FrancophonIA/ELRC3.0 huggingface dataset:
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Croatian: Osobito u slučaju većih kirurških zahvata neophodno je precizno praćenje nadomjesne terapije analizom zgrušavanja krvi (aktivnosti faktora IX u plazmi).
English: ALPROLIX pack contains:
Croatian: Pakiranje lijeka ALPROLIX sadrži:
English: Wipe the top of the vial with one of the alcohol swabs (F) provided in the pack, and allow to air dry.
Croatian: Obrišite vrh bočice jednom od alkoholom natopljenih vatica (F) priloženih u pakiranju te ostavite da se osuši na zraku.
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).
Croatian: Sažetak sigurnosnog profila Reakcije preosjetljivosti ili alergijske reakcije (koje mogu uključivati angioedem, žarenje i peckanje na mjestu primjene infuzije, zimicu, navale vrućine, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje, piskanje pri disanju) rijetko su opažene i mogu, u nekim slučajevima, napredovati do teške anafilaksije (uključujući šok).
English: Do not increase the total dose of ALPROLIX to control your bleed without talking to your doctor.
Croatian: Nemojte povisivati ukupnu dozu lijeka ALPROLIX kako biste kontrolirali krvarenje, a da prethodno niste o tome razgovarali s liječnikom.
English: 6 to <12 years
Croatian: <6 godina od 6 do <12 godina od 12 do <18 godina
English: Check the expiry date on the ALPROLIX carton.
Croatian: Provjerite rok valjanosti na kutiji lijeka ALPROLIX.
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.
Croatian: Liječenje epizoda krvarenja: Od 60 događaja krvarenja opaženih tijekom ispitivanja II, 75% dovedeno je pod kontrolu 1 injekcijom, a ukupno 91,7% epizoda krvarenja dovedeno je pod kontrolu s 2 ili manje injekcija.
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).
Croatian: 24 sata do odgovarajućeg cijeljenja rane, a potom nastavite s terapijom tijekom najmanje 7 dodatnih dana kako biste održali aktivnost faktora IX od 30% do 60% (IU/dl).
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 sljedećih hemoragijskih događaja aktivnost faktora IX ne smije se spustiti ispod navedene razine plazmatske aktivnosti (izraženo kao % u odnosu na normalnu vrijednost ili u IU/dl) unutar odgovarajućeg razdoblja.
English: The observed mean (SD) activity time profile following a single dose of ALPROLIX in patients with severe haemophilia B is shown below (see Table 4).
Croatian: Opažena srednja vrijednost (SD) profila aktivnosti u vremenu nakon jedne doze lijeka ALPROLIX u bolesnika s teškom hemofilijom B prikazana je niže (vidjeti tablicu 4).
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.
Croatian: Tijekom liječenja savjetuje se odgovarajuće određivanje razina faktora IX kao smjernica za dozu koju treba primijeniti i učestalost ponavljanja injekcija.
English: Insert the infusion set needle into a vein as instructed by your doctor or nurse and remove the tourniquet.
Croatian: Uvedite iglu kompleta za infuziju u venu prema uputama Vašeg liječnika ili medicinske sestre i uklonite povesku.
English: Study II enrolled a total of 30 previously treated male paediatric patients with severe hemophilia B (≤2% endogenous FIX activity).
Croatian: Ispitivanje II uključilo je ukupno 30 prethodno liječenih muških pedijatrijskih bolesnika s teškom hemofilijom B (≤2% aktivnosti endogenog FIX).
English: Table 5 presents the pharmacokinetic parameters calculated from the paediatric data of 35 subjects less than 18 years of age.
Croatian: prikazuje farmakokinetičke parametre izračunate iz podataka 35 pedijatrijskih ispitanika mlađih od
English: Because of the potential risk of thrombotic complications with factor IX products, 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 newborn infants, or to patients at risk of thrombotic phenomena or disseminated intravascular coagulation (DIC).
Croatian: Zbog mogućeg rizika od trombotičkih komplikacija uz lijekove s faktorom IX, potrebno je započeti klinički nadzor zbog mogućeg razvoja ranih znakova trombotičke i potrošne koagulopatije uz odgovarajuće biološko testiranje kad se ovaj lijek primjenjuje u bolesnika s bolešću jetre, bolesnika nakon kirurškog zahvata, novorođenčadi ili u bolesnika u kojih postoji rizik od trombotičkih pojava ili diseminirane intravaskularne koagulacije (DIK).
