natgillin/translations-raw huggingface dataset:
Herpes zoster eller helvedesild skyldes varicellazostervirus, som er den samme virus, der forårsager skoldkopper.
Herpes zoster, or shingles, is a disease caused by the varicella-zoster virus, the same virus that causes chickenpox.
Helvedesild opstår hos personer, som tidligere i deres liv har haft skoldkopper, som regel i barndommen.
Shingles develops in people who have had chickenpox earlier in life, generally as a child.
Når man har haft skoldkopper, bliver varicellazostervirussen liggende i ” dvale ” (inaktiv) i nervesystemet.
After chickenpox, the varicella-zoster virus stays in the body, in the nervous system, in a ‘ dormant’ (inactive) state.
Patienten udvikler helvedesild, et smertefuldt blæredannende udslæt, som regel på den ene side af kroppen.
Sometimes, generally in older people, and for reasons which are not fully understood, the virus becomes active again, and the patient develops shingles, a painful, blistering rash typically in one part of the body.
Det tager som regel flere uger inden udslettet er forsvundet, og det kan medføre smerter, som kan være svære og blive ved i månedsvis (postherpetisk neuralgi) i området omkring udslættet.
The rash takes usually several weeks to clear, and afterwards, there may also be pain, which can be severe and may be lasting months (post-herpetic neuralgia) in the area where the rash was.
Risikoen for at udvikle helvedesild synes at være forbundet med et fald i den specifikke immunitet (den måde kroppen forsvarer sig selv på) mod varicellazostervirus.
The risk to develop shingles seems to be linked to a decline in the specific immunity (the way the body defends itself) against varicella-zoster virus.
ZOSTAVAX er en vaccine, der har vist sig at “ øge ” denne specifikke immunitet, som er den mekanisme, hvorved den giver beskyttelse mod helvedesild og de smerter, der er forbundet med sygdommen.
ZOSTAVAX is a vaccine that was shown to “ boost” this specific immunity, which is thought to be the mechanism by which it protects against shingles and the pain the disease is associated with.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvordan er ZOSTAVAX blevet undersøgt?
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has ZOSTAVAX been studied?
Hovedundersøgelsen af ZOSTAVAX sammenlignede lægemidlet med placebo (et narrepræparat) hos over 38 500 patienter mellem 59 og 99 år.
The main study of ZOSTAVAX compared the medicine to a placebo (a dummy vaccine) in over 38,500 patients aged between 59 and 99 years of age.
Undersøgelsen var dobbeltblind, hvilket betyder, at hverken lægen eller patienten vidste, hvilken behandling patienten havde modtaget.
The study was a double-blind trial, which means that neither the doctor nor the patient knew what treatment the patient was receiving.
Patienterne blev fulgt i 2 - 4, 5 år efter vaccinationen.
The patients were followed for 2 to 4.5 years after vaccination.
Målestokken for virkningen af ZOSTAVAX var antallet af personer, som havde fået helvedesild og postherpetiske smerter i løbet af undersøgelsesperioden.
The measure of the effectiveness of ZOSTAVAX was based on the number of people who developed shingles and post-herpetic pain during the study.
Hvilken fordel viser undersøgelserne, at der er ved ZOSTAVAX?
What benefit has ZOSTAVAX shown during the studies?
ZOSTAVAX var mere effektiv end placebo til forebyggelse af helvedesild.
ZOSTAVAX was more effective than placebo in preventing the development of shingles.
Færre udviklede helvedesild efter vaccination med ZOSTAVAX end efter at have modtaget en injektion med placebo.
Less people developed shingles after vaccination with ZOSTAVAX than after receiving a placebo injection:
315 af 19 254 patienter, som modtog lægemidlet, fik helvedesild i løbet af undersøgelsen sammenlignet med 642 af 19 247, som modtog placebo.
315 of the 19,254 patients who received the medicine had shingles during the study, against 642 of the 19,247 who received a placebo.
Hvis 1000 personer vaccineres med ZOSTAVAX, indebærer det således, at antallet af tilfælde af helvedesild i løbet af et år vil falde med 7 fra 11 til 6.
ZOSTAVAX was also more effective than placebo in its effect on post-herpetic neuralgia:
I ZOSTAVAX- gruppen fik 27 af patienterne postherpetisk neuralgi i sammenligning med 80 i placebogruppen.
27 of the ZOSTAVAX patients had post-herpetic neuralgia, against 80 in the placebo group.
Hvilken risiko er der forbundet med ZOSTAVAX?
What is the risk associated with ZOSTAVAX?
