FrancophonIA/ELRC3.0 huggingface dataset:
English: ATP According-To-Protocol ^ Anti-gE immune response = anti-gE antibody levels, measured by anti-gE enzyme-linked immunosorbent assay (gE ELISA) * Month 3 = 1 month post-dose 2 ** Month 38 = 3 years post-dose 2
Danish: ATP i henhold til protokollen ^ Anti-gE-immunrespons = anti-gE-antistofniveauer målt med anti-gE-enzymforbundet immunosorbentanalyse (gE ELISA) * Måned 3 = 1 måned efter dosis nr. 2 ** Måned 38 = 3 år efter dosis nr. 2
English: • Powder for 1 dose in a vial
Danish: • Pulver til 1 dosis i et hætteglas
English: 50 micrograms 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms 3 glycoprotein E (gE) produced in Chinese Hamster Ovarian (CHO) cells by recombinant DNA technology
Danish: 3-O-desacyl-4'-monophosphoryllipid A (MPL) fra Salmonella minnesota 50 mikrogram 3 glykoprotein E (gE) produceret i ovarieceller fra kinesisk hamster (CHO) med rekombinant DNA-teknologi
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH POWDER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS MED PULVER
English: Animal studies do not indicate direct or indirect effects with respect to fertility in males or females (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår fertilitet hos hanner eller hunner (se pkt.
English: The immune response to Shingrix was unaffected by prior vaccination with live attenuated HZ vaccine.
Danish: Immunresponset for Shingrix var ikke påvirket af tidligere vaccination med levende svækket HZ vaccine.
English: Antigen Adjuvant
Danish: Antigen Adjuvans
English: • Sometimes, after many years, if your immune system (the body's natural defences) becomes weaker (due to age, an illness or a medicine you are taking), the virus can cause shingles.
Danish: (kroppens naturlige forsvar) svækkes (på grund af alder, en sygdom eller medicin, du tager).
English: Withdraw the entire contents of the vial containing the reconstituted vaccine into the syringe.
Danish: Træk hele indholdet af hætteglasset med den rekonstituerede vaccine op i sprøjten.
English: (≥1/10,000 to <1/1,000)
Danish: (≥1/10.000 til <1/1.000)
English: Subjects with a history of HZ were excluded from ZOE-50 and ZOE-70.
Danish: Personer med HZ i anamnesen blev udelukket fra ZOE-50 og ZOE-70.
English: Very common injection site reactions (such as pain, redness, swelling), fatigue, chills, fever
Danish: Meget almindelig reaktioner på injektionsstedet (såsom smerte, rødme, hævelse), træthed, kulderystelser, feber
English: Data from a phase II, open-label, single group, follow-up clinical study in adults ≥ 60 years (Zoster024) indicate that the vaccine-induced immune response (humoral and CMI) persists up to approximately 6 years following a 0, 2-month schedule (N= 119).
Danish: Data fra et ublindet, opfølgende klinisk fase II-studie med en enkelt gruppe voksne ≥ 60 år (Zoster024) tyder på, at det vaccinefremkaldte immunrespons (humoralt og CMI) varer ved i op til ca. 6 år efter et 0, 2-måneders-vaccinationsprogram (N= 119).
English: Table 3: Humoral immunogenicity of Shingrix in adults ≥ 50 years (ATP cohort for immunogenicity)
Danish: Tabel 3: Humoral immunogenicitet af Shingrix hos voksne ≥ 50 år (ATP-kohorte for immunogenicitet)
English: Shingrix is not indicated for prevention of primary varicella infection (chickenpox).
Danish: Shingrix er ikke indiceret til forebyggelse af primær varicella-infektion (skoldkopper).
English: Add the entire contents of the syringe into the vial containing the powder.
Danish: Tilsæt hele sprøjtens indhold til hætteglasset, der indeholder pulveret.
English: Confidence interval GMC Geometric Mean Concentration Q1; Q3 First and third quartiles
Danish: GMC Geometrisk middelkoncentration Q1; Q3 Første og tredje kvartil
English: Safety and immunogenicity data on a limited number of immunocompromised subjects with human immunodeficiency virus (HIV) or haematopoietic stem cell transplant (HCT) are available (see section 5.1).
Danish: Systemiske immunosuppressive lægemidler og immundefekt Der foreligger sikkerheds- og immunogenicitetsdata på et begrænset antal immunkompromitterede personer med humanimmundefekt virus (hiv) eller hæmatopoietisk stamcelletransplantation (HCT) (se pkt.