English: ALPROLIX can be used for all age groups.
Croatian: ALPROLIX se može primjenjivati u svim dobnim skupinama.
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.
Croatian: Tablični popis nuspojava Učestalosti u tablici niže bile su opažene u ukupno 153 bolesnika s teškom hemofilijom B u kliničkim ispitivanjima faze III i jednom produžetku ispitivanja.
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.
Croatian: I usporedilo je djelotvornost 2 profilaktička režima liječenja (fiksni tjedni interval s primjenom doze od 50 IU/kg i individualizirani interval s primjenom 100 IU/kg počevši s 10-dnevnim intervalom primjene) s liječenjem prema potrebi.
English: All of the 30 patients were treated with ALPROLIX on a prophylactic dosing regimen starting with 50-60 IU/kg every 7 days, with adjustment of dose to a maximum of 100 IU/kg and dosing interval to a minimum of once weekly and a maximum of twice weekly.
Croatian: Svih 30 bolesnika bilo je liječeno lijekom ALPROLIX u profilaktičkom režimu doziranja, počevši s dozom od 50-60 IU/kg svakih 7 dana, uz prilagodbu doze do najviše 100 IU/kg i intervala doziranja od najmanje jedanput tjedno do najviše dvaput tjedno.
English: Non-clinical data reveal no special hazard for humans based on thrombogenicity test in rabbits (Wessler stasis model) and repeated dose toxicity studies (which included assessment of local toxicity, male reproductive organs and electrocardiographic parameters) in rats and monkeys.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju testa trombogenosti u kunića (Wesslerov model stâze) i ispitivanja toksičnosti ponovljenih doza (koja su uključivala procjenu lokalne toksičnosti,
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 lijekova s faktorom IX niske čistoće bila je povezana sa slučajevima infarkta miokarda, diseminirane intravaskularne koagulacije, venske tromboze i plućne embolije.
English: After preparation, ALPROLIX can be stored at room temperature for up to 6 hours before administration.
Croatian: Nakon pripreme, ALPROLIX se može čuvati na sobnoj temperaturi najviše 6 sati prije primjene.
English: Hypersensitivity to the active substance (recombinant human coagulation factor IX, and/or Fc domain) or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar (rekombinantni ljudski koagulacijski faktor IX i/ili Fc-fragment) ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Dose and duration of the substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Croatian: Doziranje Doza i trajanje nadomjesne terapije ovise o težini nedostatka faktora IX, mjestu i opsegu krvarenja te bolesnikovom kliničkom stanju.
English: F) 2 Alcohol swabs G) 2 Plasters
Croatian: E) 1 komplet za infuziju F) 2 alkoholom natopljene vatice G) 2 flastera
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.
Croatian: lijeka ALPROLIX u tipične odrasle osobe tjelesne težine 70 kg je 2,30 dl/h u stanju dinamičke ravnoteže, a volumen distribucije lijeka ALPROLIX u stanju dinamičke ravnoteže je 194,8 dl.
English: Repeat injection every 48 hours, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Croatian: Ponovite injekciju svakih 48 sati, sve dok se ne riješi bolna epizoda krvarenja ili ne postigne zacjeljivanje.
English: Repeat injection every 24 to 48 hours until pain and acute disability are resolved.
Croatian: Ponovite injekciju svakih 24 do 48 sati, sve dok se ne izliječe bol i akutna onesposobljenost.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Croatian: Važna napomena: GSK za različite koncentrate faktora ili iz različitih kliničkih ispitivanja nisu međusobno usporedive.
English: A population pharmacokinetic model was developed based on FIX activity data from 161 subjects of all ages (2-76 years of age) weighing between 12.5 kg to 186.7 kg in three clinical studies (12 subjects in a phase 1/2a study, 123 subjects in study I and 26 subjects in study II).
Croatian: Model populacijske farmakokinetike razvijen je na temelju podataka o aktivnosti FIX u 161 ispitanika svih dobi (2-76 godine), tjelesne težine između 12,5 kg i 186,7 kg, u tri klinička ispitivanja (12 ispitanika u ispitivanju faze 1/2a, 123 ispitanika u ispitivanju
English: IR (IU/dL per IU/kg) AUC/Dose (IU*h/dL per IU/kg)
Croatian: IR (IU/dl po IU/kg) AUC/Doza (IU*h/dl po IU/kg)
English: Haemophilia B is an X-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Croatian: Hemofilija B je nasljedni poremećaj zgrušavanja krvi povezan s X kromosomom i nastaje zbog smanjenih razina faktora IX te rezultira krvarenjem u zglobove, mišiće ili unutarnje organe, spontano ili nakon ozljede ili kirurškog zahvata.
