FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Danish: Sundhedspersonalet skal derfor vurdere fordele og potentielle risici ved administration af vaccinen til personer med trombocytopeni eller blødningsforstyrrelser, hvor intramuskulær injektion er kontraindiceret, medmindre den potentielle fordel opvejer risikoen for blødning.
English: Prepandrix should be used in accordance with official guidance.
Danish: Prepandrix skal anvendes i overensstemmelse med officielle anbefalinger.
English: It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.
Danish: Den skal bruges før og under næste influenzapandemi, til beskyttelse af influenza forårsaget af virustypen H5N1.
English: One pack of Prepandrix consists of:
Danish: En pakke Prepandrix består af:
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Danish: Tegn på en allergisk reaktion kan være kløende hududslæt, stakåndethed og hævelse af ansigt eller tunge.
English: See sections 4.4, 4.8 and 6.1.
Danish: 4.4, 4.8 og 6.1.
English: There is currently no evidence to indicate that Prepandrix may be associated with a risk of narcolepsy.
Danish: Der er på nuværende tidspunkt ikke evidens for, at Prepandrix kan være forbundet med risiko for narkolepsi.
English: Therefore tell the doctor or nurse if you fainted with a previous injection.
Danish: Du skal derfor fortælle lægen eller sundhedspersonalet, hvis du tidligere er besvimet i forbindelse med en injektion.
English: Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution.
Danish: Kontrolgrupperne omfattede fritter vaccineret med adjuvans alene, med en ikke adjuveret vaccine (15 mikrogram HA) eller med en saltvandsopløsning indeholdende en phosphatbuffer.
English: Epidemiological studies relating to another AS03-adjuvanted vaccine (Pandemrix H1N1, also manufactured in the same facility as Prepandrix), in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals.
Danish: Epidemiologiske studier med en anden AS03-adjuveret vaccine (Pandemrix H1N1, som fremstilles på samme anlæg som Prepandrix) i flere europæiske lande har indikeret en øget risiko for narkolepsi med eller uden katapleksi hos vaccinerede sammenlignet med ikke-vaccinerede personer.
English: These side effects may also happen with Prepandrix.
Danish: Disse bivirkninger kan også forekomme efter Prepandrix.
English: There are no data on administration of AS03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use.
Danish: Der findes ingen data for administration af AS03-adjuverede vacciner før eller efter andre typer af prepandemiske eller pandemiske influenzavacciner.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Danish: Prækliniske data viser ikke nogen risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter akutte og gentagne doser, lokal tolerance, fertilitet hos kvinder, toksicitet for foster/nyfødt barn (til og med afslutningen af ammeperioden).
English: • Allergic reactions leading to a dangerously low blood pressure.
Danish: • Overfølsomhedsreaktioner, der kan medføre alvorligt lavt blodtryk.
English: Prepandrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Danish: Prepandrix indeholder thiomersal som konserveringsmiddel, og der er mulighed for at du kan få en overfølsomhedsreaktion.
English: In the event of either being observed (including rubber particles from the stopper), discard the vaccine.
Danish: Hvis et af ovennævnte forhold (inklusive gummipartikler fra proppen) observeres, skal vaccinen kasseres.
English: When a person is given the vaccine, the body's natural defence system (immune system) produces its own protection (antibodies) against the disease.
Danish: Hvordan Prepandrix virkerNår en person vaccineres, danner kroppens naturlige forsvarsmekanisme (immunsystemet) sin egen beskyttelse (antistoffer) mod sygdommen.
English: They may also happen with Prepandrix.
Danish: De kan også forekomme efter Prepandrix.
English: The anti-HA responses were as follows:
Danish: Anti-HA-responset var følgende:
English: Warnings and precautions
Danish: Advarsler og forsigtighedsregler:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Prepandrix in one or more subsets of the paediatric population in influenza infection caused by an influenza strain contained in the vaccine or related to a strain contained in the vaccine.
Danish: Det Europæiske Lægemiddelagentur har udsat kravet om fremlæggelse af resultaterne af studier med Prepandrix hos en eller flere undergrupper af den pædiatriske population ved influenzainfektion forårsaget af en influenzastamme indeholdt i vaccinen eller relateret til en stamme indeholdt i vaccinen (se pkt.