English: • feeling tired, chills, fever
Danish: • træthed, kulderystelser, feber.
English: • stomach and digestive complaints (including nausea, vomiting, diarrhoea and/or stomach pain)
Danish: • mave- og fordøjelsesproblemer (herunder kvalme, opkastning, diarré og/eller mavesmerter)
English: The anti-gE GMC at 1 month after the last vaccine dose was 47,758.7 mIU/ml (95% CI: 42,258.8; 53,974.4).
Danish: Anti-gE GMC 1 måned efter den sidste vaccinedosis var 47.758,7 mIU/ml (95 % CI: 42.258,8; 53.974,4).
English: • Shingles is caused by the same virus that causes chickenpox.
Danish: • Helvedesild forårsages af den samme virus, der giver skoldkopper.
English: The adverse reactions of fever and shivering were more frequent when PPV23 vaccine is coadministered with Shingrix.
Danish: Bivirkninger som feber og rysten var hyppigere, når PPV23 vaccinen blev givet samtidig med Shingrix.
English: Table 4: Cell-mediated immunogenicity of Shingrix in adults ≥ 50 years (ATP cohort for immunogenicity)
Danish: Tabel 4: Cellemedieret immunogenicitet for Shingrix hos voksne ≥ 50 år (ATP-kohorte for immunogenicitet)
English: As with other vaccines, an adequate immune response may not be elicited in these individuals.
Danish: Som for andre vacciner, opnås et beskyttende immunrespons ikke nødvendigvis hos disse personer.
English: (≥1/1,000 to <1/100)
Danish: (≥1/1.000 til <1/100)
English: ATP According-To-Protocol ^ gE-specific CD4[2+] T cell response = gE-specific CD4+ T cell activity, measured by intracellular cytokine staining (ICS) assay (CD4[2+] T cells = CD4+ T cells expressing at least 2 of 4 selected immune markers) * Month 3 = 1 month post-dose 2 ** Month 38 = 3 years post-dose 2
Danish: ATP i henhold til protokollen ^ gE-specifikt CD4[2+] T-cellerespons = gE-specifikt CD4+ T-celleaktivitet målt med intracellulært cytokin farvnings-analyse (ICS) (CD4[2+] T-celler = CD4+ T-celler, der udtrykker mindst 2 ud af 4
English: • Powder for 1 dose in a vial (type I glass) with a stopper (butyl rubber)
Danish: • Pulver til 1 dosis i et hætteglas (type I-glas) med en prop (butylgummi)
English: o Powder: Sucrose, polysorbate 80, sodium dihydrogen phosphate dihydrate, dipotassium phosphate.
Danish: o Pulver: Saccharose, polysorbat 80, natriumdihydrogenphosphatdihydrat, dikaliumphosphat.
English: Shingrix can be given with the same schedule in individuals previously vaccinated with live attenuated HZ vaccine (see section 5.1).
Danish: Shingrix kan gives med det samme program til personer, der tidligere er vaccineret med levende svækket HZ vaccine (se pkt.
English: Data in subjects ≥ 70 years of age are sourced from the pre-specified pooled analyses of ZOE-50 and ZOE
Danish: Data for personer ≥ 70 år stammer fra de præspecificerede poolede analyser af ZOE-50 og ZOE-70
English: Table 1: Shingrix efficacy against HZ
Danish: Tabel 1: Shingrix' virkning mod HZ
English: Shingrix can be given if you have already been vaccinated with a live attenuated herpes zoster vaccine.
Danish: Du kan få Shingrix, selvom du tidligere er blevet vaccineret med en levende, svækket herpes zoster vaccine.
English: • pain, redness and swelling where the injection is given
Danish: • smerter, rødme og hævelser på injektionsstedet
English: Shingrix (N=7,695) or placebo (N=7,710) administered 2 months apart, - ZOE-70 (Zoster-022): 13,900 adults ≥ 70 years were randomised to receive two doses of either Shingrix (N=6,950) or placebo (N=6,950) administered 2 months apart.
Danish: Shingrix (N=7.695) eller placebo (N=7.710), administreret med 2 måneders mellemrum, - ZOE-70 (Zoster-022): 13.900 voksne ≥ 70 år blev randomiseret til at modtage to doser af enten
English: o Suspension: Dioleoyl phosphatidylcholine, cholesterol, sodium chloride, disodium phosphate anhydrous, potassium dihydrogen phosphate and water for injections.