English: The usual dose of ALPROLIX is 50 IU per kg of body weight, given once a week or 100 IU per kg of body weight, given once every 10 days.
Croatian: Uobičajena doza lijeka ALPROLIX je 50 IU po kg tjelesne težine koja se daje jedanput tjedno ili 100 IU po kilogramu tjelesne težine koja se daje jedanput svakih 10 dana.
English: One International Unit (IU) of recombinant factor IX Fc activity is equivalent to that quantity of factor IX in one mL of normal human plasma.
Croatian: Jedna međunarodna jedinica (IU) aktivnosti rekombinantnog faktora IX Fc odgovara količini faktora IX u jednom ml normalne ljudske plazme.
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.
Croatian: Smije se koristiti samo priloženi komplet za infuziju zato što liječenje može biti neuspješno zbog adsorpcije faktora zgrušavanja krvi IX na unutrašnju površinu nekih pribora za injiciranje.
English: ALPROLIX is a medicine used for the treatment and prevention of bleeding in all age groups of patients with haemophilia B (inherited bleeding disorder caused by factor IX deficiency).
Croatian: ALPROLIX je lijek koji se primjenjuje za liječenje i sprječavanje krvarenja u svim dobnim skupinama bolesnika s hemofilijom B (nasljednim poremećajem krvarenja prouzročenim manjkom faktora IX).
English: No bleeding episodes were experienced in 33% of paediatric subjects.
Croatian: U 33% pedijatrijskih ispitanika nije bilo nijedne epizode krvarenja.
English: ALPROLIX (eftrenonacog alfa) is a long-acting, fully recombinant, fusion protein comprising human coagulation factor IX covalently linked to the Fc domain of human immunoglobulin G1, and produced by recombinant DNA technology.
Croatian: ALPROLIX (eftrenonakog alfa) je dugodjelujući, potpuno rekombinantni fuzijski protein koji se sastoji od ljudskog koagulacijskog faktora IX kovalentno vezanog na Fc-fragment ljudskog imunoglobulina G1, proizveden tehnologijom rekombinantne DNK.
English: The calculation of the required dose of recombinant factor IX Fc 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% of normal activity (IU/dL).
Croatian: Liječenje prema potrebi Izračun potrebne doze rekombinantnog faktora IX Fc temelji se na empirijskom saznanju da 1 međunarodna jedinica (IU) faktora IX po kg tjelesne težine povećava aktivnost faktora IX u plazmi za 1% normalne aktivnosti (IU/dl).
English: A total of 35 major surgical procedures were performed and assessed in 22 subjects (21 adults and adolescents, and 1 paediatric patient <12 years of age) in Study I and Study III.
Croatian: Ukupno je učinjeno i procijenjeno 35 većih kirurških zahvata u 22 ispitanika (21 odraslog ispitanika i adolescenta i 1 pedijatrijskog bolesnika u dobi
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).
Croatian: Udio ispitanika s ≥1 ciljnim zglobom na početku bio je manji u skupini koja je primala profilaksu u individualiziranim intervalima nego u skupini koja je primala profilaksu u tjednim intervalima (27,6% odnosno 57,1%).
English: Eftrenonacog alfa (recombinant human coagulation factor IX, Fc fusion protein (rFIXFc)) has 867 amino acids.
Croatian: Eftrenonakog alfa (fuzijski protein rekombinantnog ljudskog koagulacijskog faktora IX i Fc fragmenta (rFIXFc)) ima 867 aminokiselina.
English: If you are not sure what to do, ask your doctor, pharmacist or nurse.
Croatian: Ako niste sigurni što učiniti, upitajte svog liječnika, ljekarnika ili medicinsku sestru.
English: The total dose on the day of surgery ranged from 49 to 341 IU/kg and the total dose in the 14 day perioperative period ranged from 60 to 1947 IU/kg.
Croatian: Raspon ukupne doze na dan kiruruškog zahvata kretao se od 49 do 341 IU/kg, a raspon ukupne doze u 14-dnevnom perioperacijskom razdoblju kretao se od 60 do 1947 IU/kg.
