FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical efficacy of Ervebo was assessed in Protocol 010.
Maltese: L-effikaċja klinika ta' Ervebo ġiet stmata fi Protokoll 010.
English: Clinical immunogenicity
Maltese: Immunoġeniċità klinika
English: • Children <1 year of age.
Maltese: • Tfal b'età ta' <1 sena.
English: See section 4.3.
Maltese: Ara sezzjoni 4.3.
English: • Ervebo is available in a pack of 10 vials.
Maltese: • Ervebo huwa disponibbli f'pakkett ta' 10 kunjetti.
English: Ervebo contains sodium
Maltese: Ervebo fih sodium
English: Efficacy data was obtained in Protocol 010 in Guinea and immunogenicity data was obtained in Protocol 009 in Liberia, Protocol 011 in Sierra Leone, and Protocol 012 in the United States, Canada, and Europe.
Maltese: Data dwar l-effikaċja inkisbet fi Protokoll 010 fil-Guinea u data dwar immunoġeniċità inkisbet fi Protokoll 009 fil-Liberja, Protokoll 011 fi Sierra Leone, u Protokoll 012 fl-Istati Uniti, il-Kanada u lEwropa.
English: 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: 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 magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Table 1: Tabulated summary of adverse reactions considered related to vaccination MedDRA-System Organ Class Adverse Reactions
Maltese: Tabella 1: Sommarju tar-reazzjonijiet avversi meqjusa li huma marbuta mat-tilqim miġbura f'tabella Klassi tas-Sistemi u tal-Organi
English: Environmental Risk Assessment (ERA)
Maltese: Valutazzjoni tar-riskju ambjentali (ERA)
English: Anaphylaxis was reported very rarely (0.006%) in clinical trials.
Maltese: Anafilassi ġiet irrappurtata b'mod rari ħafna (0.006%) fil-provi kliniċi.
English: Thrombocytopenia and coagulation disorders
Maltese: Tromboċitopenija u disturbi tal-koagulazzjoni
English: • Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia, and AIDS or symptomatic HIV infection.
Maltese: • Immunodefiċjenza umorali jew ċellulari (primarja jew akkwiżita) severa, eż. immunodefiċjenza ikkombinata severa, agammaglobulinemija, u AIDS jew infezzjoni tal-HIV bis-sintomi.
English: • Store and transport frozen at -80°C to -60°C.
Maltese: • Aħżen u ttrasporta ffriżat f'temperatura bejn -80°C u -60°C.
English: One dose (1 mL) contains:
Maltese: Doża waħda (1 mL) fiha:
English: Ervebo is indicated for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus (see sections 4.2, 4.4 and 5.1).
Maltese: Ervebo huwa indikat għat-tilqim attiv ta' individwi li għandhom 18-il sena jew aktar biex jipproteġi kontra l-Marda bil-Virus tal-Ebola (EVD, Ebola Virus Disease) ikkawżata mill-virus tal-Ebola Zaire (ara sezzjonjiet 4.2, 4.4 u 5.1).
English: • Current immunosuppressive therapy, including high doses of corticosteroid.
Maltese: • Terapija immunosoppressiva attwali, inklużi dożi għoljin ta' kortikosterojdi.
English: The active substance is a living Vesicular Stomatitis Virus.
Maltese: Is-sustanza attiva hija Virus ħaj tal-Istomatite Vesikulari.
English: Store and transport frozen at -80°C to -60°C.
Maltese: Aħżen u ttrasporta ffriżat f'temperatura ta' -80°C sa -60°C.
English: Individuals 18 years of age or older: one dose (1 mL) (see section 5.1).
Maltese: Individwi b'età ta' 18-il sena jew aktar: doża waħda (1 mL) (ara sezzjoni 5.1).
