: V primeru šoka ukrepajte v skladu z veljavnimi zdravstvenimi standardi za zdravljenje šoka.
English: Sanquin Plasma Products B.V. Plesmanlaan 125
Slovenian: Sanquin Plasma Products B.V.
English: If you use more Nonafact than you should
Slovenian: Če ste uporabili večji odmerek zdravila Nonafact, kot bi smeli
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: • If you have further questions, ask your doctor or pharmacist or nurse.
Slovenian: • Če imate dodatna vprašanja, se posvetujte s zdravnikom, farmacevtom ali medicinsko sestro.
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 rarely and may in some cases progress to severe anaphylaxis (including shock).
Slovenian: Redko so bile opažene preobčutljivostne ali alergijske reakcije (ki lahko vključujejo angioedem, pekočo bolečino in zbadanje na mestu infundiranja, mrazenje, rdečico, generalizirano koprivnico, glavobol, koprivnico, hipotenzijo, letargijo, navzeo, nemir, tahikardijo, občutek tiščanja v prsnem košu, mravljinčenje, bruhanje, piskajoče in sopihajoče dihanje), ki lahko v nekaterih redkih primerih napredujejo v resno anafilaksijo (vključno s šokom).
English: Nonafact is presented as a powder and a solvent for solution for injection (vial of 5 ml or 10 ml)
Slovenian: Zdravilo Nonafact je pripravljeno v obliki praška in vehikla za raztopino za injiciranje (viala 5 ml ali 10 ml)
English: Invert the solvent vial and pierce the stopper of the vial containing the powder.
Slovenian: Obrnite vialo z vehiklom in prebodite zaporko viale, ki vsebuje prašek.
English: 1000 IU: one vial (glass type I) of powder + one vial (glass type I) of 10 ml solvent with stoppers (bromobutyl).
Slovenian: 1000 i.e.: ena viala (steklo tipa I) praška + ena viala (steklo tipa I) 10 ml vehikla z zaporkama (bromobutil).
English: Manufacturing also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Slovenian: Izdelava v postopku obdelave krvi ali plazme vključuje tudi postopke, ki lahko onemogočijo delovanje virusov ali slednje odstranijo.
English: Contains: sodium chloride, histidine and sucrose.
Slovenian: Vsebuje: natrijev klorid, histidin in saharozo
English: There are insufficient data to recommend the use of Nonafact in children less than 6 years of age.
Slovenian: Ni zadostnih podatkov, da bi lahko priporočili uporabo zdravila Nonafact pri otrocih, mlajših od 6 let.
English: The powder should be dissolved in the supplied amount of water for injections.
Slovenian: Prašek raztopite v priloženi količini vode za injekcije.
English: On demand treatment
Slovenian: Zdravljenje na zahtevo
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/186/001 EU/1/01/186/002 13.
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/186/001
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains nominally 500 IU or 1000 IU of human coagulation factor IX.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje nazivno 500 i.e. ali 1.000 i.e. humanega koagulacijskega faktorja IX.
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.
Slovenian: Zelo priporočljivo je, da se pri dajanju zdravila Nonafact bolnikom vedno zabeleži ime in številka serije zdravila, s čimer se ohrani povezava med posameznim bolnikom in serijo uporabljenega zdravila.
English: Therefore, factor IX should be used by pregnant or breast-feeding women only if clearly indicated.
Slovenian: Zato naj faktor IX noseče in doječe ženske uporabljajo le, kadar je to očitno potrebno.
English: Anaphylactic reaction
Slovenian: Anafilaktična reakcija
English: 500 IU: one vial (glass type I) of powder + one vial (glass type I) of 5 ml solvent with stoppers (bromobutyl).
Slovenian: 500 i.e.: ena viala (steklo tipa I) praška + ena viala (steklo tipa I) 5 ml vehikla z zaporkama (bromobutil).
English: After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Slovenian: Po večkratnem zdravljenju z izdelki humanega koagulacijskega faktorja IX moramo bolnike spremljati glede razvoja nevtralizirajočih protiteles (inhibitorjev), ki jih količinsko določimo z Bethesda enotami (BE) z uporabo ustreznega biološkega testiranja.
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.
Slovenian: Zelo priporočljivo je, da ob vsakemu prejetju odmerka zdravila Nonafact zabeležite ime in številko serije zdravila, da se s tem ohrani zapis uporabljenih serij.
English: Reconstitute with 10 ml of water for injections.
Slovenian: Rekonstituirajte z 10 ml vode za injekcije.
English: If you forget to use Nonafact
Slovenian: Če ste pozabili vzeti zdravilo Nonafact
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.
Slovenian: Za dolgoročno preprečevanje krvavitev pri bolnikih s hudo hemofilijo B so običajni odmerki od 20 i.e. do 40 i.e. faktorja IX na kilogram telesne mase v intervalih od 3 do 4 dni.
English: UNIQUE IDENTIFIER - 2D BARCODE 18.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
English: Remove from the refrigerator and allow the two vials to reach room temperature (15°C - 25°C).
Slovenian: Viali vzemite iz hladilnika in počakajte, da dosežeta sobno temperaturo (od 15 °C do 25 °C).
English: Nonafact can be administered to prevent and treat bleeding in patients suffering from haemophilia B (a congenital lack of active factor IX).
Slovenian: Zdravilo Nonafact lahko dajemo za preprečevanje in zdravljenje krvavitve pri bolnikih s hemofilijo B (prirojenim pomanjkanjem aktivnega faktorja IX).
English: • A vial of Nonafact containing 500 IU or 1000 IU of factor IX
Slovenian: • vialo zdravila Nonafact, ki vsebuje 500 i.e. ali 1000 i.e. faktorja IX
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Slovenian: FARMACEVTSKA OBLIKA Prašek in vehikel za raztopino za injiciranje.
English: If you have existing cardiovascular risk factors, substitution therapy with Factor IX may increase the cardiovascular risk.
Slovenian: Če so pri vas prisotni obstoječi dejavniki tveganja za srčno-žilne dogodke, lahko nadomestno zdravljenje s faktorjem IX poveča tveganje za srčno-žilne dogodke.
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.
Slovenian: Za dolgoročno preprečevanje krvavitev pri posameznikih s hudo hemofilijo B je treba dajati običajne odmerke 20 i.e. do 40 i.e. faktorja IX na kilogram telesne mase v intervalih 3 do 4 dni.
English: There is a potential risk that higher doses of Nonafact will cause clots to form in blood vessels, resulting in thrombosis.
Slovenian: Obstaja morebitno tveganje, da višji odmerki zdravila Nonafact povzročijo tvorbo krvnih strdkov v žilah, kar povzroči trombozo.
English: Single dose administration only.
Slovenian: Samo za dajanje enkratnega odmerka.
English: If, after administration, you develop hypersensitive reactions like hives, itching and rash, chest tightness, wheezing and light headedness contact your physician immediately.
Slovenian: Če se po dajanju pojavijo preobčutljivostne reakcije, kot so koprivnica, srbenje in izpuščaj, tiščoč občutek v prsnem košu, piskajoče in sopihajoče dihanje in omotičnost, nemudoma pokličite svojega zdravnika.
English: Life threatening bleeding
Slovenian: Življenjsko nevarne krvavitve
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).
Slovenian: Posameznike s hemofilijo B, ki prejemajo zdravila s faktorjem IX, je treba spremljati zaradi morebitnega razvoja nevtralizirajočih protiteles proti faktorju IX (inhibitorjev) (glej poglavje Možni neželeni učinki).
English: Nonafact contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Slovenian: Zdravilo Nonafact vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
English: What Nonafact contains - The active substance is human coagulation factor IX.
Slovenian: Kaj vsebuje zdravilo Nonafact: - Zdravilna učinkovina je humani koagulacijski faktor IX.
English: 1000 IU human coagulation factor IX (100 IU/ml after reconstitution).
Slovenian: 1000 i.e. humanega koagulacijskega faktorja IX (100 i.e./ml po rekonstituciji).
English: During the course of treatment it is advised that the concentrations of factor IX in your blood are checked regularly.
Slovenian: Med zdravljenjem svetujemo redno spremljanje koncentracije faktorja IX v vaši krvi.
English: Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Slovenian: Bolniki s hemofilijo B lahko razvijejo nevtralizirajoča protitelesa (inhibitorje) proti faktorju IX.
English: Solvent: water for injections
Slovenian: Vehikel: voda za injekcije
English: There is a very slight risk that Nonafact will cause clots to form in blood vessels, resulting in thrombosis.
Slovenian: Obstaja zelo majhno tveganje, da bo zdravilo Nonafact povzročilo tvorbo krvnih strdkov v krvnih žilah, kar bi povzročilo trombozo.
English: By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V.* S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: No interactions of human coagulation factor IX products with other medicinal products have been reported.
Slovenian: Ni znanih medsebojnih interakcij med izdelki s humanim koagulacijskim faktorjem IX in drugimi zdravili.
English: 500 IU human coagulation factor IX (100 IU/ml after reconstitution).
Slovenian: 500 i.e. humanega koagulacijskega faktorja IX (100 i.e./ml po rekonstituciji).
English: Do not use solutions that are cloudy or have deposits.
Slovenian: Ne uporabljajte motnih raztopin ali raztopin z usedlinami.
English: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Slovenian: Zdravljenje in preprečevanje krvavitev in njihovih posledic pri bolnikih s hemofilijo B (prirojeno pomanjkanje faktorja IX).
English: Tilt the product vial when transferring the solvent to allow the solvent to flow down the side of the vial.
Slovenian: Ko prelivate vehikel, vialo z zdravilom nagnite, da omogočite tok vehikla ob steni viale navzdol.
English: ATC code: B02BD04.
Slovenian: Farmakoterapevtska skupina: antihemoragiki, koagulacijski faktor IX, oznaka ATC: B02BD04.