natgillin/translations-raw huggingface dataset:
In other clinical trials evaluating ZOSTAVAX in subjects 50 years of age or older, including a study of concomitantly administered inactivated influenza vaccine, a higher rate of injection-site adverse experiences of mild-to-moderate intensity was reported among subjects 50-59 years of age compared with subjects ≥60 years of age (see section 5.1). 
V drugih kliničnih preskušanjih, v katerih so ocenjevali cepivo ZOSTAVAX pri osebah, starih 50 let ali več, vključno s študijo s sočasno uporabo inaktiviranega cepiva proti gripi, so pri osebah, starih od 50 do 59 let, poročali o večjem deležu blagih do zmernih neželenih učinkov na mestu injiciranja, kot pri osebah, starih ≥ 60 let (glejte poglavje 5.1).
Over the 6-month (acute and chronic) follow-up period, there was a 22% reduction (p =0.008) in the severity-by-duration score and a 52% (95% CI: [7 to 74%]) reduction (from 6.2% to 3.5%) in the risk of having zoster with severe and long-lasting pain (severity-by-duration score of >600). 
Med 6-mesečnim obdobjem spremljanja (akutne in kronične bolečine) je bil rezultat jakost-trajanje manjši za 22 % (p = 0,008), tveganje za pojav herpesa zostra s hudo in dolgotrajno bolečino (rezultat jakost-trajanje > 600) pa za 52 % (s 6,2 % na 3,5 %) (95-odstotni IZ: [7 do 74 %]).
Tell your doctor if you have ever had an allergic reaction to any of the ingredients (including neomycin or any of the ingredients listed under section 6) before you receive this vaccine. 
Pred prejetjem tega cepiva povejte zdravniku, če ste kadar koli imeli alergijsko reakcijo na katero koli sestavino (vključno z neomicinom ali katero koli sestavino, navedeno v poglavju 6).
The median follow-up was ~1.2 years (range is one day to 2.2 years) and ~3.9 years (range is one week to 4.75 years) in STPS and LTPS, respectively. 
Mediani čas spremljanja v študiji STPS je bil približno 1,2 leti (razpon od 1 dneva do 2,2 let), v študiji LTPS pa približno 3,9 let (razpon od enega tedna do 4,75 let).
Solvent for ZOSTAVAX 
Vehikel za ZOSTAVAX
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. 
Za akutno bolečino (bolečina 0-30 dni) ni bilo statistično pomembne razlike med skupino, ki je prejela cepivo, in skupino na placebu.
• Rare (may affect up to 1 in 1,000 people): Hives at the injection site 
• Redki (pojavijo se lahko pri največ 1 od 1.000 oseb): koprivnica na mestu injiciranja
Additional adverse reactions, spontaneously reported through post-marketing surveillance, are also included in Table 1. 
V preglednici 1 so vključeni tudi dodatni neželeni učinki, o katerih so spontano poročali med spremljanjem cepiva v obdobju trženja.
VIAL OF POWDER 
VIALA S PRAŠKOM
Table 5: Reduction of the zoster-associated pain by the BOI 
Preglednica 5: Zmanjšanje s herpesom zostrom povezanih bolečin glede na oceno BOI † v študiji
In the STPS, there were 84 evaluable zoster cases [8.4/1,000 person-years] in the ZOSTAVAX group and 95 evaluable cases [14.0/1,000 person-years] in the placebo group. 
V študiji STPS je bilo v skupini s cepivom ZOSTAVAX 84 primerov herpesa zostra, ki jih je bilo možno ovrednotiti [8,4/1.000 oseb-let], v skupini s placebom pa 95 takih primerov [14,0/1.000 oseb-let].
How to use ZOSTAVAX. 
Kako uporabljati cepivo ZOSTAVAX.
The safety and efficacy of ZOSTAVAX have not been established in adults who are known to be infected with HIV with or without evidence of immunosuppression (see section 4.3) however, a phase II safety and immunogenicity study in HIV-infected adults with conserved immune function (CD 4+T cell count ≥ 200 cells/µL) has been completed (see sections 4.8 and 5.1). 
