FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not administer the vaccine intravascularly or intradermally.
Danish: Vaccinen må ikke administreres intravaskulært eller intradermalt.
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Danish: Synkope (besvimelse) kan forekomme efter, eller endda før, enhver vaccination som en psykogen reaktion på kanylestikket.
English: The use of Shingrix should be in accordance with official recommendations.
Danish: Shingrix skal anvendes i overensstemmelse med officielle anbefalinger.
English: The use of Shingrix in subjects with other confirmed or suspected immunosuppressive or immunodeficient conditions is under investigation.
Danish: Anvendelse af Shingrix til personer med andre bekræftede eller formodede immunosuppressive lidelser eller immundefektlidelser er ved at blive undersøgt.
English: You should not receive Shingrix if any of the above apply to you.
Danish: Du må ikke få Shingrix, hvis noget af ovenstående gælder for dig.
English: • After you have had chickenpox, the virus that caused it stays in your body in nerve cells.
Danish: • Når du har haft skoldkopper forbliver den virus, der forårsagede det, i kroppens nerveceller.
English: Shingrix must be reconstituted prior to administration.
Danish: Shingrix skal rekonstitueres før administration.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Danish: Dette kan ledsages af flere neurologiske tegn, såsom forbigående synsforstyrrelse, paræstesi og tonisk-kloniske bevægelser af ekstremiteter under opvågningen.
English: This facilitates the recruitment and activation of antigen presenting cells carrying gE-derived antigens in the draining lymph node, which in turn leads to the generation of gE-specific CD4+ T cells and antibodies.
Danish: Dette faciliterer rekruttering og aktivering af antigenpræsenterende celler, der bærer gE-afledte antigener i den drænende lymfeknude, hvilket igen medfører dannelse af gE-specifikke CD4+ T-celler og antistoffer.
English: • long-lasting nerve pain - called post-herpetic neuralgia or PHN.
Danish: • langvarige nervesmerter - kaldet postherpetisk neuralgi eller PHN.
English: Subjects with a history of HZ prior to vaccination
Danish: Personer med HZ i anamnesen inden vaccination
English: • Shingles is a rash with blisters that is often painful.
Danish: • Helvedesild er et udslæt med blærer, som ofte smertefuldt.
English: There are no data from the use of Shingrix in pregnant women.
Danish: Der foreligger ingen data fra anvendelse af Shingrix til gravide kvinder.
English: Pharmacotherapeutic group: Varicella zoster vaccines, ATC code: J07BK03.
Danish: Farmakoterapeutisk klassifikation: Varicella zoster-vacciner, ATC-kode: J07BK03.
English: Talk to your doctor or pharmacist before you receive Shingrix if:
Danish: Kontakt lægen eller apotekspersonalet, før du får Shingrix, hvis:
English: Shingles may lead to complications.
Danish: Helvedesild kan give komplikationer.
English: METHOD OF ADMINISTRATION Mix with adjuvant
Danish: ADMINISTRATIONSMETODE Blandes med adjuvans
English: By combining the VZV specific antigen (gE) with an adjuvant system (AS01B), Shingrix is designed to induce antigen-specific cellular and humoral immune responses in individuals with pre-existing immunity against VZV.
Danish: Via kombination af det VZV-specifikke antigen (gE) med et adjuverende system (AS01B) er Shingrix designet til at fremkalde antigenspecifikke cellulære og humorale immunresponser hos personer med eksisterende immunitet over for VZV.
English: Shingrix reminds your body about the virus that causes shingles.
Danish: Shingrix minder din krop om virussen, der forårsager helvedesild.
English: As with other vaccines, vaccination with Shingrix should be postponed in subjects suffering from an acute severe febrile illness.
Danish: Som ved andre vacciner skal vaccination med Shingrix udsættes hos personer, der lider af akut og svær febersygdom.
English: Adults aged 50-69 years may experience more side effects compared to adults aged ≥ 70 years.
Danish: Voksne i alderen 50-69 år kan få flere bivirkninger end voksne i alderen fra 70 år og derover.
English: The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied.
Danish: Indvirkningen på ammede spædbørn ved administration af Shingrix til deres mødre er ikke undersøgt.
English: A further reduction of PHN incidence in subjects with confirmed HZ could not be demonstrated due to the limited number of HZ cases in the vaccine group.