English: Active immunisation against H5N1 subtype of Influenza A virus.
Danish: Aktiv immunisering mod H5N1 undertyper af influenza-A-virus.
English: • if you have a bleeding problem or you bruise easily.
Danish: • hvis du har blødningsforstyrrelser eller let får blå mærker.
English: What you need to know before you receive Prepandrix
Danish: Det skal du vide, før du får Prepandrix
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02
Danish: Farmakoterapeutisk klassifikation: Influenzavacciner, ATC-kode: J07BB02.
English: Prepandrix is a vaccine for use in adults from 18 years old.
Danish: Hvad Prepandrix er, og hvordan den anvendes Prepandrix er en vaccine, som anvendes til voksne i alderen fra 18.
English: However, in the event of an officially declared influenza pandemic, persons previously vaccinated with one or two doses of Prepandrix that contained HA antigen derived from a different clade of the same influenza subtype as the pandemic influenza strain may receive a single dose of Adjupanrix instead of two doses that are required in previously unvaccinated individuals.
Danish: I tilfælde af en officielt erklæret influenzapandemi kan personer, som tidligere er blevet vaccineret med en eller to doser Prepandrix indeholdende HA-antigen fra en anden undergruppe af samme influenza-subtype end den pandemiske influenzastamme, få en enkelt dosis Adjupanrix i stedet for de to doser, som kræves til personer, som ikke tidligere er blevet vaccineret.
English: • From 80 years onwards: you may receive two double injections of Prepandrix.
Danish: • Fra 80 år og derover: du skal muligvis have to dobbeltindsprøjtninger med Prepandrix.
English: Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be allowed to reach room temperature (for a minimum of 15 minutes); each vial should be shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Danish: Inden emulsionen (adjuvans) og suspensionen (antigen) sammenblandes skal de to komponenter have antaget stuetemperatur (efter minimum 15 minutter); hvert hætteglas skal omrystes og inspiceres for fremmede partikler og/eller ændringer i det fysiske udseende.
English: The side effects listed below have happened in the days or weeks after vaccination with other vaccines given routinely every year to prevent flu.
Danish: Bivirkningerne nedenfor er set i dagene og ugerne efter vaccination med almindelig influenzavaccine, som gives en gang om året til forebyggelse af influenza.
English: As with all vaccines, Prepandrix may not fully protect all persons who are vaccinated.
Danish: Som ved alle andre vacciner vil ikke alle vaccinerede personer være fuldstændig beskyttet mod infektion.
English: Based on very limited data, adults aged >80 years may require a double dose of Prepandrix on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1).
Danish: Baseret på meget få data kan ældre over 80 år have behov for dobbelt dosis Prepandrix på en udvalgt dag og igen efter mindst 3 uger for at opnå immunrespons (se pkt.
English: At day 42, the anti-HA antibody seroconversion rate was 98%, all subjects were seroprotected and the seroconversion factor was 88.6.
Danish: På dag 42 var anti-HA-antistofserokonverteringsraten 98 %, alle personer var serobeskyttede, og serokonverteringsfaktoren var 88,6.
English: The side effects listed below have happened with H1N1 AS03-containing vaccines.
Danish: Bivirkningerne nedenfor er set for H1N1-AS03-adjuverede vacciner.
English: Prepandrix should under no circumstances be administered intravascularly.
Danish: Prepandrix må under ingen omstændigheder gives intravaskulært.
English: Animal studies with Prepandrix containing A/Vietnam/1194/2004 do not indicate reproductive toxicity (see section 5.3).
Danish: Dyrestudier med Prepandrix indeholdende A/Vietnam/1194/2004 indikerer ikke reproduktionstoksicitet (se pkt.
English: The vaccine should be administered in accordance with the recommended posology (see section 3 “How Prepandrix is given”).
Danish: Vaccinen bør administreres i overensstemmelse med den anbefalede dosis (se punkt 3 ”Sådan bliver du behandlet med Prepandrix”).
