FrancophonIA/ELRC3.0 huggingface dataset:
English: Each vial contains 150 mg emicizumab in 1 mL of solution for injection.
Croatian: Jedna bočica sadrži 150 mg emicizumaba u 1 ml otopine za injekciju.
English: or areas where the skin is tender, red, hard or the skin is broken.
Croatian: modrice ni područja na kojima je koža osjetljiva na dodir, crvena, tvrda ili oštećena.
English: No dedicated studies of the effect of renal impairment on the pharmacokinetics of emicizumab have been conducted.
Croatian: Nisu provedena posebna ispitivanja učinka oštećenja bubrežne funkcije na farmakokinetiku emicizumaba.
English: ● 2 to 3 mL syringe: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.1 mL.
Croatian: ● Štrcaljka volumena 2 - 3 ml: Prozirna polipropilenska ili polikarbonatna štrcaljka s Luer-Lock vrhom i oznakama od po 0,1 ml.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 1 mL contains 30 mg of emicizumab at a concentration of 30 mg/mL.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica od 1 ml sadrži 30 mg emicizumaba u koncentraciji od 30 mg/ml.
English: Syringes
Croatian: Nadlaktica
English: INFORMATION IN BRAILLE hemlibra 60 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU hemlibra 60 mg
English: Injection needle
Croatian: Igla za injiciranje
English: Inject the medicine
Croatian: 13. korak: Injicirajte lijek
English: Recommendation that the laboratory director contact the patient's treating physician to discuss any abnormal test results.
Croatian: Popis laboratorijskih testova na koje emicizumab ne utječe Preporuku da voditelj laboratorija razgovara s bolesnikovim liječnikom o svim odstupanjima u nalazima testova
English: Each vial of 0.7 mL contains 105 mg of emicizumab at a concentration of 150 mg/mL.
Croatian: Jedna bočica od 0,7 ml sadrži 105 mg emicizumaba u koncentraciji od 150 mg/ml.
English: ● 1 mL syringe: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.01 mL or
Croatian: ● Štrcaljka volumena 1 ml: Prozirna polipropilenska ili polikarbonatna štrcaljka s Luer-Lock vrhom i oznakama od po 0,1 ml ili
English: How Hemlibra is given
Croatian: Kako se Hemlibra primjenjuje
English: INFORMATION IN BRAILLE hemlibra 150 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU hemlibra 150 mg
English: - can be closed with a tight-fitting, puncture resistant lid, without sharps being able to come out.
Croatian: - koja se može čvrsto zatvoriti neprobojnim poklopcem, tako da iz nje ne mogu ispasti oštri predmeti - koja je stabilna i stoji uspravno tijekom uporabe - koja je otporna na istjecanje
English: Option (For transfer of medicine from vial to syringe)
Croatian: (za prijenos lijeka iz bočice u štrcaljku)
English: ● Maintenance dose (from week 5 on) example: 60 kg x 6 mg/kg = 360 mg of emicizumab needed for the maintenance dose.
Croatian: Primjer doze održavanja (od 5. tjedna nadalje): 60 kg x 6 mg/kg = 360 mg (količina emicizumaba potrebna za dozu održavanja).
English: a Lower scores (negative change scores) are reflective of better functioning.
Croatian: Srednja vrijednost promjene u odnosu na početni rezultat (95% CI) (n = 43) a Niži rezultati (negativne promjene rezultata) ukazuju na bolje funkcioniranje.
English: ● Keep the vial on the flat working surface and insert the transfer needle and syringe straight down into the centre of the vial stopper.
Croatian: Držite bočicu na ravnoj radnoj površini i uvedite štrcaljku s iglom za prijenos ravno kroz sredinu čepa bočice.
English: Adults and Adolescents Health-Related outcome measures
Croatian: Mjere ishoda vezane uz zdravlje u odraslih i adolescenata
English: o For injection amount over 1 mL use 3 mL LDS syringe.
Croatian: Za injiciranje više od 1 ml lijeka upotrijebite LDS štrcaljku volumena 3 ml.
