natgillin/translations-raw huggingface dataset:
Dog blev der i disse undersøgelser rapporteret en højere incidens af milde til moderate bivirkninger på injektionsstedet hos 50 - 59- årige sammenlignet med patienter ≥60 år (se pkt 5. 1).
However, in these trials, 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).
Data fra et klinisk forsøg (n=368) viste, at det aktuelle køleskabsnedkølede formulering generelt tåles godt med en sikkerhedsprofil, som svarer til den frosne formulering.
Data from a clinical trial (n=368) demonstrated that the current refrigerated formulation is generally well tolerated with a safety profile comparable to that of the frozen formulation.
I en dobbeltblind, placebokontrolleret, randomiseret klinisk undersøgelse, i hvilken ZOSTAVAX blev givet til 100 forsøgspersoner i alderen fra 50 år og derover med herpes zoster (HZ) i anamnesen forud for vaccination, var sikkerhedsprofilen generelt svarende til den, der sås i den sekundære undersøgelse af uønskede hændelser i SPS- undersøgelsen.
In a double-blind, placebo-controlled, randomized clinical trial, in which ZOSTAVAX was administered to 100 subjects 50 years of age or older with a history of herpes zoster (HZ) prior to vaccination, the safety profile was generally similar to that seen in the Adverse Event Monitoring Substudy of the SPS.
Baseret på begrænsede data fra 2 kliniske undersøgelser med VZV- seronegative eller lavt seropositive forsøgspersoner (27 forsøgspersoner i alderen 30 år og derover modtog levende, svækket zoster- vaccine), sås systemiske bivirkninger og reaktioner på injektionsstedet svarende til dem, der indberettedes af andre forsøgspersoner, som modtog ZOSTAVAX i kliniske undersøgelser, med 2 ud af 27 forsøgspersoner, som indberettede feber.
Based on limited data from 2 clinical trials that enrolled VZV-seronegative or low seropositive subjects (27 subjects 30 years of age or older received live attenuated zoster vaccine), injection site and systemic adverse experiences were generally similar to those reported by other subjects who received ZOSTAVAX in clinical trials, with 2 of the 27 subjects reporting fever.
Ingen forsøgspersoner indberettede varicella- lignende eller herpes zoster- lignende udslæt.
No subjects reported varicella-like or herpes zoster-like rashes.
Der bliv ikke indberettet nogen alvorlige, vaccine- relaterede bivirkninger.
No serious vaccine-related adverse experiences were reported.
Erfaring efter markedsføringen
Post-marketing Experience
I tiden efter markedsføringen har der været spontane indberetninger om følgende yderligere bivirkninger:
During post-marketing experience, the following additional adverse events have been reported spontaneously:
Almene symptomer og reaktioner på administrationsstedet: pyreksi Immunsystemet: overfølsomhedsreaktioner herunder anafylaktiske reaktioner Hud og subkutane væv: udslæt
General disorders and administration site conditions: pyrexia Immune system disorders: hypersensitivity reactions including anaphylactic reactions Skin and subcutaneous tissue disorders: rash
FARMAKOLOGISKEEGENSKABER
PHARMACOLOGICAL PROPERTIES
Virusvaccine; ATC- kode:
Viral Vaccine; ATC code:
Virkningsmekanisme Enhver, der har været inficeret med VZV, herunder personer uden varicella i den kliniske anamnese, har risiko for at udvikle zoster.
Mechanism of Action Anyone who has been infected with VZV, including those without a clinical history of varicella, is at risk for developing zoster.
ZOSTAVAX er blevet vist at fremme VZV- specifik immunitet, hvilket menes at være mekanismen med hvilken vaccinen beskytter imod zoster og imod de relaterede komplikationer.
ZOSTAVAX was shown to boost VZV-specific immunity, which is thought to be the mechanism by which it protects against zoster and its complications.
(Se Immunogenicitet).
(See Immunogenicity.)
Evaluering af klinisk effekt ved brug af ZOSTAVAX ZOSTAVAX reducerer signifikant risikoen for zoster og PHN ved sammenligning med placebo.
Evaluation of Clinical Efficacy Afforded by ZOSTAVAX ZOSTAVAX significantly reduced the risk of developing zoster and PHN compared with placebo.
