FrancophonIA/ELRC3.0 huggingface dataset:
English: Subjects were randomised to one of two blood sampling sequences to reduce the burden of frequent blood draws on the individual subjects.
Slovenian: Preiskovanci so bili randomizirani v eno od dveh zaporedij vzorčenja krvi, da se zmanjša obremenitev posameznega preiskovanca s pogostim jemanjem krvi.
English: Perioperative management:
Slovenian: Perioperativna uporaba:
English: What you need to know before you use RIXUBIS
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo RIXUBIS
English: Whenever possible, please record the name of the product and the batch number every time you use RIXUBIS (e.g. in your diary) to keep track of the products and product batches you have used.
Slovenian: Če je možno, vsakič ko uporabite zdravilo RIXUBIS, zabeležite ime in serijo zdravila (npr. v svoj dnevnik), da zagotovite sledljivost uporabljenih zdravil in njihovih serij.
English: One International Unit of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.
Slovenian: Ena mednarodna enota aktivnosti faktorja IX ustreza količini faktorja IX v enem ml normalne človeške plazme.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov proizvjalca biološke zdravilne učinkovine
English: Patients aged 12 to 17 years of age:
Slovenian: Bolniki, stari od 12 do 17 let:
English: Manufacturer
Slovenian: Proizvjalec
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Slovenian: Zdravljenje je treba uvesti pod nadzorom zdravnika, izkušenega v zdravljenju hemofilije.
English: No interactions of RIXUBIS with other medicines are known.
Slovenian: Medsebojno delovanje zdravila RIXUBIS z drugimi zdravili ni znano.
English: A total of 26 bleeding episodes were treated with RIXUBIS, of which 23 bleeds were due to injury, 2 spontaneous and 1 of unknown origin.
Slovenian: Z zdravilom RIXUBIS je bilo zdravljenih skupno 26 epizod krvavitev, od katerih je bilo 23 krvavitev zaradi poškodbe, 2 sta bili spontani in 1 neznanega izvora.
English: The data demonstrate that the incremental recovery is consistent over time across all paediatric age groups.
Slovenian: Podatki kažejo, da je porast aktivnosti faktorja IX po odmerku stalen skozi čas v vseh pediatričnih starostnih skupinah.
English: This should be taken into consideration if you are on a controlled sodium diet.
Slovenian: To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
English: Required units
Slovenian: Potrebno št. enot
English: An additional 14 PTPs received RIXUBIS for the treatment of bleeding episodes only.
Slovenian: Drugih 14 predhodno zdravljenih bolnikov je prejemalo zdravilo RIXUBIS samo za zdravljenje epizod krvavitev.
English: Volume of distribution at steady state
Slovenian: Porazdelitveni volumen v stanju dinamičnega ravnovesja
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.
Slovenian: Če je potreben centralni venski pristop (CVAD), se morate zavedati tveganja zapletov, povezanih s CVAD, med katere sodijo lokalne okužbe, bakteriemija in tromboza na mestu katetra.
English: If you suffer from liver or cardiac disease or if you have recently had major surgery, please inform your doctor, as there is an increased risk for blood clotting (coagulation) complications.
Slovenian: Obvestite zdravnika, če imate bolezen jeter ali srca ali ste pred kratkim prestali večji kirurški poseg, saj imate povečano tveganje za zaplete s strjevanjem krvi (koagulacijo).
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če se zdravilo ne uporabi takoj, je za trajanje hrambe med uporabo in pogoje pred uporabo odgovoren uporabnik.
English: Problems from exaggerated blood clotting (thromboembolic episodes) have not been observed with this product, but may occur with any factor IX products.
Slovenian: Težav s čezmernim strjevanjem krvi (tromboembolični dogodki) pri uporabi tega zdravila niso ugotovili, vendar se lahko pojavijo pri katerem koli pripravku faktorja IX.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Slovenian: Naslednjo preglednico lahko uporabimo kot vodilo odmerjanja pri epizodah krvavitev in kirurških posegih:
English: What RIXUBIS is and what it is used for What you need to know before you use RIXUBIS How to use RIXUBIS
Slovenian: Kaj je zdravilo RIXUBIS in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo RIXUBIS Kako uporabljati zdravilo RIXUBIS Možni neželeni učinki
English: • one BAXJECT II (needle-less reconstitution device)
Slovenian: • en pripomoček BAXJECT II (brezigelni pripomoček za rekonstitucijo).
English: Inject intravenously.