Varnost in učinkovitost cepiva ZOSTAVAX nista bili dokazani pri odraslih, ki so okuženi z virusom HIV in imajo ali nimajo znakov oslabljenega imunskega odziva (glejte poglavje 4.3); vendar pa so izvedli študijo faze II glede varnosti in imunogenosti pri z virusom HIV okuženih odraslih z ohranjeno imunsko sposobnostjo (število CD4+ celic T ≥ 200 celic/µl) (glejte poglavji 4.8 in 5.1).
In SPS, the overall incidence of vaccine-related injection-site adverse reactions were 48% for ZOSTAVAX and 17% for placebo in subjects 60 years of age and older. 
V študiji SPS je bila skupna pojavnost s cepivom povezanih neželenih učinkov na mestu injiciranja pri osebah, starih 60 let ali več, 48 % pri cepivu ZOSTAVAX in 17 % pri placebu.
Women of child-bearing age should take the necessary precautions to avoid pregnancy for 1 month following vaccination. 
Ženske v rodni dobi morajo 1 mesec po cepljenju poskrbeti za ustrezno zaščito pred zanositvijo.
In ZEST, the overall incidence of vaccine-related injection site adverse reactions were 63.9% for ZOSTAVAX and 14.4% for placebo in subjects 50 to 59 years of age. 
V študiji ZEST je bila skupna pojavnost s cepivom povezanih neželenih učinkov na mestu injiciranja pri osebah, starih od 50 do 59 let, 63,9 % pri cepivu ZOSTAVAX in 14,4 % pri placebu.
In a double-blind, controlled clinical trial, 473 adults, 60 years of age or older, were randomised to receive a single dose of ZOSTAVAX either concomitantly (N=237), or nonconcomitantly (N=236) with 23-valent pneumococcal polysaccharide vaccine. 
V dvojno slepem, nadzorovanem kliničnem preskušanju so 473 odraslih, starih 60 let ali več, randomizirali tako, da so prejeli enkraten odmerek cepiva ZOSTAVAX in 23-valentno pnevmokokno polisaharidno cepivo sočasno (N = 237) ali ne (N = 236).
The estimated vaccine efficacy during the LTPS follow-up period was 21% (95% CI: [11 to 30%]) for zoster incidence, 35% (95% CI: [9 to 56%]) for PHN incidence and 37% (95% CI: [27 to 46%]) for zoster BOI. 
Med obdobjem spremljanja v študiji LTPS je bila ocenjena učinkovitost cepiva glede pojavnosti herpesa zostra 21 % (95-odstotni IZ: [11 do 30 %]), glede incidence PHN 35 % (95-odstotni IZ: [9 do 56 %]) ter glede BOI herpesa zostra 37 % (95-odstotni IZ: [27 do 46 %]).
For instructions on reconstitution of the medicinal product before administration see section 6.6. 
Za navodila glede rekonstitucije cepiva pred dajanjem glejte poglavje 6.6.
The VZV-specific immune responses to vaccine 6 weeks post-vaccination was comparable in the booster dose and first dose group. 
Za VZV specifični imunski odziv na cepivo je bil 6 tednov po cepljenju primerljiv v skupinah z obnovitvenim in s prvim odmerkom.
Common (≥1/100 to <1/10); 
Pogosti (≥ 1/100 do < 1/10)
The powder is a white to off-white compact crystalline plug. 
Prašek je bel do sivo-bel kompakten kristalni skupek.
The estimated vaccine efficacy during the STPS follow-up period was 40% (95% CI: [18 to 56%]) for zoster incidence, 60% (95% CI: [-10 to 87%]) for PHN incidence and 50% (95% CI: [14 to 71%]) for zoster BOI. 
