natgillin/translations-raw huggingface dataset:
Very rare side effects (likely to affect less than 1 in every 10,000 patients): • hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated seizures). • breathing disorders, shortness of breath, inflammation of the lungs. • inflammations of the pancreas (severe pain in the stomach or back) • liver problems, kidney failure, increased blood levels of creatinine (a waste product that your kidneys should normally remove).. • severe rashes (at the same time you may feel unwell or develop a fever), itching. • abnormal muscle breakdown (you may feel pain or weakness in your muscles) which can lead to kidney problems. • swollen glands, blood disorders (reduction in the number of blood cells, which can make infection more likely and can make you look pale, feel tired and feverish, and bruise more easily). • decreased sweating, overheating.
Zelo redki neželeni učinki (verjetno se bodo pojavili pri manj kot 1 od vsakih 10. 000 bolnikov): • halucinacije, izguba spomina, koma, nevroleptični maligni sindrom (nezmožnost gibanja, znojenje, vročina, inkontinenca), epileptični status (dolgotrajen ali ponavljajoč se napad krčev); • dihalne motnje, kratka sapa, vnetje pljuč; • vnetja trebušne slinavke (hude bolečine v trebuhu ali križu); • težave z jetri, ledvična odpoved, zvišan nivo kreatinina (odpadna snov, ki se ponavadi izloča skozi ledvice) v krvi; • hudi izpuščaji (hkrati se lahko slabo počutite ali dobite vročino), srbenje; • nenormalno razpadanje mišic (lahko čutite bolečine ali oslabelost mišic), ki lahko povzroči težave z ledvicami; • otekle bezgavke, bolezni krvi (zmanjšanje števila krvničk, zaradi katerega se lažje okužite, ste bledi, utrujeni in vročični in vam brez omembe vrednega vzroka nastajajo modrice);
STORING ZONEGRAN
SHRANJEVANJE ZDRAVILA ZONEGRAN
Keep Zonegran out of the reach and sight of children.
Zdravilo Zonegran shranjujte nedosegljivo otrokom!
Do not store above 30°C.
Shranjujte pri temperaturi do 30 ˚C.
Do not use Zonegran after the expiry date stated on the blister and the carton.
Zonegrana ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu ali škatli.
Do not use if you notice any damage to the capsules, blister or carton or any visible signs of deterioration in the medicine.
Ne uporabite zdravila, če opazite kakršnokoli poškodbo kapsul, pretisnega omota ali škatlice ali kakšne vidne znake kvarjenja zdravila.
What Zonegran contains The active substance in Zonegran hard capsules is zonisamide.
Zdravilna učinkovina v trdih kapsulah zdravila Zonegran je zonisamid.
• The other ingredients that are present in the capsule contents are: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate.
• Pomožne snovi v kapsulah so: mikrokristalna celuloza, hidrogenirano rastlinsko olje in natrijev lavrilsulfat.
• The capsule shell contains: gelatin, titanium dioxide (E171), shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
• Ovojnica kapsule vsebuje: želatino, titanijev dioksid (E171), šelak, propilenglikol, kalijev hidroksid, črni železov oksid (E172).
Additionally the 100 mg capsule shell contains sunset yellow FCF (E110) and allura red (E129).
Poleg tega ovojnica 100- miligramske kapsule vsebuje še barvili sončno rumeno FCF (E110) in rdeče AC (E129).
See Section 2 for important information about the ingredient, sunset yellow FCF (E110).
Za pomembne podatke o sestavini barvila sončno rumeno FCF (E110) glejte poglavje 2.
- Zonegran 25 mg hard capsules have a white opaque body and a white opaque cap and are
- Zonegran 25 mg trde kapsule imajo bel, neprozoren spodnji del kapsule in bel, neprozoren
printed with a logo and “ ZONEGRAN 25” in black.
zgornji del kapsule, na katerem je natisnjen logo in ''ZONEGRAN 25'' v črni barvi.