Danish: Der kunne ikke påvises en yderligere reduktion i forekomsten af PHN hos forsøgspersoner med bekræftet HZ på grund af det begrænsede antal HZ-tilfælde i vaccinegruppen.
English: Efficacy results against HZ and PHN observed in the modified Total Vaccinated Cohort (mTVC), i.e. excluding adults who did not receive the second dose of vaccine or who had a confirmed diagnosis of HZ within one month after the second dose, are presented in Table 1 and Table 2, respectively.
Danish: Virkningsresultater mod HZ og PHN observeret i den modificerede totale vaccinerede kohorte (mTVC), dvs. eksklusive voksne, som ikke fik den anden dosis af vaccinen, eller som fik en bekræftet HZ-diagnose inden for én måned efter den anden dosis, er anført i henholdsvis tabel 1 og tabel 2.
English: • you are allergic (hypersensitive) to the active substances or any of the other ingredients of this vaccine (listed in section 6).
Danish: • du er allergisk over for de aktive stoffer eller et af de øvrige indholdsstoffer i denne vaccine
English: Immunocompromised subjects
Danish: Immunkompromitterede personer
English: The immune responses to Shingrix were evaluated in a subset of subjects from the phase III efficacy studies ZOE-50 [humoral immunity and cell-mediated immunity (CMI)] and ZOE-70 (humoral immunity).
Danish: Immunresponset for Shingrix blev evalueret i en undergruppe af forsøgspersoner fra fase III-virkningsstudierne ZOE-50 [humoral immunitet og cellemedieret immunitet (CMI)] og ZOE-70 (humoral immunitet).
English: Age group (years)
Danish: Aldersgruppe (år)
English: The benefit of Shingrix in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.
Danish: Fordelen ved Shingrix til forebyggelse af PHN kan tilskrives vaccinens effekt på forebyggelse af HZ.
English: The powder and suspension should be inspected visually for any foreign particulate matter and/or variation of appearance.
Danish: Pulveret og suspensionen skal inspiceres visuelt for eventuelle fremmede partikler og/eller variationer i udseendet.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ENHEDER 1 dosis
English: Overall there was a general trend towards less severe HZ-related pain in subjects vaccinated with Shingrix compared to placebo.
Danish: Samlet set var der en generel tendens mod mindre alvorlige HZ-relaterede smerter hos forsøgspersoner, der blev vaccineret med Shingrix, sammenlignet med placebo.
English: N Number of evaluable subjects at the specified time point Q1; Q3 First and third quartiles *** The gE-specific CD4[2+] data in the ≥70 years of age group were generated in ZOE-50 because CD4+ T
Danish: N Antal evaluerbare forsøgspersoner på det specificerede tidspunkt Q1; Q3 Første og tredje kvartil *** De gE-specifikke CD4[2+]-data i aldersgruppen ≥70 år blev genereret i ZOE-50, da
English: Approximately 13,000 subjects with underlying medical conditions, including conditions associated with a higher risk of HZ, were enrolled in ZOE-50 and ZOE-70.
Danish: Ca. 13.000 forsøgspersoner med underliggende medicinske tilstande, herunder tilstande, der er forbundet med en højere risiko for HZ blev inkluderet i ZOE-50 og ZOE-70.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Shingrix in one or more subsets of the paediatric population in prevention of Varicella Zoster Virus reactivation (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Shingrix i en eller flere undergrupper af den pædiatriske population i forebyggelse af reaktivering af Varicella zoster-virus (se pkt.
English: gE-specific CD4[2+] T cell response^
Danish: gE-specifik CD4[2+] T-cellerespons^
English: Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these subjects.
Danish: Shingrix skal anvendes med forsigtighed til personer med trombocytopeni eller koagulationsforstyrrelser, da blødninger kan forekomme efter intramuskulær administration til disse personer.
English: • swollen glands in the neck, armpit or groin
Danish: • hævede kirtler i nakke, armhule eller i lysken
English: The powder and the suspension must be reconstituted prior to administration.
Danish: Pulveret og suspensionen skal rekonstitueres før administration.
English: It is not known if Shingrix affects your ability to drive or use machines.
Danish: Det er ikke kendt, om Shingrix påvirker din evne til at føre motorkøretøj eller betjene maskiner.
English: As with all vaccines, Shingrix may not fully protect all people who are vaccinated.
Danish: Som ved alle vacciner er det ikke sikkert, at Shingrix yder fuld beskyttelse til alle vaccinerede personer.
