FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: Kriterji għall-adapter tal-kunjett: 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: Hemlibra 150 mg/mL solution for injection 3 years.
Maltese: Hemlibra 150 mg/mL soluzzjoni għall-injezzjoni 3 snin.
English: In pooled phase III clinical trials, serious thrombotic events were reported in less than 1 % of patients (2/373) and in 6.5 % of patients (2/31) who received at least one dose of aPCC while being treated with emicizumab.
Maltese: III miġbura f'daqqa, ġew irrappurtati avvenimenti trombotiċi serji f'inqas minn 1 % tal-pazjenti (2/373) u f'6.5 % tal-pazjenti (2/31) li rċevew mill-inqas doża waħda ta' aPCC waqt li kienu qed jiġu ttrattati b'emicizumab.
English: There is limited experience with overdose of Hemlibra.
Maltese: Hemm esperjenza limitata b'doża eċċessiva ta' Hemlibra.
English: Each vial of Hemlibra contains 30 mg (1 mL at a concentration of 30 mg/mL) of emicizumab.
Maltese: Kull kunjett ta' Hemlibra fih 30 mg (1 mL f'konċentrazzjoni ta' 30 mg/mL) ta' emicizumab.
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).
Maltese: Fl-istudju HAVEN 1, studju kliniku randomised, b'aktar minn ċentru wieħed, open-label f'109 adolexxenti u adulti rġiel (b'età ta' ≥ 12-il sena) bl-emofilja A b'inibituri tal-fattur VIII li filpassat kienu rċevew trattament episodiku jew profilattiku b'bypassing agents (aPCC u rFVIIa).
English: Listing of laboratory tests unaffected by emicizumab;
Maltese: Lista ta' testijiet tal-laboratorju mhux affettwati minn emicizumab;
English: Mean baseline score (95% CI) (n = 54) Mean change from baseline (95% CI) (n = 43)
Maltese: Punteġġ medju fil-linja bażi (CI ta' 95%) (n = 54) Bidla medja mil-linja bażi (CI ta' 95%) (n = 43)
English: The effect of age on the pharmacokinetics of emicizumab was assessed in a population pharmacokinetic analysis which included 5 infants (≥ 1 month to < 2 years), 55 children (less than 12 years) and 50 adolescents (12 to < 18 years) with haemophilia A. Age did not affect the pharmacokinetics of emicizumab in paediatric patients.
Maltese: L-effett tal-età fuq il-farmakokinetika ta' emicizumab ġie evalwat f'analiżi tal-farmakokinetika talpopolazzjoni li inkludiet 5 trabi (≥ xahar sa < sentejn), 55 tifel/tifla (inqas minn 12-il sena) u 50 adolexxent (12 sa < 18-il sena) bl-emofilja A.
English: Emicizumab exhibited dose-proportional pharmacokinetics in patients with haemophilia A after the first dose of Hemlibra over a dose range from 0.3 to 6 mg/kg .
Maltese: Emicizumab wera farmakokinetika proporzjonali mad-doża f'pazjenti bl-emofilja A wara l-ewwel doża ta' Hemlibra fuq medda ta' dożi minn 0.3 sa 6 mg/kg.
English: Less than 5 % of patients tested positive for anti-emicizumab antibodies and < 1 % of patients had anti-emicizumab antibodies with neutralizing potential (based on declining pharmacokinetics).
Maltese: Inqas minn 5 % tal-pazjenti kellhom riżultat pożittivi tat-test għall-antikorpi kontra emicizumab u < 1 % tal-pazjenti kellhom antikorpi kontra emicizumab b'potenzjal newtralizzanti (abbażi tal-farmakokinetika li qed tonqos).
English: The impact of moderate and severe renal impairment on the pharmacokinetics of emicizumab cannot be concluded.
Maltese: L-impatt ta' indeboliment moderat u sever talkliewi fuq il-farmakokinetika ta' emicizumab ma jistax jiġi konkluż.
