natgillin/translations-raw huggingface dataset:
No deaths resulted from these events, and none of the hospitalised children required mechanical ventilation or admission to an intensive care unit.
Smrti zaradi teh dogodkov ni bilo in noben otrok, sprejet v bolnišnico, ni potreboval mehanične ventilacije ali sprejema na oddelek za intenzivno nego.
Four placebo-controlled studies included second season revaccination.
Štiri s placebom kontrolirane študije so vključevale ponovno cepljenje drugo sezono.
Adults aged 18 to 49 years
Odrasli v starosti od 18 do 49 let
For signs of allergic reactions, see section 4 “Possible side effects”.
Za znake alergijskih reakcij glejte poglavje 4, "Možni neželeni učinki".
The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Njeni znaki so podobni znakom navadne gripe, a so lahko veliko resnejši.
• if you have a blood disorder or a cancer that affects the immune system.
• če imate kakšno krvno bolezen ali raka, ki vpliva na imunski sistem.
None of the ingredients in the vaccine can cause the flu.
Nobena od sestavin cepiva ne more povzročiti gripe.
Influenza season
Sezona gripe
1 dose (0.2 ml) contains:
1 odmerek (0,2 ml) vsebuje:
Read all of this leaflet carefully before the vaccine is given because it contains important information for you or your child.
Pred uporabo cepiva natančno preberite navodilo, ker vsebuje za vas ali vašega otroka pomembne podatke!
• if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicine, or other treatment.
• če vam je zdravnik povedal, da imate oslabljen imunski sistem zaradi bolezni, zdravil ali kakšnega drugega zdravljenja.
This is because the vaccine may work less effectively.
Cepivo je namreč lahko v tem primeru manj učinkovito.
• severe allergic reaction: signs of a severe allergic reaction may include shortness of breath and swelling of the face or tongue.
• huda alergijska reakcija: med znaki hude alergijske reakcije so lahko težko dihanje in oteklost obraza ali jezika.
Adults aged 22 to 54 years
Odrasli v starosti od 22 do 54 let
The second dose should be administered after an interval of at least 4 weeks.
Drugi odmerek je treba dati po presledku vsaj 4 tednov.
No data are available for individuals with severe immunosuppression (see section 4.4).
Podatkov za osebe s hudo imunosupresijo ni na voljo (glejte poglavje 4.4).
56 Days after inactivated vaccine
56 dni po inaktiviranem cepivu
Serological response defined as a ≥4-fold rise in antibody titer (≥1:20).
Serološki odziv je opredeljen kot ≥ 4-kratno povečanje titra protiteles (≥ 1:20).
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti se cepiva ne sme mešati z drugimi zdravili.
H1N1 pandemic LAIV vaccine in children aged 2 to 17 years
Pandemsko cepivo LAIV H1N1 pri otrocih v starosti od 2 do 17 let
fewer cases than injectable fewer cases than injectable
manj primerov kot z injiciranim manj primerov kot z injiciranim
• if you have severe asthma or are currently wheezing.
• če imate hudo astmo ali trenutno piskajoče dihate.
At the time of approval of the next pandemic variation
Ob času odobritve naslednje spremembe za pandemijo.
Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Pandemska gripa je vrsta gripe, ki se pojavlja v presledkih; ti presledki lahko trajajo od manj kot 10 let do nekaj desetletij.
Children less than 12 months of age should not receive this vaccine because of the risk of side effects.
Otroci, mlajši od 12 mesecev, zaradi tveganja za neželene učinke ne smejo dobiti tega cepiva.
28 Days after inactivated vaccine
28 dni po inaktiviranem cepivu
Therefore, as some viruses are excreted in human milk, the vaccine should not be used during breastfeeding.
Ker se nekateri virusi pri človeku izločajo v materino mleko, se tega cepiva med nosečnostjo ne sme uporabljati.
The influenza strain used for the vaccine in an offically declared pandemic is recommended by the World Health Organisation.
Sev gripe, uporabljen v cepivu med uradno razglašeno pandemijo, priporoča Svetovna zdravstvena organizacija.
This is because of the risk of a very rare but serious disease (Reye's syndrome).
Vzrok za to je tveganje za zelo redko, vendar resno bolezen (Reyev sindrom).
T/LAIV efficacy
Učinkovitost T/LAIV
Data presented for clinical trial D153-P504 are for study participants who received two doses of study vaccine or placebo.
Podatki, prikazani za klinično preskušanje D153-P504, so podatki za tiste udeležence študije, ki so prejeli dva odmerka raziskovanega cepiva ali placeba.
This is because of the risk of Reye's syndrome, a very rare but serious disease that can affect the brain and liver.
Vzrok za to je tveganje za Reyev sindrom: to je zelo redka, vendar resna bolezen, ki lahko prizadene možgane in jetra.
Date of first authorisation: 20 May 2016 Date of latest renewal: 4 April 2018
Datum prve odobritve: 20. maj 2016
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a State laboratory or a laboratory designated for that purpose.
V skladu s členom 114 Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
The maximum amount of ovalbumin is less than 0.024 micrograms per 0.2 ml dose (0.12 micrograms per ml).
Največja količina ovalbumina je manjša od 0,024 mikrograma na 0,2-ml odmerek (0,12 mikrograma na ml).
• if you are in close contact with someone with a severely weakened immune system (for example, a bone marrow transplant patient needing isolation).
• če ste v tesnem stiku s kom, ki ima močno oslabel imunski sistem (npr. bolnik po presaditvi kostnega mozga, ki potrebuje izolacijo).
Geometric mean titer
Geometrična sredina titra
• If you are pregnant, think you may be pregnant, or plan to become pregnant soon, tell your doctor, nurse or pharmacist before vaccination.
• Če ste noseči, menite, da bi lahko bili noseči ali kmalu načrtujete zanositev, morate o tem pred cepljenjem obvestiti zdravnika, medicinsko sestro ali farmacevta.
Of these subjects, 319 received a second dose (256 subjects monovalent vaccine; 63 subjects placebo).
Od teh preiskovancev jih je 319 prejelo drugi odmerek (256 monovalentno cepivo, 63 placebo).
6 to 59 M 7,852 2004-2005
6 do 59 m 7.852 2004-2005
Immune response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Imunski odziv je lahko nezadosten pri bolnikih z endogeno ali iatrogeno imunosupresijo.
• DO NOT USE WITH A NEEDLE.
• NE UPORABLJAJTE GA Z IGLO.
It is used in children and adolescents 12 months to less than 18 years of age.
Uporabljamo ga pri otrocih in mladostnikih v starosti od 12 mesecev do manj kot 18 let.
• if the child is less than 12 months of age.
• če je otrok mlajši od 12 mesecev.
Liverpool L24 9JW United Kingdom
Liverpool L24 9JW, Velika Britanija
In clinical studies with the vaccine, most side effects were mild in nature and short-term.
V kliničnih študijah s tem cepivom je bila večina neželenih učinkov blagih in kratkotrajnih.
Subjects with 4-fold antibody rise (percentage)
Preiskovanci s 4-kratnim porastom protiteles (odstotek)
When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection against the influenza virus.
Ko oseba dobi cepivo, imunski sistem (naravni obrambni sistem telesa) ustvari lastna protitelesa proti virusu gripe.
Days are counted relative to the only P/IIV dose for Groups 1-4 and after the first of 2 P/IIV doses for Group 5.
Dnevi so šteti glede na edini odmerek P/IIV za 1. do 4. skupino in po prvem od dveh odmerkov P/IIV za 5. skupino.
- This vaccine has been prescribed for you or your child only.
- Cepivo je bilo predpisano vam ali vašemu otroku osebno in ga ne smete dajati drugim.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements for medical waste.
Neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi za medicinske odpadke.
Other special populations:
Druge posebne skupine bolnikov:
Additional data are provided from 289 adults enrolled in studies of vaccine candidates for an additional 7 influenza subtypes and from 240 adults and 259 children enrolled in studies of the monovalent 2009 H1N1 pandemic vaccine.
Dodatni podatki izvirajo od 289 odraslih, vključenih v študije kandidatov za cepiva za dodatnih 7 podtipov gripe in od 240 odraslih in 259 otrok, vključenih v študije monovalentnega pandemskega cepiva 2009 H1N1.
Administration of influenza antiviral agents within two weeks of vaccination may affect the response of the vaccine.
Uporaba protivirusnih zdravil proti gripi v dveh tednih po cepljenju lahko poslabša odziv na cepivo.
Most hospitalisations were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination.
Vzrok večine sprejemov v bolnišnico so bile okužbe prebavil in dihal; pojavile so se več kot 6 tednov po cepljenju.
However, in a pandemic situation, your doctor may recommend to give you the vaccine provided that appropriate medical treatement is immediately available in case of an allergic reaction.
Toda v primeru pandemije vam bo zdravnik morda vseeno priporočil uporabo cepiva, pod pogojem, da je nemudoma na voljo ustrezno zdravljenje za primer alergijske reakcije.
D153-P502 Europe 6 to 35 M
D153-P502 Evropa 6 do 35 m
M = months Number of study participants for year 1 or year 2 primary efficacy analysis.
ZDA 15 do 71 m m = mesecev Število preiskovancev v študiji za 1. ali 2. leto primarne analize učinkovitosti.
After declaration in the EU of a pandemic and after implementation of the pandemic vaccine
Po razglasitvi pandemije v EU in po uvedbi cepljenja s cepivom proti pandemični gripi.
Due to the association of Reye's syndrome with salicylates and wild-type influenza infection, healthcare providers should assess the potential risks of administering the vaccine with the potential benefits in a pandemic situation (see section 4.5).
Zaradi povezanosti Reyevega sindroma s salicilati in okužbo z divjim tipom gripe morajo zdravniki pretehtati možna tveganja uporabe cepiva v primerjavi z možnimi koristmi v primeru pandemije (glejte poglavje 4.5).
11 to 24 M 1,150 2002-2003
11 do 24 m 1.150 2002-2003
The adverse reactions reported were similar to those seen with the recommended single dose of T/LAIV and Fluenz Tetra.
Zabeleženi neželeni učinki so bili podobni tistim, ki so jih opažali s priporočenim enkratnim odmerkom T/LAIV in cepivom Fluenz Tetra.
USA, Europe, Asia/Oceania
ZDA, Evropa, Azija/Oceanija
Serum samples were available from 7 subjects in Group 3 on Day 28 and from 18 subjects in Group 5 on Day 56.
Na voljo so bili vzorci seruma 7 preiskovancev v 3. skupini 28. dan in 18 preiskovancev v 5. skupini 56 dan.
T/LAIV's efficacy data in the paediatric population consist of 9 controlled studies comprising over 20,000 infants and toddlers, children and adolescents, conducted during 7 influenza seasons.
Podatki o učinkovitosti T/LAIV v pediatrični populaciji izvirajo iz 9 kontroliranih študij, ki so skupaj zajele več kot 20.000 dojenčkov, malčkov, otrok in mladostnikov in so bile izvedene v 7 sezonah gripe.
Children less than 12 months
Otroci, mlajši od 12 mesecev
There are a moderate amount of data from the use of T/LAIV and the seasonal Fluenz Tetra vaccine in pregnant women.
Obstaja zmerna količina podatkov o uporabi T/LAIV in sezonskega cepiva Fluenz Tetra pri nosečnicah.
No data are available for individuals with significant clinical immunodeficiency.
Podatkov o osebah s pomembno klinično imunsko pomanjkljivostjo ni.
Children and adolescents from 12 months to less than 18 years of age 0.2 ml (administered as 0.1 ml per nostril).
Otroci in mladostniki, stari od 12 mesecev do manj kot 18 let 0,2 ml (uporabljeno kot 0,1 ml na nosnico).
Before use, the vaccine may be taken out of the refrigerator once for a maximum period of 12 hours at a temperature not above 25°C.
Pred uporabo se sme cepivo vzeti iz hladilnika enkrat za največ 12 ur pri temperaturi do 25 ° C. Če cepivo po tem 12-urnem obdobju ni uporabljeno, ga je treba zavreči.
Reduction in culture-confirmed influenza illness relative to placebo.
Zmanjšanje s kulturo potrjene gripe v primerjavi s placebom.
Number of study participants
Število udeležencev v študiji
• if you are already taking acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever).
• če že jemljete acetilsalicilno kislino (zdravilno učinkovino, ki jo vsebujejo številna zdravila proti bolečinam in zdravila za zniževanje visoke telesne temperature).
Number of Vietnam inactivat ed vaccine doses
Število odmerkov inaktiviranega cepiva Vietnam 2004
5 single-use nasal applicators (0.2 ml each)
5 nosnikov za enkratno uporabo (vsak 0,2 ml)
Post-marketing data from occasional inadvertent gestational use of the seasonal vaccines offer some reassurance.
Podatki v obdobju trženja cepiva o občasni naključni uporabi sezonskih cepiv med nosečnostjo, dajejo določeno zagotovilo.
Do not use this vaccine after the expiry date which is stated on the applicator label after the letters EXP.
Cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki nosnika poleg oznake EXP.
Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age.
Preprečevanje gripe v primeru uradno razglašene pandemije pri otrocih in mladostnikih v starosti od 12 mesecev do manj kot 18 let.
Study group
Študijska skupina
Animal developmental toxicity studies conducted with T/LAIV and Fluenz Tetra do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Razvojne študije na živalih, opravljene s T/LAIV in cepivom Fluenz Tetra, ne kažejo neposrednih ali posrednih škodljivih učinkov, kar zadeva toksične vplive na sposobnost razmnoževanja.
Metabolism and nutrition disorders Very common: Decreased appetite
Presnovne in prehranske motnje Zelo pogosti: zmanjšanje apetita
However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Toda v primeru pandemije je lahko uporaba tega cepiva vseeno primerna pod pogojem, da je nemudoma na voljo vse, kar je potrebno za reanimacijo, če bi bila potrebna.
The rate of wheezing was not increased in T/LAIV recipients 24 months of age and older.
Delež piskajočega dihanja ni bil večji med prejemniki T/LAIV, starimi 24 mesecev ali več.
In a pandemic situation, healthcare providers need to assess the potential benefits, alternatives, and risks of administering the vaccine to children and adolescents with significant clinical immunodeficiency due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids.
V primeru pandemije mora zdravnik oceniti morebitne koristi, alternative in tveganja uporabe cepiva za otroke in mladostnike, ki imajo pomembno klinično imunsko pomanjkljivost zaradi bolezni ali imunosupresivnega zdravljenja, na primer zaradi akutne ali kronične levkemije, limfoma, simptomatske okužbe s HIV, pomanjkljivosti celične imunosti ali visokih odmerkov kortikosteroidov.
Table 1 T/LAIV efficacy in placebo controlled paediatric studies
Preglednica 1 Učinkovitost T/LAIV v pediatričnih študijah, kontroliranih s placebom
Other medicines, other vaccines and Pandemic influenza vaccine H5N1 AstraZeneca Tell your doctor, nurse or pharmacist if the person being vaccinated is taking, has recently taken or might take any other medicines, including medicines that do not require a prescription.
Druga zdravila, druga cepiva in Cepivo proti pandemski gripi H5N1 AstraZeneca Zdravnika, medicinsko sestro ali farmacevta morate obvestiti, če oseba, ki bo cepljena, jemlje, je pred kratkim jemala ali pa bo morda začela jemati katero koli drugo zdravilo, vključno z zdravili, za katera ni potreben recept.
The incidence of wheezing within 15 days after vaccination was lower in T/LAIV recipients relative to seasonal inactivated vaccine recipients (19.5% vs. 23.8%, P=0.02).
Pojavnost piskajočega dihanja v 15 dneh po cepljenju je bila manjša med prejemniki T/LAIV kot med prejemniki sezonskega inaktiviranega cepiva (19,5 % v primerjavi s 23,8 %, p = 0,02).
The MAH should submit the final results of this study.
Imetnik dovoljenja za promet z zdravilom mora predložiti končne rezultate te študije.
In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus.
Če se stiku z imunsko zelo oslabelimi osebami ni mogoče izogniti, je treba možno tveganje za prenos virusa gripe iz cepiva pretehtati v primerjavi s tveganjem za okužbo z divjim tipom virusa gripe in njegovim prenosom.
PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (IN TRAYS)
VELIKOST PAKIRANJA Z 10 NOSNIKI ZA ENKRATNO UPORABO (V PLADNJIH)
All children will receive a second, follow-up dose after an interval of at least 4 weeks.
Vsi otroci bodo po 4-tedenskem presledku dobili še drugi, nadaljevalni odmerek.
The safety of seasonal live attenuated influenza vaccine (LAIV) in children with severe asthma and active wheezing has not been adequately studied.
Varnost sezonskega cepiva z živim oslabljenim virusom gripe (LAIV - Live Attenuated Influenza Vaccine) pri otrocih s hudo astmo in aktivnim piskajočim dihanjem ni dovolj raziskana.
P/LAIV priming dose
Primarni odmerek P/LAIV
• It is recommended that Pandemic influenza vaccine H5N1 AstraZeneca is not given at the same time as influenza-specific antiviral medicines such as oseltamivir and zanamivir.
• Priporočljivo je, da se Cepiva proti pandemski gripi H5N1 AstraZeneca ne uporabi hkrati s protivirusnimi zdravili, specifičnimi za gripo, kakršni sta na primer oseltamivir in zanamivir.
Post-marketing experience with seasonal T/LAIV Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed.
Izkušnje s sezonskim cepivom T/LAIV iz obdobja po prihodu cepiva na trg Zabeležili so zelo redke primere Guillain-Barréjevega sindroma in poslabšanja simptomov Leighovega sindroma (mitohondrijska encefalomiopatija).
In a surveillance study conducted by the US CDC (Griffin, et al, 2011) the effectiveness of the H1N1 pandemic LAIV vaccine in children 2 through 9 years of age was estimated at 81.9% (95% CI:13.6,
V spremljevalni študiji, ki so jo izvedli CDC ZDA (Griffin, et al. 2011), je bila ocenjena učinkovitost pandemskega cepiva LAIV H1N1 pri otrocih od 2. do 9. leta 81,9 % (95 % IZ:
The European Medicines Agency will review new information on this medicines at least every year and this leaflet will be updated as necessary.
Evropska agencija za zdravila bo vsaj enkrat letno ponovno pregledala nove podatke o tem zdravilu.
The study enrolled 69 subjects in 5 groups: Group 1 enrolled 11 subjects who had previously received 2 doses of the A/Vietnam/1203/2004 H5N1 pandemic live attenuated influenza vaccine (P/LAIV) in 2006-2007; Group 2 enrolled 10 subjects who had previously received 2 doses of the A/Hong Kong/213/2003 H5N1 P/LAIV in 2007; Group 3 enrolled 8 subjects who had previously received 2 doses of the A/British Columbia/CN-6/2004 H7N3 P/LAIV in 2010 (as a P/LAIV control group); Groups 4 and 5 each enrolled 20 subjects who had not been previously vaccinated with LAIV and were influenza H5 naïve.
Študija je zajela 69 oseb v 5 skupinah: 1. skupina je vključila 11 preiskovancev, ki so predhodno dobili 2 odmerka pandemskega oslabljenega cepiva proti gripi A/Vietnam/1203/2004 H5N1 (P/LAIV) v letih 2006-2007, 2. skupina je vključila 10 preiskovancev, ki so predhodno dobili 2 odmerka A/Hong Kong/213/2003 H5N1 P/LAIV leta 2007, 3. skupina je vključila 8 preiskovancev, ki so predhodno dobili 2 odmerka A/British Columbia/CN6/2004 H7N3 P/LAIV leta 2010 (kot kontrolno skupino P/LAIV), 4. in 5. skupina pa sta vsaka vključili 20 preiskovancev, ki predhodno niso bili cepljeni z LAIV in so bili naivni za gripo H5.
Europe, Asia/ Oceania, Latin America
Evropa, Azija/ Oceanija, Latinska Amerika
Clinical studies have evaluated the incidence of adverse reactions in 59 adults from 18 to 49 years of age receiving at least one dose of Pandemic influenza vaccine H5N1 AstraZeneca.
V kliničnih študijah so ocenili pojavnost neželenih učinkov pri 59 odraslih, starih od 18 do 49 let, ki so prejeli vsaj en odmerek Cepiva proti pandemski gripi H5N1 AstraZeneca.
Uncommon: Hypersensitivity reactions (including facial oedema, urticaria and very rare anaphylactic reactions)
Občasni: preobčutljivostne reakcije (vključno z edemom obraza, urtikarijo in zelo redkimi anafilaktičnimi reakcijami)
Seroresponse rates were slightly higher among subjects who were seronegative at baseline.
Deleži seropozitivnosti so bili nekoliko večji med preiskovanci, ki so bili izhodiščno seronegativni.
The European Medicines Agency has deferred the obligation to submit the results of studies with Pandemic influenza vaccine H5N1 AstraZeneca in one or more subsets of the paediatric population in prevention of influenza infection.
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s Cepivom proti pandemski gripi H5N1 AstraZeneca za eno ali več podskupin pediatrične populacije za preprečevanje okužbe z gripo.
The primary circulating strain was antigenically dissimilar from the H3N2 strain represented in the vaccine; efficacy against the mismatched A/H3N2 strain was 85.9% (95% CI: 75.3, 91.9).
Primarni sev v obtoku se je antigensko razlikoval od seva H3N2 v cepivu; učinkovitost proti neujemajočemu se sevu A/H3N2 je bila 85,9 % (95 % IZ: 75,3, 91,9).
Reduction in culture-confirmed influenza illness relative to injectable influenza vaccine.
Zmanjšanje s kulturo potrjene gripe v primerjavi s cepivom proti gripi za injiciranje.
P/LAIV H5N1 vaccine
Cepivo P/LAIV H5N1
12 to 35 M
12 do 35 m
6 to 35 M
6 do 35 m
FFU per 0.2 ml dose
enot FFU na 0,2-ml odmerek
H5N1 Hong Kong
H5N1 Hong Kong brez brez
Data for Group 3, subjects initially vaccinated with an H7N3 P/LAIV are not shown.
Podatki za 3. skupino (preiskovanci, uvodoma cepljeni s P/LAIV H7N3) niso prikazani.
In clinical studies, the safety profile of Pandemic influenza vaccine H5N1 AstraZeneca was comparable to the safety profile of the seasonal vaccines T/LAIV and Fluenz Tetra (see section 5.1 for more information).
V kliničnih študijah je bil varnostni profil Cepiva proti pandemski gripi H5N1 AstraZeneca primerljive z varnostnim profilom sezonskih cepiv T/LAIV in Fluenz Tetra (za več informacij glejte poglavje 5.1).
Immunocompromised
Imunsko oslabeli
Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event or hypersensitivity event following administration of the vaccine.
Vedno morata biti na voljo ustrezna medicinska oskrba in nadzor za primer, da se po dajanju cepiva pojavi anafilaktična ali preobčutljivostna reakcija.
Use of salicylates in children and adolescents for 4 weeks after vaccination should be avoided unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection.
Pri otrocih in mladostnikih se 4 tedne po cepljenju ne sme uporabljati salicilatov (razen če so medicinsko indicirani), ker je bil po uporabi salicilatov med okužbo z divjim tipom gripe opisan Reyev sindrom.