FrancophonIA/ELRC3.0 huggingface dataset:
English: NA 36.7
Slovenian: n/v 36,7
English: ALPROLIX can be used for all age groups.
Slovenian: Zdravilo ALPROLIX se lahko uporablja za vse starostne skupine.
English: Repeat injection every 8 to 24 hours as necessary until adequate wound healing, then therapy at least for another 7 days to maintain a factor IX activity of 30% to 60% (IU/dL).
Slovenian: Injiciranje ponavljajte vsakih 8 do 24 ur, kot je potrebno, dokler se rana zadovoljivo ne zaceli, potem nadaljujte zdravljenje še vsaj 7 dni za vzdrževanje aktivnosti faktorja IX na 30 % do 60 % (i.e./dl).
English: The haemostatic response was rated as excellent or good in 100% of major surgeries.
Slovenian: Hemostatski odziv je bil pri 100 % večjih kirurških posegov ocenjen kot odličen ali dober.
English: This product is for single use only.
Slovenian: To zdravilo je samo za enkratno uporabo.
English: ALPROLIX is used to replace the missing or deficient factor IX.
Slovenian: Zdravilo ALPROLIX se uporablja za nadomeščanje manjkajočega ali pomanjkljivo delujočega faktorja IX.
English: The dose will depend on your individual needs for replacement factor IX therapy and on whether it is used for prevention or treatment of bleeding.
Slovenian: Odmerek bo odvisen od vaših individualnih potreb glede zdravljenja za nadomeščanje faktorja IX in od tega, ali se zdravilo uporablja za preprečevanje ali za zdravljenje krvavitve.
English: • There is a small chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ALPROLIX.
Slovenian: • Obstaja majhna možnost, da boste doživeli anafilaktično reakcijo (huda, nenadna alergijska reakcija) na zdravilo ALPROLIX.
English: Factor IX products may increase the risk of unwanted blood clots in your body, especially if you have risk factors for developing blood clots.
Slovenian: Zdravila s faktorjem IX lahko povečajo tveganje za neželene krvne strdke v telesu, zlasti če imate dejavnike tveganja za razvoj krvnih strdkov.
English: The Fc fusion protein in ALPROLIX increases the length of time that the medicine works.
Slovenian: Fuzijska beljakovina Fc v zdravilu ALPROLIX podaljša čas delovanja tega zdravila.
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 4.4).
Slovenian: V nekaterih primerih so te reakcije napredovale v hudo anafilaksijo, pojavljale pa so se v tesni časovni povezavi z razvojem zaviralcev faktorja IX (glejte tudi poglavje 4.4).
English: Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Spodaj predstavljena preglednica 2 je v skladu s klasifikacijo organskih sistemov MedDRA (klasifikacija organskih sistemov in raven prednostnega izraza).
English: Prophylaxis Individualised Regimen:
Slovenian: Profilaktični individualizirani režim:
English: The elimination half-life of ALPROLIX (82 hours) is influenced by the Fc region, which in animal models was shown to be mediated by neonatal Fc receptor cycling pathways.
Slovenian: Na razpolovni čas izločanja zdravila ALPROLIX (82 ur) vpliva regija Fc, za katero se je v živalskih modelih pokazalo, da pri njej posreduje pot kroženja neonatalnega receptorja Fc.
English: If a repeat dose is required to control the bleed, the prolonged half-life of ALPROLIX should be taken into account (see section 5.2).
Slovenian: Če je za nadzor krvavitve potreben ponovni odmerek, je treba upoštevati podaljšani razpolovni čas zdravila ALPROLIX (glejte poglavje 5.2).
English: It is a vitamin-K dependent coagulation factor.
Slovenian: Je od vitamina K odvisni koagulacijski faktor.
English: If the product is not used within 6 hours, it must be discarded.
Slovenian: Če zdravila ne uporabite v 6 urah, ga morate zavreči.
English: This receptor is expressed throughout life as part of a naturally occurring pathway that protects immunoglobulins from lysosomal degradation by cycling these proteins back into circulation, resulting in their long plasma half-life.
