FrancophonIA/ELRC3.0 huggingface dataset:
English: Incremental recovery 30 min after infusion (IU/dL: IU/kg)a
Croatian: Inkrementalni oporavak 30 min nakon infuzije (IU/dl: IU/kg)
English: Attach a butterfly needle to the syringe.
Croatian: Pričvrstite leptir iglu na štrcaljku.
English: x reciprocal of observed recovery (dL/kg)
Croatian: x recipročna vrijednost opaženog povrata (dl/kg)
English: Treatment with RIXUBIS will be started by a doctor who is experienced in the care of patients with haemophilia B.
Croatian: Liječenje lijekom RIXUBIS započet će liječnik koji ima iskustva u liječenju bolesnika s hemofilijom B.
English: Your doctor will do a blood test to check if you have developed activity-neutralising antibodies (inhibitors) against RIXUBIS.
Croatian: Vaš liječnik će napraviti krvne pretrage kako bi provjerio jeste li razvili protutijela koja neutraliziraju aktivnost (inhibitore) lijeka RIXUBIS.
English: RIXUBIS is used in patients with haemophilia B (Christmas disease, an inherited bleeding disorder caused by lack of factor IX).
Croatian: RIXUBIS se koristi kod bolesnika s hemofilijom B (Christmasovom bolesti, nasljednim poremećajem krvarenja uzrokovanim manjkom faktora IX).
English: One pack contains a powder vial (type I glass) with a stopper (butyl rubber) and a flip-off seal, a vial containing 5 ml solvent (type I glass) with a stopper (chlorobutyl rubber) and a flip-off seal and a needle-less reconstitution device (BAXJECT II).
Croatian: Jedno pakiranje sadrži bočicu s praškom (staklo tipa I) s čepom (butilna guma) i "flip-off" zatvaračem, bočicu koja sadrži 5 ml otapala (staklo tipa I) s čepom (klorbutilna guma) i "flip-off" zatvaračem te uređaj za rekonstituciju bez igle (BAXJECT II).
English: The subjects received either of the products as a single intravenous infusion.
Croatian: Ispitanici su primali jedan ili drugi lijek preko jednokratne intravenske infuzije.
English: The safety and efficacy in the perioperative setting was evaluated in a phase 3 prospective, open-label, uncontrolled, multicenter study in male PTPs with severe and moderately severe haemophilia B using RIXUBIS.
Croatian: Sigurnost i djelotvornost u perioperativnom okruženju procijenjene su u prospektivnom, otvorenom, nekontroliranom, multicentričnom ispitivanju faze 3 na muškim prethodno liječenim bolesnicima s teškom ili umjereno teškom hemofilijom B koji uzimaju RIXUBIS.
English: Clinical studies with RIXUBIS included 99 subjects with at least one exposure to RIXUBIS reporting in total 5 adverse reactions.
Croatian: Klinička ispitivanja s lijekom RIXUBIS uključila su 99 ispitanika s najmanje jednim izlaganjem lijeku RIXUBIS uz prijavu ukupno 5 nuspojava.
English: For long-term prophylaxis against bleeding in patients with severe haemophilia B, the usual doses are 40 to 60 IU of factor IX per kilogram of body weight at intervals of 3 to 4 days for patients 12 years and older.
Croatian: Za dugotrajnu profilaksu krvarenja u bolesnika s teškom hemofilijom B uobičajene su doze 40 do 60 IU faktora IX po kilogramu tjelesne težine u razmacima od 3 do 4 dana za bolesnike u dobi od 12 godina i starije.
English: Insert the white plastic spike through the RIXUBIS stopper.
Croatian: Uvedite bijeli plastični šiljak kroz čep lijeka RIXUBIS.
English: Stop your infusion and contact your doctor immediately or seek emergency medical care if you experience early signs of hypersensitivity/allergic reactions like hives, rash, tightness of the chest, wheezing, low blood pressure or anaphylaxis (severe allergic reaction that can cause difficulty in swallowing and/or breathing, red or swollen face and/or hands).
