FrancophonIA/ELRC3.0 huggingface dataset:
English: As these events are reported voluntarily from a population of uncertain size, it is not possible to reliably calculate their frequency or establish a causal relationship to vaccine exposure.
Croatian: Budući da su prijave tih događaja zaprimljene iz populacije neodređene veličine, nije moguće pouzdano procijeniti njihovu učestalost ili ustanoviti uzročno-posljedični odnos s izloženošću cjepivu.
English: Vaccine efficacy (95% CI)
Croatian: Djelotvornost cjepiva (95% CI)
English: What ZOSTAVAX is and what it is used for What you need to know before you receive ZOSTAVAX How to use ZOSTAVAX
Croatian: Što je ZOSTAVAX i za što se koristi Što morate znati prije nego primite ZOSTAVAX Kako primjenjivati ZOSTAVAX Moguće nuspojave
English: The vaccine should under no circumstances be injected intravascularly.
Croatian: Cjepivo se ni u kojem slučaju ne smije injicirati intravaskularno.
English: Sometimes, after many years, the virus becomes active again and causes shingles.
Croatian: Ponekad, nakon mnogo godina, virus se može aktivirati i prouzročiti herpes zoster.
English: ZOSTAVAX can be administered at the same time as inactivated influenza vaccine.
Croatian: ZOSTAVAX se može primijeniti istodobno s inaktiviranim cjepivom protiv gripe.
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine; ATC code: J07BK02
Croatian: Farmakoterapijska skupina: cjepiva, virusno cjepivo; ATK oznaka: J07BK02
English: After reconstitution, use immediately or within 30 minutes if stored at 20°C-25°C.
Croatian: Nakon pripreme, primijeniti odmah ili u roku od 30 minuta ako se čuva na temperaturi od 20°C do 25°C.
English: See sections 4.8 and 5.1.
Croatian: Vidjeti dijelove 4.8 i 5.1.
English: ZOSTAVAX should not be given to pregnant women.
Croatian: ZOSTAVAX se ne smije dati trudnicama.
English: There is no relevant use of ZOSTAVAX in children and adolescents for prevention of primary varicella infection (chickenpox).
Croatian: Nema relevantne primjene cjepiva ZOSTAVAX u djece i adolescenata za prevenciju primarne infekcije virusom varicella (vodenih kozica).
English: The European Medicines Agency has waived the obligation to submit the results of studies with ZOSTAVAX in all the subsets of paediatric population (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja cjepiva ZOSTAVAX u svim podskupinama pedijatrijske populacije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Immunocompromised subjects The vaccine has not been studied in subjects with impaired immunity.
Croatian: Imunokompromitirani ispitanici Cjepivo nije ispitano u osoba s oslabljenim imunitetom.
English: For information about the administration of ZOSTAVAX and pneumococcal polysaccharide vaccine at the same time, talk to your doctor or health care provider.
Croatian: Za informacije o istodobnoj primjeni cjepiva ZOSTAVAX i pneumokoknog polisaharidnog cjepiva, upitajte svog liječnika ili drugog zdravstvenog radnika.
English: Traditional non-clinical studies are insufficient with respect to reproductive toxicity (see section 5.3).
Croatian: Tradicionalna neklinička ispitivanja su nedostatna za konačan zaključak o reproduktivnoj toksičnosti (vidjeti dio 5.3).
English: What ZOSTAVAX looks like and contents of the pack
Croatian: Kako ZOSTAVAX izgleda i sadržaj pakiranja
English: • if you are allergic (hypersensitive) to any of the components of this vaccine (including neomycin or any of the other ingredients listed in section 6)
Croatian: • ako ste alergični (preosjetljivi) na neki od sastojaka ovog cjepiva (uključujući neomicin ili neki drugi sastojak naveden u dijelu 6.)
English: If you have experienced any of the following, talk to your doctor or pharmacist before receiving ZOSTAVAX:
Croatian: Ako ste imali išta od sljedećeg, obratite se svom liječniku ili ljekarniku prije nego primite ZOSTAVAX:
English: Most of the reporting rashes that were VZV positive by PCR analysis were associated with wild-type VZV.
Croatian: Većina prijavljenih osipa koji su PCR analizom bili VZV pozitivni povezana je s divljim tipom VZV-a.
English: After you have had chickenpox, the virus that caused it stays in your body in nerve cells.
Croatian: Nakon što prebolite vodene kozice, virus koji ih je prouzročio ostaje u živčanim stanicama u Vašem tijelu.
English: It is recommended that the vaccine be administered immediately after reconstitution to minimise loss of potency.
Croatian: Preporučuje se primijeniti cjepivo odmah nakon rekonstitucije kako bi se gubitak potentnosti smanjio na najmanju moguću mjeru.
English: ZOSTAVAX is available in packs of 1, 10 or 20 with or without needles.
Croatian: ZOSTAVAX je dostupan u pakiranjima od 1, 10 ili 20 sa ili bez igala.
English: 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).
Croatian: Nisu provedena tradicionalna neklinička ispitivanja, ali nema nekliničkih razloga za zabrinutost koji bi se smatrali važnima za kliničku sigurnost, osim podataka navedenih u drugim dijelovima ovog sažetka opisa svojstava lijeka.
English: Manufacturer: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Croatian: Proizvođač: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, Nizozemska
English: In the LTPS, there were 263 evaluable zoster cases reported among 261 patients [10.3/1000 person-years].
Croatian: U podispitivanju LTPS moglo se procijeniti 263 slučaja herpes zostera prijavljenih u 261 bolesnika [10,3/1000 osoba-godina].
English: Final determination of zoster cases was made by Polymerase Chain Reaction (PCR) [86%], or in the absence of virus detection, as determined by a clinical evaluation committee [14%].
Croatian: Polymerase Chain Reaction, PCR) [86%] ili ih je, u slučaju da virus nije otkriven, ustanovio odbor za kliničku procjenu [14%].
English: This long-lasting nerve pain is called post-herpetic neuralgia or PHN.
Croatian: Ova dugotrajna neuropatska bol zove se postherpetična neuralgija ili PHN.
English: Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
Croatian: Kao i sva cjepiva i lijekovi, ovo cjepivo može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: See also section 3.
Croatian: Vidjeti također dio 3.
English: • Pregnancy.
Croatian: • Trudnoća.
English: Women of child-bearing age should take the necessary precautions to avoid pregnancy for 1 month following vaccination.
Croatian: Žene reproduktivne dobi moraju primjenjivati potrebne mjere opreza kako bi izbjegle trudnoću tijekom 1 mjeseca nakon cijepljenja.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: https://www.ema.europa.eu.
English: • if you have active untreated tuberculosis
Croatian: • ako imate aktivnu neliječenu tuberkulozu
English: In the SPS, the reduction in zoster was seen in almost all dermatomes.
Croatian: U ispitivanju SPS, smanjenje herpes zostera opaženo je u gotovo svim dermatomima.
English: Consequently, the frequencies of these adverse reactions have been estimated based on the adverse events reported in SPS and ZEST (regardless of vaccine relationship assigned by the investigator).
Croatian: Stoga je učestalost tih nuspojava procijenjena na temelju nuspojava prijavljenih u ispitivanjima SPS i ZEST (bez obzira na povezanost s cjepivom, koju je odredio ispitivač).
English: A total of 48,889 confirmed HZ cases and 3,316 confirmed PHN cases (>90 days of zoster-associated pain) were observed.
Croatian: Opaženo je ukupno 48 889 slučajeva potvrđenog herpes zostera i 3316 slučajeva potvrđenog PHN-a (>90 dana boli povezane s herpes zosterom).
English: Clinical trials experience.
Croatian: Iskustvo tijekom kliničkih ispitivanja.
