FrancophonIA/ELRC3.0 huggingface dataset:
English: ● To calculate the volume to be administered divide calculated dose 180 mg by 150 mg/mL: 180 mg of emicizumab ÷ 150 mg/mL = 1.20 mL of 150 mg/mL Hemlibra concentration to be injected.
Maltese: ● Biex tikkalkula l-volum li jrid jingħata, iddividi d-doża kkalkulata ta' 180 mg b'150 mg/mL: 180 mg ta' emicizumab ÷ 150 mg/mL = 1.20 mL ta' 150 mg/mL konċentrazzjoni ta' Hemlibra li trid tiġi injettata.
English: Warnings and precautions
Maltese: Reazzjonijiet avversi
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.
Maltese: Id-doża hija ta' 1.5 milligrammi għal kull kilogramma li tiżen, injettata darba fil-ġimgħa, 3 milligrammi għal kull kilogramma li tiżen, injettata kull ġimagħtejn, jew 6 milligrammi għal kull kilogramma li tiżen, injettata kull 4 ġimgħat.
English: Information that they should be given a Patient Alert Card and reminder to carry it at all times and to show it to any healthcare professionals who may treat them; Information on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and on the importance to show the patient alert card to any healthcare professionals who may treat them and to laboratory professionals that will perform their coagulation testing;
Maltese: Emboli tad-demm (tromboemboliżmu) - Informazzjoni li għandhom jingħataw Kartuna ta' Twissija għall-Pazjent u tfakkira biex iġorruha magħhom f'kull ħin u biex juruha li kull professjonist tal-kura tas-saħħa li jista' jittrattahom; - Informazzjoni dwar l-interferenza ta' emicizumab ma' ċerti testijiet tal-koagulazzjoni tallaboratorju li se taffettwa l-affidabilità tagħhom u dwar l-importanza li juru l-kartuna ta' twissija għall-pazjent lil kwalunkwe professjonist tal-kura tas-saħħa li jista' jittrattahom u lill-professjonisti tal-laboratorju li se jwettqu t-testijiet tal-koagulazzjoni tagħhom; - Tfakkira biex jirrapportaw kull avveniment avvers lit-tabib li qed jittrattahom.
English: - Immuno-based assays (e.g. ELISA, turbidimetric methods) - Genetic tests of coagulation factors (e.g.
Maltese: ● Labra għall-injezzjoni b'ilqugħ ta' sigurtà (Użata għall-injezzjoni talmediċina).
English: Posology
Maltese: Ttrattati
English: All 3 TMAs occurred when on average a cumulative amount of > 100 U/Kg/24 hours of aPCC for 24 hours or more was administered during a treatment event (see section 4.4).
Maltese: It-3 TMAs kollha seħħew meta fuq medja ngħata ammont kumulattiv ta' > 100 U/Kg/24 siegħa ta' aPCC għal 24 siegħa jew aktar matul avveniment ta' trattament (ara sezzjoni 4.4).
English: Adapted InhibQoL with aspects of caregiver burden
Maltese: Qabbad adapter tal-kunjett ġdid massiringa
English: Similar to BPA prophylaxis, self administration at home was allowed for all subsequent emicizumab doses.
Maltese: Simili għal profilassi b'BPA, għoti mill-pazjent stess id-dar kien permess għad-dożi sussegwenti kollha ta' emicizumab.
English: EXP
Maltese: Tubu
English: Table 13 HAVEN 2: Change from baseline to week 25 in the Physical Health score of patients (< 12 years of age) following treatment with Hemlibra prophylaxis as reported by patients and caregivers
Maltese: Tabella 13 HAVEN 2: Bidla mil-linja bażi sa ġimgħa 25 fil-punteġġ tas-Saħħa Fiżika tal-pazjenti (età ta' < 12-il sena) wara trattament bi profilassi b'Hemlibra kif irrappurtata mill-pazjenti u l-persuni li jieħdu ħsiebhom
English: Recap transfer needle
Maltese: Nota: Tużax siringa
English: Use of aPCC should be avoided unless no other treatment options/alternatives are available.