Med obdobjem spremljanja v študiji STPS je bila ocenjena učinkovitost cepiva glede pojavnosti herpesa zostra 40 % (95-odstotni IZ: [18 do 56 %]), glede pojavnost PHN 60 % (95-odstotni IZ: [-10 do 87 %]) ter glede BOI herpesa zostra 50 % (95-odstotni IZ: [14 do 71 %]).
In an open-label study, ZOSTAVAX was administered as: (1) a booster dose to 201 zoster history-negative subjects 70 years of age or older who had received a first dose approximately 10 years previously as participants in the SPS, and (2) a first dose to 199 zoster history-negative subjects 70 years of age or older. 
V odprti študiji so cepivo ZOSTAVAX uporabili kot: (1) obnovitveni odmerek pri 201 osebi, stari 70 let ali več, brez herpesa zostra v anamnezi, ki je prvi odmerek cepiva prejela pred približno 10 leti kot udeleženec študije SPS in (2) prvi odmerek pri 199 osebah, starih 70 let ali več, brez herpesa zostra v anamnezi.
Table 1 presents vaccine-related injection-site and systemic adverse reactions reported at a significantly greater incidence in the vaccine group versus the placebo group within 42 days postvaccination in the ZOSTAVAX Efficacy and Safety trial (ZEST) study and in the Adverse Event Monitoring Substudy of Shingles Prevention Study (SPS). 
Preglednica 1 prikazuje s cepivom povezane neželene učinke na mestu injiciranja in sistemske neželene učinke, o katerih so v študiji ZEST (ZOSTAVAX Efficacy and Safety trial) in v podštudiji spremljanja neželenih učinkov (Adverse Event Monitoring Substudy) študije SPS (Shingles Prevention Study) v 42 dneh po cepljenju poročali z značilno večjo pojavnostjo v skupini, ki je prejela cepivo, v primerjavi s skupino, ki je prejela placebo.
Adults on chronic/maintenance systemic corticosteroids In subjects 60 years of age or older who were receiving chronic/maintenance systemic corticosteroid therapy at a daily dose equivalent of 5 to 20 mg of prednisone for at least 2 weeks prior to enrollment, and 6 weeks or more following vaccination, the safety profile was generally comparable to that seen in the Adverse Event Monitoring Substudy of the SPS (see sections 4.3 and 5.1). 
Odrasli na kroničnem/vzdrževalnem zdravljenju s sistemskimi kortikosteroidi Pri osebah, starih 60 let ali več, ki so vsaj 2 tedna pred vključitvijo in 6 tednov ali več po cepljenju prejemale kronično/vzdrževalno zdravljenje s sistemskimi kortikosteroidi v dnevnem odmerku, enakovrednem 5 do 20 mg prednizona, je bil varnostni profil na splošno podoben kot v podštudiji spremljanja neželenih učinkov študije SPS (glejte poglavji 4.3 in 5.1).
Within ZEST, immune responses to vaccination were evaluated in a random 10% subcohort (n=1,136 for ZOSTAVAX and n=1,133 for placebo) of the subjects enrolled in the ZEST. 
Preskušanje učinkovitosti in varnosti cepiva ZOSTAVAX (ZEST) V študiji ZEST so imunski odziv na cepljenje vrednotili pri naključni 10 % subkohorti (n = 1.136 za cepivo ZOSTAVAX, n = 1.133 za placebo) oseb, vključenih v ZEST.
ZOSTAVAX is indicated for immunization of individuals 50 years of age or older. 
Cepivo ZOSTAVAX je indicirano za cepljenje oseb, starih 50 let ali več.
ZOSTAVAX with solvent for reconstitution supplied in a pre-filled syringe: If two needles are provided, separate needles should be used for the reconstitution and administration of the vaccine. 
Cepivo ZOSTAVAX z vehiklom za rekonstitucijo v napolnjeni injekcijski brizgi Če sta priloženi dve igli, je treba za rekonstitucijo in za injiciranje cepiva uporabiti različni igli.
The VZV-specific immune responses to both vaccines at 4 weeks post-vaccination were similar, whether administered concomitantly or nonconcomitantly. 
