FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Musculoskeletal and connective tissue disorders Common: Myalgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti: mialgija
English: .................................................................................................................per 0.2 ml dose
Slovenian: .......................................................................................................na 0,2 ml odmerek
English: Fluenz Tetra has no or negligible influence on the ability to drive and use machines.
Slovenian: Cepivo Fluenz Tetra nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Fluenz Tetra is a vaccine to prevent influenza (flu).
Slovenian: Cepivo Fluenz Tetra je cepivo za preprečevanje gripe.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Namestitev nosnika Ko je oseba v pokončnem položaju, namestite konico nekoliko v nosnico, da zagotovite vnos cepiva Fluenz Tetra v nos.
English: Table 1 Fluenz Efficacy in Placebo Controlled Paediatric Studies
Slovenian: Preglednica 1 Učinkovitost cepiva Fluenz v pediatričnih študijah, kontroliranih s placebom
English: Do not remove dose-divider clip at the other end of the applicator.
Slovenian: Ne odstranite sponke za razdelitev odmerka na drugi strani nosnika.
English: Reassortant influenza virus* (live attenuated) of the following four strains**:
Slovenian: Novi virus gripe* (živ oslabljen) naslednjih štirih sevov**:
English: Immunogenicity was evaluated by comparing geometric mean titres (GMTs) of strain-specific serum haemagglutination inhibition (HAI) antibodies post dosing.
Slovenian: 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.
English: 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
Slovenian: 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
English: Paediatric studies
Slovenian: Pediatrične študije
English: The suspension is colourless to pale yellow, clear to opalescent with a pH of approximately 7.2.
Slovenian: Suspenzija je brezbarvna do bledorumena, bistra do opalescentna ter ima pH približno 7,2.
English: Pack size of 1 or 10.
Slovenian: Pakiranje z 1 nosnikom ali 10 nosniki.
English: No data exist regarding the possible effects of Fluenz Tetra on male and female fertility.
Slovenian: Podatkov o morebitnem vplivu cepiva Fluenz Tetra na plodnost pri moških in ženskah ni.
English: The recommended dose for children and adolescents is 0.2 ml Fluenz Tetra, administered as 0.1 ml in each nostril.
Slovenian: Priporočeni odmerek je tako za otroke kot za mladostnike 0,2 ml cepiva Fluenz Tetra, danega po 0,1 ml v vsako nosnico.
English: 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.
Slovenian: 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.
English: If influenza antiviral agents and Fluenz Tetra are administered concomitantly, revaccination should be considered based on clinical judgement.
Slovenian: Pri sočasni uporabi protivirusnih zdravil in cepiva Fluenz Tetra je treba razmisliti o revakcinaciji glede na klinično presojo.
English: The co-administration of Fluenz Tetra with inactivated vaccines has not been studied.
Slovenian: Sočasne uporabe cepiva Fluenz Tetra z inaktiviranimi cepivi niso preučevali.
English: The effectiveness of Fluenz and Fluenz Tetra in preventing influenza illness in immunocompromised individuals has not been evaluated.
Slovenian: Učinkovitost cepiv Fluenz in Fluenz Tetra pri preprečevanju obolevanja za gripo imunsko oslabelih oseb ni bila ocenjena.
English: Table 2 Fluenz Relative Efficacy in Active-controlled Paediatric Studies with Injectable Influenza Vaccine
Slovenian: Preglednica 2 Relativna učinkovitost cepiva Fluenz v aktivno kontroliranih pediatričnih študijah s cepivom proti gripi, ki se injicira
English: The concurrent use of Fluenz Tetra with antiviral agents that are active against influenza A and/or B viruses has not been evaluated.
Slovenian: Sočasne uporabe cepiva Fluenz Tetra s protivirusnimi zdravili, ki delujejo proti virusom gripe A in/ali B niso ocenili.
English: 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.
Slovenian: 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
English: Fluenz Tetra is manufactured according to the same process as Fluenz.
Slovenian: Cepivo Fluenz Tetra je izdelano po enakem postopku kot cepivo Fluenz.