Maltese: L-użu ta' aPCC għandu jiġi evitat sakemm ma jkun hemm disponibbli l-ebda għażla/alternattivi ta' trattamenti oħra.
English: 3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a plastic flip-off disk.
Maltese: Kunjett wieħed ta' 3 mL tal-ħġieġ ċar tat-tip I b'tapp tal-lastku butyl laminat b'rita ta' fluoro-resin u ppressat b'għatu tal-aluminju mgħammar b'diska tal-plastik flip-off.
English: * Emicizumab is a humanised monoclonal modified immunoglobulin G4 (IgG4) antibody produced using recombinant DNA technology in mammalian Chinese Hamster Ovary (CHO) cells For the full list of excipients, see section 6.1
Maltese: ● Is-siringi, il-labar għat-trasferiment, l-adapters tal-kunjett u l-labar għall-injezzjoni mhumiex ipprovduti f'dan il-pakkett.
English: Important information after the injection:
Maltese: Differenza klinikament importanti:
English: In the study, patients received weekly Hemlibra prophylaxis (Arms A, C, and D) - 3 mg/kg once weekly for four weeks followed by 1.5 mg/kg once weekly thereafter - or no prophylaxis (Arm B).
Maltese: Flistudju, il-pazjenti rċevew profilassi b'Hemlibra darba fil-ġimgħa (Gruppi A, Ċ, u D) - 3 mg/kg darba fil-ġimgħa għal erba' ġimgħat segwiti minn 1.5 mg/kg darba fil-ġimgħa wara dan - jew l-ebda profilassi (Grupp B).
English: Step D. Uncap transfer needle
Maltese: Pass 3. Neħħi l-għatu tal-labra għattrasferiment
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).
Maltese: Għalkemm ġiet osservata konformità ogħla ma' profilassi b'emicizumab milli ma' profilassi b'FVIII preċedenti, ma setgħet tiġi identifikata l-ebda differenza fl-ABR f'pazjenti b'dożi b'konformità ta' ≥ 80% jew < 80% fuq profilassi b'FVIII skont rekwiżiti tat-tikketta standard (id-data għandha tiġi interpretata b'kawtela minħabba d-daqsijiet żgħar tal-kampjun).
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.
Maltese: Qabel it-tnedija ta' Hemlibra f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq (MAH - Marketing Authorisation Holder) għandu jaqbel dwar il-kontenut u d-disinn talprogramm edukattiv, inklużi l-mezzi ta' komunikazzjoni, il-modalitajiet għad-distribuzzjoni, u kull aspett ieħor tal-programm, mal-Awtorità Nazzjonali Kompetenti.
English: *Cavernous sinus thrombosis
Maltese: Reazzjoni fis-sit tal-injezzjoni
English: ● destruction of red blood cells (thrombotic microangiopathy)
Maltese: Qerda ta' ċelluli ħomor tad-demm (mikroanġjopatija trombotika)
English: Patients receiving Hemlibra prophylaxis should be monitored for the development of thromboembolism when administering aPCC.
Maltese: Pazjenti li jirċievu profilassi b'Hemlibra għandhom jiġu mmonitorjati għall-iżvilupp ta' tromboemboliżmu meta jingħata aPCC.
English: Table 6 HAVEN 1: Annualized Bleed Rate with Hemlibra prophylaxis arm versus no prophylaxis arm in patients ≥ 12 years of age with factor VIII inhibitors
Maltese: Tabella 6 HAVEN 1: Rata ta' Fsada Annwalizzata għall-grupp ta' profilassi b'Hemlibra kontra l-grupp mingħajr profilassi f'pazjenti b'età ta' ≥ 12-il sena b'inibituri talfattur VIII
English: ● To calculate the volume to be administered divide calculated dose 120 mg by 150 mg/mL: 120 mg of emicizumab ÷ 150 mg/mL = 0.8 mL of 150 mg/mL Hemlibra concentration to be injected.