De hyppigste bivirkninger (forekom hos mindst 1 af 10 personer) i undersøgelserne var reaktioner på injektionsstedet (rødme, smerte, hævelse, kløe, varmefornemmelse og blå mærker).
In studies, the most common side effects (seen in more than 1 patient in 10) are reactions at the site of the injection (redness, pain, swelling, itching, warmth and bruising).
Den fuldstændige liste over alle de indberettede bivirkninger ved ZOSTAVAX fremgår af indlægssedlen.
For the full list of all side effects reported with ZOSTAVAX, see the Package Leaflet.
ZOSTAVAX må ikke anvendes af personer, der kan være overf' ølsomme (allergiske) over for nogen af indholdsstofferne i vaccinen, herunder neomycin (et antibiotikum).
ZOSTAVAX should not be used in people who may be hypersensitive (allergic) to any of the ingredients of the vaccine, including neomycin (an antibiotic).
Vaccinen må ikke anvendes til personer, som har problemer med deres immunsystem, enten fordi de har haft sygdomme såsom leukæmi, lymfomer, aids, eller fordi de tager medicin, som indvirker på deres immunsystem.
The vaccine should not be used in people who have problems with their immune system, either because they have a disease such as leukaemia, lymphoma, AIDS, or because they are taking medicines that affect the immune system.
Lægemidlet må heller ikke anvendes til patienter med aktiv, ubehandlet tuberkulose, eller til gravide.
It should also not be used in patients with active untreated tuberculosis and in pregnant women.
Hvorfor er ZOSTAVAX blevet godkendt?
Why has ZOSTAVAX been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved ZOSTAVAX var større end risiciene ved forebyggelse af herpeszoster (“ zoster ” eller helvedesild) og postherpetisk neuralgi) hos personer fra 60 år og derover.
The Committee for Medicinal Products for Human Use (CHMP) decided that ZOSTAVAX’ s benefits are greater than its risks for the prevention of herpes zoster (“ zoster” or shingles) and post-herpetic neuralgia in individuals from 60 years of age.
Udvalget anbefalede udstedelse af markedsføringstilladelse for ZOSTAVAX.
They recommended that ZOSTAVAX be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af ZOSTAVAX?
Which measures are being taken to ensure the safe use of ZOSTAVAX?
Firmaet, som fremstiller ZOSTAVAX, skal se på vaccinens anvendelse til patienter, som har et svækket immunsystem.
The company that makes ZOSTAVAX will look at the use of the vaccine in patients whose immune system is weakened.
Firmaet skal desuden se på varigheden af den beskyttelse, som vaccinen giver.
They will also study the duration of the protection that the vaccine gives.
Andre oplysninger om ZOSTAVAX:
Other information about ZOSTAVAX:
Europa- kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ZOSTAVAX til Sanofi Pasteur MSD SNC den 19. maj 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for ZOSTAVAX to Sanofi Pasteur MSD SNC on 19 May 2006.
Den europæiske offentlige vurderingsrapport (EPAR) for ZOSTAVA kan ses i sin helhed her.
The full EPAR for ZOSTAVAX can be found here.
Dette sammendrag blev sidst ajourført i august 2006.
This summary was last updated in 08-2006.
EU- nummer EU/ 1/ 06/ 341/ 001
EU/ 1/ 06/ 341/ 001
Særnavn Zostavax
Zostavax
Styrke > 19400 PFU Varicella - zoster- virus (levende)
> 19,400 PFU of varicella-zoster virus (Live)
Farmaceutisk form Pulver og solvens til injektionsvæske, suspension
Powder and solvent for suspension for injection
Emballage pulver: hætteglas (glas), solvens: hætteglas (glas)
powder: vial (glass); solvent: vial (glass)
Indhold 0, 65 ml
0.65 ml
> 19400 PFU Varicella - zoster- virus (levende)
> 19,400 PFU of varicella-zoster virus (Live)
pulver: hætteglas (glas), solvens: hætteglas (glas)
powder: vial (glass); solvent: vial (glass)
Pulver og solvens til injektionsvæske, suspension i en forfyldt sprøjte
Powder and solvent for suspension for injection in a pre-filled syringe
pulver: hætteglas (glas), solvens: forfyldt sprøjte (glas)
powder: vial (glass); solvent: pre-filled syringe (glass)
10 hætteglas + 10 forfyldte sprøjter uden påmonteret kanyle
10 vials + 10 pre-filled syringes without needle
20 hætteglas + 20 forfyldte sprøjter uden påmonteret kanyle
20 vials + 20 pre-filled syringes without needle
EU/ 1/ 06/ 341/ 009
EU/ 1/ 06/ 341/ 009
10 hætteglas + 10 forfyldte sprøjter + 10 separate kanyler
10 vials + 10 pre-filled syringes + 10 separate needles
1/ 2 EU/ 1/ 06/ 341/ 010
EU/ 1/ 06/ 341/ 010
20 hætteglas + 20 forfyldte sprøjter + 20 separate kanyler
20 vials + 20 pre-filled syringes + 20 separate needles
10 hætteglas + 10 forfyldte sprøjter + 20 separate kanyler
10 vials + 10 pre-filled syringes + 20 separate needles
20 hætteglas + 20 forfyldte sprøjter + 40 separate kanyler
20 vials + 20 pre-filled syringes + 40 separate needles
ZOSTAVAX pulver og solvent til injektionsvæske, suspension
ZOSTAVAX powder and solvent for suspension for injection
zostervaccine (levende)
zoster vaccine (live)
Efter rekonstitution indeholder 1 enkelt dosis (0, 65 ml):
After reconstitution, 1 dose (0.65 ml) contains:
Varicella- zoster- virus1, Oka/ Merck- stamme, (levende, attenueret) 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.
Powder and solvent for suspension for injection.
Inden rekonstitution er pulveret en hvid/ råhvid kompakt krystallinsk "prop", og solventet er en klar, farveløs væske.
Before reconstitution, the powder is a white to off-white compact crystalline plug, and the solvent is a clear, colourless fluid.
ZOSTAVAX er indiceret til forebyggelse af herpes zoster (“ zoster ” eller helvedesild) og herpes zoster - relateret postherpetisk neuralgi (PHN).
ZOSTAVAX is indicated for prevention of herpes zoster (“ zoster” or shingles) and herpes zoster-related post-herpetic neuralgia (PHN).
Vaccinationen skal gives i en enkelt dosis som en subkutan injektion.
Individuals should receive a single dose administered subcutaneously.
Behovet for en efterfølgende dosis kendes endnu ikke.
The need for a second dose is currently unknown.
Vaccinen skal injiceres SUBKUTANT, helst i deltoidea- området.
The vaccine is to be injected SUBCUTANEOUSLY, preferably in the deltoid region.
6. 6 for klargøringsanvisninger.
See section 6.6 for preparation instructions.
VACCINEN MÅ IKKE INJICERES INTRAVASKULÆRT.
DO NOT INJECT INTRAVASCULARLY.
4. 4 og 6. 1).
• Hypersensitivity to the active substance, to any of the excipients or trace residuals (e. g., neomycin) (see sections 4.4 and 6.1).
4. 4 og 4. 6).
2 • 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).
4. 3 og 6. 1).
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic/ anaphylactoid reaction following the administration of the vaccine, as there is a possibility of hypersensitivity reactions, not only to the active substances, but also to the excipients and trace residuals (e. g., neomycin) present in the vaccine (see sections 4.3 and 6.1).
4. 3 og 4. 6).
Before vaccination of women of child-bearing potential, pregnancy must be excluded and effective contraception must be used for 3 months following vaccination (see sections 4.3 and 4.6).
ZOSTAVAX er ikke indiceret til behandling af zoster eller postherpetisk neuralgi (PHN).
ZOSTAVAX is not indicated for treatment of zoster or PHN.
Hos patienter med febrile sygdomme bør det overvejes at udskyde vaccinationen.
Deferral of vaccination should be considered in the presence of fever.
Vaccination med ZOSTAVAX vil muligvis ikke beskytte alle vaccinerede.
Vaccination with ZOSTAVAX may not result in protection in all vaccine recipients.
4. 3).
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).
Smittespredning I kliniske undersøgelser af ZOSTAVAX blev der ikke rapporteret om spredning af vaccinevirus.
Transmission In clinical trials with ZOSTAVAX, transmission of the vaccine virus has not been reported.
Erfaringer efter markedsføring af varicellavacciner viser dog, at spredning af vaccinevirus i sjældne tilfælde kan forekomme mellem vaccinerede, der udvikler et varicellalignende udslæt, og modtagelige kontaktindivider (f. eks. børnebørn (spædbørn) modtagelige for Varicella zoster- virus (VZV).
However; post-marketing experience with varicella vaccines suggests that transmission of vaccine virus may occur rarely between vaccinees who develop a varicella-like rash and susceptible contacts (for example, VZV- susceptible infant grandchildren).
Spredning af vaccinevirus fra varicellavaccinerede uden et VZV- lignende udslæt er blevet rapporteret men ikke bekræftet.
