FrancophonIA/ELRC3.0 huggingface dataset:
English: It is strongly recommended that every time that Refixia 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.
Slovenian: Zelo priporočljivo je, da se po vsaki aplikaciji zdravila Refixia zabeleži ime in številka serije uporabljenega zdravila, da se zagotovi povezava med bolnikom in serijo uporabljenega zdravila.
English: If the medicine has not been used before the new expiry date, it should be disposed of.
Slovenian: Če zdravila ne uporabite pred novim iztekom roka uporabnosti, ga morate zavreči.
English: It is a vitamin-K dependent coagulation factor and it is synthesised in the liver.
Slovenian: Je od vitamina K odvisen koagulacijski faktor, ki se sintetizira v jetrih.
English: The primary amino acid sequence of the rFIX in Refixia is identical to the Ala148 allelic form of human plasma-derived factor IX.
Slovenian: Primarno aminokislinsko zaporedje rFIX v zdravilu Refixia je identično alelni obliki Ala148 iz humane plazme pridobljenega faktorja IX.
English: The overall success rate for treatment of breakthrough bleeds was 97.1% (67 out of 69 evaluated bleeds).
Slovenian: Delež celokupne uspešnosti zdravljenja krvavitev med uporabo zdravila je znašal 97,1 % (67 od 69 ovrednotenih krvavitev).
English: A total of 69 (98.6%) of the 70 bleeding episodes were treated with one injection.
Slovenian: Skupno 69 (98,6 %) od 70 krvavitev so zdravili z eno injekcijo.
English: Additional doses of 40 IU/kg can be given.
Slovenian: Aplicira se lahko dodatne odmerke po 40 i.e./kg
English: What Refixia is and what it is used for What you need to know before you use Refixia How to use Refixia
Slovenian: Kaj je zdravilo Refixia in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Refixia Kako uporabljati zdravilo Refixia
English: Other medicines and Refixia Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: All pharmacokinetic studies with Refixia were conducted in previously treated patients with haemophilia B (factor IX ≤2%).
Slovenian: Vse farmakokinetične študije zdravila Refixia so bile izvedene pri predhodno zdravljenih bolnikih s hemofilijo B (faktor IX ≤ 2 %).
English: Half-life (t1/2) (hours)
Slovenian: Razpolovni čas (t1/2) (ure)
English: In a repeat dose toxicity study in monkeys, mild and transient body tremors were seen 3 hours post dosing and abated within 1 hour.
Slovenian: V študiji toksičnosti pri ponavljajočih se odmerkih so pri opicah 3 ure po odmerjanju opazili blag in prehoden tremor telesa, ki je popustil v 1 uri.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Slovenian: Zato je treba pri bolnikih, pri katerih se pojavi alergijska reakcija, določiti prisotnost zaviralca.
English: Of the 597 treated bleeds observed in 79 (75%) of the 105 patients, 521 (87%) of the bleeds were resolved with 1 injection and 60 (10%) of the bleeds were resolved with 2 injections of Refixia.
Slovenian: Od 597 zdravljenih krvavitev, opaženih pri 79 od 105 bolnikov (75 %), se je 521 krvavitev (87 %) ustavilo z 1 injekcijo, 60 krvavitev (10 %) pa z 2 injekcijama zdravila Refixia.
English: • Do not touch the rubber stopper with your fingers as this can transfer germs.
Slovenian: • Gumijastega zamaška se ne dotikajte s prsti, saj ga lahko tako kontaminirate z mikrobi.
English: • you have risk factors for heart disease e.g high blood pressure, obesity, or smoking.
Slovenian: • imate dejavnike tveganja za razvoj bolezni srca, npr. visok krvni tlak, debelost ali ste kadilec.
English: The use of Refixia in children below 12 years is not indicated (see section 4.2 for information on paediatric use).
Slovenian: Uporaba zdravila Refixia pri otrocih, mlajših od 12 let, ni indicirana (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: For modified long-acting factor products it is known that the one-stage clotting assay results are highly dependent on the aPTT reagent and reference standard used.