Slovenian: Ta receptor je izražen vse življenje kot del naravne poti, ki ščiti imunoglobuline pred lizosomsko razgradnjo z vključitvijo teh beljakovin nazaj v obtok, kar se odraža v njihovem dolgem razpolovnem času v plazmi.
English: 6.5 Nature and contents of container and special equipment for use, administration
Slovenian: 6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo ali dajanje
English: The benefit of treatment with ALPROLIX in these situations should be weighed against the risk of these complications.
Slovenian: V takih okoliščinah je treba pretehtati korist zdravljenja z zdravilom ALPROLIX v primerjavi s tveganjem za te zaplete.
English: Note: If you use more than one vial of ALPROLIX per injection, each vial should be prepared separately as per the previous instructions (steps 1 to 13) and the solvent syringe should be removed, leaving the vial adapter in place.
Slovenian: Opomba: Če boste uporabili več kot eno vialo zdravila ALPROLIX na injekcijo, morate vsako vialo pripraviti posebej v skladu s predhodnimi navodili (koraki 1 do 13) in injekcijsko brizgo z vehiklom odstraniti, nastavek pa pustite nameščen na viali.
English: Elderly population There is limited experience in patients ≥ 65 years.
Slovenian: Izkušnje pri bolnikih, starih ≥ 65 let, so omejene.
English: An instructional video on how to prepare and administer ALPROLIX is available by scanning the QR code with a smartphone or via the website
Slovenian: Videoposnetek z navodili glede priprave in dajanja zdravila ALPROLIX je na voljo, če poskenirate kodo QR s pametnim telefonom ali prek spletne strani.
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Slovenian: Trombin nato pretvori fibrinogen v fibrin in tako nastane krvni strdek.
English: Prophylaxis fixed weekly and individualised intervals:
Slovenian: Profilaksa s fiksnimi tedenskimi in individualiziranimi intervali:
English: The median dosing interval overall was 6.99 day (interquartile range, 6.94 to 7.03) with no difference in the median dosing interval between age cohorts.
Slovenian: Celokupno je bila mediana intervala odmerjanja 6,99 dneva (interkvartilni razpon 6,94 do 7,03), brez razlike v mediani intervala odmerjanja med starostnimi kohortami.
English: Out of 30 patients having completed Study II, 27 enrolled to Study III (extension study).
Slovenian: Od 30 bolnikov, ki so dokončali študijo II, se jih je 27 vključilo v študijo III (podaljšana študija).
English: Dosing intervals and factor consumption remained similar in Study III compared to Study II.
Slovenian: Intervali odmerjanja in poraba faktorja so ostali podobni v študiji III v primerjavi s študijo II.
English: Out of 123 subjects who completed Study I, 93 were enrolled in Study III (extension study) with median total follow-up time of 6.5 years.
Slovenian: Od 123 oseb, ki so opravile študijo I, se jih je 93 vključilo v študijo III (podaljšana študija) z mediano časa spremljanja 6,5 let.
English: NA 4.81
Slovenian: n/v 4,81
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.
Slovenian: Še zlasti pri velikih kirurških posegih je skrbno spremljanje nadomestnega zdravljenja z analizo koagulacije (aktivnosti faktorja IX v plazmi) nepogrešljivo.
English: What ALPROLIX is and what it is used for What you need to know before you use ALPROLIX How to use ALPROLIX
Slovenian: Kaj je zdravilo ALPROLIX in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ALPROLIX Kako uporabljati zdravilo ALPROLIX
English: Only the provided infusion set should be used because treatment failure can occur as a consequence of coagulation factor IX adsorption to the internal surfaces of some injection equipment.
Slovenian: Uporabljati je dovoljeno le priloženi komplet za infundiranje, saj je neuspešnost zdravljenja lahko posledica adsorpcije koagulacijskega faktorja IX na notranjo površino nekaterih oprem za injiciranje.
English: ALPROLIX is prepared by recombinant technology without addition of any human- or animal-derived components in the manufacturing process.
Slovenian: Zdravilo ALPROLIX je izdelano s pomočjo rekombinantne tehnologije brez dodajanja kakršnih koli sestavin humanega ali živalskega izvora pri postopku izdelave.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Slovenian: Pri bolnikih, ki imajo alergijske reakcije, je treba zato oceniti prisotnost zaviralca.
English: The dose of ALPROLIX is calculated depending on your body weight and the factor IX levels to be achieved.
Slovenian: Odmerek zdravila ALPROLIX se izračuna na podlagi vaše telesne mase in ravni faktorja IX, ki jo je treba doseči.
English: Do not stop using ALPROLIX without consulting your doctor.
Slovenian: Zdravila ALPROLIX ne prenehajte uporabljati, ne da bi se posvetovali z zdravnikom.
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Slovenian: V literaturi obstajajo poročila, ki kažejo povezavo med pojavom zaviralcev faktorja IX in alergijskimi reakcijami.
English: Check the expiry date on the ALPROLIX carton.
Slovenian: Preverite datum izteka roka uporabnosti na škatli zdravila ALPROLIX.
English: If you cannot use the prepared ALPROLIX solution immediately, it should be used within 6 hours when stored at room temperature.
Slovenian: Če pripravljene raztopine zdravila ALPROLIX ne morete uporabiti takoj, jo morate uporabiti v 6 urah, če jo shranjujete na sobni temperaturi.
English: The frequencies in the table below were observed in a total of 153 patients with severe haemophilia B in phase III clinical studies and an extension study.
Slovenian: Pogostnosti v spodnji preglednici so opazili pri skupno 153 bolnikih s hudo hemofilijo B v kliničnih študijah faze III in v podaljšku študije.
English: Pharmacokinetic samples were collected pre-dose and then subsequently at 11 time points up to 240 hours (10 days) post-dose.
Slovenian: Farmakokinetični vzorci so bili odvzeti pred odmerjanjem, nato pa zaporedno v 11 časovnih točkah do 240 ur (10 dni) po odmerjanju.
English: Measurements with a one-stage clotting assay utilising a kaolin-based aPTT reagent will likely result in an underestimation of activity level.
Slovenian: Merjenje z enostopenjskim strjevalnim preizkusom z uporabo reagenta aPTČ na podlagi kaolina bo verjetno dalo prenizko raven aktivnosti.
English: Therefore, if you experience allergic reactions such as those described above, you should be tested for the presence of an inhibitor.
Slovenian: Če imate alergijske reakcije, kot so opisane zgoraj, morate opraviti preiskavo za ugotavljanje prisotnosti zaviralca.
English: What ALPROLIX is and what it is used for
Slovenian: Kaj je zdravilo ALPROLIX in za kaj ga uporabljamo
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Slovenian: Odmerek na osnovi telesne mase bo morda treba prilagoditi pri bolnikih s premajhno ali preveliko telesno maso.
English: If you are using ALPROLIX to prevent bleeding, your doctor will calculate the dose for you.
Slovenian: Preprečevanje krvavitve Če zdravilo ALPROLIX uporabljate za preprečevanje krvavitev, bo zdravnik izračunal odmerek za vas.
English: Frequency, type and severity of adverse reactions in children are expected to be similar as in adults.
Slovenian: Pediatrična populacija Pričakuje se, da bodo pogostnost, vrsta in resnost neželenih učinkov pri otrocih podobne kot pri odraslih.
English: Symptoms of a possible unwanted blood clot may include: pain and/or tenderness along a vein, unexpected swelling of an arm or leg or sudden shortness of breath or difficulty breathing.
Slovenian: Simptomi morebitnih neželenih krvnih strdkov lahko vključujejo: bolečino in/ali občutljivost vzdolž vene, nepričakovano otekanje roke ali noge, nenadno kratko sapo ali težave z dihanjem.
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Slovenian: Navedena opozorila in previdnostni ukrepi veljajo za odrasle in otroke.
English: Table 5 presents the pharmacokinetic parameters calculated from the paediatric data of 35 subjects less than 18 years of age.
Slovenian: V preglednici 5 so predstavljeni farmakokinetični parametri, izračunani iz pediatričnih podatkov za 35 oseb, starih manj kot
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.
Slovenian: Faktor IX aktivirata faktor XIa v intrinzični koagulacijski poti in kompleks faktorja VII/tkivnega faktorja v ekstrinzični poti.
English: No bleeding episodes were experienced in 33% of paediatric subjects.
Slovenian: Pri 33 % pediatričnih bolnikov ni bilo epizod krvavitev.
English: The total number of exposure days was 26,106 with a median of 165 (range 1-528) exposure days persubject.
Slovenian: Skupno število dni izpostavljenosti je bilo 26.106 z mediano 165 (razpon 1-528) dni izpostavljenosti na osebo.
English: In patients with haemophilia B, factor IX is missing or not working properly.
Slovenian: Bolnikom s hemofilijo B faktor IX manjka ali ne deluje pravilno.
English: All patients received treatment with ALPROLIX and were followed for up to 52 weeks.
Slovenian: Vsi bolniki so se zdravili z zdravilom ALPROLIX, spremljali pa so jih do 52 tednov.
English: Repeat injection after 24 hours, as needed until healing is achieved1.
Slovenian: Injiciranje ponovite po 24 urah, kot je potrebno, dokler se ne zaceli1.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor IX, ATC code: B02BD04
Slovenian: Farmakoterapevtska skupina: antihemoragiki, koagulacijski faktor IX,oznaka ATC: B02BD04 Mehanizem delovanja
English: Pharmacokinetic properties were evaluated in 22 subjects (≥19 years) receiving ALPROLIX (rFIXFc).
Slovenian: Farmakokinetične lastnosti so ocenili pri 22 osebah (≥ 19 let), ki so dobivale zdravilo ALPROLIX
English: ALPROLIX pack contains:
Slovenian: Pakiranje zdravila ALPROLIX vsebuje:
English: It is a high purity factor product produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line, without the addition of any exogenous human- or animal-derived protein in the cell culture, purification or final formulation.
Slovenian: Je zdravilo s faktorjem velike čistote, pridobljeno z rekombinantno DNA tehnologijo v celični liniji humanih embrionalnih ledvičnih celic (HEK - human embryonic kidney), brez dodajanja kakršnih koli eksogenih beljakovin humanega ali živalskega izvora v celične kulture, proces prečiščevanja ali končno formulacijo zdravila.
English: The target factor IX levels will depend on the severity and location of the bleeding.
Slovenian: Ciljne ravni faktorja IX so odvisne od resnosti in mesta krvavitve.
English: No bleeding episodes were experienced in 42% of subjects while on individualised prophylaxis and in 23% of subjects while on weekly prophylaxis.
Slovenian: Epizode krvavitve se niso pojavile pri 42 % oseb na individualizirani profilaksi in pri 23,0 % oseb na tedenski profilaksi.
English: Factor IX is a protein produced naturally in the body necessary for the blood to form clots and stop bleeding.
Slovenian: Faktor IX je beljakovina, ki v telesu naravno nastaja in je potrebna za strjevanje krvi in ustavitev krvavitve.
English: Do not increase the total dose of ALPROLIX to control your bleed without talking to your doctor.
Slovenian: Skupnega odmerka zdravila ALPROLIX ne povečujte, da bi nadzorovali svojo krvavitev, ne da bi se posvetovali z zdravnikom.
English: The highest recommended dose for prophylaxis is 100 IU/kg
Slovenian: Največji priporočeni odmerek za profilakso je 100 i.e./kg.
English: What you need to know before you use ALPROLIX Do not use ALPROLIX:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo ALPROLIX Ne uporabljajte zdravila ALPROLIX:
English: Please record on the carton the date that ALPROLIX is removed from the refrigerator and set at room temperature.
Slovenian: Na škatlo zabeležite datum, ko ste zdravilo ALPROLIX vzeli iz hladilnika in postavili na sobno temperaturo.
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 tveganja alergijskih reakcij z zdravili, ki vsebujejo faktor IX, je treba začetno dajanje faktorja IX v skladu z oceno lečečega zdravnika izvesti med zdravstvenim opazovanjem, pri čemer je na voljo ustrezna zdravniška oskrba za alergijske reakcije.
English: Factor IX level required (%) (IU/dL)
Slovenian: Potrebna raven faktorja IX (%) (i.e./dl)
English: Treatment of bleeding: Of the 636 bleeding events observed during study I, 90.4 % were controlled with 1 injection and overall 97.3% with 2 or fewer injections.
Slovenian: Zdravljenje krvavitve: Od 636 dogodkov krvavitve, ki so jih opazili med študijo I, so jih 90,4 % obvladali z 1 injekcijo in celokupno 97,3 % z 2 injekcijama ali manj.
English: The use of high purity factor IX is rarely associated with thromboembolic complications.
Slovenian: Uporabo faktorja IX z veliko čistoto le redko povezujejo s trombemboličnimi zapleti.
English: Pharmacokinetic parameters of ALPROLIX were determined for adolescents in study I (pharmacokinetic sampling was conducted pre-dose followed by assessment at multiple time points up to 336 hours (14 days) post-dose) and for children in study II (pharmacokinetic sampling was conducted pre-dose followed by assessment at 7 time points up to 168 hours (7 days) post-dose).
Slovenian: Farmakokinetične parametre zdravila ALPROLIX so za mladostnike določili v študiji I (farmakokinetični vzorci so bili odvzeti pred odmerjanjem, nato pa ocenjeni v več časovnih točkah do 336 ur (14 dni) po odmerjanju), za otroke pa so jih določili v študiji II (farmakokinetični vzorci so bili odvzeti pred odmerjanjem, nato pa ocenjeni v 7 časovnih točkah do 168 ur (7 dni) po odmerjanju).
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 injections.
Slovenian: Tekom zdravljenja se priporoča ustrezno določanje ravni faktorja IX, kar je vodilo za odmerjanje zdravila in pogostnost ponovljenih injiciranj.
English: Treatment with ALPROLIX will be started by a doctor who is experienced in the care of patients with haemophilia.
Slovenian: Zdravljenje z zdravilom ALPROLIX bo uvedel zdravnik, ki ima izkušnje pri zdravljenju bolnikov s hemofilijo.
English: Study I compared the efficacy of each of 2 prophylactic treatment regimens (fixed weekly interval with dosing of 50 IU/kg, and individualised interval with 100 IU/kg starting every 10 days) to on demand treatment.
Slovenian: V študiji I so primerjali učinkovitost obeh profilaktičnih režimov zdravljenja (fiksni tedenski interval z odmerjanjem 50 i.e./kg in individualizirani interval s 100 i.e./kg, ki se je začel vsakih 10 dni) z zdravljenjem po potrebi.
English: All patients received treatment with ALPROLIX and were followed for up to 77 weeks.
Slovenian: Vsi bolniki so bili zdravljeni z zdravilom ALPROLIX, spremljali pa so jih do 77 tednov.
English: Dosing intervals and factor consumption remained similar in Study III (extension study) compared to Study I for both prophylactic regimens.
Slovenian: Intervali odmerjanja in poraba faktorja so ostali podobni v študiji III (podaljšana študija) v primerjavi s študijo I pri obeh profilaktičnih režimih.
English: Of the 35 major surgeries, 28 surgeries (80.0%) required a single pre-operative dose to maintain haemostasis during surgery.
Slovenian: 28 posegih (80,0 %) potreben en sam odmerek pred operacijo za ohranitev hemostaze med kirurškim posegom.
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.
Slovenian: V primeru spodaj navedenih krvavitev aktivnost faktorja IX ne sme pasti pod navedeno raven aktivnosti v plazmi (v % normalne vrednosti ali i.e./dl) v ustreznem obdobju.
English: The estimate of CL of ALPROLIX for a typical 70 kg adult is 2.30 dL/h and steady-state volume of distribution of ALPROLIX is 194.8 dL, respectively.
Slovenian: Ocena očistka zdravila ALPROLIX za tipičnega 70-kg odraslega je 2,30 dl/h, volumen porazdelitve v stanju dinamičnega ravnovesja zdravila ALPROLIX pa 194,8 dl.
English: Study I
Slovenian: Študija I
English: Each vial of ALPROLIX contains nominally 250, 500, 1000, 2000 or 3000 IU eftrenonacog alfa.
Slovenian: Ena viala zdravila ALPROLIX vsebuje nominalno 250, 500, 1000, 2000 ali 3000 i.e. eftrenonakoga alfa.
English: ALPROLIX should not be mixed with other solutions for injection or infusion.
Slovenian: Zdravila ALPROLIX ne smete mešati z drugimi raztopinami za injiciranje ali infundiranje.
English: A placental transfer study in mice was conducted (see section 5.3).
Slovenian: Izvedli so študijo prehajanja skozi posteljico pri miših (glejte poglavje 5.3).
English: Contents of the pack and other information What ALPROLIX contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo ALPROLIX
English: Table 2: Adverse reactions reported for ALPROLIX in clinical trials
Slovenian: Preglednica 2: Neželeni učinki, o katerih so poročali za zdravilo ALPROLIX v kliničnih preskušanjih
English: There was a lower proportion of subjects in individualised interval prophylaxis with ≥1 target joint at baseline than in weekly prophylaxis (27.6% and 57.1%, respectively).
Slovenian: Pri profilaktičnem individualiziranem intervalu je bil delež preizkušancev z ≥ 1 ciljnim sklepom ob izhodišču manjši kot pri tedenski profilaksi (27,6 % v primerjavi s 57,1 %).
English: If you use more ALPROLIX than you should
Slovenian: Če ste uporabili večji odmerek zdravila ALPROLIX, kot bi smeli
English: Minor surgery including tooth extraction
Slovenian: Kirurški poseg Manjši kirurški poseg, vključno z izruvanjem zoba
English: Repeat injection every 48 hours, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Slovenian: Injiciranje ponavljajte vsakih 48 ur, dokler krvavitev, sodeč po bolečini, ne preneha ali dokler se ne zaceli.
English: All pharmacokinetic studies with ALPROLIX were conducted in previously treated patients with severe haemophilia B. Data presented in this section were obtained by one-stage clotting assay with a silica-based aPTT reagent calibrated against factor IX plasma standards.
Slovenian: Vse farmakokinetične študije z zdravilom ALPROLIX so bile izvedene pri predhodno zdravljenih bolnikih s hudo hemofilijo B. Podatki, predstavljeni v tem poglavju, so bili pridobljeni s pomočjo enostopenjskih strjevalnih preskusov z reagentom aPTČ na podlagi silicijevega dioksida, umerjenim glede na standarde faktorja IX v plazmi.
English: Treatment of bleeding episodes: Of the 60 bleeding events observed during study II, 75% were controlled with 1 injection, and overall 91.7% of bleeding episodes were controlled with 2 or fewer injections.
Slovenian: Zdravljenje epizod krvavitve: od 60 dogodkov krvavitve, ki so jih opazili med študijo II, so jih 75 % obvladali z 1 injiciranjem, skupno 91,7 % epizod krvavitev pa so obvladali z 2 injiciranjema ali manj.
English: Following a washout period of at least 120 hours (5 days), the subjects received a single dose of 50 IU/kg of ALPROLIX.
Slovenian: Po vsaj 120-urnem (5-dnevnem) obdobju izpiranja so osebe prejele enkratni odmerek 50 i.e./kg zdravila ALPROLIX.
English: Eftrenonacog alfa (recombinant human coagulation factor IX, Fc fusion protein (rFIXFc)) has 867 amino acids.
Slovenian: Eftrenonakog alfa (rekombinantni humani koagulacijski faktor IX, fuzijska beljakovina Fc (rFIXFc)) ima 867 aminokislin.