natgillin/translations-raw huggingface dataset:
Flucelvax Tetra is given to you by your doctor or nurse as an injection into the muscle at the top of the upper arm (deltoid muscle). 
Cepivo Flucelvax Tetra vam zdravnik ali medicinska sestra injicira v mišico na vrhu nadlahti (deltoidno mišico).
EU/1/18/1326/001 10 pre filled syringes without needle EU/1/18/1326/002 1 pre filled syringe with needle EU/1/18/1326/003 10 pre filled syringes with needle 
EU/1/18/1326/001 10 napolnjenih injekcijskih brizg brez igle EU/1/18/1326/002 1 napolnjena injekcijska brizga z iglo EU/1/18/1326/003 10 napolnjenih injekcijskih brizg z iglo
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. 
Po vsakem cepljenju ali celo pred njim se lahko kot psihogeni odziv na injekcijsko iglo pojavi sinkopa
Frequency not known3 
Neznana pogostnost3
This reaction may occur with Flucelvax Tetra as with all vaccines that are injected. 
Do te reakcije lahko pride pri uporabi cepiva Flucelvax Tetra tako kot pri vseh cepivih, ki se injicirajo;
Vaccination should be postponed in patients with acute febrile illness until the fever is resolved. 
Pri bolnikih z akutno febrilno boleznijo je treba cepljenje preložiti, dokler zvišana telesna temperatura ne izzveni.
Flucelvax Tetra contains sodium chloride and potassium chloride 
Cepivo Flucelvax Tetra vsebuje natrijev klorid in kalijev klorid
Tell your doctor or nurse if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or if you have recently received any other vaccine. 
Obvestite zdravnika ali medicinsko sestro, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
The immunogenicity data with TIVc are relevant to the use of Flucelvax Tetra because both vaccines are manufactured using the same process and have overlapping compositions. 
Podatki o imunogenosti za TIVc so relevantni za uporabo cepiva Flucelvax Tetra, saj sta obe cepivi izdelani z istim postopkom in se njuni sestavi prekrivata.
A multinational, randomised, observer-blinded, placebo-controlled trial (V58P13) was performed to assess clinical efficacy and safety of TIVc during the 2007-2008 influenza season in adults aged 18 to less than 50 years. 
Izvedeno je bilo multinacionalno, randomizirano, za opazovalca slepo, s placebom nadzorovano preskušanje (V58P13) pri odraslih, starih od18 let do manj kot 50 let, za oceno klinične učinkovitosti in varnosti cepiva TIVc med sezono gripe 2007-2008.
Flucelvax Tetra is a suspension for injection in a pre-filled syringe (ready to use syringe). 
Cepivo Flucelvax Tetra je suspenzija za injiciranje v napolnjeni injekcijski brizgi (brizgi, pripravljeni za uporabo).
No human fertility data are available. 
Podatkov o učinkih na plodnost pri človeku ni.
Animal data, with cell-based trivalent influenza vaccine (TIVc), have not shown effects on female fertility. 
Podatki za trivalentno cepivo proti gripi na celični osnovi (TIVc), pridobljeni na živalih, ne kažejo vplivov na plodnost samic.
It is unknown whether Flucelvax Tetra is excreted in human milk. 
Ni znano, ali se cepivo Flucelvax Tetra izloča v materino mleko.
Age subgroup analyses in subjects 18 to less than 65 years of age and 65 years of age and above confirmed that HI antibody responses (GMT and differences in vaccine group seroconversion rates) met non-inferiority immunogenicity criteria 3 weeks following vaccination for all 4 influenza strains in both age groups. 
65 let ali več, so potrdile, da so odzivi HI protiteles (GMT in razlike v stopnjah serokonverzije med skupinami cepljenja) izpolnili merila neinferiornosti imunogenosti 3 tedne po cepljenju za vse 4 seve virusa gripe v obeh starostnih skupinah.
Antibody against one influenza virus type or subtype confers limited or no protection against another. 
Zaščita, ki jo protitelesa proti enemu tipu ali podtipu virusa gripe zagotavljajo pred drugimi (pod)tipi, je omejena ali je ni.
The efficacy experience with TIVc is relevant to Flucelvax Tetra because both vaccines are manufactured using the same process and have overlapping compositions. 