Slovenian: Znano je, da so rezultati enostopenjskega testa strjevanja krvi pri modificiranih dolgodelujočih proizvodih faktorja močno odvisni od uporabljenega aPTT reagenta in referenčnega standarda.
English: Haemostatic effect of Refixia during surgery was confirmed with a success rate of 100% in the 15 major surgeries in the trials.
Slovenian: Hemostatski učinek zdravila Refixia med kirurškim posegom potrjuje delež uspešnosti, ki je pri 15 večjih posegih v preskušanjih znašal 100 %.
English: There are insufficient data to provide information on inhibitor incidence in previously untreated patients.
Slovenian: Za navedbo informacij o pojavnosti zaviralcev pri predhodno nezdravljenih bolnikih ni dovolj podatkov.
English: The trough levels achieved with the weekly 40 IU/kg dosing regimen are summarised in section 5.2.
Slovenian: Najmanjše koncentracije, dosežene pri režimu odmerjanja 40 i.e./kg enkrat na teden, so povzete v poglavju 5.2.
English: The potency (International Units) is determined using the European Pharmacopeia one-stage clotting test.
Slovenian: Jakost (mednarodne enote) je določena z enostopenjskim testom strjevanja krvi po Evropski farmakopeji.
English: • Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible.
Slovenian: • Gumijasti zamašek viale obrišite s sterilno alkoholno blazinico in pred uporabo počakajte nekaj sekund, da se posuši na zraku, da zagotovite čim večjo sterilnost.
English: The average molecular weight of Refixia is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa.
Slovenian: Povprečna molekulska masa zdravila Refixia je približno 98 kDa, molekulska masa same beljakovine pa 56 kDa.
English: • If the CVAD line needs to be flushed before or after Refixia injection, use sodium chloride 9 mg/ml solution for injection.
Slovenian: • Če je linijo naprave za centralni venski dostop pred injiciranjem zdravila Refixia ali po njem treba sprati, uporabite raztopino natrijevega klorida (9 mg/ml) za injiciranje.
English: • Check the name, strength and colour of the package, to make sure it contains the correct product.
Slovenian: • Preverite ime, jakost in barvo pakiranja,
English: Severe or life threatening haemorrhages.
Slovenian: Hude ali življenjsko nevarne krvavitve
English: The pivotal trial included 74 adolescent (13-17 years) and adult (18-65 years) previously treated patients.
Slovenian: V ključno preskušanje je bilo vključenih 74 predhodno zdravljenih mladostnikov (13-17 let) in odraslih (18-65 let) bolnikov.
English: Do not use the equipment if it has been dropped, or if it is damaged.
Slovenian: Pripomočkov ne uporabljajte, če so vam padli ali so kakor koli poškodovani.
English: Do not stop using Refixia without talking to your doctor.
Slovenian: Ne prenehajte uporabljati zdravila Refixia, ne da bi se o tem prej posvetovali z zdravnikom.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Slovenian: Opozoriti moramo, da deleža krvavitev v enem letu med različnimi koncentracijami faktorja in med različnimi kliničnimi študijami ni mogoče primerjati.
English: • The active substance is nonacog beta pegol (pegylated human coagulation factor IX (rDNA)).
Slovenian: • Učinkovina je nonakog beta pegol (pegilirani humani koagulacijski faktor IX (rDNA)).
English: Based on modelled data using observed terminal half-lives (1549 days) in rat tissue distribution studies, the 40 kDa polyethylene-glycol (PEG) moiety will reach steady state levels in all human tissues within 1-2 years of treatment.
Slovenian: Na osnovi modeliranih podatkov z uporabo opaženih končnih razpolovnih časov (15-49 dni) v študijah porazdelitve v tkivu podgane bi 40 kDa polietilen glikola (PEG) pri človeku doseglo vrednosti v stanju dinamičnega ravnovesja v vseh tkivih v 1-2 letih zdravljenja.
English: The rate of administration should be determined by the patient's comfort level up to a maximum injection rate of 4 ml/min.
Slovenian: Hitrost aplikacije je treba določiti na osnovi stopnje ugodja pri bolniku, hitrost injiciranja pa ne sme biti večja od 4 ml/min.
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 potrebna uporaba naprave za centralni venski dostop (CVAD - Central Venous Access Device), je treba upoštevati možno tveganje za pojav zapletov, povezanih z uporabo CVAD, vključno z lokalnimi okužbami, bakteriemijo in trombozo na mestu vstavljenega katetra.
English: The use of high purity factor IX products like Refixia is rarely associated with such adverse reactions.
Slovenian: Uporaba zdravil s faktorjem IX velike čistote, kot je zdravilo Refixia, je bila le redko povezana s takšnimi neželenimi učinki.
English: * Factor IX trough levels = factor IX activity measured prior to next weekly dose (5 to 10 days post dosing) at steady state.
Slovenian: * Najmanjše koncentracije faktorja IX = aktivnost faktorja IX, izmerjena pred naslednjim tedenskim odmerkom (5 do 10 dni po odmerku) v stanju dinamičnega ravnovesja.
English: If you are in doubt contact your doctor.
Slovenian: Če ste v dvomih, se posvetujte z zdravnikom.
English: Due to the interference of polyethylene glycol (PEG) in the one-stage clotting assay with various aPTT reagents, it is recommended to use a chromogenic assay (e.g. Rox Factor IX or Biophen) when monitoring is needed.
Slovenian: Zaradi vpliva polietilen glikola (PEG) na enostopenjski test strjevanja krvi z različnimi aPTT reagenti priporočamo uporabo kromogenega testa (npr. Rox Factor IX ali Biophen), če je potrebno spremljanje.
English: As expected, body weight adjusted clearance in paediatric and adolescent patients was higher compared to adults.
Slovenian: Po pričakovanjih je bil očistek, prilagojen na telesno maso, pri otrocih in mladostnikih večji kot pri odraslih.
English: Pharmacokinetics were investigated in 16 adult and adolescent patients of which 6 were normal weight (BMI 18.5-24.9 kg/m2) and 10 were overweight (BMI 25-29.9 kg/m2).
Slovenian: Farmakokinetiko so raziskovali pri 16 odraslih in mladostnikih, od katerih je 6 bolnikov imelo normalno telesno maso (ITM 18,5-24,9 kg/m2), 10 bolnikov pa prekomerno telesno maso (ITM 2529,9 kg/m2).
English: Discuss with your doctor the dose and number of injections you need.
Slovenian: O potrebnem odmerku in številu injekcij se posvetujte z zdravnikom.
English: The reconstituted product must be injected into your vein (intravenous (IV) injection).
Slovenian: Rekonstituirano zdravilo je treba injicirati v veno (intravenska (i.v.)
English: You will also need an infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads and plasters.
Slovenian: Potrebovali boste tudi infuzijski komplet (cevka in injekcijska igla z metuljčkom), sterilne alkoholne blazinice, zložence in obliže.
English: • After injection, safely dispose of all unused Refixia solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist.
Slovenian: • Po injiciranju varno zavrzite vso neporabljeno raztopino zdravila Refixia, injekcijsko brizgo z infuzijskim kompletom, vialo z nastavkom za vialo in drug odpadni material v skladu z navodili zdravnika ali farmacevta.
English: If sudden and severe allergic reactions (e.g. anaphylactic reactions) occur, the injection must be stopped immediately.
Slovenian: Če pride do pojava nenadne in hude alergijske reakcije (npr. anafilaktična reakcija), morate takoj prekiniti z injiciranjem zdravila.
English: Novo Nordisk A/S Brennum Park 25K DK-3400 Hillerød Denmark
Slovenian: Novo Nordisk A/S Brennum Park 25K DK-3400 Hillerød Danska
English: No difference in the safety profile of Refixia was observed between previously treated adolescent (12-18 years) and adult patients.
Slovenian: Pri varnostnem profilu zdravila Refixia pri predhodno zdravljenih mladostnikih (12-18 let) in odraslih bolnikih niso opazili razlik.
English: Driving and using machines Refixia has no influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Refixia nima vpliva na sposobnost vožnje in upravljanja strojev.
English: Refixia is not indicated for use in children (below 12 years).
Slovenian: Zdravilo Refixia ni indicirano za uporabo pri otrocih (mlajših od 12 let).
English: If you have such antibodies, you may be at an increased risk of sudden and severe allergic reactions (e.g. anaphylactic reaction) during future treatment with factor IX.
Slovenian: Če imate ta protitelesa, lahko pri vas obstaja večje tveganje za pojav nenadnih in hudih alergijskih reakcij (npr. anafilaktične reakcije) pri nadaljnjem zdravljenju s faktorjem IX.
English: Your doctor may also do a blood test to check if you have developed factor IX inhibitors (neutralising antibodies) against your medicine, as inhibitors may develop together with allergic reactions.
Slovenian: Zdravnik bo morda opravil tudi krvno preiskavo, s katero bo preveril, ali je pri vas prišlo do razvoja zaviralcev faktorja IX (nevtralizirajoča protitelesa proti zdravilu), saj se zaviralci lahko razvijejo skupaj z alergijskimi reakcijami.
English: In the clinical trial programme, dose adjustment was not performed.
Slovenian: programu kliničnega preskušanja prilagajanja odmerka niso izvedli.
English: The risk for developing inhibitors is highest if you have not been treated with factor IX medicines before i.e. for small children.
Slovenian: Tveganje za razvoj zaviralcev je največje pri bolnikih, ki se predhodno še niso zdravili z zdravili s faktorjem IX, npr. pri majhnih otrocih.
English: The MAH shall complete, within the stated timeframe, the below measures: Description
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe: Opis
English: These body tremors were seen at doses of Refixia (3,750 IU/kg), which were more than 90 times higher than the recommended dose for humans (40 IU/kg).
Slovenian: Refixia (3.750 i.e./kg), ki so bili več kot 90-krat večji od priporočenega odmerka za človeka (40 i.e./kg).
English: Tremors have not been reported in the clinical trials.
Slovenian: V kliničnih preskušanjih o pojavu tremorja niso poročali.
English: • Do not use any other way to warm the vial and pre-filled syringe.
Slovenian: • Za segrevanje viale in napolnjene injekcijske brizge ne uporabljajte nobenega drugega načina.
English: The mean total consumption of Refixia during and after surgery was 241 IU/kg (range: 81-460 IU/kg).
Slovenian: Povprečna skupna poraba zdravila Refixia med in po operaciji je znašala 241 i.e./kg (razpon: 81-460 i.e./kg).
English: Your doctor will calculate your dose for you.
Slovenian: Odmerek bo izračunal zdravnik.
English: The product contains traces of hamster proteins.
Slovenian: Zdravilo vsebuje hrčkove beljakovine v sledeh.
English: • Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
Slovenian: • Nehajte pritiskati na potisni bat in pustite, da se pomakne nazaj sam od sebe, medtem ko rekonstituirana raztopina polni injekcijsko brizgo.
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.
Slovenian: Uporaba zdravil s faktorjem IX majhne čistote je bila povezana s primeri miokardnega infarkta, diseminirane intravaskularne koagulacije, venske tromboze in pljučne embolije.
English: Kidney disorder (nephrotic syndrome)
Slovenian: Bolezen ledvic (nefrotski sindrom)
English: From a microbiological point of view, the reconstituted product should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba raztopino uporabiti takoj po rekonstituciji.
English: Your doctor will do a blood test to check if you have developed inhibitors (neutralising antibodies) against Refixia.
Slovenian: Zdravnik bo s krvno preiskavo preveril, če je pri vas prišlo do razvoja zaviralcev (nevtralizirajočih protiteles) proti zdravilu Refixia.
English: Patients on prophylaxis who forget a dose are advised to take their dose upon discovery and thereafter continue with the usual once weekly dosing schedule.
Slovenian: Če bolnik, ki uporablja zdravilo za profilakso, pozabi uporabiti odmerek, mora odmerek uporabiti takoj, ko se na to spomni, nato pa naj nadaljuje z običajno shemo odmerjanja enkrat na teden.
English: The overall success rate (defined as excellent or good) for treatment of bleeds was 93% (551 out of 591).
Slovenian: Delež celokupne uspešnosti (opredeljene kot odlična ali dobra) zdravljenja krvavitev je znašal 93 % (551 od 591).
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, ki so lahko spontane ali posledica nezgode ali kirurške travme.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. it is essentially “sodium-free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni “brez natrija”.
English: See “Instructions on how to use Refixia” for more information.
Slovenian: Za več informacij glejte “Navodila za uporabo zdravila Refixia”.
English: • Do not mix Refixia with any other intravenous infusions or medications.
Slovenian: • Zdravila Refixia ne mešajte z nobenim drugim zdravilom ali tekočino za intravensko infundiranje.
English: The success rate and dose needed for treatment of the bleeding episodes were independent of the localisation of the bleed.
Slovenian: Delež uspešnosti in potreben odmerek za zdravljenje epizod krvavitve nista bila odvisna od mesta krvavitve.
English: The patients received 1 pre-operative injection of 80 IU/kg on the day of surgery, and post-operatively, injections of 40 IU/kg.
Slovenian: Bolniki so na dan operacije pred operacijo prejeli 1 injekcijo v odmerku 80 i.e./kg, po operaciji pa injekcijo v odmerku 40 i.e./kg.
English: Refixia is indicated for patients 12 years and above.
Slovenian: Zdravilo Refixia je indicirano pri bolnikih, starih 12 let in več.
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Slovenian: Poročali so o zelo redkih primerih razvoja protiteles proti hrčkovim beljakovinam in s tem povezanim pojavom preobčutljivostnih reakcij.
English: Area under the curve (AUC)inf (IU*hours/ml)
Slovenian: Površina pod krivuljo (AUC)inf (i.e.*ure/ml)
English: • Lightly squeeze the protective cap with your thumb and index finger as shown.
Slovenian: • Zaščitno zaporko rahlo stisnite s palcem in kazalcem, kot prikazuje slika.
English: Eighteen out of these 20 joints (90%) were no longer considered target joints at the end of the trial.
Slovenian: Na koncu preskušanja 18 od 20 sklepov (90 %) niso več smatrali kot sklepe s pogostimi krvavitvami.
English: Table 2 Treatment in surgery with Refixia
Slovenian: Preglednica 2: Zdravljenje z zdravilom Refixia pri kirurških posegih
English: During the shelf life Refixia may be stored up to 30°C for a single period not exceeding 6 months.
Slovenian: V času roka uporabnosti se zdravilo Refixia lahko shranjuje pri temperaturi do 30 °C za enkratno obdobje, ki ne presega 6 mesecev.
English: Incorrect technique can introduce germs that can infect the blood.
Slovenian: Zaradi nepravilne tehnike lahko pride do vnosa mikrobov in posledične okužbe krvi.
English: Area under the curve (AUC)0-168h (IU*hours/ml)
Slovenian: Površina pod krivuljo (AUC)0-168 ur (i.e.*ure/ml)
English: No mechanism behind the tremors was identified.
Slovenian: Mehanizma tremorja niso odkrili.
English: A trial including 25 paediatric previously treated patients (ages 0-12 years) who received a prophylactic dose 40 IU/kg once weekly was performed.
Slovenian: Izvedeno je bilo preskušanje, v katerega je bilo vključenih 25 predhodno zdravljenih pediatričnih bolnikov (starih 0-12 let), ki so prejemali profilaktični odmerek 40 i.e./kg enkrat na teden.
English: Read these instructions carefully before using Refixia.
Slovenian: Pred začetkom uporabe zdravila Refixia natančno preberite ta navodila.
English: • Push the plunger rod slowly until all air bubbles are gone.
Slovenian: • Pritiskajte potisni bat počasi, dokler ne izginejo vsi zračni mehurčki.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek in vehikel za raztopino za injiciranje
English: Refixia may be taken out of the refrigerator for a maximum period of 6 months and stored at room temperature (up to 30°C).
Slovenian: Zdravilo Refixia lahko vzamete iz hladilnika in ga največ 6 mesecev shranjujete pri sobni temperaturi (do 30 °C).
English: After reconstitution the solution appears as a clear and colourless liquid free of visible particles.
Slovenian: Rekonstituirana raztopina je bistra in brezbarvna tekočina brez vidnih delcev.
English: When comparing the 10 IU/kg and 40 IU/kg treatments, the annualised bleeding rate for patients in the 40 IU/kg arm was found to be 49% lower than the bleeding rate (95% CI: 5%;73%) for patients in the 10 IU/kg arm (p<0.05).
Slovenian: Pri primerjavi zdravljenja z odmerkom 10 i.e./kg in 40 i.e./kg je bil delež krvavitev v enem letu pri bolnikih v skupini z odmerkom 40 i.e./kg za 49 % manjši od deleža krvavitev (95 % interval zaupanja: 5 %; 73 %) v skupini z odmerkom 10 i.e./kg (p<0,05).
English: The equipment in this package is designed to reconstitute and inject Refixia.
Slovenian: Pripomočki v ovojnini z zdravilom so namenjeni za rekonstitucijo in injiciranje zdravila Refixia.
English: The overall success rate (defined as excellent or good) for treatment of bleeds was 95% with 98% of the bleeds treated with one or two injections.
Slovenian: Delež celokupne uspešnosti (opredeljene kot odlična ali dobra) zdravljenja krvavitev je znašal 95 %, pri čemer so 98 % krvavitev zdravili z eno ali dvema injekcijama.
English: If the protective paper is not fully sealed or if it is broken, do not use the vial adapter.
Slovenian: Če zaščitni papir ni popolnoma pritrjen ali je kakor koli poškodovan, nastavka za vialo ne uporabljajte.
English: Upon activation of Refixia, the activation peptide including the 40 kDa polyethylene-glycol moiety is cleaved off, leaving the native activated factor IX molecule.
Slovenian: Po aktiviranju zdravila Refixia se aktivacijski peptid, vključno s 40 kDa polietilen glikola odcepi, pri čemer ostane molekula nativnega aktiviranega faktorja IX.
English: • Check the reconstituted solution.
Slovenian: • Preverite rekonstituirano raztopino.
English: Table 3 Frequency of adverse reactions in clinical trials System Organ Class
Slovenian: Preglednica 3: Pogostnost neželenih učinkov v kliničnih preskušanjih
English: Refixia replaces this faulty or missing factor IX and helps blood to form clots at the site of bleeding.
Slovenian: Zdravilo Refixia nadomesti okvarjen ali manjkajoč faktor IX in pomaga pri nastanku krvnega strdka na mestu krvavitve.
English: The trial included one open-label on-demand arm with treatment for approximately 28 weeks and two prophylaxis treatment arms with single-blind randomisation to either 10 IU/kg or 40 IU/kg once-weekly for approximately 52 weeks.
Slovenian: Preskušanje je vključevalo eno odprto skupino z zdravljenjem po potrebi, v kateri je zdravljenje trajalo približno 28 tednov, in dve skupini s profilaktičnim zdravljenjem z enojno slepo randomizacijo na zdravljenje z odmerkom 10 i.e./kg ali 40 i.e./kg enkrat na teden za približno 52 tednov.