natgillin/translations-raw huggingface dataset:
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
Inject the entire content of the syringe into the vial containing the powder.
Vso vsebino injekcijske brizge iztisnite v vialo s praškom.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj pogosti
Herpes zoster/herpes zoster-like rashes and Varicella/varicella-like rashes in clinical trials In clinical trials the number of herpes zoster/herpes zoster-like rashes within the 42-day postvaccination was low in both ZOSTAVAX and placebo groups.
V kliničnih preskušanjih je bilo število primerov herpesa zostra/herpesu zostru podobnih izpuščajev v 42 dneh po cepljenju majhno tako med prejemniki cepiva ZOSTAVAX kot med prejemniki placeba.
Table 3: Efficacy of ZOSTAVAX on zoster incidence compared with placebo in the SPS in subjects 60 years of age and older*
Preglednica 3: Učinkovitost cepiva ZOSTAVAX glede pojavnosti herpesa zostra v primerjavi s placebom v študiji SPS pri osebah, starih 60 let ali več*
After reconstitution, 1 dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live, attenuated) ≥19,400 PFU
Po rekonstituciji 1 odmerek (0,65 ml) vsebuje: Virus varicella-zoster, sev Oka/Merck, (živ, oslabljen)  19.400 PFU
How to use ZOSTAVAX
Kako uporabljati cepivo ZOSTAVAX
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, 4.8 and 6.1).
Pri cepljenju obstaja možnost pojava preobčutljivostnih reakcij, ne le na učinkovino, temveč tudi na pomožne snovi in snovi, prisotne v sledeh (npr. neomicin) (glejte poglavja 4.3, 4.8 in 6.1).
Inject the entire content of the pre-filled syringe into the vial containing the powder.
Vso vsebino napolnjene injekcijske brizge iztisnite v vialo s praškom.
ZOSTAVAX contains sodium
Cepivo ZOSTAVAX vsebuje natrij
Discard if reconstituted vaccine is not used within 30 minutes.
Če cepiva ne uporabite v 30 minutah po rekonstituciji, ga zavrzite.
ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with 2 unattached needles - Pack of 1, 10, 20
ZOSTAVAX - prašek v viali in vehikel v napolnjeni injekcijski brizgi z 2 nepritrjenima iglama - pakiranje po 1, 10, 20
Transmission
Odmerjanje
Incidence rate of zoster per person years
Delež pojavnosti herpesa zostra na oseb-let
Transmission of vaccine virus from varicella vaccine recipients who do not develop a varicella-like rash has also been reported.
Poročali so tudi o prenosu cepilnega virusa z oseb, ki so bile cepljene s cepivom proti noricam in pri katerih se ni pojavil noricam podoben izpuščaj.
The need for, or timing of, a booster dose with ZOSTAVAX has not yet been determined.
Odrasli, ki so prejeli dodatne odmerke/ponovno cepljenje Potreba po obnovitvenem odmerku cepiva ZOSTAVAX ali čas njegove uporabe še nista bila določena.
If you have experienced any of the following, talk to your doctor or pharmacist before receiving ZOSTAVAX:
Pred cepljenjem s cepivom ZOSTAVAX se posvetujte z zdravnikom ali farmacevtom, če za vas velja kar koli od naštetega:
Powder and solvent for suspension for injection 1 vial (powder) + 1 vial (solvent) 10 vials (powder) + 10 vials (solvent)
prašek in vehikel za suspenzijo za injiciranje 1 viala (prašek) + 1 viala (vehikel) 10 vial (prašek) + 10 vial (vehikel)
Before mixing with the solvent, the powder is a white to off-white compact crystalline plug.
Pred dodajanjem vehikla je prašek bel do sivo-bel v grudo stisnjen kristalni prašek.
Administration of a higher than recommended dose of ZOSTAVAX was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose of ZOSTAVAX.
Profil neželenih učinkov je bil primerljiv s tistim, ki so ga opazili pri priporočenih odmerkih cepiva ZOSTAVAX.
There are no data on the use of ZOSTAVAX in pregnant women.
Cepiva ZOSTAVAX ne uporabljajte pri nosečnicah.
Number of zoster cases
Št. oseb Št. primerov herpesa zostra
Withdraw the entire content of the reconstituted vaccine using the same syringe.
Celotno vsebino rekonstituiranega cepiva povlecite v isto injekcijsko brizgo.
The ZEST study was a placebo-controlled, double-blind clinical trial in which 22,439 subjects were randomised to receive a single dose of either ZOSTAVAX or placebo and were followed for the development of zoster for a median of 1.3 years (range 0 to 2 years).
Študija ZEST je bila s placebom nadzorovano, dvojno slepo klinično preskušanje pri 22.439 osebah, randomiziranih na prejetje enega odmerka cepiva ZOSTAVAX ali placeba.
Compared with placebo, ZOSTAVAX induced a higher VZV-specific immune response at 6 weeks post-vaccination.
V primerjavi s placebom je cepivo ZOSTAVAX 6 tednov po cepljenju sprožilo pomembno večji imunski odziv, specifičen za VZV.
What ZOSTAVAX contains
Kaj vsebuje cepivo ZOSTAVAX
Headache and pain in the extremity were the most common systemic adverse reactions.
Najpogostejša sistemska neželena učinka sta bila glavobol in bolečina v okončini.
ZOSTAVAX significantly decreased the incidence of zoster compared to placebo (see Table 2).
Cepivo ZOSTAVAX je pomembno zmanjšalo pojavnost herpesa zostra v primerjavi s placebom (glejte preglednico 2).
The vaccine can be injected subcutaneously (SC) or intramuscularly (IM), preferably in the deltoid region (see sections 4.8 and 5.1).
), po možnosti v deltoidni predel (glejte poglavji 4.8 in 5.1).
ZOSTAVAX induced a significantly higher VZV-specific immune response at 4 weeks post-vaccination, compared with placebo.
Cepivo ZOSTAVAX je v 6 tednih po cepljenju sprožilo pomembno večji imunski odziv, specifičen za VZV, v primerjavi s placebom.
Withdraw the entire content of the reconstituted vaccine vial using the same syringe.
Celotno vsebino viale z rekonstituiranim cepivom povlecite v isto injekcijsko brizgo.
Discard reconstituted vaccine if it is not used within 30 minutes.
Če cepiva niste aplicirali v 30 minutah po rekonstituciji, ga zavrzite.
What is PHN?
Kaj je postherpetična nevralgija (PHN)?
Shingles Prevention Study (SPS) in Subjects 60 years of age and older:
SPS pri osebah, starih 60 let ali več
Mean BOI score
Povprečna ocena BOI
EU/1/06/341/005 - pack of 1 EU/1/06/341/006 - pack of 10 EU/1/06/341/007 - pack of 20
EU/1/06/341/005 - pakiranje po 1 EU/1/06/341/006 - pakiranje po 10 EU/1/06/341/007 - pakiranje po 20
ZOSTAVAX powder and solvent for suspension for injection ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe shingles (herpes zoster) vaccine (live)
ZOSTAVAX prašek in vehikel za suspenzijo za injiciranje ZOSTAVAX prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi cepivo proti pasovcu (herpesu zostru) (živo)
Your doctor will decide if ZOSTAVAX should be given.
O upravičenosti cepljenja s cepivom ZOSTAVAX bo presodil zdravnik.
ZOSTAVAX significantly decreased the incidence of zoster compared with placebo (see Table 3).
Cepivo ZOSTAVAX je pomembno zmanjšalo pojavnost herpesa zostra v primerjavi s placebom (glejte preglednico 3).
EU/1/06/341/008 - pack of 1 EU/1/06/341/009 - pack of 10 EU/1/06/341/010 - pack of 20
EU/1/06/341/008 - pakiranje po 1 EU/1/06/341/009 - pakiranje po 10 EU/1/06/341/010 - pakiranje po 20
Anyone who has been infected with VZV, including those without a clinical history of varicella, is at risk for developing zoster.
Tveganje za pojav herpesa zostra obstaja pri vseh osebah, ki so bile okužene z VZV, tudi tistih brez klinične oblike noric v anamnezi.
Immunogenicity of ZOSTAVAX
Imunogenost cepiva ZOSTAVAX
Varicella, Herpes zoster (vaccine strain)
Infekcijske in parazitske bolezni norice, herpes zoster (cepilni sev)
Monosodium L-glutamate monohydrate Disodium phosphate Sodium hydroxide (to adjust pH) Urea
Prašek: saharoza hidrolizirana želatina natrijev klorid kalijev dihidrogenfosfat kalijev klorid natrijev L-glutamat monohidrat natrijev hidrogenfosfat natrijev hidroksid (za uravnavo pH) sečnina
b. Tabulated summary of adverse events
b. Seznam neželenih učinkov v preglednici
Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe (solvent) + 2 needles 10 vials (powder) + 10 pre-filled syringes (solvent) + 20 needles 20 vials (powder) + 20 pre-filled syringes (solvent) + 40 needles
prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi 1 viala (prašek) + 1 napolnjena injekcijska brizga (vehikel) + 2 igli 10 vial (prašek) + 10 napolnjenih injekcijskih brizg (vehikel) + 20 igel 20 vial (prašek) + 20 napolnjenih injekcijskih brizg (vehikel) + 40 igel
EU/1/06/341/003 - pack of 1 EU/1/06/341/004 - pack of 10
EU/1/06/341/003 - pakiranje po 1 EU/1/06/341/004 - pakiranje po 10
Rare
občasni
EU/1/06/341/001 - pack of 1 EU/1/06/341/002 - pack of 10
EU/1/06/341/001 - pakiranje po 1 EU/1/06/341/002 - pakiranje po 10
ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with one unattached needle - Pack of 1, 10, 20
ZOSTAVAX - prašek v viali in vehikel v napolnjeni injekcijski brizgi z eno nepritrjeno iglopakiranje po 1, 10, 20
Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe (solvent) + 1 needle 10 vials (powder) + 10 pre-filled syringes (solvent) + 10 needles 20 vials (powder) + 20 pre-filled syringes (solvent) + 20 needles
prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi 1 viala (prašek) + 1 napolnjena injekcijska brizga (vehikel) + 1 igla 10 vial (prašek) + 10 napolnjenih injekcijskih brizg (vehikel) + 10 igel 20 vial (prašek) + 20 napolnjenih injekcijskih brizg (vehikel) + 20 igel
EU/1/06/341/012 - pack of 10 EU/1/06/341/013- pack of 20
EU/1/06/341/011 - pakiranje po 1 EU/1/06/341/012 - pakiranje po 10 EU/1/06/341/013 - pakiranje po 20
Withdraw the entire volume of solvent into a syringe.
Celoten volumen vehikla povlecite v injekcijsko brizgo.
One or 2 separate needles may be available in the packaging of the presentation containing the pre-filled syringe without attached needle.
V pakiranju z napolnjeno injekcijsko brizgo brez pritrjene igle sta lahko posebej priloženi ena ali 2 igli.