English: Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Croatian: U pojedinog bolesnika odgovor na faktor IX može biti različit, uz različite vrijednosti poluvijeka i povrata.
English: In children below the age of 12 years, higher doses or more frequent injections may be needed and the usual dose is 50 to 60 IU per kg of body weight, given once every 7 days.
Croatian: U djece mlađe od 12 godina mogu biti potrebne više doze ili češće davanje injekcija, a uobičajena doza je 50 do 60 IU po kilogramu tjelesne težine koja se daje jedanput svakih 7 dana.
English: Each vial of ALPROLIX contains nominally 250, 500, 1000, 2000 or 3000 IU eftrenonacog alfa.
Croatian: Jedna bočica lijeka ALPROLIX nominalno sadrži 250, 500, 1000, 2000 ili 3000 IU
English: The median average dose per injection to maintain hemostasis during surgery was 94.7 IU/kg (range: 49 to 152 IU/kg).
Croatian: Medijan prosječne doze po injekciji za održavanje hemostaze tijekom kirurškog zahvata iznosio je 94,7 IU/kg (raspon: od 49 do 152 IU/kg).
English: How ALPROLIX works
Croatian: Kako ALPROLIX djeluje
English: Allergic type hypersensitivity reactions have been reported with ALPROLIX.
Croatian: Preosjetljivost Zabilježene su reakcije preosjetljivosti alergijskog tipa na ALPROLIX.
English: The powder for injection in each vial must be reconstituted with the supplied solvent (sodium chloride solution) from the pre-filled syringe using the sterile vial adapter for reconstitution.
Croatian: Prašak za injekciju u svakoj bočici mora se rekonstituirati otapalom (otopina natrijevog klorida) iz priložene napunjene štrcaljke koristeći sterilni nastavak za bočicu za rekonstituciju.
English: • The other ingredients are sucrose, L-Histidine, mannitol, polysorbate 20, sodium hydroxide and hydrochloric acid.
Croatian: • Drugi sastojci su saharoza, L-histidin, manitol, polisorbat 20, natrijev hidroksid i kloridna kiselina.
English: The target factor IX levels will depend on the severity and location of the bleeding.
Croatian: Ciljne razine faktora IX ovisit će o jačini i mjestu krvarenja.
English: The median average dose per injection to treat a bleeding episode was 46.07 (IQR: 32.86-57.03) IU/kg.
Croatian: Medijan prosječne doze po injekciji za liječenje epizode krvarenja iznosio je 46,07 (IQR: 32,86-57,03) IU/kg.
English: Common side effects (may affect up to 1 in 10 people): headache, mouth numbness or tingling, pain in your side with blood in your urine (obstructive uropathy).
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba): glavobolja, utrnulost ili trnci u ustima, bol u slabinama uz krv u mokraći (opstruktivna uropatija).
English: For children below the age of 12 years, higher or more frequent doses may be required and the recommended starting dose is 50-60 IU/kg every 7 days.
Croatian: U djece mlađe od 12 godina može biti potrebna primjena viših doza ili učestalije doziranje, a preporučena početna doza je 50-60 IU/kg svakih 7 dana.
English: • 100 IU/kg once every 10 days, adjust interval based on individual response.
Croatian: • 100 IU/kg jedanput svakih 10 dana, uz prilagodbu vremenskog razmaka između doza na temelju odgovora pojedinog bolesnika.
English: When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor IX activity in patients' blood samples, plasma factor IX activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
Croatian: Kad se za određivanje aktivnosti faktora IX u uzorcima krvi bolesnika koristi in vitro jednostupanjski test zgrušavanja krvi temeljen na tromboplastinskom vremenu (aPTV), na rezultate za aktivnost faktora IX u plazmi mogu značajno utjecati i vrsta reagensa za određivanje aPTV-a i referentni standard koji se koristi u testu.
English: Pharmacokinetic properties were evaluated in 22 subjects (≥19 years) receiving ALPROLIX (rFIXFc).
Croatian: Farmakokinetička svojstva bila su procijenjena u 22 ispitanika (u dobi od ≥19 godina) koji su primali lijek
English: Subjects had a median of 0.38 (IQR: 0.00-1.43) spontaneous joint bleeds in Study III.
Croatian: Ispitanici u ispitivanju III imali su medijan od 0,38 (IQR: 0,00-1,43) spontanih krvarenja u zglobove.