- Zonegran 50 mg hard capsules have a white opaque body and a grey opaque cap and are printed
- Zonegran 50 mg trde kapsule imajo bel, neprozoren spodnji del kapsule in siv, neprozoren
with a logo and “ ZONEGRAN 50” in black.
zgornji del kapsule, na katerem je natisnjen logo in ''ZONEGRAN 50'' v črni barvi.
- Zonegran 100 mg hard capsules have a white opaque body and a red opaque cap and are printed
- Zonegran 100 mg trde kapsule imajo bel, neprozoren spodnji del kapsule in rdeč, neprozoren
with a logo and “ ZONEGRAN 100” in black.
zgornji del kapsule, na katerem je natisnjen logo in ''ZONEGRAN 100'' v črni barvi.
Zonegran capsules are packaged in blister packs supplied in boxes containing:
Zonegran kapsule so pakirane v pretisnih omotih v škatlicah, ki vsebujejo:
14, 28, 56 and 84 capsules
14, 28, 56 in 84 kapsule
14, 28, 56 and 84 capsules
14, 28, 56 84 kapsule
28, 56, 84, 98 and 196 capsules.
28, 56, 84, 98 in 196 kapsule.
Marketing Authorisation Holder Eisai Ltd., 3 Shortlands, London W6 8EE, United Kingdom.
53 Imetnik dovoljenja za promet z zdravilom Eisai Ltd., 3 Shortlands, London W6 8EE, Velika Britanija.
Manufacturer Eisai Manufacturing Ltd, Titan Court, 3 Bishop Square, Hatfield, Hertfordshire AL10 9NE, United Kingdom.
Izdelovalec Eisai Manufacturing Ltd, Titan Court, 3 Bishop Square, Hatfield, Hertfordshire AL10 9NE, Velika Britanija.
51 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
What is ZOSTAVAX?
Kaj je zdravilo ZOSTAVAX?
It is a powder and solvent to be made up into a suspension for injection.
Zdravilo ZOSTAVAX je cepivo, ki ga sestavljata prašek in vehikel za pripravo suspenzije za injiciranje.
The active substance is the attenuated (weakened) varicella-zoster virus.
Zdravilna učinkovina je atenuiran (oslabljen) virus varicella- zoster.
What is ZOSTAVAX used for?
Za kaj se zdravilo ZOSTAVAX uporablja?
ZOSTAVAX is used to vaccinate people aged 60 years or older, to prevent herpes zoster (also known as zoster or shingles) and the long-lasting nerve pain that may follow the disease (post-herpetic neuralgia).
Cepivo ZOSTAVAX se uporablja za cepljenje ljudi, starih 60 let ali več, za preprečevanje herpesa zostra (poznan tudi kot zoster ali pasovec) in dolgotrajne bolečine živca, ki se lahko razvije v bolezen (postherpetična nevralgija).
How is ZOSTAVAX used?
Kako se zdravilo ZOSTAVAX uporablja?
ZOSTAVAX is provided as two separate components: a powder that must be kept frozen, and a solvent, in a vial or pre-filled syringe, that is kept in a refrigerator or at room temperature.
Cepivo ZOSTAVAX se dobavlja v obliki dveh ločenih komponent: praška, ki ga je treba hraniti v zamrznjenem stanju, in vehikla v viali ali predhodno napolnjeni brizgi, ki ga hranimo v hladilniku ali pri sobni temperaturi.
They will then inject the suspension subcutaneously (just under the skin) preferably into the upper arm.
Potem bosta suspenzijo injicirala subkutano (pod kožo), po možnosti v zgornji predel roke.
How does ZOSTAVAX work?
Kako zdravilo ZOSTAVAX deluje?
Herpes zoster, or shingles, is a disease caused by the varicella-zoster virus, the same virus that causes chickenpox.
Isti virus povzroči tudi norice.
After chickenpox, the varicella-zoster virus stays in the body, in the nervous system, in a ‘ dormant’ (inactive) state.
Po noricah ostane virus varicella- zoster v telesu v živčnem sistemu, v ‘ mirujoči ’ (neaktivni) obliki.
Sometimes, generally in older people, and for reasons which are not fully understood, the virus becomes active again, and the patient develops shingles, a painful, blistering rash typically in one part of the body.