English: In adults 18 to 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (76.6%), muscle aches (46.8%), fatigue (43.6%), headache (25.3%) and joint pain
Danish: Efter vaccination af voksne (18-60 år) var de mest almindelige rapporterede bivirkninger: smerte ved administrationsstedet (76,6 %), myalgi (46,8 %), træthed (43,6 %), hovedpine (25,3 %) og artralgi
English: Do not use the suspension and the emulsion after the expiry date which is stated on the carton.
Danish: Brug ikke Prepandrix efter den udløbsdato, der står på pakningen.
English: Redness Swelling Fever (>38°C) Fever (>39°C) - per-dose frequency - per-subject frequency Drowsiness
Danish: Feber (> 38 °C) Feber (> 39 °C) - hyppighed pr. dosis - hyppighed pr.
English: • if you have problems with your immune system, since your response to the vaccine may then be poor.
Danish: • hvis du har nedsat immunforsvar, da virkningen af vaccinen så kan være nedsat.
English: In particular, tell your doctor or nurse if you are having any treatments (such as corticosteroid treatments or chemotherapy for cancer) that affect the immune system.
Danish: Du skal især fortælle læge eller sundhedspersonalet, hvis du får en behandling, som påvirker immunsystemet (f.eks. med kortikosteroid eller kemoterapi mod kræft).
English: If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C.
Danish: Hvis dit barn får vaccinen, skal du være opmærksom på, at bivirkningerne (især temperaturer over 38 °C) kan være mere udtalte efter den anden dosis.
English: The reproductive toxicity studies have been conducted using Prepandrix containing A/Vietnam/1194/2004.
Danish: Toksikologiske reproduktionsforsøg er udført med Prepandrix indholdende A/Vietnam/1194/2004.
English: Blood and lymphatic system disorders Common: lymphadenopathy
Danish: Blod og lymfesystem Almindelig: lymfadenopati
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs (EMAs) hjemmeside: http://www.ema.europa.eu/.
English: There are currently no data available on the use of Prepandrix in pregnancy.
Danish: Der er på nuværende tidspunkt ingen data fra anvendelse af Prepandrix til gravide kvinder.
English: After mixing, the vaccine should be used within 24 hours.
Danish: Efter rekonstitution skal vaccinen anvendes inden for 24 timer.
English: • From 18 years onwards: you will receive two doses of Prepandrix.
Danish: • Fra 18 år og derover: du vil få to vaccinationer med Prepandrix.
English: Prepandrix contains thiomersal
Danish: Prepandrix indeholder thiomersal
English: General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue, Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: induration, hævelser, smerter og rødmen ved administrationsstedet, feber, træthed Almindelig: kuldegysninger, influenzalignende symptomer, reaktioner på administrationsstedet (f.eks. varme, kløe)
English: Prepandrix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Danish: Prepandrix indeholder mindre end 1 mmol natrium (23 mg) og mindre end 1 mmol kalium (39 mg) pr. dosis, dvs. den er i det væsentlige natrium- og kaliumfri.
English: • Swollen glands in your neck, armpit or groin
Danish: • Hævede kirtler i nakke, armhule eller lyske
English: Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.
Danish: Suspension: flerdosishætteglas med antigen Emulsion: flerdosishætteglas med adjuvans.
English: The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C.
Danish: Den rekonstituerede vaccine kan enten opbevares i køleskab (2 °C - 8 °C) eller ved stuetemperatur (højst 25 °C).
English: In addition, 44.8% and 56.1% of subjects in respective dose groups had a 4-fold increase in serum neutralising antibody titres from day 0 to day 42 and 96.6% and 100% of subjects had a titre of at least 1:80 at day 42.
Danish: Derudover havde hhv. 44,8 % og 56,1 % af personerne i de respektive dosisgrupper en firdobbelt forøgelse i serum-neutraliserende antistoftiter fra dag 0 til dag 42, og hhv. 96,6 % og 100 % havde en titer på mindst 1:80 på dag 42.
English: The volume of the Prepandrix vial after mixing is at least 5 ml.
Danish: Efter rekonstitution af Prepandrix indeholder hætteglasset mindst 5 ml.
