FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Varnost in učinkovitost v perioperativnem okolju so ocenili v prospektivni, nezaslepljeni, nekontrolirani, multicentrični študiji zdravila RIXUBIS v 3. fazi pri preiskovancih moškega spola s hudo ali zmerno hemofilijo B, ki so že bili zdravljeni.
English: Degree of haemorrhage/Type of surgical procedure
Slovenian: Stopnja krvavitve/vrsta kirurškega posega
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor IX.
Slovenian: Farmakoterapevtska skupina: antihemoragiki, koagulacijski faktor IX.
English: Of a total of 249 bleeding episodes, 163 were moderate, 71 were minor, and 15 were major.
Slovenian: Od skupno 249 epizod krvavitev je bilo 163 krvavitev zmernih, 71 manjših krvavitev in 15 obsežnih krvavitev.
English: AUCinf (IU.hr/dL)
Slovenian: AUCnesk (i.e.h/dl)
English: 24 subjects (42.9%) experienced zero bleeds.
Slovenian: Pri 24 preiskovancih (42,9 %) ni bilo krvavitev.
English: Patients less than 12 years:
Slovenian: Bolniki, mlajši od 12 let:
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.
Slovenian: V literaturi so objavljena poročila o povezavi med pojavnostjo zaviralca faktorja IX in alergijskimi reakcijami, zlasti pri bolnikih z gensko mutacijo z velikim tveganjem.
English: - For administration the use of a luer-lock syringe is required.
Slovenian: - Za uporabo potrebujete brizgo z luer lock nastavkom.
English: Nonacog gamma (recombinant coagulation factor IX) is a single-chain purified glycoprotein that has 415 amino acids.
Slovenian: Nonakog gama (rekombinantni koagulacijski faktor IX) je enoverižni, prečiščen glikoprotein iz 415 aminokislin.
English: All subjects had severe (factor IX level <1%) or moderately severe (factor IX level ≤2%) haemophilia B. All 23 subjects received prophylactic treatment with RIXUBIS for a minimum of 3 months and were included in the efficacy evaluation for prophylaxis.
Slovenian: Vsi preiskovanci so imeli hudo (raven faktorja IX < 1 %) ali zmerno hudo (raven faktorja IX ≤ 2 %) hemofilijo B. Vseh 23 preiskovancev je vsaj 3 mesece prejemalo zdravilo RIXUBIS za profilakso in je bilo vključenih v oceno učinkovitosti profilakse.
English: Solvent vial: 5 ml sterilised water for injections.
Slovenian: Viala z vehiklom: 5 ml sterilizirane vode za injekcije.
English: Area under the plasma concentration-time curve from time 0-72 hours post-infusion.
Slovenian: Površina pod krivuljo odvisnosti plazemske koncentracije od časa od 0 do 72 ur po infuziji.
English: 6 - < 12 years (N=12)
Slovenian: 6 - < 12 let (N = 12)
English: Name and address of the manufacturers responsible for batch release
Slovenian: Imena in naslovi proizvjalcev, odgovornih za sproščanje serij
English: Pharmacokinetic parameters for all subjects (full analysis set) are presented in the table below.
Slovenian: V spodnji preglednici so prikazani farmakokinetični parametri za vse preiskovance (polni nabor podatkov za analizo).
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Neželeni učinki so v spodnji preglednici prikazani po razvrstitvi organskih sistemov MedDRA (organskih sistemih in prednostnih izrazih).
English: With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device.
Slovenian: Zdaj ko je pripomoček BAXJECT II nameščen na viali z vehiklom, sistem obrnite tako, da je viala z vehiklom zgoraj.
English: Treatment with RIXUBIS will be started by a doctor who is experienced in the care of patients with haemophilia B.
Slovenian: Zdravljenje z zdravilom RIXUBIS bo uvedel zdravnik z izkušnjami pri obravnavi bolnikov s hemofilijo B.
English: RIXUBIS is used in patients with haemophilia B (Christmas disease, an inherited bleeding disorder caused by lack of factor IX).
Slovenian: Zdravilo RIXUBIS uporabljajo bolniki s hemofilijo B (Christmasova bolezen, prirojena motnja strjevanja krvi, ki je posledica pomanjkanja faktorja IX).
English: The pharmacokinetic parameters were calculated from factor IX activitiy measurements in blood samples obtained up to 72 hours following each infusion.
Slovenian: Farmakokinetične parametre so izračunali iz meritev aktivnosti faktorja IX v vzorcih krvi, odvzetih do 72 ur po vsaki infuziji.
English: Your doctor will decide the dose of RIXUBIS you will receive.
Slovenian: O odmerku zdravila RIXUBIS, ki ga boste prejemali, bo presodil zdravnik.
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.
Slovenian: Profilaksa in obvladovanje krvavitev pri predhodno zdravljenih bolnikih, starih 12 let in več Učinkovitost zdravila RIXUBIS je bila ocenjena v nezaslepljenem, nekontroliranem delu kombinirane študije faze 1/3, v katero je bilo vključenih skupno 73 predhodno zdravljenih preiskovancev moškega spola, starih od 12 do 59 let, ki so prejeli zdravilo RIXUBIS za profilakso in/ali za zdravljenje epizod krvavitev po potrebi.
English: What RIXUBIS looks like and contents of the pack
Slovenian: Izgled cepiva RIXUBIS in vsebina pakiranja
English: At study completion/ termination b
Slovenian: Zaključek / prekinitev študije b
English: The pharmacokinetic parameters were calculated from factor IX activity measurements in blood samples obtained up to 72 hours following the infusion.
Slovenian: Farmakokinetične parametre so izračunali iz meritev aktivnosti faktorja IX v vzorcih krvi, odvzetih do 72 ur po infuziji.
English: The solution should be administered slowly, at a rate as determined by the patient's comfort level, not to exceed 10 ml per minute.
Slovenian: Raztopino je treba dajati počasi, s hitrostjo, ki zagotavlja ugodje bolnika, in sicer največ 10 ml na minuto.
English: Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Slovenian: Odziv na faktor IX se lahko razlikuje pri posameznih bolnikih, kar se kaže z različnimi razpolovnimi dobami in zvečanjem aktivnosti.
English: RIXUBIS was well tolerated in single dose and repeated dose toxicity studies conducted in mice, rats and cynomolgus monkeys up to doses of 7500 IU/kg (single dose) and 750 IU/kg (repeated application).
Slovenian: V študijah toksičnosti enkratnih in večkratnih odmerkov so miši, podgane in makaki Macaca fascicularis dobro prenašali zdravilo RIXUBIS do odmerkov 7500 i.e./kg (enkratni odmerek) oz. 750 i.e./kg (večkratna uporaba).
English: Grip the package at its edge and pull the package off BAXJECT II (Fig. b).
Slovenian: Ovojnino primite na robu in jo snemite s pripomočka BAXJECT II (slika b).
English: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Slovenian: Zdravljenje in profilaksa krvavitev pri bolnikih s hemofilijo B (prirojeno pomanjkanje faktorja IX).
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.
Slovenian: Izračunano kot (C30 min - izhodiščni faktor IX), deljeno z odmerkom v i.e./kg, pri čemer je C30 min vrednost meritve faktorja IX 30 minut po infuziji.
English: Pharmacokinetic parameters for evaluable subjects (per-protocol analysis) are presented in the table below.
Slovenian: V spodnji preglednici so prikazani farmakokinetični parametri za preiskovance, ki jih je bilo možno oceniti (analiza po protokolu).
English: This dose and duration will depend on the severity of your factor IX deficiency, on the location and extent of the bleeding and on your clinical condition, age and how quickly your body uses up factor IX which will have to be checked regularly.
Slovenian: Odmerek zdravila in trajanje zdravljenja sta odvisna od resnosti pomanjkanja faktorja IX, mesta in obsega krvavitve, vašega kliničnega stanja, starosti in hitrosti, s katero vaše telo porablja faktor IX, kar je treba redno preverjati.
English: Factor IX level required (%) or (IU/dL)
Slovenian: Potrebna raven faktorja IX (%) ali (i.e./dl)
English: Prophylaxis:
Slovenian: Profilaksa:
English: < 6years (N=11)
Slovenian: <6 let (N = 11)
English: RIXUBIS contains sodium
Slovenian: Zdravilo RIXUBIS vsebuje natrij
English: The data demonstrate that the incremental recovery is consistent over time (see table below).
Slovenian: Podatki kažejo, da je porast aktivnosti faktorja IX po odmerku stalen skozi čas (glejte preglednico v nadaljevanju).
English: All subjects had severe (factor IX level <1%) or moderately severe (factor IX level ≤2%) haemophilia B. Fifty-nine PTPs received RIXUBIS for prophylaxis.
Slovenian: Vsi preiskovanci so imeli hudo (raven faktorja IX < 1 %) ali zmerno hudo (raven faktorja IX ≤ 2 %) hemofilijo B. Devetinpetdeset predhodno zdravljenih bolnikov je prejelo zdravilo RIXUBIS za profilakso.
English: Of the 26 bleeding episodes, 15 were minor, 9 moderate, and 2 major.
