FrancophonIA/ELRC3.0 huggingface dataset:
English: In the paediatric population 4 to less than 6 years of age, the following additional solicited adverse reactions were reported: sleepiness (21%), irritability (19%) and change in eating habits (14%).
Estonian: 4…< 6-aastaste laste rühmas teatati järgmistest esile kutsutud kõrvaltoimetest: unisus (21%), ärrituvus (19%) ja söömisharjumuste muutus (14%).
English: Overall, the immunogenicity results were in line with those obtained in subjects older than 9 years of age and showed a similar immune response in subjects receiving Flucelvax Tetra as compared to those receiving a comparator TIVc.
Estonian: Üldiselt olid immunogeensustulemused kooskõlas üle 9-aastastel uuritavatel saadud tulemustega ning Flucelvax Tetrat kasutanud uuritavatel esines samasugune immuunvastus nagu võrdlusravimina kasutatud TIVc manustamisel.
English: 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%).
Estonian: Flucelvax Tetrat saanud uuritavatel teatati kõige sagedamini (≥ 10%) järgmistest kõrvaltoimetest: valu süstekohas (34%), peavalu (14%), väsimus (14%), müalgia (14%), erüteem (13%) ja induratsioon
English: Flucelvax Tetra is not indicated for use in children less than 9 years of age, see section 4.2.
Estonian: Flucelvax Tetra ei ole näidustatud kasutamiseks < 9-aastastel lastel, vt lõik 4.2.
English: What Flucelvax Tetra looks like and contents of the pack
Estonian: Kuidas Flucelvax Tetra välja näeb ja pakendi sisu
English: 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%).
Estonian: Lastel vanuses 9…< 18 aastat teatati kõige sagedamini (≥ 10%) järgmistest kõrvaltoimetest: valu süstekohas (58%), peavalu (22%), erüteem (19%), väsimus (18%), müalgia (16%) ja induratsioon (15%).
English: Immune responses following vaccination with TIVc in the paediatric population (9 to < 18 years) were similar to those observed in the adult population in study V58P13 (see Table 5) in whom efficacy was demonstrated (results on vaccine efficacy are presented in Table 3).
Estonian: Laste (9...< 18-aastased) immuunvastus pärast TIVc-ga vaktsineerimist sarnanes nendel uuringus V58P13 osalenud täiskasvanutel täheldatuga (vt tabel 5), kelle puhul vaktsiin oli efektiivne (vaktsiini efektiivsuse tulemused on esitatud tabelis 3).
English: Comparison of immunogenicity of TIVc in the paediatric and adult population
Estonian: TIVc immunogeensuse võrdlus lastel ja täiskasvanutel
English: Flucelvax Tetra was non-inferior to TIVc.
Estonian: Flucelvax Tetra oli TIVc-ga võrreldes mittehalvem.
English: Pack of 10 pre-filled syringes, with or without needles.
Estonian: Pakendi on 10 süstlit, nõelaga või ilma nõelata.
English: Name and address of the manufacturer(s) of the biological active substance(s) Seqirus Inc.
Estonian: Bioloogilis(t)e toimeaine(te) tootja(te) nimi (nimed) ja aadress(id) Seqirus Inc.
English: After an episode of ILI, nose and throat swab samples were collected for analysis.
Estonian: Pärast gripisarnast haigust koguti analüüsimiseks nina ja kurgu tampooniproovid.
English: The immunogenicity data in subjects 9 to less than 18 years of age are summarised in Table 4.
Estonian: Immunogeensusandmed uuritavatel vanuses 9…< 18 aastat on kokku võetud tabelis 4.
English: Nervous system disorders
Estonian: Närvisüsteemi häired Peavalu1
English: Vaccine Group Difference (95% CI)
Estonian: Vaktsiinirühma erinevus (95% CI)
English: Children 4 to less than 9 years of age received one or two doses (separated by 4 weeks) of Flucelvax Tetra based on determination of the subject's prior influenza vaccination history.
