FrancophonIA/ELRC3.0 huggingface dataset:
English: In studies of adults in which a high percentage of individuals had underlying chronic medical conditions, the safety profile of trivalent Fluenz was comparable to the safety profile observed in individuals without these conditions.
Danish: I studier med voksne, hvor en stor procentdel af personerne havde underliggende kroniske sygdomme, var sikkerhedsprofilen for trivalent Fluenz sammenlignelig med den sikkerhedsprofil, der sås hos personer uden disse sygdomme.
English: It is not known whether Fluenz Tetra is excreted in human milk.
Danish: Det er ukendt, om Fluenz Tetra udskilles i human mælk.
English: Uncommon: Hypersensitivity reactions (including facial oedema, urticaria and very rare anaphylactic reactions)
Danish: Ikke almindelig: Overfølsomhedsreaktioner (herunder ansigtsødem, urticaria og meget sjældent anafylaktiske reaktioner)
English: Ask your doctor, nurse or pharmacist if you want more information about possible side effects from Fluenz Tetra.
Danish: Spørg lægen, sundhedspersonalet eller apoteket, hvis du ønsker at få yderligere oplysninger om bivirkninger fra Fluenz Tetra.
English: Fluenz Tetra should not be administered to children and adolescents with severe asthma or active wheezing because these individuals have not been adequately studied in clinical studies.
Danish: Fluenz Tetra bør ikke gives til børn og unge med svær astma eller aktiv hvæsen, da personer med disse tilstande ikke er blevet undersøgt tilstrækkeligt i kliniske studier.
English: Fluenz Tetra is a vaccine to prevent influenza (flu).
Danish: Fluenz Tetra er en vaccine til at forebygge influenza.
English: USA, Europe, Asia/Oceania
Danish: USA, Europa, Asien/ Oceanie
English: Number of Study Participants
Danish: Antal deltagere i undersøgel-se
English: No data exist regarding the possible effects of Fluenz Tetra on male and female fertility.
Danish: Der eksisterer ingen data angående de mulige virkninger af Fluenz Tetra på mandlig og kvindelig fertilitet.
English: Nervous system disorders Very common: Headache
Danish: Nervesystemet Meget almindelig: Hovedpine
English: The most common adverse reaction observed in clinical studies was nasal congestion/rhinorrhoea.
Danish: Den hyppigste bivirkning observeret i kliniske studier var tilstoppet næse/rhinorré.
English: In 24 HIV-infected children and 25 HIV-negative children 1 through 7 years of age, and in 243 HIV-infected children and adolescents 5 through 17 years of age receiving stable anti-retroviral therapy, the frequency and duration of vaccine virus shedding were comparable to that seen in healthy individuals.
Danish: Hos 24 HIV-inficerede børn og 25 HIV-negative børn i alderen 1 til og med 7 år og hos 243 HIV-inficerede børn og unge i alderen 5 til og med 17 år, der var i stabil antiretroviral behandling, var hyppigheden og varigheden af udskillelsen af vaccinen sammenlignelig med den, der sås hos raske personer.
English: Table 1 Fluenz Efficacy in Placebo Controlled Paediatric Studies
Danish: Tabel 1 Virkning af Fluenz i placebokontrollerede pædiatriske studier
English: Administration of a higher than recommended dose of Fluenz Tetra was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose of Fluenz Tetra.
Danish: Administration af en højere dosis end den anbefalede dosis Fluenz Tetra blev sjældent rapporteret, og bivirkningsprofilen var sammenlignelig med den, der blev observeret med den anbefalede dosis af Fluenz Tetra.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements for medical waste.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Remove dose-divider clip
Danish: Klips til dosisfordeling
English: Therefore, as some viruses are excreted in human milk, Fluenz Tetra should not be used during breast-feeding.
Danish: Da nogle vira udskilles i human mælk, bør Fluenz Tetra ikke anvendes under amning.
English: • if you are allergic to gentamicin, gelatin or any of the other ingredients of this vaccine (listed in section 6 “Contents of the pack and other information”).
Danish: • hvis du er allergisk over for gentamicin eller gelatine eller et af de øvrige indholdsstoffer i denne vaccine (angivet i punkt 6).
English: Clinical experience with Fluenz is relevant to Fluenz Tetra because both vaccines are manufactured using the same process and have overlapping compositions.
Danish: Den kliniske erfaring med Fluenz er relevant for Fluenz Tetra, fordi begge vacciner er fremstillet ved hjælp af den samme proces og har overlapninger i sammensætningen.
English: Fluenz Tetra is manufactured according to the same process as Fluenz.
Danish: Fluenz Tetra er fremstillet efter den samme proces som Fluenz.
English: This is because of the risk of Reye's syndrome, a very rare but serious disease that can affect the brain and liver.
Danish: Reyes syndrom er en meget sjælden, men alvorlig sygdom, der kan påvirke hjernen og leveren.
English: • It is recommended that Fluenz Tetra is not given at the same time as influenza-specific antiviral medicines, such as oseltamivir and zanamivir.
Danish: • Det anbefales, at Fluenz Tetra ikke gives på samme tidspunkt som influenzaspecifik antiviral medicin som oseltamivir og zanamivir, da vaccinen kan blive mindre effektiv.
English: Children and adolescents from 24 months: 0.2 ml (administered as 0.1 ml per nostril).
Danish: Børn og unge fra 24 måneder: 0,2 ml (administreret som 0,1 ml pr. næsebor).
English: Overdose with Fluenz Tetra is unlikely due to its presentation as a pre-filled sprayer.
Danish: Overdosering af Fluenz Tetra er usandsynlig på grund af dets præsentation som en fyldt spray.
English: Children who have not previously had an influenza vaccine will receive a second, follow-up dose after an interval of at least 4 weeks.
Danish: Børn, som ikke tidligere har fået en influenzavaccine, vil få en anden, opfølgende dosis efter en periode på mindst 4 uger.
English: The influenza virus strains in Fluenz Tetra are (a) cold-adapted (ca); (b) temperature-sensitive (ts); and (c) attenuated (att).
Danish: Influenzavirus-stammerne i Fluenz Tetra er (a) koldadapterede (ca, cold-adapted), (b) temperaturfølsomme (ts, temperature-sensitive) og (c) svækkede (att, attenuated).
English: Safety data regarding use of Fluenz Tetra are based on data from Fluenz Tetra clinical studies in 2,231 children and adolescents 2 to 17 years of age, Fluenz clinical studies in over 29,000 children and adolescents 2 to 17 years of age and Fluenz post-authorisation safety studies in over 84,000 children and adolescents 2 to 17 years of age.
Danish: Sikkerhedsdata angående brugen af Fluenz Tetra er baseret på data fra kliniske studier med Fluenz Tetra med 2.231 børn og unge i alderen 2 til 17 år, kliniske studier med Fluenz med over 29.000 børn og unge i alderen 2 til 17 år og sikkerhedsstudier efter markedsføring med over 84.000 børn og unge i alderen 2 til 17 år.
English: Fluenz's efficacy data in the paediatric population consist of 9 controlled studies comprising over 20,000 infants and toddlers, children and adolescents, conducted during 7 influenza seasons.
Danish: Fluenz Tetras data angående virkning består af 9 kontrollerede studier, som omfattede over 20.000 spædbørn, småbørn, børn og unge, udført i løbet af 7 influenzasæsoner.
English: Adult studies
Danish: Studier af voksne
English: Fluenz Tetra vaccine viruses are grown in chicken eggs.
Danish: Fluenz Tetra-vaccinens virus er dyrket i hønseæg.
English: - Children and adolescents with clinical immunodeficiency due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids.
Danish: - Børn og unge med klinisk betydende immundefekt, som skyldes sygdomme eller immunsupprimerende behandling, såsom: akut eller kronisk leukæmi; lymfom; symptomatisk HIV-infektion; cellulær immundefekt eller behandling med højdosis kortikosteroider.
