FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 249 bleeding episodes, the majority (211; 84.7%) were treated with 1-2 infusions.
Croatian: Od 249 epizoda krvarenja, većina (211; 84,7%) je liječena 1-2 infuzijama.
English: It is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line.
Croatian: Proizvodi se rekombinantnom DNK tehnologijom u staničnoj liniji jajnika kineskog hrčka (CHO).
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Croatian: Stoga je kod bolesnika koji imaju alergijske reakcije potrebno provjeriti prisutnost inhibitora.
English: Minor surgery including tooth extraction
Croatian: Manji kirurški zahvat uključujući vađenje zuba
English: What RIXUBIS is and what it is used for What you need to know before you use RIXUBIS How to use RIXUBIS
Croatian: Što je RIXUBIS i za što se koristi Što morate znati prije nego počnete primjenjivati RIXUBIS Kako primjenjivati RIXUBIS
English: The per-protocol efficacy analysis includes 37 surgeries performed in 27 patients between 17 and 57 years of age undergoing major or minor surgical, dental or other surgical invasive procedures.
Croatian: Analiza djelotvornosti prema planu ispitivanja uključuje 37 kirurških zahvata izvedenih na 27 bolesnika u dobi od 17 do 57 godina starosti koji su podvrgnuti velikim ili manjim kirurškim, zubarskim ili drugim kirurškim invazivnim postupcima.
English: Frequency of doses (hours)/Duration of therapy (days)
Croatian: Učestalost doza (sati)/trajanje terapije (dani)
English: If the product is stored in a refrigerator, take both the RIXUBIS powder and solvent vials from the refrigerator and let them reach room temperature (between 15°C and 30°C).
Croatian: Ako se lijek čuva u hladnjaku, izvadite bočice RIXUBIS praška i otapala iz hladnjaka i pričekajte da postigne sobnu temperaturu (između 15 °C i 30 °C).
English: Patients undergoing major surgeries had to perform a pharmacokinetic (PK) evaluation.
Croatian: Bolesnici koji su se podvrgavali velikim kirurškim zahvatima morali su proći kroz farmakokinetičku (FK) procjenu.
English: In some cases, depending upon the individual patient´s pharmacokinetics, age, bleeding phenotype and physical activity, shorter dosage intervals or higher doses may be necessary.
Croatian: U nekim slučajevima, ovisno o farmakokinetici, dobi, fenotipu krvarenja i fizičkoj aktivnosti pojedinog bolesnika, mogu biti potrebni kraći razmaci između doza ili veće doze.
English: Do not use RIXUBIS if the solution is not clear and colourless.
Croatian: Nemojte upotrijebiti RIXUBIS ako otopina nije bistra i bezbojna.
English: Continuous infusion Do not administer RIXUBIS by continuous infusion.
Croatian: Kontinuirana infuzija Ne primjenjujte RIXUBIS kontinuiranom infuzijom.
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Croatian: Očekuje se da će učestalost, vrsta i ozbiljnost nuspojava u djece biti jednaki kao u odraslih osoba.
English: See tables below.
Croatian: Vidjeti donje tablice.
English: For intravenous use, single use only.
Croatian: Za intravensku primjenu, samo za jednokratnu primjenu.
English: Common side effects (may affect up to 1 in 10 patients) - altered taste - pain in limbs.
Croatian: Česte nuspojave (mogu se javiti kod do 1 od 10 bolesnika) - promjena osjeta okusa - bol u udovima.
English: Every 24 hours, at least 1 day, until healing is achieved.
Croatian: Svaka 24 sata, tijekom najmanje jednog dana, dok se ne postigne cijeljenje.
English: Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Croatian: Faktor IX je jednolančani glikoprotein s molekularnom masom od otprilike 68 000 daltona.
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.
Croatian: Ako se pojave simptomi preosjetljivosti, bolesnicima ili njihovim njegovateljima potrebno je savjetovati da odmah prestanu uzimati lijek i obrate se svome liječniku.
English: Incremental recovery 30 min after infusion
Croatian: Inkrementalni oporavak 30 min nakon infuzije
English: Volume of distribution at steady state
Croatian: Volumen distribucije u stanju dinamičke ravnoteže
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.
