natgillin/translations-raw huggingface dataset:
VZV antibody responses were generally similar in subjects 50 to 59 compared to subjects ≥ 60 years of age.
Odziv protiteles proti VZV je bil pri 50 do 59 let starih osebah v splošnem podoben kot pri osebah, starih 60 let ali več.
Revaccination The need for, or timing of, revaccination with ZOSTAVAX has not yet been determined.
7 Obnovitveno cepljenje Potrebe ali časovnega okvira za obnovitveno cepljenje s cepivom ZOSTAVAX še niso opredelili.
In a placebo-controlled, double-blind, study, 98 adults 60 years of age or older received a second dose of ZOSTAVAX 42 days following the initial dose; the vaccine was generally well tolerated.
Cepivo so na splošno dobro prenašali.
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, po drugem odmerku cepiva ZOSTAVAX je bila na splošno podobna tisti, opaženi po prvem odmerku.
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 SPC.
Razen podatkov, ki so vključeni v druga poglavja SPC- ja, dodatni predklinični podatki, pomembni za klinično varnost, niso na voljo.
Sucrose Hydrolysed gelatin Sodium chloride Potassium dihydrogen phosphate Potassium chloride Monosodium L-glutamate Anhydrous disodium phosphate Sodium hydroxide (to adjust pH) Urea
Prašek: saharoza hidrolizirana želatina natrijev klorid kalijev dihidrogenfosfat kalijev klorid natrijev L- glutamat brezvodni natrijev hidrogenfosfat natrijev hidroksid (za uravnavo pH) sečnina
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products in the same syringe.
Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili (cepivi) v isti injekcijski brizgi.
However, the in-use stability has been demonstrated for 30 minutes when stored at 20oC - 25oC.
Dokazano je bilo, da je rekonstituirano cepivo, če ga hranimo pri temperaturi 20 oC - 25 oC, stabilno 30 minut.
Store and transport refrigerated (2°C - 8°C).
Shranjujte in prevažajte v hladilniku (2 ºC – 8 ºC).
For storage conditions of the reconstituted medicinal product, see section 6.3.
8 Za pogoje shranjevanja rekonstituiranega cepiva, glejte poglavje 6. 3.
Powder in a vial (Type I glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a vial (Type I glass) with a stopper (chlorobutyl rubber) and flip off cap (aluminium) in a pack size of 1 or 10.
1 ali 10.
Avoid contact with disinfectants.
Preprečite stik z razkužili.
When reconstituted, ZOSTAVAX is a semi-hazy to translucent, off-white to pale yellow liquid.
Rekonstituirano cepivo ZOSTAVAX je pol motna do prosojna, sivo- bela do bledo rumena tekočina.
Reconstitution instructions To reconstitute the vaccine, first withdraw the entire contents of the solvent vial into a syringe.
Navodila za rekonstitucijo Pri rekonstituciji cepiva najprej izvlecite celotno vsebino viale z vehiklom v injekcijsko brizgo.
Inject all the solvent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly.
Ves vehikel iz brizge iztisnite v vialo z liofiliziranim cepivom in z nežnim tresenjem dobro premešajte.
Withdraw the entire contents into a syringe for injection.
Celotno vsebino izvlecite v injekcijsko brizgo za injiciranje cepiva.
IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY.
PRIPOROČAMO, DA CEPIVO APLICIRATE TAKOJ PO REKONSTITUCIJI, DA SE ZMANJŠA MOŽNOST IZGUBE UČINKOVITOSTI.
DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.
ČE CEPIVA NISTE APLICIRALI V 30 MINUTAH PO REKONSTITUCIJI, GA ZAVRZITE.
The reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the vaccine differs from that described above.
Če opazite kakršnekoli tuje delce ali če je videz cepiva drugačen od zgoraj opisanega, rekonstituiranega cepiva ne smete uporabiti.
SANOFI PASTEUR MSD, SNC 8, rue Jonas Salk F-69007 Lyon France
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F- 69007 Lyon Francija
May 19, 2006
19. 05. 2006
ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe
ZOSTAVAX prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi
11 • Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukaemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/ AIDS; cellular immune deficiencies. • Immunosuppressive therapy (including high-dose corticosteroids); however, ZOSTAVAX is not contraindicated for use in individuals who are receiving topical/ inhaled corticosteroids or low-dose systemic corticosteroids or in patients who are receiving corticosteroids as replacement therapy, e. g., for adrenal insufficiency. • Active untreated tuberculosis. • Pregnancy (see sections 4.4 and 4.6).
• Preobčutljivost za zdravilno učinkovino, katerokoli pomožno snov ali v sledeh prisotne snovi (npr. neomicin) (glejte poglavji 4. 4 in 6. 1). • Dedne in pridobljene imunske pomanjkljivosti zaradi stanj, kot so: akutne in kronične levkemije, limfomi, druga stanja, ki prizadenejo kostni mozeg ali limfatični sistem, imunosupresija zaradi okužbe z virusom HIV/ AIDS in celična imunska pomanjkljivost. • Imunosupresivno zdravljenje (vključno z visokimi odmerki kortikosteroidov), vendar pa uporaba cepiva ZOSTAVAX ni kontraindicirana pri osebah, ki se zdravijo z lokalnimi/ inhalacijskimi kortikosteroidi ali nizkimi odmerki sistemskih kortikosteroidov ali pa 10 prejemajo kortikosteroide kot nadomestno zdravljenje, npr. v primeru insuficience nadledvične žleze. • Aktivna, nezdravljena tuberkuloza. • Nosečnost (glejte poglavji 4. 4 in 4. 6).
12 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
It is not known whether VZV is secreted in human milk.
11 Ni znano, če se VZV izloča z materinim mlekom.
13 The remainder of subjects in the SPS received routine safety monitoring, but were not provided report cards.
Ostale osebe, vključene v SPS, so bile rutinsko nadzorovane z vidika varnosti, niso pa prejele kartončkov za poročanje.
Of these varicella-like rashes, 10 had specimens that were available and adequate for PCR testing.
12 pri noricah, je bilo odvzetih 10 vzorcev, ki so bili primerni in so zadostovali za testiranje s PCR.
However, in these trials, 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 section5.1).
V teh preskušanjih pa so pri osebah, starih od 50 do 59 let, poročali o večjem odstotku blagih do zmernih neželenih učinkov, vezanih na mesto aplikacije, kot pa pri osebah, starih 60 let ali več (glejte poglavje 5. 1).
Incidence of Zoster
Učinkovitost
Incidence of PHN** HZ Pain BOI***
Opazovani dogodek Pojavnost herpesa zostra Pojavnost PHN ** HZ Pain BOI ***
67% 61%
cepiva * 51% 67% 61%
48 to 79% 51 to 69%
95- odstotni IZ 44 do 58% 48 do 79% 51 do 69%
In the vaccine group, the risk of developing PHN after zoster was 9% (27/ 315), while in the placebo group it 15 was 13% (80/ 642).
V skupini, ki je dobila cepivo, je bilo tveganje za pojav PHN po herpesu zostru 9% (27/ 315), v skupini, ki je dobila placebo, pa 13% (80/ 642).
19% for the placebo group.
Ta učinek je bil izrazitejši pri starejših osebah (≥ 70 let), kjer se je tveganje za pojav PHN po herpes zostru v skupini, ki je dobila cepivo, zmanjšalo na 10%, v skupini na placebu pa na 19%.
Prevention of HZ cases with severe pain in the entire study population ZOSTAVAX reduced the incidence of zoster with severe and long-lasting pain (severity-by-duration score > 600) by 73% (95% CI:
14 Preprečevanje primerov herpesa zostra s hudo bolečino v celotni populaciji, vključeni v študijo 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:
[2.4 to 2.9]) in subjects 50 to 59 years of age and 2.3-fold (95% CI:
[2, 4 do 2, 9]) pri bolnikih od 50 do 59 let in za 2, 3- krat (95 - odstotni IZ:
16 Immunogenicity in subjects with a history of herpes zoster (HZ) prior to vaccination In a double-blind, placebo-controlled, randomized clinical trial, ZOSTAVAX was administered to 100 subjects 50 years of age or older with a history of herpes zoster (HZ) prior to vaccination to assess immunogenicity and safety (see section 4.8) of ZOSTAVAX.
Imunogenost pri osebah z anamnezo o herpesu zostru (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 o herpesu zostru pred cepljenjem (glejte poglavje 4. 8).
393 gpELISA units/ ml.
[1, 5 do 2, 9]), p < 0, 001, GMT 812 v primerjavi s 393 gpELISA enot/ ml).
Revaccination The need for, or timing of, revaccination with ZOSTAVAX has not yet been determined.
15 Obnovitveno cepljenje Potrebe ali časovnega okvira za obnovitveno cepljenje s cepivom ZOSTAVAX še niso opredelili.
For storage conditions of the reconstituted medicinal product, see section 6.3.
16 Za pogoje shranjevanja rekonstituiranega cepiva, glejte poglavje 6. 3.
Powder in a vial (Type I glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (Type I glass) with plunger stopper (chlorobutyl rubber) and tip cap (chlorobutyl natural rubber) with one or two unattached needles in a pack size of 1, 10 or 20.
