natgillin/translations-raw huggingface dataset:
Tabel 1: Bivirkninger rapporteret efter vaccination hos voksne i alderen 18 år og derover i kliniske studier og ved overvågning efter markedsføring
Table 1: Adverse reactions reported following vaccination in adults 18 years and older in clinical trials and post-marketing surveilance.
a Komparatorvaccinen for sammenligninger af noninferioritet er for A/H1N1, A/H3N2 og B1 - TIV1c og for B2
a The comparator vaccine for noninferiority comparisons for A/H1N1, A/H3N2 and B1 is TIV1c, for B2 it is
Det er ukendt, om Flucelvax Tetra udskilles i human mælk.
It is unknown whether Flucelvax Tetra is excreted in human milk.
Det foretrukne injektionssted er musculus deltoideus i overarmen.
The preferred site for injection is the deltoid muscle of the upper arm.
Søg omgående læge eller tag på skadestuen på det nærmeste hospital, hvis du får følgende bivirkningdu kan have brug for akut lægehjælp eller indlæggelse:
Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect - you may need urgent medical attention or hospitalisation:
Fremhævet = CHMP-immunogenicitetskriterier opfyldt.
Bold- CHMP immunogenicity criteria met.
Specifikke niveauer af titre for hæmagglutinationhæmnings (HI)-antistof efter vaccination med inaktiveret influenzavaccine er ikke blevet korreleret med beskyttelse mod influenzavirus.
Specific levels of haemagglutination inhibition (HI) antibody titres post-vaccination with inactivated influenza vaccine have not been correlated with protection from influenza virus.
Samlet set var immunogenicitetsresultaterne på linje med de, der er opnået for forsøgspersoner over 9 år, og de viste et tilsvarende immunrespons hos forsøgspersoner, der fik Flucelvax Tetra, sammenlignet med de, der fik en komparator TIVc .
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.
V58P13 (forsøgspersoner 18 til < 50 år)
V58P13 (Subjects 18 to < 50 years)
Forebyggelse af influenza hos voksne og børn fra 9 år.
Prophylaxis of influenza in adults and children from 9 years of age.
Flucelvax Tetra gives af lægen eller sygeplejersken som en indsprøjtning i musklen øverst på overarmen (deltamusklen).
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).
Immunogenicitetsdata for forsøgspersoner i alderen 9 til under 18 år er sammenfattet i tabel 4.
The immunogenicity data in subjects 9 to less than 18 years of age are summarised in Table 4.
Flucelvax Tetra fremstilles i cellekulturer og er derfor fri for æg.
Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free.
Feber (≥ 38 oC)
Fever (≥ 38°C)
Individuelle stammer
Individual strains
I den pædiatriske population i alderen 4 til under 6 år blev følgende yderligere forespurgte bivirkninger rapporteret: søvnighed (21%), irritabilitet (19%) og ændrede spisevaner (14%).
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%).
Baseret på klinisk erfaring med cellebaseret trivalent influenzavaccine (TIVc) kan Flucelvax Tetra gives samtidig med andre vacciner.
Based on clinical experience with cell-based trivalent influenza vaccine (TIVc), Flucelvax Tetra can be given at the same time as other vaccines.
V58P12 (forsøgspersoner 9 til < 18 år)
V58P12 (Subjects 9 to < 18 years)
Denne vaccine indeholder mindre end 1 mmol (39 mg) (39 mg) kalium pr. dosis, dvs. den er i det væsentlige ”kaliumfri”.
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium free'.
• Udbredte hudreaktioner, herunder kløe, knopper på huden eller ikke-specifikt udslæt
• Generalised skin reactions including itching, bumps on the skin or non-specific rash
Vaccinens virkning mod influenzavirusstammer, der matchede vaccinen, mod alle influenzavirusstammer og mod de enkelte undertyper af influenzavirus blev beregnet (tabel 3).
Vaccine efficacies against vaccine-matched influenza viral strains, against all influenza viral strains, and against individual influenza viral subtypes were calculated (Table 3).
Serokonverterings-rateb a For H1N1-, H3N2- og B1-influenzastammer er vist TIV1c-data, mens der for B2-influenzastammer er vist
Seroconversion Rateb a For H1N1, H3N2 and B1 influenza strains TIV1c data are presented, whereas for B2 influenza strain TIV2c data are presented.
Børn i alderen 4 til under 9 år fik én eller to doser (med 4 ugers mellemrum) Flucelvax Tetra baseret på en bestemmelse af forsøgspersonens tidligere influenzavaccinationshistorik.
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.
Data for reproduktions- og udviklingstoksikologi fra cellebaseret trivalent influenzavaccine (TIVc) forudsiger ikke en øget risiko for udviklingsmæssige abnormaliteter.
Reproductive and developmental toxicology data from cell-based trivalent influenza vaccine (TIVc) do not predict an increased risk of developmental abnormalities.
Et multinationalt, randomiseret, observatørblindet, placebokontrolleret studie (V58P13) blev udført til vurdering af TIVc's kliniske virkning og sikkerhed hos voksne i alderen 18 til under 50 år i løbet af influenzasæsonen 2007-2008.
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.
• Din læge eller sygeplejerske sørger for, at du kan få den rette behandling og overvågning i tilfælde af, at vaccinen skulle fremkalde en voldsom allergisk reaktion (anafylaktisk reaktion, med symptomer som vejrtrækningsbesvær, svimmelhed, svag og hurtig puls og udslæt).
• Your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du får Flucelvax Tetra.
Talk to your doctor, pharmacist or nurse before receiving Flucelvax Tetra.
0,5 ml suspension i fyldte injektionssprøjter (type I-glas) med en stempelprop (brombutylgummi) med eller uden kanyle.
0.5 ml suspension in pre-filled syringes (type I glass), with a plunger stopper (bromobutyl rubber), with or without needle.
Pædiatrisk population (i alderen 9 til under 18 år)
Paediatric population (9 to less than 18 years of age)
Flucelvax Tetra er en vaccine mod influenza.
Flucelvax Tetra is a vaccine against flu (influenza).
Det skal du vide, før du får Flucelvax Tetra Du bør ikke få Flucelvax Tetra:
What you need to know before you receive Flucelvax Tetra You should not receive Flucelvax Tetra:
Meget alvorlige bivirkninger
Very serious side effects
Tabel 5: GMT'er og serokonverteringsrater hos voksne og pædiatriske forsøgspersoner vaccineret med TIVc (V58P12 og V58P13)
Table 5: GMTs and seroconversion rates in adult and paediatric subjects vaccinated with TIVc (V58P12 and V58P13)
Klar til let opaliserende væske.
Clear to slightly opalescent liquid.
Pædiatrisk population (i alderen 4 til under 9 år)
Paediatric Population (4 to less than 9 years of age)
Hos børn, der fik en anden dosis Flucelvax Tetra eller cellebaseret trivalent influenzavaccine, svarede hyppigheden af bivirkninger efter den anden dosis vaccine til den, der blev observeret ved den første dosis i dette kliniske studie.
In children who received a second dose of Flucelvax Tetra or cell-based trivalent influenza vaccine, the incidence of adverse reactions following the second dose of vaccine was similar to that observed with the first dose in this clinical trial.
De hyppigst rapporterede (≥ 10%) bivirkninger hos forsøgspersoner, der fik Flucelvax Tetra, var smerter på injektionsstedet (34%), hovedpine (14%), træthed (14%), myalgi (14%), erytem (13%) og induration (10%).
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%).
TIVc-virkning blev defineret som forebyggelse af kulturbekræftet, symptomatisk influenzasygdom forårsaget af virus, hvor antigenerne matchede virus i vaccinen, sammenlignet med placebo.
TIVc efficacy was defined as the prevention of culture-confirmed symptomatic influenza illness caused by viruses antigenically matched to those in the vaccine compared to placebo.
Der var ingen evidens for, at tilsætning af den anden influenza B-stamme resulterede i immuninterferens i forhold til andre stammer indeholdt i vaccinen.
There was no evidence that the addition of the second influenza B strain resulted in immune interference to other strains included in the vaccine.
Ikke almindelig (≥1/1.000 til <
Uncommon (≥1/1,000 to
A/Brisbane/02/2018 (H1N1)pdm09- lignende stamme (A/Idaho/07/2018) 15 mikrogram HA** A/Kansas/14/2017 (H3N2)- lignende stamme (A/Indiana/08/2018) 15 mikrogram HA** B/Colorado/06/2017 - lignende stamme (B/Iowa/06/2017) 15 mikrogram HA** B/Phuket/3073/2013 - lignende stamme (B/Singapore/INFTT-16-0610/2016) 15 mikrogram HA** pr. 0,5 ml-dosis * opformeret i Madin Darby Canine Kidney (MDCK)-celler ** hæmagglutinin
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
Forkortelser: GMT = geometrisk middeltiter.
Abbreviations: GMT = geometric mean titre; CI = confidence interval.
Pakning med 10 fyldte injektionssprøjter med eller uden kanyler.
Pack of 10 pre-filled syringes, with or without needles.
Flucelvax Tetra indeholder natriumchlorid og kaliumchlorid
Flucelvax Tetra contains sodium chloride and potassium chloride
Immunresponser efter vaccination med TIVc i den pædiatriske population (9 til < 18 år) svarede til de immunresponser, der blev observeret i den voksne population i studie V58P13 (se tabel 5), hos de, hvor der blev påvist virkning (resultater vedrørende vaccinevirkning er vist i tabel 3).
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).
Der blev rapporteret tilsvarende hyppigheder af forespurgte lokale og systemiske bivirkninger hos forsøgspersoner, der fik Flucelvax Tetra og komparatorvaccinen, cellebaseret trivalent influenzavaccine i dette kliniske studie.
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.
Flucelvax Tetra kan indeholde spor af beta-propiolacton, cetyltrimethylammoniumbromid og polysorbat 80.
Flucelvax Tetra may contain traces of beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.
Tabel 4: GMT'er og serokonverteringsrater (med 95% CI) hos forsøgspersoner i alderen 9 til < 18 år 3 uger efter vaccination med Flucelvax Tetra eller TIV1c/TIV2c - Perprotokol-sæt (V130_03)
Table 4: GMTs and seroconversion rates (with 95% CI) in subjects 9 to <18 years of age, 3 weeks after vaccination with Flucelvax Tetra or TIV1c/TIV2c - Per Protocol Set (V130_03)
Kvalme, diarré, opkastning2
Nausea, Diarrhoea, Vomiting2
Antistofresponset på influenza B-stammer indeholdt i Flucelvax Tetra var superior i forhold til antistofresponset efter vaccination med TIVc, der indeholdt en influenza B-stamme fra den alternative linje.
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.
Flucelvax Tetra findes i pakninger, der indeholder 1 fyldt injektionssprøjte med kanyle eller 10 fyldte injektionssprøjter med eller uden kanyler.
Flucelvax Tetra is available in packs containing 1 pre filled syringe with needle or 10 prefilled syringes with or without needles.
Procentdelen af forsøgpersoner med serokonvertering eller en signifikant stigning i HI-antistoftiter er > 40%, procentdelen af forsøgspersoner, der opnåede en HI-titer ≥ 1:40, er > 70%.
The percentage of subjects with seroconversion or significant increase in HI antibody titre is >40%, the percentage of subjects achieving an HI titre ≥1:40 is >70%.
I dette studie fik forsøgspersonerne Flucelvax Tetra (N = 1.159) eller den ene af de to formuleringer af komparatorvaccinen, cellebaseret trivalent influenzavaccine (TIVc) [TIV1c (N = 593) eller TIV2c (N = 580)].
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)].
GMT (95% CI) Serokonverteringsratea 77% (70%-84%)
GMT (95% CI) Seroconversion Ratea 77% (70%-84%)
Flucelvax Tetra påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
Flucelvax Tetra has no or negligible influence on the ability to drive and use machines.
Flucelvax Tetra anvendes til at forebygge influenza hos voksne og børn fra 9 år.
Flucelvax Tetra is used to prevent flu in adults and children from 9 years of age.
Vaccinen er rettet mod fire influenzavirusstammer efter Verdenssundhedsorganisationens (WHO's) anbefalinger for sæsonen 2019/2020.
The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2019/2020 season.
De hyppigst rapporterede (≥ 10%) bivirkninger hos pædiatriske forsøgspersoner i alderen 9 til < 18 år var smerter på injektionsstedet (58%), hovedpine (22%), erytem (19%), træthed (18%), myalgi (16%) og induration (15%).
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%).
Imunogenicitetsdata med TIVc er relevante for brugen af Flucelvax Tetra, da begge vacciner fremstilles ved anvendelse af den samme proces og har overlappende sammensætninger.
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.
EU/1/18/1326/001 10 fyldte injektionssprøjter uden kanyle EU/1/18/1326/002 1 fyldt injektionssprøjte med kanyle EU/1/18/1326/003 10 fyldte injektionssprøjter med kanyle
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
Flucelvax Tetra inducerer humorale antistoffer mod hæmagglutininerne.
Flucelvax Tetra induces humoral antibodies against the haemagglutinins.
Noninferioritet blev bestemt for alle 4 influenzastammer, der er indeholdt i Flucelvax Tetra, vurderet ved hjælp af forholdene mellem GMT'er og forskellene i procentdelene af forsøgspersoner, der opnåede serokonvertering 3 uger efter vaccination.
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.
De foreliggende immunogenicitetsdata for den pædiatriske population i alderen 4 til under 9 år er opnået i studie V130_03.
The available immunogenicity data in the paediatric population 4 to less than 9 years of age were obtained in trial V130_03.
Tabel 3: Sammenligning af virkning af TIVc i forhold til placebo mod kulturbekræftet influenza for hver undertype af influenzavirus (V58P13)
Table 3: Comparative efficacy of TIVc versus placebo against culture-confirmed influenza by influenza viral subtype (V58P13)
Der foreligger ingen data om administration af Flucelvax Tetra sammen med andre vacciner.
There are no data available on coadministration of Flucelvax Tetra with other vaccines.
• Smerter, rødme, hårdhed eller hævelse på injektionsstedet
• Injection site pain, reddening, hardening or swelling at the site of the injection
Flucelvax Tetra kan gives samtidig med andre vacciner.
Flucelvax Tetra may be given at the same time as other vaccines.
Flucelvax Tetra var noninferior i forhold til TIVc.
Flucelvax Tetra was non-inferior to TIVc.
Data fra dyrestudier med cellebaseret trivalent influenzavaccine (TIVc) har ikke vist påvirkning af fertiliteten hos hundyr.
Animal data, with cell-based trivalent influenza vaccine (TIVc), have not shown effects on female fertility.
Stammer med match af antigener Samlet
Antigenically Matched Strains Overall
Tabel 2: Noninferioritet af Flucelvax Tetra i forhold til TIVc hos voksne i alderen 18 år og derover - Per-protokol-analysesæt (V130_01)
Table 2: Noninferiority of Flucelvax Tetra relative to TIVc in adults 18 years of age and above - Per protocol analysis set (V130_01)
GMT (95% CI) Serokonverteringsratea 56% (48%-65%)
GMT (95% CI) Seroconversion Ratea 56% (48%-65%)
4.8 og 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
Currently available safety and immunogenicity data are described in sections 4.8 and 5.1 but no recommendation on posology can be made.
Aktive stoffer: Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase), inaktiverede, fra følgende stammer*:
The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase), inaktiverede, fra følgende stammer*:
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
GMT (95% CI) Serokonverterings-rateb
GMT (95% CI) Seroconversion Rateb
Virkningserfaringen med TIVc er relevant for Flucelvax Tetra, da begge vacciner er fremstillet ved anvendelse af den samme proces og har overlappende sammensætninger.
The efficacy experience with TIVc is relevant to Flucelvax Tetra because both vaccines are manufactured using the same process and have overlapping compositions.
Indlægsseddel: Information til brugeren Flucelvax Tetra injektionsvæske, suspension i fyldt injektionssprøjte
Package leaflet: Information for the user Flucelvax Tetra - suspension for injection in pre-filled syringe
Flucelvax Tetra er en klar til let opaliserende suspension.
Flucelvax Tetra is a clear to slightly opalescent suspension.
TIVc's immunogenicitet hos børn i alderen 9 til under 18 år er blevet vurderet som en del af et randomiseret, dobbeltblindet, kontrolleret studie (V58P12), der blev udført i den pædiatriske population i alderen 3 til under 18 år.
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.
Fortæl altid lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
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.
Magnesiumchloridhexahydrat Dinatriumphosphatdihydrat Kaliumdihydrogenphosphat Vand til injektionsvæsker
Sodium chloride Potassium chloride Magnesium chloride hexahydrate Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Flucelvax Tetra's sikkerhed og virkning hos børn fra fødslen til under 9 år er ikke klarlagt.
The safety and efficacy of Flucelvax Tetra in children from birth to less than 9 years of age has not been established.
Vaccinegruppe forskel (95 % CI)
Vaccine Group Difference (95% CI)
Flucelvax Tetra injektionsvæske, suspension i fyldt injektionssprøjte Influenzavaccine (overfladeantigen, inaktiveret, fremstillet i cellekulturer) Sæsonen 2019/2020
Flucelvax Tetra suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 2019/2020 season
Der er ingen data for overdosering med Flucelvax Tetra.
There are no data for overdose with Flucelvax Tetra.
Anvendelse af Flucelvax Tetra under amning er ikke blevet undersøgt.
Use of Flucelvax Tetra during breast-feeding has not been studied.
Serokonverteringsrateb (95% CI)
Seroconversion Rateb (95% CI)
Injektionsvæske, suspension i fyldt injektionssprøjte (injektionsvæske).
Suspension for injection in pre-filled syringe (injection).
Ekkymose, kulderystelser
Ecchymosis, Chills
Vaccinen opfylder Verdensundhedsorganisationen (WHO's) anbefalinger for den nordlige halvkugle samt EU's bestemmelser for sæsonen 2019/2020.
The vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2019/2020 season.
Pakningsstørrelser og yderligere oplysninger Flucelvax Tetra indeholder
Contents of the pack and other information What Flucelvax Tetra contains
• kraftig hævelse af injiceret arm
• Extensive swelling of injected limb
Der er ikke udført interaktionsstudier med Flucelvax Tetra.
No interaction studies have been performed with Flucelvax Tetra.
Flucelvax Tetra var noninferior i forhold til TIVc hos børn i alderen 4 til under 18 år.
Flucelvax Tetra was noninferior to TIVc in children 4 to less than 18 years of age.
Smerter på injektionsstede t, træthed1, erytem, induration1
Injection site pain, Fatigue1,
Flucelvax Tetra - injektionsvæske, suspension i fyldt injektionssprøjte Influenzavaccine (overfladeantigen, inaktiveret, fremstillet i cellekulturer)
Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Sådanne reaktioner opstår dog kun sjældent, men de kan forekomme med Flucelvax Tetra ligesom med alle andre vacciner, der indsprøjtes.
This reaction may occur with Flucelvax Tetra as with all vaccines that are injected.
Flucelvax Tetra's sikkerhed hos voksne i alderen 18 år og derover er blevet vurderet i et randomiseret, kontrolleret studie (V130_01), hvor 1.334 forsøgspersoner fik Flucelvax Tetra.
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.
Injektionsvæske, suspension i fyldt injektionssprøjte 10 fyldte injektionssprøjter (0,5 ml) uden kanyle 1 fyldt injektionssprøjte (0,5 ml) med kanyle 10 fyldte injektionssprøjter (0,5 ml) med kanyle
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
For æg-afledte influenzavacciner foreligger der et større datasæt om sikkerheden for det andet og tredje trimester sammenlignet med det første trimester.
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.
Flucelvax Tetra kan anvendes under amning.
Flucelvax Tetra may be used during lactation.
Flucelvax Tetra's sikkerhed hos børn i alderen 4 til under 18 år er blevet vurderet i et randomiseret, kontrolleret studie (V130_03).
The safety of Flucelvax Tetra in children 4 to less than 18 years of age was evaluated in a randomised, controlled study (V130_03).