FrancophonIA/ELRC3.0 huggingface dataset:
English: Four weeks after the last vaccine administration, ferrets were challenged with the wild type homologous strain A/H1N1/Netherlands/602/2009.
Danish: Fire uger efter administration af den sidste vaccine blev fritterne eksponeret for en vildtype homolog stamme A/H1N1/Netherlands/602/2009.
English: - as with all vaccines, HUMENZA may not fully protect all persons who are vaccinated.
Danish: - som med alle vacciner er det ikke sikkert, at HUMENZA helt vil beskytte alle personer, som vaccineres.
English: 24 to 35 months 1st dose 2nd dose 1st dose 2nd dose
Danish: 12 til 23 måneder 24 til 35 måneder 1. dosis 2. dosis 1. dosis 2. dosis
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Danish: Antistofrespons hos patienter med endogen eller iatrogen immunosuppression kan være utilstrækkelig.
English: A mean body weight loss of 20% was recorded in control group 4 days after infection.
Danish: Et gennemsnitligt vægttab på 20 % blev registreret i kontrolgruppe 4 dage efter infektion.
English: In particular rates of fever (axillary temperature ≥38°C) may increase considerably after the second dose.
Danish: Hyppigheden af feber (aksil temperatur ≥ 38° C) kan især være betydeligt øget efter den anden dosis.
English: After mixing: use within 24 hours.
Danish: Efter sammenblanding: Anvendes inden for 24 timer.
English: 69007 Lyon - France
Danish: 69007 Lyon - Frankrig
English: Moreover, a higher frequency of fever and headache was reported after the second dose than after the first dose.
Danish: Endvidere blev feber og hovedpine rapporteret hyppigere efter den anden dosis end efter den første dosis.
English: HUMENZA can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for HUMENZA takes due account of the officially declared pandemic strain.
Danish: HUMENZA kan kun markedsføres, hvis der findes en officiel WHO/EU-erklæring om en pandemisk influenza og kun på betingelse af, at indehaveren af markedsføringstilladelsen af HUMENZA tager passende hensyn til den officielt erklærede pandemiske vaccinestamme.
English: It should be noted that the adverse reactions may be intensified.
Danish: Det skal bemærkes, at bivirkningerne kan forværres.
English: Like all medicines, HUMENZA can cause side effects, although not everybody gets them.
Danish: HUMENZA kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: This body weight loss was reduced to ≤ 8% in animals that received 1 or 2 doses of HUMENZA.
Danish: Vægttabet var reduceret til ≤ 8 % hos dyr, som fik 1 eller 2 doser HUMENZA.
English: If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Danish: Hvis den pandemiske situation giver mulighed for det, skal vaccinering udskydes hos patienter med høj feber eller akut infektion.
English: Read all of this leaflet carefully before you receive this vaccine.
Danish: Læs denne indlægsseddel grundigt inden du får vaccinen.
English: - No data on antibody persistence are currently available.
Danish: - Der foreligger på nuværende tidspunkt ingen data vedrørende antistofpersistens.
English: Pharmacotherapeutic group: Influenza vaccines, ATC code: J07BB02.
Danish: Farmakoterapeutisk klassifikation: Influenzavacciner, ATC kode: J07BB02.
English: The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Danish: Nedenstående bivirkninger er forekommet i dagene eller ugerne efter vaccination med vacciner, som gives rutinemæssigt hvert år for at forebygge influenza.
English: HUMENZA should under no circumstances be administered intravascularly.
Danish: HUMENZA må under ingen omstændigheder indgives intravaskulært.
English: This means that there is more evidence to come about this medicine.
Danish: Det betyder, at der kommer yderligere information om denne medicin.
English: There are very limited safety and immunogenicity data available from clinical studies with HUMENZA in adults aged over 60 years of age.
Danish: Der er meget begrænsede data vedrørende sikkerhed og immunogenicitet fra kliniske forsøg med HUMENZA til voksne over 60 år.
English: Dispose of in accordance with local regulations.
Danish: Skal bortskaffes i henhold til lokale forskrifter.
English: A partially used multidose vial must be discarded immediately if: - Sterile dose withdrawal has not been fully observed.
Danish: Et delvist brugt hætteglas med flere doser skal kasseres øjeblikkeligt, hvis: - Steril udtrækning af dosen ikke er blevet helt overholdt.
English: - Adjuvant:
Danish: - Adjuvans:
English: Excipients: The vaccine contains 11.3 micrograms thiomersal.
Danish: Vaccinen indeholder 11,3 mikrogram thiomersal.
English: See section 6.5 for the number of doses per vial.
Danish: Se afsnit 6.5 for antallet af doser pr. hætteglas.
English: • In rare cases leading to shock (a failure of the circulatory system to maintain adequate blood flow to the different organs leading to medical emergency).
Danish: • Fører i sjældne tilfælde til shock (en tilstand hvor kredsløbet ikke er i stand til at tilføre blod til de forskellige organer, hvilket fører til en medicinsk nødsituation).
English: Pandemic influenza vaccine (H1N1)
Danish: Pandemisk influenzavaccine (H1N1)
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Eventuelt ubrugt produkt eller affaldsmateriale skal kasseres i henhold til lokale krav.