Slovenian: Zdravilo injicirajte intravensko.
English: Repeat infusion every 8 to 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor IX activity of 30% to 60% (IU/dl).
Slovenian: Infuzijo ponavljajte na vsakih 8 do 24 ur, dokler se rana zadostno ne zapre, nato nadaljujte s terapijo še najmanj 7 dni za vzdrževanje aktivnosti faktorja IX med 30 % in 60 %.
English: Continuous infusion Do not administer RIXUBIS by continuous infusion.
Slovenian: Kontinuirana infuzija Zdravila RIXUBIS ne dajajte s kontinuirano infuzijo.
English: RIXUBIS was not thrombogenic at a dose of 750 IU/kg in a rabbit stasis model (Wessler-Test).
Slovenian: Zdravilo RIXUBIS ni bilo trombogeno v odmerku 750 i.e./kg v modelu staze pri kuncih (Wesslerjev preskus).
English: RIXUBIS is used for the treatment and prevention of bleeding in patients with haemophilia B of all age groups.
Slovenian: Zdravilo RIXUBIS se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo B vseh starostnih skupin.
English: Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Fig. e).
Slovenian: Rekonstituirano raztopino povlecite v brizgo tako, da počasi povlečete bat (slika e).
English: Because of the risk of allergic reactions with factor IX concentrates, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Slovenian: Zaradi tveganja za nastanek alergijskih reakcij s koncentrati faktorja IX je treba dajanje začetnih odmerkov faktorja IX po presoji lečečega zdravnika izvajati pod zdravniškim nadzorom, kjer lahko zagotovimo ustrezno medicinsko oskrbo v primeru nastopa alergijskih reakcij.
English: In each of these situations, the benefit of treatment with RIXUBIS should be weighed against the risk of these complications.
Slovenian: V vsakem od teh primerov moramo pretehtati razmerje koristi in tveganja za nastanek zapletov pri zdravljenju z zdravilom RIXUBIS.
English: Subjects in the on-demand cohort had to have at least 12 documented bleeding episodes requiring treatment within 12 months prior to enrollment.
Slovenian: Preiskovanci v kohorti z zdravljenjem po potrebi so morali imeti v 12 mesecih pred vključitvijo vsaj 12 zabeleženih epizod krvavitev, ki so zahtevale zdravljenje.
English: Do not use RIXUBIS if the solution is not clear and colourless.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da raztopina ni bistra in brezbarvna.
English: Do not refrigerate the preparation after reconstitution.
Slovenian: Pripravka po rekonstituciji ne shranjujte v hladilniku.
English: Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin.
Slovenian: Aktivirani faktor IX in aktivirani faktor VIII skupaj aktivirata faktor X, ta pa pretvori protrombin v trombin.
English: Breast-feeding It is unknown whether Factor IX/metabolites are excreted in human milk.
Slovenian: Dojenje Ni znano, ali se faktor IX/presnovki izločajo v materino mleko.
English: Known allergic reaction to hamster protein.
Slovenian: Dokazana alergijska reakcija na proteine hrčka.
English: As for all patients, dose selection for an elderly patient should be individualised.
Slovenian: Kot pri vseh bolnikih je treba odmerjanje za starostnike individualno prilagoditi.
English: During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Slovenian: Med potekom zdravljenja je priporočljivo ustrezno določanje ravni faktorja IX, kot vodilo za določanje odmerka in pogostnosti ponavljajočih se infuzij.
English: Area under the plasma concentration-time curve from time 0 to infinity.
Slovenian: Ploščina pod krivuljo odvisnosti plazemske koncentracije od časa od 0 do neskončnosti.
English: The RIXUBIS dose range in the repeat pharmacokinetics study was 64.48 to 79.18 IU/kg (n=23).
Slovenian: Razpon odmerkov zdravila RIXUBIS v študiji ponavljajoče farmakokinetike je bil od 64,48 do 79,18 i.e./kg (n = 23).
English: However, no data are available on previously untreated patients as only previously treated patients have been enrolled in the clinical studies; no immunogenicity investigation on inhibitor development was therefore made in this at risk population.
Slovenian: Vendar ni razpoložljivih podatkov o predhodno nezdravljenih bolnikih, ker so bili v klinične študije vključeni le predhodno zdravljeni bolniki.
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).
Slovenian: Aktivnost faktorja IX v plazmi je izražena v odstotkih (glede na običajno človeško plazmo) ali v mednarodnih enotah (glede na mednarodni standard za faktor IX v plazmi).