Desuden reducerer ZOSTAVAX betydeligt zosterassocierede smerter som målt ved sygdomsbyrdescoren (BOI (Burden of Illness)) for HZ- smerter (se resultater og definitioner i tabel 1).
In addition, ZOSTAVAX significantly reduced zoster-associated pain as measured by the HZ pain Burden of Illness (BOI) score (see results and definition in Table 1).
Tabel 1 Effekt af ZOSTAVAX sammenlignet med placebo i Shingles Prevention undersøgelsen (SPS)
Table 1 Efficacy of ZOSTAVAX Compared with Placebo in the Shingles Prevention Study
Vaccine -
Vaccine
Endepunkt Incidens af zoster Incidens af PHN ** HZ- smerter BOI ***
Endpoint Incidence of Zoster Incidence of PHN** HZ Pain BOI***
effekt * 51% 67% 61%
efficacy* 51% 67% 61%
95% CI 44- 58% 48- 79% 51- 69%
95% CI 44 to 58% 48 to 79% 51 to 69%
* Vaccine- effekt = Relativ reduktion i endepunktsmåling i vaccinegruppen i forhold til placebogruppen ** Klinisk signifikante zosterassocierede smerter, som varede ved eller opstod mindst 90 dage efter udbrud af udslæt. *** BOI- scoren for HZ- smerter er en sammensat score, der omfatter incidensen, sværhedsgraden og varigheden af akutte og kroniske zosterassocierede smerter over en 6 måneders followup- periode.
*Vaccine efficacy = relative reduction in the endpoint measurement in the vaccine group compared with the placebo group **Clinically significant zoster-associated pain persisting or appearing at least 90 days after the onset of rash. ***The HZ pain BOI score is a composite score that incorporates the incidence, severity, and duration of acute and chronic zoster-associated pain over a 6-month follow-up period.
I SPS- undersøgelsen (Shingles Prevention Study), en placebo- kontrolleret, dobbeltblind klinisk undersøgelse af ZOSTAVAX, blev 38. 546 patienter på 60 år og derover randomiseret til at få en enkelt dosis ZOSTAVAX (n=19. 270) eller placebo (n=19. 276).
In the Shingles Prevention Study (SPS), a placebo-controlled, double-blind clinical trial of ZOSTAVAX, 38546 subjects 60 years of age or older were randomized to receive a single dose of either ZOSTAVAX (n=19270) or placebo (n=19276).
ZOSTAVAX reducerede signifikant forekomsten af zostertilfælde sammenlignet med placebobehandlingen (hhv.
ZOSTAVAX significantly decreased the incidence of zoster compared with placebo (315 [5.4/ 1000 person-years] vs.
315 [5, 4/ 1000 personår] versus 642 tilfælde [11, 1/ 1000 personår]; p < 0, 001).
642 cases [11.1/ 1000 person-years], respectively; p < 0.001).
Den beskyttende effekt af ZOSTAVAX mod zoster var 51% (95% CI:
The protective efficacy of ZOSTAVAX against zoster was 51% (95% CI:
[44- 58%]).
[44 to 58%]).
ZOSTAVAX reducerede zosterincidensen med 64% (95% CI:
ZOSTAVAX reduced the incidence of zoster by 64% (95% CI:
[56- 71%]) hos patienter på 60- 69 år og med 38% (95% CI:
[56 to 71%]) in individuals 60-69 years of age and by 38% (95% CI:
[25- 48%]) hos patienter ≥70 år.
[25 to 48%]) in individuals ≥ 70 years of age.
I SPS- undersøgelsen sås en reduktion af zostertilfælde i næsten alle dermatomer.
In the SPS, the reduction in zoster was seen in almost all dermatomes.
Zoster ophthalmicus forekom hos 35 patienter vaccineret med ZOSTAVAX versus 69 patienter, som fik placebo.
69 subjects who received placebo.
Der forekom nedsat syn hos 2 patienter vaccineret med ZOSTAVAX versus 9 patienter, som fik placebo.
Impaired vision occurred in 2 subjects vaccinated with ZOSTAVAX vs.
ZOSTAVAX reducerede PHN- incidensen sammenlignet med placebo (hhv.
9 who received placebo.
27 tilfælde [0, 5/ 1000 personår] vs.
ZOSTAVAX decreased the incidence of PHN compared with placebo [(27 cases [0.5/ 1000 person-years] vs.
80 tilfælde [1, 4/ 1000 personår]; p < 0, 001).
80 cases [1.4/ 1000 person-years], respectively; p < 0.001).
I denne undersøgelse blev PHN defineret som klinisk signifikante zosterassocierede smerter, som varede ved eller opstod mindst 90 dage efter udbrud af udslættet.
In this trial, the definition of PHN was clinically significant zoster-associated pain persisting or appearing at least 90 days after the onset of rash.
Den beskyttende effekt af ZOSTAVAX mod PHN var 67% (95% CI:
The protective efficacy of ZOSTAVAX against PHN was 67% (95% CI:
[48- 79%]).
[48 to 79%]).
Med hensyn alene til patienter, der udviklede zoster var der en reduktion i risikoen for efterfølgende udvikling af PHN.
Referring only to subjects who developed zoster, there was a decrease in the risk of subsequently developing PHN.
I vaccinegruppen var risikoen for at udvikle PHN efter zoster 9% (27/ 315) mens den i placebogruppen var
In the vaccine group, the risk of developing PHN after zoster was 9% (27/ 315), while in the placebo group it was 13% (80/ 642).
Denne effekt var mere fremtrædende i gruppen af ældre patienter (≥70 år), hvor risikoen for at udvikle PHN efter zoster blev reduceret til 10% i vaccinegruppem mod 19% i placebogruppen.
19% for the placebo group.
61% (95% CI:
ZOSTAVAX reduced the HZ pain BOI score by approximately 61% (95% CI:
[51- 69%]), sammenlignet med placebo.
[51 to 69%]), compared with placebo.
Effekten var mere udtalt i den yngre aldersgruppe (60 til 69 år), hvor effektiviteten af ZOSTAVAX på BOI- scoren for HZ- smerter var 66% sammenlignet med 55% hos patienter ≥ 70 år; denne forskel var imidlertid ikke statistisk signifikant.
The effect was more pronounced in the younger age group (60 to 69 years) where the efficacy of ZOSTAVAX on HZ pain BOI was 66% compared to 55% in patients ≥ 70 years of age; however, this difference was not statistically significant (p=0.266).
Forebyggelse af HZ- tilfælde med svære smerter i den samlede undersøgelsespopulation ZOSTAVAX reducerede incidensen af zoster med svære og langvarige smerter (sværhedsgrad- efter - varighed- score > 600) med 73% (95% CI:
Prevention of HZ cases with severe pain in the entire study population ZOSTAVAX reduced the incidence of zoster with severe and long-lasting pain (severity-by-duration score > 600) by 73% (95% CI:
[46- 87%]) sammenlignet med placebo (henholdsvis 11 versus 40 tilfælde).
40 cases, respectively).
Reduktion af sværhedsgrad- efter- varighed af zosterassocierede smerter hos vaccinerede patienter, som fik zoster For så vidt angår akutte smerter (smerter mellem 0- 30 dage), var der ingen statistisk signifikant forskel mellem vaccinegruppen og placebogruppen.
Reduction of zoster pain severity-by-duration in vaccinated individuals who developed zoster With regard to the acute pain (pain between 0-30 days) there was no statistically significant difference between the vaccine group and the placebo group.
Sværhedsgrad- efter- varighed- scoren for HZ- associerede smerter var 89 (95% CI:
The HZ pain severity-by-duration score was 89 (95%CI:
[82 til 97%]) for vaccinegruppen mod 92 (95% CI:
92 (95% CI:
[87 til 97%]) for placebogruppen.
[87 to 97%]) for the placebo group.
Den generelle anvendelse af analgetika var sammenlignelig i begge undersøgte grupper.
The overall use of analgesic medication was similar in both study groups.
Blandt vaccinerede patienter, som udviklede PHN, reducerede ZOSTAVAX PHN- associerede (kroniske) smerter signifikant i forhold til placebo.
Among vaccinated individuals who developed PHN, ZOSTAVAX significantly reduced PHN-associated (chronic) pain compared with placebo.
I perioden fra 90 dage efter udslættets udbrud til afslutningen af followup var der en reduktion på 57% i sværhedsgrad- efter- varighed- scoren (gennemsnitsscore 347 for ZOSTAVAX og 805 for placebo; p=0, 016).
