FrancophonIA/ELRC3.0 huggingface dataset:
English: The Haemo-QoL-SF is a valid and reliable measure of HRQoL.
Slovenian: Vprašalnik Haemo-QoLSF je veljavno in zanesljivo merilo zdravstvene kakovosti življenja.
English: Do not use these instructions when using a transfer needle to withdraw Hemlibra from vial.
Slovenian: Teh navodil ne uporabljajte, če za jemanje zdravila Hemlibra iz viale uporabljate iglo za prenos.
English: Serious side effects of using aPCC while receiving Hemlibra
Slovenian: Resni neželeni učinki uporabe aPCC med zdravljenjem z zdravilom Hemlibra
English: ● Important: Always keep the sharps disposal container out of reach of children.
Slovenian: ● Pomembno: Vsebnik za ostre odpadke vedno shranjujte nedosegljiv otrokom.
English: ● Check the expiry date on the box, on the vial label and on the supplies listed below.
Slovenian: ● Preverite datum izteka roka uporabnosti na škatli, na nalepki viale in na spodaj naštetem materialu.
English: The study evaluated the pharmacokinetics, safety, and efficacy including the efficacy of weekly Hemlibra prophylaxis compared with previous episodic and prophylactic bypassing agent treatment in patients who had participated in the NIS prior to enrolment (intra-patient comparison).
Slovenian: Študija je ocenila farmakokinetiko, varnost in učinkovitost, vključno z učinkovitostjo tedenske profilakse z zdravilom Hemlibra v primerjavi s predhodno občasno oziroma profilaktično uporabo obvodnih zdravil pri bolnikih, ki so pred vključitvijo v to študijo sodelovali v neintervencijski študiji
English: ● Holding the syringe with one hand, press the safety shield down against a flat surface with a firm, quick motion until you hear a “click”.
Slovenian: ● Medtem ko držite brizgo z eno roko, s čvrstim, hitrim gibom pritisnite varnostni ščitnik navzdol ob ravno površino, dokler ne zaslišite "klik".
English: The bypassing agent dose required may therefore be lower than that used without Hemlibra prophylaxis.
Slovenian: Zato je lahko potrebni odmerek obvodnega zdravila manjši kot brez profilakse z zdravilom Hemlibra.
English: Physical health score (range 0 to 100)a
Slovenian: Ocena telesnega zdravja (razpon: 0 do 100)a
English: Due to the short half-life of FVIII, no carryover effect is assumed after it's discontinuation.
Slovenian: Zaradi kratkega razpolovnega časa FVIII se po prenehanju zdravljenja z njim ne predvideva učinek prenosa.
English: ● Take the vial out of the refrigerator 15 minutes before use and allow it to reach room temperature (below 30°C) before preparing an injection.
Slovenian: ● Vialo vzemite iz hladilnika 15 minut pred uporabo in pustite, da doseže sobno temperaturo (do 30 °C),
English: Pediatric Health-Related Outcomes Results
Slovenian: Zdravstveni izidi pri pediatričnih bolnikih
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: ● The Summary of Product Characteristics
Slovenian: ● Povzetek glavnih značilnosti zdravila
English: Using syringes and needles
Slovenian: Uporaba brizg in igel
English: Subcutaneous (under the skin) injection
Slovenian: Subkutano (podkožno) injiciranje
English: ● Guide for patients/carers
Slovenian: ● Vodnik za bolnike/skrbnike
English: Seven patients previously treated with episodic (“on-demand”) bypassing agents who had participated in the NIS prior to enrolment but were unable to enroll in HAVEN 1 prior to the closure of Arms A and B were enrolled in Arm D to receive Hemlibra prophylaxis.
Slovenian: Sedem bolnikov, ki so predhodno občasno (“po potrebi”) prejemali obvodna zdravila in so pred vključitvijo sodelovali v neintervencijski študiji, a se niso mogli vključiti v študijo HAVEN 1 pred zaključkom skupin A in B, so vključili v skupino D in so prejemali profilakso z zdravilom Hemlibra.
English: ● Once the injection needle cap has been removed, the medicine in the syringe must be injected under the skin within 5 minutes.
Slovenian: ● Po odstranitvi pokrovčka igle za injiciranje je treba zdravilo v injekcijski brizgi injicirati pod kožo v 5 minutah.
