FrancophonIA/ELRC3.0 huggingface dataset:
English: (Invented) name Pharmaceutical form Route of administration
Maltese: Għamla farmaċewtika
English: Κύπρος Γ.Α.Σταμάτης & Σια Λτδ.
Maltese: Γ.Α.Σταμάτης & Σια Λτδ.
English: Important Information:
Maltese: Informazzjoni Importanti:
English: Parameters
Maltese: Parametri
English: Arm D NIS:
Maltese: Grupp D NIS:
English: System Organ Class (SOC)
Maltese: Klassi tas-Sistemi u tal-Organi (SOC
English: ● The active substance is emicizumab.
Maltese: ● Is-sustanza attiva hi emicizumab.
English: Clinically meaningful difference: Total score: 7 points; Physical Health: 10 points.
Maltese: Punteġġ totali: 7 punti; Saħħa Fiżika: 10 punti.
English: Previous bypassing agent treatment* (N = 18)
Maltese: Trattament b'Bypassing Agent fil-Passat* (N = 18)
English: Adverse reactions (preferred term, MedDRA)
Maltese: (terminu ppreferut, MedDRA)
English: Clinically meaningful difference: VAS: 7 points, Index Utility Score: 0.07 points
Maltese: VAS: 7 punti; Punteġġ tal-Utilità tal-Indiċi: 0.07 punti
English: Haem-A-QoL at week 25
Maltese: Haem-A-QoL f'ġimgħa 25
English: Emicizumab is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific antibody structure.
Maltese: Emicizumab huwa antikorp umanizzat monoklonali mmodifikat tal-immunoglobulina G4 (IgG4immunoglobulin G4) bi struttura ta' antikorp bispeċifiku.
English: Arm D:
Maltese: Grupp D:
English: 1.PREPARATION Step 1.
Maltese: 1. PREPARAZZJONI Pass 1.
English: L-Arginine L-Histidine L-Aspartic acid Poloxamer 188
Maltese: L-Aspartic acid Poloxamer 188
English: Previous FVIII Prophylaxis (N = 48)
Maltese: Profilassi b'FVIII fil-Passat (N = 48)
English: Effects of emicizumab on coagulation tests
Maltese: Effetti ta' emicizumab fuq testijiet ta' koagulazzjoni
English: *Vascular disorders is a secondary SOC for cavernous sinus thrombosis.
Maltese: *Disturbi vaskulari hija SOC sekondarja għal trombożi tas-sinus kavernuż.
English: Clinical studies in adults and adolescents
Maltese: Studji kliniċi f'adulti u adolexxenti
English: Endpoints aABR (95% CI)
Maltese: Punt finali aABR (CI ta' 95%)
English: Do not use Hemlibra:
Maltese: Tużax Hemlibra:
English: 7a,a,a,b
Maltese: >48 siegħa a,a,a,b
English: Step 8.
Maltese: Pass 8.
English: A total of 398 patients were tested for anti-emicizumab antibodies in the HAVEN 1-4 clinical trials.
Maltese: Ġew ittestjati total ta' 398 pazjent għal antikorpi kontra emicizumab fil-provi kliniċi HAVEN 1-4.
English: No dose adjustments are recommended in patients ≥ 65 years of age (see sections 5.1 and 5.2).
Maltese: Mhux rakkomandati aġġustamenti fid-doża f'pazjenti ta' età ≥ 65 sena (ara sezzjonijiet 5.1 u 5.2).
English: Thrombotic events
Maltese: Avvenimenti trombotiċi
English: Hemlibra contains the active substance “emicizumab”.
Maltese: Hemlibra fih is-sustanza attiva “emicizumab”.
English: The following adverse drug reactions (ADRs) are based on pooled data from four phase III clinical trials (adult and adolescent studies [BH29884 - HAVEN 1, BH30071 - HAVEN 3, and BO39182HAVEN 4] and a paediatric study BH29992 - HAVEN 2]), in which a total of 373 male patients with haemophilia A received at least one dose of Hemlibra as routine prophylaxis.