Izkušnje z učinkovitostjo cepiva TIVc so relevantne za cepivo Flucelvax Tetra, saj sta obe cepivi izdelani z istim postopkom in se njuni sestavi prekrivata.
Flucelvax Tetra is used to prevent flu in adults and children from 9 years of age. 
Cepivo Flucelvax Tetra se uporablja za preprečevanje gripe pri odraslih in otrocih, starih 9 let ali več.
The safety and efficacy of Flucelvax Tetra in children from birth to less than 9 years of age has not been established. 
Varnost in učinkovitost cepiva Flucelvax Tetra pri otrocih, mlajših od 9 let, nista bili dokazani.
A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA** A/Kansas/14/2017 (H3N2) - like strain (A/Indiana/08/2018) 15 micrograms HA** B/Colorado/06/2017 - like strain (B/Iowa/06/2017) 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA** per 0.5 ml dose * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin 
A/Brisbane/02/2018 (H1N1)pdm09 podoben sev (A/Idaho/07/2018) 15 mikrogramov HA** A/Kansas/14/2017 (H3N2) podoben sev (A/Indiana/08/2018) 15 mikrogramov HA** B/Colorado/06/2017 podoben sev (B/Iowa/06/2017) 15 mikrogramov HA** B/Phuket/3073/2013 podoben sev (B/Singapore/INFTT-16-0610/2016) 15 mikrogramov HA** na 0,5-mililitrski odmerek * razmnoženih v celicah pasjih ledvic Madin Darby Canine Kidney (MDCK; to je posebna kultura celic, v kateri gojijo virus gripe) ** hemaglutinina
There are limited data from the use of Flucelvax Tetra in pregnant women. 
Podatki o uporabi cepiva Flucelvax Tetra pri nosečnicah so omejeni.
A single 0.5 ml dose. 
Enkratni odmerek 0,5 ml.
Adverse reactions reported are listed according to the following frequency categories: Very common 
Neželeni učinki so navedeni po naslednjih razredih pogostnosti: zelo pogosti (≥ 1/10); pogosti
Table 3: Comparative efficacy of TIVc versus placebo against culture-confirmed influenza by influenza viral subtype (V58P13) 
Preglednica 3: Primerjalna učinkovitost cepiva TIVc proti s celično kulturo potrjeni gripi v primerjavi s placebom, po podtipih virusa gripe (V58P13)
Pack of 10 pre-filled syringes, with or without needles. 
Pakiranje z 10 napolnjenimi injekcijskimi brizgami, z iglami ali brez njih
The most common (≥10%) adverse reactions reported in paediatric subjects of 9 to < 18 years of age were injection site pain (58%), headache (22%), erythema (19%), fatigue (18%), myalgia (16%), and induration (15%). 
9 let do <18 let, so bili bolečina na mestu injiciranja (58 %), glavobol (22 %), eritem (19 %), utrujenost (18 %), mialgija (16 %) in zatrdlina (15 %).
Suspension for injection in pre-filled syringe 10 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with needle 10 pre-filled syringes (0.5 ml) with needle 
suspenzija za injiciranje v napolnjeni injekcijski brizgi 10 napolnjenih injekcijskih brizg (0,5 ml) brez igle 1 napolnjena injekcijska brizga (0,5 ml) z iglo 10 napolnjenih injekcijskih brizg (0,5 ml) z iglo
Flucelvax Tetra may be given at the same time as other vaccines. 
Cepivo Flucelvax Tetra se lahko daje sočasno z drugimi cepivi.
The most commonly reported (≥10%) reactions in subjects who received Flucelvax Tetra were pain at the injection site (34%), headache (14%), fatigue (14%), myalgia (14%), erythema (13%) and induration (10%). 
Neželeni učinki, o katerih so najpogosteje (≥ 10 %) poročali pri osebah, ki so prejele cepivo Flucelvax Tetra, so bili bolečina na mestu injiciranja (34 %), glavobol (14 %), utrujenost (14 %), mialgija
The vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2019/2020 season. 
Cepivo je v skladu s priporočili Svetovne zdravstvene organizacije (SZO) (za severno poloblo) in priporočili EU za sezono 2019/2020.
GMT (95% CI) 
GMT (95-% IZ)
Specific levels of haemagglutination inhibition (HI) antibody titres post-vaccination with inactivated influenza vaccine have not been correlated with protection from influenza virus. 
Ni korelacije med specifičnimi ravnmi titrov protiteles za zaviranje hemaglutinacije (HI) po cepljenju z inaktiviranim cepivom proti gripi in zaščito pred virusom gripe.
The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*: 
Učinkovine so inaktivirani površinski antigeni virusa influence (hemaglutinin in nevraminidaza) naslednjih sevov*:
Flucelvax Tetra induces humoral antibodies against the haemagglutinins. 
Cepivo Flucelvax Tetra inducira humoralna protitelesa proti hemaglutininom.
Nausea, Diarrhoea, Vomiting2 
Bolezni prebavil navzea, diareja, bruhanje2
Vaccine Group Difference (95% CI) 
Razlika med skupinami cepljenja (95-% IZ)
Vomiting was uncommon in the elderly 
Bruhanje je bilo pri starejših občasno.
What Flucelvax Tetra is and what it is used for 
Kaj je cepivo Flucelvax Tetra in za kaj ga uporabljamo
Uncommon (≥1/1,000 to 
(≥ 1/1.000 do
• Injection site pain, reddening, hardening or swelling at the site of the injection 
• bolečina na mestu injiciranja, rdečina, otrditev ali otekanje na mestu injiciranja,
Contents of the pack and other information What Flucelvax Tetra contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo Flucelvax Tetra
The antibody response to influenza B strains contained in Flucelvax Tetra was superior to the antibody response after vaccination with TIVc containing an influenza B strain from the alternate lineage. 
Odziv protiteles na seva virusa gripe B, ki ju vsebuje cepivo Flucelvax Tetra, je bil superioren odzivu protiteles po cepljenju s cepivom TIVc, ki je vsebovalo sev virusa gripe B iz druge linije.
Similar rates of solicited local and systemic adverse reactions were reported in subjects who received Flucelvax Tetra and cell-based trivalent influenza vaccine comparator in this clinical trial. 
V okviru sistematičnega poročanja so v tem kliničnem preskušanju poročali o podobnih stopnjah lokalnih in sistemskih neželenih učinkov pri osebah, ki so prejele cepivo Flucelvax Tetra, in osebah, ki so prejele primerjalno trivalentno cepivo proti gripi na celični osnovi.
All Culture-Confirmed Influenza Overall 
Vsi s celično kulturo potrjeni primeri gripe
Posology Adults and children from 9 years of age: 
Odrasli in otroci, stari 9 let ali več:
Clinical efficacy of cell-based trivalent influenza vaccine (TIVc) against culture-confirmed influenza in adults 
Klinična učinkovitost trivalentnega cepiva proti gripi na celični osnovi (TIVc) proti gripi pri odraslih,
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections. 
Natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev hidrogenfosfat dihidrat, kalijev dihidrogenfosfat in voda za injekcije.
Keep the pre filled syringe in the outer carton in order to protect from light. 
Napolnjeno injekcijsko brizgo shranjujte v škatli za zagotovitev zaščite pred svetlobo.
Pack of 1 pre-filled syringe, with needle 
Pakiranje z 1 napolnjeno injekcijsko brizgo, z iglo.
Flucelvax Tetra is a clear to slightly opalescent suspension. 
Cepivo Flucelvax Tetra je bistra do rahlo motna suspenzija.
Suspension for injection in pre-filled syringe (injection). 
suspenzija za injiciranje v napolnjeni injekcijski brizgi (injekcija) bistra do rahlo opalescentna tekočina
Other medicines and Flucelvax Tetra 
Druga zdravila in cepivo Flucelvax Tetra
Vaccine efficacies against vaccine-matched influenza viral strains, against all influenza viral strains, and against individual influenza viral subtypes were calculated (Table 3). 
Izračunali so učinkovitosti cepiv proti sevom virusa gripe, ki so se ujemali s tistimi v cepivih, in sicer proti vsem sevom virusa gripe in proti posameznim podtipom virusa gripe (preglednica 3).
In this study, subjects received Flucelvax Tetra (N = 1159) or one of the two formulations of comparator cell-based trivalent influenza vaccine (TIVc) [TIV1c (N = 593), or TIV2c (N = 580)]. 
Tetra (N = 1159) ali eno od dveh formulacij primerjalnega trivalentnega cepiva proti gripi na celični osnovi (TIVc) [TIV1c (N = 593) ali TIV2c (N = 580)].
• Numbness and tingling sensation 
• otrplost in občutek mravljinčenja,
The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe. 
Cepivo se ne sme injicirati intravensko, subkutano ali intradermalno.
Table 2: Noninferiority of Flucelvax Tetra relative to TIVc in adults 18 years of age and above - Per protocol analysis set (V130_01) 
Preglednica 2: Neinferiornost cepiva Flucelvax Tetra v primerjavi s cepivom TIVc pri odraslih, starih 18 let ali več - nabor za analizo po protokolu (V130_01)
Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free. 
Cepivo Flucelvax Tetra se pripravlja v kulturah celic in ne vsebuje jajčnih beljakovin.
Flucelvax Tetra may be used during breast-feeding. 
Cepivo Flucelvax Tetra se lahko uporablja med dojenjem.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and toxicity to reproduction and development. 
Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Flucelvax Tetra was non-inferior to TIVc. 
Cepivo Flucelvax Tetra je bilo neinferiorno cepivu TIVc.
Flucelvax Tetra was noninferior to TIVc in children 4 to less than 18 years of age. 
Cepivo Flucelvax Tetra je bilo neinferiorno cepivu TIVc pri otrocih, starih od 4 leta do manj kot 18 let.
The safety of Flucelvax Tetra in adults 18 years and older was evaluated in a randomised, controlled study (V130_01), in which 1334 subjects received Flucelvax Tetra. 
Varnost cepiva Flucelvax Tetra pri odraslih, starih 18 let ali več, so ocenili v randomizirani nadzorovani študiji (V130_01), v kateri je 1.334 oseb prejelo cepivo Flucelvax Tetra.
Based on clinical experience with cell-based trivalent influenza vaccine (TIVc), Flucelvax Tetra can be given at the same time as other vaccines. 
Podatkov o sočasnem dajanju cepiva Flucelvax Tetra z drugimi cepivi ni. Na osnovi kliničnih izkušenj s trivalentnim cepivom proti gripi na celični osnovi (TIVc) se cepivo Flucelvax Tetra lahko daje sočasno z drugimi cepivi.
Attack Rate 
Stopnja obolevnosti
Individual strains 
Skupaj Individualni sevi
Flucelvax Tetra suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 2019/2020 season 
Flucelvax Tetra suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti gripi iz kulture celic, s površinskimi antigeni, inaktivirano sezona 2019/2020
• Fever (> 38°C) 
• zvišana telesna temperatura (≥ 38 °C).
The safety of Flucelvax Tetra in children 4 to less than 18 years of age was evaluated in a randomised, controlled study (V130_03). 
Varnost cepiva Flucelvax Tetra pri otrocih, starih od 4 leta do manj kot 18 let, je bila ocenjena v randomizirani nadzorovani študiji (V130_03).
Table 1: Adverse reactions reported following vaccination in adults 18 years and older in clinical trials and post-marketing surveilance. 
Preglednica 1: Neželeni učinki, o katerih so poročali v kliničnih preskušanjih in v obdobju po prihodu zdravila na trg pri odraslih, starih 18 let ali več
Allergic or immediate hypersensitivity reactions, including anaphylactic shock 
Bolezni imunskega sistema alergijske ali takojšnje preobčutljivostn e reakcije,
Pre-filled syringe label 
Nalepka napolnjene injekcijske brizge
Carton box for syringe(s) with needle: - 1 pre-filled syringe (0.5 ml) with needle - 10 pre-filled syringes (0.5 ml) with needle Carton box for syringe(s) without needle: - 10 pre-filled syringes (0.5 ml) without needle 
Kartonska škatla za injekcijsko brizgo/injekcijske brizge brez igle: - 10 napolnjenih injekcijskih brizg (0,5 ml) brez igle Kartonska škatla za injekcijsko brizgo/injekcijske brizge z iglo: - 1 napolnjena injekcijska brizga (0,5 ml) z iglo - 10 napolnjenih injekcijskih brizg (0,5 ml) z iglo
Antigenically Matched Strains Overall 
Antigensko ujemajoči se sevi
• Nausea, vomiting, diarrhoea 
• siljenje na bruhanje, bruhanje, driska,
Use of Flucelvax Tetra during breast-feeding has not been studied. 
Uporabe cepiva Flucelvax Tetra pri doječih materah niso proučili.
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija1
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja generalizirane kožne reakcije,
Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 
Flucelvax Tetra - suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti gripi iz kulture celic, s površinskimi antigeni, inaktivirano
or one of the two formulations of comparator cell-based trivalent influenza vaccine (TIVc) [TIV1c (N = 677) or TIV2c (N = 669)]. 
V tej študiji so osebe prejele cepivo Flucelvax Tetra (N = 1.334) ali eno od dveh formulacij primerjalnega trivalentnega cepiva proti gripi na celični osnovi (TIVc) [TIV1c (N = 677) ali TIV2c (N = 669)].
No interaction studies have been performed with Flucelvax Tetra. 
Študij medsebojnega delovanja s cepivom Flucelvax Tetra niso izvedli.
There are no data for overdose with Flucelvax Tetra. 
Podatkov o prevelikem odmerjanju cepiva Flucelvax Tetra ni.
Read the package leaflet before use. 
intramuskularna uporaba Pred uporabo preberite priloženo navodilo!
What Flucelvax Tetra looks like and contents of the pack 
Izgled cepiva Flucelvax Tetra in vsebina pakiranja
For egg-derived influenza vaccines larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of influenza vaccine do not indicate any adverse foetal and maternal outcomes attributable to the vaccine. 
Za cepiva proti gripi na jajčni osnovi so za drugi in tretji trimester na voljo večji nabori podatkov o varnosti kot za prvi trimester.
1 Reported as Common in the elderly population 65 years of age and older 2 Reported as Uncommon in the elderly population 65 years of age and older 3 Adverse reactions reported from post-marketing surveillance 
1 Poročana kot pogosta pri populaciji oseb, starih 65 let ali več.
GMT (95% CI) Seroconversion Rateb 
GMT (95-% IZ) Stopnja serokonverzijeb
Vaccine Group Ratio (95% CI) 
Razmerje med skupinami cepljenja (95-% IZ)
Vaccine Efficacy = (1 - Relative Risk) x 100%; ** There were too few cases of influenza due to vaccine-matched influenza A/H3N2 or B to adequately assess vaccine efficacy. 
** Ni bilo dovolj primerov gripe, ki jo povzroča s cepivom ujemajoči se podtip A/H3N2 ali B, za ustrezno oceno učinkovitosti cepiva.
In the event of any foreign particulate matter and/or variation of physical aspect is observed, do not administer the vaccine. 
Ne dajajte tega cepiva, če opazite kakršne koli trdne delce in/ali spremembo videza cepiva.
How Flucelvax Tetra is given 
Kako se cepivo Flucelvax Tetra daje
Generalised skin reactions including pruritus, urticaria or non-specific rash 
vključno s pruritusom, urtikarijo ali neznačilnim izpuščajem
Loss of appetite 
Presnovne in prehranske motnje izguba apetita
TIVc = cell-based trivalent influenza vaccine; TIVeA = egg-based trivalent influenza vaccine (Agrippal); TIVeF = egg-based trivalent influenza vaccine (Fluvirin) a Seroconversion rate = percentage of subjects with either a pre-vaccination HI titre <1:10 and post-vaccination HI titre ≥1:40 or with a pre-vaccination HI titre ≥1:10 and a minimum 4-fold increase in post-vaccination HI antibody titre. 
(Agrippal); TIVeF = trivalentno cepivo proti gripi na jajčni osnovi (Fluvirin) a Stopnja serokonverzije = odstotek oseb s titrom HI < 1 : 10 pred cepljenjem in titrom HI ≥ 1 : 40 po cepljenju ali titrom HI ≥ 1 : 10 pred cepljenjem in najmanj 4-kratnim zvišanjem titra protiteles HI po cepljenju.
Sodium chloride Potassium chloride Magnesium chloride hexahydrate Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid kalijev klorid magnezijev klorid heksahidrat natrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
GMT (95% CI) Seroconversion Rateb (95% CI) 
GMT (95-% IZ) Stopnja serokonverzijeb (95-% IZ)
Flucelvax Tetra is not indicated for use in children less than 9 years of age, see section 4.2. 
Pediatrična populacija (od 4 leta do manj kot 9 let) Cepivo Flucelvax Tetra ni indicirano za uporabo pri otrocih, mlajših od 9 let; glejte poglavje 4.2.
Non-inferiority was established for all 4 influenza strains included in Flucelvax Tetra, as assessed by ratios of GMTs and the differences in the percentages of subjects achieving seroconversion at 3 weeks following vaccination. 
Neinferiornost, ki so jo ocenili na osnovi razmerij GMT in razlik v odstotkih oseb, ki so dosegle serokonverzijo 3 tedne po cepljenju, je bila dokazana za vse 4 seve virusa gripe, vključene v cepivo Flucelvax Tetra.
The immunogenicity endpoints were geometric mean antibody titres (GMTs) of haemagglutination inhibition (HI) antibodies response and percentage of subjects who achieved seroconversions, defined as a pre-vaccination HI titre of <1:10 with a post vaccination titre ≥1:40 or with a prevaccination HI titre of ≥10 and a minimum 4-fold increase in serum HI antibody titre. 
Opazovana dogodka imunogenosti sta bila geometrična sredina titrov protiteles (GMT - geometric mean antibody titers) odziva protiteles za inhibicijo hemaglutinacije (HI) in odstotek oseb, ki so dosegle serokonverzije, opredeljene kot titer HI pred cepljenjem < 1 : 10 in titer po cepljenju ≥ 1 : 40 ali kot titer HI pred cepljenjem ≥ 1 : 10 in najmanj 4-kratno zvišanje titra protiteles HI v serumu.
The European Medicines Agency has deferred the obligation to submit the results of studies with Flucelvax Tetra in children 6 months to 4 years of age in the prevention of influenza. 
Flucelvax Tetra za otroke, stare od 6 mesecev do 4 leta, za preprečevanje gripe.
• Extensive swelling of injected limb 
• obsežno otekanje okončine, v katero je bilo injicirano cepivo.
Nervous system disorders 
Bolezni živčevja glavobol1
The immunogenicity endpoints were GMTs of HI antibodies response and percentage of subjects who achieved seroconversions (seroconversion rate), defined as a pre-vaccination HI titre of <1:10 with a post-vaccination titre ≥1:40 or with a pre-vaccination HI titre ≥ 1:10 and a minimum 4-fold increase in serum HI antibody titre. 
Opazovana dogodka imunogenosti sta bila GMT odziva protiteles HI in odstotek oseb, ki so dosegle serokonverzije (stopnja serokonverzije), opredeljene kot titer HI pred cepljenjem < 1 : 10 in titer po cepljenju ≥ 1 : 40 ali kot titer HI pred cepljenjem ≥ 1 : 10 in najmanj 4-kratno zvišanje titra protiteles HI v serumu.
Injection site pain, Fatigue1, 
Splošne težave in spremembe na mestu aplikacije bolečina na mestu injiciranja, utrujenost1, eritem, induracija1
Immunogenicity of Flucelvax Tetra was evaluated in children 9 to less than 18 years of age as part of a randomised, double-blind, controlled study (V130_03) that was performed in the paediatric population 4 to less than 18 years of age. 
Imunogenost cepiva Flucelvax Tetra pri otrocih in mladostnikih, starih od 9 let do manj kot 18 let V okviru randomizirane, dvojno slepe, nadzorovane študije (V130_03), ki je bila izvedena pri pediatrični populaciji starosti od 4 leta do manj kot 18 let, so ocenili imunogenost cepiva Flucelvax Tetra pri otrocih, starih od 9 let do manj kot 18 let.
b Seroconversion rate = percentage of subjects with either a pre-vaccination HI titre <1:10 and post-vaccination HI titre ≥1:40 or with a pre-vaccination HI titre ≥1:10 and a minimum 4-fold increase in post-vaccination HI antibody titre. 
b Stopnja serokonverzije = odstotek oseb s titrom HI < 1 : 10 pred cepljenjem in titrom HI ≥ 1 : 40 po cepljenju ali titrom HI ≥ 1 : 10 pred cepljenjem in najmanj 4-kratnim zvišanjem titra protiteles HI po cepljenju.