English: Do not use the transfer needle to inject the medicine.
Slovenian: Igle za prenos ne uporabljajte za injiciranje zdravila.
English: Option (For transfer of HEMLIBRA from vial to syringe)
Slovenian: Možnost uporabe (za prenos zdravila HEMLIBRA iz viale v brizgo)
English: ● Do not touch the needle tip.
Slovenian: ● Ne dotikajte se konice igle.
English: If you need to use more than 1 vial to inject your prescribed dose, you must use a new vial adapter for each vial.
Slovenian: Če za injiciranje predpisanega odmerka potrebujete več kot 1 vialo, morate za vsako vialo uporabiti nov adapter za vialo.
English: DISPOSAL Step 16.
Slovenian: ODLAGANJE 16. korak.
English: ● Loading dose regimen: Weeks 1 to 4: The dose is 3 milligrams for every 1 kilogram you weigh, injected once a week.
Slovenian: ● Režim polnilnega odmerka: Od 1. do 4. tedna: Odmerek je 3 miligrame na 1 kilogram telesne mase, injiciran enkrat na teden.
English: ● Take the cap off the vial(s).
Slovenian: ● Snemite pokrovček vial(e).
English: Hemlibra solution for injection vials are for single-use only.
Slovenian: Viale z raztopino zdravila Hemlibra za injiciranje so le za enkratno uporabo.
English: ● Prepare and give the injection in clean and germ-free conditions using aseptic technique.
Slovenian: ● Injekcijo pripravite in zdravilo injicirajte v čistih pogojih brez klic ter uporabite aseptičen postopek.
English: Uncommon: may affect up to 1 in 100 people
Slovenian: ● driska Občasni: pojavijo se lahko pri do 1 od 100 bolnikov
English: No data are available with respect to potential side effects of emicizumab on embryo-foetal development.
Slovenian: Podatkov o možnih neželenih učinkih emicizumaba na embrio-fetalni razvoj ni.
English: All bleeds: bleeds treated and not treated with FVIII or rFVIIa Patients exposed to emicizumab started with a loading dose of 3mg/kg/week for 4 weeks.
Slovenian: Zdravljene krvavitve = krvavitve, zdravljene s FVIII ali rFVIIa Vse krvavitve: krvavitve, ki so bile in ki niso bile zdravljene s FVIII ali rFVIIa Bolniki, izpostavljeni emicizumabu, so zdravljenje začeli s polnilnim odmerkom 3 mg/kg/teden za 4 tedne.
English: Do not throw away any loose caps, vials, needles and syringes in your household waste.
Slovenian: Pokrovčkov, vial, igel in brizg ne odvrzite med gospodinjske odpadke.
English: ● After the injection needle cap has been removed, the medicine in the syringe must be injected within 5 minutes.
Slovenian: ● Po odstranitvi pokrovčka igle za injiciranje je treba zdravilo v injekcijski brizgi injicirati v 5 minutah.
English: Tell your doctor if you are using Hemlibra before you have laboratory tests to measure how well your blood is clotting.
Slovenian: Laboratorijske preiskave Zdravnika morate obvestiti, da uporabljate zdravilo Hemlibra, preden opravite laboratorijske preiskave, ki merijo strjevanje krvi.
English: This belongs to a group of medicines called “monoclonal antibodies”.
Slovenian: imenovanih "monoklonska protitelesa".
English: Caution should be used when treating patients who are at high risk for TMA (e.g. have a previous medical history or family history of TMA), or those who are receiving concomitant medications known to be a risk factor for the development of TMA (e.g. ciclosporin, quinine, tacrolimus).
Slovenian: Pri zdravljenju bolnikov z visokim tveganjem za TMA (npr. s predhodno anamnezo ali družinsko anamnezo TMA) ali tistih, ki sočasno prejemajo zdravila, za katera je znano, da je njihovo jemanje dejavnik tveganja za razvoj TMA (npr. ciklosporin, kinin, takrolimus), je potrebna previdnost.
English: Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or the skin is broken.
Slovenian: Ne injicirajte v znamenja, brazgotine, podplute predele ali predele, kjer je koža občutljiva, pordela, trda ali razpokana.