English: This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared with H5N1 subtype strains (see section 5.1).
Danish: Indikationen er basseret på immunogenicitetsdata fra raske personer i alderen fra 18 år og derover efter administration af to vaccinedoser fremstillet ud fra stammer af undertypen H5N1 (se pkt.
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Danish: Vaccinationen skal gives som intramuskulær injektion fortrinsvist i deltoidea musklen eller det anterolaterale lår (afhængig af muskelmassen).
English: Very common: headache Uncommon: paraesthesia, somnolence, dizziness
Danish: Meget almindelig: hovedpine Ikke almindelig: paræstesi, døsighed, svimmelhed
English: • Active substance: Split influenza virus, inactivated, containing antigen* equivalent to:
Danish: • Aktivt stof: Split influenzavirus, inaktiveret, indeholdende antigen* svarende til:
English: Prepandrix contains sodium and potassium
Danish: Prepandrix indeholder natrium og kalium
English: “Possible side effects” may affect your ability to drive or use tools or machines.
Danish: Nogle af de bivirkninger, der er nævnt i punkt 4 “Bivirkninger“, kan påvirke din evne til at køre bil, anvende værktøj eller maskiner.
English: Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Danish: Efter en influenzavaccination kan der ses falsk positive resultater m.h.t antistoffer mod HIV-1, hepatitis C og specielt HTLV-1 i serum undersøgt med ELISA-metoden.
English: Against A/Vietnam 21 days after boosting with A/Vietnam N=46
Danish: Mod A/Vietnam 21 dage efter boosterdosis A/Vietnam n = 46
English: *propagated in eggs **expressed in microgram haemagglutinin
Danish: * opformeret i æg ** udtykt som mikrogram hæmagglutinin
English: The use of Prepandrix may be considered during pregnancy if this is thought to be necessary taking into account official recommendations.
Danish: Administration af Prepandrix kan overvejes til gravide, hvis det skønnes nødvendigt.
English: Prepandrix may be used in lactating women.
Danish: Prepandrix kan administreres til ammende kvinder.
English: The second dose should be given after an interval of at least three weeks and up to twelve months after the first dose.
Danish: Det anbefales, at den anden vaccination bliver givet mindst tre uger og indtil 12 måneder efter den første dosis.
English: What Prepandrix contains
Danish: Prepandrix indeholder
English: After two doses given 21 days or 6 months apart, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titre and 98-100% had a titre of at least 1:80.
Danish: Efter to doser givet med 21 dages- eller 6 måneders-mellemrum havde 96,0 % af personerne en firdobbelt stigning i serum-neutraliserende antistoftiter, og 98-100 % af personerne havde en titer på mindst 1:80.
English: If the mixed vaccine is stored in a refrigerator, it should be allowed to reach room temperature (for a minimum of 15 minutes) before each withdrawal.
Danish: Hvis den rekonstituerede vaccine opbevares i køleskab, skal vaccinen antage stuetemperatur (efter minimum 15 minutter) før hver udtagning.
English: There are no data on co-administration of Prepandrix with other vaccines.
Danish: Der foreligger ingen data om samtidig administration af Prepandrix og andre vacciner.
English: Gastrointestinal disorders Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Danish: Mave-tarm-kanalen Ikke almindelig: gastrointestinale symptomer (f.eks. diaré, opkastning, mavesmerter, kvalme)
English: In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14).
Danish: I hvert forsøg blev fire grupper med hver 6 fritter vaccineret intramuskulært med en AS03-adjuvansvaccine indeholdende HA fra H5N1/A/Vietnam/1194/04 (NIBRG-14).
English: The seroprotection at month 6, 12 and 24 were as follows:
Danish: Seroprotektionsraten ved måned 6, 12 og 24 var følgende:
English: Talk to your doctor or nurse before you are given Prepandrix:
Danish: Kontakt lægen eller sundhedspersonalet før du får Prepandrix:
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Danish: Hvis samtidig administration med andre vacciner påtænkes, skal det ske i forskellige ektremiteter.