Pasovec je boleč, mehurčast kožni izpuščaj, ki se običajno pojavi na omejenem delu telesa.
The rash takes usually several weeks to clear, and afterwards, there may also be pain, which can be severe and may be lasting months (post-herpetic neuralgia) in the area where the rash was.
Potrebnih je več tednov, da izpuščaj izgine, vendar lahko mesto izpuščaja ostane boleče, včasih zelo boleče, tudi do več mesecev (postherpetična nevralgija).
The risk to develop shingles seems to be linked to a decline in the specific immunity (the way the body defends itself) against varicella-zoster virus.
Tveganje za razvoj pasovca je verjetno povezano z zmanjšanjem določene imunosti (načina, kako se telo brani) proti virusu varicella- zoster.
ZOSTAVAX is a vaccine that was shown to “ boost” this specific immunity, which is thought to be the mechanism by which it protects against shingles and the pain the disease is associated with.
Zdravilo ZOSTAVAX je cepivo, ki dokazano “ pospešuje ” to določeno imunost, ki deluje kot mehanizem, ki varuje pred pasovcem in bolečino, ki sta povezana z boleznijo.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Raziskava je bila izvedena po metodi dvojno 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The main study of ZOSTAVAX compared the medicine to a placebo (a dummy vaccine) in over 38,500 patients aged between 59 and 99 years of age.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged slepega preizkušanja, kar pomeni, da nista ne zdravnik ne bolnik vedela, katero zdravljenje je bolnik prejel.
The patients were followed for 2 to 4.5 years after vaccination.
Bolnike so nadzorovali od 2 do 4, 5 let po cepljenju.
The measure of the effectiveness of ZOSTAVAX was based on the number of people who developed shingles and post-herpetic pain during the study.
Merilo učinkovitosti cepiva ZOSTAVAX je temeljilo na številu ljudi, pri katerih sta se med raziskavo razvila pasovec in postherpetična bolečina.
What benefit has ZOSTAVAX shown during the studies?
Kakšne koristi je zdravilo ZOSTAVAX izkazalo med raziskavami?
ZOSTAVAX was more effective than placebo in preventing the development of shingles.
Cepivo ZOSTAVAX je bilo bolj učinkovito kot placebo pri preprečevanju razvoja pasovca.
Less people developed shingles after vaccination with ZOSTAVAX than after receiving a placebo injection:
Pasovec se je po cepljenju s cepivom ZOSTAVAX razvil pri manjšemu številu ljudi v primerjavi z injiciranjem placeba:
315 of the 19,254 patients who received the medicine had shingles during the study, against 642 of the 19,247 who received a placebo.
315 od 19. 254 bolnikov, ki so prejeli zdravilo, je med raziskavo imelo pasovec, v primerjavi z 642 od 19. 247 bolnikov, ki so prejeli placebo.
This means that vaccinating 1,000 people with ZOSTAVAX will cut the number of cases of shingles seen over one year from about 11 to 6.
To pomeni, da bo cepljenje 1. 000 ljudi s cepivom ZOSTAVAX zmanjšalo število obolelih s pasovcem v obdobju enega leta od približno 11 na 6 primerov.
ZOSTAVAX was also more effective than placebo in its effect on post-herpetic neuralgia:
Cepivo je bilo obenem učinkovitejše od placeba pri učinkovanju na postherpetično nevralgijo:
27 of the ZOSTAVAX patients had post-herpetic neuralgia, against 80 in the placebo group.
27 bolnikov, ki so prejeli cepivo ZOSTAVAX, je imelo postherpetično nevralgijo v primerjavi z 80 bolniki iz skupine, ki je prejemala placebo.
What is the risk associated with ZOSTAVAX?
Kakšna tveganja so povezana z zdravilom ZOSTAVAX?
In studies, the most common side effects (seen in more than 1 patient in 10) are reactions at the site of the injection (redness, pain, swelling, itching, warmth and bruising).