English: Fluenz safety
Slovenian: Varnost cepiva Fluenz
English: 6 to 35 M 1,041
Slovenian: 6 do 35 m 1.041
English: Keep the nasal applicator in the outer carton in order to protect from light.
Slovenian: Nosnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Limited available evidence suggests that the trivalent Fluenz is not excreted in breastmilk.
Slovenian: Maloštevilni dokazi, ki so na voljo, kažejo, da se trivalentno cepivo Fluenz ne izloča v materino mleko.
English: B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 254977)
Slovenian: B/Phuket/3073/2013 - podoben sev (B/Phuket/3073/2013, MEDI 254977)
English: Fluenz Tetra will help to protect against the four virus strains contained in the vaccine, and other strains closely related to them.
Slovenian: Cepivo Fluenz Tetra vam bo pomagalo pri zaščiti pred štirimi sevi virusa, ki jih cepivo vsebuje in drugimi podobnimi sevi.
English: Chronic conditions
Slovenian: Kronična stanja
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 5 single-use nasal applicators (0.2 ml each)
Slovenian: 5 nosnikov za enkratno uporabo (vsak po 0,2 ml)
English: The active substances are: Reassortant influenza virus* (live attenuated) of the following four strains**:
Slovenian: Učinkovine so: Novi virus gripe* (živ oslabljen) naslednjih štirih sevov**:
English: It is not known whether Fluenz Tetra is excreted in human milk.
Slovenian: Ni znano, ali se cepivo Fluenz Tetra izloča v materino mleko.
English: Europe, Asia/ Oceania, Latin America
Slovenian: Evropa, Azija/ Oceanija, Južna Amerika
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The rate of wheezing was not increased in Fluenz recipients 24 months and older.
Slovenian: Stopnja sopenja se pri prejemnikih cepiva Fluenz starih 24 mesecev ali več ni povišala.
English: Children and adolescents from 24 months: 0.2 ml (administered as 0.1 ml per nostril).
Slovenian: Otroci in mladostniki stari 24 mesecev ali več: 0,2 ml (aplicirano po 0,1 ml v vsako nosnico).
English: Reduction in culture-confirmed influenza illness relative to injectable influenza vaccine.
Slovenian: Zmanjšanje obolelosti za gripo, potrjene s kulturo, glede na cepivo proti gripi, ki se injicira.
English: Danmark AstraZeneca A/S Tlf: +45 43 66 64 62
Slovenian: AstraZeneca A/S Tlf: +45 43 66 64 62
English: 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.
Slovenian: Imunski sistem (naravni obrambni sistem telesa) osebe, ki prejme cepivo, začne izločati lastno zaščito proti virusu gripe.
English: 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.
Slovenian: 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.
English: • Fluenz Tetra is administered as a divided dose in both nostrils as described below.
Slovenian: • Cepivo Fluenz Tetra se aplicira kot razdeljen odmerek v obe nosnici kot je opisano spodaj.
English: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Switzerland/3330/2017, MEDI 307134)
Slovenian: A/Brisbane/02/2018 (H1N1)pdm09 - podoben sev (A/Switzerland/3330/2017, MEDI 307134)
English: Children who have not previously had an influenza vaccine will receive a second, follow-up dose after an interval of at least 4 weeks.
Slovenian: Otroci, ki se še nikoli niso cepili proti gripi, bodo najmanj po 4 tednih prejeli še drugi, vzdrževalni odmerek.
English: Do not administer Fluenz Tetra to children and adolescents receiving salicylate therapy (see section 4.3).
Slovenian: Cepiva Fluenz Tetra se ne sme uporabiti pri otrocih in mladostnikih, ki se zdravijo s salicilati (glejte poglavje 4.3).
English: 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.
Slovenian: 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.
English: For nasal use only.
Slovenian: Samo za nazalno uporabo.
English: B/Colorado/06/2017 - like strain (B/Colorado/06/2017, MEDI 293454)
Slovenian: B/Colorado/06/2017 - podoben sev (B/Colorado/06/2017, MEDI 293454)
English: Fluenz has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
Slovenian: Cepivo Fluenz je bilo v 3 aktivno kontroliranih študijah s cepivom gripe, ki se injicira, superiorno.
English: Fluenz Tetra should under no circumstances be injected.
Slovenian: Cepiva Fluenz Tetra se ne sme v nobenem primeru injicirati.
English: SINGLE-USE NASAL APPLICATOR
Slovenian: NOSNIK ZA ENKRATNO UPORABO
English: This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 1 and 10.
Slovenian: Cepivo je v obliki pršila za nos, suspenzije, ki se nahaja v nosniku za enkratno uporabo (0,2 ml) v velikosti pakiranja 1 in 10.
English: ..................................................................................................................per 0.2 ml dose
Slovenian: ........................................................................................................na 0,2 ml odmerek
English: • if you are in close contact with someone with a severely weakened immune system
Slovenian: • če ste v tesnem stiku z nekom, ki ima hudo oslabljen imunski sistem (na primer bolnik s presajenim kostnim mozgom, ki mora biti izoliran).
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Fluenz efficacy
Slovenian: Učinkovitost cepiva Fluenz
English: A/Kansas/14/2017 (H3N2) - like strain (A/Kansas/14/2017, MEDI 308763)
Slovenian: A/Kansas/14/2017 (H3N2) - podoben sev (A/Kansas/14/2017, MEDI 308763)
English: Additional experience has occurred with marketed use of Fluenz.
Slovenian: V času trženja cepiva Fluenz so se pridobile dodatne izkušnje.
English: This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2019/2020 season.
Slovenian: Cepivo ustreza priporočilom Svetovne zdravstvene organizacije (severna polobla) in odločbi EU za sezono 2019/2020.
English: PACK SIZE OF 1 SINGLE-USE NASAL APPLICATOR PACK SIZE OF 1 SINGLE-USE NASAL APPLICATOR (IN A TRI-FOLD CARTON) PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (IN TRAYS) PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS
Slovenian: VELIKOST PAKIRANJA 1 NOSNIKA ZA ENKRATNO UPORABO VELIKOST PAKIRANJA 1 NOSNIKA ZA ENKRATNO UPORABO (V KARTONU S TREMI PREGIBI)
English: This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2019/2020 season.
Slovenian: Cepivo ustreza priporočilom SZO (Svetovne zdravstvene organizacije) (severna polobla) in odločbi EU za sezono 2019/2020.
English: PACK SIZE OF 5 SINGLE-USE NASAL APPLICATORS
Slovenian: VELIKOST PAKIRANJA 5 NOSNIKOV ZA ENKRATNO UPORABO
English: • nose bleed
Slovenian: • krvavitve iz nosu
English: Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) 2019/2020 season
Slovenian: Fluenz Tetra pršilo za nos, suspenzija cepivo proti gripi (z živimi oslabljenimi virusi, nosno) sezona 2019/2020
English: 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 with Fluenz.
Slovenian: Po začetku trženja cepiva Fluenz so opazili zelo redka poročila o Guillain-Barréjevem sindromu in poslabšanju simptomov Leigh-sindroma (mitohondrijska encefalomiopatija).
English: Respiratory, thoracic and mediastinal disorders Very common: Nasal congestion/rhinorrhoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti: zamašen nos/rinoreja Občasni: epistaksa
English: The suspension should be colourless to pale yellow, clear to opalescent.
Slovenian: Suspenzija mora biti brezbarvna do bledorumena in bistra do opalescentna.
English: If any of these apply, tell your doctor, nurse or pharmacist before vaccination.
Slovenian: Če karkoli od tega velja za vas, obvestite zdravnika, farmacevta ali medicinsko sestro pred cepljenjem.
English: Other possible side effects of Fluenz Tetra
Slovenian: Drugi možni neželeni učinki cepiva Fluenz Tetra
English: No clinically meaningful changes in immune responses to measles, mumps, varicella, orally-administered poliovirus or Fluenz have been observed.
Slovenian: Klinično pomembnih sprememb odziva imunskega sistema na cepivo proti ošpicam, mumpsu, noricam in na peroralno cepivo proti otroški paralizi ali cepivo Fluenz niso opazili.
English: • Refer to the Fluenz Tetra administration diagram (Figure 1) for step-by-step administration instructions.
Slovenian: • Za navodila za aplikacijo cepiva Fluenz Tetra po korakih glejte postopek aplikacije (slika 1).
English: The safety experience with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-live attenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra.
Slovenian: Izkušnje o varnosti s trivalentnim cepivom Fluenz so pomembne za uporabo cepiva Fluenz Tetra, saj je Fluenz Tetra (cepivo proti gripi - z živimi oslabljenimi virusi, nosno) identično cepivu Fluenz, pri čemer je edina razlika dodatek četrtega seva (drugi B sev) v cepivu Fluenz Tetra.
English: The patient can breathe normally while the vaccine is being administered - there is no need to actively inhale or sniff.
Slovenian: Oseba lahko med dajanjem cepiva normalno diha - ni potrebe za aktivno inhaliranje ali vdihavanje skozi nosnici.
English: You can breathe normally while you are given Fluenz Tetra.
Slovenian: Med prejemanjem cepiva Fluenz Tetra lahko normalno dihate.
English: Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in Fluenz clinical studies.
Slovenian: V kliničnih študijah cepiva Fluenz je bila največja incidenca rekuperacije virusa iz cepiva 2 - 3 dni po cepljenju.
English: • The patient can breathe normally while the vaccine is being administered - there is no need to actively inhale or sniff.
Slovenian: • Oseba lahko med dajanjem cepiva normalno diha - ni potrebe za aktivno inhaliranje ali vdihavanje skozi nosnici.
English: This observation with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-liveattenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra.
Slovenian: Ta sprememba pri trivalentnem cepivu Fluenz je pomembna za uporabo cepiva Fluenz Tetra, saj je Fluenz Tetra (cepivo proti gripi - z živimi oslabljenimi virusi, nosno) identično cepivu Fluenz, pri čemer je edina razlika dodatek četrtega seva (drugi B sev) v cepivu Fluenz Tetra.
English: Non-clinical data reveal no special hazard for humans based on conventional non-clinical studies of repeated dose toxicity, reproduction and developmental toxicity, local tolerance and neurovirulence.
Slovenian: Predklinični podatki 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.
English: Overdose with Fluenz Tetra is unlikely due to its presentation as a pre-filled sprayer.
Slovenian: Preveliko odmerjanje cepiva Fluenz Tetra zaradi njegove oblike v napolnjenem razpršilniku ni verjetno.
English: Immunocompromised
Slovenian: Imunska oslabelost
English: There was no evidence of significant maternal adverse outcomes in 138 pregnant women who had a record of receiving trivalent Fluenz in a US-based health insurance claims database.
Slovenian: Po podatkih ameriške baze odškodninskih zahtevkov zdravstvenega zavarovanja pri 138 nosečnicah, ki so prejemale trivalentno cepivo Fluenz, ni bilo dokazov o posebnih neželenih izidih nosečnosti za mater.
English: AV006 USA 15 to 71 M 1,259
Slovenian: ZDA 15 do 71 m 1.259
English: What Fluenz Tetra looks like and contents of the pack
Slovenian: Izgled cepiva Fluenz Tetra in vsebina pakiranja
English: Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal)
Slovenian: Fluenz Tetra pršilo za nos, suspenzija cepivo proti gripi (z živimi oslabljenimi virusi, nosno)
English: Talk to your doctor, nurse or pharmacist before vaccination:
Slovenian: Pred cepljenjem se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom:
English: Spray in other nostril Place the tip just inside the other nostril and with a single motion, depress plunger as rapidly as possible to deliver remaining vaccine.
Slovenian: Konico namestite nekoliko v drugo nosnico in z enkratnim pritiskom pritisnite na bat tako hitro, kot lahko, da vnesete preostanek cepiva.
English: Contains also: sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections.
Slovenian: Vsebuje tudi: saharozo, kalijev hidrogenfosfat, kalijev dihidrogenfosfat, želatino (svinjsko, tipa A), argininijev klorid, natrijev glutamat monohidrat, vodo za injekcije.
English: Fluenz Tetra must not be injected.
Slovenian: Cepiva Fluenz Tetra se ne sme injicirati.
English: General disorders and administration site conditions Very common: Malaise
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogosti: slabost