Danish: o Suspension: Dioleoylphosphatidylcholin, cholesterol, natriumchlorid, vandfri dinatriumphosphat, kaliumdihydrogenphosphat og vand til injektionsvæsker.
English: CI Confidence interval
Danish: Konfidensinterval
English: In a phase III, uncontrolled, open-label clinical study (Zoster-033), 96 adults ≥ 50 years of age with a physician-documented history of HZ received 2 doses of Shingrix 2 months apart.
Danish: I et ublindet, ukontrolleret, klinisk fase III-studie (Zoster-033), fik 96 voksne ≥ 50 år, med en læge-dokumenteret anamnese med HZ, 2 doser Shingrix 2 måneder fra hinanden.
English: In subjects ≥ 70 years with at least one confirmed HZ episode (ZOE-50 and ZOE-70 pooled), Shingrix significantly reduced the use and the duration of HZ-related pain medication by 39.0% (95% CI: 11.9; 63.3) and 50.6% (95% CI: 8.8; 73.2), respectively.
Danish: Hos voksne ≥ 70 år med mindst én bekræftet HZ-episode (ZOE-50 og ZOE-70 poolet), reducerede Shingrix anvendelse og varighed af HZ-relateret smertestillende medicin signifikant med henholdsvis 39,0 % (95 % CI: 11,9; 63,3) og 50,6 % (95 % CI: 8,8; 73,2).
English: Shingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant, adjuvanted)
Danish: Shingrix pulver og suspension til injektionsvæske, suspension Herpes zoster-vaccine (rekombinant, adjuveret)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant for Shingrix
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Adjuvans til Shingrix
English: After reconstitution, the vaccine should be used promptly; if this is not possible, the vaccine should be stored in a refrigerator (2°C - 8°C).
Danish: Hvis dette ikke er muligt, skal vaccinen opbevares i køleskab (2 °C - 8 °C).
English: Shingrix can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23) or reduced antigen diphtheria-tetanusacellular pertussis vaccine (dTpa).
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Shingrix kan gives samtidig med ikke-adjuveret, inaktiveret sæsoninfluenzavaccine, 23-valent pneumokokpolysaccharid vaccine (PPV23) eller reduceret antigen difteri-tetanus-acellulær pertussis vaccine (dTpa).
English: In a phase III, open-label clinical study (Zoster-026) where 238 adults ≥ 50 years of age were equally randomised to receive 2 doses of Shingrix 2 or 6 months apart, the humoral immune response following the 0, 6-month schedule was demonstrated to be non-inferior to the response with the 0, 2month schedule.
Danish: I et ublindet, klinisk fase III-studie (Zoster-026), hvor 238 voksne ≥ 50 år blev ligeligt randomiseret til at få 2 doser Shingrix med 2 eller 6 måneders mellemrum, blev det humorale immunrespons efter 0, 6måneders-vaccinationprogram demonstreret non-inferiørt til responset efter 0, 2månedersprogrammet.
English: What you need to know before you receive Shingrix
Danish: Det skal du vide, før du får Shingrix
English: The most common complication of shingles is:
Danish: Den mest almindelige komplikation ved helvedesild er:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Antigen for Shingrix
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Antigen til Shingrix i.m.
English: Median frequency (Q1; Q3)
Danish: Median hyppighed (Q1; Q3)
English: Excipients: sucrose polysorbate 80 sodium dihydrogen phosphate dihydrate dipotassium phosphate dioleoyl phosphatidylcholine cholesterol sodium chloride disodium phosphate anhydrous potassium dihydrogen phosphate water for injections
Danish: Hjælpestoffer: saccharose polysorbat 80 natriumdihydrogenphosphatdihydrat dikaliumphosphat dioleoylphosphatidylcholin cholesterol natriumchlorid dinatriumphosphat, vandfri kaliumdihydrogenphosphat vand til injektionsvæsker
English: Shingrix significantly decreased the incidence of HZ compared with placebo in subjects ≥ 50 years (6
Danish: Shingrix reducerede forekomsten af PHN signifikant i sammenligning med placebo hos voksne ≥ 50 år
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL AND 1 VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 1 HÆTTEGLAS OG 1 HÆTTEGLAS 10 HÆTTEGLAS OG 10 HÆTTEGLAS
English: 6.6 Special precautions for disposal and other handling Shingrix is presented as a vial with a brown flip-off cap containing the powder (antigen) and a vial with a blue-green flip-off cap containing the suspension (adjuvant).