Za VZV specifični imunski odziv na obe cepivi je bil 4 tedne po cepljenju podoben, ne glede na sočasno uporabo ali ne.
Powder and solvent for suspension for injection. 
prašek in vehikel za suspenzijo za injiciranje
Sucrose, hydrolysed gelatin, urea, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate monohydrate, disodium phosphate, sodium hydroxide. 
Saharoza, hidrolizirana želatina, sečnina, natrijev klorid, kalijev dihidrogenfosfat, kalijev klorid, natrijev L-glutamat monohidrat, natrijev hidrogenfosfat, natrijev hidroksid.
What is shingles? 
Kaj je pasovec?
Impaired vision occurred in 2 subjects vaccinated with ZOSTAVAX vs. 9 who received placebo. 
Do okvare vida je prišlo pri 2 osebah, ki sta bili cepljeni s cepivom ZOSTAVAX, in 9 osebah, ki so prejele placebo.
Shingles is caused by the same virus that causes chickenpox. 
Pasovec povzroča isti virus kot norice.
To reconstitute the vaccine, inject all the solvent in the pre-filled syringe into the vial of lyophilised vaccine and gently agitate to mix thoroughly. 
Pri rekonstituciji cepiva ves vehikel iz napolnjene injekcijske brizge iztisnite v vialo z liofiliziranim cepivom in z nežnim tresenjem dobro premešajte.
Vaccine-related injection-site adverse reactions were significantly greater for subjects vaccinated with ZOSTAVAX versus subjects who received placebo. 
S cepivom povezani neželeni učinki na mestu injiciranja so bili značilno pogostejši pri osebah, cepljenih s cepivom ZOSTAVAX, kot pri osebah, ki so prejele placebo.
Prevention of HZ cases with severe pain in the entire SPS study population ZOSTAVAX reduced the incidence of zoster with severe and long-lasting pain (severity-by-duration score >600) by 73% (95% CI: [46 to 87%]) compared with placebo (11 vs. 40 cases, respectively). 
Preprečevanje primerov herpesa zostra s hudo bolečino v celotni populaciji študije SPS V primerjavi s placebom je cepivo ZOSTAVAX zmanjšalo pojavnost (11 v primerjavi s 40 primeri) herpesa zostra s hudo in dolgotrajno bolečino (rezultat intenziteta-trajanje > 600) za 73 % (95-odstotni IZ: [46 do 87 %]).
Table 6: VE† of ZOSTAVAX against HZ over the study period and on average over 3 and 5 years, by age at vaccination. 
Preglednica 6: VE† cepiva ZOSTAVAX proti HZ v obdobju študije 2007 do 2014 ter povprečne vrednosti VE v obdobju 3 in 5 let, glede na starost ob cepljenju
In a double-blind, controlled clinical trial, 762 adults 50 years of age and older were randomised to receive a single dose of ZOSTAVAX administered either concomitantly (N=382) or nonconcomitantly (N=380) with inactivated split influenza vaccine. 
V dvojno slepem, nadzorovanem kliničnem preskušanju so 762 odraslih, starih 50 let in več, randomizirali tako, da so prejeli enkraten odmerek cepiva ZOSTAVAX in cepivo proti gripi sočasno (N = 382) ali ne (N = 380).
Adults with a history of herpes zoster (HZ) prior to vaccination ZOSTAVAX was administered to subjects 50 years of age or older with a history of herpes zoster (HZ) prior to vaccination (see section 5.1). 
Odrasli z anamnezo herpesa zostra (HZ) pred cepljenjem S cepivom ZOSTAVAX so cepili osebe, stare 50 let ali več, ki so imele v anamnezi herpes zoster (HZ) pred cepljenjem (glejte poglavje 5.1).
Gently agitate to dissolve completely. 
Rahlo stresajte, da se prašek popolnoma raztopi.
Subcutaneous or intramuscular use. 
subkutana ali intramuskularna uporaba Pred uporabo preberite priloženo navodilo!
Most of these adverse reactions were reported as mild in intensity. 
Večina teh neželenih učinkov je bila blagih.
Lymphadenopathy (cervical, axillary) 
Bolezni krvi in limfatičnega sistema limfadenopatija (cervikalna, aksilarna)
To reconstitute the vaccine, use the solvent provided. 
Za rekonstitucijo cepiva uporabite priloženi vehikel.
*These adverse reactions have been observed in clinical trials and through post-marketing surveillance; most of those observed in clinical trials were reported as mild in intensity. 
*Te neželene učinke so opazili v kliničnih preskušanjih in med spremljanjem cepiva v obdobju trženja.
Inject all the solvent into the vial of lyophilised vaccine. 
Ves vehikel iztisnite v vialo z liofiliziranim cepivom.
There is no information to suggest that ZOSTAVAX affects the ability to drive or use machines. 
Ni podatkov, da bi cepivo ZOSTAVAX vplivalo na sposobnost upravljanja vozil in strojev.
In a clinical study, adults 60 years of age or older received a second dose of ZOSTAVAX 42 days following the initial dose (see section 5.1). 
Odrasli, ki so prejeli dodatne odmerke/ponovno cepljenje V klinični študiji so odrasli, stari 60 let ali več, prejeli drugi odmerek cepiva ZOSTAVAX 42 dni po prvem odmerku (glejte poglavje 5.1).
ZOSTAVAX is a live, attenuated varicella-zoster vaccine and administration to individuals who are immunosuppressed or immunodeficient may result in disseminated varicella-zoster virus disease, including fatal outcomes. 
Njegova uporaba lahko pri osebah z oslabljenim ali pomanjkljivim imunskim odzivom povzroči razsejano bolezen zaradi okužbe z virusom varicella-zoster, vključno s smrtnimi izidi.
The frequency of vaccine-related adverse experiences after the second dose of ZOSTAVAX was generally similar to that seen with the first dose. 
Pogostnost neželenih učinkov, povezanih s cepivom, je bila po drugem odmerku cepiva ZOSTAVAX na splošno podobna kot po prvem odmerku.
Number of zoster confirmed cases 
Št. oseb Št. potrjenih primerov herpesa zostra
ZOSTAVAX significantly reduced the zoster pain Burden of Illness (BOI) score (see Table 5). 
Cepivo ZOSTAVAX je pomembno znižalo oceno BOI (Burden of Illness) bolečine zaradi herpesa zostra (glejte preglednico 5).
HIV-infected adults with conserved immune function In a double-blind, placebo-controlled randomised clinical trial, ZOSTAVAX was administered to HIV-infected adults (18 years of age or older; median age 49 years) on appropriate antiretroviral therapy with conserved immune function (CD4+ T cell count ≥ 200 cells/µL). 
Z virusom HIV okuženi odrasli z ohranjeno imunsko sposobnostjo V dvojno slepem, s placebom nadzorovanem randomiziranem kliničnem preskušanju so cepivo ZOSTAVAX prejeli z virusom HIV okuženi odrasli (stari 18 let ali več, mediana starost 49 let), ki so prejemali ustrezno protiretrovirusno zdravljenje in so imeli ohranjeno imunsko sposobnost (število CD4+ celic T ≥ 200 celic/µl).
Table 7: VE† of ZOSTAVAX against postherpetic neuralgia (PHN) over the study period and on average over 3 and 5 years, by age at vaccination. 
Preglednica 7: VE† cepiva ZOSTAVAX proti postherpetični nevralgiji (PHN) v obdobju študije 2007 do 2014 ter povprečne vrednosti VE v obdobju 3 in 5 let, glede na starost ob cepljenju
ZOSTAVAX - Powder in vial and solvent in vial - Pack of 1, 10 
ZOSTAVAX - prašek v viali in vehikel v viali - pakiranje po 1, 10
60 years of age and older 
60-69 let
Concurrent administration of ZOSTAVAX and anti-viral medications known to be effective against VZV has not been evaluated. 