English: Necrotizing retinitis (patients on immunosuppressive therapy)
Croatian: Poremećaji oka nekrotizirajući retinitis (bolesnici na imunosupresivnoj terapiji)
English: ZOSTAVAX Efficacy and Safety Trial (ZEST) in subjects 50 to 59 years of age:
Croatian: Ispitivanje djelotvornosti i sigurnosti cjepiva ZOSTAVAX (ZEST) u ispitanika u dobi od 50 do 59 godina:
English: Abbreviations: VE denotes vaccine effectiveness; CI confidence interval; DxCG diagnostic cost group; HCUP healthcare cost and utilization project
Croatian: Kratice: VE (engl. vaccine effectiveness), učinkovitost cjepiva; CI (engl. confidence interval), interval pouzdanosti; DxCG (engl. diagnostic cost group), skupina po dijagnostičkom trošku; HCUP (engl. healthcare cost and utilization project), projekt cijene i potrošnje zdravstvenih usluga
English: In the event of either being observed, discard the vaccine.
Croatian: U slučaju da se to opazi, cjepivo bacite.
English: What ZOSTAVAX contains
Croatian: Što ZOSTAVAX sadrži
English: The data do not indicate that concomitant administration alters the effectiveness of ZOSTAVAX.
Croatian: Podaci ne ukazuju da istodobna primjena mijenja učinkovitost cjepiva ZOSTAVAX.
English: However, in-use stability has been demonstrated for 30 minutes when stored at 20 C - 25 C.
Croatian: Međutim, dokazana stabilnost u primjeni je 30 minuta ako se čuva na temperaturi od 20°C-25°C.
English: This is a theoretical risk for vaccination with ZOSTAVAX.
Croatian: To je teoretski rizik kod cijepljenja cjepivom ZOSTAVAX.
English: Store and transport refrigerated (2 C - 8 C).
Croatian: Čuvati i prevoziti na hladnom (2C-8C).
English: Do not receive ZOSTAVAX
Croatian: Nemojte primiti ZOSTAVAX
English: Most of these local and systemic adverse reactions were reported as mild in intensity.
Croatian: Većina tih prijavljenih lokalnih i sistemskih nuspojava bila je blagog intenziteta.
English: As with many vaccines, ZOSTAVAX may not completely protect all persons who are vaccinated.
Croatian: Kao i mnoga cjepiva, ZOSTAVAX možda neće pružiti potpunu zaštitu svim osobama koje se cijepe.
English: ZOSTAVAX should be injected under the skin or into the muscle, preferably in the upper arm.
Croatian: ZOSTAVAX treba ubrizgati pod kožu ili u mišić, po mogućnosti u nadlakticu.
English: Reconstitution instructions
Croatian: Upute za rekonstituciju
English: Solicited adverse reaction within 5 days post-vaccination.
Croatian: Prijavljena nuspojava unutar 5 dana nakon cijepljenja.
English: No serious vaccine-related adverse experiences were reported.
Croatian: Nije bilo prijavljenih ozbiljnih nuspojava povezanih s cjepivom.
English: 286 subjects received two doses and 9 subjects received only one dose.
Croatian: 286 ispitanika primilo je dvije doze, dok je 9
English: In any case, pregnancy should be avoided for one month following vaccination (see section 4.3).
Croatian: U svakom slučaju, trudnoću treba izbjegavati jedan mjesec nakon cijepljenja (vidjeti dio 4.3).
English: The majority of rashes have been rated as mild to moderate; no complications from rash have been observed in the clinical setting.
Croatian: Većina osipa bila je ocjenjena kao blagi do umjereni; komplikacije od osipa nisu opažene u kliničkom okruženju.
English: Furthermore, pregnancy should be avoided for 1 month following vaccination (see section 4.6).
Croatian: Štoviše, trudnoću treba izbjegavati jedan mjesec nakon cijepljenja (vidjeti dio 4.6).
English: Within SPS, immune responses to vaccination were evaluated in a subset of the enrolled subjects (N=1395).
Croatian: U sklopu ispitivanja SPS procijenio se imunološki odgovor na cijepljenje u jednoj podskupini uključenih ispitanika (N=1395).