English: These may include heart attack, blood clots in the veins or blood clots in the lung.
Slovenian: Med te dogodke sodijo srčni infarkt, krvni strdki v venah ali krvni strdki v pljučih.
English: RIXUBIS has no influence on the ability to drive and use machines.
Slovenian: Zdravilo RIXUBIS nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: A total of 249 bleeding episodes were treated with RIXUBIS, of which 197 were joint bleeds and 52 non-joint bleeds (soft tissue, muscle, body cavity, intracranial and other).
Slovenian: Z zdravilom RIXUBIS je bilo zdravljenih skupno 249 epizod krvavitev, od katerih je bilo 197 krvavitev v sklepe in 52 drugačnih krvavitev (mehko tkivo, mišice, telesna votlina, intrakranialno in drugo).
English: 19 bleeds were non-joint (soft tissue, muscle, body cavity, intracranial and other) and 7 were joint bleeds of which 1 was a bleed into a target joint.
Slovenian: 19 krvavitev je bilo izvensklepnih (mehko tkivo, mišice, telesna votlina, interkranialno in drugo), 7 krvavitev pa v sklepe, od katerih je bila 1 krvavitev v ciljni sklep.
English: Haemostasis was maintained throughout the study duration.
Slovenian: Tekom študije je bila hemostaza ohranjena.
English: RIXUBIS Repeat Evaluation (N=23)
Slovenian: RIXUBIS Ponovna ocena (N = 23)
English: AUC0-72h (IU.hr/dL)
Slovenian: AUC0-72 h (i.e.h/dl)
English: If you are not sure check with your doctor.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom.
English: The median ABR was 2.0, for spontaneous bleeds 0.0 and for joint bleeds 0.0.
Slovenian: Mediana vrednosti ABR je bila 2,0, za spontane krvavitve 0,0 in za krvavitve v sklepe 0,0.
English: Hypersensitivity a)
Slovenian: Bolezni imunskega sistema preobčutljivost a)
English: Do not use this medicine after the expiry date which is stated on the outer box and vial label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: RIXUBIS should be administered using a rate that ensures the comfort of the patient, up to a maximum of 10 ml/min.
Slovenian: Zdravilo RIXUBIS je treba dajati s hitrostjo, ki zagotavlja ugodje bolnika, in sicer največ 10 ml/min.
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.
Slovenian: Hemofilija B je spolno vezana dedna motnja strjevanja krvi, ki nastane zaradi zmanjšane koncentracije faktorja IX in povzroči obilne krvavitve v sklepe, mišice ali notranje organe, bodisi spontane ali kot posledica nezgode ali kirurške travme.
English: • one vial of RIXUBIS 250, 500, 1000, 2000 or 3000 IU powder in a glass vial with a rubber stopper
Slovenian: • ena viala praška RIXUBIS 250, 500, 1000, 2000 ali 3000 i.e. v stekleni viali z zamaškom iz gume,
English: Do not use solutions that are cloudy or have deposits.
Slovenian: Ne uporabljajte raztopin, ki so motne ali vsebujejo usedlino.
English: The risk for developing inhibitors is highest in patients who have not been treated with a factor IX replacement medicine before or in the early phases of treatment, i.e. for small children.
Slovenian: Tveganje za pojav zaviralcev je največje pri bolnikih, ki se še niso zdravili z zdravili za nadomeščanje faktorja IX, in pri bolnikih v zgodnjih fazah zdravljenja, tj. majhnih otrocih.
English: The mean treatment duration in the on-demand cohort was 3.5±1.00 months (median 3.4, ranging from 1.2 to 5.1 months), the mean total annualised bleeding rate (ABR) was 33.9±17.37 with a median of 27.0, ranging from 12.9 to 73.1.
Slovenian: Povprečno trajanje zdravljenja v kohorti z zdravljenjem po potrebi je bilo 3,5±1,00 mesecev (mediana 3,4, razpon od 1,2 do 5,1 mesecev), povprečna skupna letna stopnja krvavitev (ABR, annual bleeding rate) je bila 33,9±17,37 z mediano 27,0 in razponom od 12,9 do 73,1.
English: • one vial of 5 ml sterilised water for injections in a glass vial with a rubber stopper
Slovenian: • ena viala s 5 ml sterilizirane vode za injekcije v stekleni viali z zamaškom iz gume,
English: Driving and using machines RIXUBIS has no influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo RIXUBIS nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: Animal reproduction studies have not been conducted with factor IX.