Cepljenje s cepivom ZOSTAVAX ob sočasnem dajanju protivirusnih zdravil, ki učinkujejo proti VZV, ni bilo ocenjeno.
Table 2: Efficacy of ZOSTAVAX on zoster incidence compared with placebo in the ZEST trial in subjects 50 to 59 years of age* 
Preglednica 2: Učinkovitost cepiva ZOSTAVAX glede pojavnosti herpesa zostra v primerjavi s placebom v preskušanju ZEST pri osebah, starih od 50 do 59 let*
No subjects reported varicella-like or herpes zoster-like rashes. 
Pri nobeni osebi niso poročali o noricam ali herpesu zostru podobnem izpuščaju.
Zostavax persistence of protection 
Trajanje zaščite s cepivom Zostavax
HIV-infected adults with conserved immune function In a clinical trial, ZOSTAVAX was administered to HIV-infected adults (18 years of age or older, CD4+ T cell count ≥ 200 cells/µL) (see section 5.1). 
Z virusom HIV okuženi odrasli z ohranjeno imunsko sposobnostjo V kliničnem preskušanju so s cepivom ZOSTAVAX cepili z virusom HIV okužene odrasle (stare 18 let ali več, število celic T CD4+ ≥ 200 celic/µl) (glejte poglavje 5.1).
Subjects on chronic/maintenance systemic corticosteroids In a double-blind, placebo-controlled, randomised clinical trial, ZOSTAVAX was administered to 206 subjects 60 years of age or older who were receiving chronic/maintenance systemic corticosteroid therapy at a daily dose equivalent of 5 to 20 mg of prednisone for at least 2 weeks prior to enrollment, and 6 weeks or more following vaccination to assess the immunogenicity and safety profile of ZOSTAVAX. 
Osebe na kroničnem/vzdrževalnem zdravljenju s sistemskimi kortikosteroidi Za oceno imunogenosti in varnostnega profila cepiva ZOSTAVAX so v dvojno slepem, s placebom nadzorovanem, randomiziranem kliničnem preskušanju s cepivom ZOSTAVAX cepili 206 oseb, starih 60 let ali več, ki so vsaj 2 tedna pred vključitvijo in 6 tednov ali več po cepljenju prejemale kronično/vzdrževalno sistemsko zdravljenje s kortikosteroidi v dnevnem odmerku, enakovrednem 5 do 20 mg prednizona.
However, in-use stability has been demonstrated for 30 minutes when stored at 20 C - 25 C. 
Dokazano je bilo, da je rekonstituirano cepivo, če ga hranimo pri temperaturi 20 ºC - 25 ºC, stabilno 30 minut.
Uncommon (≥1/1,000 to <1/100); 
Občasni (≥ 1/1.000 do < 1/100)
Table 4: Efficacy of ZOSTAVAX on PHN † incidence compared with placebo in the SPS in subjects 60 years of age and older* 
Preglednica 4: Učinkovitost cepiva ZOSTAVAX glede pojavnosti PHN † v primerjavi s placebom v študiji SPS pri osebah, starih 60 let ali več*
The vaccine should be administered subcutaneously in patients with severe thrombocytopenia or any coagulation disorder (see section 4.4). 
Bolnikom s hudo trombocitopenijo ali kakršno koli motnjo strjevanja krvi je treba cepivo injicirati subkutano (glejte poglavje 4.4).
In another study, ZOSTAVAX was administered as a booster dose to HZ history-negative subjects 70 years of age or older who had received a first dose approximately 10 years previously, and as a first dose to HZ history-negative subjects 70 years of age or older (see section 5.1). 
V drugi študiji so cepivo ZOSTAVAX uporabili kot obnovitveni odmerek pri osebah, starih 70 let ali več, ki v anamnezi niso imele HZ in so prvi odmerek prejele približno 10 let prej, in kot prvi odmerek pri osebah, starih 70 let ali več, brez HZ v anamnezi (glejte poglavje 5.1).
