FrancophonIA/ELRC3.0 huggingface dataset:
English: Hemlibra 1.5 mg/kg weekly (N = 48)
Croatian: Hemlibra 1,5 mg/kg na tjedan (N = 48)
English: ● Keep the transfer needle, injection needle and syringe dry.
Croatian: ● Držite iglu za prijenos, iglu za injiciranje i štrcaljku suhima.
English: No TMA or thrombotic events were associated with the remaining instances of aPCC treatment.
Croatian: Kod preostalih epizoda liječenja aPCC-om nisu zabilježeni slučajevi TMA ni trombotskih događaja.
English: HAVEN 2 paediatric Efficacy Results (Interim Analysis)
Croatian: Rezultati za djelotvornost u pedijatrijskih bolesnika u ispitivanju HAVEN 2 (interim analiza)
English: Bypassing agent or FVIII use during surgeries and procedures was determined by the investigator.
Croatian: Primjenu faktora VIII ili lijekova koji zaobilaze akivnost faktora VIII tijekom kirurških zahvata i postupaka utvrđivao je ispitivač.
English: Guidance on the use of bypassing agents in patients receiving Hemlibra prophylaxis
Croatian: Smjernice za primjenu lijekova koji zaobilaze aktivnost faktora VIII u bolesnika koji primaju profilaksu lijekom Hemlibra
English: You must read, understand and follow the Instructions for Use before injecting Hemlibra.
Croatian: Prije injiciranja lijeka Hemlibra morate pročitati i razumjeti Upute za uporabu, te ih se pridržavati.
English: The physician and the caregiver should determine the appropriateness of the child self-injecting Hemlibra.
Croatian: Ako je bolesnik dijete, liječnik i njegovatelj trebaju utvrditi je li samoinjiciranje lijeka Hemlibra primjereno.
English: Patients receiving Hemlibra prophylaxis should be monitored for the development of TMA when administering aPCC.
Croatian: Bolesnike koji primaju profilaksu lijekom Hemlibra treba nadzirati zbog moguće pojave TMA kod primjene aPCC-a.
English: ● Throw away the vial cap(s) into the sharps disposal container.
Croatian: ● Bacite zatvarač(e) bočice u spremnik za odlaganje oštrih predmeta.
English: Patients received Hemlibra prophylaxis3 mg/kg once weekly for four weeks followed by 6 mg/kg every four weeks thereafter.
Croatian: Bolesnici su primali profilaksu lijekom Hemlibra u dozi od 3 mg/kg jedanput na tjedan tijekom četiri tjedna, a zatim 6 mg/kg svaka četiri tjedna.
English: ● Put your used needles and syringes in a sharps disposal container right away after use.
Croatian: Odložite upotrijebljene igle i štrcaljke u spremnik za odlaganje oštrih predmeta odmah nakon uporabe.
English: ● Slowly pull back the plunger and draw some air into the syringe.
Croatian: Laganim povlačenjem klipa unatrag uvucite u štrcaljku malu količinu zraka.
English: The injection should be restricted to the recommended injection sites: the abdomen, the upper outer arms and the thighs (see section 5.2).
Croatian: Primjenu treba ograničiti na preporučena mjesta za injiciranje: abdomen, vanjski dio nadlaktica i bedra
English: ● With the needle pointing upwards, inject the air from the syringe above the medicine.
Croatian: Držeći iglu usmjerenu prema gore, ubrizgajte zrak iz štrcaljke iznad razine lijeka.
English: Before using the medicine, check the solution for particles or discoloration.
Croatian: Prije nego što primijenite lijek, provjerite nalaze li se u otopini čestice i je li promijenila boju.
English: Similar to FVIII prophylaxis, self administration at home was allowed for all subsequent emicizumab doses.
Croatian: Slično kao i kod profilakse faktorom VIII, sve su sljedeće doze emicizumaba bolesnici smjeli samostalno primijeniti kod kuće.
English: The solution should be discarded if particulate matter is visible or product is discoloured.
Croatian: Otopinu treba baciti ako su u njoj vidljive čestice ili ako je promijenila boju.
English: ● Maintenance dose regimen: Week 5 and onwards: The dose is either 1.5 milligrams for every 1 kilogram you weigh, injected once a week, 3 milligrams for every 1 kilogram you weigh, injected every 2 weeks, or 6 milligrams for every 1 kilogram you weigh, injected every 4 weeks.
Croatian: Režim primjene doze održavanja: Od 5. tjedna nadalje: Doza je 1,5 miligrama na svaki kilogram tjelesne težine primijenjena jedanput na tjedan ili 3 miligrama na svaki kilogram tjelesne težine primijenjena svaka 2 tjedna ili 6 miligrama na svaki kilogram tjelesne težine primijenjena svaka 4 tjedna.
English: Hemlibra is a colourless to slightly yellow solution.
Croatian: Hemlibra je bezbojna do blijedožuta otopina.
English: Administration by the patient and/or caregiver
Croatian: Kada lijek primjenjuje bolesnik i/ili njegovatelj
English: Serious thrombotic events were reported from a clinical trial in patients receiving Hemlibra prophylaxis when on average a cumulative amount of >100U/kg/24 hours of aPCC for 24 hours or more was administered (see section 4.8).
Croatian: U kliničkom su ispitivanju u bolesnika koji su primali profilaksu lijekom Hemlibra prijavljeni ozbiljni trombotski događaji kada se tijekom razdoblja od 24 sata ili dulje primijenila prosječna ukupna količina aPCC-a > 100 jedinica/kg/24 sata (vidjeti dio 4.8).
English: Combining Vials
Croatian: Kombiniranje bočica
English: Patients received Hemlibra prophylaxis at 3 mg/kg once weekly for the first 4 weeks followed by 1.5 mg/kg once weekly thereafter.
Croatian: Bolesnici su primali profilaksu lijekom Hemlibra u dozi od 3 mg/kg jedanput na tjedan tijekom prva 4 tjedna, a zatim u dozi od 1,5 mg/kg jedanput na tjedan.
English: Hemlibra should be inspected visually to ensure there is no particulate matter or discolouration prior to administration.
Croatian: Lijek Hemlibra treba prije primjene vizualno pregledati kako bi se potvrdilo da ne sadrži vidljive čestice i da nije promijenio boju.
English: Rate ratio, and confidence interval (CI) come from negative binomial regression (NBR) model and p-value from Stratified Wald test, comparing bleed rate between specified arms.
Croatian: Omjer stope i interval pouzdanosti (CI) proizlaze iz modela negativne binomne regresije (NBR), a p-vrijednost iz stratificiranog Waldova testa u kojem su se uspoređivale stope krvarenja između specificiranih skupina.
English: Each vial contains 105 mg emicizumab in 0.7 mL of solution for injection.
Croatian: Jedna bočica sadrži 105 mg emicizumaba u 0,7 ml otopine za injekciju.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 105 mg/0.7 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 105 mg/0,7 ml
English: Average cumulative amount of aPCC over 24 hours (U/kg/24 hours)
Croatian: Prosječna ukupna količina aPCC-a tijekom 24 sata
English: syringe.
Croatian: Hemlibra.
English: Warning on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and information that single-factor assays utilizing chromogenic or immuno-based methods are not affected by emicizumab and may be used to monitor coagulation parameters during treatment, with specific consideration for factor VIII chromogenic activity assays;
Croatian: Upozorenje o utjecaju emicizumaba na određene laboratorijske testove koagulacije s posljedičnim učinkom na njihovu pouzdanost i napomenu da emicizumab ne utječe na kromogene testove ni imunotestove za određivanje pojedinačnih faktora koagulacije te da se oni mogu koristiti za praćenje parametara koagulacije tijekom liječenja, kao i informacije o specifičnim parametrima koje treba uzeti u obzir kod kromogenih testova za određivanje aktivnosti FVIII
English: minutes on a clean flat surface away from direct sunlight.
Croatian: Prije primjene stavite bočicu(e) na čistu i ravnu površinu podalje od izravne sunčeve svjetlosti i pričekajte približno
English: ● Sharps disposal container
Croatian: Spremnik za odlaganje oštrih predmeta
English: Treatment with bypassing agents should be discontinued the day before starting Hemlibra therapy.
Croatian: Profilaktičko liječenje lijekovima koji zaobilaze akivnost faktora VIII treba prekinuti dan prije započinjanja liječenja emicizumabom.
English: Patient's bodyweight of 40 kg, under a maintenance dose regimen of 3 mg/kg every two weeks:
Croatian: Bolesnik tjelesne težine 40 kg koji prima dozu održavanja od 3 mg/kg svaka dva tjedna:
English: Reminder that all patients receiving treatment with emicizumab should be given a Patient Alert Card and reminded to carry it at all times and show it to any healthcare professionals who may treat them and to laboratory professionals that will perform their coagulation testing;
Croatian: Popis laboratorijskih testova na koje emicizumab ne utječe Podsjetnik da svi bolesnici koji se liječe emicizumabom moraju dobiti Karticu s upozorenjima za bolesnika te da ih se mora uputiti da je stalno nose sa sobom i da je pokažu svakom zdravstvenom radniku koji će sudjelovati u njihovom liječenju i svakom laboratorijskom zdravstvenom radniku koji će provoditi testove koagulacije
English: Discard vials that have been kept at room temperature for more than 7 days or exposed to temperatures above 30°C.
Croatian: Bacite bočice koje su se čuvale na sobnoj temperaturi dulje od 7 dana ili koje su bile izložene temperaturama iznad 30°C.
English: Patients received subcutaneous Hemlibra, 3 mg/kg once weekly for the first four weeks followed by either 1.5 mg/kg once weekly (Arms A and D) or 3 mg/kg every two weeks (Arm B) thereafter, or no prophylaxis (Arm C).
Croatian: Bolesnici su primali lijek Hemlibra supkutano u dozi od 3 mg/kg jedanput na tjedan tijekom prva četiri tjedna, a zatim su primali dozu od 1,5 mg/kg jedanput na tjedan (skupine A i D) ili 3 mg/kg svaka dva tjedna (skupina B) ili nisu primali profilaksu (skupina C).
English: Patient's bodyweight of 60 kg, under a maintenance dose regimen of 6 mg/kg every four weeks:
Croatian: Bolesnik tjelesne težine 60 kg koji prima dozu održavanja od 6 mg/kg svaka četiri tjedna:
English: One patient resumed Hemlibra following resolution of thrombotic event and continued to be treated safely.
Croatian: Jedan je bolesnik nakon povlačenja trombotskog događaja nastavio liječenje lijekom Hemlibra bez daljnjih problema sa sigurnošću.
English: Serious and potentially life-threatening side effects can occur when aPCC is used in patients who are also receiving Hemlibra: Potentially serious side effects of using aPCC while receiving Hemlibra
Croatian: Kada se aPCC primjenjuje u bolesnika koji primaju i lijek Hemlibra, mogu nastupiti ozbiljne i potencijalno po život opasne nuspojave:
English: Step D. Transfer medicine into syringe
Croatian: 4. korak: Prenesite lijek u štrcaljku
English: Management in the perioperative setting
Croatian: Liječenje u perioperacijskim uvjetima
English: Roche Austria GmbH Engelhorngasse 3 1211 Wien Austria
Croatian: Roche Austria GmbH Engelhorngasse 3
English: INFORMATION IN BRAILLE hemlibra 30 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU hemlibra 30 mg
English: Option (For transfer of HEMLIBRA from vial to syringe)
Croatian: (za prijenos lijeka HEMLIBRA iz bočice u štrcaljku)
English: ● Do not touch the needle tip.
Croatian: Nemojte dodirivati vrh igle.
English: ● Polycarbonate with Luer-lock connection, sterile, fitting 15 mm vial neck outer diameter, single-use, latex-free and non-pyrogenic.
Croatian: ● Polikarbonatni nastavak s Luer-Lock priključkom, sterilan, odgovara vratu bočice vanjskog promjera 15 mm, namijenjen za jednokratnu uporabu, ne sadrži lateks i nije pirogen.
English: Once transferred from the vial to the syringe, use Hemlibra straight away.
Croatian: Nakon prijenosa iz bočice u štrcaljku lijek Hemlibra treba odmah primijeniti.
English: ● Keep the vial attached to the syringe and check the syringe for larger air bubbles.
Croatian: Držite štrcaljku pričvršćenu na bočicu i provjerite ima li u štrcaljki većih mjehurića zraka.
English: ● Only use the syringes, transfer needles, and injection needles that your healthcare provider prescribes.
Croatian: Koristite samo štrcaljke, igle za prijenos i igle za injiciranje koje Vam propiše zdravstveni radnik.
English: A 1 mL syringe should be used for an injection up to 1 mL of Hemlibra solution, whereas a 2 to 3 mL syringe should be used for an injection greater than 1 mL and up to 2 mL.
Croatian: Za injiciranje do 1 ml otopine lijeka Hemlibra treba upotrijebiti štrcaljku volumena 1 ml, dok za injekcije od 1 do 2 ml treba koristiti štrcaljku volumena 2 - 3 ml.
English: ● After the injection needle cap has been removed, the medicine in the syringe must be injected within 5 minutes.
Croatian: Nakon skidanja zatvarača s igle za injiciranje, lijek u štrcaljki mora se injicirati unutar 5 minuta.
English: ● With the new vial on the flat working surface, insert the new transfer needle and syringe, straight down into the centre of the vial stopper.
Croatian: Držite novu bočicu na ravnoj radnoj površini te uvedite štrcaljku i novu iglu za prijenos ravno kroz sredinu čepa bočice.
English: The educational programme is aimed at increasing communication and medical and patient education around the important identified risks of thromboembolic events and thrombotic microangiopathy associated with the concomitant use of emicizumab and activated prothrombin complex concentrate (aPCC), and the important potential risk of life-threatening bleeding due to misinterpretation of the standard coagulation tests (unreliable in patients treated with emicizumab) and provide information on how to manage them.
Croatian: Cilj edukacijskog programa je poboljšati komunikaciju i educiranost zdravstvenih radnika i bolesnika o važnim utvrđenim rizicima od tromboembolijskih događaja i trombotske mikroangiopatije, koji su povezani s istodobnom primjenom emicizumaba i aktiviranog koncentrata protrombinskog kompleksa
English: ● Keep the vial in the original box to protect the medicine from light.
Croatian: Čuvajte bočicu u originalnom pakiranju kako biste lijek zaštitili od svjetlosti.
English: Throw away the needle and syringe
Croatian: 15. korak: Bacite iglu i štrcaljku
English: ● Throw away the used transfer needle into a sharps disposal container.
Croatian: Upotrijebljenu iglu za prijenos bacite u spremnik za odlaganje oštrih predmeta.
English: Each vial contains 60 mg emicizumab in 0.4 mL of solution for injection.
Croatian: Jedna bočica sadrži 60 mg emicizumaba u 0,4 ml otopine za injekciju.
English: Transfer needle or vial adapter
Croatian: Igla za prijenos ili nastavak za bočicu
English: Ask your healthcare provider if you have any questions.
Croatian: Ako imate bilo kakvih pitanja, obratite se svom zdravstvenom radniku.
English: Criteria for vial adapter: Polycarbonate with Luer-lock connection, sterile, fitting 15 mm vial neck outer diameter, single-use, latex-free and non-pyrogenic.
Croatian: Kriteriji za nastavak za bočicu: Polikarbonatni nastavak s Luer-Lock priključkom, sterilan, odgovara vratu bočice vanjskog promjera 15 mm, namijenjen za jednokratnu uporabu, ne sadrži lateks i nije pirogen.
English: Disposing of the medicine and supplies:
Croatian: Zbrinjavanje lijeka i pribora za primjenu:
English: Hemlibra solution is a sterile, preservative-free, and ready to use solution for subcutaneous injection that does not need to be diluted.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Otopina lijeka Hemlibra je sterilna otopina bez konzervansa za supkutanu injekciju, koja je spremna za primjenu i koju ne treba razrjeđivati.
English: Information on assays and methods not affected by emicizumab and that may be used to monitor coagulation parameters during treatment, with specific considerations for FVIII chromogenic activity assays;
Croatian: Informacije o testovima i metodama na koje emicizumab ne utječe i koji se mogu koristiti za praćenje parametara koagulacije tijekom liječenja, kao i informacije o specifičnim parametrima koje treba uzeti u obzir kod kromogenih testova za određivanje aktivnosti
English: No dedicated studies on the effect of hepatic impairment on the pharmacokinetics of emicizumab have been conducted.
Croatian: Nisu provedena posebna ispitivanja učinka oštećenja jetrene funkcije na farmakokinetiku emicizumaba.
English: ● Only use the syringes, vial adapters, and injection needles that your healthcare provider prescribes.
Croatian: ● Koristite samo štrcaljke, nastavke za bočicu i igle za injiciranje koje Vam propiše zdravstveni radnik.
English: ● A 1 mL syringe should be used for an injection up to 1 mL of Hemlibra solution.
Croatian: ● Za injiciranje do 1 ml otopine lijeka Hemlibra treba upotrijebiti štrcaljku volumena 1 ml.
English: ● Vial adapter (To be added on top of vial).
Croatian: Nastavak za bočicu (mora se pričvrstiti na vrh bočice).
English: ● With the needle pointing upwards, push on the plunger to inject the air from the syringe above the medicine.
Croatian: Držeći iglu usmjerenu prema gore, potiskujte klip kako biste zrak iz štrcaljke ubrizgali iznad razine lijeka.
English: ● Blood clots (thromboembolism)
Croatian: ● Krvni ugrušci (tromboembolija)
English: Primary analysis efficacy results of Hemlibra prophylaxis every four weeks with respect to rate of treated bleeds, all bleeds, treated spontaneous bleeds, treated joint bleeds, and treated target joint bleeds are shown in Table 8.
Croatian: HAVEN 4 Rezultati primarne analize djelotvornosti profilakse lijekom Hemlibra primijenjenim svaka četiri tjedna s obzirom na stopu liječenih krvarenja, svih krvarenja, liječenih spontanih krvarenja, liječenih krvarenja u zglobove i liječenih krvarenja u ciljne zglobove prikazani su u Tablici 8.
English: Patients have had surgical procedures without discontinuing emicizumab prophylaxis in clinical trials.
Croatian: U kliničkim su se ispitivanjima bolesnici podvrgavali kirurškim zahvatima bez prekida profilakse emicizumabom.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/0.4 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 60 mg/0,4 ml
English: Package leaflet: Information for the user Hemlibra 30 mg/mL solution for injection emicizumab
Croatian: Uputa o lijeku: Informacije za korisnika Hemlibra 30 mg/ml otopina za injekciju emicizumab
English: HAVEN 2 Health-Related Outcomes
Croatian: Ishodi vezani uz zdravlje u ispitivanju HAVEN 2
English: Hemlibra 150 mg/mL solution for injection
Croatian: Hemlibra 150 mg/ml otopina za injekciju
English: Package leaflet: Information for the user Hemlibra 150 mg/mL solution for injection emicizumab
Croatian: Uputa o lijeku: Informacije za korisnika Hemlibra 150 mg/ml otopina za injekciju emicizumab
English: ● Hold the syringe with the needle pointing up and slowly push the plunger to your prescribed dose.
Croatian: Držite štrcaljku tako da je igla usmjerena prema gore i polako pritisnite klip do doze koja Vam je propisana.
English: ● Keep the needle in the vial and check the syringe for larger air bubbles.
Croatian: Držeći iglu u bočici, provjerite jesu li se u štrcaljki pojavili veći mjehurići zraka.
English: Following discontinuation of aPCC and interruption of Hemlibra, evidence of improvement or resolution was seen within one month (see section 4.8).
Croatian: Dokazi poboljšanja ili povlačenja primijećeni su unutar mjesec dana nakon prestanka primjene aPCC-a i prekida liječenja lijekom Hemlibra (vidjeti dio 4.8).
English: Pharmacodynamics
Croatian: Farmakodinamika
English: INFORMATION IN BRAILLE hemlibra 105 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU hemlibra 105 mg
English: ABR (95% CI) % reduction (RR), p-value % patients with 0 bleeds (95% CI)
Croatian: Anualizirana stopa krvarenja (95% CI) % smanjenja (RR), p-vrijednost % bolesnika s 0 krvarenja (95% CI)
English: Remove air bubbles
Croatian: 6. korak: Uklonite mjehuriće zraka
English: Difference in adjusted means (95% CI) p-value
Croatian: Prilagođena srednja vrijednost Razlika prilagođenih srednjih vrijednosti (95% CI) p-vrijednost
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 mg/1 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 150 mg/1 ml
English: ● Once removed from the refrigerator, the unopened vial can be kept at room temperature for up to 7 days.
Croatian: Nakon vađenja iz hladnjaka, neotvorene bočice mogu se čuvati na sobnoj temperaturi do 7 dana.
English: The impact of moderate and severe renal impairment on the pharmacokinetics of emicizumab cannot be concluded.
Croatian: Ne mogu se donijeti zaključci o utjecaju umjerenog i teškog oštećenja bubrežne funkcije na farmakokinetiku emicizumaba.
English: ● Slowly pull back on the plunger and draw air into the syringe that is the same amount as your prescribed dose.
Croatian: Laganim povlačenjem klipa unatrag uvucite u štrcaljku onoliko zraka koliko iznosi Vaša propisana doza.
English: Due to the short half-life of bypassing agents, no carryover effect is assumed after it's discontinuation.
Croatian: S obzirom na kratak poluvijek lijekova koji zaobilaze aktivnost faktora VIII, ne očekuje se prijenos učinka nakon prekida njihove primjene.
English: ● The patient alert card shall contain the following key messages: Instructions for patients to carry the card at any time, including in conditions of emergency and to present the card at visits to doctors, hospital clinics, carers, laboratory professionals or pharmacists to inform on emicizumab treatment and risks; Information on serious, life-threatening thromboembolic events or thrombotic microangiopathy events that have been observed with the concomitant use of emicizumab with activated prothrombin complex concentrate (aPCC) in patients on emicizumab prophylaxis;
Croatian: Naputak bolesnicima da karticu uvijek nose sa sobom, pa tako i u hitnim slučajevima, te da je pokažu pri posjetu liječnicima, bolničkim klinikama, njegovateljima, laboratorijskim zdravstvenim radnicima ili ljekarnicima kako bi ih upoznali s činjenicom da se liječe emicizumabom i s rizicima liječenja
English: A volume greater than 2 mL per injection should not be administered.
Croatian: Jednom se injekcijom ne smije primijeniti volumen veći od 2 ml.
English: ● Using one hand, slide the transfer needle into the cap and scoop upwards to cover the needle.
Croatian: Jednom rukom uvedite iglu za prijenos u zatvarač te ga usmjeravajući iglu prema gore podignite kako bi prekrio iglu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mg/1mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 30 mg/1 ml
English: There are limited data available on the use of Hemlibra in patients with moderate renal or hepatic impairment.
Croatian: Podaci o primjeni lijeka Hemlibra u bolesnika s umjerenim oštećenjem bubrežne ili jetrene funkcije su ograničeni.
English: This is because treatment with bypassing agents may need to change while receiving Hemlibra.
Croatian: Naime, možda će trebati promijeniti liječenje lijekovima koji zaobilaze akivnost faktora VIII dok se liječite lijekom Hemlibra.
English: ● You should use an effective method of birth control (contraception) during treatment with Hemlibra and for 6 months after your last injection of Hemlibra.
Croatian: Morate koristiti učinkovitu metodu kontrole začeća (kontracepciju) tijekom liječenja lijekom
English: The patient/carer educational material should contain:
Croatian: Edukacijski materijal za bolesnike/njegovatelje treba sadržavati: ● Uputu o lijeku
English: However, single factor assays utilising chromogenic or immuno-based methods are not affected by emicizumab and may be used to monitor coagulation parameters during treatment, with specific considerations for FVIII chromogenic activity assays as described below.
Croatian: Međutim, emicizumab ne utječe na testove za određivanje pojedinačnih faktora koagulacije koji koriste kromogene metode ili imunometode, pa se oni mogu koristiti za praćenje parametara koagulacije tijekom liječenja, s time da kod kromogenih testova za određivanje aktivnosti FVIII treba uzeti u obzir specifičnosti opisane u nastavku.
English: Criteria for transfer needle: Stainless steel with Luer-lock connection, gauge 18 G, length 35mm (1½″), preferably semi-blunted tip.
Croatian: Kriteriji za iglu za prijenos: Nehrđajući čelik i Luer-Lock priključak, veličina 18 G, duljina 35 mm, po mogućnosti s polutupim vrhom.
English: HAVEN 1 health-related outcomes
Croatian: Ishodi vezani uz zdravlje u ispitivanju HAVEN 1
English: 1 mL syringe
Croatian: Štrcaljka volumena 1 ml
English: Its structure is different from factor VIII, therefore Hemlibra is not affected by factor VIII inhibitors.
Croatian: Inhibitori faktora VIII ne utječu na lijek Hemlibra jer je njegova struktura različita od strukture faktora VIII.