Maltese: ● Biex tikkalkula l-volum li jrid jingħata, iddividi d-doża kkalkulata ta' 120 mg b'150 mg/mL: 120 mg ta' emicizumab ÷ 150 mg/mL = 0.8 mL ta' konċentrazzjoni ta' 150 mg/mL ta' Hemlibra li trid tiġi injettata.
English: Arm B: Hemlibra 3 mg/kg every 2 weeks (N = 35)
Maltese: Grupp B: Hemlibra 3 mg/kg kull ġimagħtejn
English: Patient's bodyweight of 16 kg, under a maintenance dose regimen of 1.5 mg/kg once weekly:
Maltese: Piż tal-ġisem tal-pazjent ta' 16-il kg, taħt kors ta' doża ta' manteniment ta' 1.5 mg/kg darba filġimgħa:
English: Population pharmacokinetics analyses in patients with haemophilia A showed that race did not affect the pharmacokinetics of emicizumab.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni f'pazjenti bl-emofilja A wriet li r-razza ma affettwatx ilfarmakokinetika ta' emicizumab.
English: Adjust plunger to prescribed dose
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: ● Patient/Carer educational material
Maltese: ● uġigħ fil-ġogi
English: Treated bleeds ABR (95% CI) % reduction (RR), p-value
Maltese: Fsadiet Spontanji Ttrattati ABR (CI ta' 95%) % ta' tnaqqis (RR), valur p
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1271/004
English: Clinical study in paediatric patients
Maltese: Studju kliniku f'pazjenti pedjatriċi
English: ● Followed by a maintenance dose of either 1.5 mg/kg once weekly, 3 mg/kg every two weeks or 6 mg/kg every four weeks, from week 5 on: Patient bodyweight (kg) x dose (1.5; 3 or 6 mg/kg) = total amount (mg) of emicizumab to be administered
Maltese: ● Segwita minn doża ta' manteniment ta' 1.5 mg/kg darba fil-ġimgħa, 3 mg/kg kull ġimagħtejn jew 6 mg/kg kull erba' ġimgħat, minn ġimgħa 5 'il quddiem:
English: DISPOSAL Step 16.
Maltese: Pass 16.
English: Treating physicians must carefully weigh the risk of TMA and thromboembolism against the risk of bleeding when considering aPCC treatment beyond a maximum of 100 U/kg in the first 24-hours.
Maltese: It-tobba li jittrattaw iridu jqisu bir-reqqa r-riskju ta' TMA u tromboemboliżmu mar-riskju ta' fsada meta jitqies trattament b'aPCC ta' aktar mill-massimu ta' 100 U/kg fl-ewwel 24 siegħa.
English: Patients receiving Hemlibra prophylaxis should be monitored for the development of TMA when administering aPCC.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1271/002
English: In contrast, assays containing bovine coagulation factors are insensitive to emicizumab (no activity measured) and can be used to monitor endogenous or infused factor VIII activity, or to measure anti FVIII inhibitors.
Maltese: F'kuntrast ma' dan, assaġġi li fihom fatturi ta' koagulazzjoni bovini mhumiex sensittivi għal emicizumab (l-ebda attività mkejla) u jistgħu jintużaw għall-monitoraġġ tal-attività tal-fattur VIII endoġenu jew infuż, jew biex ikejlu inibituri kontra FVIII.
English: 1.5 mg/kg once weekly 3 mg/kg every two weeks
Maltese: 3 mg/kg kull ġimagħtejn 6 mg/kg kull erba' ġimgħat
English: Hemlibra can be used in adolescents and children of all ages.
Maltese: Hemlibra jista' jintuża fl-adolexxenti u tfal ta' kull età.
