FrancophonIA/ELRC3.0 huggingface dataset:
English: ProQuad may also be given to children from nine months of age in certain situations, for example as part of a national vaccination programme, during an outbreak or for travel to a region where measles is common.
Danish: ProQuad kan også gives til børn fra ni måneders alderen i visse situationer, f.eks. som led i et nationalt vaccinationsprogram, under et sygdomsudbrud eller ved rejse til en region, hvor mæslinger er en almindelig sygdom.
English: For the full list of all side effects reported with ProQuad, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved ProQuad fremgår af indlægssedlen.
English: What is the risk associated with ProQuad?
Danish: Hvilke risici er der forbundet med ProQuad?
English: ProQuad is given to children from 12 months of age to help protect them against the four diseases: measles, mumps, rubella, and chickenpox.
Danish: ProQuad gives til børn fra 12 måneders alderen som en hjælp til at beskytte dem mod de fire sygdomme: mæslinger, fåresyge, røde hunde og skoldkopper.
English: ProQuad must not be used in children who are hypersensitive (allergic) to any chickenpox vaccine or measles, mumps or rubella vaccine, to any of the other ingredients, or to neomycin.
Danish: ProQuad må ikke gives til børn, som er overfølsomme (allergiske) over for en eventuel skoldkoppevaccine eller vaccine mod mæslinger, fåresyge eller røde hunde, over for andre af indholdsstofferne eller over for neomycin.
English: For children above 12 months of age, one ProQuad injection is sufficient to provide optimal protection against measles, mumps and rubella.
Danish: Til børn over 12 måneder er én injektion af ProQuad nok til at give optimal beskyttelse mod mæslinger, fåresyge og røde hunde.
English: Why has ProQuad been approved?
Danish: Hvorfor blev ProQuad godkendt?
English: What is ProQuad?
Danish: Hvad er ProQuad?
English: The CHMP decided that ProQuad's benefits are greater than its risks and recommended that it be given marketing authorisation for use in children above 12 months of age, noting that a second vaccination against chickenpox should be given for full protection against the disease.
Danish: CHMP besluttede, at fordelene ved ProQuad opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for anvendelse af ProQuad til børn over 12 måneder.
English: ProQuad was compared with its ‘component vaccines', a triple vaccine against mumps, measles and rubella, and a vaccine against chickenpox.
Danish: ProQuad blev sammenlignet med de vacciner, den er sammensat af, nemlig en tredobbelt vaccine mod fåresyge, mæslinger og røde hunde og en vaccine mod skoldkopper.
English: What is ProQuad used for?
Danish: Hvad anvendes ProQuad til?
English: ProQuad contains weakened forms of the viruses that cause measles, mumps, rubella and chickenpox.
Danish: ProQuad indeholder en svækket form af de vira, der forårsager mæslinger, fåresyge, røde hunde og skoldkopper.
English: How has ProQuad been studied?
Danish: Hvordan blev ProQuad undersøgt?
English: What benefit has ProQuad shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved ProQuad?
English: To protect against chickenpox, a second injection is needed, given one to three months after the first one; this can be done either by giving a second dose of ProQuad, or by giving a dose of another vaccine that only protects against chickenpox.
Danish: Dette kan enten gøres ved at give en yderligere dosis ProQuad eller en dosis af en anden vaccine, som kun beskytter mod skoldkopper.
English: How is ProQuad used?
Danish: Hvordan anvendes ProQuad?
English: How does ProQuad work?
Danish: Hvordan virker ProQuad?
English: ProQuad is a vaccine against measles, mumps, rubella, and varicella (chickenpox).
Danish: ProQuad er en vaccine mod mæslinger, fåresyge, røde hunde og skoldkopper.
English: Measles, mumps, rubella and varicella vaccine (live)
Danish: Vaccine (levende) mod mæslinger, fåresyge, røde hunde og skoldkopper
English: 3 tablets
Danish: 3 tabletter
English: Pre-filled syringe (glass) 3 ml (1 mg/ml) 1 pre-filled syringe
Danish: Fyldt injektionssprøjte (glas)3 ml (1 mg/ml) 1 fyldt injektions-sprøjte
English: Pre-filled syringe (glass) 3 ml (1 mg/ml) 4 pre-filled syringes l t o r
Danish: Fyldt injektionssprøjte (glas)3 ml (1 mg/ml) 4 fyldt injektions-sprøjter r l
English: This product contains genetically modified organisms (GMOs).
