FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 48,889 confirmed HZ cases and 3,316 confirmed PHN cases (>90 days of zoster-associated pain) were observed.
Maltese: Ġew osservati total ta' 48,889 każ ikkonfermat ta' HZ u 3,316-il każ ikkonfermat ta' PHN (>90 jum ta' uġigħ assoċjat ma' zoster).
English: ZOSTAVAX is available in packs of 1 or 10.
Maltese: ZOSTAVAX huwa disponibbli f'pakketti ta' 1 jew 10.
English: After reconstitution, 1 dose (0.65 mL) contains:
Maltese: Wara rikonstituzzjoni, doża 1 (0.65 mL) fiha:
English: The median follow-up was ~1.2 years (range is one day to 2.2 years) and ~3.9 years (range is one week to 4.75 years) in STPS and LTPS, respectively.
Maltese: Segwitu medjan kien ta' ~1.2 snin (medda hija minn jum wieħed sa 2.2 snin) u ~3.9 snin (medda hija minn ġimgħa sa 4.75 sena) fl-STPS u LTPS, rispettivament.
English: HIV-infected adults with conserved immune function In a double-blind, placebo-controlled randomised clinical trial, ZOSTAVAX was administered to HIV-infected adults (18 years of age or older; median age 49 years) on appropriate antiretroviral therapy with conserved immune function (CD4+ T cell count ≥ 200 cells/µL).
Maltese: Fi prova klinika double-blind, ikkontrollata bi plaċebo fejn il-pazjenti ntgħażlu b'mod każwali, ZOSTAVAX ingħata lil adulti infettati bl-HIV (età ta' 18-il sena jew aktar; età medjana ta' 49 sena) fuq terapija antiretrovirali xierqa b'funzjoni immuni kkonservata (għadd ta' ċelluli T CD4+ ta' ≥ 200 ċellula/µL).
English: Reconstitution instructions
Maltese: Istruzzjonijiet ta' rikonstituzzjoni
English: VZV-specific immune responses were generally similar in subjects 50 to 59 compared to subjects ≥60 years of age.
Maltese: Ir-risponsi immuni speċifiċi għal VZV kienu ġeneralment simili f'suġġetti ta' 50 sa 59 sena meta mqabbla ma' suġġetti ta' ≥60 sena.
English: • Immunosuppressive therapy (including high-dose corticosteroids) (see sections 4.4 and 4.8); however, ZOSTAVAX is not contraindicated for use in individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or in patients who are receiving corticosteroids as replacement therapy, e.g., for adrenal insufficiency (see sections 4.8 and 5.1).
Maltese: • Terapija immunosuppressiva (inkluż corticosteroids f' doża kbira) (ara sezzjonijiet 4.4 u 4.8); madankollu, m'hemmx kontra-indikazzjonijiet għall-użu ta' ZOSTAVAX f'individwi li qegħdin jieħdu corticosteroids f'parti mill-ġisem/b'inalatur jew corticosteroids sistemiċi ta' doża żgħira jew f'pazjenti li qegħdin jirċievu corticosteroids bħala terapija ta' sostituzzjoni, eż., għal insuffiċjenza adrenali (ara sezzjonijiet 4.8 u 5.1).
English: VZV was detected in one (0.01%) specimen from a ZOSTAVAX recipient reporting a varicella/varicella-like rash; however, the virus strain (wild type or Oka/Merck strain) could not be determined.
Maltese: VZV instab f'kampjun wieħed (0.01%) minn persuna li rċiviet ZOSTAVAX u rrappurtat raxx tal-variċella/jixbah dak tal-variċella; madankollu, ir-razza tal-virus (tat-tip li jinstab fin-natura jew razza Oka/Merck) ma setgħetx tiġi determinata.
English: Date of first authorisation: 19 May 2006 Date of latest renewal: 11 February 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 ta' Mejju 2006
English: Data from a clinical trial (n=368) demonstrated that the current refrigerated formulation has a safety profile comparable to that of the frozen formulation.
