FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who have specific mutations of their factor IX gene such as major deletion may be more likely to develop an inhibitor to factor IX and/or experience allergic reactions.
Slovenian: Pri bolnikih, ki imajo določene mutacije na genu za faktor IX, kot na primer pomembnejše delecije, je verjetneje, da bodo razvili inhibitor faktorja IX in/ali doživeli alergijske reakcije.
English: If any suspected hypersensitivity reaction takes place that is thought to be related to the administration of BeneFIX, the rate of infusion should be decreased or the infusion stopped (see sections 4.4 and 4.8).
Slovenian: Če se pojavi kakršnakoli domnevna preobčutljivostna reakcija, ki bi lahko bila povezana z uporabo zdravila BeneFIX, moramo zmanjšati hitrost infuzije ali infuzijo prekiniti (glejte poglavji 4.4 in 4.8).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: As one PTP treated with BeneFIX developed a clinically relevant low responding inhibitor during clinical studies and experience on antigenicity with recombinant factor IX is still limited, patients treated with BeneFIX should be carefully monitored for the development of factor IX inhibitors that should be titrated in Bethesda Units using appropriate biological testing.
Slovenian: Ker se je med kliničnimi študijami pri enem PTP, zdravljenim z zdravilom BeneFIX, razvil klinično pomemben inhibitor, ki je zmanjševal odziv, in je izkušenj z antigenostjo rekombinantnega faktorja IX zaenkrat še malo, je treba bolnike, zdravljene z zdravilom BeneFIX, skrbno spremljati glede morebitnega razvoja inhibitorjev faktorja IX, ki jih je treba titrirati v enotah Bethesda z ustreznim biološkim testiranjem.
English: In younger patients, shorter dosage intervals or higher doses may be necessary.
Slovenian: Pri mlajših bolnikih bodo morda potrebni krajši presledki med odmerki ali večji odmerki.
English: The product contains traces of hamster proteins.
Slovenian: Zdravilo vsebuje sledove beljakovin hrčka.
English: After cleaning do not touch the rubber stopper with your hand or allow it to touch any surface.
Slovenian: Potem ko ste gumijasti zamašek očistili, se ga ne dotikajte več z roko ali čimerkoli drugim.
English: 1 vial with 250 IU nonacog alfa 1 vial with 500 IU nonacog alfa 1 vial with 1000 IU nonacog alfa 1 vial with 1500 IU nonacog alfa 1 vial with 2000 IU nonacog alfa 1 vial with 3000 IU nonacog alfa
Slovenian: 1 viala z 250 i.e. nonakoga alfa 1 viala s 500 i.e. nonakoga alfa 1 viala s 1.000 i.e. nonakoga alfa 1 viala s 1.500 i.e. nonakoga alfa 1 viala z 2.000 i.e. nonakoga alfa 1 viala s 3.000 i.e. nonakoga alfa
English: Baseline n = 24 Mean ± SD
Slovenian: Izhodišče n = 24 povprečje ± SD
English: Number of factor IX IU required
Slovenian: Število potrebnih i.e. faktorja IX
English: Place the vial on a flat surface.
Slovenian: Položite vialo na ravno površino.
English: Inhibitor development
Slovenian: Razvoj inhibitorja
English: Other medicines and BeneFIX
Slovenian: Druga zdravila in zdravilo BeneFIX
English: However, as with all factor IX products you should be carefully monitored for the development of factor IX inhibitors while being treated with BeneFIX.
Slovenian: Vendar pa vas bo, tako kot pri vseh zdravilih, ki vsebujejo faktor IX, treba med zdravljenjem z zdravilom BeneFIX skrbno spremljati glede razvoja inhibitorjev faktorja IX.
English: Animal reproduction studies have not been conducted with factor IX.
Slovenian: Študije o vplivu faktorja IX na razmnoževanje pri živalih niso bile izvedene.