English: Eighty-nine patients previously treated with episodic (“on demand”) FVIII were randomized in a 2:2:1 ratio to receive Hemlibra either once weekly (Arm A; N = 36), every two weeks (Arm B; N = 35) or no prophylaxis (Arm C; N = 18), with stratification by prior 24-week bleed rate (< 9 or ≥ 9).
Maltese: Disgħa u tmenin pazjent li fil-passat ġew ittrattati b'FVIII episodiku (“fuq talba”) kienu randomised fi proporzjon ta' 2:2:1 biex jirċievu Hemlibra darba fil-ġimgħa (Grupp A; N = 36), kull ġimagħtejn (Grupp B; N = 35) jew l-ebda profilassi (Grupp Ċ; N = 18), bi stratifikazzjoni skont ir-rata ta' fsada fl24 ġimgħa ta' qabel (< 9 jew ≥ 9).
English: ● If you do not have a sharps disposal container, you may use a household container that is: - made of heavy-duty plastic.
Maltese: ● Jekk m'għandekx kontenitur għar-rimi ta' oġġetti li jaqtgħu u bil-ponta, tista' tuża kontenitur domestiku li jkun: magħmul minn plastik heavy-duty.
English: Following multiple subcutaneous injections in haemophilia A patients, the apparent clearance was 0.272 L/day and the elimination apparent half-life was 26.8 days.
Maltese: Wara injezzjonijiet multipli taħt il-ġilda f'pazjenti bl-emofilja A, it-tneħħija apparenti kienet ta' 0.272 L/jum u l-half-life apparenti tal-eliminazzjoni kienet ta' 26.8 ijiem.
English: The metabolism of emicizumab has not been studied.
Maltese: Il-metaboliżmu ta' emicizumab ma ġiex studjat.
English: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Maltese: D-79639 Grenzach-Wyhlen
English: Table 10 provides a summary of the comparison between the Hemlibra prophylaxis arm (Arm A) and the no prophylaxis arm (Arm B) on the EQ-5D-5L index utility scale and visual analog scale after 24 weeks of treatment adjusting for baseline.
Maltese: It-Tabella 10 tipprovdi sommarju tat-tqabbil bejn il-grupp ta' profilassi b'Hemlibra (Grupp A) u lgrupp mingħajr profilassi (Grupp B) dwar l-iskala tal-utilità tal-indiċi u l-iskala analoga viżiva ta' EQ5D-5L wara 24 ġimgħa ta' trattament li jaġġusta għal-linja bażi.
English: Criteria for transfer needle: Stainless steel with Luer-lock connection, gauge 18 G, length 35mm (1½″), preferably semi-blunted tip.
Maltese: Azzar li ma jissaddadx b'konnessjoni Luer-Lok, gejġ ta' 18 G, tul ta' 35mm (1½″), preferibbilment ponta parzjalment spuntata.
English: Table 3 Characterisation of aPCC treatment* in the pooled phase III clinical studies
Maltese: Tabella 3 Karatterizzazzjoni ta' trattament b'aPCC* fl-istudji kliniċi ta' fażi
English: Combining Vials
Maltese: Mhux komuni
English: ● Maintenance dose (from week 5 on) example: 60 kg x 6 mg/kg = 360 mg of emicizumab needed for the maintenance dose.
Maltese: ● Eżempju ta' doża ta' manteniment (minn ġimgħa 5 'il quddiem): 60 kg x 6 mg/kg = 360 mg ta' emicizumab meħtieġa għad-doża ta' manteniment.
English: ● Maintenance dose (from week 5 on) example: 16 kg x 1.5 mg/kg = 24 mg of emicizumab needed for the maintenance dose.
Maltese: ● Eżempju ta' doża ta' manteniment (minn ġimgħa 5 'il quddiem): 16-il kg x 1.5 mg/kg = 24 mg ta' emicizumab meħtieġa għad-doża ta' manteniment.
English: Physical health score (range 0 to 100)a Mean baseline score (95% CI) (n = 18) Mean change from baseline (95% CI) (n = 15)
Maltese: Punteġġ medju fil-linja bażi (CI ta' 95%) (n = 18) Bidla medja mil-linja bażi (CI ta' 95) (n = 15)
English: 1 mL syringe
Maltese: Siringa ta' 1 mL
English: Other medicines and Hemlibra
Maltese: Mediċini oħra u Hemlibra
English: HAVEN 2 paediatric Efficacy Results (Interim Analysis)
Maltese: Riżultati tal-Effikaċja f'Pazjenti Pedjatrici f'HAVEN 2 (Analiżi Interim)
English: The pharmacokinetics of emicizumab was determined via non-compartmental analysis in healthy subjects and using a population pharmacokinetic analysis on a database composed of 389 patients with haemophilia A.
Maltese: Il-farmakokinetika ta' emicizumab kienet determinata permezz ta' analiżi mhux kompartimentali f'individwi f'saħħithom u bl-użu ta' analiżi tal-farmakokinetika tal-popolazzjoni fuq bażi ta' data magħmula minn 389 pazjent bl-emofilja A.
English: Arm B: no prophylaxis
Maltese: Grupp B: mingħajr profilassi
English: Mild hepatic impairment did not affect the pharmacokinetics of emicizumab (see section 4.2).
Maltese: Indeboliment ħafif tal-fwied ma affettwax il-farmakokinetika ta' emicizumab (ara sezzjoni 4.2).
English: Thromboembolism associated with Hemlibra and activated prothrombin complex concentrate
Maltese: Tromboemboliżmu assoċjat ma' Hemlibra u konċentrat ta' kumpless ta' prothrombin attivat
English: Chugai Pharma Manufacturing Co., Ltd. 5-1, Ukima 5-Chome Kita-Ku, Tokyo
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Chugai Pharma Manufacturing Co., Ltd.
English: In case of thrombotic complication, the physician should consider discontinuing rFVIIa or FVIII and interrupt Hemlibra prophylaxis as clinically indicated.
Maltese: F'każ ta' komplikazzjoni trombotika, it-tabib għandu jikkunsidra t-twaqqif ta' rFVIIa jew FVIII u jinterrompi profilassi b'Hemlibra kif indikat klinikament.
English: Coagulation laboratory tests based on intrinsic clotting, including the activated clotting time (ACT), activated partial thromboplastin time (e.g. aPTT), measure the total clotting time including time needed for activation of FVIII to FVIIIa by thrombin.
Maltese: It-testijiet tal-koagulazzjoni tal-laboratorju bbażati fuq koagulazzjoni intrinsika, li jinkludu l-ħin ta' koagulazzjoni attivata (ACT - activated clotting time), u l-ħin ta' thromboplastin parzjali attivat (eż. aPTT - activated partial thromboplastin time), ikejlu l-ħin ta' koagulazzjoni totali inkluż il-ħin meħtieġ għall-attivazzjoni ta' FVIII għal FVIIIa permezz ta' thrombin.
English: Treated bleeds: bleeds treated with FVIII or rFVIIa
Maltese: Il-fsadiet kollha: fsadiet ittrattati u mhux ittrattati b'FVIII jew rFVIIa
English: The predicted mean (±SD) Ctrough ,and Cmax and ratios of Cmax/Ctrough at steady- state for the recommended maintenance doses of 1.5 mg/kg once weekly, 3 mg/kg every two weeks or 6 mg/kg every four weeks are shown in Table 14 .
Maltese: Is-Ctrough, u s-Cmax medji mbassra (±SD) u l-proporzjonijiet ta' Cmax/Ctrough fi stat fiss għad-dożi ta' manteniment irrakkomandati ta' 1.5 mg/kg darba fil-ġimgħa, 3 mg/kg kull ġimagħtejn jew 6 mg/kg kull erba' ġimgħat huma murija fit-Tabella 14.
English: The efficacy of Hemlibra for routine prophylaxis in patients with hemophilia A with or without FVIII inhibitors was evaluated in four clinical studies (three adult and adolescent studies [HAVEN 3, HAVEN 1, and HAVEN 4] and a paediatric study [HAVEN 2]).
Maltese: L-effikaċja ta' Hemlibra għal profilassi normali f'pazjenti bl-emofilja A b'inibituri ta' FVIII jew mingħajrhom ġiet evalwata f'erba' studji kliniċi (tliet studji f'adulti u adolexxenti [HAVEN 3, HAVEN 1, u HAVEN 4] u studju pedjatriku [HAVEN 2]).
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
Maltese: Tabella 8 HAVEN 4: Rata ta' Fsada Annwalizzata bi profilassi b'Hemlibra f'Pazjenti b'età ta'≥12-il Sena b'Inibituri tal-Fattur VIII jew mingħajrhom
English: Table 12 HAVEN 2: Intra-patient comparison of Annualised Bleed Rate (treated bleeds) with Hemlibra prophylaxis versus previous bypassing agent prophylaxis
Maltese: Tabella 12 HAVEN 2: Paragun tal-pazjenti individwali tar-Rata ta' Fsada Annwalizzata (fsadiet ittrattati) bi profilassi b'Hemlibra kontra profilassi b'bypassing agent fil-passat
English: ABR= Annualised Bleed Rate; CI= confidence interval; RR= rate ratio; IQR=interquartile range, 25th percentile to 75
Maltese: ABR= Rata ta' Fsada Annwalizzata (Annualised Bleed Rate); CI= intervall ta' kunfidenza (confidence interval); RR= proporzjon tar-rata (rate ratio); IQR= medda interkwartili (interquartile range), il-25 perċentil sal-75 perċentil.
English: Arm A: 1.5 mg/kg Hemlibra weekly
Maltese: Grupp A: 1.5 mg/kg Hemlibra darba filġimgħa
English: The safety and efficacy of emicizumab have not been formally evaluated in the surgical setting.
Maltese: Is-sigurtà u l-effikaċja ta' emicizumab ma ġewx evalwati formalment fl-ambjent kirurġiku.
English: ● The guide for laboratory professionals shall contain the following key messages: Chemical class, mode of action, pharmacodynamics and indication for emicizumab Information on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and not accurately reflect the patient's underlying hemostatic status during emicizumab prophylaxis.
Maltese: - Il-klassi kimika, il-mekkaniżmu ta' azzjoni, il-farmakodinamika u indikazzjoni għal emicizumab - Informazzjoni dwar l-interferenza ta' emicizumab ma' ċerti testijiet tal-koagulazzjoni tallaboratorju li se taffettwa l-affidabilità tagħhom u ma tirriflettix b'mod eżatt l-istat emostatiku sottostanti tal-pazjent matul profilassi b'emicizumab.
English: Table 7 HAVEN 1: Intra-patient comparison of Annualised Bleed Rate (treated bleeds) with Hemlibra prophylaxis versus previous bypassing agent prophylaxis (NIS patients)
Maltese: Tabella 7 HAVEN 1: Paragun tal-pazjenti individwali tar-Rata ta' Fsada Annwalizzata (fsadiet ittrattati) bi profilassi b'Hemlibra kontra profilassi b'bypassing agent filpassat (pazjenti tal-NIS)
English: Emicizumab can be administered interchangeably at these anatomical sites (see section 4.2).
Maltese: Emicizumab jista' jingħata b'mod interkambjabbli f'dawn is-siti anatomiċi (ara sezzjoni 4.2).
English: All ISRs observed in the Hemlibra clinical trials were reported as being non-serious and mild to moderate in intensity, and 95 % resolved without treatment.
Maltese: L-ISRs kollha osservati fil-provi kliniċi b'Hemlibra kienu rrappurtati bħala li ma kinux serji u b'intensità ħafifa sa moderata, u 95 % għaddew mingħajr trattament.
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.
Maltese: Il-programm edukattiv għandu l-għan li jżid il-komunikazzjoni u l-edukazzjoni medika u tal-pazjent dwar ir-riskji importanti identifikati ta' avvenimenti tromboemboliċi u ta' mikroanġjopatija trombotika assoċjati mal-użu fl-istess waqt ta' emicizumab u konċentrat ta' kumpless ta' prothrombin attivat (aPCC - activated prothrombin complex concentrate), u r-riskju potenzjali importanti ta' fsada ta' periklu għall-ħajja minħabba l-interpretazzjoni ħażina ta' testijiet tal-koagulazzjoni standard (li mhumiex affidabbli f'pazjenti ttrattati b'emicizumab) u jipprovdi informazzjoni dwar kif dawn għandhom jiġu mmaniġġjati.
English: In the HAVEN 1 intra-patient analysis, Hemlibra prophylaxis resulted in statistically significant (p = 0.0003) and clinically meaningful reduction (79 %) in bleed rate for treated bleeds compared with previous bypassing agent prophylaxis collected in the NIS prior to enrolment (see Table 7).
Maltese: Fl-analiżi tal-pazjent individwali f'HAVEN 1, il-profilassi b'Hemlibra rriżultat fi tnaqqis (79 %) statistikament sinifikanti (p = 0.0003) u klinikament importanti fir-rata ta' fsada għall-fsadiet ittrattati meta mqabbla ma' profilassi preċedenti b'bypassing agent miġbura fl-NIS qabel ir-reġistrazzjoni (ara Tabella 7).
English: Factor VIII (FVIII) prophylaxis may be continued for the first 7 days of Hemlibra treatment.
Maltese: Profilassi tal-fattur VIII (FVIII) tista' titkompla għall-ewwel 7 ijiem tat-trattament b'Hemlibra.
English: ● Transfer needle: Stainless steel with Luer-lock connection, gauge 18 G, length 35mm (1½″), preferably semi-blunted tip, and
Maltese: Azzar li ma jissaddadx b'konnessjoni Luer-Lok, gejġ ta' 18 G, tul ta' 35mm (1½″), preferibbilment ponta parzjalment spuntata, u
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Maltese: 79639 Grenzach-Wyhlen
English: Table 9 HAVEN 1: Change in Haem-A-QoL Physical Health and Total score with Hemlibra prophylaxis versus no prophylaxis in patients ≥ 18 years with factor VIII inhibitors
Maltese: Tabella 9 HAVEN 1: Bidla fil-punteġġ tas-Saħħa Fiżika u Totali ta' Haem-A-QoL bi profilassi b'Hemlibra kontra l-ebda profilassi f'pazjenti ta' ≥ 18-il sena b'inibituri tal-fattur VIII
English: Roche s. r. O. Tel: +420 - 2 20382111
Maltese: Tel: +420 - 2 20382111
English: The apparent volume of distribution (V/F), estimated from the population PK analysis, in haemophilia A patients following multiple subcutaneous doses of emicizumab was 10.4 L. Metabolism
Maltese: Il-volum apparenti tad-distribuzzjoni (V/F), stmat mill-analiżi PK tal-popolazzjoni, f'pazjenti blemofilja A wara dożi multipli taħt il-ġilda ta' emicizumab kien ta' 10.4
English: In HAVEN 2, HRQoL for patients aged ≥ 8 to < 12 years was evaluated at week 25 based on the Haemo-QoL-SF questionnaire for children(see Table 13).
Maltese: F'HAVEN 2, l-HRQoL għall-pazjenti b'età ta' ≥ 8 sa < 12-il sena ġiet evalwata f'ġimgħa 25 abbażi tal-kwestjonarju dwar l-Haemo-QoL-SF għat-tfal (ara Tabella 13).
