natgillin/translations-raw huggingface dataset:
Vaccine recipients should be informed that FLUENZ is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts. 
Prejemnike cepiva je treba obvestiti, da je cepivo FLUENZ cepivo z oslabljenim živim virusom in ima potencial za prenos na imunsko oslabljene osebe.
Fluenz is a trademark of MedImmune, LLC. 
Fluenz je blagovna znamka družbe MedImmune, LLC.
Additional experience has occurred with marketed use of this vaccine. 
V času trženja cepiva so se pridobile dodatne izkušnje.
• 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, menite, da bi lahko bili noseči ali načrtujete zanositev ali če dojite, se posvetujte s svojim zdravnikom, medicinsko sestro ali farmacevtom, preden prejmete to cepivo.
Fluenz is not recommended for women who are pregnant or are breast-feeding. 
Cepiva Fluenz se ne priporoča pri nosečnicah ali ženskah, ki dojijo.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/661/002 < - 10 sprayers> 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/661/002 <10 pršilnikov >
There have been occasional reports of administration of twice the recommended dose of FLUENZ in the post-marketing setting. 
Obstajajo občasna poročila o uporabi dvakratnega priporočenega odmerka cepiva FLUENZ v obdobju po začetku trženja.
Pack size of 10. 
Pakiranje z 10 nosniki.
M = months b Reduction in culture-confirmed influenza illness relative to placebo. 
e a m = meseci b Zmanjšanje obolelosti za gripo, potrjene s kulturo, glede na placebo.
• Fluenz is administered as a divided dose in both nostrils as described below. 
• Cepivo Fluenz se aplicira kot razdeljen odmerek v obe nosnici kot je opisano spodaj.
While animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, FLUENZ is not recommended during pregnancy. 
Čeprav študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja, cepiva FLUENZ ne uporabljajte pri nosečnicah.
However, based upon the potential for influenza antiviral agents to reduce the effectiveness of FLUENZ, 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 ne priporoča uporaba cepiva do 48 ur po končanem protivirusnem zdravljenju proti gripi.
Before use, the vaccine may be taken out of the refrigerator, without being replaced, for a maximum period of 12 hours at a temperature not above 25°C. 
Pred uporabo lahko cepivo vzamete iz hladilnika za največ 12 ur pri temperaturi do 25 °C, vendar ga potem ne smete več hraniti v hladilniku.
What Fluenz is and what it is used for What you need to know before you are given Fluenz How Fluenz is given 
Kaj je cepivo Fluenz in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Fluenz Kako uporabljati cepivo Fluenz Možni neželeni učinki
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.
The co-administration of FLUENZ with inactivated vaccines has not been studied. 
Sočasne uporabe cepiva FLUENZ z inaktiviranimi cepivi niso preučevali.
As with most vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of FLUENZ. 
Kot pri vseh cepivih je treba nemudoma zagotoviti ustrezno obliko zdravljenja in zdravniškega nadzora v primeru anafilaktične reakcije po uporabi cepiva FLUENZ.
USA 15 to 71 M 1,259 
ZDA 15 do 71 m 1.259
MedImmune, LLC 297 North Bernardo Avenue, Moutain View 
MedImmune, LLC 297 North Bernardo Avenue, Mountain View
A/Victoria/361/2011 (H3N2)-like strain (A/Texas/50/2012, MEDI 237514) 
A/Victoria/361/2011 (H3N2)-podoben sev (A/Texas/50/2012, MEDI 237514)
FLUENZ is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency. 
Uporaba cepiva FLUENZ ni kontraindicirana pri osebah z asimptomatsko okužbo z virusom HIV; ali osebah, ki prejemajo lokalne/inhalacijske kortikosteroide ali nizkoodmerne sistemske kortikosteroide ter pri tistih, ki prejemajo kortikosteroide kot nadomestno zdravljenje, npr. pri insuficienci nadledvične žleze.
If the vaccine has not been used after this 12-hour period, it should be disposed of. 
Če ga ne porabite v 12 urah, ga morate zavreči.
Do not use Fluenz after the expiry date which is stated on the applicator label after the letters EXP. 
Cepiva Fluenz ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki nosnika poleg črk EXP.
• The recommended dose for children and adolescents is 0.2 ml Fluenz, administered as 0.1 ml in each nostril. 
• Priporočeni odmerek je tako za otroke kot za mladostnike 0,2 ml cepiva Fluenz, danega po 0,1 ml v vsako nosnico.
Safety data regarding use of FLUENZ have been compiled from over 28,500 children and adolescents 2 to 17 years of age from clinical studies and over 52,500 children and adolescents from post-authorisation safety studies. 
Varnostne podatke o uporabi cepiva FLUENZ so zbrali v kliničnih študijah od več kot 28.500 otrocih in mladostnikih starih od 2 do 17 let in v varnostnih študijah po začetku trženja od več kot 52.500 otrocih in mladostnikih.
e 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). 
e Primarni sev, ki je krožil, je bil antigensko različen od seva H3N2 v cepivu; učinkovitost proti neujemajočem se sevu A/H3N2 je bila 85,9% (95-% IZ: 75,3; 91,9).
FLUENZ should under no circumstances be injected. 
Cepiva FLUENZ se ne sme v nobenem primeru injicirati.
The concurrent use of FLUENZ with antiviral agents that are active against influenza A and/or B viruses has not been evaluated. 
Sočasne uporabe cepiva FLUENZ s protivirusnimi zdravili, ki delujejo proti virusom gripe A in/ali B niso ocenili.
In an active-controlled clinical study (MI-CP111), an increased rate of hospitalisations (for any cause) through 180 days after final vaccination dose was observed in infants and toddlers 6-11 months of age (6.1% FLUENZ versus 2.6% injectable influenza vaccine). 
V aktivni kontrolirani klinični študiji (MI-CP111) so opazili povečano stopnjo hospitalizacij (zaradi vseh razlogov) v obdobju 180 dni po končnem odmerku vakcinacije pri dojenčkih in malčkih starih od 6-11 mesecev (6,1% cepivo FLUENZ v primerjavi z 2,6% cepivo proti gripi, ki se injicira).
The adverse reactions reported were similar to those seen with the recommended single dose of FLUENZ. 
Neželeni učinki, o katerih so poročali, so bili podobni tistim pri priporočenem enkratnem odmerku cepiva FLUENZ.
Fertility No data exist regarding the possible effects of FLUENZ on male and female fertility. 
Plodnost Podatkov o morebitnem vplivu cepiva FLUENZ na plodnost pri moških in ženskah ni.
It is not known whether FLUENZ is excreted in human milk. 
Ni znano, ali se cepivo FLUENZ izloča v materino mleko.
5 single-use nasal applicators (0.2 ml each) Store in a refrigerator. 
5 nosnikov za enkratno uporabo (vsak po 0,2 ml) Shranjujte v hladilniku.
D153-P514 Europe 6 to 71 M 2,085 2002-2003 
D153-P514 Evropa 6 do 71 m 2.085 2002-2003
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 (e.g. gelatin), or to gentamicin (a possible trace residue), eggs or egg proteins (e.g. ovalbumin). 
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (npr. želatino) ali gentamicin (možen ostanek v sledeh), jajca ali jajčne beljakovine (npr. ovalbumin).
Fluenz is a vaccine to prevent influenza (flu). 
Cepivo Fluenz je cepivo za preprečevanje gripe.
NAME OF THE MARKETING AUTHORISATION HOLDER MedImmune, LLC 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM MedImmune, LLC
Several studies against placebo have shown that FLUENZ may have some efficacy in adults. 
Več študij, kjer so cepivo primerjali s placebom, je pokazalo, da cepivo FLUENZ morda nekoliko učinkuje pri odraslih.
If influenza antiviral agents and FLUENZ are administered concomitantly, revaccination should be considered when appropriate. 
Pri sočasni uporabi protivirusnih zdravil in cepiva FLUENZ je treba razmisliti o revakcinaciji, če je ustrezno.
D153-P515 Europe fewer cases than injectable fewer cases than injectable a 
D153-P515 Evropa 6 do 17 let manj primerov kot pri cepivu, ki se injicira manj primerov kot pri cepivu, ki se injicira a m = meseci.
Fluenz will be administered under the supervision of a doctor, nurse or pharmacist. 
Cepivo Fluenz boste prejeli pod nadzorom zdravnika, medicinske sestre ali farmacevta.
Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids. 
Otroci in mladostniki s klinično imunodeficienco zaradi bolezni ali imunosupresivnega zdravljenja kot: akutne in kronične oblike levkemije; limfom; simptomatska okužba z virusom HIV; celična imunodeficienca in uporaba kortikosteroidov v visokih odmerkih.
Pregnancy There are limited data from the use of FLUENZ in pregnant women. 
Nosečnost Podatkov o uporabi cepiva FLUENZ pri nosečnicah je malo.
Do not inject. 
NE INJICIRAJTE.
Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed in the post-marketing setting. 
Po začetku trženja so opazili zelo redka poročila o Guillain-Barréjevem sindromu in poslabšanju simptomov Leigh-sindroma (mitohondrijska encefalomiopatija).
fewer cases than injectable c fewer cases than injectable 
manj primerov kot pri cepivu, ki se injicira c manj primerov kot pri cepivu, ki se injicira
Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection. 
Otroci in mladostniki stari manj kot 18 let, ki se zdravijo s salicilatom zaradi povezave z Reyevim sindromom pri uporabi salicilatov in okužbo z gripo virusa divjega tipa.
You can breathe normally while you are given Fluenz. 
Med prejemanjem cepiva Fluenz lahko normalno dihate.
Table 1 FLUENZ Efficacy in Placebo Controlled Paediatric Studies 
Preglednica 1 Učinkovitost cepiva FLUENZ v pediatričnih študijah, kontroliranih s placebom
Other possible side effects of Fluenz 
Drugi možni neželeni učinki cepiva Fluenz
• Children who have not previously had an influenza vaccine will receive a second, follow-up dose after an interval of at least 4 weeks. 
• Otroci, ki se še nikoli niso cepili proti gripi, bodo najmanj po 4 tednih prejeli še drugi, vzdrževalni odmerek.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (2 X 5 NASAL APPLICATORS) 
PODATKI NA ZUNANJI OVOJNINI VELIKOST PAKIRANJA 10 NOSNIKOV ZA ENKRATNO UPORABO (2 X 5 NOSNIKOV)
• FLUENZ is administered as a divided dose in both nostrils. 
• Cepivo FLUENZ se aplicira kot razdeljen odmerek v obe nosnici.
10 single-use nasal applicators (0.2 ml each) 
10 nosnikov za enkratno uporabo (vsak po 0,2 ml)
In the same study, an increased rate of wheezing through 42 days was observed in infants and toddlers 6-23 months of age (5.9% FLUENZ versus 3.8% injectable influenza vaccine). 
V isti študiji so opazili povišano stopnjo sopenja v obdobju 42 dni pri dojenčkih in malčkih starih od 6-23 mesecev (5,9% cepivo FLUENZ v primerjavi s 3,8% cepivo proti gripi, ki se injicira).
What Fluenz looks like and contents of the pack 
Izgled cepiva Fluenz in vsebina pakiranja
D153-P501 Asia/Oceania 12 to 35 M 2,764 
D153-P501 Azija/ Oceanija 12 do 35 m 2.764
FLUENZ demonstrated 64.4% (1.4, 88.8) fewer cases than injectable influenza vaccine in 476 infants and toddlers 6-23 months of age and 48.2% (12.7, 70.0) fewer cases in 1,579 children 24-71 months of age. 
Z cepivom FLUENZ je bilo 64,4% (1,4; 88,8) manj primerov kot pri cepivu proti gripi, ki se injicira, pri 476 dojenčkih in malčkih starih od 6-23 mesecev in 48,2% (12,7; 70,0) manj primerov pri 1.579 otrok starih od 24-71 mesecev.
How to store Fluenz 
Kako uporabljati cepivo Fluenz
Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in clinical studies. 
V kliničnih študijah je bila največja incidenca rekuperacije virusa iz cepiva 2-3 dni po cepljenju.
The suspension is colourless to pale yellow, clear to opalescent. 
Suspenzija je brezbarvna do bledorumena, bistra do opalescentna.
This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 10. 
Cepivo je v obliki pršila za nos, suspenzije, ki se nahaja v nosniku za enkratno uporabo (0,2 ml) v velikosti pakiranja 10.
FLUENZ is supplied as a 0.2 ml suspension in a single-use nasal applicator (Type 1 glass), with nozzle (polypropylene with polyethylene transfer valve), nozzle tip-protector cap (synthetic rubber), plunger rod, plunger-stopper (butyl rubber), and a dose-divider clip. 
Cepivo FLUENZ je na voljo kot 0,2 ml suspenzija v nosniku za enkratno uporabo (steklo tipa 1), s šobo (polipropilen s polietilenskim ventilom za prenos), zaporko za zaščito konice šobe (sintetična guma), batom, batnim zamaškom (butil guma) in sponko za razdelitev odmerka.
It is not recommended to administer FLUENZ to infants and toddlers 12-23 months of age. 
Uporaba cepiva FLUENZ pri dojenčkih in malčkih starih od 12-23 mesecev se ne priporoča.
Improved Efficacy (95% CI) 
Izboljšana učinkovitost (95-% IZ)
The rate of hospitalisations was not increased in FLUENZ recipients 12 months and older. 
Stopnja hospitalizacije se pri prejemnikih cepiva FLUENZ starih 12 mesecev ali več ni povišala.
FLUENZ has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine. 
Cepivo FLUENZ je bilo v 3 aktivno kontroliranih študijah s cepivom gripe, ki se injicira, superiorno.
PHARMACEUTICAL FORM AND CONTENTS Nasal spray, suspension 
FARMACEVTSKA OBLIKA IN VSEBINA pršilo za nos, suspenzija
Do not use salicylates in children and adolescents younger than 18 years of age for 4 weeks after vaccination unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection. 
Salicilata se ne sme uporabljati še 4 tedne po cepljenju pri otrocih in mladostnikih starih manj kot 18 let, razen če je to medicinsko indicirano, ker so po uporabi salicilata v času okužbe z gripo virusa divjega tipa poročali o Reyevem sindromu.
In study participants who received 2 doses in year 1 and placebo in year 2, efficacy in year 2 was 56.2% (95% CI: 30.5, 72.7) and 44.8% (95% CI: 18.2, 62.9), respectively, in D153-P501, thus supporting the need for second-season revaccination. 
Pri preiskovancih v študiji, ki so 1. leto prejeli 2 odmerka in placebo 2. leto, je bila učinkovitost 2. leto 56,2% (95-% IZ: 30,5; 72,7) oziroma 44,8% (95-% IZ: 18,2; 62,9) pri študiji D153-P501, kar govori v prid potrebi po revakcinaciji v drugi sezoni.
FLUENZ demonstrated 55.7% (39.9, 67.6) fewer cases than injectable influenza vaccine in 3,659 infants and toddlers 6-23 months of age and 54.4% (41.8, 64.5) fewer cases in 4,166 children 24-59 months of age. 
c Z cepivom FLUENZ je bilo 55,7% (39,9; 67,6) manj primerov kot pri cepivu proti gripi, ki se injicira, pri 3.659 dojenčkih in malčkih starih od 6-23 mesecev in 54,4% (41,8; 64,5) manj primerov pri 4.166 otrok starih od 24-59 mesecev.
Tell your doctor, nurse or pharmacist if the person being vaccinated is taking, has recently taken or might take any other medicines. 
Druga zdravila, druga cepiva in cepivo Fluenz Obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če oseba, ki se cepi, jemlje, je pred kratkim jemala ali pa bo morda začela jemati katero koli drugo zdravilo.
In previously unvaccinated study participants who received one dose in year 1, efficacy was 57.7% (95% CI: 44.7, 67.9) and 56.3% (95% CI: 43.1, 66.7), respectively, thus supporting the need for two doses of vaccine in previously unvaccinated children. 
Pri preiskovancih v študiji, ki se pred tem niso cepili in so prejeli le en odmerek v 1. letu, je bila učinkovitost 57,7% (95-% IZ: 44,7; 67,9) oziroma 56,3% (95-% IZ: 43,1; 66,7), to govori v prid potrebi po dveh odmerkih cepiva pri predhodno necepljenih otrocih.
Do not administer FLUENZ to infants and toddlers younger than 12 months. 
Cepiva FLUENZ se ne sme uporabiti pri dojenčkih in malčkih mlajših od 12 mesecev.
This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2013/2014 season. 
Cepivo ustreza priporočilom Svetovne zdravstvene organizacije (severna polobla) in odločbi EU za sezono 2013/2014.
Table 2 FLUENZ Relative Efficacy in Active-controlled Paediatric Studies with Injectable 
Preglednica 2 Relativna učinkovitost cepiva FLUENZ v aktivno kontroliranih pediatričnih študijah s cepivom proti gripi, ki se injicira
• It is recommended that Fluenz is not given at the same time as influenza-specific antiviral medicines. 
• Priporoča se, da se cepiva Fluenz ne daje sočasno s protivirusnimi zdravili, specifičnimi za gripo, ker bo cepivo morda manj učinkovito.
The rate of wheezing was not increased in FLUENZ recipients 24 months and older. 
Stopnja sopenja se pri prejemnikih cepiva FLUENZ starih 24 mesecev ali več ni povišala.
Figure 1 FLUENZ Administration 
Slika 1 Aplikacija cepiva FLUENZ
FLUENZ should not be used in infants and toddlers below 24 months of age because of safety concerns (see section 4.4). 
Cepivo FLUENZ se ne sme uporabljati pri dojenčkih in malčkih mlajših od 24 mesecev zaradi pomislekov glede varnosti (glejte poglavje 4.4).
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2013/2014 season. 
Cepivo ustreza priporočilom SZO (Svetovne zdravstvene organizacije) (severna polobla) in odločbi EU za sezono 2013/2014.
NAME OF THE MEDICINAL PRODUCT FLUENZ nasal spray suspension Influenza vaccine (live attenuated, nasal) 2013/2014 season 
FLUENZ pršilo za nos, suspenzija cepivo proti gripi (z živimi oslabljenimi virusi, nosno) Sezona 2013/2014
METHOD AND ROUTE(S) OF ADMINISTRATION For nasal use only. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Samo za nazalno uporabo.
b Reduction in culture-confirmed influenza illness relative to injectable influenza vaccine. 
Zmanjšanje obolelosti za gripo, potrjene s kulturo, glede na cepivo proti gripi, ki se injicira.
Respiratory, thoracic, and mediastinal disorders Very common: Nasal congestion/rhinorrhoea Uncommon: Epistaxis 
Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti: zamašen nos/rinoreja Občasni: epistaksa
DO NOT INJECT FLUENZ. 
CEPIVA FLUENZ NE INJICIRAJTE.
Please read the package leaflet for disposal of medicines no longer required. 
Za odstranjevanje zdravil, ki jih več ne potrebujete, preberite navodilo za uporabo.
No clinically meaningful changes in immune responses to measles, mumps, varicella, orally-administered poliovirus or FLUENZ have been observed. 
Klinično pomembnih sprememb odziva imunskega sistema na cepivo proti ošpicam, mumpsu, noricam in na peroralno cepivo proti otroški paralizi ali cepivo FLUENZ niso opazili.
If any of these apply, tell your doctor, nurse or pharmacist before vaccination. 
Če karkoli od tega velja za vas, obvestite svojega zdravnika, medicinsko sestro ali farmacevta pred cepljenjem.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION FLUENZ 
IME ZDRAVILA IN POT(I) UPORABE FLUENZ cepivo proti gripi
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Uporaba cepiva
Efficacy (95% CI)b All strains regardless of match 
Učinkovitost (95-% IZ)b Vsi sevi neodvisno od ujemanja
Do not administer FLUENZ to children and adolescents younger than 18 years of age receiving salicylate therapy (see section 4.3). 
Cepiva FLUENZ se ne sme uporabiti pri otrocih in mladostnikih mlajših od 18 let, ki se zdravijo s salicilatom (glejte poglavje 4.3).
In a clinical study, an increase in hospitalisations was observed in infants and toddlers younger than 12 months after vaccination (see section 4.8). 
V klinični študiji so po cepljenju opazili povečano stopnjo hospitalizacije pri dojenčkih in malčkih mlajših od 12 mesecev (glejte poglavje 4.8).
FLUENZ IS FOR NASAL USE ONLY. 
CEPIVO FLUENZ JE SAMO ZA NAZALNO UPORABO.
FLUENZ is not indicated for use in infants and toddlers younger than 24 months (see section 4.4). 
Cepivo FLUENZ ni indicirano za uporabo pri dojenčkih in malčkih mlajših od 24 mesecev (glejte poglavje 4.4).
Non-clinical data with FLUENZ reveal no special hazard for humans based on conventional non-clinical studies of repeated dose toxicity, reproduction and developmental toxicity, local tolerance, and neurovirulence. 
Predklinični podatki s cepivom FLUENZ na osnovi običajnih študij predklinične varnosti, toksičnosti pri ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja in razvoja, lokalnega prenašanja in nevrovirulence ne kažejo posebnega tveganja za človeka.
Fluenz must not be injected. 
Cepiva Fluenz se ne sme injicirati.
Efficacy (95% CI) 
Učinkovitost (95-% IZ)
Contents of the pack and other information 
Shranjevanje cepiva Fluenz Vsebina pakiranja in dodatne informacije
Fluenz will be given as a spray in each nostril. 
Cepivo Fluenz se daje v obliki pršila v vsako nosnico.
No data exist regarding the safety of intranasal administration of FLUENZ in children with unrepaired craniofacial malformations. 
O intranazalnem dajanju cepiva FLUENZ otrokom z nepopravljenimi kraniofacialnimi deformacijami ni podatkov.
• Refer to the FLUENZ administration diagram (Figure 1) for step-by-step administration instructions. 
• Za navodila za aplikacijo cepiva FLUENZ po korakih glejte postopek aplikacije (slika 1).
- If you have any further questions, ask your doctor, nurse or pharmacist. 
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, medicinsko sestro ali s farmacevtom.
Check expiry date Product must be used before date on applicator label. 
Preverite rok uporabnosti Cepivo uporabite pred datumom na oznaki nosnika.
Very rare (may affect up to 1 in 1,000,000 people): 
Zelo redki (pojavijo se pri največ 1 od 1.000.000 oseb):
Position the applicator With the patient in an upright position, place the tip just inside the nostril to ensure Fluenz is delivered into the nose. 
Namestitev nosnika Ko je oseba v pokončnem položaju, namestite konico nekoliko v nosnico, da zagotovite vnos cepiva Fluenz v nos.
Contents of the pack and other information What Fluenz contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo Fluenz Zdravilne učinkovine so:
The suspension is a colourless to pale yellow liquid that is clear to slightly cloudy. 
Suspenzija je brezbarvna do bledorumena, bistra do nekoliko motna tekočina.
In a clinical study, an increased rate of wheezing was observed in infants and toddlers 12-23 months of age after vaccination (see section 4.8). 
V klinični študiji so po cepljenju opazili povečano stopnjo sopenja pri dojenčkih in malčkih starih od 12-23 mesecev (glejte poglavje 4.8).
Summary of adverse reactions 
Povzetek neželenih učinkov
Tell your doctor straight away or seek urgent medical care if you experience any of the effects above. 
Če opazite kateri koli zgoraj naštet neželeni učinek, nemudoma obvestite svojega zdravnika ali poiščite nujno medicinsko pomoč.
D153-P502 Europe c c 
D153-P502 Evropa