English: Pharmacokinetic Parameter Estimates for BeneFIX (75 IU/kg) at Baseline and Month 6 in Previously Treated Patients with Haemophilia B
Slovenian: Ocene farmakokinetičnih parametrov za zdravilo BeneFIX (75 i.e./kg) v izhodišču in v 6. mesecu pri predhodno zdravljenih bolnikih s hemofilijo B Parameter
English: Cmax (IU/dL) AUC∞ (IU∙hr/dL) t1/2 (hr)
Slovenian: AUC∞ (i.e.∙h/dl) t1/2 (h)
English: Children 2 to < 6
Slovenian: Otroci 2 do < 6
English: Therefore, close monitoring of factor IX plasma activity (which measures the ability of your blood to form clots) has to be performed to adjust doses as appropriate.
Slovenian: Zato je treba natančno spremljati aktivnost faktorja IX v plazmi (le-ta meri sposobnost vaše krvi za strjevanje), da lahko ustrezno prilagodimo odmerke.
English: • Infusion-site reaction (including itching and redness at the infusion site), infusion-site pain and discomfort
Slovenian: • reakcija na mestu infundiranja (vključno s srbenjem in rdečico na mestu infundiranja), bolečina in neprijeten občutek na mestu infundiranja
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Slovenian: Pri bolnikih z obstoječimi dejavniki srčno-žilnega tveganja lahko nadomestno zdravljenje z zdravilom s faktorjem IX poveča srčno-žilno tveganje.
English: People who are born with haemophilia B (Christmas disease) lack sufficient factor IX to control bleeding.
Slovenian: Ljudje s prirojeno hemofilijo B (Christmasova bolezen) nimajo dovoljkoagulacijskega faktorja IX za nadzor krvavitve.
English: Amount of BeneFIX per 1 ml of prepared solution for injection
Slovenian: Količina zdravila BeneFIX na 1 ml pripravljene raztopine za injiciranje
English: Do not touch the inside of the cap or the syringe tip.
Slovenian: Ne dotikajte se notranjosti pokrovčka ali vrha brizge.
English: If you take more BeneFIX than you should
Slovenian: Če ste uporabili večji odmerek zdravila BeneFIX, kot bi smeli
English: Recombinant coagulation factor IX is a glycoprotein that is secreted by genetically engineered mammalian cells derived from a Chinese hamster ovary (CHO) cell line.
Slovenian: Rekombinantni koagulacijski faktor IX je glikoprotein, ki ga izločajo sesalske celice, pridobljene z genetskim inženiringom iz linije ovarijskih celic kitajskega hrčka (CHO).
English: BeneFIX, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Slovenian: Kadar je rekonstituirano, zdravilo BeneFIX vsebuje polisorbat-80, za katerega je znano, da poveča hitrost izločanja di-(2-etilheksil)ftalata (DEHP) iz polivinilklorida (PVC).
English: Do not freeze in order to prevent damage to the pre-filled syringe.
Slovenian: Ne zamrzujte, da ne bo prišlo do poškodbe napolnjene injekcijske brizge.
English: Hypersensitivity/allergic reactions
Slovenian: Preobčutljivostne/alergijske reakcije
English: If any suspected hypersensitivity reaction takes place that is thought to be related to the administration of BeneFIX see sections 4.2 and 4.4.
Slovenian: Če se pojavi kakršnakoli domnevna preobčutljivostna reakcija, ki bi lahko bila povezana z uporabo zdravila BeneFIX, glejte poglavji 4.2 in 4.4.
English: • Hypersensitivity/allergic reactions
Slovenian: • preobčutljivostne/alergijske reakcije
English: Lift the package away from the adapter and discard the package.
Slovenian: Dvignite zavitek z nastavka in ga zavrzite.
English: If allergic/anaphylactic reactions occur, stop the infusion immediately and contact your doctor or seek emergency medical care immediately.
Slovenian: Če se pojavijo alergijske/anafilaktične reakcije, nemudoma prekinite infuzijo in obiščite zdravnika ali poiščite nujno medicinsko pomoč.
English: BeneFIX is used for the treatment and prevention of bleeding in patients with haemophilia B (congenital factor IX deficiency) in all age groups.
Slovenian: Zdravilo BeneFIX se uporablja za zdravljenje in preprečevanje krvavitve pri bolnikih s hemofilijo B (prirojeno pomanjkanje faktorja IX) pri vseh starostnih skupinah.