English: Recombinant human serum albumin, trometamol buffer, water for injections, hydrochloric acid, sodium hydroxide
Maltese: Albumina rikombinanti tas-serum tal-bniedem, buffer trometamol, ilma għall-injezzjonijiet, hydrochloric acid, sodium hydroxide
English: Immunogenicity testing has been performed in Protocol 009, Protocol 011 and Protocol 012, and includes the assessment of binding immunoglobulin G (IgG) specific to purified Kikwit ZEBOV GP by validated enzyme linked immunosorbent assay (GP-ELISA) as well as validated neutralization of vaccine virus by a plaque reduction neutralization test (PRNT).
Maltese: Ittestjar tal-immunoġeniċità sar fil-Protokoll 009, fil-Protokoll 011 u fil-Protokoll 012, u inkluda listima tal-irbit tal-immunoglobulina G (IgG, immunoglobulin G) speċifika għal Kikwit ZEBOV GP ippurifikat permezz ta' assaġġ immunosorbenti marbut mal-enzimi (GP-ELISA, enzyme linked immunosorbent assay) validat kif ukoll newtralizzazzjoni validata tal-virus tat-tilqima permezz tat-test ta' newtralizzazzjoni ta' tnaqqis tal-plakka (PRNT, plaque reduction neutralization test).
English: Vaccine efficacy was 100% (unadjusted 95% CI: 63.5% to 100%; 95% CI adjusted for multiplicity: 14.4% to 100%) (0 cases in the immediate arm; 10 cases in 4 rings in the delayed arm).
Maltese: CI ta' 95% aġġustat għall-multipliċità: 14.4% sa 100%) (0 każijiet fil-grupp immedjat; 10 każijiet f'4 ċrieki fil-grupp imdewwem).
English: One dose (1 mL): Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live attenuated) ≥72 million pfu
Maltese: Tilqima tal-Ebola Zaire (rVSVΔG-ZEBOV-GP, ħaj, attenwat) ≥72 miljun pfu
English: Safety and efficacy of Ervebo have not been assessed in immunocompromised individuals.
Maltese: Is-sigurtà u l-effikaċja ta' Ervebo ma ġewx stmati f'individwi immunokompromessi.
English: Musculoskeletal and connective tissue disorders:
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi:
English: In a Phase 1 trial in children 6 to 17 years of age (median age = 10), non-validated ELISA and Pseudovirion Neutralization Assay (PsVNA) results at Day 28 and Day 180 post-vaccination were similar to those observed in adults in the same study (see also sections 4.4 and 4.8).
Maltese: Fi prova ta' Fażi 1 fi tfal b'età minn 6 snin sa 17-il sena (età medjana = 10), riżultati mhux validati b'ELISA u Assaġġ ta' Newtralizzazzjoni tal-Psewdovirjon (PsVNA, Pseudovirion Neutralization Assay) f'Jum 28 u Jum 180 wara t-tilqim kienu simili għal dawk osservati fl-adulti fl-istess studju (ara wkoll sezzjonijiet 4.4 u 4.8).
English: 31 Jan 2020
Maltese: 31 ta' Jannar
English: Rash was characterized in a variety of ways including generalized rash (2.3%), vesicular rash (0.5%), dermatitis (0.3%), or cutaneous vasculitis (0.01%) in clinical trials.
Maltese: Fi provi kliniċi raxx kien ikkaratterizzat f'diversi modi inklużi raxx mifrux (2.3%), raxx bl-infafet (0.5%), dermatite (0.3%), jew vaskulite kutanja (0.01%).
English: Placebo Group
Maltese: Plaċebo
English: • Chills,
Maltese: • Nawsja,
English: The most common systemic adverse reactions reported following vaccination with Ervebo were headache (36.9%), pyrexia (34.3%), myalgia (32.5%), fatigue (18.5%), arthralgia (17.1%), nausea
Maltese: L-aktar reazzjonijiet sistemiċi avversi rrappurtati b'mod komuni wara t-tilqim b'Ervebo kienu uġigħ ta' ras (36.9%), deni (34.3%), mijalġja (32.5%), għeja (18.5%), artralġja (17.1%), nawsja (8.0%), tkexkix ta' bard (6.3%), artrite (3.7%), raxx (3.6%), iperidrosi (3.2%), u uġigħ fl-addome (1.4%).
English: Arthralgia and arthritis
Maltese: Artralġja u artrite
English: In the Phase 1 study with the highest rate of arthritis, 6 of 24 patients (25%) who reported arthritis after vaccination had persistent joint symptoms two years after vaccination.
Maltese: Fl-istudju ta' Fażi 1 bl-ogħla rata ta' artrite, 6 minn 24 pazjent (25%) li rrappurtaw artrite wara t-tilqim kellhom sintomi persistenti fil-ġogi sentejn wara t-tilqim.
English: Other medicines and Ervebo
Maltese: Mediċini oħra u Ervebo
English: The MAH should provide additional qualification data for the critical reagent used in the identity test (quality control release test for AS and FP).
Maltese: L-MAH għandu jipprovdi data addizzjonali ta' kwalifikazzjoni għar-reaġent kritiku użat fit-test ta' identità (test ta' rilaxx tal-kontroll ta' kwalità għal AS u FP).
English: Recombinant human serum albumin Trometamol buffer
Maltese: Buffer trometamol
English: Vaccine virus RNA was mainly detected from Day 1 to Day 7.
Maltese: L-RNA tal-virus tat-tilqima ġiet osservata l-aktar minn Jum 1 sa Jum 7.
English: CI = Confidence interval; GMT = Geometric mean titer; PRNT = Plaque Reduction Neutralization Test *Protocol 011 from Month 9-12
Maltese: CI = Intervall ta' kunfidenza (Confidence interval); GMT = Titer ġeometriku medju (Geometric mean titer); PRNT = Test ta' Newtralizzazzjoni ta' Tnaqqis tal-Plakka (Plaque Reduction Neutralization Test) *Protokoll 011 mix-Xhur 9-12 §Protokolli 009 u 011 użaw irradjazzjoni gamma tal-kampjuni biex jitnaqqas ir-riskju ta' infezzjoni bil-virus tal-Ebola li jinstab fin-natura għall-ħaddiema tal-laboratorju
English: Water for injections Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Maltese: Ilma għall-injezzjonijiet Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide (għall-aġġustament tal-pH)
English: Arthritis has been reported by subjects in clinical trials at a frequency that ranged from 0% in several protocols to 23.5% in one Phase 1 study.
Maltese: Artrite ġiet irrappurtata mill-individwi fi provi kliniċi bi frekwenza li varjat minn 0% f'diversi protokolli sa 23.5% fi studju wieħed ta' Fażi 1.
English: • Because Ervebo does not contain the whole Ebola virus, it cannot give you Ebola virus disease.
Maltese: • Peress li Ervebo ma fihx il-virus sħiħ tal-Ebola, huwa ma jistax iqabbdek il-marda tal-virus Ebola.
English: pfu= plaque-forming units
Maltese: 3pfu, plaque-forming units = unitajiet li jiffurmaw plakka
English: No adverse events of infections were observed in Phase 1/2 trials.
Maltese: Ma kienu osservati l-ebda avvenimenti avversi ta' infezzjonijiet fil-provi ta' Fażi 1/2.
English: Protocol 012 Combined Consistency Lots Group
Maltese: Protokoll 012 Grupp tal
English: Serious side effects are rare.
Maltese: Effetti sekondarji serji huma rari.
English: Ervebo consists of a live, attenuated recombinant vesicular stomatitis virus-based vector expressing the envelope glycoprotein gene of Zaire Ebola virus (rVSVΔG-ZEBOV-GP).
Maltese: recombinant vesicular stomatitis virus-based vector expressing the envelope glycoprotein gene of
English: The safety profile of Ervebo in children and adolescents 6 to17 years of age was generally similar to that observed in adults.