English: - Bethesda assays (bovine chromogenic) for FVIII inhibitor titers - Thrombin time (TT) - One-stage, prothrombin time (PT)-based, single-factor assays - Chromogenic-based single-factor assays other than FVIII1
Maltese: - Assaġġi Bethesda (kromoġeniċi bovini) għal titers ta' inibitur ta' FVIII - Ħin ta' thrombin (TT - thrombin time) - Assaġġi ta' fattur uniku, ibbażati fuq ħin ta' prothrombin (PT - prothrombin time), ta' stadju wieħed - Assaġġi ta' fattur uniku bbażati fuq kromoġenika minbarra FVIII - Assaġġi bbażati fuq l-immunità (eż. ELISA, metodi turbidimetriċi) - Testijiet ġenetiċi ta' fatturi ta' koagulazzjoni (eż. Fattur V Leiden, Prothrombin 20210)
English: Patients (aged ≥ 12 years old) with haemophilia A with or without factor VIII inhibitors (Study BO39182 - HAVEN 4)
Maltese: Pazjenti (b'età ta' ≥ 12-il sena) bl-emofilja A b'inibituri tal-fattur VIII jew mingħajrhom (Studju BO39182 - HAVEN 4)
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.
Maltese: Għandha tintuża siringa ta' 1 mL għal injezzjoni sa 1 mL ta' soluzzjoni ta' Hemlibra, filwaqt li għandha tintuża siringa ta' 2 sa 3 mL għal injezzjoni ta' aktar minn 1 mL u sa 2 mL.
English: Step F. Transfer medicine to syringe
Maltese: Pass F. Ittrasferixxi l-mediċina għal ġossiringa
English: The exposure (Cavg, ss) of multiple doses is comparable between 1.5 mg/kg every week, 3mg/kg every 2 weeks and 6mg/kg dose every 4 weeks.
Maltese: L-esponiment (Cavg, ss) għal dożi multipli huwa paragunabbli bejn dożi ta' 1.5 mg/kg kull ġimgħa, 3 mg/kg kull ġimagħtejn u 6 mg/kg kull 4 ġimgħat.
English: PREPARATION
Maltese: LISTA
English: For injection amount between 1 mL and 2 mL use a 2 mL or 3 mL syringe.
Maltese: Għal ammont ta' injezzjoni bejn 1 mL u 2 mL uża siringa ta' 2 mL
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.
Maltese: ● Biex tikkalkula l-volum li jrid jingħata, iddividi d-doża kkalkulata ta' 24 mg bi 30 mg/mL: 24 mg ta' emicizumab ÷ 30 mg/mL = 0.8 mL ta' konċentrazzjoni ta' 30 mg/mL ta' Hemlibra li trid tiġi injettata darba fil-ġimgħa.
English: ● Maintenance dose (from week 5 on) example: 40 kg x 3 mg/kg = 120 mg of emicizumab needed for the maintenance dose.
Maltese: ● Eżempju ta' doża ta' manteniment (minn ġimgħa 5 'il quddiem): 40 kg x 3 mg/kg = 120 mg ta' emicizumab meħtieġa għad-doża ta' manteniment.
English: Syringes
Maltese: Siringi
English: ● 2 to 3 mL syringe: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.1 mL.
Maltese: ● Siringa ta' 2 sa 3 mL: Siringa trasparenti tal-polypropylene jew tal-polycarbonate b'tarf LuerLok, immarkar ta' 0.1 mL.
English: Hemlibra weekly prophylaxis was evaluated in a single-arm, multicentre, open-label clinical study in paediatric patients (age < 12 years old, or 12 to 17 years old weighing < 40 kg) with haemophilia A with factor VIII inhibitors.
Maltese: Il-profilassi b'Hemlibra darba fil-ġimgħa ġiet evalwata fi studju kliniku bi grupp wieħed, b'aktar minn ċentru wieħed, open-label f'pazjenti pedjatriċi (età ta' < 12-il sena, jew 12 sa 17-il sena li jiżnu < 40 kg) b'emofilja A b'inibituri tal-fattur VIII.