ZOSTAVAX significantly decreased the incidence of Post-herpetic Neuralgia (PHN) compared with placebo (see Table 4). 
Cepivo ZOSTAVAX je pomembno zmanjšalo pojavnost postherpetične nevralgije (PHN) v primerjavi s placebom (glejte preglednico 4).
ZOSTAVAX should not be given to pregnant women. 
Nosečnic se s cepivom ZOSTAVAX ne sme cepiti.
Traditional non-clinical studies are insufficient with respect to reproductive toxicity (see section 5.3). 
Podatkov o uporabi cepiva ZOSTAVAX pri nosečnicah ni. Ni dovolj običajnih predkliničnih študij o škodljivem vplivu cepiva na sposobnost razmnoževanja (glejte poglavje 5.3).
When completely reconstituted, the vaccine is a semi-hazy to translucent, off-white to pale yellow liquid. 
Po rekonstituciji je cepivo pol motna do prosojna, sivo-bela do bledo rumena tekočina.
* The analysis was performed on the Modified Intent-To-Treat (MITT) population that included all subjects randomised in the study who were followed for at least 30 days post-vaccination and did not develop an evaluable case of zoster within the first 30 days post vaccination † Age strata at randomisation were 60-69 and ≥ 70 years of age 
* Analiza je bila opravljena na modificirani populaciji z-namenom-zdravljenja (MITT), ki je zajela vse osebe, ki so jih randomizirali v študijo in so jih spremljali vsaj 30 dni po cepljenju ter se jim v 30 dneh po cepljenju ni pojavil ocenljiv primer herpesa zostra.
A concurrent placebo control was not available in the LTPS; data from prior placebo recipients were used to estimate vaccine efficacy. 
Za oceno učinkovitosti cepiva so uporabili podatke od predhodnih prejemnikov placeba.
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 Summary of Product Characteristics (SmPC). 
Razen podatkov, ki so vključeni v druga poglavja Povzetka glavnih značilnosti zdravila (SmPC-ja), dodatnih predkliničnih podatkov, pomembnih za klinično varnost, ni na voljo.
• Uncommon (may affect up to 1 in 100 people): Nausea; swollen gland (neck, armpit) 
• Občasni (pojavijo se lahko pri največ 1 od 100 oseb): siljenje na bruhanje; otekle bezgavke (vratne, pazdušne)
Rare (≥1/10,000 to <1/1,000); 
Redki (≥ 1/10.000 do < 1/1.000)
The number of subjects who reported varicella/varicella-like rashes was less than 0.7% for ZOSTAVAX and placebo. 
Delež oseb, pri katerih so poročali o noricah/noricam podobnih izpuščajih, je bil manjši od 0,7 % pri cepivu ZOSTAVAX in pri placebu.
Subjects with a history of herpes zoster (HZ) prior to vaccination In a double-blind, placebo-controlled, randomised clinical trial, ZOSTAVAX was administered to 100 subjects 50 years of age or older with a history of herpes zoster prior to vaccination to assess immunogenicity and safety (see section 4.8) of ZOSTAVAX. 
Osebe z anamnezo hepesa zostra (HZ) pred cepljenjem Za oceno imunogenosti in varnosti cepiva ZOSTAVAX so v dvojno slepem, s placebom nadzorovanem, randomiziranem kliničnem preskušanju s cepivom ZOSTAVAX cepili 100 oseb, starih 50 let ali več, z anamnezo herpesa zostra pred cepljenjem (glejte poglavje 4.8).
Sucrose, hydrolysed gelatin, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate monohydrate, disodium phosphate, sodium hydroxide (to adjust pH), and urea. 
Prašek saharoza, hidrolizirana želatina, natrijev klorid, kalijev dihidrogenfosfat, kalijev klorid, natrijev L-glutamat monohidrat, natrijev hidrogenfosfat, natrijev hidroksid (za uravnavo pH) in sečnina