FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not inject two doses on the same day to make up for a forgotten dose.
Slovenian: Ne injicirajte si dveh odmerkov na isti dan, če ste pozabili uporabiti prejšnji odmerek.
English: After you inject your dose, throw away any unused Hemlibra left in the vial.
Slovenian: Potem, ko ste odmerek injicirali, morebitni neporabljeni preostanek zdravila Hemlibra v viali zavrzite.
English: Hemlibra is intended for use under the guidance of a healthcare professional.
Slovenian: Zdravilo Hemlibra je namenjeno za uporabo pod nadzorom zdravstvenega delavca.
English: Two hundred and sixtysix (71 %) were adults, 47(13 %) were adolescents (≥ 12 to < 18 years), 55 (15 %) were children (≥ 2 to < 12 years) and five (1 %) were infants and toddlers (1 month to < 2 years).
Slovenian: Dvesto šestinšestdeset bolnikov (71 %) je bilo odraslih, 47 (13 %) mladostnikov (≥ 12 do < 18 let), 55 (15 %) otrok (≥ 2 do < 12 let) in pet (1 %) dojenčkov in malčkov (1 mesec do < 2 leti).
English: Treatment for the TMA events included supportive care with or without plasmapheresis and haemodialysis.
Slovenian: Zdravljenje TMA je obsegalo podporno oskrbo s plazmaferezo in hemodializo ali brez njiju.
English: - properly labelled to warn of hazardous waste inside the container.
Slovenian: - biti ustrezno označen z opozorilom, da vsebuje nevarne odpadke.
English: Arm D:
Slovenian: Skupina D:
English: The overly shortened intrinsic clotting time will then disturb all single factor assays based on aPTT, such as the one stage FVIII activity assay (see section 4.4, Table 1).
Slovenian: Pretirano kratki časi intrinzičnega časa strjevanja nato zmotijo vse teste posameznih faktorjev na podlagi aPTČ, na primer enostopenjski test aktivnosti FVIII (glejte poglavje 4.4, preglednica 1).
English: Following single subcutaneous injection in healthy subjects, the elimination half-life was approximately 4 to 5 weeks.
Slovenian: Po enkratni subkutani injekciji pri zdravih osebah je bil razpolovni čas izločanja približno 4 do
English: Adapted InhibQoL with aspects of caregiver burden
Slovenian: Prilagojen vprašalnik InhibQoL, ki upošteva vidike bremena skrbnikov
English: Further management should be tailored to the individual clinical circumstances.
Slovenian: Nadaljnje zdravljenje je treba prilagoditi kliničnimu poteku pri posameznem bolniku.
English: Emicizumab remains active in the presence of inhibitors against factor VIII and so will produce a false negative result in clotting based Bethesda assays for functional inhibition of factor VIII.
Slovenian: Emicizumab ostane aktiven v prisotnosti inhibitorjev faktorja VIII in tako povzroči lažno negativen rezultat v testih strjevanja na podlagi metode Bethesda za funkcijsko zavrtje faktorja VIII.
English: Treated spontaneous bleeds
Slovenian: Zdravljene spontane krvavitve
English: Bleed definitions adapted based on ISTH criteria.
Slovenian: Definicije krvavitev so prirejene na podlagi meril ISTH.
English: The most common ADRs reported in ≥ 10% of patients treated with at least one dose of Hemlibra were: injection site reactions (20 %), arthralgia (15 %) and headache (14 %).
Slovenian: Najpogostejši neželeni učinki, zabeleženi pri ≥ 10 % bolnikov, ki so prejeli vsaj en odmerek zdravila Hemlibra, so bili: reakcije na mestu injiciranja (20 %), artralgija (15 %) in glavobol (14 %).
English: The dose of Hemlibra depends on your weight and your doctor will calculate the amount (in mg) and corresponding amount of Hemlibra solution (in mL) to be injected:
Slovenian: Odmerek zdravila Hemlibra je odvisen od vaše telesne mase; zdravnik bo izračunal količino (v mg) in ustrezni volumen zdravila Hemlibra (v ml) za injiciranje takole:
English: ● Do not try to warm the vial by any other way.
Slovenian: ● Vial ne poskušajte segrevati kako drugače.
English: Forty one patients ≥ 12 years old were evaluated for efficacy with a median observation time of 25.6 weeks (range 24.1-29.4).