English: Self-injection for children below the age of 7 years is not recommended.
Maltese: Mhux rakkomandat li tfal taħt l-età ta' 7 snin jinjettaw lilhom infushom.
English: Such intrinsic pathway based tests will yield overly shortened clotting times with emicizumab, which does not require activation by thrombin.
Maltese: Tali testijiet ibbażati fuq passaġġ intrinsiku se jipproduċu ħinijiet ta' koagulazzjoni mqassra żżejjed b'emicizumab, li ma jeħtieġx attivazzjoni permezz ta' thrombin.
English: % patients with zero bleeds (95% CI)
Maltese: % ta' pazjenti bl-ebda fsada (CI ta' 95%)
English: ● Loading dose (3 mg/kg) once weekly for the first 4 weeks: Patient bodyweight (kg) x dose (3 mg/kg) = total amount (mg) of emicizumab to be administered
Maltese: Il-piż tal-ġisem tal-pazjent (kg) x id-doża (1.5; 3 jew 6 mg/kg) = l-ammont totali (mg) ta' emicizumab li jrid jingħata
English: For bypassing agent guidance refer to section 4.4.
Maltese: Għal gwida dwar il-bypassing agent irreferi għal sezzjoni 4.4.
English: Despite limited experience with concomitant administration of anti-fibrinolytics with aPCC or rFVIIa in patients treated with Hemlibra, you should know that there may be a possibility of thrombotic events using anti-fibrinolytics administered intravenously in combination with aPCC or rFVIIa.
Maltese: Madankollu, il-possibbiltà ta' avvenimenti trombotiċi għandha tiġi kkunsidrata meta jintużaw antifibrinolitiċi sistemiċi flimkien ma' aPCC jew rFVIIa f'pazjenti li jkunu qed jirċievu emicizumab.
English: Each vial of 0.7 mL contains 105 mg of emicizumab at a concentration of 150 mg/mL.
Maltese: Kull kunjett ta' 0.7 mL fih 105 mg ta' emicizumab f'konċentrazzjoni ta' 150 mg/mL.
English: Other secondary objectives of the randomised comparison of Arms A and B were the efficacy of weekly Hemlibra prophylaxis in reducing the number of all bleeds, spontaneous bleeds, joint bleeds and target joint bleeds (see Table 6), as well as assessing patients' HRQoL and health status (see Tables 9 and 10).
Maltese: L-iskopijiet sekondarji l-oħra tal-paragun randomised tal-Gruppi A u B kienu l-effikaċja ta' profilassi b'Hemlibra darba fil-ġimgħa biex tnaqqas in-numru ta' fsadiet kollha, ta' fsadiet spontanji, ta' fsadiet fil-ġogi u ta' fsadiet fil-ġogi fil-mira (ara Tabella 6), kif ukoll l-evalwazzjoni tal-HRQoL u tal-istat tas-saħħa talpazjenti (ara Tabelli 9 u 10).
English: Method of administration
Maltese: System Organ Class)
English: Mild renal impairment did not affect the pharmacokinetics of emicizumab.
Maltese: Indeboliment ħafif tal-kliewi ma affettwax il-farmakokinetika ta' emicizumab.
English: Table 1 Coagulation test results affected and unaffected by emicizumab
Maltese: Tabella 1 Riżultati tat-test ta' koagulazzjoni affettwati u mhux affettwati minn emicizumab
English: Both serious thrombotic events occurred when on average a cumulative amount of > 100 U/Kg/24 hours of aPCC for 24 hours or more was administered during a treatment event.
Maltese: Iż-żewġ avvenimenti trombotiċi serji seħħew meta fuq medja ngħata ammont kumulattiv ta' > 100 U/Kg/24 siegħa ta' aPCC għal 24 siegħa jew aktar matul avveniment ta' trattament.