English: You can use one of the peel-off labels found on the vial to document the batch number in your diary or for reporting any side effects.
Slovenian: Eno od nalepk na viali lahko uporabite, da dokumentirate številko serije v svojem dnevnikuali za poročanje o neželenih učinkih.
English: Your doctor may decide to change the dose of BeneFIX you receive during your treatment.
Slovenian: Zdravnik se lahko odloči, da bo med zdravljenjem spremenil odmerek zdravila BeneFIX, ki ga prejemate.
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.
Slovenian: Zato vas zdravnik utegne skrbneje spremljati glede znakov alergijske reakcije, če je znano, da imate tako mutacijo, še posebej takrat, ko začnete prvič jemati zdravilo BeneFIX.
English: • Renal infarct (interruption to the blood supply to the kidney)
Slovenian: • infarkt ledvice (prekinjen dotok krvi v ledvice)
English: Sufficient data have not been obtained from clinical studies on the treatment of previously untreated patients (PUPs) with BeneFIX.
Slovenian: V kliničnih študijah še ni dovolj podatkov o zdravljenju bolnikov, ki predhodno niso bili zdravljeni (PUP - previously untreated patients) z zdravilom BeneFIX.
English: Do not touch the syringe tip or the inside of the cap.
Slovenian: Ne dotikajte se vrha brizge ali notranjosti pokrovčka.
English: A population pharmacokinetic model was developed using data collected in 73 patients aged 7 months to 60 years.
Slovenian: S podatki, ki so jih zbrali pri 73 bolnikih, starih od 7 mesecev do 60 let, so razvili populacijski farmakokinetični model.
English: There have been reports of severe blood clotting events, including life-threatening blood clots in critically ill babies, while receiving continuous-infusion BeneFIX through a central venous catheter.
Slovenian: Obstajajo poročila o hudih primerih strjevanja krvi, vključno z življenjsko ogrožajočimi krvnimi strdki pri kritično bolnih dojenčkih med prejemanjem kontinuirane infuzije zdravila BeneFIX skozi centralni venski kateter.
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 je priporočljivo ustrezno določanje ravni faktorja IX, kar naj služi kot smernica za odmerjanje in pogostost ponovnih infuzij.
English: • Phlebitis (pain and redness of veins), flushing
Slovenian: • flebitis (boleče in rdeče obarvane vene), zardevanje
English: - The other ingredients are sucrose, glycine, L-histidine, polysorbate 80.
Slovenian: Druge sestavine zdravila so saharoza, glicin, L-histidin, polisorbat 80.
English: - Research has shown a link between the occurrence of a factor IX inhibitor and allergic reactions.
Slovenian: Raziskave so pokazale, da obstaja povezava med pojavom inhibitorja faktorja IX in alergijskimi reakcijami.
English: * ADR identified post-marketing a including cellulitis b low-titer transient inhibitor formation c including drug hypersensitivity, angioedema, bronchospasm, wheezing, dyspnoea, and laryngospasm d including migraine, sinus headache e including scintillating scotoma and blurred vision f including heart rate increased, sinus tachycardia g including hot flush, feeling hot, skin warm h including blood pressure decreased i superior vena cava (SVC) syndrome in critically ill neonates, while receiving continuous-infusion of BeneFIX through a central venous catheter j including productive cough k including rash macular, rash papular, rash maculopapular l developed in a hepatitis C antibody-positive patient 12 days after a dose of BeneFIX for a bleeding episode.
Slovenian: * neželeni učinki, ugotovljeni v obdobju trženja vključno s celulitisom tvorba nizkih titrov prehodnih inhibitorjev vključno s preobčutljivostjo na zdravilo, angioedemom, bronhospazmom, sopenjem, dispnejo in laringospazmom vključno z migreno, sinusnim glavobolom vključno s teihopsijo in zamegljenim vidom vključno s povečanim srčnim utripom, sinusno tahikardijo vključno z vročinskimi oblivi, občutkom vročine, toplo kožo vključno z znižanjem krvnega tlaka sindrom zgornje vene kave pri kritično bolnih novorojenčkih med prejemanjem kontinuirane infuzije zdravila BeneFIX skozi centralni venski kateter vključno s produktivnim kašljem vključno z makuloznim izpuščajem, papuloznim izpuščajem, makulopapuloznim izpuščajem pojavil se je pri bolniku, pozitivnem na protitelesa proti hepatitisu C, 12 dni po odmerku zdravila BeneFIX zaradi epizode krvavitve.