Danish: 6.6 Regler for bortskaffelse og anden håndtering Shingrix fås som et hætteglas med et brunt, aftageligt låg, der indeholder pulveret (antigen) og et hætteglas med et blågrønt, aftageligt låg, der indeholder suspensionen (adjuvans).
English: In subjects with at least one confirmed HZ episode, Shingrix significantly reduced the maximum average pain score versus placebo over the entire HZ episode (mean = 3.9 vs. 5.5, P-value = 0.049 and mean = 4.5 vs. 5.6, P-value = 0.043, in subjects ≥ 50 years (ZOE-50) and ≥ 70 years (ZOE-50 and
Danish: Hos forsøgspersoner med mindst én bekræftet HZ-episode, reducerede Shingrix den maksimale gennemsnitlige smerte-score sammenlignet med placebo over hele HZ-episoden (gennemsnit = 3,9 vs. 5,5; P-værdi = 0,049 og gennemsnit = 4,5 vs. 5,6; P-værdi = 0,043 hos voksne henholdsvis ≥ 50 år (ZOE-50) og ≥ 70 år (ZOE-50 og ZOE-70 poolet)).
English: • generally feeling unwell
Danish: • generel utilpashed.
English: Laboratory confirmation of HZ cases was not part of the study procedures.
Danish: Det var ikke en del af studiets procedurer, at bekræfte HZ-tilfælde via et laboratorie.
English: The anti-gE GMC at 1 month after the last vaccine dose was 38,153.7 mIU/ml (95% CI: 34,205.8; 42,557.3) and 44,376.3 mIU/ml (95% CI: 39,697.0; 49,607.2) following the 0, 6-month schedule and the 0, 2-month schedule, respectively.
Danish: Anti-gE GMC 1 måned efter sidste vaccinedosis var 38.153,7 mIU/ml (95 % CI: 34.205,8; 42.557,3) og 44.376,3 mIU/ml (95 % CI: 39.697,0; 49.607,2), for henholdsvis 0, 6måneders-vaccinationsprogrammet og 0,2-måneders-vaccinationsprogrammet.
English: In the pooled analysis of ZOE-50 and ZOE70, Shingrix significantly reduced these HZ-related complications by 93.7% (95% CI: 59.5; 99.9) and 91.6% (95% CI: 43.3; 99.8) in adults ≥ 50 years (1 vs. 16 cases) and adults ≥ 70 years (1 vs. 12 cases), respectively.
Danish: I den poolede analyse af ZOE-50 og ZOE-70 reducerede Shingrix signifikant disse HZ-relaterede komplikationer med 93,7 % (95 % CI: 59,5; 99,9) og 91,6 % (95 % CI: 43,3; 99,8) hos henholdsvis voksne ≥ 50 år (1 vs. 16 tilfælde) og voksne ≥ 70 år (1 vs. 12 tilfælde).
English: After reconstitution, one dose (0.5 ml) contains: Varicella Zoster Virus1 glycoprotein E antigen2
Danish: Efter rekonstitution indeholder én dosis (0,5 ml): Varicella zoster-virus1 glykoprotein E-antigen2 50 mikrogram
English: The efficacy in reducing BOI was 98.4% (95% CI: 92.2; 100) in subjects ≥ 50 years (ZOE-50) and 92.1% (95% CI: 90.4; 93.8) in subjects ≥ 70 years (ZOE-50 and ZOE-70 pooled).
Danish: Virkningen på reduktion af BOI var 98,4 % (95 % CI: 92,2; 100) hos forsøgspersoner ≥ 50 år (ZOE50) og 92,1 % (95 % CI: 90,4; 93,8) hos forsøgspersoner ≥ 70 år (ZOE-50 og ZOE-70 poolet).
English: Common injection site pruritus, malaise
Danish: Almindelig pruritus på injektionsstedet, utilpashed
English: vs. 210 cases in ZOE-50) and in subjects ≥ 70 years (25 vs. 284 cases in the pooled analysis of ZOE50 and ZOE-70).
Danish: (0 vs. 18 tilfælde i ZOE-50) og hos voksne ≥ 70 år (4 vs. 36 tilfælde i den poolede analyse af ZOE-50 og ZOE-70).