English: Anti-gE immune response^
Danish: Anti-gE-immunrespons^
English: If flexibility in the vaccination schedule is necessary, the second dose can be administered between 2 and 6 months after the first dose.
Danish: Hvis der er behov for fleksibilitet i vaccinationsprogrammet, kan den anden dosis gives mellem 2 og 6 måneder efter den første dosis.
English: * PHN was defined as zoster-associated pain rated as ≥3 (on a 0-10 scale), persisting or appearing more than 90 days after onset of zoster rash using Zoster Brief Pain Inventory (ZBPI) CI Confidence interval ** Over a median follow-up period of 4.1 years *** Over a median follow-up period of 4.0 years
Danish: * PHN blev defineret som zoster-associeret smerte vurderet til ≥ 3 (på en skala fra 0-10), vedvarende eller optrædende mere end 90 dage efter debut af zosterudslæt ifølge Zoster Brief Pain Inventory (ZBPI) CI Konfidensinterval ** Over en median opfølgningsperiode på 4,1 år *** Over en median opfølgningsperiode på 4,0 år
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1272/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1272/001
English: The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of appearance.
Danish: Den rekonstituerede vaccine skal inspiceres visuelt for eventuelle fremmede partikler og/eller variationer i udseendet.
English: Rare hypersensitivity reactions including rash, urticaria, angioedema1
Danish: Overfølsomhedsreaktioner herunder udslæt, urticaria, angioødem1
English: Shingrix contains sodium and potassium
Danish: Shingrix indeholder natrium og kalium
English: One pack of Shingrix consists of:
Danish: Én pakning Shingrix består af:
English: Shingrix cannot be used as a treatment if you already have shingles or shingles-related complications.
Danish: Shingrix kan ikke anvendes som behandling, hvis du allerede har helvedesild eller komplikationer i forbindelse med helvedesild.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Powder and suspension to be reconstituted before administration
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Pulver og suspension skal rekonstitueres før administration
English: Two phase I/II clinical studies, Zoster-001 and Zoster-015, were conducted in subjects with autologous hematopoietic stem cell transplant or HIV infection.
Danish: Der blev udført to kliniske fase I/II-studier, Zoster-001 og Zoster-015, med forsøgspersoner med autologe hæmatopoietiske stamcelletransplantationer eller hiv-infektion.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Danish: Tegnene på en allergisk reaktion kan omfatte kløende hududslæt, stakåndethed og hævelse af ansigt eller tunge.
English: Immunogenicity in subjects receiving 2 doses of Shingrix 6 months apart
Danish: Immunogenicitet hos forsøgspersoner, der får 2 doser Shingrix med 6 måneders mellemrum
English: Shingrix elicited higher gE-specific immune responses (humoral and CMI) at 1 month post-dose 2 when compared to pre-vaccination levels.
Danish: Shingrix fremkaldte højere gE-specifikke immunresponser (humoral og CMI) 1 måned efter dosis nr. 2, sammenlignet med niveauet før vaccinationen.
English: The median frequency of gE-specific CD4[2+] T cells was greater than 3.7-fold above baseline prevaccination median frequency.
Danish: Den mediane hyppighed af gE-specifikke CD4[2+] T-celler var større end 3,7 gange over den mediane baseline hyppighed før vaccinationen.
English: Fainting can occur before or after any needle injection.
Danish: Besvimelse kan forekomme før eller efter alle kanylestik.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIGE FOR BATCHFRIGIVELSE
English: The evaluated HZ-related complications were: HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease, and stroke.
Danish: De evaluerede HZ-relaterede komplikationer var: HZ-vaskulitis, dissemineret sygdom, oftalmisk sygdom, neurologisk sygdom, visceral sygdom og slagtilfælde.
English: Side effects reported after the marketing of Shingrix:
Danish: Bivirkninger rapporteret efter markedsføring af Shingrix:
English: Post-hoc analysis of efficacy against confirmed HZ undertaken in patients with common conditions (chronic kidney disease, chronic obstructive pulmonary disease, coronary artery disease, depression or diabetes mellitus), indicates that the vaccine efficacy is aligned with the overall HZ efficacy.
Danish: Post-hoc analyse af virkningen mod bekræftet HZ, der blev udført hos patienter med almindelige tilstande (kronisk nyresygdom, kronisk obstruktiv lungesygdom, koronararteriesygdom, depression eller diabetes mellitus) indikerer, at vaccines virkning er ens med den samlede HZ-effekt.
English: The need for booster doses following the primary vaccination schedule has not been established (see section 5.1).
Danish: Det er ikke klarlagt, om der er behov for boosterdoser efter det primære vaccinationsprogram (se pkt.
English: 10 vials: powder (antigen) 10 vials: suspension (adjuvant)
Danish: 10 hætteglas: pulver (antigen) 10 hætteglas: suspension (adjuvans)
English: • itching where the injection is given (pruritus)
Danish: • kløe på injektionsstedet (pruritus)
English: plant extract Quillaja saponaria Molina, fraction 21 (QS-21)
Danish: planteekstrakt Quillaja saponaria Molina, fraktion 21 (QS-21)
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår graviditet, embryo-/føtal udvikling, fødsel eller postnatal udvikling (se pkt.
English: • you have a bleeding problem or bruise easily.
Danish: • hvis du har blødningsforstyrrelser eller nemt får blå mærker.
English: 1Adverse reactions from spontaneous reporting Reporting of suspected adverse reactions
Danish: 1Bivirkninger fra spontane indberetninger
English: The median anti-gE antibody concentration was greater than 7-fold above the baseline pre-vaccination median concentration.
Danish: Den mediane anti-gE-antistofkoncentration var større end 7 gange over den mediane baselinekoncentration før vaccinationen.
English: Varicella Zoster Virus1 glycoprotein E antigen2,3
Danish: Varicella zoster-virus1 glykoprotein E-antigen2,3
English: You may be more likely to experience fever and/or shivering when 23-valent pneumococcal polysaccharide vaccine is given at the same time as Shingrix.
Danish: Du kan være mere tilbøjelig til at opleve feber og/eller rysten, når der gives en 23-valent pneumokokpolysaccharidvaccine på samme tid som Shingrix.
English: The burden-of-illness (BOI) score incorporates the incidence of HZ with the severity and duration of acute and chronic HZ-related pain over a 6 month period following rash onset.
Danish: Sygdomsbyrde-scoren (burden-of-illness (BOI)) inkorporerer forekomsten af HZ med sværhedsgraden og varigheden af akut og kronisk HZ-associeret smerte over en periode på 6 måneder efter første forekomst af udslæt.
English: You should not receive Shingrix if
Danish: Du må ikke få Shingrix, hvis
English: The safety and efficacy of Shingrix in children and adolescents have not been established.
Danish: Shingrix' sikkerhed og virkning hos børn og unge er ikke klarlagt.
English: cell activity was not assessed in ZOE-70
Danish: CD4+ T-celleaktivitet ikke blev vurderet i ZOE-70
English: If flexibility in the vaccination schedule is necessary, the second dose can be administered between 2 and 6 months after the first dose (see section 5.1).
Danish: Hvis der er behov for fleksibilitet i vaccinationsprogrammet, så kan den anden dosis administreres mellem 2 og 6 måneder efter den første dosis (se pkt.
English: Number of PHN* cases
Danish: Antal tilfælde af PHN*
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1272/001 - 1 vial and 1 vial EU/1/18/1272/002 - 10 vials and 10 vials
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1272/001 - 1 hætteglas og 1 hætteglas EU/1/18/1272/002 - 10 hætteglas og 10 hætteglas
English: The immune responses of the co-administered vaccines were unaffected, with the exception of lower geometric mean concentrations (GMCs) for one of the pertussis antigens (pertactin) when Shingrix is co-administered with the dTpa vaccine.
Danish: Immunresponset var ikke påvirket for de samtidigt administrerede vacciner, med undtagelse af lavere geometriske middelkoncentrationer (GMCs) for en af pertussis antigenerne (pertactin), når Shingrix blev administreret samtidig med dTpa vaccinen.
English: If either is observed, do not administer the vaccine.
Danish: Hvis en af delene observeres, må vaccinen ikke administreres.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: If either is observed, do not reconstitute the vaccine.
Danish: Hvis en af delene observeres, må vaccinen ikke rekonstitueres.
English: Shingrix cannot be used to prevent chickenpox (varicella).
Danish: Shingrix kan ikke anvendes til at forebygge skoldkopper (varicella).
English: • allergic reactions including rash, hives (urticaria), swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
Danish: • allergiske reaktioner herunder udslæt, nældefeber (urticaria), hævelse af ansigtet, tungen eller halsen, der kan gøre det vanskeligt at synke eller trække vejret (angioødem).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH SUSPENSION
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS MED SUSPENSION
English: Effect of Shingrix on HZ-related pain
Danish: Shingrix' effekt på HZ-relaterede smerter
English: Number of PHN cases
Danish: Antal tilfælde af PHN
English: were ≥50 years of age, received at least one dose of Shingrix, which was shown to be immunogenic and well-tolerated.
Danish: I alt 135 voksne, hvoraf 73 var ≥ 50 år, fik mindst én dosis Shingrix, som blev påvist at være immunogen og veltolereret.
English: An immunological correlate of protection has not been established; therefore the level of immune response that provides protection against HZ is unknown.
Danish: Derfor er niveauet af immunrespons, der giver beskyttelse mod HZ ikke kendt.
English: Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in adults 50 years of age or older (see section 5.1).
Danish: Shingrix er indiceret til forebyggelse af herpes zoster (HZ) og postherpetisk neuralgi (PHN), hos voksne i alderen 50 år eller ældre (se pkt.
English: For adjuvant see also section 2.
Danish: For adjuvans, se pkt.
English: Side effects reported during clinical trials with Shingrix:
Danish: Bivirkninger rapporteret i kliniske studier med Shingrix:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ENHEDER 1 dosis (0,5 ml)
English: 1 Varicella Zoster Virus = VZV 2 adjuvanted with AS01B containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms
Danish: 1 Varicella zoster-virus = VZV 2 adjuveret med AS01B indeholdende: planteekstrakt Quillaja saponaria Molina, fraktion 21 (QS-21) 50 mikrogram 3-O-desacyl-4'-monophosphoryllipid A (MPL) fra Salmonella minnesota 50 mikrogram
English: This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (39 mg) kalium pr. dosis, dvs. den er i det væsentlige kaliumfri.
English: Shingrix is available in a pack size of 1 vial of powder plus 1 vial of suspension or in a pack size of 10 vials of powder plus 10 vials of suspension.
Danish: Shingrix er tilgængelig i en pakningsstørrelse med 1 hætteglas med pulver plus 1 hætteglas med suspension eller i en pakningsstørrelse med 10 hætteglas med pulver plus 10 hætteglas med suspension.
English: There are limited data to support the use of Shingrix in individuals with a history of HZ and in frail individuals including those with multiple comorbidities (see section 5.1).
Danish: Der er begrænsede data til at understøtte brugen af Shingrix hos personer med HZ i anamnesen og svage personer, herunder patienter med flere komorbiditeter (se pkt.
English: • Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber).
Danish: • Suspension til 1 dosis i et hætteglas (type I-glas) med en prop (butylgummi).
English: What you need to know before you receive Shingrix 3.
Danish: Det skal du vide, før du får Shingrix 3.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Sundhedspersoner anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V. 4.9 Overdosering
English: Prior to immunisation
Danish: Inden vaccination
English: Table 2: Shingrix efficacy against PHN
Danish: Tabel 2: Shingrix' virkning mod PHN
English: Shingrix is a vaccine that helps to protect adults against shingles (herpes zoster) and post-herpetic neuralgia (PHN), the long-lasting nerve pain that follows shingles.
Danish: Shingrix er en vaccine, der hjælper med at beskytte voksne mod helvedesild (herpes zoster) og postherpetisk neuralgi (PHN), den langvarige nervesmerte som følger efter helvedsild.
English: In three phase III, controlled, open-label clinical studies, adults ≥ 50 years of age were randomised to receive 2 doses of Shingrix 2 months apart administered either concomitantly at the first dose or nonconcomitantly with an unadjuvanted inactivated seasonal influenza vaccine (N=828; Zoster-004), a PPV23 vaccine (N=865; Zoster-035) or a dTpa vaccine formulated with 0.3 milligrams Al3+ (N=830; Zoster-042).
Danish: I tre kontrollerede, ublindede kliniske fase III-studier blev voksne ≥ 50 år randomiseret til at modtage 2 doser Shingrix med 2 måneders mellemrum, enten administreret samtidig ved første dosis eller ikke samtidig med en ikke-adjuveret, inaktiveret sæsoninfluenzavaccine (N= 828; Zoster-004), en PPV23 vaccine (N=865; Zoster-035) eller en dTpa vaccine fremstillet med 0,3 milligram Al3+ (N=830; Zoster-042).