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 At day 42, and after 6, 12 and 24 months the neutralising antibody responses were as follows: Serum neutralising antibody
Danish: 1seroprotektionsrate: andelen af personer med hæmagglutinationshæmnings (HI) titer ≥ 1:40 På dag 42, og efter 6, 12 og 24 måneder var det neutraliserende antistofrespons følgende: Serumneutraliserende antistof
English: The seroprotection rate, booster seroconversion rate and booster factor against A/Indonesia/5/2005 21 days after booster vaccination was 100%, 99.7% and 123.8, respectively.
Danish: Seroprotektionsraten, boosterserokonverteringsraten og boosterfaktoren mod A/Indonesia/5/2005 var henholdsvis 100 %, 99,7 % og 123,8 21 dage efter boostervaccination.
English: Excipient with known effect The vaccines contains 5 micrograms thiomersal (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på Vaccinerne indeholder 5 mikrogram thiomersal (se pkt.
English: Prepandrix should not be given:
Danish: Du må ikke få Prepandrix:
English: Prepandrix can still be given but your response to the vaccine may be poor.
Danish: Du kan godt få Prepandrix, men virkningen af vaccinen kan være nedsat.
English: A 4-fold increase in serum neutralising antibody titres was observed in 79.2% of subjects twenty-one days after the first dose, 95.8% twenty-one days after the second dose and 87.5% six months after the second dose.
Danish: En firdobbelt stigning i serum-neutraliserende antistoftiter blev set hos 79,2 rsonerne 21 dage efter første dosis, hos 95,8 % af personerne 21 dage efter anden dosis og hos 87,5 % af personerne seks måneder efter anden dosis.
English: No post-marketing surveillance data are available following Prepandrix administration.
Danish: Der findes ingen data fra overvågning efter markedsføring for Prepandrix.
English: The administration of a second half adult or an adult dose did not enhance the reactogenicity, except for rates of general symptoms which were higher after the second dose, particularly for rates of fever in <6 year olds.
Danish: Der blev hverken ved administration af halv eller fuld voksendosis set en øget reaktogenicitet efter anden dosis, bortset fra hyppigheden af almene symptomer, som var højere efter anden dosis, især hyppigheden af feber hos børn < 6 år.
English: • Warmth, itching or bruising where the injection was given
Danish: • Varme, kløe eller blåt mærke ved det sted hvor indsprøjtningen blev givet
English: In subjects > 60 years of age, the most frequently reported adverse reaction after vaccination was injection site pain (32.6%).
Danish: Efter vaccination af personer > 60 år, var den mest almindelige bivirkning, smerte ved administrationsstedet (32,6 %).
English: 2.5 ml per vial
Danish: 2,5 ml pr. hætteglas
English: • Generalised skin reactions including urticaria (hives)
Danish: • Reaktioner i huden f.eks. nældefeber (udslæt).
English: List of adverse reactions Adverse reactions reported are listed according to the following frequency:
Danish: Liste over bivirkninger De sete bivirkninger er opstillet ud fra følgende hyppighed:
English: A second dose of 0.5 ml should be given after an interval of at least three weeks and up to twelve months after the first dose for maximum efficacy.
Danish: For at opnå maksimal effekt skal anden vaccinedosis på 0,5 ml gives i intervallet mindst 3 uger og indtil 12 måneder efter den initiale dosis.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.
Danish: Brug af anden medicin sammen med Prepandrix Fortæl altid lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig eller hvis du for nylig er blevet vaccineret med en anden vaccine.
English: Prepandrix consists of two containers:
Danish: Prepandrix består af to hætteglas:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Antigen suspension for Prepandrix
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Antigen, suspension til Prepandrix
English: 2 % of subjects with titres ≥1:28
Danish: 1 geometrisk middeltiter 2 andel af personer med en titer ≥ 1:28
English: anti-HA antibody
Danish: Anti-HA-antistof
English: From post-marketing experience with AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1), the following adverse reactions have been reported:
Danish: Ved overvågning efter markedsføring af AS03-adjuveret vaccine indeholdende 3,75 µg HA fra A/California/7/2009 (H1N1) blev følgende bivirkninger rapporteret: