natgillin/translations-raw huggingface dataset:
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%].
Primere herpesa zostra so dokončno potrdili z uporabo verižne reakcije s polimerazo (PCR) [86 %] ali v odsotnosti virusne detekcije s potrditvijo kliničnega ocenjevalnega odbora [14 %].
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).
Posledično so pogostnosti teh neželenih učinkov ocenjene na podlagi neželenih učinkov, o katerih so poročali v študijah SPS in ZEST (ne glede na povezavo s cepivom, določeno s strani raziskovalca).
A total of 48,889 confirmed HZ cases and 3,316 confirmed PHN cases (>90 days of zoster-associated pain) were observed.
Opazili so skupaj 48.889 potrjenih primerov HZ ter 3.316 potrjenih primerov PHN (> 90 dni bolečine, povezane s herpes zostrom).
See sections 4.8 and 5.1.
Glejte poglavji 4.8 in 5.1.
No data are currently available regarding concomitant use with other vaccines.
Podatkov o sočasni uporabi z drugimi cepivi trenutno ni na voljo.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKIH UČINKOVIN IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
This is a theoretical risk for vaccination with ZOSTAVAX.
To je teoretično tveganje, ki obstaja tudi pri cepljenju s cepivom ZOSTAVAX.
This long-lasting nerve pain is called post-herpetic neuralgia or PHN.
Ta dolgotrajna bolečina živca se imenuje postherpetična nevralgija ali PHN.
Individuals should receive a single dose (0.65 mL).
Oseba mora prejeti enkraten odmerek (0,65 ml).
Varicella-zoster virus
Virus varicella-zoster
In an interim analysis of the 2007 to 2014 study period, out of 1,355,720 study individuals, 392,677 received ZOSTAVAX.
Pri vmesni analizi iz obdobja študije med leti 2007 in 2014 je od 1.355.720 posameznikov, ki so bili vključeni v študijo, cepivo ZOSTAVAX prejelo 392.677 posameznikov.
The following side effects have been observed:
Opazili so naslednje neželene učinke:
• 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)
• če ste alergični (preobčutljivi) na katero koli sestavino tega cepiva (vključno z neomicinom ali katero koli drugo sestavino, navedeno v poglavju 6),
• Pregnancy.
• Nosečnost.
However, a history of contact dermatitis due to neomycin is not a contraindication to receiving live virus vaccines.
Vendar pa kontaktni dermatitis zaradi neomicina v anamnezi ni kontraindikacija za cepiva z živimi virusi.
3-year postvaccination 5-year postvaccination
3 leta po cepljenju 5 let po cepljenju
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden boste cepljeni s tem cepivom.
Store and transport refrigerated (2 C - 8 C).
Shranjujte in prevažajte v hladilniku (2 ºC - 8 ºC).
Manufacturer: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Izdelovalec: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, Nizozemska
The persistence of protection following vaccination has been evaluated through longer-term follow-up in Short-term Persistence Substudy (STPS) and Long-term Persistence Substudy (LTPS) and supports the continued benefit of ZOSTAVAX throughout the follow-up periods studied.
Trajanje zaščite po cepljenju so ocenili v dolgoročnem spremljanju v podštudiji STPS (Short-term Persistence Substudy) in podštudiji LTPS (Long-term Persistence Substudy) in je podprlo trajno korist cepiva ZOSTAVAX v proučevanih obdobjih spremljanja.
In the SPS, the reduction in zoster was seen in almost all dermatomes.
V študiji SPS so opazili zmanjšanje herpesa zostra na skoraj vseh dermatomih.
The results showed that ZOSTAVAX is effective in reducing HZ and PHN incidence in vaccinated individuals as compared to an unvaccinated reference group.
Rezultati kažejo, da je cepivo ZOSTAVAX učinkovito pri zmanjšanju pojavnosti HZ in PHN pri cepljenih osebah v primerjavi z necepljeno referenčno skupino.
Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
Kot vsa cepiva in zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh osebah.
Vaccine effectiveness (VE) against HZ was evaluated for up to eight years postvaccination.
Učinkovitost cepiva (VE - Vaccine effectiveness) proti HZ je bila ovrednotena v obdobju do 8 let po cepljenju.
The need for a booster dose is not known.
Ni znano, ali je potreben obnovitveni odmerek.
VE against PHN was evaluated for up to eight years postvaccination.
VE proti PHN je bila ovrednotena v obdobju do 8 let po cepljenju.
No serious vaccine-related adverse experiences were reported.
O resnih neželenih učinkih, povezanih s cepivom, niso poročali.
The two vaccines should be given as separate injections at different body sites.
Cepivi se morata dajati v ločenih injekcijah in na različne dele telesa.
A decision must be made whether to discontinue breast-feeding or to not administer ZOSTAVAX taking into account the benefit of breast-feeding for the child and the benefit of vaccination for the woman.
Odločiti se je treba med prenehanjem dojenja in neuporabo cepiva ZOSTAVAX, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti cepljenja za mater.
Necrotizing retinitis (patients on immunosuppressive therapy)
Bolezni oči nekrotizirajoči retinitis (bolniki na imunosupresivnem zdravljenju)
Other medicines and ZOSTAVAX
Druga zdravila in cepivo ZOSTAVAX
*The analysis was performed on the intent-to-treat (ITT) population that included all subjects randomised in the ZEST study
*Analiza je bila opravljena na populaciji z-namenom-zdravljenja (ITT), ki je zajela vse osebe, randomizirane v študiji ZEST.
This risk appears to be causally related to a decline in VZV-specific immunity.
Tveganje je domnevno vzročno povezano s slabljenjem imunosti, specifične za VZV.
ZOSTAVAX is available in packs of 1, 10 or 20 with or without needles.
Cepivo ZOSTAVAX je na voljo v pakiranjih po 1, 10 ali 20 z ali brez igle.
ZOSTAVAX Efficacy and Safety Trial (ZEST) in subjects 50 to 59 years of age:
Preskušanje učinkovitosti in varnosti cepiva ZOSTAVAX (ZEST - ZOSTAVAX Efficacy and Saftey Trial) pri osebah, starih od 50 do 59 let:
The VZV-specific immune responses following Doses 1 and 2 were similar (see section 4.3).
Imunski odziv, specifičen za VZV, je bil podoben po 1. in 2. odmerku (glejte poglavje 4.3).
After reconstitution, use immediately or within 30 minutes if stored at 20°C-25°C.
Po pripravi uporabite takoj ali v 30 minutah, če ste cepivo hranili pri temperaturi 20 ºC - 25 ºC.
What you need to know before you receive ZOSTAVAX
Kaj morate vedeti, preden boste cepljeni s cepivom ZOSTAVAX
• if you have active untreated tuberculosis
• če imate aktivno, nezdravljeno tuberkulozo,
ZOSTAVAX should be injected under the skin or into the muscle, preferably in the upper arm.
Cepivo ZOSTAVAX je treba injicirati pod kožo ali v mišico, po možnosti v zgornji predel roke.
However, ZOSTAVAX is expected to have no or negligible influence on ability to drive and use machines.
Vendar se pri cepivu ZOSTAVAX pričakuje, da nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili (cepivi).
The solvent is a clear and colourless liquid.
Vehikel je bistra, brezbarvna tekočina.
The majority of rashes have been rated as mild to moderate; no complications from rash have been observed in the clinical setting.
Večina izpuščajev je bila ocenjena kot blagih do zmernih; zapletov z izpuščajem v kliničnem okolju niso opazili.
In the LTPS, there were 263 evaluable zoster cases reported among 261 patients [10.3/1000 person-years].
Tekom študije LTPS so med 261 bolniki zabeležili 263 primerov herpesa zostra, ki jih je bilo možno ovrednotiti [10,3/1.000 oseb-let].
There is no relevant use of ZOSTAVAX in children and adolescents for prevention of primary varicella infection (chickenpox).
Cepivo ZOSTAVAX ni namenjeno za uporabo pri otrocih in mladostnikih za preprečevanje primarne okužbe z virusom varicella (noric).
ZOSTAVAX can be administered concomitantly with inactivated influenza vaccine as separate injections and at different body sites (see section 5.1).
Cepivo ZOSTAVAX se lahko daje sočasno s cepivi proti gripi z inaktiviranimi virusi v ločenih injekcijah in na različne dele telesa (glejte poglavje 5.1).
It is recommended that the vaccine be administered immediately after reconstitution to minimise loss of potency.
Priporočamo, da cepivo aplicirate takoj po rekonstituciji, da se zmanjša možnost izgube učinkovitosti.
No studies on the effects on the ability to drive or use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
† PHN was defined as zoster-associated pain rated as ≥3 (on a 0-10 scale), persisting or appearing more than 90 days after onset of zoster rash using Zoster Brief Pain Inventory (ZBPI).
† PHN je bila opredeljena kot bolečina, povezana s herpesom zostrom, ocenjena z ≥ 3 (na lestvici od 0 do 10), ki je trajala ali se je pojavila več kot 90 dni po nastanku izpuščaja herpesa zostra (z uporabo lestvice ZBPI [Zoster Brief Pain Inventory]).
Within SPS, immune responses to vaccination were evaluated in a subset of the enrolled subjects (N=1395).
V študiji SPS so imunski odziv na cepljenje vrednotili pri podskupini vključenih oseb (N = 1.395).
The concomitant use of ZOSTAVAX and a 23-valent pneumococcal polysaccharide vaccine resulted in reduced immunogenicity of ZOSTAVAX in a small clinical trial.
Sočasna uporaba cepiva ZOSTAVAX in 23-valentnega pnevmokoknega polisaharidnega cepiva je v majhnem kliničnem preskušanju zmanjšala imunogenost cepiva ZOSTAVAX.
This vaccine should be given subcutaneously to individuals with severe thrombocytopenia or any coagulation disorder, because these individuals may bleed following intramuscular injections.
To cepivo je treba osebam s hudo trombocitopenijo ali kakršno koli motnjo strjevanja krvi dati subkutano, ker se pri takšnih osebah po intramuskularnem injiciranju lahko pojavi krvavitev.
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).
Bolnike, ki so v preteklosti prejemali imunosupresivno zdravljenje, je treba pred uporabo cepiva ZOSTAVAX skrbno oceniti glede ponovne vzpostavitve imunskega sistema (glejte poglavje 4.3).
For information about the administration of ZOSTAVAX and pneumococcal polysaccharide vaccine at the same time, talk to your doctor or health care provider.
Za informacije o sočasni uporabi cepiva ZOSTAVAX in pnevmokoknega polisaharidnega cepiva se obrnite na zdravnika ali drugo zdravstveno osebje.
Most of these local and systemic adverse reactions were reported as mild in intensity.
Večina teh lokalnih in sistemskih neželenih učinkov je bila blagih.
The data do not indicate that concomitant administration alters the effectiveness of ZOSTAVAX.
Podatki ne kažejo, da bi sočasna uporaba spremenila učinkovitost cepiva ZOSTAVAX.
When evaluated at 4 weeks post-vaccination, the immunogenicity of the current refrigerator-stable formulation was shown to be similar to the immunogenicity of the earlier frozen formulation of ZOSTAVAX.
Ob vrednotenju štiri tedne po cepljenju se je pokazalo, da je imunogenost sedanje, v hladilniku stabilne oblike, podobna imunogenosti predhodne zamrznjene oblike cepiva ZOSTAVAX.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines or vaccines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo ter če ste pred kratkim prejeli ali pa boste morda prejeli drugo cepivo.
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.
Ta učinek je bil izrazitejši pri starejših osebah (≥ 70 let), kjer se je tveganje za pojav PHN po herpesu zostru v skupini, ki je prejela cepivo, zmanjšalo na 10 %, v skupini na placebu pa na 19 %.
The safety profile was generally similar to the Adverse Event Monitoring Substudy of the SPS.
Varnostni profil je bil na splošno podoben kot v podštudiji spremljanja neželenih učinkov študije SPS.
ZOSTAVAX cannot be used to treat existing shingles or the pain associated with existing shingles.
Cepiva ZOSTAVAX se ne more uporabljati za zdravljenje že obstoječega pasovca ali bolečine, ki je povezana z že obstoječim pasovcem.
ZOSTAVAX is available in packs of 1 or 10.
Cepivo ZOSTAVAX je na voljo v pakiranjih po 1 ali 10.
Table 1: Adverse Reactions from Clinical Trial Experience and Post-Marketing Surveillance
Preglednica 1: Neželeni učinki iz kliničnih preskušanj in iz obdobja trženja cepiva
Long-term effectiveness study in individuals 50 years of age or older In a large-scale ongoing US prospective observational cohort study of the long-term effectiveness of ZOSTAVAX, individuals 50 years of age or older at the time of vaccination are being followed for the occurrence of HZ and PHN using validated endpoints.
Dolgoročne študije učinkovitosti pri posameznikih, starih 50 let ali več V obsežni prospektivni, opazovalni, kohortni študiji dolgoročne učinkovitosti cepiva ZOSTAVAX, ki poteka v ZDA, posameznike, v času cepljenja stare 50 let ali več, spremljajo glede pojavnosti HZ in PHN z uporabo validiranih končnih točk.
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).
V obdobju od 90 dni po pojavu izpuščaja do konca obdobja spremljanja se je rezultat jakost-trajanje zmanjšal za 57 % (srednji rezultat 347 za cepivo ZOSTAVAX in 805 za placebo; p = 0,016).
Furthermore, pregnancy should be avoided for 1 month following vaccination (see section 4.6).
Poleg tega ženska ne sme zanositi 1 mesec po cepljenju (glejte poglavje 4.6).
Vaccine-related serious adverse reactions were reported for 0.01% subjects vaccinated with ZOSTAVAX and subjects who received placebo.
O resnih neželenih učinkih, povezanih s cepivom, so poročali pri 0,01 % oseb, cepljenih s cepivom ZOSTAVAX, in oseb, ki so prejele placebo.
After reconstitution, 1 dose (0.65 mL) contains:
Po rekonstituciji 1 odmerek (0,65 ml) vsebuje:
Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Imetnik dovoljenja za promet s cepivom: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Francija
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).
V skupini, ki je prejela cepivo, je bilo tveganje za pojav PHN po herpesu zostru 9 % (27/315), v skupini, ki je prejela placebo, pa 13 % (80/642).
Although, ZOSTAVAX is indicated as a single dose regimen (see section 4.2), a two-dose regimen was used.
Čeprav je cepivo ZOSTAVAX indicirano v enem odmerku (glejte poglavje 4.2), sta bila uporabljena dva odmerka.
The STPS was initiated to accrue additional information on the persistence of vaccine efficacy for subjects who received ZOSTAVAX in SPS.
Podštudija STPS je bila izvedena, da bi pridobili dodatne informacije o trajanju učinkovitosti cepiva pri osebah, ki so prejele cepivo ZOSTAVAX v študiji SPS.
Immunocompromised subjects The vaccine has not been studied in subjects with impaired immunity.
Imunokomprimirane osebe Cepiva pri osebah s pomanjkljivo imunostjo niso preučevali.
• if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicines, or other treatment
• če vam je zdravnik povedal, da imate zaradi bolezni, zdravil ali drugih oblik zdravljenja oslabljen imunski sistem,
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem cepivu se lahko obrnete na predstavništvo imetnika dovoljenja za promet s cepivom:
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.
Pretehtati je treba tveganje za prenos oslabljenega cepilnega virusa s cepljene osebe na dovzetne osebe, ki so bile v stiku s cepljeno osebo, in tveganje za pojav naravnega herpesa zostra ter možen prenos divjega tipa VZV na dovzetne osebe.
The most common adverse reactions reported in pivotal clinical trials were injection-site reactions.
Najpogostejši neželeni učinki, o katerih so poročali v ključnih kliničnih preskušanjih, so bili reakcije na mestu injiciranja.
The needle should be pushed into the extremity of the syringe and rotated a quarter of a turn (90) to secure the connection.
Iglo morate potisniti na konico brizge in jo obrniti za četrt obrata (90 º), da je pravilno nameščena.
Concomitant administration
Sočasna uporaba
After you have had chickenpox, the virus that caused it stays in your body in nerve cells.
Po prebolelih noricah njihov povzročitelj (virus) ostane v telesu v živčnih celicah.
ZOSTAVAX contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Cepivo ZOSTAVAX vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
ZOSTAVAX powder for injection SC/IM
ZOSTAVAX prašek za injiciranje s.c./i.m.
It is unknown whether VZV is secreted in human milk.
Ni znano, ali se VZV izloča v materino mleko.
The vaccine should under no circumstances be injected intravascularly.
Cepiva ne smete nikoli injicirati intravaskularno.
Of the 295 ZOSTAVAX recipients, one case of serious vaccine related maculo-papular rash was reported on Day 4 following Dose 1 of ZOSTAVAX (see section 4.3).
Med 295 prejemniki cepiva ZOSTAVAX so poročali o enem resnem primeru makulopapuloznega izpuščaja, povezanega s cepivom, in sicer 4. dan po 1. odmerku cepiva ZOSTAVAX (glejte poglavje 4.3).
In clinical trials with ZOSTAVAX, transmission of the vaccine virus has not been reported.
Med kliničnim preskušanjem cepiva ZOSTAVAX o prenosu cepilnega virusa niso poročali.
If you have a blood clotting disorder or low levels of platelets in your blood, the injection will be given under the skin.
Če imate motnjo strjevanja krvi ali nizko raven trombocitov v krvi, vam bodo cepivo injicirali pod kožo.
† 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.
† Ocena BOI bolečine zaradi herpesa zostra je sestavljena ocena, ki vključuje pojavnost, izrazitost in trajanje akutnih in kroničnih bolečin zaradi herpesa zostra v 6-mesečnem obdobju spremljanja.