English: Powder and suspension for suspension for injection 1 vial: powder (antigen)
Danish: Pulver og suspension til injektionsvæske, suspension 1 hætteglas: pulver (antigen) 1 hætteglas: suspension (adjuvans)
English: 1 Varicella Zoster Virus = VZV 2 adjuvanted with AS01B containing:
Danish: 2 adjuveret med AS01B indeholdende:
English: The reconstituted vaccine is an opalescent, colourless to pale brownish liquid.
Danish: Den rekonstituerede vaccine er en opaliserende, farveløs til lys brunlig væske.
English: ≥70 years, especially for general adverse reactions such as myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms.
Danish: Forekomsten af bivirkninger var højere hos personer i alderen 50-69 år sammenlignet med personer i alderen ≥ 70 år, især ved generelle bivirkninger som myalgi, træthed, hovedpine, kulderystelser, feber og gastrointestinale symptomer.
English: Immunogenicity in individuals previously vaccinated with live attenuated herpes zoster (HZ) vaccine In a phase III, open-label, multicentre clinical study (Zoster-048), a 2 dose schedule of Shingrix 2 months apart was assessed in 215 adults ≥ 65 years of age with a previous history of vaccination with live attenuated HZ vaccine ≥ 5 years earlier compared to 215 matched subjects who had never received live attenuated HZ vaccine.
Danish: I et ublindet, multicenter, fase III klinisk studie (Zoster-048) blev et program bestående af 2 doser Shingrix med 2 måneders mellemrum vurderet hos 215 voksne ≥ 65 år med en tidligere vaccinationshistorie med en levende svækket HZ vaccine der lå ≥ 5 år tidligere, sammenlignet med 215 matchede personer der aldrig før havde fået en levende svækket HZ vaccine.
English: Shingrix is presented as a vial with a brown flip-off cap containing the powder (antigen) and a vial with a blue-green flip-off cap containing the suspension (adjuvant).
Danish: Shingrix fås som et hætteglas med et brunt, aftageligt låg, der indeholder pulveret (antigen) og et hætteglas med et blågrønt, aftageligt låg, der indeholder suspensionen (adjuvans).
English: Shingrix significantly reduced the maximum worst pain score versus placebo over the entire HZ episode (mean = 5.7 vs. 7.0, P-value = 0.032).
Danish: Shingrix reducerede derudover den maksimale værste smerte-score for forsøgspersoner ≥ 70 år (ZOE-50 og ZOE-70 poolet) sammenlignet med placebo over hele HZ-episoden (gennemsnit = 5,7 vs. 7,0; P-værdi = 0,032) signifikant.
English: Pooled ZOE-50 and ZOE-70
Danish: Poolet ZOE-50 og ZOE-70
English: Withdraw the entire contents of the vial containing the suspension into the syringe.
Danish: Træk hele indholdet af hætteglasset med suspensionen op i sprøjten.
English: Very common (these may occur with more than 1 in 10 doses of the vaccine):
Danish: Meget almindelig (kan forekomme ved flere end 1 ud af 10 doser af vaccinen):
English: 3.8% severe/dose), myalgia (32.9% overall/dose; 2.9% severe/dose), fatigue (32.2% overall/dose;
Danish: De hyppigst rapporterede bivirkninger var smerter på injektionsstedet (68,1 % samlet/dosis; 3,8 % alvorlig/dosis), myalgi (32,9 % samlet/dosis; 2,9 % alvorlig/dosis), træthed (32,2 % samlet/dosis; 3,0 % alvorlig/dosis) og hovedpine (26,3 % samlet/dosis; 1,9 % alvorlig/dosis).
English: • Powder and suspension for suspension for injection.
Danish: • Pulver og suspension til injektionsvæske, suspension.
English: • Suspension for 1 dose in a vial
Danish: • Suspension til 1 dosis i et hætteglas.
English: Ireland GlaxoSmithKline (Ireland) Ltd
Danish: România GlaxoSmithKline (GSK) SRL
English: Other complications of shingles are:
Danish: Andre komplikationer ved helvedesild er:
English: Median fold increase of frequency vs. pre-vaccination (Q1; Q3)
Danish: Median gange stigning i hyppighed vs. pre-vaccination (Q1; Q3)
English: How to prepare Shingrix:
Danish: Sådan klargøres Shingrix:
English: • The suspension is an opalescent, colourless to pale brownish liquid.
Danish: • Suspensionen er en opaliserende, farveløs til lys brunlig væske.