Transmission of vaccine virus from varicella vaccine recipients without a varicella-zoster virus (VZV)-like rash has been reported but has not been confirmed.
Dette udgør en teoretisk risiko for vaccination med ZOSTAVAX.
This is a theoretical risk for vaccination with ZOSTAVAX.
Risikoen for at overføre attenueret vaccinevirus til modtagelige individer skal ses i forhold til risikoen for at udvikle naturlig infektion med herpes zoster, som kan spredes til disse individer.
The risk of transmitting the attenuated vaccine virus to a susceptible individual should be weighed against the risk of developing natural herpes zoster that could be transmitted to a susceptible individual.
ZOSTAVAX kan ordineres parallelt med inaktiveret influenzavaccine som separate injektioner og på et andet sted på kroppen (se pkt 5. 1).
ZOSTAVAX can be administered concomitantly with inactivated influenza vaccine as separate injections and at different body sites (see section 5.1).
3 Undersøgelser blandt gravide kvinder foreligger ikke.
There are no studies in pregnant women.
Det vides heller ikke, om ZOSTAVAX kan forårsage føtale skader ved indgivelse til gravide kvinder eller påvirker forplantningsevnen.
It is also not known whether ZOSTAVAX can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
Da ZOSTAVAX ikke er indiceret til personer under 50 år, er ZOSTAVAX ikke beregnet til at blive taget af gravide kvinder.
As ZOSTAVAX is not indicated in individuals less than 50 years of age, ZOSTAVAX is not intended to be administered to pregnant women.
4. 3 og 4. 4).
In any case, pregnancy should be avoided for three months following vaccination (see sections 4.3 and 4.4).
Det vides ikke, om VZV udskilles i human mælk.
It is not known whether VZV is secreted in human milk.
Da visse typer virus udskilles i human mælk, skal der derfor udvises forsigtighed ved vaccination med ZOSTAVAX til ammende kvinder.
Therefore, because some viruses are secreted in human milk, caution should be exercised if ZOSTAVAX is administered to a breast-feeding woman.
Der er ikke foretaget undersøgelser af indflydelsen på evnen til at føre bil eller betjene maskiner.
No studies on the effects on the ability to drive or use machines have been performed.
Sikkerheden af ZOSTAVAX er blevet vurderet i kliniske undersøgelser af mere end 20. 000 voksne.
In clinical trials, ZOSTAVAX has been evaluated for safety in more than 20000 adults.
I den mest omfattende af disse undersøgelser, Shingles Prevention Study (SPS), fik 38. 546 patienter en enkelt dosis ZOSTAVAX i den frosne formulering (n=19. 270) eller placebo (n=19. 276) og blev overvåget med henblik på sikkerhed på alle trin i undersøgelsen.
In the largest of these trials, the Shingles Prevention Study (SPS), 38546 subjects received a single dose of either the frozen formulation of ZOSTAVAX (n=19270) or placebo (n=19276) and were monitored for safety throughout the study.
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 forsøgspersoner, 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).
I en sekundær undersøgelse af uønskede hændelser (Adverse Event Monitoring Substudy) fik en undergruppe af patienter fra SPS- undersøgelsen (n=3345 modtog ZOSTAVAX og n=3271 modtog placebo) udleveret vaccinationsindberetningskort til registrering af uønskede reaktioner, der forekom fra dag 0 til dag 42 efter vaccination; disse patienter blev desuden overvåget rutinemæssigt mht. sikkerhed.
In the Adverse Event Monitoring Substudy, a subgroup of individuals from the SPS (n=3345 received ZOSTAVAX and n=3271 received placebo) were provided vaccination report cards to record adverse reactions occurring from Days 0 to 42 postvaccination in addition to undergoing routine safety monitoring throughout the study.
Følgende vaccine- relaterede 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.
Hovedparten af bivirkningerne blev rapporteret som værende af mild intensitet.
Most of these adverse reactions were reported as mild in intensity.
Adskillige bivirkninger blev rapporteret (dag 0- 4 efter vaccination); disse er angivet med *.
Several adverse reactions were solicited (Days 0-4 postvaccination) and are designated with the * symbol.