English: Fluenz safety
Danish: Sikkerhed ved Fluenz
English: Depress the plunger With a single motion, depress plunger as rapidly as possible until the dose-divider clip prevents you from going further.
Danish: Stemplet trykkes ned Stemplet trykkes ned så hurtigt som muligt med en enkelt bevægelse, indtil klipsen til dosisfordeling forhindrer dig i at trykke længere ned.
English: • allergic reactions
Danish: • overfølsomhedsreaktioner
English: - Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
Danish: - Børn og unge under 18 år, som modtager salicylatbehandling på grund af forbindelsen mellem Reyes syndrom og salicylater og vildtype-influenzainfektion.
English: Limited available evidence suggests that the trivalent Fluenz is not excreted in breastmilk.
Danish: Begrænset tilgængelig dokumentation tyder på, at den trivalente Fluenz ikke udskilles i modermælk.
English: Vaccine recipients should be informed that Fluenz Tetra is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts.
Danish: Modtagere af vaccinen skal informeres om, at Fluenz Tetra er en vaccination med svækket levende virus, og at den derfor potentielt kan overføres ved kontakt med immunkompromitterede personer.
English: Non-clinical data reveal no special hazard for humans based on conventional non-clinical studies of repeated dose toxicity, reproduction and developmental toxicity, local tolerance and neurovirulence.
Danish: De prækliniske data med Fluenz gav ingen grund til at mistænke særlig risiko for mennesker, vurderet ud fra prækliniske konventionel studie af toksicitet efter gentagne doser, reproduktions- og udviklingstoksicitet, lokal tolerance eller neurovirulens.
English: The primary circulating strain was antigenically dissimilar from the H3N2 strain represented in the vaccine; efficacy against the mismatched A/H3N2 strain was 85.9% (95% CI: 75.3, 91.9).
Danish: Den primære cirkulerende stamme var på antigenniveau forskellig fra H3N2-stammen, som repræsenteres i vaccinen; virkning over for den ikke-matchede A/H3N2-stamme var 85,9 % (95 % CI: 75,3; 91,9).
English: If influenza antiviral agents and Fluenz Tetra are administered concomitantly, revaccination should be considered based on clinical judgement.
Danish: Hvis antivirale stoffer mod influenza og Fluenz Tetra administreres samtidigt, skal re-vaccination overvejes, baseret på en klinisk vurdering.
English: The recommended dose for children and adolescents is 0.2 ml Fluenz Tetra, administered as 0.1 ml in each nostril.
Danish: Den anbefalede dosis for børn og unge er 0,2 ml Fluenz Tetra, indgivet som 0,1 ml i hvert næsebor.
English: • DO NOT USE WITH A NEEDLE.
Danish: • Må ikke anvendes med en kanyle.
English: • Do not use with a needle.
Danish: • MÅ IKKE ANVENDES MED EN KANYLE.
English: The incidence of wheezing within 15 days after vaccination was lower in Fluenz recipients relative to inactivated vaccine recipients (19.5% vs. 23.8%, P=0.02).
Danish: Forekomsten af hvæsen inden for 15 dage efter vaccinationen var lavere hos dem, der havde fået Fluenz, i forhold til dem, der havde fået inaktiveret vaccine (19,5 % i forhold til 23,8 %, P=0,02).
English: The effectiveness of Fluenz and Fluenz Tetra in preventing influenza illness in immunocompromised individuals has not been evaluated.
Danish: Virkningen af Fluenz og Fluenz Tetra med hensyn til forebyggelse af influenzasygdom hos immunkompromitterede personer er ikke blevet evalueret.
English: Reassortant influenza virus* (live attenuated) of the following four strains**:
Danish: Reassortant influenzavirus* (levende svækket) fra følgende fire stammer**:
English: The active substances are: Reassortant influenza virus* (live attenuated) of the following four strains**:
Danish: Aktive stoffer: Reassortant influenzavirus* (levende svækket) fra følgende fire stammer**:
English: A total of 2,312 children and adolescents were randomised by site at a 3:1:1 ratio to receive either Fluenz Tetra or one of two formulations of comparator vaccine Fluenz, each containing a B strain that corresponded to one of the two B strains in Fluenz Tetra (a B strain of the Yamagata lineage and a B strain of the Victoria lineage).
Danish: I alt 2.312 børn og unge blev randomiseret efter forsøgscenter i forholdet 3:1:1 til at modtage enten Fluenz Tetra eller en af de to formuleringer fra sammenligningsvaccinen Fluenz, som hver havde et indhold af B-stammen, der svarede til den ene af de to B-stammer i Fluenz Tetra (en B-stamme i Yamagatalinjen og en B-stamme i Victorialinjen).
English: No adverse effects on HIV viral load or CD4 counts were identified following trivalent Fluenz administration.
Danish: Der blev ikke konstateret nogen uønsket påvirkning af den virale belastning af HIV eller CD4-celletallene efter administration af trivalent Fluenz.
English: 6 to 35 M 1,041
Danish: 6 til 35 M 1.041
English: Talk to your doctor, nurse or pharmacist before vaccination:
Danish: Kontakt lægen, sundhedspersonalet eller apotekspersonalet før vaccinationen:
English: • Do not give acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever) to children for 4 weeks after vaccination with Fluenz Tetra unless your doctor, nurse or pharmacist tells you otherwise.
Danish: • Giv ikke acetylsalicylsyre (et stof, der findes i meget medicin, som bruges til at lindre smerter og nedsætte feber) til børn i 4 uger efter vaccination med Fluenz Tetra, medmindre lægen, sundhedspersonalet eller apoteket fortæller dig noget andet, da der kan være risiko for Reyes syndrom.
English: In a study (D153-P515) of children 6 to 17 years of age with asthma (trivalent Fluenz: n=1,114, trivalent injectable influenza vaccine: n=1,115), there were no significant differences between treatment groups in the incidence of asthma exacerbations, mean peak expiratory flow rate, asthma symptom scores, or night-time awakening scores.
Danish: I et studie (D153-P515) med børn i alderen 6 til 17 år med astma (trivalent Fluenz: n=1.114, trivalent injicerbar influenzavaccine: n=1.115), var der ingen signifikante forskelle mellem behandlingsgrupperne i forekomsten af forværringer i astmaen, middelværdi for maksimal strømningshastighed for eksspiration, score for astmasymptomer eller score for opvågnen om natten.
English: No data exist regarding the safety of intranasal administration of Fluenz Tetra in children with unrepaired craniofacial malformations.
Danish: Der foreligger ingen data angående sikkerheden af intranasal administration af Fluenz Tetra til børn med ikke-opererede kraniofaciale misdannelser.
English: 6 to 35 M 1,886
Danish: 6 til 35 M 1.886
English: The co-administration of trivalent Fluenz with the live attenuated vaccines: measles, mumps, rubella, varicella and orally-administered poliovirus has been studied.
Danish: Samtidig administration af trivalent Fluenz med levende, svækkede vacciner: mæslinger, fåresyge, rubella, varicella og oralt indgivet poliovirus er blevet undersøgt.
English: (See also, How Fluenz Tetra is given, in section 3).
Danish: (Se også Sådan indgives Fluenz Tetra, i pkt.
English: Fluenz Tetra is a tetravalent vaccine that contains antigens for four influenza virus strains, an A/(H1N1) strain, an A/(H3N2) strain, and two B strains (one from each lineage).
Danish: Fluenz Tetra er en tetravalent vaccine, der indeholder antigener mod fire stammer af influenzavira, en A/(H1N1)-stamme, en A/(H3N2)-stamme og to B-stammer (én fra hver linje).
English: Chronic conditions
Danish: Kroniske tilstande
English: Reduction in culture-confirmed influenza illness relative to placebo.
Danish: Reduktion i influenzasygdom bekræftet ved dyrkning i forhold til placebo.
English: Twenty mild to moderately immunocompromised children and adolescents 5 through 17 years of age (receiving chemotherapy and/or radiation therapy or who had recently received chemotherapy) were randomised 1:1 to trivalent Fluenz or placebo.
Danish: Tyve mildt til moderat immunkompromitterede børn og unge i alderen fra 5 til og med 17 år (der var i behandling med kemoog/eller stråleterapi, eller som for nylig havde fået kemoterapi) blev randomiseret i forholdet 1:1 til trivalent Fluenz eller placebo.
English: The suspension is colourless to pale yellow, clear to opalescent with a pH of approximately 7.2.
Danish: Suspensionen er farveløs til svag gullig, klar til opaliserende med en pH på ca. 7,2.
English: Fluenz Tetra is supplied as a 0.2 ml suspension in a single-use nasal applicator (Type 1 glass), with nozzle (polypropylene with polyethylene transfer valve), nozzle tip-protector cap (synthetic rubber), plunger rod, plunger-stopper (butyl rubber) and a dose-divider clip.
Danish: Fluenz Tetra leveres som en 0,2 ml suspension i en nasal applikator (type 1 glas) til engangsbrug, med studs (polypropylen med overførselsventil af polyethylen), beskyttelseslåg til studsen (syntetisk gummi), stempelstang, stempelprop (butylgummi) og en klips til dosisfordeling.
English: Table 2 Fluenz Relative Efficacy in Active-controlled Paediatric Studies with Injectable Influenza Vaccine
Danish: Tabel 2 Relativ virkning af Fluenz i aktivt kontrollerede pædiatriske studier med injicerbar influenzavaccine
English: In clinical studies, the safety profile of Fluenz Tetra was similar to the safety profile of Fluenz.
Danish: I kliniske studier svarede sikkerhedsprofilen for Fluenz Tetra til sikkerhedsprofilen for Fluenz.
English: Fluenz Tetra demonstrated immunologic non-inferiority to the two formulations of Fluenz as the upper bound for each of the four 95% CIs for the post-dose strain-specific GMT HAI antibody ratios was ≤ 1.5.
Danish: Der blev påvist immunologisk noninferioritet for Fluenz Tetra i forhold til de to formuleringer af Fluenz, da den øvre grænse for hver af de fire konfidensintervaller på 95 % for forholdstallet for GMT for stammespecifikke HAI-antistoffer efter administration var ≤ 1,5.
English: Do not use salicylates in children and adolescents for 4 weeks after vaccination unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection.
Danish: Salicylater må ikke anvendes til børn og unge i 4 uger efter vaccinationen, med mindre det er medicinsk indiceret, da tilfælde af Reyes syndrom er blevet rapporteret efter brug af salicylater ved infektioner med vildtype-influenza.
English: Fluenz Tetra is not recommended for women who are pregnant or are breast-feeding.
Danish: Fluenz Tetra frarådes til kvinder, som er gravide eller ammer.
English: For children who have not previously been vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.
Danish: Børn, som ikke tidligere er blevet vaccineret mod sæsonbestemt influenza, bør have en anden dosis efter mindst 4 uger.
English: - Severe allergic reaction (e.g. anaphylaxis) to eggs or to egg proteins (e.g. ovalbumin).
Danish: - Alvorlig allergisk reaktion (f.eks. anafylakse) over for æg eller over for æggeproteiner (f.eks. ovalbumin).
English: In the same study, an increased rate of wheezing through 42 days was observed in infants and toddlers 6-23 months of age (5.9% Fluenz versus 3.8% injectable influenza vaccine).
Danish: I det samme studie blev der observeret en forøget hyppighed af hvæsen gennem 42 dage hos spædbørn og små børn i alderen 6-23 måneder (5,9 % Fluenz versus 3,8 % injicerbar influenzavaccine).
English: Fluenz Tetra is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
Danish: Fluenz Tetra er derimod ikke kontraindiceret til personer med asymptomatisk HIV-infektion, til personer, som modtager topikale/inhalerede kortikosteroider eller systemiske lavdosis-kortikosteroider, eller til personer, som er i substitutionssbehandling med kortikosteroider som, f.eks. ved binyrebarkinsufficiens.
English: Prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age.
Danish: Influenzaprofylakse hos børn og unge i alderen 24 måneder op til 18 år.
English: Fluenz efficacy
Danish: Fluenz' virkning
English: The rate of wheezing was not increased in Fluenz recipients 24 months and older.
Danish: Hyppigheden af hvæsen var ikke forøget hos modtagere af Fluenz i alderen 24 måneder og derover.
English: No clinically meaningful changes in immune responses to measles, mumps, varicella, orally-administered poliovirus or Fluenz have been observed.
Danish: Der blev ikke observeret klinisk betydende ændringer i immunresponset over for mæslinger, fåresyge, varicella, oralt indgivet poliovirus eller Fluenz.
English: In an active-controlled clinical study (MI-CP111), an increased rate of hospitalisations (for any cause) through 180 days after final vaccination dose was observed in infants and toddlers 6-11 months of age (6.1% Fluenz versus 2.6% injectable influenza vaccine).
Danish: I et klinisk studie med aktiv kontrol (MICP111) blev der observeret en forøget hyppighed af indlæggelser (af alle årsager) i en periode på 180 dage efter den sidste vaccinationsdosis hos spædbørn og små børn i alderen 6-11 måneder (6,1 % Fluenz Tetra versus 2,6 % injicerbar influenzavaccine).
English: Europe, Asia/ Oceania, Latin America
Danish: Europa, Asien/ Oceanien , Latinamerika
English: Fluenz Tetra has no or negligible influence on the ability to drive and use machines.
Danish: Fluenz Tetra påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: • After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
Danish: • Efter indgivelse af halvdelen af dosen i et næsebor, skal den anden halvdel af dosen straks eller kort tid efter indgives i det andet næsebor.
English: EU/1/13/887/002 <1 sprayer> EU/1/13/887/001 <10 sprayers> EU/1/13/887/003 <1 sprayer> EU/1/13/887/004 <10 sprayers>
Danish: EU/1/13/887/002 1 beholder EU/1/13/887/001 10 beholder EU/1/13/887/003 1 beholder EU/1/13/887/004 10 beholder
English: Other medicines, other vaccines and Fluenz Tetra
Danish: Brug af anden medicin og andre vacciner sammen med Fluenz Tetra
English: Immunogenicity was evaluated by comparing geometric mean titres (GMTs) of strain-specific serum haemagglutination inhibition (HAI) antibodies post dosing.
Danish: Immunogeniciteten blev evalueret ved at sammenligne de geometriske middeltitre (GMT) for stammespecifikke hæmagglutationsinhiberende (HAI) antistoffer i serum efter administrationen.
English: Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal)
Danish: Fluenz Tetra næsespray, suspension Influenzavaccine (levende svækket, nasal)
English: Fluenz Tetra is not indicated for use in infants and toddlers younger than 24 months (see section 4.2).
Danish: Fluenz Tetra er ikke indiceret til brug hos spædbørn og små børn under 24 måneder (se pkt.
English: However, based upon the potential for influenza antiviral agents to reduce the effectiveness of Fluenz Tetra, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy.
Danish: Baseret på muligheden for, at antivirale stoffer mod influenza potentielt kan reducere Fluenz Tetras virkning, frarådes det imidlertid at give vaccinen i de første 48 timer, efter ophør af behandling med antivirale stoffer mod influenza.
English: As with most vaccines, appropriate medical treatment and supervision should always be readily available to manage an anaphylactic event or serious hypersensitivity event following the administration of Fluenz Tetra.
Danish: Relevant medicinsk behandling og overvågning skal altid være umiddelbart tilgængelig til behandling af en anafylaktisk hændelse eller en alvorlig overfølsomhedsreaktion efter administration af Fluenz Tetra.