FrancophonIA/ELRC3.0 huggingface dataset:
English: To measure change in health status, the Index Utility Score (IUS) and the Visual Analog Scale (VAS) from the EuroQoL Five-Dimension-Five Levels Questionnaire (EQ-5D-5L) was examined.
Maltese: Biex titkejjel il-bidla fl-istat tas-saħħa, ġew eżaminati lPunteġġ tal-Utilità tal-Indiċi (IUS - Index Utility Score) u l-Iskala Analoga Viżiva (VAS - Visual Analog Scale) mill-Kwestjonarju ta' Ħames Dimensjonijiet-Ħames Livelli tal-EuroQol (EQ-5D-5LEuroQoL Five-Dimension-Five Levels Questionnaire).
English: Rate ratio and confidence interval (CI) comes from negative binomial regression (NBR) model and pvalue from Stratified Wald test, comparing ABR between specified arms.
Maltese: Proporzjon tar-rata u intervall ta' kunfidenza (CI - confidence interval) ġejjin minn mudell ta' rigressjoni binomjali negattiva (NBR - negative binomial regression) u l-valur p minn Test ta' Wald stratifikat, li jqabbel ABR bejn gruppi speċifikati.
English: ● Polycarbonate with Luer-lock connection, sterile, fitting 15 mm vial neck outer diameter single-use, latex-free and non-pyrogenic.
Maltese: ● Polycarbonate b'konnessjoni Luer-Lok, sterili, li jaqbel ma' dijametru ta' barra tal-għonq tal kunjett ta' 15 mm, għal użu ta' darba, mingħajr latex u mhux piroġeniku.
English: For each treatment arm, the mean exposure times (+SD) were 28.86 weeks (8.37) for Arm A, 8.79 (3.62) for Arm B, 21.56 (11.85) for Arm C and 7.08 (3.89) for Arm D. One patient in Arm A withdrew from study prior to initiation of Hemlibra.
Maltese: Għal kull grupp ta' trattament, iż-żminijiet medji ta' esponiment (+ SD) kienu ta' 28.86 ġimgħa (8.37) għal Grupp A, 8.79 (3.62) għal Grupp B, 21.
English: Transfer Needle
Maltese: ● Siringa
English: Pharmacokinetic parameters derived from the population PK model.
Maltese: Il-parametri tal-farmakokinetika ġejjin mill-mudell tal-PK tal-popolazzjoni.
English: Similar PK profiles were observed following once weekly dosing (3 mg/kg/week for 4 weeks followed by 1.5 mg/kg/week) in adults/adolescents (≥ 12 years) and children (< 12 years) (see Figure 1).
Maltese: Profili simili tal-PK ġew osservati wara dożaġġ darba fil-ġimgħa (3 mg/kg/ġimgħa għal 4 ġimgħat segwiti minn 1.5 mg/kg/ġimgħa) f'adulti/adolexxenti (≥ 12-il sena) u tfal (< 12-il sena) (ara Figura 1).
English: Transfer medicine to syringe
Maltese: Ittrasferixxi l-mediċina għal ġossiringa
English: The vials should never be exposed to temperatures above 30 °C.
Maltese: Il-kunjetti qatt m'għandhom jiġu esposti għal temperaturi ta' 'l fuq minn 30 °C.
English: ● muscle aches
Maltese: ● uġigħ ta' ras
English: Following a single intravenous dose of 0.25 mg/kg emicizumab in healthy subjects, the volume of distribution at steady state was 106 mL/kg (i.e. 7.4 L for a 70-kg adult).
Maltese: Wara doża waħda ġol-vini ta' 0.25 mg/kg ta' emicizumab f'individwi f'saħħithom, il-volum taddistribuzzjoni fi stat fiss kien ta' 106 mL/kg (jiġifieri 7.4 L għal adult ta' 70 kg).
English: Hemlibra is intended for long-term prophylactic treatment.
Maltese: Hemlibra huwa maħsub għal trattament profilattiku fit-tul.
English: Following multiple subcutaneous administrations of 3 mg/kg once weekly for the first 4 weeks in haemophilia A patients, mean (±SD) trough plasma concentrations of emicizumab achieved 52.6±13.6 µg/mL at Week 5.
Maltese: Wara għoti multiplu taħt il-ġilda ta' 3 mg/kg darba fil-ġimgħa għall-ewwel 4 ġimgħat f'pazjenti blemofilja A, il-konċentrazzjonijiet l-aktar baxxi medji (±SD) fil-plażma ta' emicizumab kisbu 52.6±13.6 µg/mL f'Ġimgħa 5.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Hemlibra 30 mg/mL solution for injection
Maltese: U KWANTITATTIVA Hemlibra 30 mg/mL soluzzjoni għall-injezzjoni
English: There were 82 instances of aPCC treatment* in patients receiving Hemlibra prophylaxis, of which eight instances (10%) consisted of on average a cumulative amount of >100 U/kg/24 hours of aPCC for 24 hours or more; two of the eight instances were associated with thrombotic events and three of the eight instances were associated with TMA (Table 3).
Maltese: Kien hemm 82 każ ta' trattament b'aPCC* f'pazjenti li kienu qed jirċievu profilassi b'Hemlibra, fejn tmien każijiet (10%) minnhom kienu jikkonsistu minn medja ta' ammont kumulattiv ta' > 100 U/kg/24 siegħa ta' aPCC għal 24 siegħa jew aktar; tnejn mit-tmien każijiet kienu assoċjati ma' avvenimenti trombotiċi u tlieta mit-tmien każijiet kienu assoċjati ma' TMA (Tabella 3).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/0.4 mL
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni Kunjett wieħed 60 mg/0.4ml
English: Connect syringe to vial adapter
Maltese: Neħħi s-siringa mill-adapter tal-kunjett
English: Paediatric
Maltese: Pedjatrika
English: ● Destruction of red blood cells (thrombotic microangiopathy): confusion, weakness, swelling of arms and legs, yellowing of skin and eyes, vague belly (abdominal) or back pain, feeling sick (nausea), being sick (vomiting) or urinating lessthese symptoms may be signs of thrombotic microangiopathy.
Maltese: ● Qerda taċ-ċelluli ħomor tad-demm (mikroanġjopatija trombotika): konfużjoni, dgħufija, nefħa tad-dirgħajn u s-saqajn, sfurija tal-ġilda u tal-għajnejn, uġigħ mhux ċar fiż-żaqq jew fid-dahar, dardir, rimettar jew tgħaddi l-awrina inqas ta' spissdawn is-sintomi jistgħu jkunu sinjali ta' mikroanġjopatija trombotika.
English: ● 1 mL syringe: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.01 mL or
Maltese: ● Siringa ta' 1 mL: Siringa trasparenti tal-polypropylene jew tal-polycarbonate b'tarf Luer-Lok, immarkar ta' 0.01 mL jew
English: Treated bleeds = bleeds treated with FVIII All bleeds = bleeds treated and not treated with FVIII.
Maltese: Fsadiet ittrattati = fsadiet ittrattati b'FVIII Il-fsadiet kollha = fsadiet ittrattati u mhux ittrattati b'FVIII.
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.
Maltese: III randomised, b'aktar minn ċentru wieħed u open-label f'152 raġel adult u adolexxenti (b'età ta' ≥ 12-il sena u > 40 kg) bl-emofilja A severa mingħajr inibituri ta' FVIII li fil-passat irċevew trattament episodiku (“fuq talba”) jew profilattiku b'FVIII.
English: Fifty-three patients previously treated with episodic (“on-demand”) bypassing agents were randomised in a 2:1 ratio to receive Hemlibra prophylaxis (Arm A) or no prophylaxis (Arm B), with stratification by prior 24-week bleed rate (< 9 or ≥ 9).
Maltese: Tlieta u ħamsin pazjent ittrattati fil-passat b'bypassing agents episodiċi (“fuq talba”) kienu randomised fi proporzjon ta' 2:1 biex jirċievu profilassi b'Hemlibra (Grupp A) jew l-ebda profilassi (Grupp B), bi stratifikazzjoni skont ir-rata ta' fsada fl-24 ġimgħa ta' qabel (< 9 jew ≥ 9).
English: In clinical trials, no cases of TMA or thrombotic events were observed with use of activated recombinant human FVII (rFVIIa) alone in patients receiving Hemlibra prophylaxis.
Maltese: Fi provi kliniċi, ma ġie osservat l-ebda każ ta' TMA jew avvenimenti trombotiċi bl-użu ta' FVII attivat rikombinanti uman (rFVIIa - activated recombinant human FVII) waħdu f'pazjenti li kienu qed jirċievu profilassi b'Hemlibra.
English: Laboratory tests affected and unaffected by emicizumab are shown in Table 1 below.
Maltese: It-testijiet tal-laboratorju affettwati u mhux affettwati minn emicizumab huma murija fit-Tabella 1 hawn taħt.
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
Maltese: - Introduzzjoni fil-qosor għal emicizumab (klassi kimika, mekkaniżmu ta' azzjoni, farmakodinamika u indikazzjoni) - Informazzjoni rilevanti (eż. is-serjetà, is-severità, il-frekwenza, iż-żmien sal-bidu, irriversibilità kif applikabbli) tat-tħassib dwar is-sigurtà li ġej assoċjat mal-użu ta' Hemlibra: avvenimenti tromboemboliċi assoċjati mal-użu fl-istess waqt ta' emicizumab u konċentrat ta' kumpless ta' prothrombin attivat (aPCC), - mikroanġjopatija trombotika assoċjata mal-użu fl-istess waqt ta' emicizumab u aPCC - fsada ta' periklu għall-ħajja minħabba l-interpretazzjoni ħażina tat-testijiet talkoagulazzjoni standard (li mhumiex affidabbli f'pazjenti ttrattati b'emicizumab) Gwida dwar l-użu ta' bypassing agents flimkien ma' emicizumab, li tinkludi linformazzjoni li ġejja:
English: No dose adjustments are recommended in paediatric patients (see section 5.2).
Maltese: Mhux rakkomandati aġġustamenti fid-doża f'pazjenti pedjatriċi (ara sezzjoni 5.2).
English: Treated bleeds: bleeds treated with bypassing agents.
Maltese: Fsadiet ittrattati: fsadiet ittrattati b'bypassing agents.
English: Median ABR (IQR) * Previous prophylactic treatment for 15 of the 18 patients; previous episodic (on-demand) treatment for 3 subject Rate ratio and confidence interval (CI) comes from negative binomial regression (NBR) model and p-value from Stratified Wald test, comparing ABR between specified arms.
Maltese: ABR medjana (IQR) * Trattament profilattiku fil-passat għal 15 mit-18-il pazjent; trattament episodiku (fuq talba) fil-passat għal 3 individwi
English: Each mL of solution contains 30 mg of emicizumab* Each vial of 1 mL contains 30 mg of emicizumab at a concentration of 30 mg/mL.
Maltese: Kull mL ta' soluzzjoni fih 30 mg ta' emicizumab* Kull kunjett ta' 1 mL fih 30 mg ta' emicizumab f'konċentrazzjoni ta' 30 mg/mL.
English: The effect of age on the pharmacokinetics of emicizumab was assessed in a population pharmacokinetic analysis which included thirteen subjects aged 65 years and older (no subjects were older than 77 years of age).
Maltese: L-effett tal-età fuq il-farmakokinetika ta' emicizumab ġie evalwat f'analiżi tal-farmakokinetika talpopolazzjoni li inkludiet tlettax-il individwu b'età ta' 65 sena u aktar (l-ebda individwu ma kellu aktar minn 77 sena).
English: ● A 2 to 3 mL syringe should be used for an injection greater than 1 mL and up to 2 mL of Hemlibra solution.
Maltese: ● Għandha tintuża siringa ta' 2 sa 3 mL għal injezzjoni ta' aktar minn 1 mL u sa 2 mL ta' soluzzjoni ta' Hemlibra.
English: Uncap transfer needle
Maltese: Labra għat-Trasferiment
English: Although a higher adherence was observed with emicizumab prophylaxis than with prior bypassing agent (BPA) prophylaxis, no difference in ABR in patients with ≥ 80% or < 80% compliant doses on BPA 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'bypassing agent (BPA - bypassing agent) precedenti, ma setgħet tiġi identifikata l-ebda differenza fl-ABR f'pazjenti b'dożi b'konformità ta' ≥ 80% jew < 80% fuq profilassi b'BPA skont rekwiżiti tat-tikketta standard (id-data għandha tiġi interpretata b'kawtela minħabba d-daqsijiet żgħar tal-kampjun).
English: The total volume of Hemlibra to be injected subcutaneously is calculated as follows: Total amount (mg) of emicizumab to be administered ÷ vial concentration (mg/mL) = total volume of Hemlibra (mL) to be injected.
Maltese: L-ammont totali (mg) ta' emicizumab li jrid jingħata ÷ il-konċentrazzjoni tal-kunjett (mg/mL) = ilvolum totali ta' Hemlibra (mL) li jrid jiġi injettat.
English: Hemlibra increases the patient's coagulation potential.
Maltese: Hemlibra jżid il-potenzjal ta' koagulazzjoni tal-pazjent.
English: ● Hold the syringe by the barrel with the transfer needle pointing up.
Maltese: ● Oqgħod attent/a li ma tiġbidx ilplanġer 'il barra mis-siringa.
English: Table 5 HAVEN 3 study: Intra-patient comparison of Annualized Bleed Rate (treated Bleeds) with Hemlibra prophylaxis versus previous FVIII prophylaxis
Maltese: Studju HAVEN 3: Paragun tal-pazjenti ndividwali tar-Rata ta' Fsada Annwalizzata (Fsadiet ittrattati) bi profilassi b'Hemlibra kontra profilassi b'FVIII fil-passat
English: It is important to know the symptoms of thrombotic microangiopathy, in case you develop the condition (see section 4, “Possible side effects” for a list of symptoms).
Maltese: Huwa importanti li tkun taf is-sintomi ta' mikroanġjopatija trombotika, f'każ li inti tiżviluppa l-kondizzjoni (ara sezzjoni 4, “Effetti sekondarji possibbli” għal-lista tassintomi).
English: The developing hemostatic system in neonates and infants is dynamic and evolving, and the relative concentrations of pro- and anticoagulant proteins in these patients should be taken into consideration when making a benefit-risk assessment, including potential risk of thrombosis (e.g. central venous catheter-related thrombosis).
Maltese: Is-sistema emostatika li tkun għada qed tiżviluppa fit-trabi tat-twelid u t-trabi hija dinamika u qed tevolvi, u lkonċentrazzjonijiet relattivi tal-proteini pro- u antikoagulanti f'dawn il-pazjenti għandhom jiġu kkunsidrati meta jiġi vvalutat il-bilanċ bejn il-benefiċċju u r-riskju, inkluż ir-riskju potenzjali ta' trombożi (eż. trombożi relatata ma' kateter f'vina ċentrali).
English: Endpoint aABR (95% CI) bN = 59
Maltese: Punti finali aABR (CI ta' 95%) bABR Medjana (IQR) % tal-Ebda Fsada (CI ta' 95%)
English: Storing Hemlibra vials, needles and syringes:
Maltese: Ħażna ta' kunjetti ta' Hemlibra, labar u siringi:
English: Tabulated list of adverse drug reactions
Maltese: Lista ta' reazzjonijiet avversi tal-mediċina f'tabella
English: % Zero Bleeds (95%CI)
Maltese: % ta' Żero Fsadiet (CI ta' 95%)
English: Results Affected by emicizumab
Maltese: Dożi ttardjati jew maqbuża
English: No incompatibilities between Hemlibra and polypropylene or polycarbonate syringes , polycarbonate vial adapters and stainless steel needles have been observed.
Maltese: Ma ġiet osservata l-ebda inkompatibbiltà bejn Hemlibra u s-siringi tal-polypropylene jew talpolycarbonate, l-adapters tal-kunjett tal-polycarbonate u l-labar tal-azzar li ma jissaddadx.
English: For comprehensive instructions on the administration of Hemlibra, see section 6.6 and package leaflet.
Maltese: Għal istruzzjonijiet komprensivi dwar l-għoti ta' Hemlibra, ara sezzjoni 6.6 u l-fuljett ta' tagħrif.
English: Duration of aPCC treatment
Maltese: Tul ta' trattament b'aPCC
English: Thrombotic microangiopathy associated with Hemlibra and activated prothrombin complex concentrate
Maltese: Mikroanġjopatija trombotika assoċjata ma' Hemlibra u konċentrat ta' kumpless ta' prothrombin attivat
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Hemlibra in one or more subsets of the paediatric population in the treatment of hereditary factor VIII deficiency (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Hemlibra f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fit-trattament ta' defiċjenza talfattur VIII ereditarja (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Women of childbearing potential receiving Hemlibra should use effective contraception during, and for at least 6 months after cessation of Hemlibra treatment (see section 5.2).
Maltese: Nisa li jistgħu joħorġu tqal li jirċievu Hemlibra għandhom jużaw kontraċezzjoni effettiva waqt, u għal mill-inqas 6 xhur wara t-twaqqif tat-trattament b'Hemlibra (ara sezzjoni 5.2).
English: Dose up-titration to 3 mg/kg once weekly was allowed after 24 weeks on Hemlibra prophylaxis for patients who experienced two or more qualified bleeds (i.e. spontaneous and verified clinically significant bleeds occurring at steady state).
Maltese: 3 mg/kg darba fil-ġimgħa kienet permessa wara 24 ġimgħa fuq profilassi b'Hemlibra għall-pazjenti li kellhom żewġ fsadiet ikkwalifikati jew aktar (jiġifieri fsadiet spontanji u klinikament sinifikanti vverifikati li seħħew fi stat fiss).
English: Treated bleeds ABR (95% CI)
Maltese: Fsadiet fil-Ġogi fil-Mira Ttrattati ABR (CI ta' 95%)
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.
Maltese: ● Biex tikkalkula l-volum li jrid jingħata, iddividi d-doża kkalkulata ta' 360 mg b'150 mg/mL: 360 mg ta' emicizumab ÷ 150 mg/mL = 2.4 mL ta' 150 mg/mL konċentrazzjoni ta' Hemlibra li trid tiġi injettata kull erba' ġimgħat.
English: Hemlibra was investigated in a single arm, multicenter, phase III clinical study in 41 adult and adolescent males (aged ≥ 12 years and > 40 kg) who have hemophilia A with FVIII inhibitors or severe hemophilia A without FVIII inhibitors who previously received either episodic (“on demand”) or prophylactic treatment with bypassing agents or FVIII.
Maltese: III bi grupp wieħed u b'aktar minn ċentru wieħed f'41 raġel adult u adolexxenti (b'età ta' ≥ 12-il sena u > 40 kg) li għandhom emofilja A b'inibituri ta' FVIII jew emofilja A severa mingħajr inibituri ta' FVIII li fil-passat irċevew trattament episodiku (“fuq talba”) jew profilattiku b'bypassing agents jew FVIII.
English: ● Syringe Note: For injection amount up to 1 mL use a 1 mL syringe.
Maltese: Nota: Għal ammont ta' injezzjoni sa 1 mL uża siringa ta' 1 mL.
English: Characterization of the interaction between emicizumab and aPCC treatment in pivotal clinical trials
Maltese: Karatterizzazzjoni tal-interazzjoni bejn emicizumab u trattament b'aPCC fi provi kliniċi prinċipali
English: Hepatic impairment
Maltese: Medja aġġustata
English: Use in children and adolescents
Maltese: Riżultati tal-Effikaċja f'Adulti u Adolexxenti
English: NAME OF THE MEDICINAL PRODUCT Hemlibra 150 mg/mL solution for injection emicizumab
Maltese: Hemlibra 150 mg/mL soluzzjoni għall-injezzjoni emicizumab
English: NAME OF THE MEDICINAL PRODUCT Hemlibra 30 mg/mL solution for injection emicizumab
Maltese: Hemlibra 30 mg/mL soluzzjoni għall-injezzjoni emicizumab
English: In total three patients (0.8 %) in the clinical trials receiving Hemlibra prophylaxis withdrew from treatment due to ADRs, which were TMA, skin necrosis contemporaneous with superficial thrombophlebitis, and headache.
Maltese: B'kollox tliet pazjenti (0.8 %) fil-provi kliniċi li kienu qed jirċievu profilassi b'Hemlibra waqqfu ttrattament minħabba ADRs, li kienu TMA, nekrosi tal-ġilda fl-istess waqt ma' tromboflebite superfiċjali, u wġigħ ta' ras.
English: Weekly Hemlibra prophylaxis showed a statistically significant and clinically meaningful improvement compared with no prophylaxis in the pre-specified endpoints of Haem-A-QoL Physical Health Scale score at the Week 25 assessment.
Maltese: Il-profilassi b'Hemlibra darba fil-ġimgħa wriet titjib statistikament sinifikanti u klinikament importanti meta mqabbel ma' mingħajr profilassi fil-punt finali speċifikat minn qabel tal-punteġġ tal-Iskala tas-Saħħa Fiżika ta' Haem-A-QoL fl-evalwazzjoni f'Ġimgħa 25.
English: Guidance on the use of bypassing agents in patients receiving Hemlibra prophylaxis
Maltese: Gwida dwar l-użu ta' bypassing agents f'pazjenti li jirċievu profilassi b'Hemlibra
English: The physician should immediately discontinue aPCC and interrupt Hemlibra therapy if clinical symptoms, imaging, and/or laboratory findings consistent with thrombotic events occur, and manage as clinically indicated.
Maltese: It-tabib għandu jwaqqaf aPCC immedjatament u jinterrompi terapija b'Hemlibra jekk iseħħu sintomi kliniċi, immaġini u/jew sejbiet tal-laboratorju konsistenti ma' avvenimenti trombotiċi, u għandu jimmaniġġa kif indikat klinikament.
English: Table 9 provides a summary of the comparison between the Hemlibra prophylaxis arm (Arm A) and the no prophylaxis arm (Arm B) on the Haem-A-QoL Total Score and Physical Health scale after 24 weeks of treatment adjusting for baseline.
Maltese: It-Tabella 9 tipprovdi sommarju tat-tqabbil bejn il-grupp ta' profilassi b'Hemlibra (Grupp A) u l-grupp mingħajr profilassi (Grupp B) dwar il-Punteġġ Totali u l-iskala tasSaħħa Fiżika ta' Haem-A-QoL wara 24 ġimgħa ta' trattament li jaġġusta għal-linja bażi.
English: Hemlibra 30 mg/mL solution for injection 30 months.
Maltese: Hemlibra 30 mg/mL soluzzjoni għall-injezzjoni 30 xahar.
English: Where to inject Hemlibra
Maltese: X'inhu Hemlibra
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;
Maltese: Istruzzjonijiet għall-pazjenti biex iġorru l-kartuna f'kull ħin, inkluż f'kondizzjonijiet ta' emerġenza u biex jippreżentaw il-kartuna meta jżuru tobba, kliniki tal-isptar, persuni li jieħdu ħsiebhom, professjonisti tal-laboratorju jew spiżjara biex jinformawhom dwar ittrattament b'emicizumab u r-riskji;
English: No data are available with respect to potential side effects of emicizumab on embryo-foetal development.
Maltese: M'hemm l-ebda data disponibbli fir-rigward tal-effetti sekondarji potenzjali ta' emicizumab fuq liżvilupp tal-embrijun u tal-fetu.
English: Arm C: Hemlibra 1.5 mg/kg weekly
Maltese: Grupp Ċ: Hemlibra 1.5 mg/kg darba fil-ġimgħa
English: INCLUDED IN THE BOX:
Maltese: INKLUŻI FIL-KAXXA:
English: Included in the box:
Maltese: Inklużi fil-kaxxa:
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).
Maltese: Għandha tintuża kawtela meta jiġu ttrattati pazjenti li jkunu f'riskju għoli għal TMA (eż. ikollhom storja medika preċedenti jew storja fil-familja ta' TMA), jew dawk li jkunu qed jirċievu mediċini flistess waqt magħrufa li huma fattur ta' riskju għall-iżvilupp ta' TMA (eż. ciclosporin, quinine, tacrolimus).
English: Criteria: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.01 mL.
Maltese: Siringa trasparenti tal-polypropylene jew tal-polycarbonate b'tarf Luer-Lok, immarkar ta' 0.01 mL.
English: Hemlibra is a medicine used for treating patients of all ages with
Maltese: Hemlibra huwa mediċina użata għat-trattament ta' pazjenti ta' kull età
English: ABR (95% CI) % reduction (RR), p-value
Maltese: ABR (CI ta' 95%) % ta' tnaqqis (RR)
English: Uncap injection needle
Maltese: Injezzjoni taħt il-ġilda
English: Assays containing human coagulation factors are responsive to emicizumab but may overestimate the clinical haemostatic potential of emicizumab.
Maltese: Bħal bil-proteini terapewtiċi kollha, hemm potenzjal ta' rispons immuni f'pazjenti ttrattati b'emicizumab.
English: When used together with a vial adapter, a low dead space plunger 1 mL syringe (transparent polypropylene or polycarbonate syringe with Luer lock tip, graduation 0.01 mL) must be used.
Maltese: Meta tintuża flimkien ma' adapter tal-kunjett, trid tintuża siringa ta' 1 mL bi planġer bi spazju residwu żgħir (low dead space) (siringa trasparenti tal-polypropylene jew tal-polycarbonate b'tarf Luer-Lok, immarkar ta' 0.01 mL).
English: Treated Bleeds ABR (95% CI) % reduction (RR), p-value
Maltese: Fsadiet Ittrattati ABR (CI ta' 95%) % ta' tnaqqis (RR), valur p
English: Needles
Maltese: Treddigħ
English: When used together with a vial adapter, a low dead space plunger 3 mL syringe (transparent polypropylene or polycarbonate syringe with Luer lock tip, graduation 0.1 mL) must be used.
Maltese: Meta tintuża flimkien ma' adapter tal-kunjett, trid tintuża siringa ta' 3 mL bi planġer bi spazju residwu żgħir (siringa trasparenti tal-polypropylene jew tal-polycarbonate b'tarf Luer-Lok, immarkar ta' 0.1 mL).