Maltese: III (studji f'adulti u adolexxenti [BH29884 - HAVEN 1, BH30071 - HAVEN 3, u BO39182 - HAVEN 4] u studju pedjatriku BH29992 - HAVEN 2]), fejn total ta' 373 pazjent raġel bl-emofilja A irċevew mill-inqas doża waħda ta' Hemlibra bħala profilassi normali.
English: The corresponding frequency categories for each ADR are based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenza korrispondenti għal kull ADR huma bbażati fuq il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Table 10 HAVEN 1: EQ-5D-5L scores in patients ≥ 12 years at week 25
Maltese: Tabella 10 HAVEN 1: punteġġi EQ-5D-5L f'pazjenti ta' ≥ 12-il sena f'ġimgħa 25
English: Clinical experience indicates a drug interaction exists with emicizumab and aPCC (see sections 4.4 and 4.8).
Maltese: Esperjenza klinika tindika li teżisti interazzjoni tal-mediċina b'emicizumab u aPCC (ara sezzjonijiet 4.4 u 4.8).
English: % reduction (RR), p-value
Maltese: % ta' tnaqqis (RR), valur p
English: Table 14 Mean (± SD) steady-state emicizumab concentrations
Maltese: Tabella 14 Konċentrazzjonijiet medji (± SD) ta' emicizumab fi stat fiss
English: ● Syringe with Low Dead Space (LDS) Plunger Important:
Maltese: ● Siringa bi Planġer bi Spazju Residwu Żgħir (LDS - Low Dead Space) Importanti:
English: Roche Austria GmbH Engelhorngasse 3 1211 Wien Austria
Maltese: Roche Austria GmbH Engelhorngasse 3
English: Treatment (including routine prophylaxis) with bypassing agents (e.g. aPCC and rFVIIa) should be discontinued the day before starting Hemlibra therapy (see section 4.4).
Maltese: It-trattament (inkluża profilassi normali) b'bypassing agents (eż. aPCC u rFVIIa) għandu jitwaqqaf filġurnata ta' qabel tibda t-terapija b'Hemlibra (ara sezzjoni 4.4).
English: Chromogenic factor VIII activity tests may be manufactured with either human or bovine coagulation proteins.
Maltese: Testijiet tal-attività kromoġenika tal-fattur VIII jistgħu jiġu mmanifatturati kemm bi proteini ta' koagulazzjoni umani kif ukoll bovini.
English: Arm CNIS: previous bypassing agent prophylaxis
Maltese: Grupp ĊNIS: profilassi b'bypassing agent fil-passat
English: INJECTION Step 7.
Maltese: INJEZZJONI Pass 7.
English: bMedian ABR (IQR)
Maltese: ABR medjana (IQR)
English: Table 11 HAVEN 2: Overview of efficacy (interim analysis)
Maltese: Tabella 11 HAVEN 2: Deskrizzjoni fil-qosor tal-effikaċja (analiżi interim)
English: ● Laboratory professionals educational material
Maltese: ● Materjal edukattiv għall-professjonisti tal-laboratorju
English: Examples of bypassing agents include activated prothrombin complex concentrate (aPCC) and recombinant FVIIa (rFVIIa).
Maltese: Eżempji ta' bypassing agents jinkludu konċentrat ta' kumpless ta' prothrombin attivat (aPCC - activated prothrombin complex concentrate) u FVIIa rikombinanti (rFVIIa - recombinant FVIIa).
English: Median ABR (IQR)
Maltese: ABR Medjana (IQR)
English: ● Gauze
Maltese: ● Garża
English: Other side effects when using Hemlibra
Maltese: Effetti sekondarji oħra meta tuża Hemlibra
English: Mean (±95% CI) plasma emicizumab concentration versus time profiles for patients ≥ 12 years (studies HAVEN 1 and HAVEN 3) compared with patients < 12 years (study HAVEN 2)
Maltese: Konċentrazzjoni medja (CI ta' ±95%) ta' emicizumab fil-plażma kontra profili taż-żmien għal pazjenti ta' ≥ 12-il sena (studji HAVEN 1 u HAVEN 3) imqabbla ma' pazjenti ta' < 12-il sena (studju HAVEN 2)
English: Use of Hemlibra in patients aged 65 and over with haemophilia A is supported by adult and adolescent studies HAVEN 1, HAVEN 3, and HAVEN 4.
Maltese: L-użu ta' Hemlibra f'pazjenti b'età ta' 65 sena jew aktar bl-emofilja A huwa appoġġat mill-istudji f'adulti u adolexxenti HAVEN 1, HAVEN 3, u HAVEN 4.
English: 2 to 3 mL syringe
Maltese: Siringa ta' 2 sa 3 mL
English: Patients (aged ≥ 12 years old and > 40 kg) with hemophilia A without FVIII inhibitors (Study BH30071 - HAVEN 3)
Maltese: Pazjenti (b'età ta' ≥ 12-il sena u > 40 kg) bl-emofilja A mingħajr inibituri ta' FVIII (Studju BH30071 - HAVEN 3)
English: - Activated partial thromboplastin time (aPTT) - Bethesda assays (clotting-based) for FVIII inhibitor titers - One-stage, aPTT-based, single-factor assays - aPTT-based activated protein C resistance (APC-R) - Activated clotting time (ACT)
Maltese: - Ħin ta' thromboplastin parzjali attivat (aPTTactivated partial thromboplastin time) - Assaġġi Bethesda (ibbażati fuq koagulazzjoni) għal titers ta' inibitur ta' FVIII - Assaġġi ta' fattur uniku, ibbażati fuq aPTT, ta' stadju wieħed - Reżistenza għall-proteina Ċ attivata (APC-Ractivated protein C resistance) ibbażata fuq aPTT
English: Step 9.
Maltese: Pass 9.
English: The paediatric population studied comprises a total of 107 patients, of which 5 (5 %) were infants and toddlers (1 month to less than 2 years of age), 55 (51 %) were children (from 2 to less than 12 years of age) and 47 (44 %) were adolescents (from 12 to less than 18 years old).
Maltese: Il-popolazzjoni pedjatrika studjata tinkludi total ta' 107 pazjenti, li 5 (5 %) minnhom kienu trabi u trabi li telqu jimxu (b'età ta' xahar sa inqas minn sentejn), 55 (51 %) kienu tfal (minn sentejn sa inqas minn 12-il sena) u 47 (44 %) kienu adolexxenti (minn 12 sa inqas minn 18-il sena).
English: There are no data in patients over 77 years old.
Maltese: M'hemm l-ebda data f'pazjenti b'età ta' aktar minn 77 sena.
English: This belongs to a group of medicines called “monoclonal antibodies”.
Maltese: Din tagħmel parti minn grupp ta' mediċini msejħa “antikorpi monoklonali”.
English: In this Study baseline Total Scores (mean = 41.14 and 44.58, respectively) and Physical Health scale scores (mean = 52.41 and 57.19, respectively) were similar for Hemlibra prophylaxis and no prophylaxis.
Maltese: F'dan l-Istudju l-Punteġġi Totali fil-linja bażi (medja = 41.14 u 44.58, rispettivament) u l-punteġġi taliskala tas-Saħħa Fiżika (medja = 52.41 u 57.19, rispettivament) kienu simili għal profilassi b'Hemlibra u mingħajr profilassi.
English: The Haemo-QoL-SF is a valid and reliable measure of HRQoL.
Maltese: L-Haemo-QoL-SF huwa kejl validu u affidabbli tal-HRQoL.
English: The most serious adverse drug reactions (ADRs) reported from the clinical trials with Hemlibra were thrombotic microangiopathy (TMA) and thrombotic events, including cavernous sinus thrombosis (CST) and superficial vein thrombosis contemporaneous with skin necrosis (see below and section 4.4).
Maltese: L-aktar reazzjonijiet avversi tal-mediċina (ADRs - adverse drug reactions) serji rrappurtati mill-provi kliniċi b'Hemlibra kienu mikroanġjopatija trombotika (TMA - thrombotic microangiopathy) u avvenimenti trombotiċi, inklużi trombożi tas-sinus kavernuż (CST - cavernous sinus thrombosis) u trombożi ta' vina superfiċjali flimkien ma' nekrosi tal-ġilda (ara hawn taħt u sezzjoni 4.4).
English: <24 hours 24-48 hours
Maltese: <24 siegħa 24-48 siegħa b
English: Step 11.
Maltese: Pass 11.
English: Step 10.
Maltese: Pass 10.
English: ● Blood clots (thromboembolism)
Maltese: ● Emboli tad-demm (tromboemboliżmu)
English: Hemlibra 1.5 mg/kg weekly (N = 48)
Maltese: Hemlibra 1.5 mg/kg fil-ġimgħa (N = 48)
English: Thrombotic microangiopathy
Maltese: Mikroanġjopatija trombotika
English: Each vial of Hemlibra contains 60 mg (0.4 mL at a concentration of 150 mg/mL), 105 mg (0.7 mL at a concentration of 150 mg/mL) or 150 mg (1 mL at a concentration of 150 mg/mL) of emicizumab.
Maltese: Kull kunjett ta' Hemlibra fih 60 mg (0.4 mL f'konċentrazzjoni ta' 150 mg/mL), 105 mg (0.7 mL f'konċentrazzjoni ta' 150 mg/mL) jew 150 mg (1 mL f'konċentrazzjoni ta' 150 mg/mL) ta' emicizumab.
English: Criteria: Stainless steel with Luer-lock connection, gauge 26 G (acceptable range: 25-27 gauge), length preferably 9 mm (3/8″) or maximally 13mm (½″), preferably including needle safety feature.
Maltese: Azzar li ma jissaddadx b'konnessjoni Luer-Lok, gejġ ta' 26 G (medda aċċettabbli: gejġ ta' 25-27), tul preferibbilment ta' 9 mm (3/8″) jew massimu ta' 13mm (½″), preferibbilment inkluża karatteristika ta' sigurtà tal-labra.
English: Paediatric patients (age < 12 years old, or 12 to 17 years old weighing < 40 kg) with haemophilia A with factor VIII inhibitors (Study BH29992 - HAVEN 2)
Maltese: 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 (Studju BH29992 - HAVEN 2)
English: Step 12.
Maltese: Pass 12.
English: Vial Adapter
Maltese: Adapter tal-Kunjett
English: 60 mg/0.4 mL
Maltese: INDIVIDWALI 60 mg/0.4ml
English: Vial adapters
Maltese: Adapters tal-kunjett
English: INFORMATION IN BRAILLE hemlibra 105 mg
Maltese: INFORMAZZJONI BIL-BRAILLE hemlibra 105 mg
English: 2.INJECTION Step 6.
Maltese: INJEZZJONI Pass 6.
English: ● haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
Maltese: ● b'emofilja A (defiċjenza konġenitali tal-fattur VIII) b'inibituri tal-fattur VIII
English: Bleeds a Calculated with negative binomial regression (NBR) model b
Maltese: Ikkalkulata b'mudell ta' rigressjoni binomjali negattiva (NBR - negative binomial regression) b ABR ikkalkulata
English: Two hundred and sixtysix (71 %) were adults, 47(13 %) were adolescents (≥ 12 to < 18 years), 55 (15 %) were children (≥ 2 to < 12 years) and five (1 %) were infants and toddlers (1 month to < 2 years).
Maltese: Mitejn u sitta u sittin (71%) kienu adulti, 47 (13 %) kienu adolexxenti (≥ 12 sa < 18-il sena), 55 (15 %) kienu tfal (≥ 2 sa < 12-il sena) u ħamsa (1 %) kienu trabi u trabi li telqu jimxu (xahar sa < sentejn).
English: Thrombophlebitis superficial
Maltese: Tromboflebite superfiċjali
English: Most of the patients with hemophilia A in the population pharmacokinetic analysis had normal renal function (N = 332; creatinine clearance [CLcr] ≥ 90 mL/min) or mild renal impairment (N = 27; CLcr of 60-89 mL/min).
Maltese: Ħafna mill-pazjenti bl-emofilja A fl-analiżi tal-farmakokinetika tal-popolazzjoni kellhom funzjoni normali tal-kliewi (N = 332; tneħħija tal-kreatinina [CLcr - creatinine clearance] ta' ≥ 90 mL/min)
English: Hemlibra can be used in all age groups.
Maltese: Hemlibra jista' jintuża fil-gruppi ta' età kollha.
English: Pharmacotherapeutic group: antihemorrhagics, other systemic hemostatics; ATC code: B02BX06
Maltese: Kategorija farmakoterapewtika: sustanzi kontra l-emorraġija, emostatiċi sistemiċi oħra, Kodiċi ATC:
English: The most common ADRs reported in ≥ 10% of patients treated with at least one dose of Hemlibra were: injection site reactions (20 %), arthralgia (15 %) and headache (14 %).
Maltese: L-aktar ADRs komuni rrappurtati f'≥ 10% tal-pazjenti ttrattati b'mill-inqas doża waħda ta' Hemlibra kienu: reazzjonijiet fis-sit tal-injezzjoni (20 %), artralġja (15 %) u wġigħ ta' ras (14 %).
English: LIST OF EXCIPIENTS Excipients: L-Arginine, L-Histidine, L-Aspartic acid, Poloxamer 188, water for injections.
Maltese: L-Arginine, L-Histidine, L-Aspartic acid, Poloxamer 188, ilma għall-injezzjonijiet.
English: Patients (aged ≥ 12 years old) with haemophilia A with factor VIII inhibitors (Study BH29884HAVEN 1)
Maltese: Pazjenti (b'età ta' ≥ 12-il sena) b'emofilja A b'inibituri tal-fattur VIII (Studju BH29884 - HAVEN 1)
English: Treated bleeds = bleeds treated with bypassing agents.
Maltese: Fsadiet ittrattati = fsadiet ittrattati b'bypassing agents.
English: INFORMATION IN BRAILLE hemlibra 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE hemlibra 30 mg
English: Cavg, ss = average concentration at steady state; Cmax, ss = maximum plasma concentration at steady state; Ctrough, ss = trough concentration at steady state; QW = once weekly; Q2W = every two weeks; Q4W = every four weeks.
Maltese: Cavg, ss = konċentrazzjoni medja fi stat fiss; Cmax, ss = konċentrazzjoni massima fil-plażma fi stat fiss; Ctrough, ss = konċentrazzjoni l-aktar baxxa fi stat fiss; QW = darba fil-ġimgħa;
English: Step 15.
Maltese: Pass 15.
English: Treated bleeds ABR (95% CI) % patients with 0 bleeds (95% CI) Median ABR (IQR) % reduction (RR), p-value 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: Fsadiet Ittrattati ABR (CI ta' 95%) % ta' pazjenti b'0 fsadiet (CI ta' 95%) ABR medjana (IQR) % ta' tnaqqis (RR), valur p 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: The mean exposure time (+SD) for all patients on study was 21.38 weeks (12.01).
Maltese: Iż-żmien medju ta' esponiment (+SD) għall-pazjenti kollha fl-istudju kien ta' 21.38 ġimgħa (12.01).
English: The safety profile of Hemlibra was overall consistent between infants, children, adolescents, and adults.
Maltese: Il-profil tas-sigurtà ta' Hemlibra kien konsistenti b'mod ġenerali bejn it-trabi, it-tfal, l-adolexxenti, u ladulti.
English: Bleed definitions adapted based on ISTH criteria.
Maltese: Definizzjonijiet ta' fsada adattati abbażi tal-kriterji ISTH.
English: There is limited experience with bypassing agent or FVIII use during surgeries and procedures.
Maltese: Hemm esperjenza limitata bl-użu ta' bypassing agent jew FVIII waqt kirurġiji u proċeduri.
English: Step 17.
Maltese: Pass 17.
English: Following intravenous administration of 0.25 mg/kg in healthy subjects, the total clearance of emicizumab was 3.26 mL/kg/day (i.e. 0.228 L/d for a 70-kg adult) and the mean terminal half-life was 26.7 days.
Maltese: Wara għoti ġol-vini ta' 0.25 mg/kg f'individwi f'saħħithom, it-tneħħija totali ta' emicizumab kienet ta' 3.26 mL/kg/jum (jiġifieri 0.228 L/jum għal adult ta' 70 kg) u l-half-life terminali medja kienet ta' 26.7 ijiem.
English: Relative bioavailability decreased with older age, but no clinically important differences were observed in the pharmacokinetics of emicizumab between subjects < 65 years and subjects ≥ 65 years.
Maltese: Il-bijodisponibbiltà relattiva tnaqqset f'età akbar, iżda ma ġiet osservata l-ebda differenza klinikament importanti fil-farmakokinetika ta' emicizumab bejn individwi ta' < 65 sena u individwi ta' ≥ 65 sena.
English: Physical health score (range 0 to 100)a
Maltese: Punteġġ tas-saħħa fiżika (medda minn 0 sa 100)a
English: Examples:
Maltese: Kriterji:
English: For more information on using aPCC while receiving Hemlibra, see in section 2: “Potentially serious side effects of using aPCC while receiving Hemlibra”.
Maltese: Għal aktar informazzjoni dwar l-użu ta' aPCC waqt li tkun qed tirċievi Hemlibra, ara fis-sezzjoni 2: “Effetti sekondarji potenzjalment serji tal-użu ta' aPCC waqt li tkun qed tirċievi Hemlibra”.
English: ● severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII
Maltese: ● b'emofilja A severa (defiċjenza konġenitali tal-fattur VIII, FVIII < 1%) mingħajr inibituri talfattur VIII.
English: INFORMATION IN BRAILLE hemlibra 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE hemlibra 150 mg
English: Table 2 Summary of adverse drug reactions from pooled HAVEN clinical trials with Hemlibra
Maltese: Tabella 2 Sommarju tar-reazzjonijiet avversi tal-mediċina mill-provi kliniċi HAVEN miġbura f'daqqa b'Hemlibra
English: Step 14.
Maltese: Pass 14.
English: Thrombotic microangiopathy b Thrombotic event
Maltese: Mikroanġjopatija trombotika b
English: Dose linearity
Maltese: Linearità tad-doża
English: th percentile
Maltese: Mira Ttrattati
English: In pooled phase III clinical trials, thrombotic microangiopathy (TMA) events were reported in less than 1 % of patients (3/373) and in 9.7 % of patients (3/31) who received at least one dose of aPCC while being treated with emicizumab.
Maltese: III miġbura f'daqqa, ġew irrappurtati avvenimenti ta' mikroanġjopatija trombotika (TMA - thrombotic microangiopathy) f'inqas minn 1 % tal-pazjenti (3/373) u f'9.7 % talpazjenti (3/31) li rċevew mill-inqas doża waħda ta' aPCC waqt li kienu qed jiġu ttrattati b'emicizumab.
English: ADRs from the phase III clinical trials in patients who received Hemlibra are listed by MedDRA system organ class (Table 2).
Maltese: III f'pazjenti li rċevew Hemlibra huma elenkati skont il-klassi tassistemi u tal-organi MedDRA (Tabella 2).
English: ABR= Annualised Bleed Rate; CI= confidence interval; RR= rate ratio; IQR= interquartile range, 25th percentile to 75th percentile, NA=Not Applicable
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, NA= Mhux Applikabbli (Not Applicable)
English: Step 13.
Maltese: Pass 13.
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.
Maltese: L-istudji kliniċi HAVEN f'adulti u adolexxenti evalwaw riżultati tal-kwalità tal-ħajja relatata malemofilja rrappurtati mill-pazjenti bil-kwestjonarju dwar il-Kwalità tal-Ħajja Speċifika għall-Emofilja (HAEM-A-QoL - Haemophilia-Specific Quality of Life) għall-adulti (> 18 years) u l-verżjoni tiegħu għall-adolexxenti (Haemo-QoL-SF, għal 8 sa <18-il sena), il-Punteġġ tas-Saħħa Fiżika (jiġifieri, nefħa li tuġa', il-preżenza ta' wġigħ fil-ġogi, uġigħ maċ-ċaqliq, diffikultà għal mixi 'l bogħod u l-bżonn ta' aktar ħin biex il-persuna tkun lesta) u l-Punteġġ Totali (sommarju tal-punteġġi kollha) kienu punti finali ta' interess definiti mill-protokoll.
English: This rapid improvement is distinct from the usual clinical course observed in atypical hemolytic uremic syndrome and classic TMAs, such as thrombotic thrombocytopenic purpura (see section 4.8).
Maltese: Dan it-titjib rapidu huwa distint mill-kors kliniku normali osservat f'sindrome uremiku emolitiku atipiku u f'TMAs klassiċi, bħal purpura tromboċitopenika trombotika (ara sezzjoni 4.8).
English: INFORMATION IN BRAILLE hemlibra 60 mg
Maltese: INFORMAZZJONI BIL-BRAILLE hemlibra 60 mg
English: Average cumulative amount of aPCC over 24 hours (U/kg/24 hours)
Maltese: Ammont kumulattiv medju ta' aPCC fuq 24 siegħa (U/kg/24 siegħa)
English: Of all instances of aPCC treatment, 68 % consisted of only one infusion < 100 U/kg.
Maltese: Millkażijiet kollha ta' trattament b'aPCC, 68 % kienu jikkonsistu minn infużjoni waħda biss ta' < 100 U/kg.
English: There are limited data available on the use of Hemlibra in patients with moderate renal impairment (only 2 patients with CLcr of 30-59 mL/min) and no data in patients with severe renal impairment.
Maltese: Hemm data limitata disponibbli dwar l-użu ta' Hemlibra f'pazjenti b'indeboliment moderat tal-kliewi (2 pazjenti biss b'CLcr ta' 30-59 mL/min) u m'hemm lebda data f'pazjenti b'indeboliment sever tal-kliewi.
English: Difference in adjusted means (95% CI) p-value
Maltese: Differenza fil-medji aġġustati (CI ta' 95%) valur p
English: Patients presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13 activity.
Maltese: Il-pazjenti dehru bi tromboċitopenija, anemija emolitika mikroanġjopatika, u ħsara akuta fil-kliewi, mingħajr defiċjenzi severi fl-attività ta' ADAMTS13.
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).
Maltese: Fl-analiżi tal-pazjent individwali (intra-patient analysis) tal-istudju kliniku HAVEN 3, profilassi b'Hemlibra rriżultat fi tnaqqis statistikament sinifikanti (p<0.0001) (68 %) fir-rata ta' fsada għallfsadiet ittrattati meta mqabbla ma' profilassi b'FVIII fil-passat miġbura fl-NIS qabel ir-reġistrazzjoni (ara Tabella 5).
English: What Hemlibra contains
Maltese: MHUX INKLUŻI FIL
English: The most commonly reported ISR symptoms were injection site erythema (11 %), injection site pain (4 %) and injection site pruritus (3 %).
Maltese: Issintomi tal-ISR irrappurtati bl-aktar mod komuni kienu eritema fis-sit tal-injezzjoni (11 %), uġigħ fissit tal-injezzjoni (4 %) u ħakk fis-sit tal-injezzjoni (3 %).
English: Preparing the syringe for injection:
Maltese: Preparazzjoni tas-siringa għall-injezzjoni:
English: Physical health score (range 0 to 100)
Maltese: Punteġġ Totali (medda minn 0 sa 100)