English: ● Collect all supplies listed below to prepare and give your injection.
Slovenian: ● Za pripravo injekcije in injiciranje zdravila zberite ves spodaj našteti material.
English: Do not use the transfer needle to inject medicine as this may cause harm such as pain and bleeding.
Slovenian: Igle za prenos ne uporabljajte za injiciranje zdravila, ker vam lahko to škoduje, na primer povzroči bolečine in krvavitev.
English: For injection, you can use your:
Slovenian: Injicirate lahko v:
English: Hemlibra is provided in single-use vials as ready to use solution which does not need to be diluted.
Slovenian: Kako uporabljati zdravilo Hemlibra Zdravilo Hemlibra je na voljo v vialah za enkratno uporabo kot že pripravljena raztopina, ki je ni treba razredčiti.
English: ● Vial containing the medicine
Slovenian: ● Vialo z zdravilom
English: ● Firmly press down the plastic blister pack with the vial adapter onto the new vial at an angle, until you hear a ‘click'.
Slovenian: ● Trdno pritisnite plastični pretisni omot z adapterjem za vialo na novo vialo pod kotom, dokler ne zaslišite "klik".
English: Guidance on the use of bypassing agents in patients receiving Hemlibra prophylaxis
Slovenian: Smernice za uporabo obvodnih zdravil pri bolnikih, ki prejemajo profilakso z zdravilom Hemlibra
English: ● When using Hemlibra, any other medicine injected under the skin should be given in a different area.
Slovenian: ● Ko uporabljate zdravilo Hemlibra, je treba vsa druga zdravila za podkožno injiciranje dati na drugem mestu.
English: Cavg, ss = average concentration at steady state; Cmax, ss = maximum plasma concentration at steady state; Ctrough, ss = trough concentration at steady state; QW = once weekly; Q2W = every two weeks; Q4W = every four weeks.
Slovenian: Cavg, ss = povprečna koncentracija v stanju dinamičnega ravnovesja; Cmax, ss = največja koncentracija v plazmi v stanju dinamičnega ravnovesja; Ctrough, ss = najmanjša koncentracija v plazmi pred naslednjim odmerkom v stanju dinamičnega ravnovesja;
English: The efficacy of Hemlibra for routine prophylaxis in patients with hemophilia A with or without FVIII inhibitors was evaluated in four clinical studies (three adult and adolescent studies [HAVEN 3, HAVEN 1, and HAVEN 4] and a paediatric study [HAVEN 2]).
Slovenian: Učinkovitost zdravila Hemlibra za rutinsko profilakso pri bolnikih s hemofilijo A z inhibitorji FVIII ali brez njih so ocenili v štirih kliničnih študijah (treh študijah pri odraslih in mladostnikih [HAVEN 3,
English: The primary objective of the study was to evaluate in patients previously treated with episodic FVIII the efficacy of prophylactic Hemlibra weekly (Arm A) or every two weeks (Arm B) compared to no prophylaxis (Arm C) based on the number of bleeds requiring treatment with coagulation factors (see Table 4).
Slovenian: Primarni cilj študije je bil med bolniki, predhodno občasno zdravljenimi s FVIII, oceniti učinkovitost profilaktične uporabe zdravila Hemlibra vsak teden (skupina A) ali vsaka dva tedna (skupina B) v primerjavi z bolniki brez profilakse (skupina C) na podlagi števila krvavitev, ki so zahtevale zdravljenje s koagulacijskimi faktorji (glejte preglednico 4).
English: Thrombotic microangiopathy
Slovenian: Trombotična mikroangiopatija
English: No dose adjustments are recommended in paediatric patients (see section 5.2).
Slovenian: Pediatrični bolniki Za pediatrične bolnike ni priporočenih prilagoditev odmerjanja (glejte poglavje 5.2).
English: % Zero Bleeds (95% CI) bN = 59
Slovenian: % brez krvavitev (95-% IZ) bn = 59
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije in/ali drugih motenj strjevanja krvi.
English: ● Physician educational material
Slovenian: ● Izobraževalno gradivo za zdravnike
English: ● Blood clots (thromboembolism): swelling, warmth, pain or redness - these symptoms may be signs of a blood clot in a vein near the surface of the skin.
Slovenian: Oteklost, toplota, bolečina ali rdečina - ti simptomi so lahko znaki krvnega strdka v veni blizu površine kože.
English: Relative bioavailability decreased with older age, but no clinically important differences were observed in the pharmacokinetics of emicizumab between subjects < 65 years and subjects ≥ 65 years.
Slovenian: Relativna biološka uporabnost se je s starostjo zmanjšala, vendar med preiskovanci, starimi < 65 let, in preiskovanci, starimi ≥ 65 let, niso opazili klinično pomembnih razlik v farmakokinetiki emicizumaba.
English: What Hemlibra looks like and contents of the pack
Slovenian: Izgled zdravila Hemlibra in vsebina pakiranja
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: Reversible hemorrhage, perivascular mononuclear cell infiltration, degeneration/necrosis of subcutis and swelling of endothelium in the subcutis was noted in animals after subcutaneous injection.
Slovenian: Po subkutanem injiciranju so pri živalih opazili reverzibilno krvavitev, perivaskularno infiltracijo z mononuklearnimi celicami, degeneracijo/nekrozo podkožja in edem endotelija v podkožju.
English: It is a colourless to slightly yellow liquid.
Slovenian: ● Je brezbarvna do rumenkasta tekočina.
English: ● destruction of red blood cells (thrombotic microangiopathy)
Slovenian: ● Propadanje rdečih krvnih celic (trombotična mikroangiopatija)
English: ● The guide for laboratory professionals shall contain the following key messages: Chemical class, mode of action, pharmacodynamics and indication for emicizumab Information on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and not accurately reflect the patient's underlying hemostatic status during emicizumab prophylaxis.
Slovenian: Kemijski razred, mehanizem delovanja, farmakodinamika in indikacija emicizumaba; Informacije, da emicizumab moti nekatere laboratorijske koagulacijske teste, kar vpliva na njihovo zanesljivost, in med profilakso z emicizumabom natančno ne odražajo bolnikovega osnovnega hemostatičnega statusa.
English: Previous bypassing agent treatment* (N = 18)
Slovenian: Predhodno zdravljenje z obvodnim zdravilom* (n = 18)
English: HRQoL for patients ages < 12 years was also evaluated at week 25 based on the Adapted InhibQoL with Aspects of Caregiver Burden questionnaire completed by caregivers (see Table 13).
Slovenian: Zdravstveno kakovost življenja bolnikov, mlajših od 12 let, so v 25. tednu ocenili tudi s prilagojenim vprašalnikom InhibQoL, ki upošteva vidike bremena skrbnikov (Adapted InhibQoL with Aspects of Caregiver Burden); ta vprašalnik so izpolnili bolnikovi skrbniki.
English: No TMA or thrombotic events were associated with the remaining instances of aPCC treatment.
Slovenian: Preostali primeri zdravljenja z aPCC niso bili povezani s TMA ali trombotičnimi dogodki.
English: In summary, intrinsic pathway clotting-based laboratory test results in patients treated with Hemlibra should not be used to monitor its activity, determine dosing for factor replacement or anti-coagulation, or measure factor VIII inhibitors titers.
Slovenian: Če povzamemo, se pri bolnikih, zdravljenih z zdravilom Hemlibra, ne sme uporabljati rezultatov laboratorijskih testov intrinzične poti strjevanja za nadzor aktivnosti, določanje odmerkov za nadomeščanje faktorja ali antikoagulacijo ali za merjenje titrov inhibitorjev faktorja VIII.
English: Important: Always keep the sharps disposal container out of reach of children.
Slovenian: Pomembno: Vsebnik za ostre odpadke vedno shranjujte nedosegljiv otrokom.
English: Patients exposed to emicizumab started with a loading dose of 3 mg/kg/week for 4 weeks.
Slovenian: Bolniki, izpostavljeni emicizumabu, so zdravljenje začeli s polnilnim odmerkom 3 mg/kg/teden za 4 tedne.
English: LIST OF EXCIPIENTS Excipients: L-Arginine, L-Histidine, L-Aspartic acid, Poloxamer 188, water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: L-arginin, L-histidin, L-asparaginska kislina, poloksamer 188, voda za injekcije
English: Emicizumab restores the tenase cofactor activity of missing activated factor VIII (FVIIIa).
Slovenian: Vpliv emicizumaba na koagulacijske teste Emicizumab obnovi aktivnost tenaznega kofaktorja manjkajočega aktiviranega faktorja VIII (FVIIIa).
English: The amount of Hemlibra solution given in each injection must not be more than 2 mL
Slovenian: Količina raztopine zdravila Hemlibra, ki jo uporabite pri enem injiciranju, ne sme presegati 2 ml.
English: ● Do not rub the injection site after injection.
Slovenian: ● Mesta injiciranja po injiciranju ne drgnite.
English: Patients (aged ≥ 12 years old and > 40 kg) with hemophilia A without FVIII inhibitors (Study BH30071 - HAVEN 3)
Slovenian: Bolniki (stari ≥ 12 let s telesno maso > 40 kg) s hemofilijo A brez inhibitorjev FVIII (študija BH30071 - HAVEN 3)
English: Dose linearity
Slovenian: Linearnost glede na odmerek
English: Do not insert injection needle into vial adapter.
Slovenian: Igle za injiciranje ne vstavljajte v adapter za vialo.
English: Thromboembolism associated with Hemlibra and activated prothrombin complex concentrate
Slovenian: Trombembolija, povezana z zdravilom Hemlibra in koncentratom aktiviranega protrombinskega kompleksa
English: Do not use the transfer needle to inject medicine as this may cause pain and bleeding 2.
Slovenian: Igle za prenos ne uporabljajte za injiciranje zdravila, ker lahko to povzroči bolečino in krvavitev.
English: Throw away the syringe and needle.
Slovenian: Zavrzite brizgo in iglo
English: Do not throw the cap away.
Slovenian: Pokrovčka igle ne vrzite proč.
English: ● Clean the chosen injection site area using an alcohol wipe.
Slovenian: ● Očistite izbrani predel za injiciranje z alkoholnim lističem.
English: ● Move the safety shield away from the needle and towards the syringe barrel.
Slovenian: ● Pomaknite varnostni ščitnik z igle proti telesu brizge.
English: Note: You must use a new transfer needle each time you withdraw medicine from a new vial.
Slovenian: Opomba: Vsakokrat, ko jemljete zdravilo iz nove viale, morate uporabiti novo iglo za prenos.
English: The total time the medicine is stored at room temperature should not be more than 7 days.
Slovenian: Celotni čas, med katerim je zdravilo shranjeno na sobni temperaturi, skupaj ne sme preseči 7 dni.
English: The exposure (Cavg, ss) of multiple doses is comparable between 1.5 mg/kg every week, 3mg/kg every 2 weeks and 6mg/kg dose every 4 weeks.
Slovenian: Izpostavljenost (Cavg, ss) večkratnim odmerkom je primerljiva med odmerki 1,5 mg/kg enkrat na teden, 3 mg/kg enkrat na 2 tedna in 6 mg/kg enkrat na 4 tedne.
English: There are limited data available on the use of Hemlibra in patients with moderate renal impairment (only 2 patients with CLcr of 30-59 mL/min) and no data in patients with severe renal impairment.
Slovenian: Podatkov o uporabi zdravila Hemlibra pri bolnikih z zmerno okvaro ledvic je malo (le dva bolnika z očistkom kreatinina v območju od 30 do 59 ml/min), pri bolnikih s hudo okvaro ledvic pa jih ni. O vplivu zmerne in hude okvare ledvic na farmakokinetiko emicizumaba ne moremo sklepati.
English: ● Laboratory professionals educational material
Slovenian: ● Izobraževalno gradivo za laboratorijske delavce
English: ● Clean the top of the vial(s) stopper with an alcohol wipe.
Slovenian: ● Očistite zamašek vial(e) z alkoholnim lističem.
English: Table 10 provides a summary of the comparison between the Hemlibra prophylaxis arm (Arm A) and the no prophylaxis arm (Arm B) on the EQ-5D-5L index utility scale and visual analog scale after 24 weeks of treatment adjusting for baseline.
Slovenian: Preglednica 10 prikazuje povzetek primerjav med skupino, ki je prejemala profilakso z zdravilom Hemlibra (skupina A), in skupino brez profilakse (skupina B) na indeksno oceno koristnosti in vizualno analogno skalo EQ-5D-5L po 24 tednih s korekcijo za izhodiščno vrednost.
English: Although a higher adherence was observed with emicizumab prophylaxis than with prior FVIII prophylaxis, no difference in ABR in patients with ≥80% or < 80% compliant doses on FVIII prophylaxis according to standard label requirements could be identified (data to be interpreted with caution due to small sample sizes).
Slovenian: Čeprav so pri profilaksi z emicizumabom opazili večjo adherenco kot pri predhodni profilaksi s FVIII, razlike v na leto preračunanem deležu krvavitev pri bolnikih s komplianco profilakse s FVIII ≥ 80 % ali < 80 % glede na standardne zahteve predpisovanja, ni bilo mogoče določiti (podatke moramo zaradi majhnih velikosti vzorcev previdno interpretirati).
English: ● Monitoring using a FVIII chromogenic assay may guide the administration of coagulation factors, and testing for thrombophilic traits may be considered.
Slovenian: ● Nadomestno zdravljenje s koagulacijskimi faktorji lahko vodimo s pomočjo kromogenih testov aktivnosti FVIII, razmisliti pa velja tudi o testih za ugotavljanje morebitnih trombotičnih stanj.
English: ● Keep the vial in the original box to protect the medicine from light.
Slovenian: ● Vialo shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
English: ● Slowly pull back the plunger and draw some air into the syringe.
Slovenian: ● Počasi izvlecite bat, da boste v brizgo potegnili nekaj zraka.
English: ● Throw away the used vial/vial adapter into a sharps disposal container.
Slovenian: ● Uporabljeno vialo/adapter za vialo zavrzite v vsebnik za ostre odpadke.
English: Transfer needle or vial adapter
Slovenian: Igla za prenos ali adapter za vialo
English: 1.5 mg/kg once weekly 3 mg/kg every two weeks
Slovenian: 1,5 mg/kg enkrat na teden 3 mg/kg na dva tedna 6 mg/kg na štiri tedne
English: There is limited experience with overdose of Hemlibra.
Slovenian: Izkušenj s prevelikim odmerjanjem zdravila Hemlibra je malo.
English: ● If you forget your scheduled injection, inject the forgotten dose as soon as possible before the day of the next scheduled dose.
Slovenian: Če ste pozabili uporabiti zdravilo Hemlibra ● Če pozabite uporabiti injekcijo v skladu z urnikom, si pozabljeni odmerek injicirajte čim prej pred dnem, ko je po urniku na vrsti naslednji odmerek.
English: ● Remove the needle and syringe from the injection site at the same angle as inserted.
Slovenian: ● Izvlecite iglo in brizgo iz mesta injiciranja pod istim kotom, pod katerim ste jo zabodli.
English: Only the first five emicizumab doses had to be administered under supervision to ensure safety and injection technique proficiency.
Slovenian: Za zagotovitev varnosti in strokovnega znanja o tehniki injiciranja je bilo treba dajati pod nadzorom le prvih pet odmerkov emicizumaba.
English: - the cap covering the stopper is missing.
Slovenian: - če manjka pokrovček, ki pokriva zamašek.
English: Contents of the pack and other information Instructions for use
Slovenian: Shranjevanje zdravila Hemlibra Vsebina pakiranja in dodatne informacije Navodila za uporabo
English: Information on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability in the emicizumab setting and warning that these tests should not be used to monitor for emicizumab activity, determine need for factor replacement dosing, or measure FVIII inhibitors.
Slovenian: Informacije, da emicizumab moti nekatere laboratorijske koagulacijske teste, kar vpliva na njihovo zanesljivost med uporabo emicizumaba, in opozorilo, da se teh testov ne sme uporabljati za spremljanje aktivnosti emicizumaba, določanje potrebe po odmerkih za nadomeščanje faktorja ali za merjenje inhibitorjev faktorja VIII;
English: Only patients from the NIS were included in this comparison, because bleed and treatment data were collected with the same level of granularity as used in HAVEN 3.
Slovenian: ker so bili podatki o krvavitvah in zdravljenju zbrani enako podrobno kot v študiji HAVEN 3.