English: Hemlibra 30 mg/mL solution for injection
Croatian: Hemlibra 30 mg/ml otopina za injekciju
English: Table 8 HAVEN 4: Annualized Bleed Rate with Hemlibra prophylaxis in Patients ≥12 Years of Age with or without Factor VIII Inhibitors Hemlibra 6mg/kg Q4W
Croatian: Tablica 8 HAVEN 4: Anualizirana stopa krvarenja kod profilakse lijekom Hemlibra u bolesnika u dobi od ≥ 12 godina s inhibitorima faktora VIII ili bez njih
English: Table 2 Summary of adverse drug reactions from pooled HAVEN clinical trials with Hemlibra
Croatian: Tablica 2 Sažetak nuspojava prema objedinjenim podacima iz kliničkih ispitivanja lijeka
English: Treated Bleeds
Croatian: Liječena krvarenja
English: The efficacy results of HEMLIBRA prophylaxis compared with no prophylaxis with respect to rate of treated bleeds, all bleeds, treated spontaneous bleeds, treated joint bleeds, and treated target joint bleeds are shown in Table 4.
Croatian: Rezultati za djelotvornost profilakse lijekom HEMLIBRA u odnosu na liječenje bez profilakse 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 4.
English: Table 5 HAVEN 3 study: Intra-patient comparison of Annualized Bleed Rate (treated Bleeds) with Hemlibra prophylaxis versus previous FVIII prophylaxis
Croatian: Tablica 5 Ispitivanje HAVEN 3: Intraindividualna usporedba anualizirane stope krvarenja (liječenih krvarenja) kod profilakse lijekom Hemlibra u odnosu na prethodnu profilaksu faktorom VIII
English: ● To calculate the volume to be administered divide calculated dose 24 mg by 30 mg/mL: 24 mg of emicizumab ÷ 30 mg/mL = 0.8 mL of 30 mg/mL Hemlibra concentration to be injected once weekly.
Croatian: 24 mg emicizumaba ÷ 30 mg/ml = 0,8 ml (volumen lijeka Hemlibra koncentracije 30 mg/ml koji treba injicirati jedanput na tjedan).
English: The bypassing agent dose required may therefore be lower than that used without Hemlibra prophylaxis.
Croatian: Potrebna doza lijeka koji zaobilazi akivnost faktora VIII stoga bi mogla biti manja nego ona koja se koristi kada nema profilakse lijekom
English: Emicizumab is a monoclonal antibody and cleared via catabolism rather than hepatic metabolism and a change in dose is not expected to be required for patients with hepatic impairment.
Croatian: Emicizumab je monoklonsko protutijelo koje se eliminira katabolizmom, a ne metabolizmom u jetri,
English: ● Do not detach the injection needle.
Croatian: Nemojte skidati iglu za injiciranje.
English: ● Use the syringes, transfer needles and injection needles only once.
Croatian: Svaku štrcaljku, iglu za prijenos i iglu za injiciranje smijete upotrijebiti samo jednom.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: INCLUDED IN THE BOX:
Croatian: Uključeno u pakiranje:
English: Each vial of 1 mL contains 150 mg of emicizumab at a concentration of 150 mg/mL.
Croatian: Jedna bočica od 1 ml sadrži 150 mg emicizumaba u koncentraciji od 150 mg/ml.
English: ● Maintenance dose (from week 5 on) example: 16 kg x 1.5 mg/kg = 24 mg of emicizumab needed for the maintenance dose.
Croatian: Primjer doze održavanja (od 5. tjedna nadalje): 16 kg x 1,5 mg/kg = 24 mg (količina emicizumaba potrebna za dozu održavanja).
English: % patients with zero bleeds (95% CI)
Croatian: % bolesnika s nula krvarenja (95% CI)
English: One patient resumed Hemlibra following resolution of TMA and continued to be treated safely.
Croatian: Jedan je bolesnik nakon povlačenja TMA nastavio liječenje lijekom Hemlibra bez daljnjih problema sa sigurnošću.
English: Throw away the syringe and needle.
Croatian: 17. korak: Bacite štrcaljku i iglu.
English: NAME OF THE MEDICINAL PRODUCT Hemlibra 30 mg/mL solution for injection Hemlibra 150 mg/mL solution for injection
Croatian: Hemlibra 30 mg/ml otopina za injekciju Hemlibra 150 mg/ml otopina za injekciju
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hemlibra 150 mg/mL solution for injection emicizumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Hemlibra 150 mg/ml otopina za injekciju emicizumab
English: Mild renal impairment did not affect the pharmacokinetics of emicizumab.
Croatian: Blago oštećenje bubrežne funkcije nije utjecalo na farmakokinetiku emicizumaba.
English: ● Put your used vial adapters, needles and syringes in a sharps disposal container straight away after use.
Croatian: Odložite upotrijebljene nastavke za bočicu, igle i štrcaljke u spremnik za odlaganje oštrih predmeta odmah nakon uporabe.
English: Treated bleeds All bleeds Treated spontaneous bleeds Treated joint bleeds Treated target joint bleeds ABR = annualized bleed rate; CI = confidence interval; IQR = interquartile range, 25th percentile to 75th percentile a Calculated with negative binomial regression (NBR) model.
Croatian: CI = interval pouzdanosti; IKR = interkvartilni raspon, od 25. percentila do 75. percentila a Izračunato primjenom modela negativne binomne regresije (NBR).
English: ● Hold the position of the syringe and let go of the pinched injection site.
Croatian: Držite štrcaljku na mjestu i otpustite nabor kože.
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.
Croatian: Mjere ishoda od posebnog interesa definirane planom ispitivanja bile su rezultat za tjelesno zdravlje (tj. bolne otekline, prisutnost boli u zglobovima, bol pri kretanju, otežano hodanje na veće udaljenosti i dulje vrijeme potrebno da se bolesnik spremi) i ukupni rezultat (sažetak svih rezultata).
English: ● Remove the syringe and transfer needle from the vial.
Croatian: Izvucite štrcaljku i iglu za prijenos iz bočice.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hemlibra 30 mg/mL solution for injection emicizumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Hemlibra 30 mg/ml otopina za injekciju emicizumab
English: There is a possibility for hypercoagulability with rFVIIa or FVIII with emicizumab based on preclinical experiments.
Croatian: Pretklinički pokusi pokazali su da postoji mogućnost razvoja hiperkoagulabilnosti kada se uz emicizumab primjenjuje rFVIIa ili FVIII.
English: Table 7 HAVEN 1: Intra-patient comparison of Annualised Bleed Rate (treated bleeds) with Hemlibra prophylaxis versus previous bypassing agent prophylaxis (NIS patients)
Croatian: Tablica 7 HAVEN 1: Intraindividualna usporedba anualizirane stope krvarenja (liječenih krvarenja) kod profilakse lijekom Hemlibra u odnosu na prethodnu profilaksu lijekom koji zaobilazi aktivnost faktora VIII (bolesnici iz neintervencijskog ispitivanja)
English: ● Push and twist a new transfer needle clockwise on to the syringe until it is fully attached.
Croatian: ● Nataknite novu iglu za prijenos na štrcaljku i okrećite je u smjeru kazaljke na satu sve dok ne bude čvrsto pričvršćena.
English: A syringe, a transfer needle (or vial adapter) and an injection needle are needed to withdraw Hemlibra solution from the vial and inject it subcutaneously.
Croatian: Za izvlačenje otopine lijeka Hemlibra iz bočice i supkutanu injekciju potrebni su štrcaljka, igla za prijenos (ili nastavak za bočicu) i igla za injiciranje.
English: Most of the patients with haemophilia A in the population pharmacokinetic analysis had normal hepatic function (bilirubin and AST ≤ ULN, N = 300) or mild hepatic impairment
Croatian: Većina bolesnika s hemofilijom A obuhvaćena populacijskom farmakokinetičkom analizom imala je normalnu jetrenu funkciju (bilirubin i AST ≤ GGN, N = 300) ili blago oštećenje jetrene funkcije (bilirubin ≤ GGN i AST > GGN ili bilirubin od 1,0 do 1,5 × GGN i bilo koja vrijednost AST-a, N = 51).
English: ● Throw away any used vial(s), needles, vial or injection needle caps and used syringes in a sharps or puncture-proof container.
Croatian: Bacite sve upotrijebljene bočice, igle, zatvarače bočice ili igle za injiciranje i upotrijebljene štrcaljke u spremnik za oštre predmete/neprobojan spremnik.
English: ● Patient/Carer educational material
Croatian: Edukacijski materijal za bolesnike/njegovatelje
English: - Immuno-based assays (e.g. ELISA, turbidimetric methods) - Genetic tests of coagulation factors (e.g.
Croatian: - kromogeni testovi za određivanje pojedinačanih faktora koagulacije osim FVIII1 - imunotestovi (npr. ELISA, turbidimetrijske metode)
English: Remove transfer needle
Croatian: Skinite iglu za prijenos
English: How to use Hemlibra
Croatian: Kako primjenjivati lijek Hemlibra
English: In case a bypassing agent is indicated in a patient receiving Hemlibra prophylaxis, see below for dosing guidance on the use of bypassing agents.
Croatian: Ako je u bolesnika koji prima profilaksu lijekom Hemlibra indicirana primjena lijeka koji zaobilazi aktivost faktora VIII, vidjeti tekst u nastavku za smjernice za doziranje lijekova koji zaobilaze aktivnost faktora VIII.
English: Very common: may affect more than 1 in 10 people
Croatian: Ostale nuspojave kod primjene lijeka Hemlibra Vrlo česte: mogu se javiti u više od 1 na 10 osoba
English: The primary objective of the study was to evaluate, among patients previously treated with episodic (“on-demand”) bypassing agents, the treatment effect of weekly Hemlibra prophylaxis compared with no prophylaxis (Arm A vs.
Croatian: Primarni cilj ispitivanja bio je ocijeniti - među bolesnicima koji su prethodno primali lijekove koji zaobilaze akivnost faktora VIII za liječenje epizoda krvarenja („po potrebi“) - terapijski učinak tjedne profilakse lijekom Hemlibra u odnosu na liječenje bez profilakse (skupina A naspram skupine B) na broj epizoda krvarenja koje su zahtijevale liječenje faktorima koagulacije tijekom vremena (najmanje
English: Thrombotic microangiopathy
Croatian: Opis odabranih nuspojava Trombotska mikroangiopatija
English: In the HAVEN 1 study a randomised, multicentre, open-label clinical study in 109 adolescent and adult males (aged ≥ 12 years old) with haemophilia A with factor VIII inhibitors who had previously received either episodic or prophylactic treatment with bypassing agents (aPCC and rFVIIa).
Croatian: 109 adolescentnih i odraslih muškaraca (u dobi od ≥ 12 godina) s hemofilijom A i inhibitorima faktora VIII koji su prethodno primali lijekove koji zaobilaze akivnost faktora VIII (aPCC i rFVIIa) za liječenje epizoda krvarenja ili za profilaksu.
English: Cover needle with safety shield
Croatian: 14. korak: Pokrijte iglu sigurnosnim pokrovom
English: ● The guide for patients/carers shall contain the following key messages: - What is emicizumab, how emicizumab has been tested, and how to use emicizumab; - Warning on the risks associated with the concomitant use of bypassing agents and Hemlibra and to discuss with their doctor if they are receiving activated prothrombin complex concentrate (aPCC) when being prescribed or while receiving Hemlibra;
Croatian: Upozorenje o rizicima povezanima s istodobnom primjenom lijeka Hemlibra i lijekova koji zaobilaze akivnost faktora VIII te napomenu da razgovaraju s liječnikom ako u trenutku propisivanja lijeka Hemlibra ili tijekom liječenja lijekom Hemlibra primaju aktivirani koncentrat protrombinskog kompleksa (aPCC)
English: % patients with 0 bleeds (95% CI)
Croatian: % bolesnika s 0 krvarenja (95%CI)
English: 1.5 mg/kg once weekly 3 mg/kg every two weeks
Croatian: 3 mg/kg svaka dva tjedna
English: ABR (95% CI) a % reduction (RR), p-value % patients with zero bleeds (95% CI)
Croatian: Anualizirana stopa krvarenja (95% CI) % smanjenja (RR), p-vrijednost % bolesnika s 0 krvarenja (95% CI) Medijan anualizirane stope krvarenja (IKR)
English: In the HAVEN 3 clinical study intra-patient analysis, Hemlibra prophylaxis resulted in a statistically significant (p<0.0001) reduction (68 %) in bleed rate for treated bleeds compared with previous FVIII prophylaxis collected in the NIS prior to enrollment (see Table 5).
Croatian: Hemlibra statistički je značajno (p < 0,0001) snizila (68%) stopu liječenih krvarenja u odnosu na prethodnu profilaksu faktorom VIII, o kojoj su se podaci prikupljali u neintervencijskom ispitivanju provedenom prije uključivanja (vidjeti Tablicu 5).
English: Arm A: Hemlibra 1.5 mg/kg weekly (N = 36)
Croatian: Skupina A: Hemlibra 1,5 mg/kg na tjedan (N = 36)
English: ● Maintenance dose (from week 5 on) example: 40 kg x 3 mg/kg = 120 mg of emicizumab needed for the maintenance dose.
Croatian: Primjer doze održavanja (od 5. tjedna nadalje): 40 kg x 3 mg/kg = 120 mg (količina emicizumaba potrebna za dozu održavanja).
English: Arm A: 1.5 mg/kg Hemlibra weekly
Croatian: Skupina A: Hemlibra 1,5 mg/kg na tjedan
English: Table 12 HAVEN 2: Intra-patient comparison of Annualised Bleed Rate (treated bleeds) with Hemlibra prophylaxis versus previous bypassing agent prophylaxis
Croatian: Tablica 12 HAVEN 2: Intraindividualna usporedba anualizirane stope krvarenja (liječenih krvarenja) uz profilaksu lijekom Hemlibra u odnosu na prethodnu profilaksu lijekom koji zaobilazi aktivnost faktora VIII
English: ● Transfer needle: Stainless steel with Luer-lock connection, gauge 18 G, length 35mm (1½″), preferably semi-blunted tip, and
Croatian: Igla za prijenos: Nehrđajući čelik i Luer-Lock priključak, veličina 18 G, duljina 35 mm, po mogućnosti s polutupim vrhom i
English: ● Vial containing the medicine
Croatian: ● Bočica s lijekom
English: ● To calculate the volume to be administered divide calculated dose 360 mg by 150 mg/mL: 360 mg of emicizumab ÷ 150 mg/mL = 2.4 mL of 150 mg/mL Hemlibra concentration to be injected every four weeks.
Croatian: 150 mg/ml: 360 mg emicizumaba ÷ 150 mg/ml = 2,4 ml (volumen lijeka Hemlibra koncentracije 150 mg/ml koji treba injicirati svaka četiri tjedna).
English: ● Gauze
Croatian: ● proljev
English: 3.DISPOSAL
Croatian: 3. ODLAGANJE
English: The laboratory professional educational material should contain:
Croatian: Edukacijski materijal za laboratorijske zdravstvene radnike treba sadržavati: ● Sažetak opisa svojstava lijeka
English: Table 14 Mean (± SD) steady-state emicizumab concentrations
Croatian: Tablica 14 Srednje vrijednosti (± standardno odstupanje) koncentracija emicizumaba u stanju dinamičke ravnoteže
English: ● Loading dose (first 4 weeks) example: 16 kg x 3 mg/kg = 48 mg of emicizumab needed for the loading dose.
Croatian: Primjer udarne doze (prva 4 tjedna): 16 kg x 3 mg/kg = 48 mg (količina emicizumaba potrebna za udarnu dozu).
English: ● Syringe Note: For injection amount up to 1 mL use a 1 mL syringe.
Croatian: Napomena: Za injiciranje do 1 ml lijeka upotrijebite štrcaljku volumena 1 ml.
English: Table 4 HAVEN 3 study: Annualised Bleed Rate for Hemlibra prophylaxis arm versus no prophylaxis arm in patients ≥ 12 years of age without factor VIII inhibitors
Croatian: Tablica 4 Ispitivanje HAVEN 3: Anualizirana stopa krvarenja u bolesnika u dobi od ≥ 12 godina bez inhibitora faktora VIII u skupini koja je primala profilaksu lijekom Hemlibra naspram skupine koja nije primala profilaksu
English: Arm B) on the number of bleeds requiring treatment with coagulation factors over time (minimum of 24 weeks or date of discontinuation) (see Table 6).
Croatian: 24 tjedna ili do datuma prekida primjene) (vidjeti Tablicu 6).
English: The HAVEN 3 study was a randomized, multicenter, open-label, phase III clinical study in 152 adult and adolescent males (aged ≥ 12 years and > 40 kg) with severe hemophilia A without FVIII inhibitors who previously received either episodic (“on demand”) or prophylactic treatment with FVIII.
Croatian: provedeno u 152 adolescentna i odrasla muškarca (u dobi od ≥ 12 godina i tjelesne težine > 40 kg) s teškom hemofilijom A bez inhibitora FVIII koji su prethodno primali FVIII za liječenje epizoda krvarenja („po potrebi“) ili za profilaksu.
English: Move safety shield
Croatian: 11. korak: Pomaknite sigurnosni pokrov
English: Relevant information (e.g. seriousness, severity, frequency, time to onset, reversibility as applicable) of the following safety concerns associated with the use of Hemlibra: - thromboembolic events associated with the concomitant use of emicizumab and activated prothrombin complex concentrate (aPCC), - thrombotic microangiopathy associated with the concomitant use of emicizumab and aPCC - life-threatening bleeding due to misinterpretation of the standard coagulation tests
Croatian: - Relevantne informacije (npr. informacije o ozbiljnosti, težini, učestalosti, vremenu do njihova nastupa i reverzibilnosti, prema potrebi) za sljedeće sigurnosne probleme povezane s primjenom lijeka Hemlibra:
English: ● Do not touch exposed needles or place them on a surface once the cap has been removed.
Croatian: Nakon što skinete zatvarač, nemojte dodirivati izložene igle i nemojte ih odlagati ni na kakvu površinu.
English: Difference in adjusted means (95% CI)
Croatian: Prilagođena srednja vrijednost Razlika prilagođenih srednjih vrijednosti (95% CI)
English: For bypassing agent guidance refer to section 4.4.
Croatian: Za postupak prijavljivanja nuspojava, pogledajte dio 4.
English: Needles
Croatian: FVIII
English: ● Loading dose (first 4 weeks) example: 60 kg x 3 mg/kg = 180 mg of emicizumab needed for the loading dose.
Croatian: Primjer udarne doze (prva 4 tjedna): 60 kg x 3 mg/kg = 180 mg (količina emicizumaba potrebna za udarnu dozu).
English: Different Hemlibra vial concentrations (30 mg/mL and 150 mg/mL) should not be combined in a single injection to administer the prescribed dose.
Croatian: Kod pripreme ukupnog volumena koji treba primijeniti ne smiju se miješati različite koncentracije lijeka Hemlibra (30 mg/ml i 150 mg/ml) u jednoj injekciji.
English: Step 1.
Croatian: Korak A.
English: Breast-feeding
Croatian: L-arginin
English: Arm CNIS: previous bypassing agent prophylaxis
Croatian: Skupina CNII: prethodna profilaksa lijekom koji zaobilazi akivnost faktora VIII
English: Do not insert injection needle into vial adapter.
Croatian: Nemojte injicirati lijek iglom za prijenos.
English: The efficacy results of Hemlibra prophylaxis compared with no prophylaxis with respect to rate of treated bleeds, all bleeds, treated spontaneous bleeds, treated joint bleeds, and treated target joint bleeds are shown in Table 6.
Croatian: HAVEN 1 Rezultati za djelotvornost profilakse lijekom HEMLIBRA u odnosu na liječenje bez profilakse, 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 6.
English: Patients with mild and moderate hepatic impairment were included in clinical trials.
Croatian: U klinička su ispitivanja bili uključeni bolesnici s blagim i umjerenim oštećenjem jetrene funkcije.
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).
Croatian: Adapted InhibQoL), kojim se ocjenjuju i različiti aspekti opterećenja njegovatelja, a koji su ispunjavali njegovatelji (vidjeti Tablicu 13).
English: Elderly
Croatian: Bedro
English: Animal reproduction studies have not been conducted with Hemlibra.
Croatian: Hemlibra na reprodukciju u životinja.
English: Attach injection needle to syringe
Croatian: 8. korak: Pričvrstite iglu za injiciranje na štrcaljku
English: Arm A: Hemlibra 1.5 mg/kg weekly (N=29)
Croatian: Skupina A: Hemlibra 1,5 mg/kg na tjedan (N=29)
English: Arm A: Hemlibra 1.5 mg/kg weekly (N=25)
Croatian: Skupina A: Hemlibra 1,5 mg/kg na tjedan (N=25)
English: ● Throw away the cap into a sharps disposal container.
Croatian: ● Bacite zatvarač u spremnik za odlaganje oštrih predmeta.
English: 3.DISPOSAL Step 16.
Croatian: 13. korak: Pomaknite klip do propisane doze
English: ● Loading dose (first 4 weeks) example: 40 kg x 3 mg/kg = 120 mg of emicizumab needed for the loading dose.
Croatian: Primjer udarne doze (prva 4 tjedna): 40 kg x 3 mg/kg = 120 mg (količina emicizumaba potrebna za udarnu dozu).