1, 10 ali 20.
Powder in a vial (Type I glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (Type I glass) with plunger stopper (chlorobutyl rubber) and tip cap (chlorobutyl natural rubber) without needle in pack size of 1, 10 or 20.
1, 10 ali 20.
Powder in a vial (Type I glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (Type I glass) with plunger stopper (chlorobutyl rubber) and needle shield (natural rubber), in a pack size of 1 or 10.
1 ali 10.
Reconstitution instructions To reconstitute the vaccine, inject all the solvent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly.
Navodila za rekonstitucijo Pri rekonstituciji cepiva ves vehikel iz brizge iztisnite v vialo z liofiliziranim cepivom in z nežnim tresenjem dobro premešajte.
One or 2 separate needles may be available in the secondary packaging of the presentation containing the pre-filled syringe without the attached needle.
V škatli z napolnjeno injekcijsko brizgo brez pritrjene igle sta lahko posebej priloženi ena ali 2 igli.
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°), da je pravilno nameščena
18 The reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the vaccine differs from that described above.
Če opazite kakršnekoli tuje delce ali če je videz cepiva drugačen od zgoraj opisanega, rekonstituiranega cepiva ne smete uporabiti.
EU/ 1/ 06/ 341/ 003 EU/ 1/ 06/ 341/ 004 EU/ 1/ 06/ 341/ 005 EU/ 1/ 06/ 341/ 006 EU/ 1/ 06/ 341/ 007 EU/ 1/ 06/ 341/ 008 EU/ 1/ 06/ 341/ 009 EU/ 1/ 06/ 341/ 010 EU/ 1/ 06/ 341/ 011 EU/ 1/ 06/ 341/ 012 EU/ 1/ 06/ 341/ 013
17 EU/ 1/ 06/ 341/ 006 EU/ 1/ 06/ 341/ 007 EU/ 1/ 06/ 341/ 008 EU/ 1/ 06/ 341/ 009 EU/ 1/ 06/ 341/ 010 EU/ 1/ 06/ 341/ 011 EU/ 1/ 06/ 341/ 012 EU/ 1/ 06/ 341/ 013
19 ANNEX II
18 DODATEK II
Waarderweg 39 2031 BN Haarlem The Netherlands
Waarderweg 39 2031 BN Haarlem Nizozemska
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version [submitted on August 15th, 2006] of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, ki so opisane v načrtu farmakovigilance, sprejetem v različici 5 načrta za obvladovanje tveganja (RMP), (predstavljenem 15. avgusta 2006) v Modulu 1. 8. 2. vloge, ter vseh nadaljnih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
22 PODATKI NA ZUNANJI OVOJNINI
ZOSTAVAX powder and solvent for suspension for injection zoster vaccine (live)
ZOSTAVAX prašek in vehikel za suspenzijo za injiciranje cepivo proti herpesu zostru (živo)
Varicella-zoster virus, Oka/ Merck strain, (live, attenuated) ≥ 19400 PFU* *PFU = Plaque-forming units
Virus varicella- zoster, sev Oka/ Merck, (živi, oslabljen) ≥ 19. 400 PFU * * PFU (Plaque- forming units) = enote, ki tvorijo plak
Sucrose, hydrolysed gelatin, urea, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate, anhydrous disodium phosphate, sodium hydroxide.
Saharoza, hidrolizirana želatina, sečnina, natrijev klorid, kalijev dihidrogenfosfat, kalijev klorid, natrijev L- glutamat, brezvodni natrijev hidrogenfosfat, natrijev hidroksid.
Powder and solvent for suspension for injection Pack of 1 single dose vial (powder) + 1 single dose vial (solvent) Pack of 10 single dose vials (powder) + 10 single dose vials (solvent)
prašek in vehikel za suspenzijo za injiciranje škatla z 1 enoodmerno vialo (prašek) + 1 enoodmerno vialo (vehikel) škatla z 10 enoodmernimi vialami (prašek) + 10 enoodmernimi vialami (vehikel)
STORE AND TRANSPORT REFRIGERATED.
ZDRAVILO SHRANJUJTE IN PREVAŽAJTE NA HLADNEM.
Read the package leaflet for disposal of medicines no longer required
Za odstranjevanje cepiva, ki ga ne rabite več, preberite navodilo za uporabo.
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
SC
ZOSTAVAX prašek za suspenzijo za injiciranje s. c.