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;
Maltese: Twissija dwar l-interferenza ta' emicizumab ma' ċerti testijiet tal-koagulazzjoni tallaboratorju li se taffettwa l-affidabilità tagħhom u informazzjoni li assaġġi b'fattur wieħed li jużaw metodi kromoġeniċi jew immunoloġiċi mhumiex affettwati minn emicizumab u jistgħu jintużaw għall-monitoraġġ tal-parametri tal-koagulazzjoni matul it-trattament, b'konsiderazzjoni speċifika għall-assaġġi tal-attività kromoġenika tal-fattur VIII; Dettalji tal-kuntatt tat-tabib li ppreskriva emicizumab lill-pazjent.
English: The study also evaluated the efficacy of weekly Hemlibra prophylaxis compared with previous episodic (on-demand) and prophylactic bypassing agents (separate comparisons) in patients who had participated in the NIS prior to enrolment (Arms A and C, respectively) (see Table 7).
Maltese: L-istudju evalwa wkoll l-effikaċja ta' profilassi b'Hemlibra darba fil-ġimgħa meta mqabbla ma' bypassing agents episodiċi (fuq talba) u profilattiċi preċedenti (paraguni separati) f'pazjenti li kienu pparteċipaw fl-NIS qabel ir-reġistrazzjoni (Gruppi A u Ċ, rispettivament) (ara Tabella 7).
English: Criteria: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.1 mL.
Maltese: Siringa trasparenti tal-polypropylene jew tal-polycarbonate b'tarf Luer-Lok, immarkar ta' 0.1 mL.
English: At the time of the interim analysis, efficacy was evaluated in 59 patients who were < 12 years old and had been receiving weekly Hemlibra prophylaxis for at least 12 weeks, including four patients aged < 2 years old, 17 patients aged 2 to < 6 years, 38 patients aged 6 to < 12 years old.
Maltese: Fiż-żmien tal-analiżi interim, l-effikaċja ġiet evalwata f'59 pazjent li kellhom < 12-il sena u kienu ilhom jirċievu profilassi b'Hemlibra fil-ġimgħa għal mill-inqas 12-il ġimgħa, inklużi erba' pazjenti b'età ta' < sentejn, 17-il pazjent b'età ta' 2 sa < 6 snin, 38 pazjent b'età ta' 6 sa < 12-il sena.
English: Attach transfer needle to syringe
Maltese: Ittrasferixxi l-mediċina għal ġos-siringa
English: Each vial of 1 mL contains 150 mg of emicizumab at a concentration of 150 mg/mL.
Maltese: Kull kunjett ta' 1 mL fih 150 mg ta' emicizumab f'konċentrazzjoni ta' 150 mg/mL.
English: bCalculated ABR Bleed definitions adapted based on ISTH criteria.
Maltese: Fsadiet ittrattati = fsadiet ittrattati b'FVIII. Definizzjonijiet ta' fsada adattati abbażi tal-kriterji ISTH.
English: The efficacy of Hemlibra prophylaxis was also compared with previous prophylactic FVIII treatment (Arm D) in patients who had participated in a non-interventional study (NIS) prior to enrollment (see Table 5).
Maltese: L-effikaċja ta' profilassi b'Hemlibra ġiet imqabbla wkoll ma' trattament b'FVIII profilattiku fil-passat (Grupp D) f'pazjenti li kienu pparteċipaw fi studju mingħajr intervent (NIS - non-interventional study) qabel ir-reġistrazzjoni (ara Tabella 5).
English: Emicizumab restores the tenase cofactor activity of missing activated factor VIII (FVIIIa).
Maltese: Emicizumab ireġġa' lura l-attività tal-kofattur tenase tal-fattur VIII attivat (FVIIIa - activated factor VIII) nieqes.
English: HAVEN 2 Health-Related Outcomes
Maltese: Relatati mas-Saħħa f'HAVEN 2
English: Repeat steps A to F with each additional vial until you have more than your prescribed dose.