Danish: Dette produkt indeholder genetisk modificerede organismer (GMO'er).
English: 18 weeks.
Danish: 18 uger.
English: • Check the appearance of the vaccine before administration.
Danish: • Kontroller vaccinens udseende før administration.
English: Date of first authorisation: 04 December 2013 Date of latest renewal: 20 November 2018
Danish: Dato for første markedsføringstilladelse: 4. december 2013 Dato for seneste fornyelse: 20. november 2018
English: Some side effects may be serious
Danish: Nogle bivirkninger kan være alvorlige
English: Small white particles may be present.
Danish: Små hvide partikler kan være til stede.
English: Pack size of 1 or 10.
Danish: Pakningsstørrelse på 1 eller 10.
English: See section 6.6 for administration instructions.
Danish: 6.6 for instruktion i administration.
English: Immunisation must be carried out by nasal administration.
Danish: Immuniseringen skal ske via nasal administration.
English: See section 5 for advice on storage and disposal.
Danish: 5 for rådgivning om opbevaring og bortskaffelse.
English: • if you are in close contact with someone with a severely weakened immune system
Danish: • hvis du er i tæt kontakt med nogen med alvorligt svækket immunsystem
English: (for example, a bone marrow transplant patient needing isolation).
Danish: (for eksempel en knoglemarvstransplanteret patient med behov for isolation).
English: If the vaccine has not been used after this 12 hour period, it should be discarded.
Danish: Hvis vaccinen ikke er blevet anvendt i løbet af denne 12-timers periode, skal den bortskaffes.
English: Read all of this leaflet carefully before the vaccine is given because it contains important information for you or your child.
Danish: Læs denne indlægsseddel grundigt, inden vaccinen gives, da den indeholder vigtige oplysninger til dig eller dit barn.
English: M=months.
Danish: M=måneder.
English: You do not need to actively inhale or sniff.
Danish: Du behøver ikke at aktivt inhalere eller snøfte.
English: • if the child is less than 24 months of age.
Danish: • hvis barnet er under 24 måneder.
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection against the influenza virus.
Danish: Når en person får vaccinen, vil immunsystemet (kroppens naturlige forsvarssystem) producere dets egen beskyttelse mod influenzavirus.
English: Since 1985, two distinct lineages of influenza B viruses (Victoria and Yamagata) have circulated worldwide.
Danish: Siden 1985 har to tydelige linjer af influenza B-virus (Victoria og Yamagata) cirkuleret verden over.
English: Y=years.
Danish: Y=år.
English: Each year the vaccine targets four strains of influenza, following the annual recommendations by the World Health Organisation.
Danish: Hvert år er vaccinen er rettet mod fire stammer af influenzavirus, efter de årlige anbefalinger fra Verdenssundhedsorganisationen (World Health Organisation, WHO).
English: • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicine or other treatment.
Danish: • hvis din læge har informeret dig om, at du har et svækket immunsystem som følge af en sygdom, medicin eller anden behandling.
English: He or she will decide if Fluenz Tetra is suitable for you.
Danish: Han eller hun vil afgøre, om Fluenz Tetra er egnet for dig.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler bør navn og batchnummer på det administrerede produkt registreres tydeligt.
English: *** fluorescent focus units.
Danish: *** fluorescent focus units (FFU).
English: Age range as described in the protocol for the study.
Danish: Aldersinterval, som beskrevet i studieprotokollen.
English: Stability data indicate that the vaccine components are stable for 12 hours when stored at temperatures from 8°C to 25°C.
Danish: Stabilitetsdata viser, at vaccinekomponenterne er stabile i 12 timer, når de opbevares ved temperaturer fra 8 °C - 25 °C.
English: • if you have a blood disorder or a cancer that affects the immune system.
Danish: • hvis du har en blodsygdom eller en kræftsygdom, som påvirker immunsystemet.
English: The immune response to rubella vaccine was significantly altered.
Danish: Immunrespons over for rubella-vaccine var ændret signifikant.
English: For signs of allergic reactions, see section 4 “Possible side effects”.
Danish: Ved tegn på overfølsomhedsreaktioner, se punkt 4 ”Bivirkninger”.
English: Data presented for clinical trial D153-P504 are for study participants who received two doses of study vaccine.
Danish: Data præsenteret for klinisk studie D153-P504 er for deltagere i studiet, som fik to doser vaccine i studiet.
English: • if you have ever had a severe allergic reaction to eggs or egg proteins.
Danish: • hvis du nogensinde har haft en alvorlig allergisk reaktion over for æg eller æggeprotein.