V raziskavah so bili najpogostejši neželeni učinki (opaženi pri več kot 1 od 10 bolnikov) reakcije na mestu injiciranja (rdečina, bolečina, oteklina, srbenje, toplota in modrica).
For the full list of all side effects reported with ZOSTAVAX, see the Package Leaflet.
Celovit seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva ZOSTAVAX, najdete v Navodilih za uporabo.
ZOSTAVAX should not be used in people who may be hypersensitive (allergic) to any of the ingredients of the vaccine, including neomycin (an antibiotic).
Cepiva ZOSTAVAX ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) katerokoli sestavino cepiva, vključno z neomicinom (antibiotik).
The vaccine should not be used in people who have problems with their immune system, either because they have a disease such as leukaemia, lymphoma, AIDS, or because they are taking medicines that affect the immune system.
Cepiva ne smejo uporabljati osebe, ki imajo težave s svojim imunskim sistemom, bodisi ker imajo bolezen, kot je levkemija, limfom ali AIDS, ali ker jemljejo zdravilo, ki vpliva na imunski sistem.
It should also not be used in patients with active untreated tuberculosis and in pregnant women.
Prav tako se cepiva ne sme uporabljati pri bolnikih z aktivno, nezdravljeno tuberkulozo, ali pri nosečnicah.
Why has ZOSTAVAX been approved?
Zakaj je bilo zdravilo ZOSTAVAX odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that ZOSTAVAX’ s benefits are greater than its risks for the prevention of herpes zoster (“ zoster” or shingles) and post-herpetic neuralgia in individuals from 60 years of age.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila ZOSTAVAX pri preprečevanju virusa zoster (“ zoster ” ali pasovec) in postherpetične nevralgije pri posameznikih, starih 60 let ali več, večje od z njim povezanih tveganj.
They recommended that ZOSTAVAX be given marketing authorisation.
Zato je priporočil, da se za zdravilo ZOSTAVAX podeli dovoljenje za promet z zdravilom.
Which measures are being taken to ensure the safe use of ZOSTAVAX?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila ZOSTAVAX?
The company that makes ZOSTAVAX will look at the use of the vaccine in patients whose immune system is weakened.
Podjetje, ki izdeluje zdravilo ZOSTAVAX, bo spremljalo uporabo cepiva pri bolnikih, ki imajo oslabljen imunski sistem.
They will also study the duration of the protection that the vaccine gives.
Obenem bo podjetje preučilo, koliko časa traja zaščita, ki jo daje cepivo.
Other information about ZOSTAVAX:
Druge informacije o zdravilu ZOSTAVAX:
The European Commission granted a marketing authorisation valid throughout the European Union for ZOSTAVAX to Sanofi Pasteur MSD SNC on 19 May 2006.
Evropska komisija je dovoljenje za promet z zdravilom ZOSTAVAX, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pasteur MSD SNC dne 19. maja 2006.
The full EPAR for ZOSTAVAX can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo ZOSTAVAX je na voljo tukaj.
EU/ 1/ 06/ 341/ 001
Številka EU EU/ 1/ 06/ 341/ 001
Zostavax
Izmišljeno ime Zostavax
> 19,400 PFU of varicella-zoster virus (Live)
Jakost > 19400 PFU virusa varicella - zoster (živ)
Powder and solvent for suspension for injection
Farmacevtska oblika Prašek in vehikel za suspenzijo za injiciranje
Subcutaneous use
pot uporabe Subkutana uporaba
powder: vial (glass); solvent: vial (glass)
Ovojnina prašek: viala (steklo); vehikel: viala (steklo)
1 vial + 1 vial
Vsebina Velikost pakiranja 0, 65 ml 1 viala + 1 viala
> 19,400 PFU of varicella-zoster virus (Live)
> 19400 PFU virusa varicella - zoster (živ)
10 vials + 10 vials
0, 65 ml 10 vial + 10 vial
Powder and solvent for suspension for injection in a pre-filled syringe
Prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi
1 vial + 1 pre-filled syringe with attached needle
0, 65 ml 1 viala + 1 napolnjena injekcijska brizga z nameščeno iglo
10 vials + 10 pre-filled syringes with attached needle
0, 65 ml 10 vial + 10 napolnjenih injekcijskih brizg z nameščenimi iglami
1 vial + 1 pre-filled syringe without needle
0, 65 ml 1 viala + 1 napolnjena injekcijska brizga brez igle
10 vials + 10 pre-filled syringes without needle
0, 65 ml 10 vial + 10 napolnjenih injekcijskih brizg brez igel
20 vials + 20 pre-filled syringes without needle
0, 65 ml 20 vial + 20 napolnjenih injekcijskih brizg brez igel
1 vial + 1 pre-filled syringe + 1 separate needle
0, 65 ml 1 viala + 1 napolnjena injekcijska brizga + 1 nepritrjena igla
10 vials + 10 pre-filled syringes + 10 separate needles
0, 65 ml 10 vial + 10 napolnjenih injekcijskih brizg + 10 nepritrjenih igel
20 vials + 20 pre-filled syringes + 20 separate needles
0, 65 ml 20 vial + 20 napolnjenih injekcijskih brizg + 20 nepritrjenih igel
1 vial + 1 pre-filled syringe + 2 separate needles
0, 65 ml 1 viala + 1 napolnjena injekcijska brizga +2 nepritrjeni igli
EU/ 1/ 06/ 341/ 012
1/ 2 EU/ 1/ 06/ 341/ 012
10 vials + 10 pre-filled syringes + 20 separate needles
10 vial + 10 napolnjenih injekcijskih brizg + 20 nepritrjenih igel
20 vials + 20 pre-filled syringes + 40 separate needles
20 vial + 20 napolnjenih injekcijskih brizg + 40 nepritrjenih igel
zoster vaccine (live)
cepivo proti herpesu zostru (živo)
After reconstitution, 1 dose (0.65 ml) contains:
Po rekonstituciji 1 odmerek (0, 65 ml) vsebuje:
Varicella-zoster virus1, Oka/ Merck strain, (live, attenuated) not less than 19400 PFU2 1 produced in human diploid (MRC-5) cells 2 PFU = Plaque-forming units
Virus varicella- zoster1, sev Oka/ Merck, (živ, atenuiran) ne manj kot 19. 400 PFU2 1 pridobljen na humanih diploidnih (MRC- 5) celicah 2 PFU (Plaque- forming units) = enote, ki tvorijo plak
Before reconstitution, the powder is a white to off-white compact crystalline plug, and the solvent is a clear, colourless fluid.
Pred rekonstitucijo je prašek bel do sivo- bel, v grudo stisnjen kristalni prašek, vehikel pa bistra, brezbarvna tekočina.
ZOSTAVAX is indicated for prevention of herpes zoster (“ zoster” or shingles) and herpes zoster-related post-herpetic neuralgia (PHN).
Cepivo ZOSTAVAX je indicirano za preprečevanje herpesa zostra (“ zoster ” ali pasovec) in z njim povezane postherpetične nevralgije (PHN – post- herpetic neuralgia).
Individuals should receive a single dose administered subcutaneously.
Oseba mora prejeti enkraten odmerek, ki se ga aplicira subkutano.
The vaccine is to be injected SUBCUTANEOUSLY, preferably in the deltoid region.
Trenutno ni znano, ali je potreben drugi odmerek.
See section 6.6 for preparation instructions.
Glejte poglavje 5. 1.
DO NOT INJECT INTRAVASCULARLY.
Za navodila za pripravo glejte poglavje 6. 6.
4.3 Contraindications
NE INJICIRAJTE INTRAVASKULARNO!
• Hypersensitivity to the active substance, to any of the excipients or trace residuals (e. g., neomycin) (see sections 4.4 and 6.1).
4. 3 Kontraindikacije
2 • 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 2 prejemajo kortikosteroide kot nadomestno zdravljenje, npr. v primeru insuficience nadledvične žleze. • Aktivna, nezdravljena tuberkuloza. • Nosečnost (glejte poglavji 4. 4 in 4. 6).
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 and 6.1).