26 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
25 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Solvent for ZOSTAVAX Water for injections
Vehikel za ZOSTAVAX Voda za injekcije
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
26 PODATKI NA ZUNANJI OVOJNINI
ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with attached needle Pack of 1, 10
ZOSTAVAX – prašek v viali in vehikel v napolnjeni injekcijski brizgi s pritrjeno iglo – pakiranje po 1, 10
ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe zoster vaccine (live)
ZOSTAVAX prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi cepivo proti herpesu zostru (živo)
Powder and solvent for suspension for injection in a pre-filled syringe Pack of 1single dose vial (powder) + 1 pre-filled syringe with attached needle (solvent) Pack of 10 single dose vials (powder) + 10 pre-filled syringes with attached needle (solvent)
prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi škatla z 1 enoodmerno vialo (prašek) + 1 napolnjeno injekcijsko brizgo s pritrjeno iglo (vehikel) škatla z 10 enoodmernimi vialami (prašek) + 10 napolnjenimi injekcijskimi brizgami s pritrjenimi iglami (vehikel)
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
After reconstitution, 1dose (0.65 ml) contains:
Po rekonstituciji 1 odmerek (0, 65 ml) vsebuje:
Pack of 1single dose vial (powder) + 1 pre-filled syringe without needle (solvent) Pack of 10 single dose vials (powder) + 10 pre-filled syringes without needle (solvent) Pack of 20 single dose vials (powder) + 20 pre-filled syringes without needle (solvent)
prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi škatla z 1 enoodmerno vialo (prašek) + 1 napolnjeno injekcijsko brizgo brez igle (vehikel) škatla z 10 enoodmernimi vialami (prašek) + 10 napolnjenimi injekcijskimi brizgami brez igel (vehikel) škatla z 20 enoodmernimi vialami (prašek) + 20 napolnjenimi injekcijskimi brizgami brez igel (vehikel)
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
Varicella-zoster virus Oka/ Merck strain, (live, attenuated) ≥ 19400 PFU* *PFU = Plaque-forming units
Virus varicella- zoster, sev Oka/ Merck, (živi, oslabljen) ≥ 19. 400 PFU * * PFU (Plaque- forming units) = enote, ki tvorijo plak
Pack of 20 single dose vials (powder) + 20 pre-filled syringes (solvent) + 20 unattached needles.
prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi škatla z 1 enoodmerno vialo (prašek) + 1 napolnjeno injekcijsko brizgo (vehikel) + 1 nepritrjeno iglo škatla z 10 enoodmernimi vialami (prašek) + 10 napolnjenimi injekcijskimi brizgami (vehikel) + 10 nepritrjenimi iglami škatla z 20 enoodmernimi vialami (prašek) + 20 napolnjenimi injekcijskimi brizgami (vehikel) + 20 nepritrjenimi iglami
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
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
32 PODATKI NA ZUNANJI OVOJNINI
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
Pack of 20 single dose vials (powder) + 20 pre-filled syringes (solvent) + 40 unattached needles.
prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi škatla z 1 enoodmerno vialo (prašek) + 1 napolnjeno injekcijsko brizgo (vehikel) + 2 nepritrjenima iglama škatla z 10 enoodmernimi vialami (prašek) + 10 napolnjenimi injekcijskimi brizgami (vehikel) + 20 nepritrjenimi iglami škatla z 20 enoodmernimi vialami (prašek) + 20 napolnjenimi injekcijskimi brizgami (vehikel) + 40 nepritrjenimi iglami
EU/ 1/ 06/ 341/ 011– pack of 1 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
36 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
35 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
PACKAGE LEAFLET
37 NAVODILO ZA UPORABO
ZOSTAVAX Powder and solvent for suspension for injection zoster vaccine (live)
ZOSTAVAX Prašek in vehikel za suspenzijo za injiciranje cepivo proti herpesu zostru (živo)
Read all of this leaflet before you are vaccinated.
Pred cepljenjem natančno preberite navodilo!
What ZOSTAVAX is and what it is used for 2.
Kaj je cepivo ZOSTAVAX in za kaj ga uporabljamo 2.
Before you receive ZOSTAVAX 3.
Kaj morate vedeti, preden boste cepljeni s cepivom ZOSTAVAX 3.
How to use ZOSTAVAX 4.
Kako se uporablja cepivo ZOSTAVAX 4.
How to store ZOSTAVAX 6.
Shranjevanje cepiva ZOSTAVAX 6.
WHAT ZOSTAVAX IS AND WHAT IT IS USED FOR
KAJ JE CEPIVO ZOSTAVAX IN ZA KAJ GA UPORABLJAMO
ZOSTAVAX is used to vaccinate individuals 50 years of age or older.
ZOSTAVAX se uporablja za cepljenje oseb, starih 50 let ali več.