English: fewer cases than injectable fewer cases than injectable
Danish: færre tilfælde end for injicerbar færre tilfælde end for injicerbar
English: This is because of the risk of a very rare but serious disease (Reye's syndrome).
Danish: Dette skyldes risikoen for en meget sjælden, men alvorlig sygdom (Reyes syndrom).
English: Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Immunocompromised
Danish: Immunkompromitterede
English: Number of study participants for year 1 efficacy analysis.
Danish: Antal deltagere i undersøgelsen til analysen af virkningen i år 1.
English: Tell your doctor straight away or seek urgent medical care if you experience any of the effects above.
Danish: Fortæl det straks til din læge eller søg akut lægehjælp, hvis du oplever noget af ovenstående.
English: • if you are already taking acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever).
Danish: • hvis du allerede tager acetylsalicylsyre (et stof, der findes i mange lægemidler til at lindre smerter og nedsætte feber).
English: As a result, they replicate in the nasopharynx and induce protective immunity.
Danish: Som følge deraf replicerer de i nasofarynks og inducerer beskyttende immunitet.
English: At the end of this period, Fluenz Tetra should be used immediately or discarded.
Danish: Efter denne periode bør Fluenz Tetra anvendes straks eller kasseres.
English: Several studies against placebo have shown that Fluenz may have some efficacy in adults.
Danish: Flere studier sammenlignet med placebo har vist, at Fluenz kan have en vis virkning hos voksne.
English: None of the ingredients in the vaccine can cause the flu.
Danish: Ingen af indholdsstofferne i vaccinen kan forårsage influenza.
English: Fluenz Tetra will be administered under the supervision of a doctor, nurse or pharmacist.
Danish: Fluenz Tetra vil blive indgivet under overvågning af en læge, sygeplejerske eller apoteket.
English: The use of Fluenz Tetra should be based on official recommendations.
Danish: Brugen af Fluenz Tetra bør være baseret på officielle anbefalinger.
English: Influenza Season
Danish: Influenza-sæso
English: Four placebo-controlled studies included second season revaccination.
Danish: Fire placebokontrollerede studier omfattede gentagen vaccination i 2. sæson.
English: Children less than 24 months of age should not receive this vaccine because of the risk of side effects.
Danish: Børn under 24 måneder må ikke få denne vaccine på grund af risikoen for bivirkninger.
English: Pharmacotherapeutic group: Influenza vaccines, influenza live attenuated; ATC Code: J07BB03
Danish: Farmakoterapeutisk klassifikation: Influenzavacciner, influenza levende svækket; ATC-kode: J07BB03
English: Check expiry date Product must be used before date on applicator label.
Danish: Kontroller udløbsdatoen Produktet skal anvendes før datoen på applikatorens etiket.
English: Summary of the safety profile
Danish: Resume af sikkerhedsprofil
English: In more than 300 case reports in the AstraZeneca safety database of vaccine administration to pregnant women, no unusual patterns of pregnancy complications or foetal outcomes were observed.
Danish: I mere end 300 rapporter i AstraZeneca's bivirkningsdatabase med administration af vaccine hos gravide kvinder, observeredes ingen usædvanlige mønstre af graviditetskomplikationer eller virkninger hos fostret.
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Danish: Bivirkningshyppigheder rapporteres som: Meget almindelig (≥1/10) Almindelig (≥1/100 til <1/10) Ikke almindelig (≥1/1.000 til <1/100) Sjælden (≥1/10.000 til <1/1.000) Meget sjælden (<1/10.000)
English: You can breathe normally while you are given Fluenz Tetra.
Danish: Du kan trække vejret normalt mens du får Fluenz Tetra.
English: There is a moderate amount of data from the use of Fluenz Tetra in pregnant women.
Danish: Der er en moderat mængde data fra anvendelse af Fluenz Tetra til gravide kvinder.
English: Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination.
Danish: Modtagere af vaccinen skal så vidt muligt undgå tæt kontakt med svært immunkompromitterede personer (f.eks. knoglemarvstransplanterede patienter, der har behov for isolation) i 1-2 uger efter vaccinationen.
English: Liverpool L24 9JW United Kingdom
Danish: Liverpool L24 9JW Storbritannien
English: Healthcare professionals are asked to report any suspected adverse reactions via national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Prepare the applicator Remove rubber tip protector.
Danish: Forbered applikatoren Fjern beskyttelseshætten af gummi.
English: Fluenz Tetra Influenza vaccine 2019/2020 season
Danish: Fluenz Tetra Influenzavaccine Sæson 2019/2020
English: Do not use this vaccine after the expiry date which is stated on the applicator label after the letters EXP.
Danish: Brug ikke denne vaccine efter den udløbsdato, der står på applikatoretiketten efter bogstaverne EXP.
English: Frequency and duration of vaccine virus shedding in these immunocompromised children and adolescents were comparable to that seen in healthy children and adolescents.
Danish: Hyppigheden og varigheden af udskillelsen af vaccinevirus hos disse immunkompromitterede børn og unge var sammenlignelig med den, der sås hos raske børn og unge.
English: Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed in the post-marketing setting with Fluenz.
Danish: Meget sjældne rapporter om Guillain-Barrés syndrom og forværring af symptomer på Leighs syndrom (mitokondriel encefalomyopati) er også blevet observeret efter markedsføringen af Fluenz.
English: Keep the nasal applicator in the outer carton in order to protect from light.
Danish: Opbevar den nasale applikator i den ydre karton for at beskytte mod lys.
English: The vaccine may contain residues of the following substances: egg proteins (e.g. ovalbumin) and gentamicin.
Danish: Denne vaccine kan indeholde rester af følgende stoffer: æggeprotein (f.eks. ovalbumin) og gentamicin.
English: Africa, Latin America
Danish: Afrika, Latinamerika
English: Metabolism and nutrition disorders Very common: Decreased appetite
Danish: Metabolisme og ernæring Meget almindelig: Nedsat appetit
English: See Table 1 and 2 for a summary of efficacy results in the paediatric population.
Danish: Se Tabel 1 og 2 for et resume over de pædiatriske resultater
English: • severe allergic reaction: signs of a severe allergic reaction may include shortness of breath and swelling of the face or tongue.
Danish: • Svære overfølsomhedsreaktioner: Tegn på en svær overfølsomhedsreaktion kan omfatte stakåndethed og hævelse af ansigt eller tunge.
English: Administration of influenza antiviral agents within two weeks of vaccination may affect the response of the vaccine.
Danish: Administration af antivirale stoffer mod influenza indenfor to uger efter vaccinationen kan påvirke respons på vaccinen.
English: Additional experience has occurred with marketed use of Fluenz.
Danish: Der er samlet yderligere erfaring med brug af Fluenz efter markedsføring.
English: Most hospitalisations were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination.
Danish: De fleste indlæggelser skyldtes gastrointestinale infektioner og infektioner i luftveje og fandt sted mere end 6 uger efter vaccinationen.
English: Do not pass it on to others.
Danish: Lad derfor være med at give vaccinen til andre.
English: Your doctor, nurse or pharmacist will decide if Fluenz Tetra can be given at the same time as other vaccines.
Danish: Lægen, sundhedspersonalet eller apotekspersonalet vil afgøre, om Fluenz Tetra kan gives på samme tidspunkt som andre vacciner.
English: • if you have severe asthma or are currently wheezing.
Danish: • hvis du har svær astma eller aktuelt har hvæsende vejrtrækning.
English: • If you are pregnant, think you may be pregnant, plan to become pregnant soon or are breast-feeding, tell your doctor, nurse or pharmacist before receiving this vaccine.
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger snart at blive gravid, eller hvis du ammer, skal du spørge din læge, sundhedspersonalet eller apoteket til råds, før du får denne vaccine.
English: • Refer to the Fluenz Tetra administration diagram (Figure 1) for step-by-step administration instructions.
Danish: • Se indgivelsesdiagrammet for Fluenz Tetra (figur 1) for trinvis instruktion i indgivelse.
English: While animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, and post-marketing data offer some reassurance in the event of inadvertent administration of the vaccine, Fluenz Tetra is not recommended during pregnancy.
Danish: Selvom dyrestudier hverken indikerer direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet, og data efter markedsføringen giver nogen beroligelse i tilfælde af utilsigtet administration af vaccinen, bør Fluenz Tetra ikke anvendes under graviditeten.
English: • Do not use Fluenz Tetra if the expiry date has passed or the sprayer appears damaged, for example, if the plunger is loose or displaced from the sprayer or if there are any signs of leakage.
Danish: • Fluenz Tetra må ikke anvendes, hvis udløbsdatoen er overskredet, eller hvis beholderen ser ud til at være beskadiget, for eksempel hvis stemplet er løst eller er faldet ud af beholderen, eller hvis der er tegn på lækage.
English: There was no evidence of significant maternal adverse outcomes in 138 pregnant women who had a record of receiving trivalent Fluenz in a US-based health insurance claims database.
Danish: Der var ingen evidens for signifikante maternelle bivirkninger hos 138 gravide kvinder, som tidligere havde modtaget trivalent Fluenz ifølge en database med skadesanmeldelser til en sundhedsforsikring med base i USA.
English: However, this alteration might not be of clinical relevance with the two dose immunisation schedule of the rubella vaccine.
Danish: Det er imidlertid muligt, at denne ændring ikke er klinisk relevant ved et 2 dosers administrationsregime med rubella-vaccine.
English: Before use, the vaccine may be taken out of the refrigerator once for a maximum period of 12 hours at a temperature not above 25°C.
Danish: Vaccinen kan tages ud af køleskabet højst 12 timer før brug og opbevares ved en temperatur, der ikke overstiger 25°C.
English: A multicentre, randomised, double-blind, active-controlled, non-inferiority study was conducted to assess the immunogenicity of Fluenz Tetra compared to Fluenz (active control) in children and adolescents 2-17 years of age.
Danish: Et randomiseret, dobbeltblindet, aktivt kontrolleret multicenter-, noninferioritetsstudie blev udført for at vurdere immunogeniciteten for Fluenz Tetra sammenlignet med Fluenz (aktiv kontrol) hos børn og unge i alderen 2-17 år.
English: Follow your doctor, nurse or pharmacist's instructions about if and when your child should return for the second dose.
Danish: Følg vejledningen fra lægen, sundhedspersonalet eller apoteket om, hvorvidt og hvornår dit barn skal have den anden dosis.
English: In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus.
Danish: I tilfælde hvor kontakt med svært immunkompromitterede personer ikke kan undgås, skal den potentielle risiko for transmission af virus fra influenzavaccinen vægtes i forhold til risikoen for at få og transmittere vildtype-influenzavirus.
English: The maximum amount of ovalbumin is less than 0.024 micrograms per 0.2 ml dose (0.12 micrograms per ml).
Danish: Den maksimale mængde ovalbumin er mindre end 0,024 mikrogram pr. 0,2 ml dosis (0,12 mikrogram pr. ml).
English: Fluenz Tetra will help to protect against the four virus strains contained in the vaccine, and other strains closely related to them.
Danish: Fluenz Tetra vil hjælpe med at beskytte mod de fire virusstammer, som vaccinen indeholder, og andre stammer, der nært relateret til dem.
English: However, a conclusion on clinical benefit of this vaccine in adults could not be made given that results observed in some studies versus injectable influenza vaccines were suggestive of a lower efficacy of Fluenz.
Danish: Der kunne dog ikke drages en konklusion om de kliniske fordele af denne vaccine hos voksne, da de observerede resultater i nogle studier sammenlignet med injicerbar vaccine kunne tyde på en svagere virkning af Fluenz.
English: Do not remove dose-divider clip at the other end of the applicator.
Danish: Klipsen til dosisfordeling i den anden ende af applikatoren må ikke fjernes.
English: In clinical studies with the vaccine, most side effects were mild in nature and short term.
Danish: I de kliniske undersøgelser af vaccinen var de fleste bivirkninger af en mild type og kortvarige.
English: Although safety in children and adolescents with mild to moderate asthma has been established, data in children with other pulmonary diseases or with chronic cardiovascular, metabolic or renal diseases are limited.
Danish: Selvom sikkerheden hos børn og unge med mild til moderat astma er undersøgt, er data fra børn med andre lungesygdomme, med kroniske kardiovaskulære eller metaboliske sygdomme eller med nyresygdomme begrænsede.
English: D153-P502 Europe 6 to 35 M 1,616
Danish: D153-P502 Europa 6 til 35 M 1.616
English: Position the applicator With the patient in an upright position, place the tip just inside the nostril to ensure Fluenz Tetra is delivered into the nose.
Danish: Placer applikatoren Mens patienten er i en opretstående stilling, placeres spidsen lige indenfor næseboret for at sikre, at Fluenz Tetra indgives i næsen.
English: Instructions for healthcare professionals
Danish: Vejledning for sundhedspersonale
English: Do not inject.
Danish: Må ikke injiceres.
English: Asia/ Oceania
Danish: Asien/ Oceanien
English: It is used in children and adolescents 24 months to less than 18 years of age.
Danish: Den anvendes hos børn og unge i alderen 24 måneder op til 18 år.