Croatian: Prekinite svoju infuziju i odmah se javite liječniku ili potražite hitnu liječničku pomoć ako se pojave rani znakovi preosjetljivosti/alergijskih reakcija kao što su koprivnjača, osip, stezanje u prsištu, piskanje u plućima, sniženi krvni tlak ili anafilaksija (teška alergijska reakcija koja može uzrokovati poteškoće pri gutanju i/ili disanju, crveno ili otečeno lice i/ili ruke).
English: The recommended initial loading dose of RIXUBIS was to ensure that during surgery, factor IX activity levels of 80-100% for major surgeries and 30-60% for minor surgeries were maintained.
Croatian: Preporučena je početna udarna doza lijeka RIXUBIS kako bi se osiguralo da se tijekom zahvata održavaju razine aktivnosti faktora IX od 80-100% za velike kirurške zahvate i 30-60% za manje kirurške zahvate.
English: - For reconstitution use only the solvent and the reconstitution device (BAXJECT II) provided in the pack.
Croatian: Za rekonstituciju se smije koristiti samo otapalo i uređaj za rekonstituciju (BAXJECT II) koji su priloženi u pakiranju.
English: The risk is highest during the early phases of initial exposure to factor IX concentrates in previously untreated patients (PUPs), in particular in patients with high-risk gene mutations.
Croatian: Rizik je najveći tijekom ranih faza početnog izlaganja koncentratu faktora IX u prethodno neliječenih bolesnika, osobito u bolesnika s visokorizičnim genskim mutacijama.
English: Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Croatian: Hemofilija B spolno je vezani nasljedni poremećaj koagulacije krvi zbog smanjenih razina faktora IX te dovodi do obilnog krvarenja u zglobovima, mišićima ili unutarnjim organima, bilo spontano ili uzrokovano slučajnom ili kirurškom traumom.
English: A randomised, blinded, controlled, crossover pharmacokinetic study of RIXUBIS and a comparator was conducted in non-bleeding male subjects (≥15 years of age) as part of the combined phase 1/3 pivotal study.
Croatian: Randomizirano, slijepo, kontrolirano, ukriženo, farmakokinetičko ispitivanje lijeka RIXUBIS i usporednog lijeka provedeno je na muškim ispitanicima koji ne krvare (≥15 godina starosti) kao dio kombiniranog pivotalnog ispitivanja faze 1/3.
English: One International Unit of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.
Croatian: Jedna internacionalna jedinica aktivnosti faktora IX odgovara količini faktora IX u jednom ml normalne ljudske plazme.
English: Nonacog gamma (recombinant coagulation factor IX) is a single-chain purified glycoprotein that has 415 amino acids.
Croatian: Nonakog gama (rekombinantni faktor zgrušavanja IX) je jednolančani prošišćeni glikoprotein koji se sastoji od 415 aminokiselina.
English: Degree of haemorrhage/Type of surgical procedure
Croatian: Stupanj krvarenja/vrsta kirurškog zahvata
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Croatian: Postoji potencijalni rizik od tromboembolijskih epizoda nakon primjene lijekova koji sadrže faktor IX, uz povećan rizik uz pripravke niske čistoće.
English: RIXUBIS is indicated in patients of all age groups.
Croatian: RIXUBIS je indiciran u bolesnika svih dobnih skupina.
English: This should be taken into consideration if the patient is on a controlled sodium diet.
Croatian: To je potrebno uzeti u obzir ako je bolesnik na dijeti s kontroliranim unosom natrija.
English: More extensive haemarthrosis, muscle bleeding or haematoma
Croatian: Opsežnija hemartroza, krvarenje u mišiću ili hematom
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Croatian: Ako je potreban centralni venski kateter, potrebno je uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom, uključujući lokalne infekcije, bakterijemiju i trombozu na mjestu uvođenja katetera.