Estonian: Lapsed vanusevahemikus 4…< 9 aastat said ühe annuse või kaks annust (4-nädalase vahega) Flucelvax Tetrat, lähtuvalt uuritava gripivastaste vaktsineerimiste anamneesist.
English: GMT (95% CI) Seroconversion Ratea 77% (70%-84%)
Estonian: GMT (95% CI) Serokonversiooni määra 77% (70%...84%)
English: The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Estonian: Teised koostisosad on: naatriumkloriid, kaaliumkloriid, magneesiumkloriidheksahüdraat, dinaatriumvesinikfosfaatdihüdraat, kaaliumdivesinikfosfaat ja süstevesi.
English: The efficacy experience with TIVc is relevant to Flucelvax Tetra because both vaccines are manufactured using the same process and have overlapping compositions.
Estonian: TIVc efektiivsusalased kogemused on Flucelvax Tetra hindamisel asjakohased, sest mõlema vaktsiini tootmisel on kasutatud sama protsessi ning nende koostisosad kattuvad osaliselt.
English: Flucelvax Tetra is a clear to slightly opalescent suspension.
Estonian: Flucelvax Tetra on läbipaistev kuni kergelt küütlev suspensioon.
English: Flucelvax Tetra suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 2019/2020 season
Estonian: Flucelvax Tetra süstesuspensioon süstlis Gripivaktsiin (pinnaantigeen, inaktiveeritud, valmistatud rakukultuuris) 2019/2020 gripihooaeg
English: After shaking, the normal appearance of the vaccine is a clear to slightly opalescent suspension.
Estonian: Pärast loksutamist on vaktsiin välimuselt üldjuhul läbipaistev kuni kergelt küütlev suspensioon.
English: Flucelvax Tetra contains sodium chloride and potassium chloride
Estonian: Flucelvax Tetra sisaldab naatriumkloriidi ja kaaliumkloriidi
English: Bold- CHMP immunogenicity criteria met.
Estonian: Paksus kirjas = inimravimite komitee immunogeensuskriteerium täidetud.
English: B/Phuket/3073/2013 - like strain (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA**
Estonian: B/Phuket/3073/2013 - sarnane tüvi (B/Singapore/INFTT-16-0610/2016) 15 mikrogrammi HA**
English: Table 3: Comparative efficacy of TIVc versus placebo against culture-confirmed influenza by influenza viral subtype (V58P13)
Estonian: TIVc versus platseebo efektiivsus rakukultuuriga kinnitatud gripiviiruse vastu gripiviiruse alatüübi järgi (V58P13)
English: Reproductive and developmental toxicology data from cell-based trivalent influenza vaccine (TIVc) do not predict an increased risk of developmental abnormalities.
Estonian: Rakupõhise trivalentse gripivaktsiini (TIVc) reproduktsiooni- ja arengutoksilisuse uuringute andmeil ei ole väärarengute tekkeriski suurenemist oodata.
English: The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
Estonian: Toimeained on gripiviiruse pinnaantigeenid (hemaglutiniin ja neuraminidaas), inaktiveeritud, sisaldavad järgmisi tüvesid*:
English: 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).
Estonian: Flucelvax Tetrat manustab teile teie arst või meditsiiniõde süstina õlavarre lihasesse (deltalihasesse).
English: Children 9 to less than 18 years of age received a single dose of Flucelvax Tetra.
Estonian: Lapsed vanusevahemikus 9…< 18 aastat said ühe annuse Flucelvax Tetrat.
English: There are limited data from the use of Flucelvax Tetra in pregnant women.
Estonian: Flucelvax Tetra kasutamise kohta rasedatel on andmeid piiratud hulgal.
English: Nausea, Diarrhoea, Vomiting2
Estonian: Iiveldus Kõhulahtisus Oksendamine2
English: Pre-filled syringe label
Estonian: Süstli etikett
English: Flucelvax Tetra induces humoral antibodies against the haemagglutinins.
Estonian: Flucelvax Tetra indutseerib hemaglutiniinide vastaste humoraalsete antikehade teket.
English: Clear to slightly opalescent liquid.
Estonian: Läbipaistev kuni kergelt küütlev vedelik.
English: A single syringe contains 0.5 ml of suspension for injection.
Estonian: Üks süstel sisaldab 0,5 ml süstesuspensiooni.
English: Flucelvax Tetra may contain traces of beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.
Estonian: Flucelvax Tetra võib sisaldada mikrokogustes beetapropiolaktooni, tsetüültrimetüülammooniumbromiidi ja polüsorbaati 80.
English: What Flucelvax Tetra is and what it is used for
Estonian: Mis ravim on Flucelvax Tetra ja milleks seda kasutatakse
English: Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI).
Estonian: Gripijuhtumite tuvastamiseks kasutati gripisarnaste haiguste aktiivset ja passiivset jälgimist.
English: This reaction may occur with Flucelvax Tetra as with all vaccines that are injected.
Estonian: Selline reaktsioon võib tekkida nii Flucelvax Tetra kui ka kõikide teiste süstitavate vaktsiinide kasutamisel.
English: 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.
Estonian: TIVc immunogeensusandmed on Flucelvax Tetra kasutamise aspektist asjakohased, sest mõlema vaktsiini valmistamisel on kasutatud sama meetodit ja vaktsiinide koostis on kattuv.
English: The preferred site for injection is the deltoid muscle of the upper arm.
Estonian: Eelistatav süstekoht on õlavarre deltalihas.
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Estonian: Mis tahes vaktsineerimise järel, või mõnikord koguni enne seda, võib tekkida psühhogeenne reaktsiooni nõelatorkele, mis avaldub sünkoobi ehk minestamisena.
English: Posology Adults and children from 9 years of age:
Estonian: Täiskasvanud ja lapsed alates 9. eluaastast
English: The following side effects have been reported during clinical trials and during general use:
Estonian: Kliiniliste uuringute ja tavakasutuse käigus on teatatud järgmistest kõrvaltoimetest.
English: GMT (95% CI) Seroconversion Ratea 56% (48%-65%)
Estonian: GMT (95% CI) Serokonversiooni määra 56% (48%...65%)
English: Paediatric population (9 to less than 18 years of age)
Estonian: Lapsed (9…< 18-aastased)
English: Paediatric Population (4 to less than 9 years of age)
Estonian: Lapsed (4…< 9-aastased)
English: Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
Estonian: Gripiviiruse pinnaantigeenid (hemaglutiniin ja neuraminidaas), inaktiveeritud, sisaldavad järgmisi tüvesid*:
English: Children less than 9 years of age reported similar rates of adverse reactions compared to older children.
Estonian: Võrreldes vanemate lastega esines < 9-aastastel lastel kõrvaltoimeid sarnase esinemissagedusega.
English: A/Kansas/14/2017 (H3N2) - like strain (A/Indiana/08/2018) 15 micrograms HA**
Estonian: A/Kansas/14/2017 (H3N2) - sarnane tüvi (A/Indiana/08/2018) 15 mikrogrammi HA**
English: Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Estonian: Flucelvax Tetra süstesuspensioon süstlis Gripivaktsiin (pinnaantigeen, inaktiveeritud, valmistatud rakukultuuris)
English: • Injection site pain, reddening, hardening or swelling at the site of the injection
Estonian: • Valu, punetus, kõvastumine või paistetus süstekohas
English: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA**
Estonian: A/Brisbane/02/2018 (H1N1)pdm09 - sarnane tüvi (A/Idaho/07/2018) 15 mikrogrammi HA**
English: The vaccine should be visually inspected for particulate matter and discoloration prior to administration.
Estonian: Enne vaktsiini manustamist tuleb seda visuaalselt kontrollida tahkete osakeste ja värvimuutuste osas.
English: Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Estonian: Naatriumkloriid, kaaliumkloriid, magneesiumkloriidheksahüdraat, dinaatriumvesinikfosfaatdihüdraat, kaaliumdivesinikfosfaat ja süstevesi.
English: 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
Estonian: Süstesuspensioon süstlis 10 süstlit (0,5 ml), ilma nõelata 1 süstel (0,5 ml), nõelaga 10 süstlit (0,5 ml), nõelaga
English: Flucelvax Tetra is a suspension for injection in a pre-filled syringe (ready to use syringe).
Estonian: Flucelvax Tetra on süstesuspensioon süstlis (kasutamisvalmis süstal).
English: 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.
Estonian: TIVc = rakupõhine kolmevalentne gripivaktsiin; TIVeA = munapõhine kolmevalentne gripivaktsiin (Agrippal); TIVeF = munapõhine kolmevalentne gripivaktsiin (Fluvirin) a Serokonversiooni määr = nende uuritavate osakaal, kellel oli kas vaktsineerimiseelne HI tiiter < 1:10 ja vaktsineerimisjärgne HI tiiter ≥ 1:40 või vaktsineerimiseelne HI tiiter ≥ 1:10 ja vaktsineerimisjärgselt HI
English: GMT (95% CI) Seroconversion Rateb (95% CI)
Estonian: GMT (95% CI) Serokonversiooni määrb (95% CI)
English: 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.
Estonian: Antikehareaktsioon Flucelvax Tetras sisalduvate B-gripiviiruse tüvede vastu oli parem kui muud päritolu B-gripiviiruse tüve sisaldava TIVc-ga vaktsineerimise järgselt.
English: B/Colorado/06/2017 - like strain (B/Iowa/06/2017) 15 micrograms HA**
Estonian: B/Colorado/06/2017 - sarnane tüvi (B/Iowa/06/2017) 15 mikrogrammi HA**
English: Generalised skin reactions including pruritus, urticaria or non-specific rash
Estonian: Generaliseerunud nahareaktsioonid, sh kihelus, urtikaaria või ebaspetsiifiline nahalööve
English: How Flucelvax Tetra is given 4.
Estonian: Kuidas Flucelvax Tetrat manustatakse 4.
English: • Numbness and tingling sensation
Estonian: • Tuimus ja torkimistunne
English: Immunogenicity of TIVc in children 9 to less than 18 years of age was evaluated as part of a randomised, double-blind, controlled study (V58P12) that was performed in the paediatric population 3 to less than 18 years of age.
Estonian: TIVc immunogeensust lastel vanuses 9…< 18 aastat hinnati osana randomiseeritud topeltpimedast kontrollrühmaga uuringust (V58P12), mis viidi läbi lastega vanuses 3…< 18 aastat.
English: 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.
Estonian: Munapõhiste gripivaktsiinide osas on teise ja kolmanda trimestri kohta rohkem ohutusandmeid kui esimese trimestri kohta.
English: GMT (95% CI) Seroconversion Rateb
Estonian: GMT (95% CI) Serokonversiooni määrb
English: Common (may affect up to 1 in 10 people):
Estonian: Sage (võivad esineda kuni 1 inimesel 10st)
English: Flucelvax Tetra is a vaccine against flu (influenza).
Estonian: Flucelvax Tetra on gripivastane vaktsiin.
English: 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.
Estonian: Flucelvax Tetra ohutust 18-aastastel ja vanematel täiskasvanutel hinnati randomiseeritud, kontrollrühmaga uuringus (V130_01), kus Flucelvax Tetrat said 1334 uuritavat.
English: • Generalised skin reactions including itching, bumps on the skin or non-specific rash
Estonian: • Üldised nahareaktsioonid, sh sügelus, naha ebatasasus või ebaspetsiifiline lööve
English: Flucelvax Tetra may be used during lactation.
Estonian: Flucelvax Tetrat võib kasutada imetamise ajal.
English: Paediatric population
Estonian: Haigestunute osakaal
English: Uncommon (may affect up to 1 in 100 people):
Estonian: Aeg-ajalt (võivad esineda kuni 1 inimesel 100st)
English: There are no data available on coadministration of Flucelvax Tetra with other vaccines.
Estonian: Flucelvax Tetra koosmanustamise kohta teiste vaktsiinidega andmed puuduvad.
English: Vomiting was uncommon in the elderly
Estonian: Oksendamist esines eakate seas aeg-ajalt.
English: • Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.
Estonian: • Mis tahes nõelatorke järgselt, või koguni enne seda, võib esineda minestamist.
English: A/H3N2** A/H1N1
Estonian: Üksiktüved A/H3N2**
English: Tell your doctor immediately if you experience any of the following side effects - you may need medical attention:
Estonian: Kui teil peaks tekkima mõni allpool loetletud kõrvaltoimetest, teavitage viivitamatult oma arsti, kuna võite vajada kiiret arstiabi:
English: Seroconversion Rateb (95% CI)
Estonian: Serokonversiooni määrb (95% CI)
English: Flucelvax Tetra is available in packs containing 1 pre filled syringe with needle or 10 prefilled syringes with or without needles.
Estonian: Flucelvax Tetra tarnitakse järgmistes pakendites: 1 süstel (0,5 ml) nõelaga või 10 süstlit nõelaga või ilma nõelata.
English: Table 1: Adverse reactions reported following vaccination in adults 18 years and older in clinical trials and post-marketing surveilance.
Estonian: Kliinilistes uuringutes ja turuletulekujärgse järelevalve ajal teatatud kõrvaltoimed pärast 18-aastaste ja vanemate täiskasvanute vaktsineerimist
English: Immunogenicity of Flucelvax Tetra in Children and Adolescents 9 to less than 18 Years of Age
Estonian: Flucelvax Tetra immunogeensus lastel ja noorukitel vanuses 9…< 18 aastat
English: It is unknown whether Flucelvax Tetra is excreted in human milk.
Estonian: Ei ole teada, kas Flucelvax Tetra eritub rinnapiima.
English: Pack of 1 pre-filled syringe, with needle
Estonian: Pakendis on 1 süstel, nõelaga.
English: A single 0.5 ml dose.
Estonian: Ühekordne 0,5 ml annus.
English: Vaccine Group Ratio (95% CI)
Estonian: Vaktsiinirühma osakaal (95% CI)
English: 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.
Estonian: Selles kliinilises uuringus oli Flucelvax Tetrat ja võrreldavat rakupõhist trivalentset gripivaktsiini saanud uuritavatel esile kutsutud paiksete ja süsteemsete kõrvaltoimete esinemissagedus sarnane.
English: The available immunogenicity data in the paediatric population 4 to less than 9 years of age were obtained in trial V130_03.
Estonian: 4...< 9-aastaste laste saadaolevad immunogeensusandmed on saadud uuringust V130_03.
English: There are no data for overdose with Flucelvax Tetra.
Estonian: Flucelvax Tetra üleannustamise kohta andmed puuduvad.
English: Extensive swelling of injected limb
Estonian: Süstitud jäseme ulatuslik tursumine
English: 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.
Estonian: TIVc kliinilise efektiivsuse ja ohutuse hindamiseks viidi 2007/2008 gripihooajal 18...< 50-aastaste täiskasvanute seas läbi rahvusvaheline randomiseeritud, vaatlejatele pimendatud, platseebokontrolliga uuring (V58P13).
English: HI data, egg-derived assay
Estonian: HI andmed, munapõhine analüüs
English: How to store Flucelvax Tetra 6.
Estonian: Kuidas Flucelvax Tetrat säilitada 6.
English: Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Estonian: Vaktsiini manustamise järgselt harva esinevate anafülaktiliste reaktsioonide puhuks peab alati valmis olema vastav meditsiiniline ravi ja jälgimisvõimalused.
English: Table 2: Noninferiority of Flucelvax Tetra relative to TIVc in adults 18 years of age and above - Per protocol analysis set (V130_01)
Estonian: Flucelvax Tetra mittehalvemus võrreldes TIVc-ga 18-aastastel ja vanematel täiskasvanutel lähtuvalt uuringuplaanipõhistest analüüsidest (V130_01)
English: * propagated in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown); ** haemagglutinin
Estonian: (tegemist on spetsiaalse rakukultuuriga, milles gripiviirust kasvatatakse) ** hemaglutiniin
English: Immunogenicity of Flucelvax Tetra in children 4 to less than 9 years of age
Estonian: Flucelvax Tetra immunogeensus lastel vanuses 4...< 9 aastat
English: 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
Estonian: Pappkarp ilma nõelata süstli(te)ga: 10 süstlit (0,5 ml), ilma nõelata Pappkarp nõelaga süstli(te)ga:
English: 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.
Estonian: Flucelvax Tetra immunogeensust lastel vanuses 9…< 18 aastat hinnati osana randomiseeritud topeltpimedast kontrollrühmaga uuringust (V130_03), mis viidi läbi lastega vanuses 4…< 18 aastat.
English: You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects, you can help provide more information on the safety of this medicine.
Estonian: Kõrvaltoimetest võite ka ise teavitada riikliku teavitussüsteemi, mis on loetletud V lisas, kaudu.
English: The safety of Flucelvax Tetra in children 4 to less than 18 years of age was evaluated in a randomised, controlled study (V130_03).
Estonian: Flucelvax Tetra ohutust lastel vanusevahemikus 4…< 18 aastat hinnati randomiseeritud, kontrollirühmaga uuringus (V130_03).
English: Sodium chloride Potassium chloride Magnesium chloride hexahydrate Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Estonian: Magneesiumkloriidheksahüdraat Dinaatriumvesinikfosfaatdihüdraat Kaaliumdivesinikfosfaat Süstevesi
English: Antigenically Matched Strains Overall
Estonian: Antigeenidega ühilduvad tüved Kokku
English: • Extensive swelling of injected limb
Estonian: • süstitud jäseme ulatuslik turse.
English: Flucelvax Tetra may be given at the same time as other vaccines.
Estonian: Flucelvax Tetrat on lubatud kasutada koos teiste vaktsiinidega.
English: Use of Flucelvax Tetra during breast-feeding has not been studied.
Estonian: Flucelvax Tetra kasutamise kohta imetamise ajal ei ole uuringuid läbi viidud.
English: Seqirus Netherlands B.V. Paasheuvelweg 28
Estonian: Paasheuvelweg 28
English: or one of the two formulations of comparator cell-based trivalent influenza vaccine (TIVc) [TIV1c (N = 677) or TIV2c (N = 669)].
Estonian: [TIV1c (N = 677) või TIV2c (N = 669)].
English: Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) This medicine is subject to additional monitoring.
Estonian: Pakendi infoleht: teave kasutajale Flucelvax Tetra süstesuspensioon süstlis gripivaktsiin (pinnaantigeen, inaktiveeritud, valmistatud rakukultuuris) Käesoleva ravimi suhtes kohaldatakse täiendavat järelevalvet, mis võimaldab kiiresti tuvastada uut ohutusteavet.
English: No interaction studies have been performed with Flucelvax Tetra.
Estonian: Flucelvax Tetra koostoimeid ei ole uuritud.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and toxicity to reproduction and development.
Estonian: Korduvtoksilisuse ning reproduktsiooni- ja arengutoksilisuse konventsionaalsete uuringute mittekliinilised andmed ei ole näidanud kahjulikku toimet inimesele.
English: There are no reproductive and developmental toxicology studies with Flucelvax Tetra.
Estonian: Flucelvax Tetraga ei ole reproduktsiooni- ja arengutoksilisuse uuringuid tehtud.