Pri cepljenju obstaja možnost pojava preobčutljivostnih reakcij, ne le na zdravilno učinkovino, temveč tudi na pomožne snovi in snovi, prisotne v sledeh (npr. neomicin) (glejte poglavji 4. 3 in 6. 1).
However, a history of contact dermatitis due to neomycin is not a contraindication to receiving live virus vaccines.
Vendar pa kontaktni dermatits zaradi neomicina v anamnezi ni kontraindikacija za cepiva z živimi virusi.
Before vaccination of women of child-bearing potential, pregnancy must be excluded and effective contraception must be used for 3 months following vaccination (see sections 4.3 and 4.6).
Ženske v rodni dobi morajo še 3 mesece po cepljenju uporabljati učinkovito kontracepcijo (glejte poglavji 4. 3 in 4. 6).
Deferral of vaccination should be considered in the presence of fever.
V primeru zvišane telesne temperature je treba razmisliti o odložitvi cepljenja.
Vaccination with ZOSTAVAX may not result in protection in all vaccine recipients.
Cepivo ZOSTAVAX morda ne bo zaščitilo vseh cepljenih oseb.
The safety and efficacy of ZOSTAVAX have not been established in adults who are known to be infected with HIV with or without evidence of immunosuppression (see section 4.3).
Varnost in učinkovitost cepiva ZOSTAVAX nista bili dokazani pri odraslih, ki so okuženi z virusom HIV in bodisi imajo, bodisi nimajo znakov oslabljenega imunskega odziva (glejte poglavje 4. 3).
Transmission In clinical trials with ZOSTAVAX, transmission of the vaccine virus has not been reported.
Prenos vakcinalnega virusa Med kliničnim preskušanjem cepiva ZOSTAVAX o prenosu vakcinalnega virusa niso poročali.
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, VZV- susceptible infant grandchildren).
Izkušnje s cepivi proti noricam iz obdobja trženja pa kažejo, da lahko v redkih primerih pride do prenosa vakcinalnega virusa s cepljene osebe, pri kateri se je pojavil noricam podoben izpuščaj, na dovzetno osebo, ki je v stiku (na primer, za okužbo z VZV dovzeten otrok).
Transmission of vaccine virus from varicella vaccine recipients without a varicella-zoster virus (VZV)-like rash has been reported but has not been confirmed.
Poročali so tudi o prenosu vakcinalnega virusa z oseb, ki so bile cepljene s cepivi proti noricam in pri katerih se okužbi z virusom varicella- zoster (VZV - varicella- zoster virus) podoben izpuščaj ni pojavil, vendar pa teh poročil niso potrdili.
The risk of transmitting the attenuated vaccine virus to a susceptible individual should be weighed against the risk of developing natural herpes zoster that could be transmitted to a susceptible individual.
Tveganje za prenos oslabljenega vakcinalnega virusa na dovzetne osebe je treba primerjati s tveganjem za pojav naravnega herpesa zostra, ki se lahko prenaša na dovzetne osebe.
ZOSTAVAX can be administered concomitantly with inactivated influenza vaccine as separate injections and at different body sites (see section 5.1).
ZOSTAVAX se lahko daje sočasno s cepivi proti gripi z inaktiviranimi virusi v ločenih injekcijah in na različne dele telesa (glejte poglavje 5. 1).
There are no studies in pregnant women.
Študije pri nosečnicah niso bile izvedene.
It is also not known whether ZOSTAVAX can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
Ni znano, če lahko cepivo ZOSTAVAX škoduje razvoju ploda ali vpliva na sposobnost razmnoževanja, če se ga aplicira nosečnici.
However naturally-occurring varicella-zoster virus infection is known to sometimes cause foetal harm.
Znano pa je, da naravna okužba z virusom varicella- zoster včasih škoduje razvoju ploda.
As ZOSTAVAX is not indicated in individuals less than 50 years of age, ZOSTAVAX is not intended to be administered to pregnant women.
Ker ZOSTAVAX ni indiciran pri osebah, mlajših od 50 let, ZOSTAVAX tudi ni namenjen uporabi pri nosečnicah.