Slovenian: Od 26 epizod krvavitev je bilo 15 manjših krvavitev, 9 zmernih krvavitev in 2 obsežni krvavitvi.
English: - The other ingredients in the powder are sucrose, mannitol, sodium chloride, calcium chloride, L-histidine, polysorbate 80.
Slovenian: - Druge sestavine (pomožne snovi) v prašku so saharoza, manitol, natrijev klorid, kalcijev klorid, L-histidin, polisorbat 80.
English: Mannitol Sodium chloride Calcium chloride L-Histidine Polysorbate 80
Slovenian: Prašek saharoza manitol natrijev klorid kalcijev klorid L-histidin polisorbat 80
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Slovenian: Njihov nastanek se pokaže v obliki nezadostnega kliničnega odziva na zdravljenje.
English: Previously treated patients 12 years and older:
Slovenian: Predhodno zdravljeni bolniki, stari 12 let in več:
English: RIXUBIS was administered by bolus infusions.
Slovenian: Zdravilo RIXUBIS je bilo dano z bolusno infuzijo.
English: The same table as for adults can be used to guide dosing in bleeding episodes and surgery (see above).
Slovenian: Kot vodilo odmerjanja pri epizodah krvavitev in kirurških posegih lahko uporabimo enako preglednico kot za odrasle (glejte zgoraj).
English: The median ABR on prophylaxis with RIXUBIS for all bleeds was 2.0, for spontaneous bleeds 0.0, and for joint bleeds 0.0.
Slovenian: Mediana vrednost ABR za profilakso z zdravilom RIXUBIS je bila 2,0 za vse krvavitve, 0,0 za spontane krvavitve in 0,0 za krvavitve v sklepe.
English: Your doctor may also do a blood test to check if you have developed activity-neutralising antibodies
Slovenian: Zdravnik bo morda opravil tudi preiskavo krvi, da preveri, ali so se pri vas pojavila protitelesa, ki nevtralizirajo aktivnost zdravila RIXUBIS (zaviralci).
English: Week 5 (N=71)
Slovenian: 5. teden (N = 71)
English: Single use injection.
Slovenian: Samo za enkratno injiciranje.
English: The following side effects have been observed with RIXUBIS:
Slovenian: Pri uporabi zdravila RIXUBIS so se pojavili naslednji stranski učinki:
English: VIAL LABEL FOR THE POWDER
Slovenian: NALEPKA NA VIALI S PRAŠKOM
English: However, depending on your body weight and your dose of RIXUBIS, you could receive more than one vial.
Slovenian: Glede na telesno maso in odmerjanje zdravila RIXUBIS lahko prejmete več kot eno vialo.
English: Calculated as (Cmax-baseline factor IX) divided by the dose in IU/kg, where Cmax is the maximal post-infusion factor IX measurement.
Slovenian: Izračunano kot (Cmax - izhodiščni faktor IX), deljeno z odmerkom v i.e./kg, pri čemer je Cmax največja vrednost meritve faktorja IX po infuziji.
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.
Slovenian: Za dolgoročno profilakso krvavitev pri bolnikih s hudo hemofilijo B, starih 12 let ali več, običajno uporabljamo odmerke od 40 do 60 i.e. faktorja IX na kg telesne mase na vsake 3 do 4 dni.
English: Insert the white plastic spike through the RIXUBIS stopper.
Slovenian: Belo plastično konico uvedite skozi zamašek viale s praškom RIXUBIS.
English: Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by factor VII/tissue factor complex in the extrinsic pathway.
Slovenian: V intrinzični koagulacijski poti je faktor IX aktiviran s faktorjem XIa, v ekstrinzični koagulacijski poti pa s kompleksom faktorja VII in tkivnega faktorja.
English: Contents: 1 powder vial, 1 solvent vial, 1 BAXJECT II device
Slovenian: Prašek in vehikel za raztopino za injiciranje Vsebina: 1 viala s praškom, 1 viala z vehiklom, 1 pripomoček BAXJECT II
English: Fertility There is no information on the effects of factor IX on fertility.
Slovenian: Plodnost O učinku rekombinantnega faktorja IX na plodnost ni podatkov.
English: It works by replacing the missing factor IX to enable the patient's blood to clot.
Slovenian: Zdravilo RIXUBIS deluje tako, da nadomesti manjkajoči faktor IX in omogoči strjevanje bolnikove krvi.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Slovenian: Bolnike morate poučiti o zgodnjih znakih preobčutljivosti, vključno s koprivnico, generalizirano urtikarijo, tiščanjem v prsih, oteženim dihanjem, hipotenzijo in anafilakso.
English: Administration Use Aseptic Technique
Slovenian: Uporaba Uporabljajte aseptično tehniko.
English: Mean±SD Median (range)
Slovenian: Povprečje ± SD Mediana (razpon)
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.
Slovenian: Pri določanju aktivnosti faktorja IX v krvi bolnikov z in vitro enostopenjskim testom strjevanja na osnovi aktiviranega parcialnega tromboplastinskega časa (aPTČ), lahko na aktivnost faktorja IX v plazmi pomembno vplivata tako vrsta reagenta za aPTČ kot tudi referenčni standard, ki se uporablja v testu.
English: By replacement therapy the plasma levels of factor IX is increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Slovenian: Z nadomestnim zdravljenjem povečamo plazemsko koncentracijo faktorja IX in tako omogočimo začasno odpravo pomanjkanja tega faktorja in zmanjšamo nagnjenost bolnika h krvavitvam.
English: Cleanse stoppers with alcohol swabs.
Slovenian: Zamaška očistite z zložencem, omočenim z alkoholom.
English: All patients were dosed based on their most recent individual incremental recovery.
Slovenian: Odmerjanje pri vseh bolnikih je temeljilo na njihovem nedavnem individualnem porastu aktivnosti faktorja IX po odmerku.
English: Reconstituted medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Rekonstituirana zdravila je treba pred uporabo pregledati glede prisotnosti delcev in sprememb barve.
English: Exposure Day 1 (N=73)
Slovenian: 1. dan izpostavitve (N = 73)
English: Excipients: sodium chloride, sucrose, calcium chloride, histidine, mannitol, polysorbate 80.
Slovenian: Pomožne snovi: natrijev klorid, saharoza, kalcijev klorid, histidin, manitol, polisorbat 80.
English: The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
Slovenian: Število danih enot faktorja IX izražamo v mednarodnih enotah (i.e.), skladno z veljavnim standardom SZO za pripravke faktorja IX.
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Slovenian: V zelo redkih primerih so v povezavi s preobčutljivostnimi reakcijami opazili pojav protiteles proti proteinom hrčka.
English: You or somebody else might also administer RIXUBIS as an injection but only after receiving adequate training.
Slovenian: Po ustreznem usposabljanju si lahko zdravilo RIXUBIS kot injekcijo dajete sami ali vam jo da kdo drug.
English: Connect the syringe to BAXJECT II (Fig. d).
Slovenian: Brizgo privijte na pripomoček BAXJECT II (slika d).
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.
Slovenian: Porast aktivnosti faktorja IX po odmerku 30 minut po infuziji so določili za vse preiskovance v kombinirani študiji faze 1/3 na 1. dan izpostavitve, 5., 13. in 26. teden ter na koncu študije ali ob prekinitvi sodelovanja, če se to ni ujemalo s 26. tednom.
English: Incremental recovery 30 min after infusion (IU/dL: IU/kg)a
Slovenian: Porast aktivnosti faktorja IX po odmerku 30 min po infuziji (i.e./dl: i.e./kg)
English: RIXUBIS is to be administered intravenously after reconstitution of the powder with the provided solvent.
Slovenian: Zdravilo RIXUBIS se daje intravensko po rekonstituciji praška s priloženim vehiklom.
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.
Slovenian: Povprečje (± SD) odmerka zdravila RIXUBIS v polnem naboru protokolnih podatkov za analizo (n = 23) je bilo 75,50 ± 3,016 i.e./kg, mediana 75,25 i.e./kg, razpon pa od 70,0 do 83,6 i.e./kg.
English: The mean (± SD) and median dose of RIXUBIS in the per protocol analysis set (n=25) were 74.69±2.37 and 74.25 IU/kg, respectively, with a range of 71.27 to 79.38 IU/kg.
Slovenian: Povprečje (± SD) odmerka zdravila RIXUBIS v naboru protokolnih podatkov za analizo (n = 25) je bilo 74,69 ± 2,37 i.e./kg, mediana 74,25 i.e./kg, razpon pa od 71,27 do 79,38 i.e./kg.
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.
Slovenian: Med takšne reakcije sodijo pekoč občutek in zbadanje na mestu infundiranja zdravila, mrzlica, pordelost, letargija, nemirnost, mravljinčenje, koprivnica, srbenje in izpuščaj, nizek krvni tlak, pospešeno bitje srca, tiščanje v prsih, oteženo dihanje, otekanje žrela, anafilaksija (huda alergijska reakcija), glavobol, siljenje na bruhanje in bruhanje.
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.
Slovenian: Odmerek zdravila in trajanje nadomestne terapije sta odvisna od stopnje pomanjkanja faktorja IX, mesta in obsega krvavitve, bolnikovega kliničnega stanja, starosti in farmakokinetičnih parametrov faktorja IX, kot sta porast aktivnosti faktorja IX po odmerku in razpolovna doba.
English: All (N=23)
Slovenian: Vsi (N = 23)
English: Swirl gently until all material is dissolved.
Slovenian: Celoten sistem previdno vrtite, da se vsebina raztopi.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Slovenian: V redkih primerih so opazili preobčutljivostne ali alergijske reakcije (vključno z angioedemom, pekočim občutkom in zbadanjem na mestu infundiranja zdravila, mrzlico, pordelostjo, generalizirano urtikarijo, glavobolom, koprivnico, hipotenzijo, letargijo, siljenjem na bruhanje, nemirnostjo, tahikardijo, tiščanjem v prsih, ščemenjem, bruhanjem in težkim dihanjem), ki so v nekaterih primerih napredovale do hude anafilaksije (vključno s šokom).
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.
Slovenian: Porast aktivnosti faktorja IX po odmerku 30 minut po infuziji so določili za vse preiskovance v kombinirani študiji faze 2/3 ob začetni farmakokinetični oceni (na 1. dan izpostavitve), 5., 13. in 26. teden ter na koncu študije ali ob prekinitvi sodelovanja, če se to ni ujemalo s 26. tednom.
English: If symptoms of hypersensitivity occur, patients or their caregivers should be advised to discontinue use of the medicinal product immediately and contact their physician.
Slovenian: Bolnikom ali negovalcem morate naročiti, da nemudoma prekinejo uporabo zdravila in se posvetujejo z zdravnikom, če se pojavijo simptomi preobčutljivosti.
English: Week 26 (N=55)
Slovenian: 26. teden (N = 55)
English: RIXUBIS 250 IU powder and solvent for solution for injection RIXUBIS 500 IU powder and solvent for solution for injection RIXUBIS 1000 IU powder and solvent for solution for injection RIXUBIS 2000 IU powder and solvent for solution for injection RIXUBIS 3000 IU powder and solvent for solution for injection
Slovenian: RIXUBIS 250 i.e. prašek in vehikel za raztopino za injiciranje RIXUBIS 500 i.e. prašek in vehikel za raztopino za injiciranje RIXUBIS 1000 i.e. prašek in vehikel za raztopino za injiciranje RIXUBIS 2000 i.e. prašek in vehikel za raztopino za injiciranje RIXUBIS 3000 i.e. prašek in vehikel za raztopino za injiciranje
English: Careful monitoring of replacement therapy is especially important in cases of major surgery or life-threatening haemorrhages.
Slovenian: Posebej pri večjih kirurških posegih in smrtno nevarnih krvavitvah je zelo pomembno natančno spremljanje nadomestne terapije.
English: The potency (IU) is determined using the European Pharmacopoeia one stage clotting assay.
Slovenian: Aktivnost (i.e.) se določa z enostopenjskim testom strjevanja v skladu z Evropsko farmakopejo.
English: RIXUBIS did not cause any adverse clinical, respiratory, or cardiovascular effects up to 450 IU/kg in cynomolgus monkeys.
Slovenian: Pri makakih Macaca fascicularis zdravilo RIXUBIS ni povzročilo neželenih kliničnih, dihalnih ali srčno-žilnih učinkov do odmerka 450 i.e./kg.
English: Prophylaxis and control of bleeding in PTPs below 12 years:
Slovenian: Profilaksa in obvladovanje krvavitev pri predhodno zdravljenih bolnikih, starih do 12 let:
English: Only plastic luer-lock syringes should be used with this product.
Slovenian: Za zdravilo uporabljajte le plastične brizge z luer lock nastavkom.
English: Early haemarthrosis, muscle bleeding or oral bleeding
Slovenian: Zgodnja hemartroza, krvavitev v mišico ali krvavitev v ustno votlino
English: Hypersensitivity Allergic type reactions have been manifested by dyspnoea, pruritus, generalised urticaria and rash.
Slovenian: Preobčutljivost Alergijske reakcije so se pokazale z dispnejo, srbenjem, generalizirano urtikarijo in izpuščajem.
English: RIXUBIS 250 IU powder and solvent for solution for injection
Slovenian: RIXUBIS 250 i.e. prašek in vehikel za raztopino za injiciranje
English: Nervous system disorders
Slovenian: Bolezni živčevja disgevzija pogosti
English: In case of self-administration or administration by a caregiver appropriate training is needed.
Slovenian: Če si zdravilo daje bolnik sam ali mu ga daje negovalec, je potrebno ustrezno usposabljanje.