Maltese: Tagħrif minn prova klinika (n=368) wera li l-formulazzjoni mkessħa preżenti għandha profil ta' sigurtà komparabbli ma' dak tal-formulazzjoni ffriżata.
English: VIAL OF SOLVENT
Maltese: KUNJETT TA' SOLVENT
English: ZOSTAVAX significantly decreased the incidence of Post-herpetic Neuralgia (PHN) compared with placebo (see Table 4).
Maltese: Infezzjoni b'Herpes (PHN Post-herpetic Neuralgia) meta mqabbel ma' plaċebo (ara Tabella 4).
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine; ATC code: J07BK02
Maltese: Vaċċini, Vaċċin Virali; Kodiċi ATC:
English: In clinical trials with ZOSTAVAX, transmission of the vaccine virus has not been reported.
Maltese: Fi provi kliniċi b'ZOSTAVAX, it-trasmissjoni tal-virus tal-vaċċin ma ġietx irrapportata.
English: In other clinical trials evaluating ZOSTAVAX in subjects 50 years of age or older, including a study of concomitantly administered inactivated influenza vaccine, a higher rate of injection-site adverse experiences of mild-to-moderate intensity was reported among subjects 50-59 years of age compared with subjects ≥60 years of age (see section 5.1).
Maltese: Fi provi kliniċi oħra li vvalutaw ZOSTAVAX f'individwi ta' 50 sena jew aktar, inkluż studju fejn ingħatat tilqima inattivata kontra l-influwenza fl-istess ħin, ġiet irrappurtata rata ogħla ta' esperjenzi avversi fil-post tal-injezzjoni ta' intensità ħafifa sa moderata fost individwi ta' 50-59 sena meta mqabbla ma' individwi ta' ≥60 sena (ara sezzjoni 5.1).
English: In SPS, the overall incidence of vaccine-related injection-site adverse reactions were 48% for ZOSTAVAX and 17% for placebo in subjects 60 years of age and older.
Maltese: F'SPS, l-inċidenza totali ta' reazzjonijiet avversi fis-sit tal-injezzjoni marbuta mat-tilqima kienet 48% għal ZOSTAVAX u17% għall-plaċebo f'individwi ta' 60 sena jew aktar.
English: ZOSTAVAX contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: ZOSTAVAX fih inqas minn 1mmol ta' sodium (23 mg) f'kull doża, i.e. huwa essenzjalment ‘mingħajr sodium'.
English: Fertility ZOSTAVAX has not been evaluated in fertility studies.
Maltese: Fertilità ZOSTAVAX ma kienx evalwat fi studji dwar il-fertilità.
English: Table 1 presents vaccine-related injection-site and systemic adverse reactions reported at a significantly greater incidence in the vaccine group versus the placebo group within 42 days postvaccination in the ZOSTAVAX Efficacy and Safety trial (ZEST) study and in the Adverse Event Monitoring Substudy of Shingles Prevention Study (SPS).
Maltese: Tabella 1 tippreżenta reazzjonijiet avversi fis-sit tal-injezzjoni u sistemiċi relatati mat-tilqima li ġew irrappurtati b'inċidenza ferm ogħla fil-grupp tat-tilqima meta mqabbel mal-grupp ta' plaċebo fi żmien 42 jum wara t-tilqim fl-istudju tal-prova tal-Effikaċja u s-Sigurtà ta' ZOSTAVAX (ZESTZOSTAVAX Efficacy and Safety Trial) u fis-Sottostudju ta' Monitoraġġ ta' Każijiet Avversi tal-Istudju dwar il-Prevenzjoni tal-Ħruq ta' Sant'Antnin (SPS - Shingles Prevention Study).
English: Powder and solvent for suspension for injection.
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni.
English: Adults on chronic/maintenance systemic corticosteroids In subjects 60 years of age or older who were receiving chronic/maintenance systemic corticosteroid therapy at a daily dose equivalent of 5 to 20 mg of prednisone for at least 2 weeks prior to enrollment, and 6 weeks or more following vaccination, the safety profile was generally comparable to that seen in the Adverse Event Monitoring Substudy of the SPS (see sections 4.3 and 5.1).
Maltese: Adulti fuq kortikosterojdi sistemiċi b'mod kroniku/ta' manteniment F'individwi b'età ta' 60 sena jew aktar li kienu qed jirċievu terapija kronika/ta' manteniment b'kortikosterojdi sistemiċi b'doża ta' kuljum ekwivalenti għal 5 sa 20 mg ta' prednisone għal millinqas ġimagħtejn qabel ma ddaħħlu fl-istudju, u għal 6 ġimgħat jew aktar wara t-tilqim, il-profil ta' sigurtà kien komparabbli b'mod ġenerali ma dak li deher fis-Sottostudju ta' Monitoraġġ ta' Avvenimenti Avversi tal-SPS (ara sezzjonijiet 4.3 u 5.1).
English: In a double-blind, controlled clinical trial, 473 adults, 60 years of age or older, were randomised to receive a single dose of ZOSTAVAX either concomitantly (N=237), or nonconcomitantly (N=236) with 23-valent pneumococcal polysaccharide vaccine.
Maltese: Fi prova klinika kkontrollata, double blind, 473 adult, ta' 60 sena jew aktar, intgħażlu b'mod każwali sabiex jirċievu doża waħda ta' ZOSTAVAX jew fl-istess ħin (N=237), jew mhux fl-istess ħin (N=236) ma' vaċċin polisakkaride pnewmokokkali ta' 23 valenti.
English: In a double-blind, controlled clinical trial, 762 adults 50 years of age and older were randomised to receive a single dose of ZOSTAVAX administered either concomitantly (N=382) or nonconcomitantly (N=380) with inactivated split influenza vaccine.
Maltese: Fi prova klinika kkontrollata, double-blind, 762 adult ta' 50 sena u aktar ġew magħżula b'mod każwali biex jirċievu doża waħda ta' ZOSTAVAX mogħtija jew flimkien ma' (N=382) jew mhux flimkien ma' (N=380) vaċċin mhux attivat maqsum tal-influwenza.
English: Mean BOI score
Maltese: Punteġġ BOI
English: Subjects on chronic/maintenance systemic corticosteroids In a double-blind, placebo-controlled, randomised clinical trial, ZOSTAVAX was administered to 206 subjects 60 years of age or older who were receiving chronic/maintenance systemic corticosteroid therapy at a daily dose equivalent of 5 to 20 mg of prednisone for at least 2 weeks prior to enrollment, and 6 weeks or more following vaccination to assess the immunogenicity and safety profile of ZOSTAVAX.
Maltese: Individwi li kienu qed jirċievu kortikosterojdi sistemiċi b'mod kroniku/ta' manteniment Fi prova klinika, randomised, double blind, ikkontrollata bi plaċebo, ZOSTAVAX ingħata lil 206 individwu ta' 60 sena jew aktar li kienu qed jirċievu terapija ta' manteniment/kronika b'kortikosterojd sistemiku b'doża ta' kuljum ekwivalenti għal 5 sa 20 mg ta' prednisone għal tal-inqas ġimagħtejn qabel ma ddaħħlu fil-prova, u għal 6 ġimgħat jew aktar wara t-tilqim biex jiġu stmati limmunoġeniċità u l-profil ta' sigurtà ta' ZOSTAVAX.
English: HIV-infected adults with conserved immune function In a clinical trial, ZOSTAVAX was administered to HIV-infected adults (18 years of age or older, CD4+ T cell count ≥ 200 cells/µL) (see section 5.1).
Maltese: Fi prova klinika, ZOSTAVAX ingħata lill-adulti infettati bl-HIV (b'età ta' 18-il sena jew aktar, għadd ta' ċelluli T CD4+ ta' ≥ 200 ċellula/µL) (ara sezzjoni 5.1).
English: Nausea
Maltese: persuna
English: Merck Sharp & Dohme d.o.o.
Maltese: Merck Sharp & Dohme s.r.o.
English: The following side effects have been observed:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: * Cox models adjusted for calendar time, age, sex, race/ethnic group, healthcare resource utilization (flu vaccination, number of weeks with an outpatient visit per year), co-morbid conditions (DxCG score, HCUP risk score), immunocompromise status during follow-up ‡ VE over study period is the VE calculated over the full duration of the study (2007-2014) at the time of this interim analysis § Average VE was calculated as the weighted average of the annual VE estimates over 3 and 5 years, respectively, where the weights are the proportion of the overall time period covered ¶ Data not available
Maltese: * Mudelli Cox aġġustati għaż-żmien tal-kalendarju, l-età, is-sess, ir-razza/il-grupp etniku, l-użu ta' riżorsi tal-kura tas-saħħa (tilqim għall-influwenza, numru ta' ġimgħat b'vista bħala outpatient fis-sena), kondizzjonijiet ta' komorbidità (punteġġ DxCG, punteġġ ta' riskju HCUP), stat immunokompromess waqt is-segwitu ‡
English: Abbreviations: VE denotes vaccine effectiveness; CI confidence interval; DxCG diagnostic cost group; HCUP healthcare cost and utilization project
Maltese: VE turi l-effikaċja tal-tilqima; CI intervall ta' kunfidenza (confidence interval); DxCG grupp tal-ispiża dijanjostika; HCUP proġett tal-ispiża u l-użu tal-kura tas-saħħa
English: Powder and solvent for suspension for injection 1 vial (powder) + 1 vial (solvent) 10 vials (powder) + 10 vials (solvent)
Maltese: U KONTENUT Trab u solvent għal suspensjoni għall-injezzjoni kunjett 1 (trab) + kunjett 1 (solvent) 10 kunjetti (trab) + 10 kunjetti (solvent)
English: Over the 6-month (acute and chronic) follow-up period, there was a 22% reduction (p =0.008) in the severity-by-duration score and a 52% (95% CI: [7 to 74%]) reduction (from 6.2% to 3.5%) in the risk of having zoster with severe and long-lasting pain (severity-by-duration score of >600).
Maltese: 008) fl-iskor tas-severità skond it-tul ta' żmien u tnaqqis ta' 52% (95% CI: [7 sa 74%]) (minn 6.2% sa 3.5%) fir-riskju ta' zoster b'uġigħ qawwi u fit-tul (skor tas-severità skond it-tul ta' żmien ta' >600).
English: The STPS was initiated to accrue additional information on the persistence of vaccine efficacy for subjects who received ZOSTAVAX in SPS.
Maltese: L-STPS inbeda biex tiġi akkumulata informazzjoni addizjonali dwar il-persistenza tal-effikaċja tat-tilqima għal individwi li rċivew ZOSTAVAX fl-SPS.
English: Additional adverse reactions, spontaneously reported through post-marketing surveillance, are also included in Table 1.
Maltese: Reazzjonjiet avversi addizzjonali, irrappurtati b'mod spontanju permezzz ta' sorveljanza wara ttqegħid fis-suq, huma inklużi wkoll f'Tabella 1.
English: Number of zoster cases
Maltese: Numru ta' każijiet ta' zoster
English: The safety and efficacy of ZOSTAVAX have not been established in adults who are known to be infected with HIV with or without evidence of immunosuppression (see section 4.3) however, a phase II safety and immunogenicity study in HIV-infected adults with conserved immune function (CD 4+T cell count ≥ 200 cells/µL) has been completed (see sections 4.8 and 5.1).
Maltese: II dwar is-sigurtà u l-immunoġeniċità f'adulti infettati bl-HIV b'funzjoni immuni kkonservata (għadd taċ-ċelluli T CD 4+ ta' ≥ 200 ċellula/µL) (ara sezzjonijiet 4.8 u 5.1).
English: Impaired vision occurred in 2 subjects vaccinated with ZOSTAVAX vs. 9 who received placebo.
Maltese: Żewġ (2) suġġetti mlaqqmin b'ZOSTAVAX esperjenzaw problemi fil-viżta kontra 9 li rċevew placebo.
English: In SPS and ZEST, the number of subjects who reported herpes zoster/herpes zoster-like rashes was less than 0.2% for ZOSTAVAX and placebo groups, with no significant difference observed between the two groups.
Maltese: F'SPS u ZEST, in-numru ta' individwi li rrappurtaw raxx ta' herpes zoster/jixbah dak ta' herpes zoster kien inqas minn 0.2% għall-gruppi ta' ZOSTAVAX u tal-plaċebo, mingħajr l-ebda differenza sinifikanti osservata bejn iż-żewġ gruppi.
English: The risk of transmitting the attenuated vaccine virus from a vaccinee to a susceptible contact should be weighed against the risk of developing natural zoster and potentially transmitting wild-type VZV to a susceptible contact.
Maltese: Ir-riskju ta' trasmissjoni tal-virus attenwat tat-tilqima minn persuna li ġiet imlaqqma għal persuna suxxettibbli li tiġi f'kuntatt magħha għandu jitqies kontra r-riskju ta' l-iżvilupp ta' herpes zoster naturali u l-possibbiltà li jiġi trasmess VZV li jinstab fin-natura lil persuna suxxettibbli li tiġi f'kuntatt magħha.
English: ZOSTAVAX is a live, attenuated varicella-zoster vaccine and administration to individuals who are immunosuppressed or immunodeficient may result in disseminated varicella-zoster virus disease, including fatal outcomes.
Maltese: ZOSTAVAX huwa vaċċin ħaj attenwat ta' varicella-zoster u l-għoti tiegħu lil individwi li huma immunosoppressi jew immunodefiċjenti jista' jwassal għal mard mifrux bil-virus ta' varicella zoster, inklużi riżultati fatali.
English: Clinical Efficacy
Maltese: Effikaċja Klinika
English: § Age-adjusted estimate based on the age strata (60-69 and ≥70 years of age) at randomisation.
Maltese: Stima aġġustata għall-età abbażi tal-klassijiet tal-età (età ta' 60-69 u ta' ≥70) meta saret l-għażla b'mod każwali.
English: EXP
Maltese: PFU
English: ZOSTAVAX is not indicated for treatment of zoster or PHN.
Maltese: ZOSTAVAX mhuwiex indikat għal trattament ta' zoster jew PHN.
English: Solvent for ZOSTAVAX
Maltese: X'fih ZOSTAVAX
English: The 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: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Subjects with a history of herpes zoster (HZ) prior to vaccination In a double-blind, placebo-controlled, randomised clinical trial, ZOSTAVAX was administered to 100 subjects 50 years of age or older with a history of herpes zoster prior to vaccination to assess immunogenicity and safety (see section 4.8) of ZOSTAVAX.
Maltese: Fi prova klinika randomizzata, ikkontrollata bi plaċebo, double-blind, ZOSTAVAX ingħata lil 100 suġġett ta' 50 sena jew aktar bi storja ta' ħerpes zoster qabel it-tilqim, biex tkun ivvalutata limmunoġeniċità u s-sigurtà (ara sezzjoni 4.8) ta' ZOSTAVAX.
English: The number of subjects who reported varicella/varicella-like rashes was less than 0.7% for ZOSTAVAX and placebo.
Maltese: In-numru ta' individwi li rrappurtaw raxx tal-variċella/jixbah dak tal-variċella kien inqas minn 0.7% għal ZOSTAVAX u l-plaċebo.
English: The general safety profiles of the SC and IM routes were otherwise comparable, but injection-site adverse reactions were significantly less frequent in the IM group (34%) compared with the SC group (64%).
Maltese: Il-profili ġenerali ta' sigurtà tar-rottot SC u IM mill-bqija kienu komparabbli, iżda rreazzjonijiet avversi fis-sit tal-injezzjoni kienu b'mod sinifikanti anqas frekwenti fil-grupp IM (34%) meta mqabbel mal-grupp SC (64%).
English: In a clinical study, adults 60 years of age or older received a second dose of ZOSTAVAX 42 days following the initial dose (see section 5.1).
Maltese: Fi studju kliniku, adulti b'età ta' 60 sena jew aktar irċivew it-tieni doża ta' ZOSTAVAX 42 jum wara l-ewwel doża (ara sezzjoni 5.1).
English: Pregnancy and breast-feeding).
Maltese: Pain Inventory).
English: ZOSTAVAX is indicated for immunization of individuals 50 years of age or older.
Maltese: ZOSTAVAX huwa indikat għall-immunizzazzjoni ta' individwi ta' 50 sena jew aktar.
English: ZOSTAVAX is available in packs of 1, 10 or 20 with or without needles.
Maltese: ZOSTAVAX huwa disponibbli f'pakketti ta' 1, 10 jew 20 bi jew mingħajr labar.
English: Within ZEST, immune responses to vaccination were evaluated in a random 10% subcohort (n=1,136 for ZOSTAVAX and n=1,133 for placebo) of the subjects enrolled in the ZEST.
Maltese: Prova dwar l-Effikaċja u s-Sigurtà ta' ZOSTAVAX (ZEST - ZOSTAVAX Efficacy and Safety Trial) F'ZEST, ir-risponsi immuni għat-tilqima kienu evalwati f'sottokoorti random ta' 10% (n=1,136 għal ZOSTAVAX u n=1,133 għall-plaċebo) tal-individwi li ddaħħlu f'ZEST.
English: Other medicines and ZOSTAVAX
Maltese: Mediċini oħra u ZOSTAVAX
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: What ZOSTAVAX contains
Maltese: ¶ Dejta mhux disponibbli
English: After reconstitution, use immediately or within 30 minutes if stored at 20°C-25°C.
Maltese: Wara rikonstituzzjoni, uża minnufih jew fi żmien 30 minuta jekk maħżun f'temperatura ta' 20°C25°C.
English: Table 2: Efficacy of ZOSTAVAX on zoster incidence compared with placebo in the ZEST trial in subjects 50 to 59 years of age*
Maltese: Tabella 2: Effikaċja ta' ZOSTAVAX fuq l-inċidenza ta' zoster meta mqabbel mal-plaċebo filprova ZEST f'individwi ta' età minn 50 sa 59 sena*
English: ZOSTAVAX Efficacy and Safety Trial (ZEST) in subjects 50 to 59 years of age:
Maltese: f'individwi ta' età minn 50 sa 59 sena:
English: Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe (solvent) + 2 needles 10 vials (powder) + 10 pre-filled syringes (solvent) + 20 needles 20 vials (powder) + 20 pre-filled syringes (solvent) + 40 needles
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni f'siringa mimlija għal-lest kunjett 1 (trab) + siringa waħda mimlija għal-lest (solvent) + 2 labriet 10 kunjetti (trab) + 10 siringi mimlijin għal-lest (solvent) + 20 labra 20 kunjett (trab) + 20 siringa mimlijin għal-lest (solvent) + 40 labra
English: ZOSTAVAX powder for injection SC/IM
Maltese: • jekk inti infettat bl-HIV
English: Furthermore, pregnancy should be avoided for 1 month following vaccination (see section 4.6).
Maltese: Barra dan, it-tqala għandha tiġi evitata għal xahar wara li tingħata t-tilqima (ara sezzjoni 4.6).
English: Vaccine-related serious adverse reactions were reported for 0.01% subjects vaccinated with ZOSTAVAX and subjects who received placebo.
Maltese: Reazzjonijiet avversi serji marbuta mat-tilqima ġew irrappurtati f'0.01% tal-individwi mlaqqma b'ZOSTAVAX u individwi li rċivew plaċebo.
English: Adults with a history of herpes zoster (HZ) prior to vaccination ZOSTAVAX was administered to subjects 50 years of age or older with a history of herpes zoster (HZ) prior to vaccination (see section 5.1).
Maltese: ZOSTAVAX ingħata lil individwi b'età ta' 50 sena jew aktar bi storja ta' herpes zoster (HZ - herpes zoster) qabel it-tilqim (ara sezzjoni 5.1).
English: EU/1/06/341/012 - pack of 10 EU/1/06/341/013- pack of 20
Maltese: EU/1/06/341/011 EU/1/06/341/012 EU/1/06/341/013
English: Overall, among vaccinated individuals who developed zoster, ZOSTAVAX significantly reduced overall acute and chronic zoster-associated pain compared with placebo.
Maltese: Globalment fost l-individwi mlaqqmin li żviluppaw zoster, ZOSTAVAX naqqas b'mod sinifikanti luġigħ globali akut u kroniku assoċjat ma' zoster meta mqabbel mal-placebo.
English: Rarely (may affect up to 1 in 1,000 people), allergic reactions may occur.
Maltese: B'mod rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000), jistgħu jseħħu reazzjonijiet allerġiċi.
English: ZOSTAVAX significantly decreased the incidence of zoster compared with placebo (see Table 3).
Maltese: ZOSTAVAX naqqas b'mod sinifikanti l-inċidenza ta' zoster meta mqabbel ma' plaċebo (ara Tabella 3).
English: ‡ Age strata at randomisation were 60-69 and ≥70 years of age.
Maltese: Il-klassijiet tal-età meta saret l-għażla b'mod każwali kienu etajiet ta' 60-69 u ta' ≥70 sena.
English: The vaccine can be injected subcutaneously (SC) or intramuscularly (IM), preferably in the deltoid region (see sections 4.8 and 5.1).
Maltese: It-tilqima tista' tiġi injettata taħt il-ġilda (SC - subcutaneously) jew ġol-muskoli (IMintramuscularly), preferibbilment fil-parti deltoid (ara sezzjonijiet 4.8 u 5.1).
English: How to use ZOSTAVAX.
Maltese: Mhux applikabbli.
English: ZOSTAVAX was administered either subcutaneously (SC) or intramuscularly (IM) in subjects 50 years of age or older (see section 5.1).
Maltese: ZOSTAVAX ingħata taħt il-ġilda (SC) jew ġol-muskoli (IM) f'individwi b'età ta' 50 sena jew aktar (ara sezzjoni 5.1).
English: ZOSTAVAX - Powder in vial and solvent in vial - Pack of 1, 10
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA ZOSTAVAX - trab f'kunjett u solvent f'kunjett - Pakkett ta' 1, 10
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Uġigħ ta' ras1
English: The safety profile was generally similar to the Adverse Event Monitoring Substudy of the SPS.
Maltese: Il-profil ta' sigurtà kien jixbah b'mod ġenerali dak tas-Sottostudju ta' Monitoraġġ ta' Avvenimenti Avversi tal-SPS.
English: Consequently, the frequencies of these adverse reactions have been estimated based on the adverse events reported in SPS and ZEST (regardless of vaccine relationship assigned by the investigator).
Maltese: Konsegwenza ta' dan, il-frekwenzi ta' dawn ir-reazzjonijiet avversi ġew stmati abbażi tal-każijiet avversi rrappurtati f'SPS u ZEST (irrispettivament mirrelazzjoni mat-tilqima li assenja l-investigatur).
English: Clinical trials experience.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Adverse reaction terms
Maltese: U MANIFATTUR RESPONSABBLI
English: This long-lasting nerve pain is called post-herpetic neuralgia or PHN.
Maltese: Dan l-uġigħ fin-nervituri fit-tul huwa msejjaħ post-herpetic neuralgia jew PHN.