English: Powder: sucrose, L-histidine, mannitol, polysorbate 20, sodium hydroxide, hydrochloric acid
Croatian: Prašak: saharoza, L-histidin, manitol, polisorbat 20, natrijev hidroksid, kloridna kiselina
English: No bleeding episodes were experienced in 42% of subjects while on individualised prophylaxis and in 23% of subjects while on weekly prophylaxis.
Croatian: Nije bilo nijedne epizode krvarenja u 42% ispitanika dok su primali individualiziranu profilaksu i u 23,0%
English: It is strongly recommended that every time that ALPROLIX 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 zabilježiti ime i broj serije lijeka prilikom svake primjene lijeka ALPROLIX bolesniku, kako bi se održala poveznica između bolesnika i serije ovog lijeka.
English: What you need to know before you use ALPROLIX Do not use ALPROLIX:
Croatian: Što morate znati prije nego počnete primjenjivati ALPROLIX
English: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Croatian: Liječenje i profilaksa krvarenja u bolesnika s hemofiijom B (urođeni nedostatak faktora IX).
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.
Croatian: (interkvartilni raspon od 6,94 do 7,03) s time da nije bilo razlike u medijanu intervala doziranja između dobnih kohorti.
English: Measurements with a one-stage clotting assay utilising a kaolin-based aPTT reagent will likely result in an underestimation of activity level.
Croatian: Mjerenja pomoću jednostupanjskog testa zgrušavanja krvi u kojem se koristi reagens za određivanje aPTV-a na bazi kaolina vjerojatno će dati niži rezultat za razinu aktivnosti od stvarne.
English: The potency (International Units) is determined using the European Pharmacopoeia one stage clotting test against an in-house standard that is referenced to the WHO factor IX standard.
Croatian: Potentnost (međunarodne jedinice) se određuje jednostupanjskim testom zgrušavanja krvi prema Europskoj farmakopeji u odnosu na standard ustanove usklađen s preporučenim standardom za faktor IX Svjetske zdravstvene organizacije (SZO).
English: Powder: 250 IU eftrenonacog alfa (approx. 50 IU/mL after reconstitution), Powder: 500 IU eftrenonacog alfa (approx. 100 IU/mL after reconstitution) Powder: 1000 IU eftrenonacog alfa (approx. 200 IU/mL after reconstitution) Powder: 2000 IU eftrenonacog alfa (approx. 400 IU/mL after reconstitution) Powder: 3000 IU eftrenonacog alfa (approx. 600 IU/mL after reconstitution)
Croatian: Prašak: 250 IU eftrenonakoga alfa (približno 50 IU/ml nakon rekonstitucije), Prašak: 500 IU eftrenonakoga alfa (približno 100 IU/ml nakon rekonstitucije) Prašak: 1000 IU eftrenonakoga alfa (približno 200 IU/ml nakon rekonstitucije) Prašak: 2000 IU eftrenonakoga alfa (približno 400 IU/ml nakon rekonstitucije) Prašak: 3000 IU eftrenonakoga alfa (približno 600 IU/ml nakon rekonstitucije)
English: Post Marketing Experience
Croatian: Iskustvo nakon stavljanja lijeka u promet
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.
Croatian: DNK u staničnoj liniji bubrega ljudskog embrija (HEK) bez dodavanja ikakvog egzogenog proteina ljudskog ili životinjskog podrijetla tijekom kultiviranja stanica, pročišćavanja ili konačne formulacije.
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: To je koagulacijski faktor koji ovisi o vitaminu K. Faktor IX se aktivira faktorom XIa u unutarnjem putu koagulacije i kompleksom faktora VII/tkivnog faktora u vanjskom putu koagulacije.
English: Table 3: Pharmacokinetic parameters of ALPROLIX (50 IU/kg dose)
Croatian: Tablica 3: Farmakokinetički parametri lijeka ALPROLIX (u dozi od 50 IU/kg) Farmakokinetički parametri1
English: In post-marketing experience, FIX inhibitor development and hypersensitivity (including anaphylaxis) have been observed.
Croatian: Nakon stavljanja lijeka u promet opaženi su razvoj inhibitora faktora IX i preosjetljivost (uključujući anafilaksiju).
English: If you stop using ALPROLIX
Croatian: Ako prestanete primjenjivati ALPROLIX
English: Perioperative management (surgical prophylaxis):
Croatian: Perioperacijsko liječenje (kirurška profilaksa):
English: This product is for single use only.
Croatian: Ovaj je lijek samo za jednokratnu primjenu.