Croatian: Rizik od razvoja inhibitora je najviši u bolesnika koji nisu liječeni nadomjesnim lijekom za faktor IX prije ili u ranim fazama liječenja, odnosno kod male djece.
English: Clinical studies of RIXUBIS did not include subjects aged 65 and over.
Croatian: Klinička ispitivanja lijeka RIXUBIS ne uključuju ispitanike u dobi od 65 i više godina.
English: It works by replacing the missing factor IX to enable the patient's blood to clot.
Croatian: Djeluje tako da zamjenjuje faktor IX koji nedostaje kako bi omogućio zgrušavanje krvi bolesnika.
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Croatian: Najmanje 1 dan sve dok epizoda krvarenja, na koju upućuje bol, ne prestane ili se ne postigne cijeljenje.
English: In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity level (in % of normal or IU/dL) in the corresponding period.
Croatian: U slučaju sljedećih hemoragijskih događaja, aktivnost faktora IX ne smije pasti ispod zadane razine aktivnosti u plazmi (u % od normalne ili IU/dl) u odgovarajućem razdoblju.
English: What you need to know before you use RIXUBIS
Croatian: Što morate znati prije nego počnete primjenjivati RIXUBIS
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Croatian: U bolesnika s postojećim kardiovaskularnim faktorima rizika nadomjesna terapija u kojoj se koristi FIX može povećati kardiovaskularni rizik.
English: No interactions of RIXUBIS with other medicines are known.
Croatian: Nisu poznate interakcije lijeka RIXUBIS s drugim lijekovima.
English: Do not use RIXUBIS - if you are allergic to nonacog gamma or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to hamster proteins
Croatian: Nemojte primjenjivati RIXUBIS - ako ste alergični na nonakog gamu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako ste alergični na bjelančevine hrčka
English: Subjects were randomised to one of two blood sampling sequences to reduce the burden of frequent blood draws on the individual subjects.
Croatian: Ispitanici su randomizirani u jednu od dvije sekvence uzorkovanja krvi kako bi se smanjio teret čestog vađenja krvi pojedinim ispitanicima.
English: Of the 26 bleeding episodes, 15 were minor, 9 moderate, and 2 major.
Croatian: Od 26 epizoda krvarenja, 15 su bila manja, 9 umjerena, a 2 velika.
English: This should be taken into consideration if you are on a controlled sodium diet.
Croatian: To je potrebno uzeti u obzir ako ste na dijeti s kontroliranim unosom natrija.
English: Repeat infusion every 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Croatian: Ponoviti infuziju svaka 24 sata tijekom 3-4 dana ili dulje do prestanka boli i akutne onesposobljenosti.
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Croatian: Vrlo je rijetko opažen razvoj protutijela na proteine hrčka uz povezane reakcije preosjetljivosti.
English: Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by factor VII/tissue factor complex in the extrinsic pathway.
Croatian: Faktor IX se aktivira faktorom XIa u unutarnjem putu koagulacije i faktorom VII/kompleksom tkivnog faktora u vanjskom putu.
English: Perioperative management:
Croatian: Perioperativno zbrinjavanje:
English: Subjects in the on-demand cohort had to have at least 12 documented bleeding episodes requiring treatment within 12 months prior to enrollment.
Croatian: Ispitanici u kohorti koja se liječila prema potrebi morali su imati barem 12 zabilježenih epizoda krvarenja koje zahtijevaju liječenje unutar 12 mjeseci prije uključivanja.
English: RIXUBIS should be administered using a rate that ensures the comfort of the patient, up to a maximum of 10 ml/min.
Croatian: RIXUBIS je potrebno primjenjivati brzinom koja osigurava udobnost bolesnika, do najviše 10 ml/min.
English: Do not refrigerate the preparation after reconstitution.
Croatian: Nemojte odlagati pripravak u hladnjak nakon rekonstitucije.
English: Incorrect dosing can occur as a consequence of human coagulation factor IX adsorption to the internal surfaces of some infusion equipment.
Croatian: Pogrešno doziranje može se dogoditi kao posljedica adsorpcije koagulacijskog faktora, ljudskog IX, na unutarnju površinu neke opreme za infuziju.
English: Nine subjects (39.1%) experienced zero bleeds.
Croatian: Devet ispitanika (39,1%) nije imalo krvarenja.
English: Pharmacokinetic parameters for all subjects (full analysis set) are presented in the table below.
Croatian: Farmakokinetički parametri za sve ispitanike (obavljena cjelovita analiza) navedeni su u donjoj tablici.
English: The recommended dose range for paediatric patients less than 12 years is 40 to 80 IU/kg at intervals of 3 to 4 days.
Croatian: Preporučeni raspon doza za pedijatrijske bolesnike mlađe od 12 godina je 40 do 80 IU/kg u razmacima od 3 do 4 dana.
English: AUC0-72h (IU.hr/dL)
Croatian: AUC0-72h (IU.h/dl)
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Sljedeća tablica prikazana je prema MedDRA klasifikaciji organskih sustava (SOC i razina preporučenog pojma).
English: RIXUBIS did not cause any adverse clinical, respiratory, or cardiovascular effects up to 450 IU/kg in cynomolgus monkeys.
Croatian: RIXUBIS nije uzrokovao nikakve kliničke, respiratorne ili kardiovaskularne učinke do 450 IU/kg u makaki majmuna.
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).
Croatian: Ponoviti infuziju svakih 8 do 24 sata do odgovarajućeg cijeljenja rane, a zatim nastaviti terapiju još najmanje 7 dana da bi se aktivnost faktora IX održavala na razini od 30% do 60% (IU/dl).
English: The data demonstrate that the incremental recovery is consistent over time across all paediatric age groups.
Croatian: Podaci dokazuju da je prirast po jedinici doze dosljedan tijekom vremena u svim pedijatrijskim dobnim skupinama.
English: Of a total of 249 bleeding episodes, 163 were moderate, 71 were minor, and 15 were major.
Croatian: Od ukupno 249 epizoda krvarenja, 163 bila su umjerena; 71 manja, a 15 velika.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Croatian: Sljedeća tablica može se koristiti za usmjeravanje doziranja pri epizodama krvarenja i operaciji:
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.
Croatian: Nakon ponovljenog liječenja lijekovima koji sadrže koagulacijski faktor IX, ljudski (rDNK), potrebno je kod bolesnika nadzirati razvoj neutralizirajućih protutijela (inhibitora) koje bi trebalo izraziti u Bethesda jedinicama (BU) pomoću odgovarajućega biološkog testiranja.
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).
Croatian: Aktivnost faktora IX u plazmi izražava se ili kao postotak (u odnosu na normalnu ljudsku plazmu) ili u internacionalnim jedinicama (u odnosu na međunarodni standard za faktor IX u plazmi).
English: RIXUBIS was not thrombogenic at a dose of 750 IU/kg in a rabbit stasis model (Wessler-Test).
Croatian: RIXUBIS nije bio trombogen pri dozi od 750 IU/kg u modelu staze u kunića (Wesslerov test).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu za ovaj lijek putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: The European Medicines Agency has waived the obligation to submit the results of studies with RIXUBIS in previously untreated patients in the treatment and prophylaxis of bleeding in haemophilia B (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka RIXUBIS na prethodno neliječenim bolesnicima u liječenju i profilaksi krvarenja u hemofiliji B (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The solvent is clear and colourless.
Croatian: Otapalo je bistro i bezbojno.
English: In case of self-administration or administration by a caregiver appropriate training is needed.
Croatian: U slučaju samostalne primjene ili primjene od strane njegovatelja potrebna je odgovarajuća obuka.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. zanemarive količine natrija.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Croatian: Naročito u slučaju velikih kirurških zahvata nezamjenjivo je precizno praćenje nadomjesne terapije uz pomoć analize koagulacije (aktivnosti faktora IX u plazmi).
English: Factor IX level required (%) or (IU/dL)
Croatian: Potrebna razina faktora IX (%) ili (IU/dl)
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).
Croatian: RIXUBIS se dobro podnosio u jednoj dozi i u ispitivanjima toksičnosti ponovljenih doza provedenim na miševima, štakorima i makaki majmunima do doza od 7500 IU/kg (jedna doza) i 750 IU/kg (ponovljena primjena).
English: However, depending on your body weight and your dose of RIXUBIS, you could receive more than one vial.
Croatian: Međutim, ovisno o Vašoj tjelesnoj težini i dozi lijeka RIXUBIS, možete primiti više od jedne bočice lijeka.
English: Hypersensitivity a)
Croatian: Poremećaji imunološkog sustava preosjetljivost a)
English: Each powder vials contains nominally 250, 500, 1000, 2000 or 3000 IU, corresponding to a concentration of 50, 100, 200, 400 or 600 IU/ml after reconstitution with 5 ml solvent.
Croatian: Svaka bočica s praškom sadrži nominalno 250, 500, 1000, 2000 ili 3000 IU, što odgovara koncentraciji od 50, 100, 200, 400 ili 600 IU/ml nakon pripreme s 5 ml otapala.
English: All patients were dosed based on their most recent individual incremental recovery.
Croatian: Svim bolesnicima doza je određena na temelju njihova najnovijeg individualnog prirasta po jedinici doze.
English: If you stop using RIXUBIS Do not stop using RIXUBIS without consulting your doctor.
Croatian: Ne prekidajte primjenu lijeka RIXUBIS bez savjetovanja sa svojim liječnikom.
English: Not known
Croatian: nepoznato
English: Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Croatian: Pojedini bolesnici mogu se razlikovati u odgovoru na faktor IX, demonstrirajući različite poluvijekove i povrate.
English: On demand treatment:
Croatian: Liječenje prema potrebi:
English: An additional 14 PTPs received RIXUBIS for the treatment of bleeding episodes only.
Croatian: Dodatnih 14 prethodno liječenih bolesnika dobilo je lijek RIXUBIS samo za liječenje epizoda krvarenja.
English: Previously treated patients 12 years and older:
Croatian: Prethodno liječeni bolesnici u dobi od 12 godina i stariji:
English: - For administration the use of a luer-lock syringe is required.
Croatian: - Za primjenu je potrebna uporaba luer-lock štrcaljke.
English: Adverse Drug Reactions, from clinical trials and spontaneous reports MedDRA Standard System Organ Class
Croatian: Nuspojave iz kliničkih ispitivanja i spontanih izvješća MedDRA standardna klasifikacija organskih sustava (SOC)
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.
Croatian: Ova doza i trajanje ovisit će o težini nedostatka faktora IX, o mjestu i opsegu krvarenja, i o Vašem kliničkom stanju, dobi i o tome kako brzo Vaše tijelo iskorištava faktor IX što će se morati redovito provjeravati.
English: Only plastic luer-lock syringes should be used with this product.
Croatian: Uz ovaj lijek moraju se koristiti samo plastične luer-lock štrcaljke.
English: AUCinf (IU.hr/dL)
Croatian: AUCinf (IU.h/dl)
English: Cleanse stoppers with alcohol swabs.
Croatian: Očistite čepove alkoholnim tupferima.
English: Place the vials on a flat clean surface.
Croatian: Stavite bočice na čistu ravnu površinu.
English: Turn the package over and insert the clear plastic spike through the solvent stopper.
Croatian: Okrenite pakiranje naopako i uvedite prozirni plastični šiljak kroz čep otapala.
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).
Croatian: Ukupno 249 epizoda krvarenja liječeno je lijekom RIXUBIS, od kojih su 197 bila krvarenja zglobova, a 52 krvarenja nije bilo u zglobovima (meko tkivo, mišić, tjelesna šupljina, intrakranijalno i drugo).
English: The RIXUBIS dose range in the repeat pharmacokinetics study was 64.48 to 79.18 IU/kg (n=23).
Croatian: Raspon doza lijeka RIXUBIS u ponovljenom farmakokinetičkom ispitivanju bio je 64,48 do 79,18 IU/kg (n=23).
English: Area under the plasma concentration-time curve from time 0 to infinity.
Croatian: Površina ispod krivulje koncentracija u plazmi-vrijeme u razdoblju od 0 do beskonačnosti.
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.
Croatian: Kad god je to moguće, molimo Vas da zabilježite naziv i broj serije lijeka pri svakoj uporabi lijeka RIXUBIS (na primjer u Vašem dnevniku) kako biste pratili primijenjene lijekove i serije lijeka.
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.
Croatian: Nadomjesnom terapijom povećava se razina faktora IX u plazmi i tako omogućuje privremena korekcija nedostatka faktora te korekcija sklonosti krvarenju.
English: The required dose is determined using the following formula:
Croatian: Potrebna doza određuje se pomoću sljedeće formule: Potrebne jedinice
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Croatian: Liječenje se mora provoditi pod nadzorom liječnika s iskustvom u liječenju hemofilije.
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.
Croatian: Sva 23 muška ispitanika prošla su početnu farmakokinetičku procjenu lijeka RIXUBIS u stanju bez krvarenja kao dio kombiniranog pedijatrijskog ispitivanja faze 2/3.
English: Driving and using machines RIXUBIS has no influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima RIXUBIS ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Posology is the same in adults and paediatric population from 12 to 17.
Croatian: Bolesnici u dobi od 12 do 17 godina: doziranje je jednako u odraslih osoba i pedijatrijske populacije u dobi od 12 do 17 godina.
English: RIXUBIS is used for the treatment and prevention of bleeding in patients with haemophilia B of all age groups.
Croatian: RIXUBIS se koristi za liječenje i prevenciju krvarenja kod bolesnika s hemofilijom B u svim dobnim skupinama.
English: Known allergic reaction to hamster protein.
Croatian: Poznate alergijske reakcije na proteine hrčka.
English: Animal reproduction studies have not been conducted with factor IX.
Croatian: Nisu provedena reproduktivna ispitivanja faktora IX na životinjama.
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.
Croatian: Otopina se mora primijeniti polako, brzinom koja je ugodna bolesniku, ne brže od 10 ml po minuti.
English: RIXUBIS has no influence on the ability to drive and use machines.
Croatian: RIXUBIS ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: If you forget to use RIXUBIS
Croatian: Ako ste zaboravili primijeniti RIXUBIS
English: Fertility There is no information on the effects of factor IX on fertility.
Croatian: Nema informacija o učinku faktora IX na plodnost.
English: RIXUBIS contains sodium
Croatian: RIXUBIS sadrži natrij
English: The data demonstrate that the incremental recovery is consistent over time (see table below).
Croatian: Podaci dokazuju da je prirast po jedinici doze dosljedan tijekom vremena (vidjeti donju tablicu).
English: No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
Croatian: Nisu zabilježene interakcije lijekova koji sadrže koagulacijski faktor IX, ljudski (rDNK) s drugim lijekovima.
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.
Croatian: Zbog rizika od alergijskih reakcija s koncentratima faktora IX, početnu primjenu faktora IX potrebno je, sukladno procjeni nadležnog liječnika, provoditi pod liječničkim nadzorom, na mjestu gdje bi mogla biti pružena odgovarajuća medicinska skrb u slučaju alergijskih reakcija.
English: • one vial of 5 ml sterilised water for injections in a glass vial with a rubber stopper
Croatian: • jednu bočicu od 5 ml sterilizirane vode za injekcije u staklenoj bočici s gumenim čepom
English: Fifty-six of these PTPs who received RIXUBIS for a minimum of 3 months were included in the efficacy evaluation for prophylaxis.
Croatian: Pedeset i šest od tih prethodno liječenih bolesnika koji su primali lijek RIXUBIS najmanje 3 mjeseca bili su uključeni u procjenu djelotvornosti za profilaksu.
English: • one vial of RIXUBIS 250, 500, 1000, 2000 or 3000 IU powder in a glass vial with a rubber stopper
Croatian: • jednu bočicu praška RIXUBIS 250, 500, 1000, 2000 ili 3000 IU u staklenoj bočici s gumenim čepom
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.
Croatian: Djelotvornost lijeka RIXUBIS procijenjena je u kombiniranom ispitivanju faze 2/3, u kojoj je ukupno 23 muških prethodno liječenih bolesnika u dobi između 1,8 i 11,8 godina (medijan dobi 7,10 godina) uz 11 bolesnika < 6 godina, primilo RIXUBIS za profilaksu i kontrolu epizoda krvarenja.
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.
Croatian: Srednja vrijednost trajanja liječenja u kohorti koja se liječila prema potrebi bila je 3,5±1,00 mjeseci (medijan 3,4, u rasponu od 1,2 do 5,1 mjeseci), srednja ukupna godišnja stopa krvarenja bila je 33,9±17,37 uz medijan 27,0, u rasponu od 12,9 do 73,1.