Slovenian: Enainštirideset (41) bolnikov, starih ≥ 12 let, so ocenili glede učinkovitosti v času opazovanja, ki je mediano trajal 25,6 tedna (razpon: od 24,1 do 29,4).
English: There are no clinical studies of emicizumab use in pregnant women.
Slovenian: Kliničnih študij o uporabi emicizumaba pri nosečnicah ni.
English: Treatment (including routine prophylaxis) with bypassing agents (e.g. aPCC and rFVIIa) should be discontinued the day before starting Hemlibra therapy (see section 4.4).
Slovenian: Zdravljenje (tudi redno profilakso) z obvodnimi zdravili ("obvodna zdravila" (bypassing agents), npr. aPCC in rFVIIa), je treba prekiniti na dan pred uvedbo zdravljenja z zdravilom Hemlibra (glejte poglavje 4.4).
English: Move safety shield
Slovenian: Pomaknite varnostni ščitnik
English: ● Outer area of the upper arm (only if a caregiver is giving the injection).
Slovenian: ● v zunanji del nadlakti (le če vam injekcijo da skrbnik).
English: Prior to launch of Hemlibra in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: ● Dodatni ukrepi za zmanjševanje tveganj Pred prihodom zdravila Hemlibra na trg se mora imetnik dovoljenja za promet z zdravilom v vsaki državi članici z nacionalnim pristojnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načinom razdeljevanja in vsemi ostalimi vidiki programa.
English: Administration by the patient and/or caregiver
Slovenian: Dajanje zdravila s strani bolnika in/ali skrbnika
English: ● If your prescribed dose is more than 2 mL, you will need to have more than one subcutaneous injection of Hemlibra; contact your healthcare provider for the injection instructions.
Slovenian: ● Če imate predpisan odmerek več kot 2 ml, boste potrebovali več kot eno subkutano injekcijo zdravila Hemlibra; za navodila za injiciranje se obrnite na zdravnika.
English: Inject air into vial
Slovenian: Injicirajte zrak v vialo
English: ● If you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the injection site for at least 10 seconds, until bleeding has stopped.
Slovenian: ● Če na mestu injiciranja opazite kapljice krvi, lahko na mesto injiciranja za vsaj 10 sekund pritisnete s sterilnim kosmom vate ali sterilno gazo, dokler se krvavitev ne ustavi.
English: Only 6 patients had moderate hepatic impairment (1.5 × ULN < bilirubin ≤ 3 × ULN and any AST).
Slovenian: Le 6 bolnikov je imelo zmerno okvaro jeter (1,5 × ZMN < bilirubin £ 3 × ZMN in kakršen koli AST).
English: Emicizumab is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific antibody structure.
Slovenian: Emicizumab je humanizirano monoklonsko protitelo - spremenjeni imunoglobulin G4 (IgG4) z bispecifično strukturo protitelesa.
English: ● For each injection, use a different area of the body to the one you used last time.
Slovenian: ● Za vsako injiciranje uporabite drug predel na telesu, kot ste ga uporabili predhodno.
English: ● Place the supplies on a clean, well-lit flat work surface.
Slovenian: ● Položite ves material na čisto in dobro osvetljeno, ravno delovno površino.
English: In rare cases, a blood clot can form inside blood vessels and block them, which may be life-threatening.
Slovenian: V redkih primerih se lahko v žilah tvori krvni strdek in jih zamaši, kar je lahko življenjsko ogrožajoče.
English: Emicizumab has no structural relationship or sequence homology to factor VIII and, as such, does not induce or enhance the development of direct inhibitors to factor VIII.
Slovenian: Emicizumab nima strukturne sorodnosti ali homolognosti zaporedja s faktorjem VIII in tako ne povzroči in ne pospešuje razvoja neposrednih inhibitorjev faktorja VIII.
English: It is important to know the symptoms of such internal blood clots, in case they develop (see section 4, “Possible side effects” for a list of symptoms).
Slovenian: Pomembno je, da poznate simptome takšnih notranjih krvnih strdkov za primer, da bi se vam ti pojavili (za seznam simptomov glejte poglavje 4, "Možni neželeni učinki").
English: Annualized bleed rate and percent of patients with zero bleeds were calculated (see Table 11).
