natgillin/translations-raw huggingface dataset:
Fluenz Tetra 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 Tetra 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.
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, 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).
No adverse effects on HIV viral load or CD4 counts were identified following trivalent Fluenz administration.
Nobenih negativnih učinkov na virusno breme HIV ali na število celic CD4 ni bilo ugotovljenih po dajanju trivalentnega cepiva Fluenz.
Name and address of the manufacturer of the biological active substances
Ime in naslov izdelovalca biološke zdravilne učinkovine
As with most vaccines, appropriate medical treatment and supervision should always be readily available to manage an anaphylactic event or serious hypersensitivity event following the administration of Fluenz Tetra.
Kot pri vseh cepivih je treba nemudoma zagotoviti ustrezno obliko zdravljenja in zdravniškega nadzora za obvladovanje anafilaktičnega dogodka ali dogodka resne preobčutljivosti po uporabi cepiva Fluenz Tetra.
Study Number
Številka študije
Therefore, as some viruses are excreted in human milk, Fluenz Tetra should not be used during breast-feeding.
Ker se nekateri virusi izločajo v materino mleko, se cepiva Fluenz Tetra med dojenjem ne sme uporabljati.
The most common adverse reaction observed in clinical studies was nasal congestion/rhinorrhoea.
Najpogostejši neželeni učinek, opažen v kliničnih študijah, je bil zamašen nos/rinoreja.
A total of 2,312 children and adolescents were randomised by site at a 3:1:1 ratio to receive either Fluenz Tetra or one of two formulations of comparator vaccine Fluenz, each containing a B strain that corresponded to one of the two B strains in Fluenz Tetra (a B strain of the Yamagata lineage and a B strain of the Victoria lineage).
Skupno 2.312 otrok in mladostnikov je bilo randomiziranih v razmerju 3:1:1, pri čemer so prejeli cepivo Fluenz Tetra ali eno od obeh primerjalnih cepiv Fluenz, od katerih je vsako vsebovalo sev B, ki je odgovarjal enemu od obeh sevov B v cepivu Fluenz Tetra (sev B v liniji Yamagata in sev B v liniji Victoria).
Vaccine recipients should be informed that Fluenz Tetra is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts.
Prejemnike cepiva je treba obvestiti, da je cepivo Fluenz Tetra cepivo z oslabljenim živim virusom in ima potencial za prenos na imunsko oslabljene osebe.
Fluenz Tetra will be administered under the supervision of a doctor, nurse or pharmacist.
Cepivo Fluenz Tetra boste prejeli pod nadzorom zdravnika, medicinske sestre ali farmacevta.
Reduction in culture-confirmed influenza illness relative to placebo.
Zmanjšanje obolelosti za gripo, potrjene s kulturo, glede na placebo.
He or she will decide if Fluenz Tetra is suitable for you.
Odločil/-a se bo, ali je cepivo Fluenz Tetra za vas primerno.
Fluenz Tetra vaccine viruses are grown in chicken eggs.
Virusi za cepiva Fluenz Tetra proti gripi se vzgajajo v piščančjih jajcih.
- Children and adolescents with 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.
- 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.
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).
What Fluenz Tetra is and what it is used for
Kaj je zdravilo Fluenz Tetra in za kaj ga uporabljamo
In clinical studies, the safety profile of Fluenz Tetra was similar to the safety profile of Fluenz.
V kliničnih študijah je bil varnostni profil cepiva Fluenz Tetra podoben varnostnemu profilu cepiva Fluenz.
What you need to know before you are given Fluenz Tetra
Kaj morate vedeti, preden boste prejeli cepivo Fluenz Tetra
• Do not use Fluenz Tetra if the expiry date has passed or the sprayer appears damaged, for example, if the plunger is loose or displaced from the sprayer or if there are any signs of leakage.
• Cepiva Fluenz Tetra ne smete uporabljati, če mu je potekel rok uporabnosti ali če opazite, da je pršilnik poškodovan, na primer če bat ne tesni ali izpade iz pršilnika ali opazite kakršnekoli znake iztekanja tekočine.
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.
Obvestite zdravnika, farmacevta ali medicinsko sestro, če oseba, ki se cepi, jemlje, je pred kratkim jemala ali pa bo morda začela jemati katero koli drugo zdravilo.
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.
- 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.
Clinical experience with Fluenz is relevant to Fluenz Tetra because both vaccines are manufactured using the same process and have overlapping compositions.
Klinične izkušnje s cepivom Fluenz so pomembne za cepivo Fluenz Tetra, saj sta obe cepivi izdelani po enakem postopku in imata prekrivajoče sestavine.
In clinical studies with the vaccine, most side effects were mild in nature and short term.
Pri kliničnih študijah cepiva je bila večina neželenih učinkov blaga in kratkotrajna.
The incidence of wheezing within 15 days after vaccination was lower in Fluenz recipients relative to inactivated vaccine recipients (19.5% vs. 23.8%, P=0.02).
Pojavnost sopenja v 15 dneh po cepljenju je bila nižja pri preiskovancih, ki so prejeli cepivo Fluenz kot pri preiskovancih, ki so prejeli inaktivirano cepivo (19,5 % v primerjavi s 23,8 %; P=0,02).
Fluenz Tetra is not recommended for women who are pregnant or are breast-feeding.
Cepiva Fluenz Tetra se ne priporoča pri nosečnicah ali ženskah, ki dojijo.
Depress the plunger With a single motion, depress plunger as rapidly as possible until the dose-divider clip prevents you from going further.
Pritisnite na bat Z enkratnim pritiskom pritisnite na bat tako hitro, kot lahko, dokler vas ne ustavi sponka za razdelitev odmerka.
- Severe allergic reaction (e.g. anaphylaxis) to eggs or to egg proteins (e.g. ovalbumin).
- Huda alergijska reakcija (npr. anafilaksija) na jajca ali jajčne beljakovine (npr. ovalbumin).
Nervous system disorders Very common: Headache
Bolezni živčevja Zelo pogosti: glavobol
In a study (D153-P515) of children 6 to 17 years of age with asthma (trivalent Fluenz: n=1,114, trivalent injectable influenza vaccine: n=1,115), there were no significant differences between treatment groups in the incidence of asthma exacerbations, mean peak expiratory flow rate, asthma symptom scores, or night-time awakening scores.
V študiji (D153-P515) otrok, starih od 6 do 17 let, ki imajo astmo (trivalentno cepivo Fluenz: n=1.114, trivalentno cepivo proti gripi, ki se injicira: n=1.115), ni bilo posebnih razlik v pojavnosti izbruhov astme, največjega pretoka zraka med izdihom, pogostosti simptomov astme ali pogostosti zbujanja ponoči med zdravljenimi skupinami.
In more than 300 case reports in the AstraZeneca safety database of vaccine administration to pregnant women, no unusual patterns of pregnancy complications or foetal outcomes were observed.
V več kot 300 kliničnih primerih v varnostni bazi podatkov družbe AstraZeneca ni bilo mogoče opaziti neobičajnih zapletov v nosečnosti ali izidov za plod pri uporabi cepiva pri nosečnicah.
Uncommon: Hypersensitivity reactions (including facial oedema, urticaria and very rare anaphylactic reactions)
Občasni: preobčutljivostna reakcija (vključno z obraznim edemom, urtikarijo in zelo redko z anafilaktičnimi reakcijami)
• It is recommended that Fluenz Tetra is not given at the same time as influenza-specific antiviral medicines, such as oseltamivir and zanamivir.
• Priporoča se, da se cepiva Fluenz Tetra ne daje sočasno s protivirusnimi zdravili, specifičnimi za gripo kot sta oseltamivir in zanamivir, ker bo cepivo morda manj učinkovito.
6 to 35 M 1,886
6 do 35 m 1.886
Fluenz Tetra is not indicated for use in infants and toddlers younger than 24 months (see section 4.2).
Cepivo Fluenz Tetra ni indicirano za uporabo pri dojenčkih in malčkih mlajših od 24 mesecev (glejte poglavje 4.2).
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.
For children who have not previously been vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.
Pri otrocih, ki prej še niso bili cepljeni proti sezonski gripi, je treba drugi odmerek uporabiti, ko minejo vsaj 4 tedni.
Twenty mild to moderately immunocompromised children and adolescents 5 through 17 years of age (receiving chemotherapy and/or radiation therapy or who had recently received chemotherapy) were randomised 1:1 to trivalent Fluenz or placebo.
Dvajset otrok in mladostnikov z blago do zmerno imunsko oslabelostjo v starosti od 5 do 17 let (ki so prejemali kemoterapijo in/ali radioterapijo ali ki so pred kratkim prejemali kemoterapijo) je bilo randomiziranih 1:1 na trivalentno cepivo Fluenz ali placebo.
Fluenz Tetra is a tetravalent vaccine that contains antigens for four influenza virus strains, an A/(H1N1) strain, an A/(H3N2) strain, and two B strains (one from each lineage).
Cepivo Fluenz Tetra je štirivalentno cepivo, ki vsebuje antigene za štiri seve virusa gripe: sev A/(H1N1), sev A/(H3N2) in dva seva B (en za vsako linijo).
In 24 HIV-infected children and 25 HIV-negative children 1 through 7 years of age, and in 243 HIV-infected children and adolescents 5 through 17 years of age receiving stable anti-retroviral therapy, the frequency and duration of vaccine virus shedding were comparable to that seen in healthy individuals.
Pri 24 otrocih okuženih s HIV in 25 otrocih, ki niso bili okuženi s HIV, starimi od 1 do 7 let ter pri 243 otrocih in mladostnikih okuženih s HIV, starimi od 5 do 17 let, ki so prejemali protiretrovirusno zdravljenje, sta bili pogostost in trajanje izločanja cepnega virusa primerljivi z zdravimi osebami.
Safety data regarding use of Fluenz Tetra are based on data from Fluenz Tetra clinical studies in 2,231 children and adolescents 2 to 17 years of age, Fluenz clinical studies in over 29,000 children and adolescents 2 to 17 years of age and Fluenz post-authorisation safety studies in over 84,000 children and adolescents 2 to 17 years of age.
Varnostni podatki o uporabi cepiva Fluenz Tetra temeljijo na kliničnih študijah cepiva Fluenz Tetra, ki so vključevale 2.231 otrok in mladostnikov starih od 2 do 17 let, kliničnih študijah cepiva Fluenz, ki so vključevale več kot 29.000 otrok in mladostnikov starih od 2 do 17 let in na varnostnih študijah cepiva Fluenz po začetku trženja, ki so vključevale več kot 84.000 otrok in mladostnikov starih od 2 do 17 let.
Musculoskeletal and connective tissue disorders Common: Myalgia
Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti: mialgija
.................................................................................................................per 0.2 ml dose
.......................................................................................................na 0,2 ml odmerek
Fluenz Tetra has no or negligible influence on the ability to drive and use machines.
Cepivo Fluenz Tetra nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Fluenz Tetra is a vaccine to prevent influenza (flu).
Cepivo Fluenz Tetra je cepivo za preprečevanje gripe.
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).
Position the applicator With the patient in an upright position, place the tip just inside the nostril to ensure Fluenz Tetra is delivered into the nose.
Namestitev nosnika Ko je oseba v pokončnem položaju, namestite konico nekoliko v nosnico, da zagotovite vnos cepiva Fluenz Tetra v nos.
Table 1 Fluenz Efficacy in Placebo Controlled Paediatric Studies
Preglednica 1 Učinkovitost cepiva Fluenz v pediatričnih študijah, kontroliranih s placebom
Do not remove dose-divider clip at the other end of the applicator.
Ne odstranite sponke za razdelitev odmerka na drugi strani nosnika.
Reassortant influenza virus* (live attenuated) of the following four strains**:
Novi virus gripe* (živ oslabljen) naslednjih štirih sevov**:
Immunogenicity was evaluated by comparing geometric mean titres (GMTs) of strain-specific serum haemagglutination inhibition (HAI) antibodies post dosing.
Imunogenost je bila ocenjena s primerjanjem geometričnega povprečja titrov (GMTs - geometric mean titres) serumskih protiteles specifičnih za sev, ki zavirajo hemaglutinacijo (HAIhaemagglutination inhibition antibodies) po uporabi.
What Fluenz Tetra is and what it is used for What you need to know before you are given Fluenz Tetra How Fluenz Tetra is given
Kaj je cepivo Fluenz Tetra in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Fluenz Tetra Kako uporabljati cepivo Fluenz Tetra Možni neželeni učinki
Paediatric studies
Pediatrične študije
The suspension is colourless to pale yellow, clear to opalescent with a pH of approximately 7.2.
Suspenzija je brezbarvna do bledorumena, bistra do opalescentna ter ima pH približno 7,2.
Pack size of 1 or 10.
Pakiranje z 1 nosnikom ali 10 nosniki.
No data exist regarding the possible effects of Fluenz Tetra on male and female fertility.
Podatkov o morebitnem vplivu cepiva Fluenz Tetra na plodnost pri moških in ženskah ni.
The recommended dose for children and adolescents is 0.2 ml Fluenz Tetra, administered as 0.1 ml in each nostril.
Priporočeni odmerek je tako za otroke kot za mladostnike 0,2 ml cepiva Fluenz Tetra, danega po 0,1 ml v vsako nosnico.
In a study of children and adolescents 9 to 17 years of age with moderate to severe asthma (trivalent Fluenz: n=24, placebo: n=24), the primary safety criterion, change in percent predicted forced expiratory volume in 1 second (FEV1) measured before and after vaccination, did not differ between treatment arms.
V študiji otrok in mladostnikov starih od 9 do 17 let, ki imajo zmerno do hudo astmo (trivalentno cepivo Fluenz: n=24, placebo: n=24) se primarni varnostni kriterij, tj. sprememba v odstotkih napovedanega forsiranega ekspiracijskega volumna v prvi sekundi (FEV1) izmerjenega pred in po cepljenju, ni razlikoval v krakih.
If influenza antiviral agents and Fluenz Tetra are administered concomitantly, revaccination should be considered based on clinical judgement.
Pri sočasni uporabi protivirusnih zdravil in cepiva Fluenz Tetra je treba razmisliti o revakcinaciji glede na klinično presojo.
The co-administration of Fluenz Tetra with inactivated vaccines has not been studied.
Sočasne uporabe cepiva Fluenz Tetra z inaktiviranimi cepivi niso preučevali.
The effectiveness of Fluenz and Fluenz Tetra in preventing influenza illness in immunocompromised individuals has not been evaluated.
Učinkovitost cepiv Fluenz in Fluenz Tetra pri preprečevanju obolevanja za gripo imunsko oslabelih oseb ni bila ocenjena.
Table 2 Fluenz Relative Efficacy in Active-controlled Paediatric Studies with Injectable Influenza Vaccine
Preglednica 2 Relativna učinkovitost cepiva Fluenz v aktivno kontroliranih pediatričnih študijah s cepivom proti gripi, ki se injicira
The concurrent use of Fluenz Tetra with antiviral agents that are active against influenza A and/or B viruses has not been evaluated.
Sočasne uporabe cepiva Fluenz Tetra s protivirusnimi zdravili, ki delujejo proti virusom gripe A in/ali B niso ocenili.
Fluenz Tetra demonstrated immunologic non-inferiority to the two formulations of Fluenz as the upper bound for each of the four 95% CIs for the post-dose strain-specific GMT HAI antibody ratios was ≤ 1.5.
Cepivo Fluenz Tetra je pokazalo imunsko neinferiornost na dve obliki cepiva Fluenz, saj je bila zgornja meja vseh štirih 95 % intervalov zaupanja pri razmerju GMT protiteles specifičnih za sev, ki zavirajo hemaglutinacijo po aplikaciji
Fluenz Tetra is manufactured according to the same process as Fluenz.
Cepivo Fluenz Tetra je izdelano po enakem postopku kot cepivo Fluenz.
Fluenz safety
Varnost cepiva Fluenz
6 to 35 M 1,041
6 do 35 m 1.041
Keep the nasal applicator in the outer carton in order to protect from light.
Nosnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Limited available evidence suggests that the trivalent Fluenz is not excreted in breastmilk.
Maloštevilni dokazi, ki so na voljo, kažejo, da se trivalentno cepivo Fluenz ne izloča v materino mleko.
B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 254977)
B/Phuket/3073/2013 - podoben sev (B/Phuket/3073/2013, MEDI 254977)
Fluenz Tetra will help to protect against the four virus strains contained in the vaccine, and other strains closely related to them.
Cepivo Fluenz Tetra vam bo pomagalo pri zaščiti pred štirimi sevi virusa, ki jih cepivo vsebuje in drugimi podobnimi sevi.
Do not use salicylates in children and adolescents 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.
Salicilatov se ne sme uporabljati še 4 tedne po cepljenju pri otrocih in mladostnikih, razen če je to medicinsko indicirano, ker so po uporabi salicilatov v času okužbe z gripo virusa divjega tipa poročali o Reyevem sindromu.
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 1,609 children 24-71 months of age.
S 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 1.609 otrok starih od 24 - 71 mesecev.
5 single-use nasal applicators (0.2 ml each)
5 nosnikov za enkratno uporabo (vsak po 0,2 ml)
The active substances are: Reassortant influenza virus* (live attenuated) of the following four strains**:
Učinkovine so: Novi virus gripe* (živ oslabljen) naslednjih štirih sevov**:
It is not known whether Fluenz Tetra is excreted in human milk.
Ni znano, ali se cepivo Fluenz Tetra izloča v materino mleko.
Europe, Asia/ Oceania, Latin America
Evropa, Azija/ Oceanija, Južna Amerika
Fluenz demonstrated 55.7% (39.9, 67.6) fewer cases than injectable influenza vaccine in 3,686 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.
S cepivom Fluenz je bilo 55,7 % (39,9; 67,6) manj primerov kot pri cepivu proti gripi, ki se injicira, pri 3.686 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.
Fluenz Tetra 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 Tetra je na voljo kot 0,2 ml suspenzija v nosniku za enkratno uporabo (steklo tia 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.
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.
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.
Children and adolescents from 24 months: 0.2 ml (administered as 0.1 ml per nostril).
Otroci in mladostniki stari 24 mesecev ali več: 0,2 ml (aplicirano po 0,1 ml v vsako nosnico).
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.
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.
Imunski sistem (naravni obrambni sistem telesa) osebe, ki prejme cepivo, začne izločati lastno zaščito proti virusu gripe.
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.
• Fluenz Tetra is administered as a divided dose in both nostrils as described below.
• Cepivo Fluenz Tetra se aplicira kot razdeljen odmerek v obe nosnici kot je opisano spodaj.
A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Switzerland/3330/2017, MEDI 307134)
A/Brisbane/02/2018 (H1N1)pdm09 - podoben sev (A/Switzerland/3330/2017, MEDI 307134)
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.
Do not administer Fluenz Tetra to children and adolescents receiving salicylate therapy (see section 4.3).
Cepiva Fluenz Tetra se ne sme uporabiti pri otrocih in mladostnikih, ki se zdravijo s salicilati (glejte poglavje 4.3).
Administration of a higher than recommended dose of Fluenz Tetra was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose of Fluenz Tetra.
V redkih primerih so poročali o uporabi odmerka cepiva Fluenz Tetra, večjega od priporočenega, in profil neželenih učinkov je bil primerljiv kot pri uporabi priporočenega odmerka cepiva Fluenz Tetra.
For nasal use only.
Samo za nazalno uporabo.