English: Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with
Maltese: Hemlibra huwa indikat għal profilassi normali ta' episodji ta' fsada f'pazjenti
English: NAME OF THE MEDICINAL PRODUCT Hemlibra 30 mg/mL solution for injection Hemlibra 150 mg/mL solution for injection
Maltese: Hemlibra 30 mg/mL soluzzjoni għall-injezzjoni Hemlibra 150 mg/mL soluzzjoni għall-injezzjoni
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).
Maltese: Ġew irrappurtati avvenimenti trombotiċi serji minn prova klinika f'pazjenti li kienu qed jirċievu profilassi b'Hemlibra meta fuq medja ngħata ammont kumulattiv ta' >100U/kg/24 siegħa ta' aPCC għal 24 siegħa jew aktar (ara sezzjoni 4.8).
English: Cases of thrombotic microangiopathy (TMA) were reported from a clinical trial in patients receiving Hemlibra prophylaxis when on average a cumulative amount of >100U/kg/24 hours of activated prothrombin complex concentrate (aPCC) for 24 hours or more was administered (see section 4.8).
Maltese: Ġew irrappurtati każijiet ta' mikroanġjopatija trombotika (TMA - thrombotic microangiopathy) minn prova klinika f'pazjenti li kienu qed jirċievu profilassi b'Hemlibra meta fuq medja ngħata ammont kumulattiv ta' >100U/kg/24 siegħa ta' konċentrat ta' kumpless ta' prothrombin attivat (aPCCactivated prothrombin complex concentrate) għal 24 siegħa jew aktar (ara sezzjoni 4.8).
English: Hemlibra 150 mg/mL solution for injection
Maltese: Hemlibra 150 mg/mL soluzzjoni għall-injezzjoni
English: Emicizumab did not cause any changes in the reproductive organs of male or female cynomolgus monkeys up to the highest tested dose of 30 mg/kg/week (equivalent to 11 times the human exposure at the highest dose of 3 mg/kg/week, based on AUC).
Maltese: Emicizumab ma kkawża l-ebda bidla fl-organi riproduttivi ta' xadini cynomolgus irġiel jew nisa salogħla doża ttestjata ta' 30 mg/kg/ġimgħa (ekwivalenti għal 11-il darba l-esponiment tal-bniedem flogħla doża ta' 3 mg/kg/ġimgħa, abbażi tal-AUC).
English: The patient/carer educational material should contain:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni:
English: Injection site reactions (ISRs) were reported very commonly (20 %) from clinical trials.
Maltese: Reazzjonijiet fis-sit tal-injezzjoni (ISRs - injection site reactions) kienu rrappurtati b'mod komuni ħafna (20 %) mill-provi kliniċi.
English: Attach injection needle to syringe
Maltese: Preparazzjoni tas-siringa għall-injezzjoni
English: ABR (95% CI) % reduction (RR), p-value % patients with 0 bleeds (95% CI)
Maltese: ABR (CI ta' 95%) % ta' tnaqqis (RR), valur p % ta' pazjenti bl-ebda fsada (CI ta' 95%)
English: Please see below recommended features:
Maltese: TA' EĊĊIPJENTI Eċċipjenti:
English: Pharmacodynamics
Maltese: FARMAĊEWTIKU
English: Bypassing agent or FVIII use during surgeries and procedures was determined by the investigator.
Maltese: L-użu ta' bypassing agent jew FVIII waqt kirurġiji u proċeduri kien determinat mill-investigatur.
English: ABR (95% CI) a % reduction (RR), p-value % patients with zero bleeds (95% CI)
Maltese: ABR (CI ta' 95%) a % ta' tnaqqis (RR), valur p % ta' pazjenti bl-ebda fsada (CI ta' 95%)