Slovenian: Izračunali so na leto preračunani delež krvavitev in odstotek bolnikov, ki niso imeli nobene krvavitve (glejte preglednico 11).
English: Your healthcare provider should show you how to prepare, measure, and inject Hemlibra properly before you use it for the first time.
Slovenian: Zdravnik vam mora pokazati, kako zdravilo Hemlibra pravilno pripravite, odmerite in injicirate, preden boste to zdravilo prvič uporabili.
English: Some patients with haemophilia A can develop factor VIII inhibitors (antibodies against factor VIII) which stop the replacement factor VIII from working.
Slovenian: Nekaterim bolnikom s hemofilijo A se lahko pojavijo inhibitorji faktorja VIII (protitelesa proti faktorju VIII), ki preprečijo delovanje nadomestnega faktorja VIII.
English: ● Make sure the name Hemlibra is on the box and vial label.
Slovenian: ● Preverite, da je na škatli in nalepki viale ime Hemlibra.
English: Characterization of the interaction between emicizumab and aPCC treatment in pivotal clinical trials
Slovenian: Opredelitev interakcije med emicizumabom in zdravljenjem z aPCC v ključnih kliničnih preskušanjih
English: The HAVEN adult and adolescent clinical studies evaluated patient-reported hemophilia-related quality of life outcomes with the Haemophilia-Specific Quality of Life (Haem-A-QoL) questionnaire for adults (> 18 years) and its adolescent version (Haemo-QoL-SF, for 8 to <18 years),the Physical Health Score (i.e., painful swellings, presence of joint pain, pain with movement, difficulty walking far and needing more time to get ready) and Total Score (summary of all scores) were protocol defined endpoints of interest.
Slovenian: V kliničnih študijah HAVEN pri odraslih in mladostnikih so ocenili izide s hemofilijo povezane kakovosti življenja po navedbi bolnikov z vprašalnikom Haem-A-QoL (Haemophilia-Specific Quality of Life - za hemofilijo specifična kakovost življenja) pri odraslih (starih > 18 let) in z različico tega vprašalnika za mladostnike Haemo-QoL-SF pri bolnikih, starih od 8 do < 18 let; ocena telesnega zdravja (tj. boleče otekline, prisotnost bolečin v sklepih, bolečine pri gibanju, težave pri daljši hoji in bolnikova potreba po več časa, da se pripravi) in celotna ocena (seštevek vseh ocen) sta bila v protokolu opredeljena pomembna opazovana dogodka.
English: ADRs from the phase III clinical trials in patients who received Hemlibra are listed by MedDRA system organ class (Table 2).
Slovenian: Neželeni učinki v kliničnih preskušanjih faze III pri bolnikih, ki so prejemali zdravilo Hemlibra, so našteti po organskih sistemih MedDRA (preglednica 2).
English: ● Before opening the vial, read the vial label to make sure you have the correct medicine strength(s) to give the dose prescribed for you.
Slovenian: ● Preden vialo odprete, preberite nalepko viale in se tako prepričajte, da imate ustrezno jakost zdravila za pripravo odmerka, ki vam je bil predpisan.
English: During treatment with Hemlibra, other medicinal products for subcutaneous administration should, preferably, be injected at different anatomical sites.
Slovenian: Med zdravljenjem z zdravilom Hemlibra je treba druga zdravila za subkutano uporabo po možnosti injicirati na drugih anatomskih mestih.
English: ● Make sure that you use a new injection needle for each injection and dispose of it after a single use.
Slovenian: ● Poskrbite, da boste za vsako injiciranje uporabili novo injekcijsko iglo in da boste iglo po enkratni uporabi zavrgli.
English: ● Hemlibra is given by injection under the skin (subcutaneously).
Slovenian: ● Zdravilo Hemlibra je treba injicirati pod kožo (subkutano).
English: Patients who receive an accidental overdose should immediately contact their physician and be monitored closely.
Slovenian: Bolniki, ki naključno prejmejo prevelik odmerek, se morajo nemudoma obrniti na zdravnika.
English: Inspecting the medicine and your supplies:
Slovenian: Pregled zdravila in materiala:
English: Table 10 HAVEN 1: EQ-5D-5L scores in patients ≥ 12 years at week 25
Slovenian: Študija HAVEN 1: Ocene EQ-5D-5L pri bolnikih, starih ≥ 12 let, v 25. tednu
English: Thrombotic events
Slovenian: Trombotičen dogodek
English: Do not stop using Hemlibra without talking to your doctor.