BEFORE YOU RECEIVE ZOSTAVAX
KAJ MORATE VEDETI, PREDEN BOSTE CEPLJENI S CEPIVOM ZOSTAVAX
Further information- what ZOSTAVAX contains) • if you have a blood disorder or any type of cancer that weakens your immune system
S cepivom ZOSTAVAX ne smete biti cepljeni • če ste alergični na (preobčutljivi za) katerokoli sestavino (na primer neomicin) cepiva ZOSTAVAX (vključno s katerokoli sestavino, ki je navedena v odstavku “ Pomožne snovi so ” - glejte poglavje 6.
39 • 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 • if you have active untreated tuberculosis • if you are pregnant (see Pregnancy and breast-feeding)
Dodatne informacije - Kaj vsebuje cepivo ZOSTAVAX); • če imate krvno bolezen ali katerokoli vrsto raka, ki je oslabil vaš imunski sistem; • če vam je zdravnik povedal, da imate zaradi bolezni, zdravil ali drugih oblik zdravljenja oslabljen imunski sistem; • če imate aktivno, nezdravljeno tuberkulozo; • če ste noseči (glejte Nosečnost in dojenje).
Take special care with ZOSTAVAX
38 Bodite posebno pozorni pri cepljenju s cepivom ZOSTAVAX
Talk to your doctor or pharmacist before being vaccinated with ZOSTAVAX: • if you have or have had any medical problems and about any allergies • if you have a fever • if you have HIV infection • if you are pregnant or think you could be pregnant, if you are planning to become pregnant, you should consult your doctor as pregnancy must be excluded before vaccination.
Posvetovati se morate s svojim zdravnikom, saj je pred cepljenjem treba izključiti nosečnost.
Women of child- bearing potential must use effective birth control to avoid pregnancy for 3 months following vaccination.
Ženske v rodni dobi morajo 3 mesece po cepljenju za preprečitev nosečnosti uporabljati zanesljivo kontracepcijo.
ZOSTAVAX cannot be used to treat existing shingles or the pain associated with existing shingles.
Cepiva ZOSTAVAX se ne sme uporabljati za zdravljenje že obstoječega pasovca ali bolečine, ki je povezana z že obstoječim pasovcem.
Using other medicines and other vaccines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Uporaba drugih zdravil in cepiv Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
ZOSTAVAX can be administered at the same time as inactivated influenza vaccine.
ZOSTAVAX se lahko daje sočasno s cepivi proti gripi z inaktiviranimi virusi.
Pregnancy and breast-feeding ZOSTAVAX should not be given to pregnant women.
Nosečnost in dojenje Nosečnic se s cepivom ZOSTAVAX ne sme cepiti.
Women of child-bearing potential should take the necessary precautions to avoid pregnancy for 3 months following vaccination.
Ženske v rodni dobi morajo 3 mesece po cepljenju poskrbeti za ustrezno zaščito pred zanositvijo.
Inform your doctor if you are breast-feeding or intending to breast-feed.
Če dojite ali nameravate dojiti, o tem obvestite svojega zdravnika.
Your doctor will decide if ZOSTAVAX should be given.
O upravičenosti cepljenja s cepivom ZOSTAVAX bo presodil vaš zdravnik.
Driving and using machines There is no information to suggest that ZOSTAVAX affects the ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni podatkov, da bi cepivo ZOSTAVAX vplivalo na sposobnost upravljanja vozil in strojev.
Important information about the ingredients of ZOSTAVAX 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 “ the other ingredients are” - see section 6.
Pomembne informacije o nekaterih sestavinah cepiva ZOSTAVAX Preden boste cepljeni s tem cepivom svojemu zdravniku povejte, če ste kdaj imeli alergijsko reakcijo na katerokoli sestavino tega cepiva (vključno z neomicinom ali katerokoli drugo sestavino, ki je navedena v odstavku “ Pomožne snovi so ” - glejte poglavje 6.
Further information- what ZOSTAVAX contains) before you receive this vaccine.
Dodatne informacije - Kaj vsebuje cepivo ZOSTAVAX).
HOW TO USE ZOSTAVAX
KAKO SE UPORABLJA CEPIVO ZOSTAVAX
ZOSTAVAX should be injected under the skin, preferably in the upper arm.
Cepivo ZOSTAVAX je treba injicirati pod kožo, po možnosti v zgornji predel roke.
ZOSTAVAX is given as a single dose by injection.
Cepivo ZOSTAVAX se daje v obliki enkratnega odmerka z injekcijo.
Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet.
Navodila za pripravo cepiva, namenjena zdravstvenemu osebju, se nahajajo na koncu navodila.