English: Preliminary information suggests a relationship may exist between the presence of major deletion mutations in a patient's factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions.
Slovenian: Preliminarni podatki kažejo na možnost obstoja povezave med prisotnostjo pomembnejših delecijskih mutacij na bolnikovem genu za faktor IX in zvečanim tveganjem za nastanek inhibitorjev in akutnih preobčutljivostnih reakcij.
English: The reconstituted solution may be stored at room temperature prior to administration.
Slovenian: Rekonstituirano raztopino lahko do uporabe hranite pri sobni temperaturi.
English: It should be noted that patients with a factor IX inhibitor may be at an increased risk of anaphylaxis during future treatment with BeneFIX.
Slovenian: Upoštevati je treba, da utegnejo imeti bolniki z inhibitorjem faktorja IX večje tveganje za anafilaksijo med prihodnjim zdravljenjem z zdravilom BeneFIX.
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Slovenian: Shranjujte pri temperaturi do 30 °C.
English: There have been post-marketing reports of thrombotic events, including life-threatening superior vena cava (SVC) syndrome in critically ill neonates, while receiving continuous-infusion BeneFIX through a central venous catheter (see also section 4.8).
Slovenian: Obstajajo poročila iz obdobja trženja zdravila o trombotičnih dogodkih, vključno z življenjsko ogrožajočim sindromom zgornje vene kave (SVC) pri kritično bolnih novorojenčkih med prejemanjem kontinuirane infuzije zdravila BeneFIX skozi centralni venski kateter (glejte tudi poglavje 4.8).
English: Degree of haemorrhage/Type of surgical procedure
Slovenian: Stopnja krvavitve/Vrsta operativnega posega
English: Τηλ: +357 22 817690 Latvija
Slovenian: Τηλ: +357 22 817690
English: As with any patient receiving BeneFIX, dose selection for an elderly patient should be individualised.
Slovenian: Kot pri vseh bolnikih, ki prejemajo zdravilo BeneFIX, mora biti odmerjanje prilagojeno posamezniku.
English: Other sterile disposable syringes may be used for administration.
Slovenian: Za dajanje zdravila lahko uporabite druge sterilne brizge za enkratno uporabo.
English: Close monitoring of factor IX plasma activity should be performed as clinically indicated, as well as calculation of pharmacokinetic parameters such as recovery and half-life, in order to adjust doses as appropriate.
Slovenian: Skrbno je treba spremljati plazemsko aktivnost faktorja IX, kot je to klinično indicirano, pa tudi izračunavati farmakokinetične parametre, na primer porast koncentracije faktorja IX in razpolovni čas, da lahko odmerek ustrezno prilagodimo.
English: - Because of the risk of allergic reactions with factor IX, your initial administrations of BeneFIX should be performed under medical observation where proper medical care for allergic reactions can be provided.
Slovenian: Zaradi tveganja alergijskih reakcij pri faktorju IX je treba začetne aplikacije zdravila BeneFIX opraviti pod medicinskim nadzorom, kjer vam bo v primeru alergijskih reakcij možno nuditi ustrezno medicinsko oskrbo.
English: Adolescents 12 to < 18
Slovenian: Mladostniki 12 do < 18
English: - If allergic or anaphylactic-type reactions occur, stop the infusion immediately and contact a doctor or seek emergency medical care immediately.
Slovenian: Če se pojavijo alergijske reakcije ali reakcije anafilaktičnega tipa, nemudoma prekinite infuzijo in obiščite zdravnika ali poiščite nujno medicinsko pomoč.
English: BeneFIX is administered by intravenous infusion after reconstitution of the lyophilised powder for solution for injection with sterile 0.234% sodium chloride solution (see section 6.6).
Slovenian: Zdravilo BeneFIX se daje z intravensko infuzijo po rekonstituciji liofiliziranega praška za raztopino za injiciranje s sterilno 0,234 % raztopino natrijevega klorida (glejte poglavje 6.6).