[Meget almindelig (≥1/ 10); Almindelig (≥1/ 100, < 1/ 10); Usædvanlig (≥1/ 1. 000, < 1/ 100); Sjælden (≥1/ 10. 000, < 1/ 1. 000); Meget sjælden (< 1/ 10. 000), herunder enkeltstående indberetninger]
[Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1000, < 1/ 100); Rare (≥ 1/ 10,000, < 1/ 1,000); Very rare (< 1/ 10,000) including isolated cases]
Sygdomme i nervesystemet Almindelig: hovedpine
Nervous system disorder Common: headache
Almene lidelser og reaktioner på indgivelesstedet 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
Den samlede incidens af vaccinerelaterede bivirkninger på indstiksstedet var signifikant højere for patienter vaccineret med ZOSTAVAX end for patienter, som fik placebo (48% for ZOSTAVAX og 17% for placebo).
The overall incidence of vaccine-related injection-site adverse reactions was significantly greater for subjects vaccinated with ZOSTAVAX versus subjects who received placebo (48% for ZOSTAVAX and 17% for placebo).
De øvrige deltagere i SPS- undersøgelsen blev overvåget rutinemæssigt for sikkerhed, men fik ikke udleveret indberetningskort.
4 The remainder of subjects in the SPS received routine safety monitoring, but were not provided report cards.
Typen af indberettede bivirkninger hos disse patienter svarede generelt til undergruppen af patienter i den sekundære undersøgelse.
The types of events reported in these patients were generally similar to the subgroup of patients in the Adverse Event Monitoring Substudy.
4 Inden for SPS- undersøgelsens rapporteringsperiode på 42 dage efter vaccination var antallet af rapporterede zosterlignende udslæt hos alle patienter lille (17 for ZOSTAVAX, 36 for placebo; p=0, 009).
Within the 42-day postvaccination reporting period in the SPS, the number of reported zosteriform rashes among all subjects was small (17 for ZOSTAVAX, 36 for placebo; p=0.009).
Af disse 53 patienter med zosterlignende udslæt havde 41 prøver, som var tilgængelige og egnede til PCR - analyse.
Of these 53 zosteriform rashes, 41 had specimens that were available and adequate for PCR testing.
Der blev påvist vildtype- VZV i 25 (5 for ZOSTAVAX og 20 for placebo) af disse prøver.
Wild-type VZV was detected in 25 (5 for ZOSTAVAX, 20 for placebo) of these specimens.
Oka/ Merck- stammen af VZV blev ikke påvist i nogen af disse prøver.
The Oka/ Merck strain of VZV was not detected from any of these specimens.
Inden for samme rapporteringsperiode på 42 dage efter vaccination (SPS- undersøgelsen) var antallet (n=59) af rapporterede varicellalignende udslæt også lavt.
Within the same 42-day postvaccination reporting period in the SPS, the number (n=59) of reported varicella-like rashes was also small.
Af disse patienter med varicellalignende udslæt havde 10 prøver, som var tilgængelige og egnede til PCR- analyse.
Of these varicella-like rashes, 10 had specimens that were available and adequate for PCR testing.
Der blev ikke påvist VZV i nogen af disse prøver.
VZV was not detected in any of these specimens.
I øvrige kliniske undersøgelser, til supportering af den initiale godkendelse af den frosne ZOSTAVAX - formulering, var hyppigheden af rapporterede zoster - og varicellalignende udslæt ikke relateret til injektionssted inden for 42 dage efter vaccination også lav hos både zostervaccinepatienter og placebopatienter.
In other clinical trials in support of the initial licensure of the frozen formulation of ZOSTAVAX, the reported rates of noninjection-site zosteriform and varicella-like rashes within 42 days postvaccination were also low in both zoster vaccine recipients and placebo recipients.
Af de 17 rapporterede ikke- injektionsstedsrelaterede zoster - og varicellalignende udslæt var 10 prøver tilgængelige og egnede til PCR- analyse.
Of the 17 reported noninjection-site zosteriform and varicella-like rashes, 10 specimens were available and adequate for PCR testing.
PCR- analyser af læsionsprøver identificerede Oka/ Merck- stammen hos kun to patienter, som rapporterede et varicellalignende udslæt (udbrud på hhv. dag 8 og 17).
The Oka/ Merck strain was identified by PCR analysis from the lesion specimens of only two subjects who reported varicella-like rashes (onset on Day 8 and 17).
I andre kliniske undersøgelser, som evaluerede brugen af ZOSTAVAX til voksne på 50 år eller derover, herunder et studie af parallelt ordineret inaktiveret influenzavaccine, svarede sikkerhedsprofilen generelt til profilen blandt patienter i den sekundære SPS- overvågningsundersøgelse.
In other clinical trials evaluating ZOSTAVAX in subjects 50 years of age or older, including a study of concomitantly administered inactivated influenza vaccine, the safety profile was generally similar to that seen in the Adverse Event Monitoring Substudy of the SPS.