In the period from 90 days after rash onset to the end of follow-up, there was a 57% reduction in the severity-by-duration score (average scores of 347 for ZOSTAVAX and 805 for placebo; p=0.016).
Blandt vaccinerede patienter, som udviklede zoster, reducerede ZOSTAVAX signifikant de generelle akutte og kroniske zosterassocierede smerter i forhold til placebo.
Among vaccinated individuals who developed zoster, ZOSTAVAX significantly reduced overall acute and chronic zoster-associated pain compared with placebo.
Inden for den 6 måneders (akutte og kroniske) followup- periode var der en 22% reduktion (p =0, 008) i sværhedsgrad- efter- varighed- scoren og en 52% (95% CI [7 til 74%]) reduktion (fra 6, 2% til 3, 5%) i risikoen for at få HZ med svære og langvarige smerter (sværhedsgrad- efter- varighed- score på > 600).
[7 to 74%]) reduction (from 6.2% to 3.5%) in the risk of having HZ with severe and long-lasting pain (severity-by-duration score of > 600).
Immunogenicitet af ZOSTAVAX I SPS- undersøgelsen blev immunresponser på vaccinen evalueret i en undergruppe af patienter i forsøget (N=1395).
Immunogenicity of ZOSTAVAX Within the Shingles Prevention Study (SPS), immune responses to vaccination were evaluated in a subset of the enrolled subjects (N=1395).
ZOSTAVAX udviste højere VZV- specifikke immunresponser 6 uger efter vaccination sammenlignet med placebo.
ZOSTAVAX elicited higher VZV-specific immune responses at 6 weeks postvaccination compared with placebo.
Der blev påvist stigninger i både VZV- antistofniveau, målt med en gpELISA - analyse (1, 7- foldig forskel, GMT på 479 versus 288 gpELISA- enheder/ ml, p < 0, 001) og i T- celleaktivitet, målt med en IFN- γ (interferon- gamma) ELISPOT- analyse for VZV (2, 2- foldig forskel, GMC på 70 versus 32 spot- formende celler pr.
288 gpELISA units/ ml, p < 0.001), and T-cell activity, measured by VZV interferon- gamma enzyme-linked immunospot (IFN-γ ELISPOT) assay (2.2-fold difference, geometric mean count [GMC] of 70 vs.
1 million mononukleære celler for perifert blod [SFC/ 106 PBMC' er], p < 0, 001).
32 spot-forming cells per million peripheral blood mononuclear cells [SFC/ 106 PBMCs], p < 0.001) were demonstrated.
Ved evaluering 4 uger efter vaccination blev immunogeniciteten af den nuværende køleskabsstabile formulering påvist at være sammenlignelig med immunogeniciteten af den tidligere frosne ZOSTAVAX - formulering.
When evaluated at 4 weeks postvaccination, the immunogenicity of the current refrigerator-stable formulation was shown to be similar to the immunogenicity of the earlier frozen formulation of ZOSTAVAX.
I en integreret analyse af to kliniske undersøgelser, der evaluerede immunresponset på ZOSTAVAX 4 uger efter vaccination, var responset generelt ensartet hos personer mellem 50 til 59 (N=389) sammenlignet med personer ≥60 år (N=731) (GMT på henholdsvis 668 versus 614 gpELISA- enheder/ ml).
614 gpELISA units/ ml, respectively).
Den geometriske middelstigning i immunrespons efter vaccination målt med gpELISA var 2, 6- foldig (95% CI: [2, 4 til 2, 9]) hos personer fra 50 til 59 år og 2, 3- foldig (95% CI: [2, 1 til 2, 4]) hos personer ≥60 år.
[2.1 to 2.4]) in subjects ≥ 60 years age.
Immunogenicitet efter samtidig indgivelse I en kontrolleret, dobbeltblindet klinisk undersøgelse, blev 762 voksne personer på 50 år eller ældre randomiseret til at modtage en enkelt dosis ZOSTAVAX enten parallelt (N=382) eller ikke- parallelt
Immunogenicity following concomitant administration In a double-blind, controlled clinical trial, 762 adults 50 years of age and older were randomized to receive a single dose of ZOSTAVAX administered either concomitantly (N=382) or nonconcomitantly (N=380) with inactivated split influenza vaccine.
Antistofresponset på begge vacciner 4 uger efter vaccinationen var tilsvarende, uanset om de blev givet parallelt eller ikke- parallelt.
