FrancophonIA/ELRC3.0 huggingface dataset:
English: 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
Danish: 1 Rapporteret som almindelig i den ældre population på 65 år og derover 2 Rapporteret som ikke almindelig i den ældre population på 65 år og derover 3 Bivirkninger rapporteret fra overvågning efter markedsføring
English: Comparison of immunogenicity of TIVc in the paediatric and adult population
Danish: Sammenligning af TIVc's immunogenicitet i den pædiatriske og voksne population
English: All Culture-Confirmed Influenza Overall
Danish: Al kulturbekræftet influenza Samlet
English: Children less than 9 years of age reported similar rates of adverse reactions compared to older children.
Danish: Børn under 9 år rapporterede tilsvarende hyppigheder af bivirkninger sammenlignet med ældre børn.
English: In some human studies, antibody titres of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects.
Danish: I nogle humane studier har antistoftitre på 1:40 eller derover været forbundet med beskyttelse mod influenzasygdom hos op til 50% af forsøgspersonerne.
English: HI data, egg-derived assay
Danish: HI-data, æg-afledt assay
English: Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.
Danish: Endvidere er det muligt, at antistof mod én antigen variant af influenzavirus ikke beskytter mod en ny antigen variant af den samme type eller undertype.
English: Flucelvax Tetra is manufactured using Madin Darby Canine Kidney (MDCK) cells.
Danish: Flucelvax Tetra fremstilles ved anvendelse af Madin Darby Canine Kidney (MDCK)-celler.
English: • You should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”).
Danish: • Du skal fortælle det til lægen, hvis dit immunforsvar er nedsat, eller hvis du er i behandling med medicin, som påvirker immunforsvaret, f.eks. medicin mod kræft (kemoterapi) eller medicin, der indeholder kortikosteroid (se punktet ”Brug af anden medicin sammen med Flucelvax Tetra”).
English: The vaccine should be visually inspected for particulate matter and discoloration prior to administration.
Danish: Vaccinen skal inspiceres visuelt for partikler og misfarvning før administration.
English: ILI was defined according to Centers for Disease Control and Prevention (CDC) case definition, i.e., a fever (oral temperature ≥100.0°F / 38°C) and cough or sore throat.
Danish: Influenzalignende sygdom blev defineret i henhold til definitionen fra Centers for Disease Control and Prevention (CDC), dvs. feber (oral temperatur ≥ 100,0 °F/ 38 °C) og hoste eller ondt i halsen.
English: Bold = Non-inferiority criterion met.
Danish: Fremhævet = Noninferioritetskriterium opfyldt.
English: Similar rates of local and system adverse reactions were reported in the overall paediatric population 4 to < 18 years of age.
Danish: Der blev rapporteret tilsvarende hyppigheder af lokale og systemiske bivirkninger i den samlede pædiatriske population i alderen 4 til < 18 år.
English: However, inactivated influenza vaccines can be used in all stages of pregnancy.
Danish: Inaktiverede influenzavacciner kan imidlertid anvendes på alle graviditetsstadier.
English: Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) This medicine is subject to additional monitoring.
Danish: Influenzavaccine (overfladeantigen, inaktiveret, fremstillet i cellekulturer) Dette lægemiddel er underlagt supplerende overvågning.
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Danish: Der kan også forekomme synkope (besvimmelse) efter eller endog før en vaccination som en psykogen reaktion på kanyleinjektionen.
English: • You should tell your doctor if you have a bleeding problem or bruise easily.
Danish: • Du skal fortælle det til lægen, hvis du har et blødningsproblem eller let får blå mærker.
English: Children 9 to less than 18 years of age received a single dose of Flucelvax Tetra.
Danish: Børn i alderen 9 til under 18 år fik en enkelt dosis Flucelvax Tetra.
English: Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI).
Danish: Influenzatilfældene blev identificeret ved aktiv og passiv overvågning af influenzalignende sygdom.
English: Vomiting was uncommon in the elderly
Danish: Opkastning var ikke almindelig hos ældre.
English: Adults and children from 9 years of age: One dose of 0.5 ml
Danish: Voksne og børn fra 9 år: Én dosis på 0,5 ml.
English: % Lower Limit of OneSided 97.5% CI
Danish: % Nedre grænse for ensidigt CI på 97,5%
English: After shaking, the normal appearance of the vaccine is a clear to slightly opalescent suspension.
Danish: Efter omrystning fremstår vaccinen normalt som en klar til let opaliserende suspension.
English: A single syringe contains 0.5 ml of suspension for injection.
Danish: En enkelt sprøjte indeholder 0,5 ml injektionsvæske, suspension.
English: A total of 11,404 subjects were enrolled to receive TIVc (N = 3828), Agrippal (N = 3676) or placebo (N = 3900) in a 1:1:1 ratio.
Danish: Der indgik i alt 11.404 forsøgspersoner, som fik TIVc (N = 3.828), Agrippal (N = 3.676) eller placebo (N = 3.900) i forholdet 1:1:1.
English: Tell your doctor immediately if you experience any of the following side effects - you may need medical attention:
Danish: Søg omgående læge, hvis du får en eller flere af følgende bivirkninger - du kan have brug for lægehjælp:
English: Name and address of the manufacturer(s) of the biological active substance(s) Seqirus Inc.
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) Seqirus Inc.
English: As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.
Danish: Som det gælder for alle vacciner, giver Flucelvax Tetra muligvis ikke fuldstændig beskyttelse for alle personer, der vaccineres.
English: Do not use this vaccine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke vaccinen efter den udløbsdato, der står på etiketten og på æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The incidence of some adverse reactions were considerably lower among subjects ≥ 65 years of age when compared to subjects 18 to < 65 years of age (see table below).
Danish: Forekomsten af visse bivirkninger var betydeligt lavere blandt forsøgspersoner i alderen ≥ 65 år sammenlignet med forsøgspersoner i alderen 18 til < 65 år (se tabellen nedenfor).
English: As with all injectable vaccines, Flucelvax Tetra must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration.
Danish: Som ved alle injicerbare vaccines skal Flucelvax Tetra administreres med forsigtighed til personer med trombocytopeni eller en blødningsforstyrrelse, da der kan forekomme blødning efter en intramuskulær administration.
English: This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free'.
Danish: Denne vaccine indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige ”natriumfri”.
English: Name and address of the manufacturer(s) responsible for batch release Seqirus Vaccines Ltd
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Seqirus Vaccines Ltd
English: There are limited data from the use of Flucelvax Tetra in pregnant women.
Danish: Der er begrænsede data fra anvendelse af Flucelvax Tetra til gravide kvinder.
English: • beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.
Danish: • beta-propiolacton, cetyltrimethylammoniumbromid eller polysorbat 80, som er sporrester fra fremstillingsprocessen.
English: Flucelvax Tetra should be used in accordance with official recommendations.
Danish: Flucelvax Tetra skal anvendes i overensstemmelse med officielle anbefalinger.
English: • Numbness and tingling sensation
Danish: • Følelsesløshed og snurrende fornemmelse
English: 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.
Danish: Analyser af aldersundergrupper hos forsøgspersoner i alderen 18 til under 65 år og alderen 65 år og derover bekræftede, at HI-antistofresponser (GMT og forskelle i vaccinegruppeserokonverteringsrater) opfyldte immunogenicitetskriterier for noninferioritet 3 uger efter vaccination for alle 4 influenzastammer i begge aldersgrupper.
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient to prevent influenza.
Danish: Hos patienter med endogen eller iatrogen immunsuppression kan antistofresponset være utilstrækkeligt til forebyggelse af influenza.
English: A protective immune response may not be elicited in all vaccine recipients.
Danish: Der fremkaldes ikke nødvendigvis et beskyttende immunrespons hos alle vaccinerede.
English: Keep the pre filled syringe in the outer carton in order to protect from light.
Danish: Opbevar den fyldte injektionssprøjte i den ydre karton for at beskytte mod lys.
English: Ask you pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Flucelvax Tetra injection Influenza vaccine 2019/2020 season
Danish: Flucelvax Tetra injektionsvæske Influenzavaccine Sæsonen 2019/2020
English: In this study, 1159 paediatric subjects received Flucelvax Tetra (584 subjects aged > 9 to < 18 years; 575 subjects aged > 4 to < 9 years).
Danish: I dette studie fik 1.159 pædiatriske forsøgspersoner Flucelvax Tetra (584 forsøgspersoner i alderen > 9 til <18 år og 575 forsøgspersoner i alderen > 4 til < 9 år).
English: Flucelvax Tetra provides active immunisation against four influenza virus strains (two A subtypes and two B types) contained in the vaccine.
Danish: Flucelvax Tetra giver aktiv immunisering mod fire influenzavirusstammer (to A-undertyper og to Btyper), der er indeholdt i vaccinen.
English: For intramuscular injection only.
Danish: Udelukkende til intramuskulær injektion.
English: Generalised skin reactions including pruritus, urticaria or non-specific rash
Danish: Generaliserede hudreaktioner, herunder pruritus, urticaria eller ikke-specifikt udslæt
English: Clinical efficacy of cell-based trivalent influenza vaccine (TIVc) against culture-confirmed influenza in adults
Danish: Klinisk virkning af cellebaseret trivalent influenzavaccine (TIVc) mod kulturbekræftet influenza hos voksne
English: Table 1: Adverse reactions reported following vaccination in adults 18 years and older in clinical trials and post-marketing surveilance.
Danish: Tabel 1: Bivirkninger rapporteret efter vaccination hos voksne i alderen 18 år og derover i kliniske studier og ved overvågning efter markedsføring
English: a The comparator vaccine for noninferiority comparisons for A/H1N1, A/H3N2 and B1 is TIV1c, for B2 it is
Danish: a Komparatorvaccinen for sammenligninger af noninferioritet er for A/H1N1, A/H3N2 og B1 - TIV1c og for B2
English: It is unknown whether Flucelvax Tetra is excreted in human milk.
Danish: Det er ukendt, om Flucelvax Tetra udskilles i human mælk.
English: The preferred site for injection is the deltoid muscle of the upper arm.
Danish: Det foretrukne injektionssted er musculus deltoideus i overarmen.
English: 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:
Danish: Søg omgående læge eller tag på skadestuen på det nærmeste hospital, hvis du får følgende bivirkningdu kan have brug for akut lægehjælp eller indlæggelse:
English: Bold- CHMP immunogenicity criteria met.
Danish: Fremhævet = CHMP-immunogenicitetskriterier opfyldt.
English: Specific levels of haemagglutination inhibition (HI) antibody titres post-vaccination with inactivated influenza vaccine have not been correlated with protection from influenza virus.
Danish: Specifikke niveauer af titre for hæmagglutinationhæmnings (HI)-antistof efter vaccination med inaktiveret influenzavaccine er ikke blevet korreleret med beskyttelse mod influenzavirus.
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.
Danish: 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 .
English: V58P13 (Subjects 18 to < 50 years)
Danish: V58P13 (forsøgspersoner 18 til < 50 år)
English: Prophylaxis of influenza in adults and children from 9 years of age.
Danish: Forebyggelse af influenza hos voksne og børn fra 9 år.
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).
Danish: Flucelvax Tetra gives af lægen eller sygeplejersken som en indsprøjtning i musklen øverst på overarmen (deltamusklen).
English: The immunogenicity data in subjects 9 to less than 18 years of age are summarised in Table 4.
Danish: Immunogenicitetsdata for forsøgspersoner i alderen 9 til under 18 år er sammenfattet i tabel 4.
English: Seqirus Netherlands B.V. Нидерландия Тел.
Danish: Seqirus Netherlands B.V.
English: Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free.
Danish: Flucelvax Tetra fremstilles i cellekulturer og er derfor fri for æg.
English: Fever (≥ 38°C)
Danish: Feber (≥ 38 oC)
English: Individual strains
Danish: Individuelle stammer
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%).
Danish: 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%).
English: Based on clinical experience with cell-based trivalent influenza vaccine (TIVc), Flucelvax Tetra can be given at the same time as other vaccines.
Danish: Baseret på klinisk erfaring med cellebaseret trivalent influenzavaccine (TIVc) kan Flucelvax Tetra gives samtidig med andre vacciner.
English: V58P12 (Subjects 9 to < 18 years)
Danish: V58P12 (forsøgspersoner 9 til < 18 år)
English: This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium free'.
Danish: Denne vaccine indeholder mindre end 1 mmol (39 mg) (39 mg) kalium pr. dosis, dvs. den er i det væsentlige ”kaliumfri”.
English: • Generalised skin reactions including itching, bumps on the skin or non-specific rash
Danish: • Udbredte hudreaktioner, herunder kløe, knopper på huden eller ikke-specifikt udslæt
English: Vaccine efficacies against vaccine-matched influenza viral strains, against all influenza viral strains, and against individual influenza viral subtypes were calculated (Table 3).
Danish: Vaccinens virkning mod influenzavirusstammer, der matchede vaccinen, mod alle influenzavirusstammer og mod de enkelte undertyper af influenzavirus blev beregnet (tabel 3).
English: Seroconversion Rateb a For H1N1, H3N2 and B1 influenza strains TIV1c data are presented, whereas for B2 influenza strain TIV2c data are presented.
Danish: Serokonverterings-rateb a For H1N1-, H3N2- og B1-influenzastammer er vist TIV1c-data, mens der for B2-influenzastammer er vist
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.
Danish: 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.
English: Reproductive and developmental toxicology data from cell-based trivalent influenza vaccine (TIVc) do not predict an increased risk of developmental abnormalities.
Danish: Data for reproduktions- og udviklingstoksikologi fra cellebaseret trivalent influenzavaccine (TIVc) forudsiger ikke en øget risiko for udviklingsmæssige abnormaliteter.
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.
Danish: 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.
English: • 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.
Danish: • 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).
English: Talk to your doctor, pharmacist or nurse before receiving Flucelvax Tetra.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du får Flucelvax Tetra.
English: 0.5 ml suspension in pre-filled syringes (type I glass), with a plunger stopper (bromobutyl rubber), with or without needle.
Danish: 0,5 ml suspension i fyldte injektionssprøjter (type I-glas) med en stempelprop (brombutylgummi) med eller uden kanyle.
English: Paediatric population (9 to less than 18 years of age)
Danish: Pædiatrisk population (i alderen 9 til under 18 år)
English: Flucelvax Tetra is a vaccine against flu (influenza).
Danish: Flucelvax Tetra er en vaccine mod influenza.
English: What you need to know before you receive Flucelvax Tetra You should not receive Flucelvax Tetra:
Danish: Det skal du vide, før du får Flucelvax Tetra Du bør ikke få Flucelvax Tetra:
English: Very serious side effects
Danish: Meget alvorlige bivirkninger
English: Table 5: GMTs and seroconversion rates in adult and paediatric subjects vaccinated with TIVc (V58P12 and V58P13)
Danish: Tabel 5: GMT'er og serokonverteringsrater hos voksne og pædiatriske forsøgspersoner vaccineret med TIVc (V58P12 og V58P13)
English: Clear to slightly opalescent liquid.
Danish: Klar til let opaliserende væske.
English: Paediatric Population (4 to less than 9 years of age)
Danish: Pædiatrisk population (i alderen 4 til under 9 år)
English: 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.
Danish: 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.
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%).
Danish: 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%).
English: 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.
Danish: TIVc-virkning blev defineret som forebyggelse af kulturbekræftet, symptomatisk influenzasygdom forårsaget af virus, hvor antigenerne matchede virus i vaccinen, sammenlignet med placebo.
English: There was no evidence that the addition of the second influenza B strain resulted in immune interference to other strains included in the vaccine.
Danish: Der var ingen evidens for, at tilsætning af den anden influenza B-stamme resulterede i immuninterferens i forhold til andre stammer indeholdt i vaccinen.
English: Uncommon (≥1/1,000 to
Danish: Ikke almindelig (≥1/1.000 til <
English: 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
Danish: 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
English: Abbreviations: GMT = geometric mean titre; CI = confidence interval.
Danish: Forkortelser: GMT = geometrisk middeltiter.
English: Pack of 10 pre-filled syringes, with or without needles.
Danish: Pakning med 10 fyldte injektionssprøjter med eller uden kanyler.
English: Flucelvax Tetra contains sodium chloride and potassium chloride
Danish: Flucelvax Tetra indeholder natriumchlorid og kaliumchlorid
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).
Danish: 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).
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.
Danish: 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.
English: Flucelvax Tetra may contain traces of beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.
Danish: Flucelvax Tetra kan indeholde spor af beta-propiolacton, cetyltrimethylammoniumbromid og polysorbat 80.
English: 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)
Danish: 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)
English: Nausea, Diarrhoea, Vomiting2
Danish: Kvalme, diarré, opkastning2