natgillin/translations-raw huggingface dataset:
The Committee also recommended that the vaccine be authorised in children from nine to 12 months of age only in certain situations, for example as part of a national vaccination programme, during an outbreak or for travel to a region where measles is common.
Odbor je poleg tega priporočil, da se cepivo v določenih okoliščinah lahko uporablja tudi pri otrocih, ki so dopolnili devet do 12 mesecev, kot npr. v okviru nacionalnega programa cepljenja, ob izbruhu bolezni ali potovanju v kraje, kjer so ošpice pogost pojav.
For children above 12 months of age, one ProQuad injection is sufficient to provide optimal protection against measles, mumps and rubella.
Pri otrocih, ki so stari več kot 12 mesecev, zadostuje ena injekcija cepiva ProQuad za optimalno zaščito proti ošpicam, mumpsu in rdečkam.
ProQuad is available as a powder and solvent that are made up into a suspension for injection.
Na voljo je v obliki praška in vehikla za pripravo suspenzije za injiciranje.
ProQuad must not be used in children who are hypersensitive (allergic) to any chickenpox vaccine or measles, mumps or rubella vaccine, to any of the other ingredients, or to neomycin.
Cepivo ProQuad se ne sme uporabljati pri otrocih, ki so preobčutljivi za (alergični na) katero koli cepivo proti noricam oziroma cepivo proti ošpicam, mumpsu in rdečkam, katero koli drugo sestavino zdravila ali na neomicin.
The main studies were carried out to look at the ability of one or two doses of the vaccine to trigger an immune response in 5,446 healthy children (aged 12 to 23 months).
Glavne študije so bile izvedene pri 5 446 zdravih otrocih (starih od 12 do 23 mesecev), da bi proučili sposobnost sprožanja imunskega odziva z dajanjem enega ali dveh odmerkov cepiva.
ProQuad may also be given to children from nine months of age in certain situations, for example as part of a national vaccination programme, during an outbreak or for travel to a region where measles is common.
V določenih okoliščinah se daje tudi otrokom, ki so dopolnili devet mesecev starosti, npr. v okviru nacionalnega programa cepljenja, ob izbruhu bolezni ali pri potovanju v kraje, kjer so ošpice pogost pojav.
Why has ProQuad been approved?
Zakaj je bilo zdravilo ProQuad odobreno?
ProQuad is given to children from 12 months of age to help protect them against the four diseases: measles, mumps, rubella, and chickenpox.
Cepivo ProQuad se daje otrokom po dopolnjenem 12. mesecu starosti za zaščito pred naslednjimi štirimi boleznimi: ošpicami, mumpsom, rdečkami in noricami.
ProQuad contains weakened forms of the viruses that cause measles, mumps, rubella and chickenpox.
Cepivo ProQuad vsebuje oslabljene oblike virusov, ki povzročajo ošpice, mumps, rdečke in norice.
ProQuad was compared with its ‘component vaccines', a triple vaccine against mumps, measles and rubella, and a vaccine against chickenpox.
Cepivo ProQuad so primerjali s „sestavljenimi cepivi“, tj. trojnim cepivom proti mumpsu, ošpicam in rdečkam, ter cepivom proti noricam.
How has ProQuad been studied?
Kako je bilo zdravilo ProQuad raziskano?
What is ProQuad used for?
Za kaj se zdravilo ProQuad uporablja?
How does ProQuad work?
Kako zdravilo ProQuad deluje?
How is ProQuad used?
Kako se zdravilo ProQuad uporablja?
What is ProQuad?
Kaj je zdravilo ProQuad?
ProQuad is a vaccine against measles, mumps, rubella, and varicella (chickenpox).
Zdravilo ProQuad je cepivo proti ošpicam, mumpsu, rdečkam in noricam (vodenim kozam).
Measles, mumps, rubella and varicella vaccine (live)
ProQuad cepivo proti ošpicam, mumpsu, rdečkam in noricam (živo)
Children between nine and 12 months of age should receive a second dose at least three months after the first dose to ensure that they are adequately protected against measles and chickenpox.
Da se zagotovi ustrezna zaščita pred ošpicami in noricami, morajo otroci, stari od 9 do 12 mesecev, drugi odmerek prejeti najmanj tri mesece po prvem odmerku.
Invented name Strength Pharmaceutical Form Route of Administration Packaging
Številka EU Izmišljeno Ime Jakost Farmacevtska Oblika Pot Uporabe
Package size
Velikost Pakiranja
Pre-filled syringe (glass) 3 ml (1 mg/ml) 4 pre-filled syringes l t o r
4 napolnjene injekcijske brizge o ā
Pre-filled syringe (glass) 3 ml (1 mg/ml) 1 pre-filled syringe
1 napolnjena injekcijska brizga
18 weeks.
18 tednov
Date of first authorisation: 04 December 2013 Date of latest renewal: 20 November 2018
Datum prve odobritve: 4. december 2013 Datum zadnjega podaljšanja: 20. november 2018
FFU***
FFE***
Age range as described in the protocol for the study.
Starostni razpon kot je opisan v protokolu za študijo.
Small white particles may be present.
Prisotni so lahko majhni beli delci.
This product contains genetically modified organisms (GMOs).
To cepivo vsebuje gensko spremenjene organizme (GSO).
See section 5 for advice on storage and disposal.
Glejte poglavje 5 za navodila o shranjevanju in odstranjevanju.
Each year the vaccine targets four strains of influenza, following the annual recommendations by the World Health Organisation.
Cepivo vsako leto cilja na štiri seve virusa gripe v skladu z vsakoletnimi priporočili Svetovne zdravstvene organizacije.
*** fluorescent focus units.
*** fluorescentna fokusna enota.
As a result, they replicate in the nasopharynx and induce protective immunity.
Posledično se replicirajo v nazofarinksu in inducirajo zaščitno imunost.
See Table 1 and 2 for a summary of efficacy results in the paediatric population.
Glejte preglednici 1 in 2 za povzetek rezultatov učinkovitosti v pediatrični populaciji.
Some side effects may be serious
Nekateri neželeni učinki so lahko resni
For signs of allergic reactions, see section 4 “Possible side effects”.
Za znake alergijskih reakcij glejte poglavje 4 ”Možni neželeni učinki”.
Number of study participants for year 1 efficacy analysis.
Število preiskovancev v študiji v 1. letu analize učinkovitosti.
** produced in VERO cells by reverse genetic technology.
** pridobljen v celicah VERO s tehnologijo reverzne genetike.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih
Read all of this leaflet carefully before the vaccine is given because it contains important information for you or your child.
Preden prejmete to cepivo, natančno preberite navodilo, ker vsebuje pomembne podatke za vas ali vašega otroka!
Data presented for clinical trial D153-P504 are for study participants who received two doses of study vaccine.
Podatki predstavljeni v klinični študiji D153-P504 so za preiskovance v študiji, ki so prejeli dva odmerka študijskega cepiva.
Do not inject.
Ne injicirajte.
Stability data indicate that the vaccine components are stable for 12 hours when stored at temperatures from 8°C to 25°C.
Podatki o stabilnosti kažejo, da so sestavine cepiva stabilne 12 ur, če je cepivo shranjeno pri temperaturi od 8 °C do 25 °C.
• if the child is less than 24 months of age.
• če je otrok star manj kot 24 mesecev.
• if you have a blood disorder or a cancer that affects the immune system.
• če imate krvno bolezen ali raka, ki vplivata na vaš imunski sistem.
Since 1985, two distinct lineages of influenza B viruses (Victoria and Yamagata) have circulated worldwide.
Od leta 1985 sta v svetu znani dve liniji virusa gripe tipa B (Victoria in Yamagata).
• if you have ever had a severe allergic reaction to eggs or egg proteins.
• če ste že kdaj imeli hudo alergijsko reakcijo na jajca oziroma jajčne beljakovine.
Four placebo-controlled studies included second season revaccination.
Štiri s placebom kontrolirane študije so vključevale drugo sezonsko revakcinacijo.
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 lahko cepivo enkrat vzamete iz hladilnika za največ 12 ur pri temperaturi do 25 °C.
• severe allergic reaction: signs of a severe allergic reaction may include shortness of breath and swelling of the face or tongue.
• huda alergijska reakcija: Znaki alergijske reakcije lahko vključujejo zasoplost in oteklost obraza ali jezika.
Influenza Season
Sezona gripe
In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili.
This is because of the risk of Reye's syndrome, a very rare but serious disease that can affect the brain and liver.
To je zaradi tveganja Reyevega sindroma, zelo redke, vendar resne bolezni, ki lahko prizadane možgane in jetra.
M=months.
a m = meseci b
• if you are allergic to gentamicin, gelatin or any of the other ingredients of this vaccine (listed in section 6 “Contents of the pack and other information”).
• če ste alergični na gentamicin, na želatino ali katero koli sestavino tega cepiva (navedeno v poglavju 6 ”Vsebina pakiranja in dodatne informacije”).
Follow your doctor, nurse or pharmacist's instructions about if and when your child should return for the second dose.
Upoštevajte navodila zdravnika, medicinske sestre ali farmacevta glede tega, če in kdaj naj se otrok vrne po drugi odmerek.
At the end of this period, Fluenz Tetra should be used immediately or discarded.
Ob koncu tega obdobja je treba cepivo Fluenz Tetra uporabiti takoj ali ga zavreči.
None of the ingredients in the vaccine can cause the flu.
Nobena sestavina cepiva ne more povzročiti gripe.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime zdravila in številko serije uporabljenega zdravila.
Not all pack sizes may be available in your country.
V vaši državi morda niso na voljo vsa navedena pakiranja.
(See also, How Fluenz Tetra is given, in section 3).
(Glejte tudi Kako se aplicira cepivo Fluenz Tetra, poglavje 3).
• 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 kot posledico bolezni, zdravila, ki ga jemljete ali drugega načina zdravljenja.
* propagated in fertilised hens' eggs from healthy chicken flocks.
* razmnožen v oplojenih kokošjih jajcih zdravih piščančjih jat.
Pharmacotherapeutic group: Influenza vaccines, influenza live attenuated; ATC Code: J07BB03
Farmakoterapevtska skupina: cepiva proti gripi, oslabljen živ virus; oznaka ATC: J07BB03
If the vaccine has not been used after this 12 hour period, it should be discarded.
Če zdravila v teh 12 urah ne porabite, ga morate zavreči.
Most hospitalisations were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination.
Največ hospitalizacij je bilo zaradi infekcij gastrointestinalnega in respiratornega trakta, ki so se pojavile več kot 6 tednov po cepljenju.
You do not need to actively inhale or sniff.
Ni potrebno aktivno inhalirati ali vdihavati skozi nosnice.
Common: Pyrexia
Pogosti: pireksija
Children less than 24 months of age should not receive this vaccine because of the risk of side effects.
Otroci, mlajši od 24 mesecev, ne smejo prejeti tega cepiva zaradi tveganja neželenih učinkov.
• if you have severe asthma or are currently wheezing.
• če imate hudo obliko astme ali trenutno sopete.
Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination.
Prejemniki cepiva morajo, kjer je to mogoče, preprečiti tesen stik s hudo imunsko oslabljenimi osebami (npr. prejemniki kostnega mozga, ki po presaditvi potrebujejo izolacijo) še 1 - 2 tedna po cepljenju.
The vaccine may contain residues of the following substances: egg proteins (e.g. ovalbumin) and gentamicin.
Cepivo lahko vsebuje ostanke naslednjih snovi: jajčne beljakovine (npr. ovalbumin) in gentamicin.
Healthcare professionals are asked to report any suspected adverse reactions via national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
It is used in children and adolescents 24 months to less than 18 years of age.
Uporablja se za otroke in mladostnike stare od 24 mesecev do manj kot 18 let.
Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Pogostnosti neželenih učinkov so poročane kot: zelo pogosti (≥1/10) pogosti (≥1/100 do <1/10) občasni (≥1/1.000 do <1/100) redki (≥1/10.000 do <1/1.000) zelo redki (<1/10.000)
This is because of the risk of a very rare but serious disease (Reye's syndrome).
Vzrok je v tveganju za zelo redko, a resno bolezen (Reyev sindrom).
• Do not use with a needle.
• Ne uporabljajte z iglo.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements for medical waste.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi za medicinske odpadke.
• 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 (snov, prisotna v številnih zdravilih za lajšanje bolečin in nižanje povišane telesne temperature).
Administration of influenza antiviral agents within two weeks of vaccination may affect the response of the vaccine.
Uporaba protivirusnih zdravil proti gripi v roku dveh tednov po cepljenju lahko vpliva na odziv cepiva.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljena za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Fluenz Tetra Influenza vaccine 2019/2020 season
Fluenz Tetra cepivo proti gripi sezona 2019/2020
Instructions for healthcare professionals
Navodila za zdravstveno osebje
See section 6.6 for administration instructions.
Glejte poglavje 6.6 za navodila o uporabi zdravila.
- This vaccine has been prescribed for you or your child only.
- To cepivo je bilo predpisano vam ali vašemu otroku osebno in ga ne smete dajati drugim.
Your doctor, nurse or pharmacist will decide if Fluenz Tetra can be given at the same time as other vaccines.
Zdravnik, farmacevt ali medicinska sestra se bo odločil, ali lahko prejmete cepivo Fluenz Tetra sočasno z drugimi cepivi.
• Do not give acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever) to children for 4 weeks after vaccination with Fluenz Tetra unless your doctor, nurse or pharmacist tells you otherwise.
• Otrokom ne dajajte acetilsalicilne kisline (učinkovina, ki je prisotna v številnih zdravilih za lajšanje bolečin in nižanje povišane telesne temperature) še 4 tedne po cepljenju s cepivom Fluenz Tetra, razen če vam zdravnik, medicinska sestra ali farmacevt ne naročijo nasprotno.
The use of Fluenz Tetra should be based on official recommendations.
Uporaba cepiva Fluenz Tetra mora temeljiti na uradnih priporočilih.
The immune response to rubella vaccine was significantly altered.
Imunski odziv na cepivo proti rdečkam je bil značilno spremenjen.
• If you are pregnant, think you may be pregnant, plan to become pregnant soon or are breast-feeding, tell your doctor, nurse or pharmacist before receiving this vaccine.
• če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden prejmete to cepivo.
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 manj kot 0,024 mikrograma na 0,2-mililitrski odmerek (0,12 mikrograma na ml).
A multicentre, randomised, double-blind, active-controlled, non-inferiority study was conducted to assess the immunogenicity of Fluenz Tetra compared to Fluenz (active control) in children and adolescents 2-17 years of age.
Multicentrična, randomizirana, dvojno slepa, aktivna kontrolirana in neinferiorna študija je bila izvedena za ocenitev imunogenosti cepiva Fluenz Tetra v primerjavi s cepivom Fluenz (aktivna kontrola) pri otrocih in mladostnikih starih od 2 do 17 let.
There is a moderate amount of data from the use of Fluenz Tetra in pregnant women.
Obstaja zmerna količina podatkov o uporabi cepiva Fluenz Tetra pri nosečnicah.
Frequency and duration of vaccine virus shedding in these immunocompromised children and adolescents were comparable to that seen in healthy children and adolescents.
Pogostost in trajanje izločanja cepnega virusa pri teh imunsko oslabelih otrocih in mladostnikih sta bili primerljivi z zdravimi otroci in mladostniki.
However, this alteration might not be of clinical relevance with the two dose immunisation schedule of the rubella vaccine.
Vendar pa morda ta sprememba ni klinično pomembna pri režimu imunizacije z dvema odmerkoma cepiva proti rdečkam.
Africa, Latin America
Afrika, Južna Amerika
Fluenz Tetra should not be administered to children and adolescents with severe asthma or active wheezing because these individuals have not been adequately studied in clinical studies.
Cepiva Fluenz Tetra ne smete uporabljati pri otrocih in mladostnikih s hudo astmo ali aktivnim sopenjem, saj te osebe niso bile ustrezno preučene v kliničnih študijah.
fewer cases than injectable fewer cases than injectable
manj primerov kot pri cepivu, ki se injicira manj primerov kot pri cepivu, ki se injicira
Prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age.
Preprečevanje gripe pri otrocih in mladostnikih od 24 mesecev do manj kot 18 let.
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.
V okoliščinah, kjer stika s hudo imunsko oslabljenimi osebami ni mogoče preprečiti, je treba pretehtati tveganje možnosti prenosa virusa iz cepiva proti gripi glede na tveganje pridobitve ter prenosa virusa gripe divjega tipa.
- Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 (e.g. gelatin), or to gentamicin (a possible trace residue).
- Preobčutljivost na učinkovino, katero koli pomožno snov, navedeno v poglavju 6.1 (npr. želatino) ali gentamicin (možen ostanek v sledeh).
Fluenz'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 cepiva Fluenz v pediatrični populaciji so sestavljeni iz 9 kontroliranih študij, ki so zajele več kot 20.000 dojenčkov in malčkov, otrok in mladostnikov in so se izvajale v 7 sezonah gripe.
• Check the appearance of the vaccine before administration.
• Pred uporabo preverite videz cepiva.
6 to 59 M 7,852 2004-2005
6 do 59 m 7.852 2004 - 2005
While animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, and post-marketing data offer some reassurance in the event of inadvertent administration of the vaccine, Fluenz Tetra is not recommended during pregnancy.
Čeprav študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja in podatki iz obdobja po začetku trženja dajejo pomirjujoče informacije v primeru nenamernega dajanja cepiva, Fluenz Tetra ne uporabljajte pri nosečnicah.
D153-P502 Europe 6 to 35 M 1,616
D153-P502 Evropa 6 do 35 m 1.616
USA, Europe, Asia/Oceania
ZDA, Evropa, Azija/ Oceanija
Although safety in children and adolescents with mild to moderate asthma has been established, data in children with other pulmonary diseases or with chronic cardiovascular, metabolic or renal diseases are limited.
Čeprav so ugotavljali varnost pri otrocih in mladostnikih z blago do zmerno astmo, so podatki pri otrocih z drugimi pljučnimi boleznimi ali s kroničnimi kardiovaskularnimi, presnovnimi ali ledvičnimi boleznimi pomanjkljivi.
11 to 24 M 1,150 2002-2003
11 do 24 m 1.150 2002 - 2003
Do not use this vaccine after the expiry date which is stated on the applicator label after the letters EXP.
Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki nosnika poleg oznake EXP.
Prepare the applicator Remove rubber tip protector.
Pripravite nosnik Odstranite gumijasto zaščito konice.
The influenza virus strains in Fluenz Tetra are (a) cold-adapted (ca); (b) temperature-sensitive (ts); and (c) attenuated (att).
Sevi virusa gripe v cepivu Fluenz Tetra so (a) hladno-prilagojeni (cold-adapted, ca); (b) občutljivi na temperaturo (temperature-sensitive, ts); in (c) oslabljeni (attenuated, att).
Other medicines, other vaccines and Fluenz Tetra
Druga zdravila, druga cepiva in cepivo Fluenz Tetra
Fluenz Tetra should not be used in infants and toddlers below 24 months of age because of safety concerns regarding increased rates of hospitalisation and wheezing in this population (see section 4.8).
Cepiva Fluenz Tetra se ne sme uporabljati pri dojenčkih in malčkih, mlajših od 24 mesecev zaradi pomislekov glede varnosti zaradi povečane stopnje hospitalizacije in sopenja pri tej populaciji (glejte poglavje 4.8).
Number of Study Participants
Število sodelujočih v študiji
Nasal spray, suspension
pršilo za nos, suspenzija
Metabolism and nutrition disorders Very common: Decreased appetite
Presnovne in prehranske motnje Zelo pogosti: zmanjšan apetit
However, a conclusion on clinical benefit of this vaccine in adults could not be made given that results observed in some studies versus injectable influenza vaccines were suggestive of a lower efficacy of Fluenz.
Vendar pa sklepanja o kliničnih koristih tega cepiva pri odraslih niso mogoča, ker kažejo rezultati nekaterih študij, kjer so cepivo primerjali s cepivi proti gripi, ki se injicirajo, manjšo učinkovitost cepiva Fluenz.
Adult studies
Študije pri odraslih
However, based upon the potential for influenza antiviral agents to reduce the effectiveness of Fluenz Tetra, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy.
Vendar pa se zaradi potenciala protivirusnih zdravil proti gripi za zmanjšanje učinkovitosti cepiva Fluenz Tetra ne priporoča uporabe cepiva do 48 ur po končanem protivirusnem zdravljenju proti gripi.
12 to 35 M 2,764
12 do 35 m 2.764
EU/1/13/887/002 <1 sprayer> EU/1/13/887/001 <10 sprayers> EU/1/13/887/003 <1 sprayer> EU/1/13/887/004 <10 sprayers>
EU/1/13/887/002 <1 pršilnik> EU/1/13/887/001 <10 pršilnikov> EU/1/13/887/003 <1 pršilnik> EU/1/13/887/004 <10 pršilnikov>
In studies of adults in which a high percentage of individuals had underlying chronic medical conditions, the safety profile of trivalent Fluenz was comparable to the safety profile observed in individuals without these conditions.
V študijah z odraslimi, kjer je imel velik odstotek oseb obstoječo kronično bolezen, je bil varnostni profil trivalentnega cepiva Fluenz primerljiv z varnostnim profilom, ki so ga opazili pri osebah brez teh bolezni.