English: The active ingredient in BeneFIX is nonacog alfa.
Slovenian: Učinkovina v zdravilu BeneFIX je nonakog alfa.
English: Agglutination of red blood cells in the tube/syringe There have been reports of agglutination of red blood cells in the tube/syringe with the administration of BeneFIX.
Slovenian: Aglutinacija rdečih krvničk v infuzijskem sistemu/brizgi Obstajajo poročila o aglutinaciji rdečih krvničk v infuzijskem sistemu/brizgi ob dajanju zdravila BeneFIX.
English: With the syringe still connected to the adapter, gently rotate the vial until the powder is dissolved.
Slovenian: Medtem, ko je brizga še spojena z nastavkom, vialo previdno sukajte, dokler se prašek ne raztopi.
English: Remove the plastic flip-top cap from the BeneFIX vial to expose the central portion of the rubber stopper.
Slovenian: Snemite plastično zaporko z viale zdravila BeneFIX, da se pokaže osrednji del gumijastega zamaška.
English: • Infusion site cellulitis (pain and redness of the skin)
Slovenian: • celulitis na mestu infundiranja (boleča in rdeče obarvana koža)
English: - It is recommended that evey time you use BeneFIX, you record the name and batch number of the product.
Slovenian: Priporočljivo je, da ob vsaki uporabi zdravila BeneFIX zabeležite ime in številko serije zdravila.
English: A solvent (0.234% sodium chloride solution) is also supplied for reconstitution.
Slovenian: Priložen je tudi vehikel (0,234-odstotna raztopina natrijevega klorida) za rekonstitucijo.
English: A kidney disorder has been reported following high doses of plasma-derived factor IX to induce immune tolerance in haemophilia B patients with factor IX inhibitors and a history of allergic reactions (see also “Warnings and precautions”).
Slovenian: Poročali so o motnji delovanja ledvic po dajanju velikih odmerkov faktorja IX, pridobljenega iz plazme, za indukcijo imunske tolerance pri bolnikih s hemofilijo B z inhibitorji faktorja IX in anamnezo alergijskih reakcij (glejte tudi “Opozorila in previdnostni ukrepi”).
English: Each vial of BeneFIX contains nominally 250, 500, 1000, 1500, 2000 or 3000 IU of nonacog alfa.
Slovenian: Ena viala zdravila BeneFIX vsebuje nominalno 250, 500, 1.000, 1.500, 2.000 ali 3.000 i.e. nonakoga alfa.
English: • one pre-filled syringe of solvent, 5 ml sterile 0.234% sodium chloride solution for injection for reconstitution, with one plunger rod
Slovenian: • eno napolnjeno injekcijsko brizgo vehikla, 5 ml sterilne 0,234-odstotne raztopine natrijevega klorida za injekcije za rekonstitucijo, z enim batom,
English: Because of the risk of allergic reactions with factor IX concentrates, 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 tveganja alergijskih reakcij pri koncentratih faktorja IX je treba opraviti začetne aplikacije faktorja IX, če lečeči zdravnik tako presodi, pod medicinskim nadzorom, kjer je možno nuditi ustrezno medicinsko oskrbo v primeru alergijskih reakcij.
English: LIST OF EXCIPIENTS Sucrose, glycine, L-histidine, sodium chloride, polysorbate 80.
Slovenian: Saharoza, glicin, L-histidin, natrijev klorid, polisorbat 80.
English: Strength of BeneFIX per ml prepared solution
Slovenian: Jakost zdravila BeneFIX na ml pripravljene raztopine
English: BeneFIX is provided as a powder for injection in a glass vial and a solvent provided in pre-filled syringe.
Slovenian: Zdravilo BeneFIX je na voljo kot prašek za injekcijo v stekleni viali in vehikel, priložen v napolnjeni injekcijski brizgi.
English: Note: If the solution is not to be used immediately, the syringe cap should be carefully replaced.
Slovenian: Opomba: Če raztopine ne boste uporabili takoj, pazljivo namestite pokrovček brizge.
English: In addition, the solution should be withdrawn from the vial using the vial adapter.
Slovenian: Poleg tega morate raztopino izvleči iz viale s pomočjo nastavka za vialo.
English: Children 6 to < 12
Slovenian: Otroci 6 do < 12
English: Renal infarct l
Slovenian: Bolezni sečil infarkt ledvice
English: Treatment failure can occur as a consequence of human coagulation factor IX adsorption to the internal surfaces of some infusion equipment.
Slovenian: Zaradi adsorpcije humanega koagulacijskega faktorja IX na notranjo površino nekaterih vrst infuzijske opreme lahko pride do neuspeha zdravljenja.
English: BeneFIX works by replacing factor IX in haemophilia B patients to enable their blood to clot.
Slovenian: Zdravilo BeneFIX deluje tako, da pri bolnikih s hemofilijo B nadomesti faktor IX in omogoči strjevanje krvi.
English: Factor IX activity is absent or greatly reduced in patients with haemophilia B and substitution therapy may be required.
Slovenian: Pri bolnikih s hemofilijo B aktivnosti faktorja IX ni ali je močno zmanjšana, tako da utegne biti potrebno nadomestno zdravljenje.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: Allergic-type hypersensitivity reactions are possible with BeneFIX.
Slovenian: Pri zdravilu BeneFIX so možne preobčutljivostne reakcije alergijskega tipa.
English: • one sterile infusion set
Slovenian: •en sterilen infuzijski sistem,
English: BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU of powder in a 10 mL vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium) and 5 mL of clear, colourless solvent in a prefilled syringe (type 1 glass) with a plunger stopper (bromobutyl), a tip-cap (bromobutyl) and a sterile vial adapter reconstitution device, a sterile infusion set, two alcohol swabs, a plaster, and a gauze pad.
Slovenian: BeneFIX 250 i.e., 500 i.e., 1.000 i.e., 1.500 i.e., 2.000 i.e., 3.000 i.e. praška v 10-mililitrski viali (steklo tipa I) z zamaškom (iz klorobutila) in zaporko (iz aluminija) in 5 ml bistrega in brezbarvnega vehikla v napolnjeni injekcijski brizgi (steklo tipa I), zamašeni z batom (iz bromobutila), s koničastim pokrovčkom (iz bromobutila) in sterilnim rekonstitucijskim nastavkom za vialo, sterilen infuzijski sistem, dva alkoholna zloženca, obliž in blazinica iz gaze.
English: While holding the adapter in the package, place the vial adapter over the vial.
Slovenian: Medtem ko držite nastavek v zavitku, ga namestite čez vialo.
English: BeneFIX is an injectable clotting (coagulation) factor IX product that is produced by recombinant DNA technology.
Slovenian: Zdravilo BeneFIX je zdravilo za injiciranje s (koagulacijskim) faktorjem IX, izdelanim s tehnologijo rekombinantne DNA.
English: No adverse events have been reported in association with this observation.
Slovenian: V povezavi s tem pojavom niso poročali o neželenih učinkih.
English: In case of severe allergic reactions, alternative therapy should be considered.
Slovenian: V primeru hudih alergijskih reakcij je treba razmisliti o zdravljenju s kakšnim drugim zdravilom.
English: Do not remove the adapter from the package.
Slovenian: Ne vzemite nastavka iz zavitka.
English: BeneFIX can cause harm to an unborn baby when given to pregnant women.
Slovenian: Ni znano, ali lahko zdravilo BeneFIX, če ga prejemajo nosečnice, povzroči okvaro nerojenega otroka.
English: METHOD OF ADMINISTRATION Single use injection.
Slovenian: Injekcija za enkratno uporabo.
English: Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Slovenian: Pri bolnikih s hemofilijo B se lahko razvijejo nevtralizirajoča protitelesa (inhibitorji) proti faktorju IX.
English: Because the use of BeneFIX by continuous infusion has not been evaluated, BeneFIX should not be mixed with infusion solutions or be given in a drip.
Slovenian: Ker uporabe zdravila BeneFIX s kontinuirano infuzijo niso ovrednotili, zdravila BeneFIX ne smete mešati z raztopinami za infundiranje ali dajati v kapalni infuziji.