Maltese: Il-profil tas-sigurtà ta' Ervebo fi tfal u adolexxenti b'età minn 6 snin sa 17-il sena ġeneralment kien jixbah dak osservat fl-adulti.
English: This trial compared Ervebo to normal saline placebo in 1,000 adults ≥18 years of age in Liberia.
Maltese: Din il-prova qabblet Ervebo ma' plaċebo ta' normal saline f'1,000 adult b'età ta' ≥18-il sena fil-Liberja.
English: The median age of consenting CCCs was 35 years old.
Maltese: L-età medjana ta' CCCs li taw il-kunsens tagħhom kienet ta' 35 sena.
English: Over 93.8% of vaccine recipients met seroresponse criteria defined as a ≥2-fold increase from baseline and ≥200 EU/mL at any time post-vaccination by GPELISA and over 80.4% of subjects met seroresponse criteria defined as a ≥4-fold increase from baseline at any time post-vaccination by PRNT.
Maltese: Aktar minn 93.8% tal-individwi li rċivew ittilqima ssodisfaw il-kriterji ta' serorispons iddefiniti bħala żieda ta' ≥2 darbiet mil-linja bażi u ≥200 EU/mL fi kwalukwe ħin wara t-tilqim permezz ta' GP-ELISA u aktar minn 80.
English: The clinical development program included four Phase 2/3 (Protocols 009-012) clinical trials.
Maltese: Il-programm ta' żvilupp kliniku kien jinkludi erbgħa provi kliniċi ta' Fażi 2/3 (Protokolli 009-012).
English: Frequencies are reported as:
Maltese: Il-frekwenzi kienu rrappurtati bħala:
English: Over 80.1% of subjects continued to meet the seroresponse criteria for GP-ELISA and over 63.5% of vaccine recipients continued to meet seroresponse criteria for PRNT at 12 months.
Maltese: 1% tal-individwi komplew jissodisfaw il-kriterji ta' serorispons għal GP-ELISA u aktar minn 63.5% tal-individwi li rċivew it-tilqima komplew jissodisfaw il-kriterji ta' serorispons għal PRNT wara 12-il xahar.
English: • Ervebo should be administered intramuscularly.
Maltese: • Ervebo huwa soluzzjoni għall-injezzjoni.
English: • Ervebo is a vaccine for adults who are 18 years of age and older.
Maltese: • Ervebo huwa tilqima għall-adulti li għadhom 18-il sena jew aktar.
English: Of those 9,096 subjects, 4,160 received Ervebo (2,119 subjects were vaccinated in the immediate arm and 2,041 subjects were vaccinated in the delayed arm).
Maltese: Minn dawk id-9,096 individwu, 4,160 irċivew Ervebo (2,119-il individwu tlaqqmu fil-grupp ta' tilqim immedjat u 2,041 individwu tlaqqmu fil-grupp ta' tilqim imdewwem).
English: This vaccine contains less than 1 mmol (23 mg) of sodium per dose.
Maltese: Din it-tilqima fiha inqas minn 1 mmol (23 mg) ta' sodium f'kull doża.
English: Mechanism of action
Maltese: Grupp tal
English: Shedding of vaccine virus has been detected by PCR in urine or saliva in 19 out of 299 adult subjects and in skin vesicles in 4 out of 10 adult subjects.
Maltese: Tixrid tal-virus tat-tilqima ġie osservat permezz ta' PCR fl-awrina jew fil-bżieq f'19 minn 299 individwu adult u fl-infafet fil-ġilda f'4 minn 10 individwi adulti.
English: The most common injection-site adverse reactions were injection-site pain (70.3%), swelling (16.7%) and erythema (13.7%).
Maltese: 3%), nefħa (16.7%) u eritema (13.7%).
English: • Contact with semen from a man who had Ebola.
Maltese: • Kuntatt ma' semen minn raġel li kellu l-Ebola.
English: Protocol 009 Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) was a Phase 2 randomized, double-blind, placebo-controlled trial which evaluated the safety and immunogenicity of Ebola vaccine candidates including Ervebo.
Maltese: Il-protokoll 009 Sħubija għar-Riċerka dwar it-Tilqim tal-Ebola fil-Liberja (PREVAIL, Partnership for Research on Ebola Vaccines in Liberia) kien prova arbitrarja ta' Fażi 2, ikkontrollata bi plaċebo, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema tilqima qed tintuża, li evalwat is-sigurtà u limmunoġeniċità ta' kandidati tat-tilqima tal-Ebola inkluż Ervebo.
English: • Nausea,
Maltese: • Deni,
English: However, infectious virus was detected at Day 1 and persistent infectious virus was not detected at any subsequent timepoints measured (Days 56, 84 and 112).
Maltese: Madankollu, virus infettiv seta' jitkejjel f'Jum 1 u virus infettiv persistenti ma seta' jitkejjel fl-ebda punt ta' żmien sussegwenti li fih ittieħed il-kejl (Jiem 56, 84 u 112).
English: Across the Phase 1 through Phase 3 trials, 234 children and adolescents 6 to 17 years of age received a dose of Ervebo.
Maltese: Mill-provi ta' Fażi 1 sal-provi ta' Fażi 3, 234 tifel u tifla u adolexxenti b'età minn 6 snin sa 17-il sena rċivew doża ta' Ervebo.
English: • someone who has a weak immune system.
Maltese: • persuna li għandha sistema immuni dgħajfa.
English: What is Ebola?
Maltese: X'inhi l-Ebola?
English: • Muscle aches,
Maltese: • Uġigħ fil-muskoli,
English: CI = Confidence interval; GP-ELISA = Anti-Glycoprotein Human Enzyme-Linked Immunosorbent Assay (EU/mL); GMT = Geometric mean titer *Protocol 011 from Month 9-12
Maltese: Glikoproteina (Anti-Glycoprotein Human Enzyme-Linked Immunosorbent Assay) (EU/mL);
English: live, attenuated) ≥72 million pfu Recombinant Vesicular Stomatitis Virus (rVSV) strain Indiana with a deletion of the VSV envelope glycoprotein (G) replaced with the Zaire Ebola Virus (ZEBOV) Kikwit 1995 strain surface glycoprotein (GP) Produced in Vero cells.
Maltese: Tilqima tal-Ebola Zaire (rVSVΔG-ZEBOV-GP1,2 ħaj, attenwat) ≥72 miljun pfu3 1Virus rikombinanti tal-Istomatite Vesikulari (rVSV, recombinant Vesicular Stomatitis Virus) tarrazza Indiana bi tneħħija tal-glikoproteina (G) tal-envelopp ta' VSV li minflokha tpoġġiet ilglikoproteina (GP, glycoprotein) tas-superfiċje tal-Virus Zaire Ebola (ZEBOV) tar-razza Kikwit 1995 2Magħmul f'ċelluli Vero.
English: Arthritis
Maltese: Artrite§
English: EU/1/19/1392/001 - pack of 10
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1392/001 - pakkett ta' 10
English: This being a conditional marketing authorisation and pursuant to Article 14-a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14-a(4) tarRegolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li ġejjin:
English: Protocol 012 was a Phase 3 randomized, double-blind, placebo-controlled trial which evaluated the safety and immunogenicity of three consistency lots and a high dose lot (approximately five times higher than the dose in consistency lots and dose used in other Phase 2/3 trials) of Ervebo compared to normal saline placebo.
Maltese: Il-protokoll 012 kien prova arbitrarja, ikkontrollata bi plaċebo, ta' Fażi 3, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema tilqima qed tintuża li evalwat is-sigurtà u l-immunoġeniċità ta' tliet lottijiet ta' konsistenza u lott b'doża għolja (madwar ħames darbiet aktar mid-doża tal-lottijiet ta' konsistenza u doża użata fi provi oħra ta' Fażi 2/3) ta' Ervebo imqabbla ma' plaċebo ta' normal saline.
English: Summary of Geometric Mean Titers for the GP-ELISA from Protocols 009, 011 and 012 Clinical Trials
Maltese: Sommarju tat-Titres Ġeometriċi Medji għall-GP-ELISA mill-Provi Kliniċi tal-Protokolli 009, 011 u 012
English: In clinical trials with reports of arthritis, the median onsets were between 10 and 12 days (range from 0 to 25 days).
Maltese: Fi provi kliniċi b'rapporti ta' artrite, il-bidu medjan tagħhom kien bejn 10 u 12-il jum (firxa minn 0 sa 25 jum).
English: • Pregnant or breast-feeding women (see section 4.6),
Maltese: • Nisa tqal jew li qed ireddgħu (ara sezzjoni 4.6),
English: Ervebo solution for injection Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live)
Maltese: Ervebo soluzzjoni għall-injezzjoni Tilqima tal-Ebola Zaire (rVSVΔG-ZEBOV-GP, ħaj)
English: The surface protein of the virus has been replaced with that of Zaire Ebola Virus (rVSVΔG-ZEBOV-GP).
Maltese: Il-proteina tas-superfiċje tal-virus ġiet sostitwita b'dik tal-Virus Zaire Ebola (rVSVΔG-ZEBOV-GP).
English: As shown in Tables 2 and 3, the geometric mean titers (GMT) of GP-ELISA and PRNT increased from pre-vaccination to post-vaccination.
Maltese: Kif muri fit-Tabelli 2 u 3, it-titres ġeometriċi medji (GMT, geometric mean titers) ta' GP-ELISA u PRNT żdiedu minn qabel it-tilqim sa wara t-tilqim.
English: In 6 out of 18 subjects tested, the vaccine virus was detected in rashes (described as dermatitis, vesicles or cutaneous vasculitis lesions) suggesting a virally mediated process post-vaccination.
Maltese: F'6 minn 18-il individwu ttestjat, il-virus tat-tilqima instab fir-raxxijiet (deskritti bħala dermatite, infafet, jew feriti kutanji tal-vaskulite) li jissuġġerixxi proċess medjat mill-virus wara t-tilqim.
English: • Skin rash,
Maltese: • Raxx fil-ġilda,
English: • Immunocompromised individuals and individuals receiving immunosuppressive therapy (see section above),
Maltese: • Individwi immunokompromessi u individwi li jkunu qed jirċievu terapija immunosoppressiva (ara s-sezzjoni fuq),
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: A MANIFATTUR(I) TAS-SUSTANZA/I BIJOLOĠIKA(ĊI) ATTIVA/I
English: Protocol 011 named Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) was a Phase 2/3 randomized open-label trial which evaluated safety and immunogenicity of Ervebo in adults ≥18 years of age working in healthcare facilities or on frontline activities related to the Ebola response in Sierra Leone.
Maltese: Il-protokoll 011 imsejjaħ Il-Prova ta' Sierra Leone biex tiġi Introdotta Tilqima kontra l-Ebola (STRIVE, Trial to Introduce a Vaccine against Ebola) kien prova arbitrarja, ta' Fażi 2/3, fejn kemm linvestigaturi kif ukoll l-individwi kienu jafu liema tilqima qed tintuża, li evalwat is-sigurtà u limmunoġeniċità ta' Ervebo f'adulti ta' ≥18-il sena li kienu qed jaħdmu f'faċilitajiet tal-kura tas-saħħa jew kienu l-eqreb lejn attivitajiet marbuta mar-rispons tal-Ebola fi Sierra Leone.
English: Protocols 009 and 011 used gamma irradiation of specimens to reduce risk of wild-type Ebola virus infection of laboratory workers
Maltese: *Protokoll 011 mix-Xhur 9-12 §Protokolli 009 u 011 użaw irradjazzjoni gamma tal-kampjuni biex jitnaqqas ir-riskju ta' infezzjoni bil-virus tal-Ebola li jinstab fin-natura għall-ħaddiema tal-laboratorju
English: However, as a precaution, vaccinees should attempt to avoid exposure of livestock to blood and bodily fluids for at least 6 weeks following vaccination to avoid the theoretical risk of spread of the vaccine virus.
Maltese: Madankollu, bħala prekawzjoni, persuni mlaqqma għandhom jippruvaw jevitaw li jesponu bhejjem tal-irziezet għal demm jew fluwidi tal-ġisem għal mill-inqas 6 ġimgħat wara t-tilqim biex jiġi evitat ir-riskju teoretiku ta' tixrid tal-virus tat-tilqima.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: In a biodistribution study conducted in non-human primates, vaccine virus RNA was detected in lymphoid organs up to 112 days post-vaccination.
Maltese: Fi studju ta' biodistribuzzjoni li sar fi primati mhux umani, l-RNA tal-virus tat-tilqima seta' jitkejjel florgani limfojd sa 112-il jum wara t-tilqim.
English: In this trial, 9,096 subjects ≥18 years of age who were considered CCCs of an index case with laboratory-confirmed EVD were randomized to immediate (4,539 subjects in 51 clusters) or 21 days delayed (4,557 subjects in 47 clusters) vaccination with Ervebo.
Maltese: F'din il-prova, 9,096 individwu ta' ≥18-il sena li tqiesu bħala CCCs tal-ewwel każ minn grupp b'EVD ikkonfermata fil-laboratorju ntagħżlu b'mod arbitrarju għal tilqim immedjat (4,539 individwu f'51 ġemgħa) jew imdewwem b'21 jum (4,557 individwu f'47 ġemgħa) b'Ervebo.
English: There are limited amount of data (less than 300 pregnancy outcomes) from the use of Ervebo in pregnant women, or women who became pregnant after receiving the vaccine.
Maltese: Hemm data limitata (inqas minn 300 riżultat ta' tqala) dwar l-użu ta' Ervebo f'nisa tqal jew nisa li ħarġu tqal wara li rċivew it-tilqima.
English: • Ervebo is given to protect you from getting Ebola virus disease caused by the Zaire Ebola virus,
Maltese: • Ervebo jingħata biex jipproteġik milli tieħu il-marda tal-virus tal-Ebola ikkawżata mill-virus talEbola Zaire, li huwa tip ta' virus tal-Ebola.
English: In this trial, 8,673 adult subjects were enrolled and 8,651 with valid consents randomized to immediate (within 7 days of enrolment) or deferred (18 to 24 weeks after enrolment) vaccination with Ervebo.
Maltese: F'din il-prova, ġew irreġistrati 8,673 individwu adult u 8,651 b'kunsens validu intagħżlu b'mod arbitrarju għal tilqim immedjat (fi żmien 7 ijiem minn meta ġew irreġistrati) jew pospost (18 sa 24 ġimgħa wara li ġew irreġistrati) b'Ervebo.
English: which is a type of Ebola virus.
Maltese: Zaire Ebola virus).
English: The MAH should complete master cell banks (MCB)/working cell bank (WCB) qualification to include also tests for specified viruses.
Maltese: master cell banks)/bank ta' ċelluli biex taħdem bihom (WCB, working cell bank)
English: Impact to serological testing
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul talRMP.
English: • Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.
Maltese: • Storja ta' immunodefiċjenza konġenitali jew ereditarja fil-familja, ħlief jekk tintwera kompetenza immuni fil-persuna li possibbilment se tieħu it-tilqima.