Slovenian: Ne prenehajte uporabljati zdravila Hemlibra, ne da bi se prej posvetovali z zdravnikom.
English: Median Efficacy Period (weeks)
Slovenian: Mediano obdobje učinkovitosti
English: Repeat steps A to F with each additional vial until you have more than your prescribed dose.
Slovenian: Ponavljajte korake od A do F z vsako dodatno vialo, dokler nimate količine, ki je večja od predpisanega odmerka.
English: At the time of the primary analysis, two patients underwent up-titration of their maintenance dose to 3 mg/kg once weekly.
Slovenian: V času primarne analize so dvema bolnikoma vzdrževalni odmerek povečali na 3 mg/kg enkrat na teden.
English: The developing hemostatic system in neonates and infants is dynamic and evolving, and the relative concentrations of pro- and anticoagulant proteins in these patients should be taken into consideration when making a benefit-risk assessment, including potential risk of thrombosis (e.g. central venous catheter-related thrombosis).
Slovenian: Razvoj hemostatičnega sistema pri novorojenčkih in dojenčkih je dinamičen in se spreminja, zato je treba pri teh bolnikih za oceno koristi in tveganja upoštevati relativno koncentracijo prokoagulacijskih in antikoagulacijskih beljakovin, vključno z možnim tveganjem za trombozo (npr. trombozo, povezano s centralnim venskim katetrom).
English: In HAVEN 2, HRQoL for patients aged ≥ 8 to < 12 years was evaluated at week 25 based on the Haemo-QoL-SF questionnaire for children(see Table 13).
Slovenian: V študiji HAVEN 2 so zdravstveno kakovost življenja bolnikov, starih od ≥ 8 do < 12 let, ocenili v 25. tednu z vprašalnikom Haemo-QoL-SF za otroke (glejte preglednico 13).
English: Patients in Arm C could switch to Hemlibra (3 mg/kg every two weeks) after completing at least 24 weeks without prophylaxis.
Slovenian: Bolniki v skupini C so lahko prešli na zdravilo Hemlibra (3 mg/kg na dva tedna), ko so dokončali vsaj 24 tednov brez profilakse.
English: Mean (±95% CI) plasma emicizumab concentration versus time profiles for patients ≥ 12 years (studies HAVEN 1 and HAVEN 3) compared with patients < 12 years (study HAVEN 2)
Slovenian: Slika 1: Povprečna (± 95-% IZ) koncentracija emicizumaba v plazmi glede na čas za bolnike ≥ 12 let (študiji HAVEN 1 in HAVEN 3) v primerjavi z bolniki < 12 let (študija HAVEN 2)
English: Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with
Slovenian: Zdravilo Hemlibra je indicirano za redno profilakso krvavitev pri bolnikih s:
English: The most commonly reported ISR symptoms were injection site erythema (11 %), injection site pain (4 %) and injection site pruritus (3 %).
Slovenian: Najpogosteje zabeleženi simptomi reakcij na mestu injiciranja so bili eritem na mestu injiciranja (11 %), bolečina na mestu injiciranja (4 %) in srbenje na mestu injiciranja (3 %).
English: Your doctor will consider the benefit of you taking Hemlibra against the risk to your baby.
Slovenian: Zdravnik bo upošteval koristi uporabe zdravila Hemlibra v primerjavi s tveganjem za otroka.
English: ● Be careful not to pull the plunger out of the syringe.
Slovenian: ● Pazite, da bata ne potegnete iz brizge.
English: The primary objective of the study was to evaluate the efficacy of Hemlibra prophylaxis given every four weeks in maintaining adequate bleed control, based on treated bleeds.
Slovenian: Primarni cilj študije je bila ocena učinkovitosti profilakse z zdravilom Hemlibra, uporabljenim na štiri tedne, na vzdrževanje ustreznega nadzora krvavitev (na podlagi zdravljenih krvavitev).
English: If bleeding is not controlled with the initial dose of aPCC up to 50 U/kg, additional aPCC doses should be administered under medical guidance or supervision with consideration made to laboratory monitoring for the diagnosis of TMA or thromboembolism and verification of bleeds prior to repeated dosing.
Slovenian: Če krvavitev ni obvladana z začetnim odmerkom aPCC do 50 e./kg, je treba dodatne odmerke aPCC uporabiti pod vodstvom ali nadzorom zdravnika; poskrbeti je treba za laboratorijsko spremljanje morebitne diagnoze TMA ali trombembolije in potrditev krvavitve pred ponovnim odmerjanjem.
English: In case of thrombotic complication, the physician should consider discontinuing rFVIIa or FVIII and interrupt Hemlibra prophylaxis as clinically indicated.
Slovenian: V primeru trombotičnega zapleta mora zdravnik razmisliti o prenehanju uporabe rFVIIa ali FVIII in prekiniti profilakso z zdravilom Hemlibra, kot je klinično indicirano.
English: ● Injection needle with safety shield (Used to inject medicine).
Slovenian: ● Igle za injiciranje z varnostnim ščitnikom (uporablja se za injiciranje zdravila).
English: Preparing the syringe for injection:
Slovenian: Priprava brizge za injiciranje:
English: Prophylactic therapy with Hemlibra shortens the aPTT and increases the reported factor VIII activity (using a chromogenic assay with human coagulation factors).
Slovenian: Profilaktično zdravljenje z zdravilom Hemlibra skrajša aPTČ in poveča aktivnost faktorja VIII (rezultat, dobljen z uporabo kromogenega testa s človeškimi koagulacijskimi faktorji).
English: Guidance on the use of bypassing agents concomitantly with emicizumab and on the dosing recommendations for patients requiring treatment with bypassing agents in the perioperative setting;
Slovenian: Smernice o uporabi obvodnih zdravil sočasno z emicizumabom in priporočila za odmerjanje pri bolnikih, ki potrebujejo zdravljenje z obvodnimi zdravili v perioperativnem okolju;
English: Following subcutaneous administration in haemophilia A patients, the absorption half-life was 1.6 days.
Slovenian: Po subkutani uporabi pri bolnikih s hemofilijo A je bil absorpcijski razpolovni čas 1,6 dneva.
English: As with all therapeutic proteins, there is the potential for an immune response in patients treated with emicizumab.
Slovenian: Tako kot pri vseh terapevtskih beljakovinah obstaja pri bolnikih, zdravljenih z emicizumabom,
English: ● or with severe haemophilia A who have not developed factor VIII inhibitors (the FVIII blood level is less than 1%).
Slovenian: ● hudo hemofilijo A, pri katerih se niso pojavili inhibitorji faktorja VIII (raven FVIII v krvi je nižja od 1 %).
English: In this Study baseline Total Scores (mean = 41.14 and 44.58, respectively) and Physical Health scale scores (mean = 52.41 and 57.19, respectively) were similar for Hemlibra prophylaxis and no prophylaxis.
Slovenian: V tej študiji so bile izhodiščne vrednosti celotne ocene (povprečje = 41,14 oziroma 44,58) in ocene na lestvici telesnega zdravja (povprečje = 52,41 in 57,19) podobne med skupinama s profilakso z zdravilom Hemlibra oz. obravnavo brez profilakse.
English: There are limited data available on the use of Hemlibra in patients with moderate renal or hepatic impairment.
Slovenian: Na voljo so omejeni podatki za uporabo zdravila Hemlibra pri bolnikih z zmerno okvaro ledvic ali jeter.
English: Examples of bypassing agents include activated prothrombin complex concentrate (aPCC) and recombinant FVIIa (rFVIIa).
Slovenian: Primera obvodnih zdravil sta koncentrat aktiviranega protrombinskega kompleksa (aPCC - activated prothrombin complex concentrate) in rekombinantni FVIIa (rFVIIa).
English: Arm C: includes no prophylaxis period only.
Slovenian: Skupina C: vključuje le obdobje brez profilakse.
English: ● If you have bruising (small area of bleeding under the skin), an ice pack can also be pressed gently on the site.
Slovenian: ● Če se pojavi podplutba (majhna krvavitev pod kožo), lahko na mesto rahlo pritisnete leden vložek.
English: cMedian ABR (IQR) bN = 59
Slovenian: cMediani ABR (IQR) bn = 59
English: Recommendation that the laboratory director contact the patient's treating physician to discuss any abnormal test results.
Slovenian: Priporočilo, da se vodja laboratorija o kakršnih koli nenormalnih izvidih posvetuje z bolnikovim lečečim zdravnikom.
English: Stop using Hemlibra and aPCC and talk to a doctor immediately if you or your caregiver notices any of the following side effects:
Slovenian: Nemudoma prenehajte uporabljati zdravilo Hemlibra in aPCC in se nemudoma posvetujte z zdravnikom, če vi ali vaš skrbnik opazite katerega od naslednjih neželenih učinkov:
English: Roche Austria GmbH Engelhorngasse 3 1211 Wien Austria
Slovenian: Roche Austria GmbH Engelhorngasse 3 1211 Wien Avstrija
English: - the medicine contains particles.
Slovenian: - če zdravilo vsebuje delce.
English: Following a single intravenous dose of 0.25 mg/kg emicizumab in healthy subjects, the volume of distribution at steady state was 106 mL/kg (i.e. 7.4 L for a 70-kg adult).
Slovenian: Po enkratnem intravenskem odmerku 0,25 mg/kg emicizumaba pri zdravih preiskovancih je bil volumen porazdelitve v stanju dinamičnega ravnovesja 106 ml/kg (to pomeni 7,4 l za 70 kg težkega odraslega).
English: At the time of the primary analysis, five patients underwent up-titration of their maintenance dose.
Slovenian: Ob času primarne analize je bilo povečanje vzdrževalnega odmerka zabeleženo pri petih bolnikih.
English: ● Do not try to remove the used injection needle from the used syringe.
Slovenian: ● Ne poskušajte uporabljene igle za injiciranje sneti z uporabljene brizge.
English: The patient should not take two doses on the same day to make up for a missed dose.
Slovenian: Bolnik ne sme uporabiti dveh odmerkov v istem dnevu, če je pozabil uporabiti prejšnji odmerek.
English: Physical health score (range 0 to 100)
Slovenian: Ocena telesnega zdravja (razpon: 0 do 100)
English: If you use more Hemlibra than you should
Slovenian: Če ste uporabili večji odmerek zdravila Hemlibra, kot bi smeli
English: The apparent volume of distribution (V/F), estimated from the population PK analysis, in haemophilia A patients following multiple subcutaneous doses of emicizumab was 10.4 L. Metabolism
Slovenian: Navidezni volumen porazdelitve (V/F), ocenjen s populacijsko farmakokinetično analizo, je bil pri bolnikih s hemofilijo A po večkratnih subkutanih odmerkih emicizumaba 10,4 l.
English: Hemlibra restores the function of missing activated factor VIII that is needed for effective blood clotting.
Slovenian: Zdravilo Hemlibra obnovi funkcijo manjkajočega aktiviranega faktorja VIII, ki je potreben za učinkovito strjevanje krvi.
English: No incompatibilities between Hemlibra and polypropylene or polycarbonate syringes , polycarbonate vial adapters and stainless steel needles have been observed.
Slovenian: Med zdravilom Hemlibra ter polipropilenskimi ali polikarbonatnimi brizgami, polikarbonatnimi adapterji za viale in iglami iz nerjavnega jekla niso opažali inkompatibilnosti.
English: You may need to use more than 1 vial to give yourself the correct dose.
Slovenian: Za ustrezen odmerek boste morda morali uporabiti več kot 1 vialo.
English: The following adverse drug reactions (ADRs) are based on pooled data from four phase III clinical trials (adult and adolescent studies [BH29884 - HAVEN 1, BH30071 - HAVEN 3, and BO39182HAVEN 4] and a paediatric study BH29992 - HAVEN 2]), in which a total of 373 male patients with haemophilia A received at least one dose of Hemlibra as routine prophylaxis.
Slovenian: (študijah pri odraslih in mladostnikih [BH29884 - HAVEN 1, BH30071 - HAVEN 3 in BO39182HAVEN 4] in študiji pri pediatričnih bolnikih BH29992 - HAVEN 2]), v katerih je skupno 373 moških bolnikov s hemofilijo A prejelo vsaj en odmerek zdravila Hemlibra za redno profilakso.
English: It is important to know the symptoms of thrombotic microangiopathy, in case you develop the condition (see section 4, “Possible side effects” for a list of symptoms).
Slovenian: Pomembno je, da poznate simptome trombotične mikroangiopatije za primer, da bi se vam ta pojavila (za seznam simptomov glejte poglavje 4, "Možni neželeni učinki").