English: Median fold increase of concentrations vs. prevaccination (Q1; Q3)
Danish: Median gange stigning i koncentration vs. pre-vaccination (Q1; Q3)
English: After reconstitution, 1 dose (0.5 ml) contains 50 micrograms of recombinant Varicella Zoster Virus glycoprotein E adjuvanted with AS01B
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Efter rekonstitution indeholder 1 dosis (0,5 ml) 50 mikrogram rekombinant Varicella zoster-virus glykoprotein E, adjuveret med AS01B
English: Adjuvant
Danish: Adjuvans
English: Shingrix significantly decreased the incidence of PHN compared with placebo in adults ≥ 50 years (0 vs. 18 cases in ZOE-50) and in adults ≥ 70 years (4 vs. 36 cases in the pooled analysis of ZOE-50 and
Danish: Shingrix reducerede forekomsten af HZ signifikant i sammenligning med placebo hos forsøgspersoner ≥ 50 år (6 vs. 210 tilfælde i ZOE-50) og hos forsøgspersoner ≥ 70 år (25 vs. 284 tilfælde i den poolede analyse af ZOE-50 og ZOE-70).
English: Potassium dihydrogen phosphate
Danish: Natriumdihydrogenphosphatdihydrat Dikaliumphosphat
English: 4.7 Effects on ability to drive and use machines No studies on the effects of Shingrix on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier om virkningen af Shingrix på evnen til at føre motorkøretøj og betjene maskiner.
English: Pooled ZOE-50 and ZOE-70***
Danish: Poolet ZOE-50 og ZOE-70***
English: The suspension is an opalescent, colourless to pale brownish liquid.
Danish: Suspensionen er en opaliserende, farveløs til lys brunlig væske.
English: Immunogenicity of Shingrix
Danish: Shingrix' immunogenicitet
English: Pooled ZOE-50 and ZOE-70**
Danish: Poolet ZOE-50 og ZOE-70**
English: In the fourth year after vaccination, the efficacy against HZ was 93.1 % (95% CI: 81.2; 98.2) and 87.9% (95% CI: 73.3; 95.4) in adults ≥ 50 years and adults ≥ 70 years, respectively.
Danish: I det fjerde år efter vaccination var virkningen mod HZ 93,1 % (95 % CI: 81,2; 98,2) og 87,9 % (95 %
English: Very common gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain)
Danish: Meget almindelig gastrointestinale symptomer (inklusive kvalme, opkastning, diarré og/eller abdominalsmerter) Knogler, led, muskler og bindevæv Meget almindelig myalgi Ikke almindelig artralgi
English: Efficacy of Shingrix
Danish: Shingrix' virkning
English: What is in this leaflet
Danish: Hvad er helvedesild
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Danish: Sjælden (kan forekomme ved op til 1 ud af 1.000 doser af vaccinen):
English: Uncommon lymphadenopathy
Danish: Ikke almindelig lymfadenopati
English: Common (these may occur with up to 1 in 10 doses of the vaccine):
Danish: Almindelig (kan forekomme ved op til 1 ud af 10 doser af vaccinen):
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription, or have recently received any other vaccine.
Danish: Brug af anden medicin sammen med Shingrix Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Danish: Som det er tilfældet for alle vacciner, er det ikke sikkert, at alle vaccinerede personer opnår et tilstrækkeligt immunrespons.
English: CONDITIONS OR RESTRICTIONS REGARDING SYPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING
English: - ZOE-50 (Zoster-006): 15,405 adults ≥ 50 years were randomised to receive two doses of either
Danish: I to placebokontrollerede, observatørblindede fase III-studier af Shingrix' virkning: - ZOE-50 (Zoster-006): 15.405 voksne ≥ 50 år blev randomiseret til at modtage to doser af enten
English: How Shingrix works
Danish: Sådan virker Shingrix
English: CONDITIONS FOR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Uncommon (these may occur with up to 1 in 100 doses of vaccine)
Danish: Ikke almindelig (kan forekomme ved op til 1 ud af 100 doser af vaccinen):
English: Slovenija GlaxoSmithKline d.o.o.
Danish: Hrvatska GlaxoSmithKline d.o.o.
English: Suspension (AS01B Adjuvant System):
Danish: Suspension (AS01B adjuverende system): Dioleoylphosphatidylcholin Cholesterol
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you receive Shingrix.
Danish: Kontakt lægen eller apotekspersonalet, før du får Shingrix, hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl).