FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Adverse reactions reported for ELOCTA in clinical trials MedDRA System Organ Class
Maltese: Tabella 2: Reazzjonijiet avversi rrappurtati għal ELOCTA fil-provi klinici Sistema tal-Klassifika tal-Organi
English: • The other ingredients are sucrose, sodium chloride, L-Histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, hydrochloric acid and water for injections.
Maltese: • Is-sustanzi l-oħra huma sucrose, sodium chloride, L-Histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, hydrochloric acid u ilma għall-injezzjonijiet.
English: Each vial of ELOCTA contains nominally 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 5000 or 6000 IU efmoroctocog alfa.
Maltese: Kull kunjett ta' ELOCTA nominalment fih 250, 500, 750, 1000, 1500, 2000, 3000,
English: The total number of exposure days was 80,848 with a median of 294 (range 1-735) exposure days per subject.
Maltese: In-numru totali ta' jiem ta' esponiment kien ta' 80,848 b'medjan ta' 294 (medda 1-735) ta' jiem ta' esponiment għal kull individwu.
English: Frequencies have been evaluated according to 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), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi ġew evalwati skont 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: AUC/Dose (IU*h/dL per IU/kg)
Maltese: AUC/Doża (IU*siegħa/dL kull IU/kg)
English: Calcium chloride dihydrate Polysorbate 20
Maltese: Calcium chloride dihydrate
English: Excipient with known effect 0.6 mmol (or 14 mg) sodium per vial.
Maltese: 0.6 mmol (jew 14 mg) ta' sodium f'kull kunjett.
English: Repeat injection every 8 to 24 hours until threat is resolved.
Maltese: Irrepeti l-injezzjoni kull 8 sa 24 siegħa,
English: 2 Investigator term: vascular pain after injection of ELOCTA
Maltese: 2 Terminu tal-investigatur: uġigħ vaskulari wara l-injezzjoni ta' ELOCTA.
English: Respective median Annualized Bleed Rate (ABR) was 1.60 (min 0, max 18.2) and 0.74 (min 0, max 15.6).
Maltese: Ir-Rata ta' Ħruġ ta' Demm Annwalizzata (ABR, Annualized Bleed Rate) medjana rispettiva kienet ta' 1.60 (minimu 0, massimu 18.2) u 0.74 (minimu 0, massimu 15.6).
English: Median total time on Study I+III was 4.2 years and median no of exposure days was 309.
Maltese: Iż-żmien totali medjan fi Studju I+III kien ta' 4.2 snin u n-numru medjan ta' jiem ta' esponiment kien ta' 309.
English: Remove the plastic flip-top cap from the ELOCTA vial.
Maltese: Neħħi l-għatu flip-top tal plastik mill-kunjett ta' ELOCTA.
English: Content: 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol swabs, 2 plasters, 1 gauze.
Maltese: Kontenut: 1 kunjett bit-trab, 3 mL ta' solvent f'siringa mimlija għal-lest, 1 lasta tal-planġer, 1 adapter tal kunjett, 1 sett tal-infużjoni, 2 biċċiet bl-alkoħol, 2 stikek, 1 garża.
English: Efmoroctocog alfa (recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc)) has 1,890 amino acids.
Maltese: Efmoroctocog alfa (fattur VIII tal-koagulazzjoni umana rikombinanti, proteina tal-fużjoni Fc (rFVIIIFc))
English: Perioperative management (surgical prophylaxis): A total of 48 major surgical procedures were performed and assessed in 34 subjects in Study I and Study III.
Maltese: Twettqu u ġew evalwati total ta' 48 proċedura kirurġika maġġuri f'34 individwu fi Studju I u Studju III.
English: Individualised prophylaxis: 25 to 65 IU/kg every 3 to 5 days.
Maltese: Profilassi individwalizzata: 25 sa 65
English: No interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported.
Maltese: L-ebda interazzjoni ta' fattur tal-koagulazzjoni uman VIII (rDNA) ma' prodotti mediċinali oħra ma ġiet irrapportata.
English: Peel back the protective paper lid from the clear plastic vial adapter (D).
Maltese: Qaxxar lura l-għatu protettiv tal-karti mill-adapter tal-kunjett tal-plastik ċar (D).
English: 12 adolescent subjects age 12 up to 18 years were included in the adult study population on prophylactic treatment.
Maltese: 12-il individwu adolexxenti b'età minn 12 sa 18-il sena kienu nklużi fil-popolazzjoni adulta tal-istudju dwar trattament profilattiku.
English: Table 4: Pharmacokinetic parameters of ELOCTA using the chromogenic assay Pharmacokinetic parameters1
Maltese: Tabella 4: Parametri farmakokinetiċi ta' ELOCTA bl-użu ta' assaġġ kromoġeniku Parametri farmakokinetiċi1
English: The factor VIII/von Willebrand factor complex consists of 2 molecules (factor VIII and von Willebrand factor) with different physiological functions.
Maltese: Il-kumpless ta' fattur VIII/fattur von Willebrand jikkonsisti minn 2 molekuli (fattur VIII u l-fattur von
English: • The active substance is efmoroctocog alfa (recombinant coagulation factor VIII, Fc fusion protein).
Maltese: • Is-sustanza attiva hi efmoroctocog alfa (fattur VIII tal-koagulazzjoni rikombinanti, proteina tal fużjoni
English: Out of 153 subjects who completed Study I, 150 were enrolled onto Study III (extension study).
Maltese: Mill-153 individwu li lestew Studju I, 150 ġew irreġistrati fi Studju III (studju ta' estensjoni).
English: Individualised prophylaxis: Median annual factor consumption was 4212 IU/kg (min 2877, max 7943) in Study I and 4223 IU/kg (min 2668, max 8317) in Study III.
Maltese: Il-konsum annwali medjan tal-fattur kien ta' 4212 IU/kg (minimu 2877, massimu 7943) fi Studju I u 4233 IU/kg (minimu 2668, massimu 8317) fi Studju III.
English: ELOCTA is comprised of recombinant B-domain deleted human coagulation factor VIII covalently linked to the Fc domain of human immunoglobulin G1.
Maltese: ELOCTA jikkonsisti minn fattur VIII tal-koagulazzjoni umana rikombinanti b'dominju B imħassar, marbuta b'mod kovalenti mad-dominju Fc ta' immunoglobulina umana
English: • There is a small chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ELOCTA.
Maltese: • Hemm ċans żgħir li jista' jkollok reazzjoni anafilattika (reazzjoni allerġika severa, li tiġi f'daqqa) għal ELOCTA.
English: ELOCTA 250 ELOCTA 500 ELOCTA 750 ELOCTA 1000 ELOCTA 1500 ELOCTA 2000 ELOCTA 3000 ELOCTA 4000
Maltese: ELOCTA 3000 ELOCTA 4000 ELOCTA 5000
English: FVIII inhibition
Maltese: immunoglobulina umana
English: Sodium chloride
Maltese: Sodium chloride L-Histidine
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Maltese: Ta' min jinnota li l-ABR mhix komparabbli bejn konċentrati differenti ta' fattur u bejn studji kliniċi differenti.
English: The safety, efficacy, and pharmacokinetics of ELOCTA were evaluated in 2 multinational, open-label, pivotal studies; a phase 3 study, referred to as Study I and a phase 3 paediatric study, referred to as Study II (see Paediatric population).
Maltese: multinazzjonali u open-label; studju ta' fażi 3, magħruf bħala Studju I, u studju pedjatriku ta' fażi 3, magħruf bħala Studju II (ara Popolazzjoni pedjatrika).
English: In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Maltese: F'pazjenti b'fatturi ta' riskju kardjovaskulari eżistenti, terapija ta' sostituzzjoni b'FVIII tista' żżid ir riskju kardjovaskulari.
English: ELOCTA can be used in children and adolescents of all ages.
Maltese: ELOCTA jista' jintuża fi tfal u adolexxenti ta' kull età.
English: B) 3 mL solvent in pre-filled syringe C) 1 Plunger rod
Maltese: B) 3 mL ta' solvent f'siringa mimlija għal lest
English: Out of 67 subjects having completed Study II, 61 enrolled onto Study III (extension study).
Maltese: Mis-67 individwu li lestew Studju II, 61 ġew irreġistrati fi Studju III (studju ta' estensjoni).
English: Tables 5 and 6 present the pharmacokinetic parameters calculated from the paediatric data of subjects less than 18 years of age.
Maltese: Tabelli 5 u 6 jippreżentaw il-parametri farmakokinetiċi kkalkulati mid-dejta pedjatrika ta' individwi li kellhom inqas minn 18-il sena.
English: Each pack of ELOCTA contains 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol swabs, 2 plasters and 1 gauze pad.
Maltese: Kull pakkett ta' ELOCTA fih 1 kunjett bit-trab, 3 mL ta' solvent f'siringa mimlija għal-lest, 1 lasta talplanġer, 1 adapter tal-kunjett, 1 sett tal-infużjoni, 2 biċċiet bl-alkoħol, 2 stikek, 1 pad tal-garża.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02
Maltese: Kategorija farmakoterapewtika: mediċini kontra l-emorraġiji; fattur tal-koagulazzjoni tad-demm VIII, Kodiċi ATC:
English: Arthralgia Myalgia Back pain Joint swelling
Maltese: Artralġja Mijalġja Uġigħ fid-dahar Nefħa fil-ġogi
English: Weekly prophylaxis: 65 IU/kg
Maltese: Profilassi ta' kull ġimgħa: 65
English: Abbreviations: CI = confidence interval; Cmax= maximum activity; AUC = area under the FVIII activity time curve; t½= terminal half-life; CL = clearance; Vss = volume of distribution at steady-state; MRT = mean residence time.
Maltese: CI = intervall ta' kunfidenza; AUC = erja taħt il-kurva ħin-attività ta' FVIII; t½ = half-life terminali; CL = tneħħija; MRT = ħin medju ta' residenza; Vss = volum ta' distribuzzjoni fl-istat fiss
English: The prepared product should be injected intravenously over several minutes.
Maltese: Il-prodott ippreparat għandu jiġi injettat ġol-vina fuq medda ta' diversi minuti.
English: Rarely, inhibitors may develop after the first 100 exposure days.
Maltese: Rarament, l-inibituri jistgħu jiżviluppaw wara l-ewwel 100 jum ta' esponiment.
English: On-demand treatment: Median annual factor consumption was 1039 IU/kg (min 280, max 3571) for 23 patients randomised to the on-demand treatment arm in Study I and 671 IU/kg (min 286, max 913) for 6 patients remaining on on-demand treatment for at least one year in Study III.
Maltese: Il-konsum annwali medjan tal-fattur kien ta' 1039 IU/kg (minimu 280, massimu 3571) għal 23 pazjent li ntgħażlu b'mod każwali għall-grupp ta' trattament fil-pront fi Studju I u 671 IU/kg (minimu 286, massimu 913) għal 6 pazjenti li baqgħu fuq trattament fil-pront għal mill-inqas sena fi Studju III.
English: If you are on a controlled sodium diet see section 2.
Maltese: Jekk qiegħed fuq dieta kkontrollata tas-sodium, ara sezzjoni 2.
English: Subjects that switched from on-demand treatment to weekly prophylaxis during Study III had a median ABR of 1.67.
Maltese: L-individwi li qalbu minn trattament fil-pront għal profilassi ta' kull ġimgħa matul Studju III kellhom ABR medjana ta' 1.67.
English: Median annual factor consumption was 5146 IU/kg (min 3695, max 8474) in Study II and 5418 IU/kg (min 3435, max 9564) in Study III.
Maltese: Il-konsum annwali medjan tal-fattur kien ta' 5146 IU/kg (minimu 3695, massimu 8474) fi Studju II u 5418 IU/kg (minimu 3435, massimu 9564) fi Studju III.
English: ELOCTA pack contains:
Maltese: Tużax ELOCTA:
English: Pharmacokinetic samples were collected pre-dose and then subsequently at 7 time points up to 120 hours (5 days) post-dose.
Maltese: Il-kampjuni farmakokinetiċi nġabru qabel id-doża u mbagħad sussegwentement f'7 punti ta' ħin sa 120 siegħa (5 ijiem) wara d-doża.
English: ELOCTA (efmoroctocog alfa) is a fully recombinant fusion protein with extended half-life.
Maltese: ELOCTA (efmoroctocog alfa) hu proteina tal-fużjoni rikombinanti b'mod sħiħ, b'half-life estiża.
English: Can be stored at room temperature (up to 30°C) for a single period up to 6 months.
Maltese: Jista' jinħażen fit-temperatura tal-kamra (sa 30°C) għal perjodu wieħed sa 6 xhur.
English: The dose may be adjusted based on patient response in the range of 25 to 65 IU/kg (see section 5.1 and 5.2).
Maltese: IU/kg (ara sezzjoni 5.1 u 5.2).
English: Prophylaxis, age <6 years: Median dose interval was 3.50 days in Study II and Study III.
Maltese: Il-medjan tal-intervall tad-doża kien ta' 3.50 jum fi Studju II u Studju III.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Prophylaxis, age 6 up to 12 years: Median dose interval was 3.49 days in Study II and 3.50 days in Study III.
Maltese: Il-medjan tal-intervall tad-doża kien ta' 3.49 jum fi Studju II u 3.50 jum fi Studju III.
English: Repeat injection every 12 to 24 hours for 3-4 days or more until pain and acute disability are resolved.
Maltese: Irrepeti l-injezzjoni kull 12 sa 24 siegħa għal 3-4 ijiem jew aktar sakemm l-uġigħ u d diżabilità akuta jkunu għaddew.
English: The frequencies in Table 2 below were observed in a total of 276 patients with severe haemophilia A in phase III clinical studies and an extension study with a duration of up to four years.
Maltese: Il-frekwenzi fit-Tabella 2 hawn taħt ġew osservati f'total ta' 276 pazjent b'emofilja A severa fi studji kliniċi ta' fażi
English: Elderly There is limited experience in patients ≥65 years.
Maltese: Anzjani Hemm esperjenza limitata f'pazjenti li jkollhom ≥65 sena.
English: Minor surgery including tooth extraction
Maltese: Operazzjoni minuri li tinkludi estrazzjoni tas-snien
English: Table 6: Pharmacokinetic parameters of ELOCTA for paediatrics using the chromogenic assay Pharmacokinetic parameters1
Maltese: Tabella 6: Parametri farmakokinetiċi ta' ELOCTA għal individwi pedjatriċi bl-użu tal-assaġġ kromoġeniku
English: Immunogenicity
Maltese: MEDIĊINALI
English: L-Histidine
Maltese: L-Iżvezja
English: Feeling cold
Maltese: Tqala u treddigħ
English: Incremental Recovery (IU/dL per IU/kg)
Maltese: Irkupru Inkrementali (IU/dL kull IU/kg)
English: CL (mL/h/kg)
Maltese: MRT (sigħat) CL (mL/siegħa/kg)
English: Powder: 250 IU efmoroctocog alfa (approx. 83 IU/mL after reconstitution) Powder: 500 IU efmoroctocog alfa (approx. 167 IU/mL after reconstitution) Powder: 750 IU efmoroctocog alfa (approx. 250 IU/mL after reconstitution) Powder: 1000 IU efmoroctocog alfa (approx. 333 IU/mL after reconstitution) Powder: 1500 IU efmoroctocog alfa (approx. 500 IU/mL after reconstitution) Powder: 2000 IU efmoroctocog alfa (approx. 667 IU/mL after reconstitution) Powder: 3000 IU efmoroctocog alfa (approx. 1000 IU/mL after reconstitution) Powder: 4000 IU efmoroctocog alfa (approx. 1333 IU/mL after reconstitution) Powder: 5000 IU efmoroctocog alfa (approx. 1667 IU/mL after reconstitution) Powder: 6000 IU efmoroctocog alfa (approx. 2000 IU/mL after reconstitution)
Maltese: IU ta' efmoroctocog alfa (madwar 167 IU/mL wara r-rikostituzzjoni) Trab: 750 IU ta' efmoroctocog alfa (madwar 250 IU/mL wara r-rikostituzzjoni) Trab: 1000
English: Hypersensitivity to the active substance (recombinant human coagulation factor VIII, and/or Fc domain) or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva (fattur VIII tal-koagulazzjoni umana rikombinanti, u/jew dominju Fc) jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1. 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu Sensittività eċċessiva
English: Incremental Recovery (IU/dL per IU/kg) AUC/Dose (IU*h/dL per IU/kg) Cmax (IU/dL) CL (mL/h/kg) t½ (h) MRT (h) Vss (mL/kg) 1 Pharmacokinetic parameters are presented in Geometric Mean (95% CI) Abbreviations: CI = confidence interval; Cmax= maximum activity; AUC = area under the FVIII activity time curve; t½= terminal half-life; CL = clearance; Vss = volume of distribution at steady-state; MRT = mean residence time.
Maltese: CI = intervall ta' kunfidenza; AUC = erja taħt il-kurva ħin-attività ta' FVIII; t½ = half-life terminali; CL = tneħħija; MRT = ħin medju ta' residenza; Vss = volum ta' distribuzzjoni fl-istat fiss * Il-parametri farmakokinetiċi f'individwi ta' minn 12 sa <18-il sena kienu jinkludu individwi millpartijiet kollha tal-istudju fi Studju I bi skemi differenti ta' kampjunar
English: For children not previously treated with factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however, patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Maltese: Għal tfal li ma kinux ikkurati qabel b'mediċini li fihom fattur VIII, antikorpiinibituri (ara sezzjoni 2) jistgħu jiffurmaw b'mod komuni ħafna (aktar minn pazjent 1 minn kull 10); madankollu, pazjenti li jkunu rċivew kura b'fattur VIII fil-passat (aktar minn 150 jum ta' kura), ir-riskju huwa mhux komuni (inqas minn pazjent 1 minn kull 100).
English: Contents of the pack and other information Instructions for preparation and administration
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Pharmacokinetic properties were evaluated in 28 subjects (≥15 years) receiving ELOCTA (rFVIIIFc).
Maltese: Il-propjetatiet farmakokinetiċi ġew evalwati fi 28 individwu (≥15-il sena) li kienu qed jirċievu ELOCTA
English: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Maltese: Kura u l-profilassi ta' ħruġ ta' demm f'pazjenti b'emofilija A (defiċjenza konġenitali ta' fattur VIII).
English: Adverse reactions were monitored for a total of 893.72 subject-years.
Maltese: Ir-reazzjonijiet avversi kienu mmonitorjati għal total ta' 893.
English: Pharmacokinetic parameters of ELOCTA were determined for adolescents in study I (pharmacokinetic sampling was conducted pre-dose followed by assessment at multiple time points up to 120 hours (5 days) post-dose) and for children in study II (pharmacokinetic sampling was conducted pre-dose followed by assessment at multiple time points up to 72 hours (3 days) post-dose).
Maltese: (5 ijiem) wara d-doża) u għat-tfal fi Studju II (it-teħid ta' kampjuni farmakokinetiċi twettaq qabel id-doża, segwit minn evalwazzjoni f'punti multipli sa 72 siegħa (3 ijiem) wara d-doża).
English: Respective median ABR was 3.59 (min 0, max 58.0) and 2.24 (min 0, max 17.2).
Maltese: IU/kg (minimu 2758, massimu 3984) fi Studju III. L-ABR medjana rispettiva kienet ta' 3.59 (minimu 0, massimu 58.0) u 2.24 (minimu 0, massimu 17.2).
English: ELOCTA 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU efmoroctocog alfa.
Maltese: Kull kunjett nominalment fih 3000 IU ta' efmoroctocog alfa.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Maltese: B'mod partikulari, fil-każ ta' interventi kirurġiċi maġġuri, hu indispensabbli li jsir monitoraġġ preċiż tat-terapija ta' sostituzzjoni permezz ta' analiżi tal koagulazzjoni (attività ta' fattur VIII fil-plażma).
English: After preparation, ELOCTA can be stored at room temperature for up to 6 hours before administration.
Maltese: Wara l-preparazjoni, ELOCTA jista' jinħażen fit-temperatura tal-kamra għal sa 6 sigħat qabel l-għoti.
English: Do not use external heat.
Maltese: Tużax sħana esterna.
English: Documentation
Maltese: LISTA
English: ELOCTA 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU efmoroctocog alfa.
Maltese: Kull kunjett nominalment fih 4000 IU ta' efmoroctocog alfa.
English: Other medicines and ELOCTA
Maltese: X'fih ELOCTA
English: Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X on phospholipid surfaces.
Maltese: Fattur VIII attivat jaġixxi bħala kofattur għal fattur IX attivat, u jaċċellera l-konverżjoni ta' fattur X għal fattur X attivat fuq uċuh fosfolipidi.
English: Headache, dizziness, taste alteration, slow heartbeat, high blood pressure, hot flushes, vascular pain after injection, cough, abdominal pain, rash, joint swelling, muscle pain, back pain, joint pain, general discomfort, chest pain, feeling cold, feeling hot and low blood pressure.
Maltese: Għandek tikkuntattja lit-tabib tiegħek immedjatament jekk ikollok kwalunkwe minn dawn is-sintomi li ġejjin ta' reazzjonijiet allerġiċi: nefħa tal-wiċċ, raxx, ħakk ġeneralizzat, ħorriqija, tagħfis tas-sider, diffikultà biex tieħu nifs, ħruq u tingiż fis-sit tal-injezzjoni, tertir ta' bard, fwawar, uġigħ ta' ras, pressjoni tad-demm baxxa, tħossok ma tiflaħx b'mod ġenerali, dardir, nuqqas ta' kwiet f'ġismek u taħbit mgħaġġel tal-qalb, tħossok stordut jew tintilef minn sensik.
English: ELOCTA 250 IU powder for injection ELOCTA 500 IU powder for injection ELOCTA 750 IU powder for injection ELOCTA 1000 IU powder for injection ELOCTA 1500 IU powder for injection ELOCTA 2000 IU powder for injection ELOCTA 3000 IU powder for injection ELOCTA 4000 IU powder for injection ELOCTA 5000 IU powder for injection ELOCTA 6000 IU powder for injection efmoroctocog alfa recombinant coagulation factor VIII IV
Maltese: IU trab għall-injezzjoni ELOCTA 3000 IU trab għall-injezzjoni ELOCTA 4000 IU trab għall-injezzjoni ELOCTA 5000
English: Pharmacokinetic parameters after 50 IU/kg dose of ELOCTA are presented in Tables 3 and 4.
Maltese: IU doża/kg ta' ELOCTA huma ppreżentati f'Tabelli 3 u 4.
English: ELOCTA is given as an injection into a vein.
Maltese: ELOCTA jingħata bħala injezzjoni ġo vina.
English: ELOCTA 750 IU powder and solvent for solution for injection Each vial contains nominally 750 IU efmoroctocog alfa.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni ELOCTA 750
English: 79.2 % of first injections were rated as excellent or good by the patients.
Maltese: 79.2% tal-ewwel injezzjonijiet kienu kklassifikati bħala eċċellenti jew tajbin mill-pazjenti.
English: 1 Pharmacokinetic parameters are presented in Geometric Mean (95% CI) Abbreviations: CI = confidence interval; AUC = area under the FVIII activity time curve; t½ = terminal half-life;
Maltese: 1 Il-parametri farmakokinetiċi huma ppreżentati fil-Medja Ġeometrika (95% CI) Taqsiriet:
English: Study II enrolled a total of 71 previously treated male paediatric patients <12 years of age with severe haemophilia A. Of the 71 enrolled subjects, 69 received at least 1 dose of ELOCTA and were evaluable for efficacy (35 were <6 years of age and 34 were 6 to <12 years of age).
Maltese: Studju II rreġistra total ta' 71 pazjent pedjatriku maskili b'età ta' <12-il sena b'emofilija A severa li kienu kkurati fil-passat.
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre inhibitors which are transiently present or remain consistently low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Maltese: Ir-rilevanza klinika tal-iżvilupp tal-inibituri se tiddependi fuq it-titru tal-inibitur, b'inibituri ta' titru baxx li jkunu preżenti temporanjament jew jibqgħu b'titru baxx b'mod konsistenti jkollhom inqas riskju ta' rispons kliniku insuffiċjenti minn inibituri b'titru għoli.
English: 1 In some patients and circumstances the dosing interval can be prolonged up to 36 hours.
Maltese: 1 F'xi pazjenti u ċirkustanzi, l-intervall tad-dożaġġ jista' jiġi mtawwal għal sa 36 siegħa.
English: It is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line without the addition of any exogenous human- or animal-derived protein in the cell culture process, purification or final formulation.
Maltese: Hu prodott permezz ta' teknoloġija tad-DNA rikombinanti f'razza ta' ċelluli ta' kliewi embrijoniċi tal-bniedem (HEK) mingħajr iż-żieda ta' kwalunkwe proteina esoġena derivata mill-bniedem jew mill-annimali fil-proċess ta' kultura taċ-ċelluli, purifikazzjoni jew formulazzjoni finali.
English: Respective median Annualized Bleed Rate (ABR) was 0.00 (min 0, max 10.5) and 1.18 (min 0, max 9.2).
Maltese: (minimu 0, massimu 10.5) u 1.18 (minimu 0, massimu 9.2).