Maltese: Irrepeti l-passi A sa F għal kull kunjett addizzjonali sakemm ikollok aktar mid-doża preskritta tiegħek.
English: o For injection amount over 1 mL use 3 mL LDS syringe.
Maltese: LDS ta' 3 mL għal dożi sa 1 mL.
English: ● Loading dose (first 4 weeks) example: 60 kg x 3 mg/kg = 180 mg of emicizumab needed for the loading dose.
Maltese: ● Eżempju ta' doża għolja tal-bidu (l-ewwel 4 ġimgħat): 60 kg x 3 mg/kg = 180 mg ta' emicizumab meħtieġa għad-doża għolja tal-bidu.
English: Other objectives of the study included evaluation of the randomized comparison of Arms A or B and Arm C for the efficacy of Hemlibra prophylaxis in reducing the number of all bleeds, spontaneous bleeds, joint bleeds, and target joint bleeds (see Table 4), as well as assessing patient treatment preference using a preference survey.
Maltese: Għanijiet oħra tal-istudju kienu jinkludu evalwazzjoni tal-paragun randomised tal-Gruppi A jew B u l-Grupp Ċ għall-effikaċja ta' profilassi b'Hemlibra biex tnaqqas innumru ta' fsadiet kollha, ta' fsadiet spontanji, ta' fsadiet fil-ġogi u ta' fsadiet fil-ġogi fil-mira (ara Tabella 4), kif ukoll biex tivvaluta l-preferenza ta' trattament tal-pazjent bl-użu ta' stħarriġ talpreferenza.
English: EQ-5D-5L scores after 24 weeks
Maltese: Punteġġi EQ-5D-5L wara 24 Ġimgħa Grupp B: mingħajr profilassi (N=16)
English: Different Hemlibra concentrations (30 mg/mL and 150 mg/mL) should not be combined in the same syringe when making up the total volume to be administered.
Maltese: Konċentrazzjonijiet tal-kunjetti differenti ta' Hemlibra (30 mg/mL u 150 mg/mL) m'għandhomx jiġu kkombinati f'injezzjoni waħda biex tingħata d-doża preskritta.
English: Treated spontaneous bleeds
Maltese: Dawwar u iġbed
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
Maltese: Tabella 4 Studju HAVEN 3: Rata ta' Fsada Annwalizzata għall-grupp ta' profilassi b'Hemlibra kontra l-grupp mingħajr profilassi f'pazjenti ta' ≥ 12-il sena mingħajr inibituri tal-fattur VIII
English: In the intra-patient analysis, Hemlibra weekly prophylaxis resulted in a clinical meaningful reduction (98 %) in treated bleed rate in 18 paediatric patients who had at least 12 weeks of Hemlibra prophylaxis compared to their bleed rate collected in the NIS prior to enrolment (Table 12).
Maltese: Fl-analiżi tal-pazjent individwali fi żminijiet differenti, il-profilassi b'Hemlibra darba fil-ġimgħa rriżultat fi tnaqqis klinikament sinifikanti (98 %) fir-rata ta' fsadiet ittrattati fi 18-il pazjent pedjatriku li kellhom mill-inqas 12-il ġimgħa ta' profilassi b'Hemlibra meta mqabbla mar-rata ta' fsada tagħhom miġbura fl-NIS qabel ir-reġistrazzjoni (Tabella 12).
English: Total score (range 0 to 100) Adjusted mean Difference in adjusted means (95% CI) Arm B: includes no prophylaxis period only.
Maltese: Medja aġġustata Differenza fil-medji aġġustati (CI ta' 95%) Grupp B: jinkludi perjodu mingħajr profilassi biss.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1271/003
English: Hemlibra is a solution for injection.
Maltese: Hemlibra huwa soluzzjoni għall-injezzjoni.