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.
Toda v ameriški kohortni študiji učinkovitosti pri 35.025 odraslih, starih ≥ 60 let, v kateri so posamezniki sočasno prejeli cepivo ZOSTAVAX in 23-valentno pnevmokokno polisaharidno cepivo (n = 16.532), niso opazili večjega tveganja za herpes zoster kot pri posameznikih, ki so prejeli cepivo ZOSTAVAX od enega meseca do enega leta po 23-valentnem pnevmokoknem polisaharidnem cepivu (n = 18.493) v rutinski praksi.
ZOSTAVAX was shown to boost VZV-specific immunity, which is thought to be the mechanism by which it protects against zoster and its complications (See Immunogenicity).
Dokazano je bilo, da cepivo ZOSTAVAX poživi imunost, specifično za VZV, kar je domnevno mehanizem, s katerim ščiti pred herpesom zostrom in njegovimi komplikacijami (glejte Imunogenost).
What ZOSTAVAX looks like and contents of the pack
Izgled cepiva ZOSTAVAX in vsebina pakiranja
Subjects with severe thrombocytopenia or any other coagulation disorder were excluded.
Izključene so bile osebe s hudo trombocitopenijo ali kakršno koli drugo motnjo strjevanja krvi.
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.
Prilagojeno razmerje ogroženosti v primerjavi deležev pojavnosti HZ v obeh skupinah je bilo med mediano 4,7-letnim spremljanjem 1,04 (95 % IZ: 0,92 do 1,16).
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, varicella-zoster virus (VZV) susceptible infant grandchildren].
Izkušnje s cepivi proti noricam iz obdobja trženja pa kažejo, da lahko v redkih primerih pride do prenosa cepilnega virusa s cepljene osebe, pri kateri se je pojavil noricam podoben izpuščaj, na dovzetno osebo, ki je bila v stiku s cepljeno osebo [na primer za okužbo z VZV (varicella-zoster virus) dovzetni otroci].
ZOSTAVAX is used to vaccinate individuals 50 years of age or older.
Cepivo ZOSTAVAX se uporablja za cepljenje oseb, starih 50 let ali več.
However, among vaccinated individuals who developed PHN, ZOSTAVAX significantly reduced PHN-associated (chronic) pain compared with placebo.
Vendar pa je med cepljenimi posamezniki, pri katerih se je pojavila PHN, cepivo ZOSTAVAX pomembno zmanjšalo s PHN povezano (kronično) bolečino v primerjavi s placebom.
Hypersensitivity reactions including anaphylactic reactions
Bolezni imunskega sistema preobčutljivostne reakcije, vključno z anafilaktičnimi reakcijami redki
ZOSTAVAX can be administered at the same time as inactivated influenza vaccine.
Cepivo ZOSTAVAX se lahko daje sočasno s cepivi proti gripi z inaktiviranimi virusi.
The Oka/Merck strain of VZV was not detected from any specimens in SPS or ZEST.
Seva VZV Oka/Merck niso zaznali v nobenem vzorcu v študijah SPS ali ZEST.
ZOSTAVAX is not indicated for treatment of zoster or PHN.
Cepivo ZOSTAVAX ni indicirano za zdravljenje herpesa zostra ali PHN.
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%).
Splošna varnostna profila sta bila pri subkutani in intramuskularni uporabi primerljiva, vendar so bili neželeni učinki na mestu injiciranja pri intramuskularni uporabi (34 %) značilno manj pogosti kot pri subkutani (64 %).
1, Oka/Merck strain, (live, attenuated) not less than 19,400 PFU produced in human diploid (MRC-5) cells PFU = Plaque-forming units
1, sev Oka/Merck, (živ, atenuiran) ne manj kot 19.400 PFU pridobljen na humanih diploidnih (MRC-5) celicah PFU (Plaque-forming units) = enote, ki tvorijo plak
After reconstitution, the vaccine should be used immediately.
Cepivo je treba uporabiti nemudoma po rekonstituciji.
Do not use this vaccine after the expiry date which is stated on the outer carton after EXP.
Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti cepiva se izteče na zadnji dan navedenega meseca.
, Swelling Injection site: Induration 1, Haematoma
, otekanje na mestu injiciranja: zatrdlina 1, hematom toplota
Ophthalmic zoster occurred in 35 subjects vaccinated with ZOSTAVAX vs. 69 subjects who received placebo.
Herpes zoster ophthalmicus se je pojavil pri 35 osebah, ki so bile cepljene s cepivom ZOSTAVAX, in 69 osebah, ki so prejele placebo.