English: The adjusted hazard ratio comparing the incidence rate of HZ in the two groups was 1.04 (95% CI, 0.92, 1.16) over a median follow-up of 4.7 years.
Croatian: Prilagođen omjer hazharda koji uspoređuje stopu incidencije herpes zostera u ove dvije skupine iznosio je 1,04 (95% CI, 0,92; 1,16) tijekom medijana praćenja od 4,7 godina.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove https://www.ema.europa.eu
English: 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).
Croatian: U cijepljenoj skupini, rizik od razvoja PHN-a nakon herpes zostera bio je 9% (27/315), dok je u skupini koja je primila placebo iznosio 13% (80/642).
English: The following side effects have been observed:
Croatian: Opažene su sljedeće nuspojave:
English: Gently agitate to dissolve completely.
Croatian: Nježno protresite da se potpuno otopi.
English: The risk of transmitting the attenuated vaccine virus from a vaccinee to a susceptible contact should be weighed against the risk of developing natural zoster and potentially transmitting wild-type VZV to a susceptible contact.
Croatian: Rizik od prijenosa virusa iz atenuiranog cjepiva s cijepljene osobe na osjetljivu osobu prilikom kontakta treba procijeniti u odnosu na rizik od razvoja prirodnog zostera i mogućeg prijenosa divljeg tipa virusa varicella-zoster na osjetljivu osobu prilikom kontakta.
English: *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.
Croatian: *Ove su nuspojave opažene u kliničkim ispitivanjima i tijekom praćenja nakon stavljanja cjepiva u promet; većina nuspojava koje su bile opažene u kliničkim ispitivanjima bila je blagog intenziteta.
English: After reconstitution, 1 dose (0.65 mL) contains:
Croatian: Nakon rekonstitucije, 1 doza (0,65 ml) sadrži:
English: Subcutaneous or intramuscular use.
Croatian: Za supkutanu ili intramuskularnu primjenu.
English: 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).
Croatian: U jednom kliničkom ispitivanju, odrasli u dobi od 60 godina ili stariji primili su drugu dozu cjepiva ZOSTAVAX 42 dana nakon prve doze (vidjeti dio 5.1).
English: Subjects with severe thrombocytopenia or any other coagulation disorder were excluded.
Croatian: Ispitanici s teškom trombocitopenijom ili nekim drugim poremećajem koagulacije bili su isključeni.
English: During the course of the STPS, placebo recipients were offered ZOSTAVAX, at which time they were considered to have completed the STPS.
Croatian: Tijekom trajanja podispitivanja STPS, ispitanicima koji su bili primili placebo bio je ponuđen ZOSTAVAX, u vrijeme kad se smatralo da su završili s podispitivanjem STPS.
English: However, ZOSTAVAX is expected to have no or negligible influence on ability to drive and use machines.
Croatian: Međutim, očekuje se da ZOSTAVAX neće utjecati ili će zanemarivo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: In subjects who developed zoster, ZOSTAVAX decreased the risk of subsequently developing PHN.
Croatian: U ispitanika koji su razvili herpes zoster ZOSTAVAX je smanjio rizik kasnijeg razvoja PHN-a.
English: Fertility ZOSTAVAX has not been evaluated in fertility studies.
Croatian: Plodnost ZOSTAVAX nije procijenjen u ispitivanjima plodnosti.
English: The VZV-specific immune responses following Doses 1 and 2 were similar (see section 4.3).
Croatian: Specifični imunološki odgovori protiv virusa varicella-zoster nakon 1. i 2. doze bili su slični (vidjeti dio 4.3).
English: ZOSTAVAX can be administered concomitantly with inactivated influenza vaccine as separate injections and at different body sites (see section 5.1).
Croatian: ZOSTAVAX se može primijeniti istodobno s inaktiviranim cjepivom protiv gripe, ali zasebnom injekcijom i na različito mjesto na tijelu (vidjeti dio 5.1).
English: Table 1: Adverse Reactions from Clinical Trial Experience and Post-Marketing Surveillance
Croatian: Tablica 1: Nuspojave iz iskustva tijekom kliničkih ispitivanja i praćenja nakon stavljanja cjepiva u promet
English: However naturally-occurring varicella-zoster virus infection is known to sometimes cause foetal harm.
Croatian: Međutim, zna se da prirodno nastala infekcija virusom varicella-zoster može ponekad prouzročiti oštećenje fetusa.
English: The most common adverse reactions reported in pivotal clinical trials were injection-site reactions.
Croatian: Najčešće prijavljene nuspojave u pivotalnim kliničkim ispitivanjima bile su reakcije na mjestu injekcije.
English: This effect was more prominent in the group of older subjects (≥70 years of age), where the risk of developing PHN after zoster was reduced to 10% in the vaccine group vs. 19% for the placebo group.
Croatian: Taj je učinak bio izraženiji u skupini starijih ispitanika (u dobi od 70 godina ili starijih), u kojoj je rizik od razvoja PHN-a nakon herpes zostera bio smanjen na 10% u cijepljenoj skupini naspram 19% u skupini koja je primala placebo.
English: There are no data on the use of ZOSTAVAX in pregnant women.
Croatian: Nema podataka o primjeni cjepiva ZOSTAVAX u trudnica.
English: Do not use this vaccine after the expiry date which is stated on the outer carton after EXP.
Croatian: Ovo cjepivo se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake "EXP".
English: Patients who previously received immune suppressive therapy should be carefully evaluated for the reconstitution of the immune system prior to receiving Zostavax (see section 4.3).
Croatian: U bolesnika koji su prethodno primili imunosupresivnu terapiju treba pažljivo procjeniti rekonstituciju imunološkog sustava prije primjene cjepiva ZOSTAVAX (vidjeti dio 4.3).
English: Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Croatian: Nositelj odobrenja: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Francuska
English: The general safety profiles of the SC and IM routes were otherwise comparable, but injection-site adverse reactions were significantly less frequent in the IM group (34%) compared with the SC group (64%).
Croatian: Opći sigurnosni profil s.c. i i.m. puta primjene bio je usporediv u svemu osim nuspojavama na mjestu injekcije, koje su bile značajno manje česte u i.m. skupini (34%) u usporedbi sa s.c. skupinom (64%).
English: The STPS was initiated to accrue additional information on the persistence of vaccine efficacy for subjects who received ZOSTAVAX in SPS.
Croatian: Podispitivanje STPS bilo je pokrenuto radi prikupljanja dodatnih informacija o trajnosti djelotvornosti cjepiva u ispitanika koji su primili ZOSTAVAX u ispitivanju SPS.
English: The Oka/Merck strain of VZV was not detected from any specimens in SPS or ZEST.
Croatian: Soj Oka/Merck VZV-a nije bio otkriven niti u jednom od uzoraka u ispitivanjima SPS ili ZEST.
English: If you have a blood clotting disorder or low levels of platelets in your blood, the injection will be given under the skin.
Croatian: Ako imate poremećaj zgrušavanja krvi ili niske razine krvnih pločica, dobit ćete injekciju pod kožu.
English: In clinical trials with ZOSTAVAX, transmission of the vaccine virus has not been reported.
Croatian: U kliničkim ispitivanjima cjepiva ZOSTAVAX nije prijavljen prijenos virusa iz cjepiva.
English: 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.
Croatian: ZOSTAVAX je živo, atenuirano cjepivo protiv virusa varicella-zoster i primjena osobama koje su imunosuprimirane ili imunodeficijentne može rezultirati diseminiranom bolešću koju uzrokuje virus varicella-zoster, uključujući smrtne ishode.
English: The needle should be pushed into the extremity of the syringe and rotated a quarter of a turn (90) to secure the connection.
Croatian: Iglu treba nataknuti na vršak štrcaljke i zakrenuti je za četvrtinu kruga (90) kako bi se pričvrstila.
English: The vaccine can be injected subcutaneously (SC) or intramuscularly (IM), preferably in the deltoid region (see sections 4.8 and 5.1).
Croatian: Cjepivo se može injicirati supkutano (s.c.) ili intramuskularno (i.m.), po mogućnosti u deltoidno područje (vidjeti dijelove 4.8 i 5.1).
English: 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).
Croatian: U razdoblju od 90 dana nakon pojave osipa do kraja praćenja, smanjenje bodovnog rezultata jačine po trajanju boli iznosilo je 57% (prosječni rezultat bio je 347 za ZOSTAVAX i 805 za placebo; p=0,016).
English: ZOSTAVAX powder for injection SC/IM
Croatian: ZOSTAVAX prašak za injekciju s.c./i.m.
English: , Swelling Injection site: Induration 1, Haematoma
Croatian: , oticanje mjesto injekcije: induracija 1, hematom toplina
English: 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.
Croatian: ZOSTAVAX s otapalom za rekonstituciju dostupnim u napunjenoj štrcaljki: Ako su priložene dvije igle, za rekonstituciju treba koristiti jednu, a za primjenu cjepiva drugu iglu.
English: Shingles is caused by the same virus that causes chickenpox.
Croatian: Herpes zoster uzrokuje isti virus koji uzrokuje vodene kozice.
English: 1, Oka/Merck strain, (live, attenuated) not less than 19,400 PFU (plaque-forming units).
Croatian: 1, soj Oka/Merck, (živi, oslabljeni) ne manje od 19 400 PFU (jedinice koje stvaraju plak).
English: The vaccine should be administered subcutaneously in patients with severe thrombocytopenia or any coagulation disorder (see section 4.4).
Croatian: Cjepivo treba primijeniti supkutano u bolesnika s teškom trombocitopenijom ili s bilo kojim poremećajem koagulacije (vidjeti dio 4.4).
English: However in a US effectiveness cohort study of 35,025 adults ≥ 60 years old, no increased risk of herpes zoster was observed in individuals who received ZOSTAVAX and 23-valent pneumococcal polysaccharide vaccine concomitantly (n=16,532) as compared to individuals receiving ZOSTAVAX one month to one year after 23-valent pneumococcal polysaccharide vaccine (n=18,493) in routine practice.
Croatian: Međutim, u kohortnom ispitivanju učinkovitosti provedenom u Sjedinjenim Američkim Državama u 35 025 odraslih osoba starosti ≥ 60 godina nije zapažen povećan rizik od herpes zostera u osoba koje su istodobno primile ZOSTAVAX i 23-valentno pneumokokno polisaharidno cjepivo (N=16 532) u usporedbi s osobama koje su u rutinskoj praksi primile ZOSTAVAX nakon jednog mjeseca do unutar godine dana nakon primjene 23-valentnog pneumokoknog polisaharidnog cjepiva (N=18 493).
English: ZOSTAVAX is indicated for immunization of individuals 50 years of age or older.
Croatian: ZOSTAVAX je indiciran za imunizaciju osoba u dobi od 50 godina i starijih.
English: † The zoster 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.
Croatian: † Rezultat za bol povezanu s herpes zosterom na ljestvici BOI kompozitni je rezultat koji uključuje incidenciju, težinu i trajanje akutne ili kronične boli povezane s herpes zosterom tijekom 6-mjesečnog razdoblja praćenja.
English: In SPS and ZEST, the number of subjects who reported herpes zoster/herpes zoster-like rashes was less than 0.2% for ZOSTAVAX and placebo groups, with no significant difference observed between the two groups.
Croatian: U ispitivanjima SPS i ZEST, broj ispitanika koji su prijavili slučajeve osipa herpes zostera/nalik herpes zosteru bio je manji od 0,2% i za ZOSTAVAX i placebo skupinu, bez značajne razlike primijećene u te dvije skupine.
English: § Age-adjusted estimate based on the age strata (60-69 and ≥70 years of age) at randomisation.
Croatian: § Dobno prilagođena procjena na temelju dobnih podskupina (60-69 i ≥70 godina) pri randomizaciji.