English: To ensure that the desired factor IX activity plasma level has been attained, careful monitoring using an appropriate factor IX activity assay is advised and, if necessary, appropriate adjustments to the dose and the frequency of repeated infusions should be performed.
Croatian: Kako bi se osiguralo postizanje željene razine aktivnosti faktora IX u plazmi, savjetuje se pažljivo praćenje pomoću odgovarajućeg testa aktivnosti faktora IX te, u slučaju potrebe, potrebno je izvršiti odgovarajuće prilagodbe doze i učestalosti ponovljenih infuzija.
English: Haemostatic efficacy at resolution of a bleed was rated excellent or good in 96.2% of all treated bleeding episodes.
Croatian: Hemostatska djelotvornost pri zaustavljanju krvarenja ocijenjena je izvrsno ili dobro u 96,2% svih liječenih epizoda krvarenja.
English: Prophylaxis and control of bleeding in PTPs below 12 years:
Croatian: Profilaksa i kontrola krvarenja u prethodno liječenih bolesnika mlađih od 12 godina:
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: Pri korištenju in vitro jednofaznog testa zgrušavanja temeljenom na tromboplastinskom vremenu (aPTV) za određivanje aktivnosti faktora IX u uzorcima krvi bolesnika, na rezultate aktivnost faktora IX u plazmi mogu znatno utjecati vrsta aPTV reagensa i referentni standard koji se koristi u testu.
English: The solution should be clear or slightly opalescent.
Croatian: Otopina mora biti bistra ili blago opalescentna.
English: Depending on body weight and Posology of RIXUBIS, patients could receive more than one vial.
Croatian: Ovisno o tjelesnoj težini i doziranju lijeka RIXUBIS, bolesnici mogu primiti više od jedne bočice lijeka.
English: Exposure Day 1 (N=73)
Croatian: 1. dan izloženosti (N=73)
English: Do not use this medicine after the expiry date which is stated on the outer box and vial label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici na bočici iza Rok valjanosti.
English: The pharmacokinetic evaluation was repeated for RIXUBIS in an open-label, uncontrolled study with RIXUBIS in male subjects who participated in the initial PK crossover study and had received prophylaxis with RIXUBIS for 26±1 weeks (mean ± SD) and accumulated at least 30 exposure days (EDs) to RIXUBIS.
Croatian: Farmakokinetička procjena ponovljena je za lijek RIXUBIS u otvorenom, nekontroliranom ispitivanju s lijekom RIXUBIS na muškim ispitanicima koji su sudjelovali u početnom farmakokinetičkom, ukriženom ispitivanju i koji su primili profilaksu s lijekom RIXUBIS tijekom 26±1 tjedna (srednja vrijednost ± SD) i prikupili barem 30 dana izloženosti lijeku RIXUBIS.
English: There have been reports in the literature showing an association between the occurrence of a factor IX inhibitor and allergic reactions, in particular in patients with a high-risk gene mutation.
Croatian: Postoje izvješća u literaturi koja pokazuju povezanost između pojave inhibitora faktora IX i alergijskih reakcija, osobito u bolesnika s visokorizičnim genskim mutacijama.
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Croatian: Postoje izvješća u literaturi koja pokazuju korelaciju između pojave inhibitora faktora IX i alergijskih reakcija.
English: Open the package of BAXJECT II device by peeling away the paper lid without touching the inside (Fig. a).
Croatian: Otvorite pakiranje uređaja BAXJECT II tako da uklonite papirnati pokrov ne dirajući unutrašnjost (Sl. a).
English: RIXUBIS Repeat Evaluation (N=23)
Croatian: Ponovljena procjena (N=23)
English: Dose and duration of the substitution therapy depends on the severity of the factor IX deficiency, on the location and extent of the bleeding, and on the patient's clinical condition, age and pharmacokinetic parameters of factor IX, such as incremental recovery and half-life.
Croatian: Doza i trajanje nadomjesne terapije ovisi o težini nedostatka faktora IX, o mjestu i opsegu krvarenja, i o kliničkom stanju bolesnika, dobi i farmakokinetičkim parametrima faktora IX, poput prirasta po jedinici doze i poluvijeka.
English: Area under the plasma concentration-time curve from time 0-72 hours post-infusion.
Croatian: Površina ispod krivulje koncentracija u plazmi-vrijeme u razdoblju od 0 do 72 sata nakon infuzije.
English: 6 - < 12 years (N=12)
Croatian: 6 - < 12 godina (N=12)
English: Prophylaxis and control of bleeding in previously treated patients 12 years and older The efficacy of RIXUBIS has been evaluated in the open-label, uncontrolled part of a combined phase 1/3 study, in which a total of 73 male, previously treated patients (PTPs) between 12 and 59 years of age received RIXUBIS either for prophylaxis and/or for the treatment of bleeding episodes on an on-demand basis.
Croatian: Profilaksa i kontrola krvarenja u prethodno liječenih bolesnika u dobi od 12 godina i starijih Djelotvornost lijeka RIXUBIS procijenjena je u otvorenom, nekontroliranom dijelu kombiniranog ispitivanja faze 1/3, u kojem je ukupno 73 muških, prethodno liječenih bolesnika u dobi između 12 i 59 godina starosti dobilo RIXUBIS bilo za profilaksu i/ili za liječenje epizoda krvarenja temeljem iskazane potrebe.
English: Haemostatic efficacy at resolution of bleed was rated excellent or good in 96% of all treated bleeding episodes.
Croatian: Hemostatska djelotvornost pri zaustavljanju krvarenja ocijenjena je izvrsno ili dobro u 96% svih liječenih epizoda krvarenja.
English: The median ABR was 2.0, for spontaneous bleeds 0.0 and for joint bleeds 0.0.
Croatian: Medijan godišnje stope krvarenja bio je 2,0, za spontana krvarenja 0,0, a za krvarenja zglobova 0,0.
English: Use the reconstituted solution immediately.
Croatian: Pripremljena otopina mora se odmah upotrijebiti.
English: Fig. a
Croatian: Sl. a
English: Fig. e
Croatian: Sl. e
English: The vacuum will draw the solvent into the RIXUBIS vial (Fig. c).
Croatian: Vakuum će uvući otapalo u bočicu s lijekom RIXUBIS (Sl. c).
English: Single use injection.
Croatian: Injekcija za jednokratnu primjenu.
English: The pharmacokinetic parameters were calculated from factor IX activity measurements in blood samples obtained up to 72 hours following the infusion.
Croatian: Farmakokinetički parametri su izračunati iz mjerenja aktivnosti faktora IX u krvnim uzorcima uzetima i do 72 sata nakon infuzije.
English: The pharmacokinetic parameters were calculated from factor IX activitiy measurements in blood samples obtained up to 72 hours following each infusion.
Croatian: Farmakokinetički parametri su izračunati iz mjerenja aktivnosti faktora IX u krvnim uzorcima uzetima i do 72 sata nakon svake infuzije.
English: Breast-feeding It is unknown whether Factor IX/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se faktor IX/metaboliti u majčino mlijeko.
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: Korištenje lijekova koji zadrže faktor IX niske čistoće povezano je s pojavama infarkta miokarda, diseminirane intravaskularne koagulacije, venske tromboze i plućne embolije.
English: Reconstitution Use Aseptic Technique
Croatian: Rekonstitucija Koristiti aseptičku tehniku.
English: Solvent vial: 5 ml sterilised water for injections.
Croatian: Bočica otapala: 5 ml sterilizirane vode za injekcije.
English: Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Fig. e).
Croatian: Uvucite rekonstituiranu otopinu u štrcaljku polagano izvlačeći klip (Sl. e).
English: The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
Croatian: Broj primijenjenih jedinica faktora IX izražava se u internacionalnim jedinicama (IU), koje su povezane s važećim standardom Svjetske zdravstvene organizacije za lijekove s faktorom IX.
English: Pharmacokinetic parameters for evaluable subjects (per-protocol analysis) are presented in the table below.
Croatian: Farmakokinetički parametri za ispitanike koji se mogu procijeniti (analiza prema planu ispitivanja) navedeni su u donjoj tablici.
English: During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Croatian: Tijekom trajanja liječenja, odgovarajuće određivanje razina vrijednosti faktora IX savjetuje se kao vodič za dozu koju treba primijeniti i učestalost ponavljanja infuzija.
English: With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device.
Croatian: S uređajem BAXJECT II pričvršćenom na bočicu s otapalom, okrenite sustav tako da bočica s otapalom bude na vrhu uređaja.
English: Do not remove the blue cap from the BAXJECT II device.
Croatian: Nemojte skidati plavi zatvarač s uređaja BAXJECT II.
English: Calculated as (C30min-baseline factor IX) divided by the dose in IU/kg, where C30min is the factor IX measurement 30 minutes after infusion.
Croatian: Izračunat kao (C30 min faktora IX na početku) podijeljen s dozom u IU/kg, gdje je C30 min mjerenje vrijednosti faktora IX 30 minuta nakon infuzije.
English: Haemostasis was maintained throughout the study duration.
Croatian: Tijekom trajanja ispitivanja održavana je hemostaza.
English: Mannitol Sodium chloride Calcium chloride L-Histidine Polysorbate 80
Croatian: Prašak saharoza manitol natrijev klorid kalcijev klorid L-histidin polisorbat 80
English: Prophylaxis:
Croatian: Profilaksa:
English: All (N=23)
Croatian: Svi (N=23)
English: How to use RIXUBIS
Croatian: Kako primjenjivati RIXUBIS
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: Rijetko su opaženi preosjetljivost ili alergijske reakcije (koje mogu uključivati angioedem, peckanje i probadanje na mjestu infuzije, zimicu, navale crvenila, osip, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje i piskanje u plućima) koje u nekim slučajevima mogu napredovati do teške anafilaksije (uključujući šok).
English: Date of first authorisation: 19 December 2014 Date of latest renewal: DD month YYYY
Croatian: Datum posljednje obnove odobrenja: DD mjesec GGGG
English: Administration Use Aseptic Technique
Croatian: Koristiti aseptičku tehniku.
English: Incremental recovery 30 minutes after infusion was determined for all subjects in the combined phase 1/3 study at exposure day 1, at their week 5, 13, and 26 visits, and at the time of study completion or termination, if it did not coincide with the week 26 visit.
Croatian: Inkrementalni oporavak 30 minuta nakon infuzije određen je za sve ispitanike u kombiniranom ispitivanju faze 1/3 1. dana izloženosti, pri njihovim posjetima u 5., 13. i 26. tjednu, te u vrijeme završetka ili prekida ispitivanja, ako se ono nije poklopilo s posjetom u 26. tjednu.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Croatian: Bolesnici moraju biti informirani o ranim znakovima reakcija preosjetljivosti uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsištu, piskanje u plućima, hipotenziju i anafilaksiju.
English: - The other ingredients in the powder are sucrose, mannitol, sodium chloride, calcium chloride, L-histidine, polysorbate 80.
Croatian: - Drugi sastojci praška su saharoza, manitol, natrijev klorid, kalcijev klorid, L-histidin, polisorbat 80.
English: The mean (± SD) and median dose of RIXUBIS in the full analysis set (n=23) was 75.50 ± 3.016 and 75.25 IU/kg, respectively, with a range of 70.0 to 83.6 IU/kg.
Croatian: Srednja vrijednost (± SD) i medijan doze lijeka RIXUBIS u obavljenoj cjelovitoj analizi (n=23) iznosili su 75,50 ± 3,016 odnosno 75,25 IU/kg, uz raspon od 70,0 do 83,6 IU/kg.
English: Week 5 (N=71)
Croatian: 5. tjedan (N=71)
English: Such reactions may include burning sensations and stinging at the infusion site, chills, flushing, lethargy, restlessness, tingling, hives, itching and rash, low blood pressure, fast heart rate, tightness of the chest, wheezing, swelling of the throat, anaphylaxis (severe allergic reaction), headache, nausea and vomiting.
Croatian: Te reakcije mogu uključivati osjećaj peckanja i probadanje na mjestu infuzije, zimicu, navale crvenila, bezvoljnost, nemir, trnce, koprivnjaču, svrbež i osip, sniženi krvni tlak, ubrzan puls, stezanje u prsištu, piskanje u plućima, oticanje grla, anafilaksiju (tešku alergijsku reakciju), glavobolju, mučninu i povraćanje.
English: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Croatian: Liječenje i profilaksa krvarenja u bolesnika s hemofilijom B (prirođeni nedostatak faktora IX).
English: Do not use solution that are cloudy or have deposits.
Croatian: Nemojte koristiti otopinu koja je mutna ili ima naslage.
English: Patients with factor IX inhibitors may be at an increased risk of anaphylaxis during future treatment with factor IX.
Croatian: Bolesnici s inhibitorima faktora IX mogu biti pod povećanim rizikom od anafilaksije tijekom budućeg liječenja faktorom IX.
English: Incremental recovery 30 minutes after infusion was determined for all subjects in the combined phase 2/3 study at the initial pharmacokinetic evaluation (exposure day 1), at week 5, 13, and 26 visits, and at the time of study completion or termination, if it did not coincide with the week 26 visit.
Croatian: Inkrementalni oporavak 30 minuta nakon infuzije određen je za sve ispitanike u kombiniranom ispitivanju faze 2/3 pri početnoj farmakokinetičkoj procjeni (1. dan izloženosti), pri posjetima u 5., 13. i 26. tjednu, te u vrijeme završetka ili prekida ispitivanja, ako se ono nije poklopilo s posjetom u 26. tjednu.
English: RIXUBIS is to be administered intravenously after reconstitution of the powder with the provided solvent.
Croatian: RIXUBIS se primjenjuje intravenski nakon rekonstitucije praška s priloženim otapalom.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava disgeuzija često
English: Hypersensitivity Allergic type reactions have been manifested by dyspnoea, pruritus, generalised urticaria and rash.
Croatian: Preosjetljivost Reakcije alergijskog tipa očitovale su se kao dispneja, svrbež, generalizirana urtikarija i osip.
English: = body weight (kg) x desired factor IX rise (%) or (IU/dL)
Croatian: x željeni porast faktora IX (%) ili (IU/dl)
English: RIXUBIS contains recombinant coagulation factor IX (nonacog gamma).
Croatian: RIXUBIS sadrži rekombinantni koagulacijski faktor IX (nonakog gama).
English: Grip the package at its edge and pull the package off BAXJECT II (Fig. b).
Croatian: Primite pakiranje za rub i skinite pakiranje s uređaja BAXJECT II (Sl. b).
English: The following side effects have been observed with RIXUBIS:
Croatian: Sljedeće su nuspojave zabilježene uz RIXUBIS.
English: Incremental recovery for RIXUBIS 30 minutes after infusion, paediatric patients 6 to < 12 years:
Croatian: Inkrementalni oporavak za RIXUBIS 30 minuta nakon infuzije, pedijatrijski bolesnici 6 do < 12 godina:
English: < 6years (N=11)
Croatian: < 6 godina (N=11)
English: RIXUBIS 250 IU powder and solvent for solution for injection
Croatian: RIXUBIS 250 IU prašak i otapalo za otopinu za injekciju
English: Allergic-type hypersensitivity reactions are possible with RIXUBIS.
Croatian: Moguće su reakcije preosjetljivosti alergijskog tipa na RIXUBIS.