English: Diarrhoea
Maltese: Teratoġeniċità
English: Prophylactic therapy with Hemlibra shortens the aPTT and increases the reported factor VIII activity (using a chromogenic assay with human coagulation factors).
Maltese: Terapija profilattika b'Hemlibra tqassar l-aPTT u żżid l-attività rrappurtata tal-fattur VIII (bl-użu ta' assaġġ kromoġeniku b'fatturi ta' koagulazzjoni umana).
English: syringe.
Maltese: INJEZZJONI
English: These two pharmacodynamic markers do not reflect the true haemostatic effect of emicizumab in vivo (aPTT is overly shortened and reported factor VIII activity may be overestimated) but provide a relative indication of the pro-coagulant effect of emicizumab.
Maltese: Dawn iż-żewġ markaturi farmakodinamiċi ma jirriflettux l-effett emostatiku veru ta' emicizumab in vivo (aPTT huwa mqassar iżżejjed u l-attività rrappurtata tal-fattur VIII tista' tkun sopravalutata) iżda jipprovdu indikazzjoni relattiva tal-effett prokoagulanti ta' emicizumab.
English: Other objectives were to evaluate the clinical efficacy of Hemlibra prophylaxis on all bleeds, treated spontaneous bleeds, treated joint bleeds and treated target joint bleeds (see Table 8).
Maltese: Għanijiet oħra kienu li tiġi evalwata l-effikaċja klinika ta' profilassi b'Hemlibra fuq il-fsadiet kollha, il-fsadiet spontanji ttrattati, il-fsadiet fil-ġogi ttrattati u l-fsadiet fil-ġogi fil-mira ttrattati (ara Tabella 8).
English: Instructions for Use Hemlibra Injection
Maltese: Informazzjoni importanti wara l-injezzjoni
English: Following subcutaneous administration in haemophilia A patients, the absorption half-life was 1.6 days.
Maltese: Wara għoti taħt il-ġilda f'pazjenti bl-emofilja A, il-half-life tal-assorbiment kienet ta' 1.6 ijiem.
English: 6 mg/kg every four weeks
Maltese: Hemlibra 6mg/kg Q4W
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1271/001
English: The median observation time for these patients was 29.6 weeks (range: 18.4 to 63.0 weeks).
Maltese: Iżżmien medjan ta' osservazzjoni għal dawn il-pazjenti kien ta' 29.6 ġimgħat (medda: 18.4 sa 63.0 ġimgħa).
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.
Maltese: ● Għandek tuża metodu effettiv ta' kontroll tat-twelid (kontraċezzjoni) waqt it-trattament b'Hemlibra u għal 6 xhur wara l-aħħar injezzjoni tiegħek ta' Hemlibra.
English: Roche farmacevtska družba d.o.o.
Maltese: Roche Pharma AG
English: Each mL of solution contains 150 mg of emicizumab* Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of 150 mg/mL.
Maltese: Kull mL ta' soluzzjoni fih 150 mg ta' emicizumab* Kull kunjett ta' 0.4 mL fih 60 mg ta' emicizumab f'konċentrazzjoni ta' 150 mg/mL.
English: Patients have had surgical procedures without discontinuing emicizumab prophylaxis in clinical trials.
Maltese: Pazjenti kellhom proċeduri kirurġiċi mingħajr ma waqqfu profilassi b'emicizumab fi provi kliniċi.
English: Injection needle
Maltese: Injetta l-mediċina
English: ● Loading dose (first 4 weeks) example: 40 kg x 3 mg/kg = 120 mg of emicizumab needed for the loading dose.
Maltese: 40 kg x 3 mg/kg = 120 mg ta' emicizumab meħtieġa għad-doża għolja tal-bidu.
English: The total aPCC dose should not exceed 100 U/kg in the first 24-hours of treatment.
Maltese: Id-doża totali ta' aPCC m'għandhiex taqbeż 100 U/kg flewwel 24 siegħa ta' trattament.