The antibody responses to both vaccines at 4 weeks postvaccination were similar, whether administered concomitantly or nonconcomitantly.
4. 8).
7 Immunogenicity in subjects with a history of herpes zoster (HZ) prior to vaccination In a double-blind, placebo-controlled, randomized clinical trial, ZOSTAVAX was administered to 100 subjects 50 years of age or older with a history of herpes zoster (HZ) prior to vaccination to assess immunogenicity and safety (see section 4.8) of ZOSTAVAX.
ZOSTAVAX inducerede et signifikant højere VZV- specifikt immunrespons målt med gpELISA 4 uger efter vaccination sammenlignet med placebo (2, 1- foldig forskel (95% CI:
ZOSTAVAX induced a significantly higher VZV-specific immune response measured by gpELISA at 4 weeks postvaccination, compared with placebo (2.1-fold difference (95% CI:
[1, 5 til 2, 9]), p < 0, 001, GMT på 812 versus 393 gpELISA- enheder/ ml).
393 gpELISA units/ ml).
VZV- antistofresponser var generelt tilsvarende hos forsøgspersoner fra 50 til 59 år sammenlignet med forsøgspersoner ≥60 år.
VZV antibody responses were generally similar in subjects 50 to 59 compared to subjects ≥ 60 years of age.
Revaccination Behovet og tidspunktet for revaccination med ZOSTAVAX er endnu ikke fastlagt.
Revaccination The need for, or timing of, revaccination with ZOSTAVAX has not yet been determined.
I en placebokontrolleret, dobbeltblindet undersøgelse fik 98 voksne patienter på eller over 60 år en booster- dosis af ZOSTAVAX 42 dage efter den første dosis.
In a placebo-controlled, double-blind, study, 98 adults 60 years of age or older received a second dose of ZOSTAVAX 42 days following the initial dose; the vaccine was generally well tolerated.
Hyppigheden af vaccinerelaterede bivirkninger efter den anden dosis ZOSTAVAX svarede hovedsageligt til de bivirkninger, der blev rapporteret i forbindelse med den første vaccinedosis.
The frequency of vaccine-related adverse experiences after the second dose of ZOSTAVAX was generally similar to that seen with the first dose.
Evaluering af de farmakokinetiske egenskaber kræves ikke for vacciner.
Evaluation of pharmacokinetic properties is not required for vaccines.
Der er ikke foretaget traditionelle prækliniske undersøgelser, men ingen prækliniske forhold er vurderet relevante for den kliniske sikkerhed ud over data, der er inkluderet under andre punkter i dette produktresumé.
Traditional non-clinical studies were not performed, but there are no non-clinical concerns considered relevant to clinical safety beyond data included in other sections of the SPC.
Sakkarose Hydrolyseret gelatine Natriumchlorid Kaliumdihydrogenfosfat Kaliumchlorid Mononatrium- L- glutamat Dinatriumfosfat, vandfri Natriumhydroxid (til justering af pH) Urinstof
Sucrose Hydrolysed gelatin Sodium chloride Potassium dihydrogen phosphate Potassium chloride Monosodium L-glutamate Anhydrous disodium phosphate Sodium hydroxide (to adjust pH) Urea
8 Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette lægemiddel ikke blandes med andre lægemidler i samme sprøjte.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products in the same syringe.
Vaccinens stabilitet ved brug er dog vist at være 30 minutter, når den opbevares ved 20- 25 oC.
However, the in-use stability has been demonstrated for 30 minutes when stored at 20oC - 25oC.
Opbevares i køleskab og transporteres nedkølet (2 °C- 8 ºC).
Store and transport refrigerated (2°C - 8°C).
Pulver i hætteglas (type I- glas) med gummiprop (butylgummi) og låg (aluminium); solvent i hætteglas (type I- glas) med gummiprop (chlorbutylgummi) og låg (aluminium) i pakninger à 1 eller 10 styk.
Powder in a vial (Type I glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a vial (Type I glass) with a stopper (chlorobutyl rubber) and flip off cap (aluminium) in a pack size of 1 or 10.
Undgå kontakt med desinficerende midler.
Avoid contact with disinfectants.
Brug det vedlagte solvent til rekonstitution af vaccinen.
To reconstitute the vaccine, use the solvent provided.
Rekonstitutionsanvisninger Træk først hele indholdet i hætteglasset med solvent op i en sprøjte.
Reconstitution instructions To reconstitute the vaccine, first withdraw the entire contents of the solvent vial into a syringe.
Injicér al solventet i sprøjten i hætteglasset med frysetørret vaccine, og omryst det forsigtigt, så det blandes helt.
Inject all the solvent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly.
Træk hele mængden op i en injektionssprøjte.
Withdraw the entire contents into a syringe for injection.
DET ANBEFALES, AT VACCINEN GIVES STRAKS EFTER REKONSTITUTION FOR IKKE AT MISTE STYRKE.
IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY.
DEN REKONSTITUEREDE VACCINE SKAL BORTSKAFFES, HVIS DEN IKKE ANVENDES INDEN FOR 30 MINUTTER.
DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.
Rekonstitueret vaccine må ikke anvendes, hvis den indeholder partikler, eller hvis den har et andet udseende end beskrevet ovenfor.
The reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the vaccine differs from that described above.
Eventuelt ubrugt produkt eller affald skal bortskaffes i henhold til lokale krav.
Any unused product or waste material should be disposed of in accordance with local requirements.
9 SANOFI PASTEUR MSD, SNC 8, rue Jonas Salk F- 69007 Lyon Frankrig
SANOFI PASTEUR MSD, SNC 8, rue Jonas Salk F-69007 Lyon France
EU/ 1/ 06/ 341/ 001 EU/ 1/ 06/ 341/ 002
EU/ 1/ 06/ 341/ 001 EU/ 1/ 06/ 341/ 002
19. maj 2006
May 19, 2006
ZOSTAVAX pulver og solvent til injektionsvæske, suspension, i fyldt injektionssprøjte
ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe
Varicella- zoster- virus1, Oka/ Merck- stamme, (levende, attenueret) ≥ 19400 PFU2 1 produceret i humane diploide (MRC- 5) celler 2 PFU = Plaqueformende enheder
Varicella-zoster virus1, Oka/ Merck strain, (live, attenuated) not less than 19400 PFU2 1 produced in human diploid (MRC-5) cells 2 PFU = Plaque-forming units
Pulver og solvent til injektionsvæske, suspension, i fyldt injektionssprøjte.
Powder and solvent for suspension for injection in a pre-filled syringe.
4. 4 og 4. 6).
11 • Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukaemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/ AIDS; cellular immune deficiencies. • Immunosuppressive therapy (including high-dose corticosteroids); 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. • Active untreated tuberculosis. • Pregnancy (see sections 4.4 and 4.6).
12 Undersøgelser blandt gravide kvinder foreligger ikke.
There are no studies in pregnant women.
Det vides dog, at naturligt opstået varicella- zostervirusinfektion undertiden kan forårsage føtale skader.
However naturally-occurring varicella-zoster virus infection is known to sometimes cause foetal harm.
I løbet af undersøgelsen blev der rapporteret om vaccine- relaterede alvorlige uønskede hændelser hos 2 patienter vaccineret med ZOSTAVAX (forværring af asthma og polymyalgia rheumatica) og hos 3 patienter, som fik placebo (Goodpastures syndrom, anafylaktisk reaktion og polymyalgia rheumatica).
During the study, vaccine-related serious adverse reactions were reported for 2 subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who received placebo (Goodpasture’ s syndrome, anaphylactic reaction, and polymyalgia rheumatica).
Følgende vaccinerelaterede systemiske og injektionsstedforbundne bivirkninger blev rapporteret langt hyppigere i vaccinegruppen sammenlignet med placebogruppen.
The following vaccine-related injection-site and systemic adverse reactions were reported at a significantly greater incidence in the vaccine group versus the placebo group in the Adverse Event Monitoring Substudy.
Almene lidelser og reaktioner på indgivelsesstedet Meget almindelig: erytem, * smerte/ ømhed, * hævelse * Almindelig: hæmatom, kløe, varmefornemmelse
General disorders and administration site conditions Very common: erythema, * pain/ tenderness, * swelling* Common: haematoma, pruritus, warmth
De øvrige deltagere i SPS- undersøgelsen blev overvåget rutinemæssigt for sikkerhed, men fik ikke udleveret indberetningskort.
13 The remainder of subjects in the SPS received routine safety monitoring, but were not provided report cards.