Slovenian: Študije vpliva faktorja IX na razmnoževanje pri živalih niso bile opravljene.
English: On demand treatment:
Slovenian: Zdravljenje po potrebi:
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.
Slovenian: S priporočenim začetnim polnilnim odmerkom zdravila RIXUBIS so zagotovili, da so se med kirurškim posegom ohranjale ravni aktivnosti faktorja IX med 80 in 100 % za večje kirurške posege in med 30 in 60 % za manjše kirurške posege.
English: The vacuum will draw the solvent into the RIXUBIS vial (Fig. c).
Slovenian: Vakuum bo posesal vehikel v vialo s praškom RIXUBIS (slika c).
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.
Slovenian: Tveganje je največje v zgodnjih fazah začetne izpostavljenosti koncentratom faktorja IX pri predhodno nezdravljenih bolnikih, zlasti bolnikih z genskimi mutacijami z velikim tveganjem.
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).
Slovenian: Eno pakiranje vsebuje: vialo s praškom (steklo tipa I) z zamaškom (butilna guma) in potezno zaporko, vialo s 5 ml vehikla (steklo tipa I) z zamaškom (klorobutilna guma) in »flip-off« zaporko ter brezigelni pripomoček za rekonstitucijo (BAXJECT II).
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 primerih spodaj navedenih vrst krvavitev aktivnost faktorja IX ne sme pasti pod navedeno raven aktivnosti v plazmi (v % normalne vrednosti ali i.e./dl) v določenem obdobju.
English: Haemostatic efficacy at resolution of a bleed was rated excellent or good in 96.2% of all treated bleeding episodes.
Slovenian: Hemostatska učinkovitost ob prenehanju krvavitve je bila ocenjena kot odlična ali dobra pri 96,2 % zdravljenih epizod krvavitev.
English: Patients undergoing major surgeries had to perform a pharmacokinetic (PK) evaluation.
Slovenian: Bolniki z večjimi kirurškimi posegi so bili farmakokinetično ocenjeni.
English: x reciprocal of observed recovery (dL/kg)
Slovenian: x obratna vrednost ugotovljene aktivnosti (dl/kg)
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Slovenian: Najmanj 1 dan, dokler se krvavitev, ki se kaže z bolečino, ne ustavi oziroma ne dosežemo celjenja.
English: Do not remove the blue cap from the BAXJECT II device.
Slovenian: Ne snemite modrega pokrovčka s pripomočka BAXJECT II.
English: There are no or limited amount of data from the use of Factor IX in pregnant women.
Slovenian: Podatkov o uporabi faktorja IX pri nosečnicah ni oziroma so omejeni.
English: Adverse Drug Reactions, from clinical trials and spontaneous reports MedDRA Standard System Organ Class
Slovenian: Neželeni učinki iz kliničnih preskušanj in spontanih poročil Organski sistem po standardu MedDRA Neželeni učinki
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Slovenian: Pri bolnikih z obstoječimi srčno-žilnimi dejavniki tveganja lahko nadomestna terapija s koagulacijskim faktorjem IX poveča srčno-žilno tveganje.
English: Patients who have specific mutations of their factor IX gene such as major deletion may be more likely to have factor IX inhibitors and an allergic reaction in the early period with any factor IX concentrate.
Slovenian: Pri bolnikih, ki imajo specifične mutacije v genu za faktor IX, kot je velika delecija, obstaja večja verjetnost pojava zaviralca faktorja IX in alergijske reakcije v zgodnjem obdobju zdravljenja s katerim koli koncentratom faktorja IX.
English: Clinical studies with RIXUBIS included 99 subjects with at least one exposure to RIXUBIS reporting in total 5 adverse reactions.
Slovenian: V klinične študije zdravila RIXUBIS je bilo vključenih 99 oseb z vsaj eno izpostavitvijo zdravilu RIXUBIS, pri katerih se je pojavilo skupno 5 neželenih učinkov.
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.
Slovenian: Opravljena je bila randomizirana, zaslepljena, kontrolirana, navzkrižna farmakokinetična študija zdravila RIXUBIS in primerjalnega zdravila pri preiskovancih moškega spola brez krvavitev (starih ≥ 15 let) kot del kombinirane ključne študije faze 1/3.
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.
Slovenian: Farmakokinetično oceno so ponovili za zdravilo RIXUBIS v nezaslepljeni, nekontrolirani študiji zdravila RIXUBIS pri preiskovancih moškega spola, ki so sodelovali v prvotni farmakokinetični navzkrižni študiji in so prejemali profilakso z zdravilom RIXUBIS 26 ± 1 tednov (povprečje ± SD) ter akumulirali vsaj 30 dni izpostavljenosti zdravilu RIXUBIS.
English: Depending on body weight and Posology of RIXUBIS, patients could receive more than one vial.
Slovenian: Glede na telesno maso in odmerjanje zdravila RIXUBIS lahko bolniki prejmejo več kot eno vialo.
English: The production of factor IX in the body is controlled by the factor IX gene.
Slovenian: Nastajanje faktorja IX v telesu uravnava gen za faktor IX.
English: Reconstitution Use Aseptic Technique
Slovenian: Rekonstitucija Uporabljajte aseptično tehniko.
English: It is a vitamin K-dependent coagulation factor and it is synthesised in the liver.
Slovenian: To je od vitamina K odvisen faktor koagulacije, ki se sintetizira v jetrih.
English: (IU/dL: IU/kg)
Slovenian: (i.e./dl: i.e./kg)
English: Catheter-related complications
Slovenian: Zapleti, povezani z uporabo katetra
English: Incremental recovery 30 min after infusion
Slovenian: Porast aktivnosti faktorja IX po odmerku 30 min po infuziji
English: All 23 male subjects underwent an initial pharmacokinetic evaluation of RIXUBIS in a non-bleeding state as part of the combined phase 2/3 paediatric study.
Slovenian: Vseh 23 preiskovancev moškega spola je prestalo začetno farmakokinetično ocenjevanje zdravila RIXUBIS brez krvavitev kot del kombinirane pediatrične študije faze 2/3.
English: After repeated treatment with human coagulation factor IX (rDNA) products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Slovenian: Ob ponovnem zdravljenju s pripravki, ki vsebujejo humani koagulacijski faktor IX (rDNA), moramo bolnike opazovati in nadzirati možnost pojava nevtralizirajočih protiteles (zaviralcev) in določati njihovo koncentracijo s primernimi biološkimi testi, ki podajajo koncentracijo v enotah Bethesda (BU).
English: Turn the package over and insert the clear plastic spike through the solvent stopper.
Slovenian: Ovojnino obrnite in uvedite prozorno plastično konico skozi zamašek vehikla.
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).
Slovenian: Nemudoma prekinite infuzijo in obvestite svojega zdravnika ali poiščite nujno medicinsko pomoč, če se pri vas pojavijo zgodnji znaki preobčutljivostnih/alergijskih reakcij, kot so koprivnica, izpuščaj, tiščanje v prsih, piskajoče dihanje, nizek krvni tlak ali anafilaksa (huda alergijska reakcija, ki povzroči oteženo požiranje in/ali dihanje, pordevanje ali otekanje obraza in/ali dlani).
English: Haemostatic efficacy at resolution of bleed was rated excellent or good in 96% of all treated bleeding episodes.
Slovenian: Hemostatska učinkovitost ob prenehanju krvavitve je bila ocenjena kot odlična ali dobra pri 96 % zdravljenih epizodah krvavitev.
English: Nine subjects (39.1%) experienced zero bleeds.
Slovenian: Pri 9 (39,1 %) preiskovancih ni bilo krvavitev.
English: The efficacy of RIXUBIS has been evaluated in a combined phase 2/3 study, in which a total of 23 male PTPs between 1.8 and 11.8 years (median age 7.10 years) with 11 patients < 6 years, received RIXUBIS for prophylaxis and control of bleeding episodes.
Slovenian: Učinkovitost zdravila RIXUBIS je bila ocenjena v kombinirani študiji faze 2/3, v katero je bilo vključenih skupno 23 predhodno zdravljenih preiskovancev moškega spola, starih od 1,8 do 11,8 let (mediana 7,10 let) (pri čemer je bilo 11 bolnikov starih < 6 let), ki so prejeli zdravilo RIXUBIS za profilakso in obvladovanje epizod krvavitev.
English: Of the 249 bleeding episodes, the majority (211; 84.7%) were treated with 1-2 infusions.
Slovenian: Večina (211; 84,7 %) od 249 epizod krvavitev je bila zdravljena z 1 do 2 infuzijama.
English: How to use RIXUBIS
Slovenian: Kako uporabljati zdravilo RIXUBIS
English: Attach a butterfly needle to the syringe.
Slovenian: Na brizgo namestite iglo z metuljčkom.