English: Intramuscular use.
Danish: Intramuskulær brug.
English: Prospective cohort safety study protocol update to be submitted within one week of Commission Decision granting
Danish: Opdatering af protokollen for den prospektive kohortesikkerheds undersøgelse skal indsendes inden for en uge fra kommissionens beslutning om bevilling af markedsføringstill adelse.
English: • Differences in the perception of touch, pain, heat and cold (paraesthesia),
Danish: • Forskelle i opfattelsen af berøring, smerte, varme og kulde (parastæsi).
English: This vaccine complies with the WHO recommendation and EU decision for the pandemic.
Danish: Denne vaccine opfylder WHO's anbefaling og EU's beslutning vedr.
English: • Clinical trials
Danish: • Kliniske undersøgelser
English: HUMENZA is a vaccine to prevent pandemic influenza (flu).
Danish: HUMENZA er en vaccine til forebyggelse af pandemisk influenza.
English: Do not use the antigen (suspension) and the adjuvant (emulsion) after the expiry date which is stated on the carton and the label after EXP.
Danish: Brug ikke antigenet (suspension) og adjuvansen (emulsion) efter den udløbsdato (EXP), der står på pakningen og etiketten.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Danish: Din læge er opmærksom på dette og har et nødberedskab klar i sådanne tilfælde.
English: See section 4.4. for Special warnings and special precautions for use.
Danish: Se afsnit 4.4 for 'Særlige advarsler og forsigtighedsregler vedrørende brugen'.
English: Therefore, monitoring of temperature and measures to lower fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 8 years of age) after each vaccination.
Danish: Monitorering af kropstemperatur og temperaturnedsættende foranstaltninger (såsom feberstillende midler efter behov) anbefales hos små børn (f.eks. op til en alder af cirka 8 år) efter hver vaccination.
English: Important information about some of the ingredients of HUMENZA This medicine contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i HUMENZA Denne medicin indeholder thiomersal som er et konserveringsmiddel, og det er muligt, at du vil opleve en allergisk reaktion.
English: Local and systemic reactions occurred within 7 days following any vaccine administration.
Danish: Lokale og systemiske reaktioner forekom i løbet af 7 dage efter indgivelse af enhver vaccine.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 10.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at lægemiddelovervågningssystemet, som beskrevet i version 10.0 i Modul 1.8.1 i ansøgningsmaterialet til markedsføringstillladelsen, er på plads og fungerer, før produktet når markedet, og så længe det markedsførte produkt bliver anvendt.
English: Independently of the cohort safety study (9,000 subjects), the MAH commits to implement a post-licensure prospective clinical safety study (N=3,000 subjects from 6 months of age).
Danish: Uafhængig af kohorte-sikkerhedsundersøgelsen (9.000 personer), forpligter MAH sig til at implementere et postlicensure prospektivt klinisk sikkerhedsstudie (N=3.000 personer ældre end 6 måneders).
English: Elderly 81 years of age and over
Danish: Ældre på 81 år og derover
English: • Including swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema) in very rare cases.
Danish: • Inkluderer hævelse, som er mest udtalt i hoved og hals, inklusive i ansigtet, læber, tunge, hals eller i meget sjældne tilfælde af andre dele af kroppen (angioødem).
English: The protection against infection in the lungs was associated with vaccine-induced HI titers ≥ 40, a titer described in humans to be associated with protection against seasonal influenza.
Danish: Beskyttelsen mod infektion i lungerne var forbundet med vaccine-inducerede HI-titre ≥ 40, en titer som hos mennesker forbindes med beskyttelse mod sæsonbetinget influenza.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Danish: Som med alle vacciner til injektion skal passende medicinsk behandling og overvågning altid være umiddelbart tilgængeligt i tilfælde af en sjælden anafylaktisk reaktion efter indgivelse af vaccinen.
English: This leaflet was last approved in {MM/YYYY}
Danish: Denne indlægsseddel blev senest godkendt { MM/ÅÅÅÅ }
English: If vaccination is considered to be necessary, facilities for resuscitation should be immediately available in case of need.
Danish: Hvis vaccination skønnes nødvendig, skal genoplivningsudstyr være umiddelbart inden for rækkevidde, i tilfælde af, at behovet skulle opstå.
English: When HUMENZA is given for the first dose, it is recommended that HUMENZA (and not another vaccine against H1N1) be given for the complete vaccination course.
Danish: Når HUMENZA gives som første dosis, bør HUMENZA (og ikke en anden vaccine mod H1N1) anvendes under hele vaccinationsprogrammet.
English: • The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 pandemic vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Danish: • Indehaveren af markedsføringstilladelsen skal sammen med medlemslandene aftale foranstaltninger, der muliggør identifikation og sporbarhed af den A/H1N1 pandemiske vaccine, som administreres til hver enkelt patient, for herved at minimere administrationsfejl og hjælpe patienter og sundhedspersonale med at indberette bivirkninger.
English: In all age goups, the side effects listed above usually disappeared without treatment within 1 to 3 days after onset.
Danish: Hos alle aldersgrupper forsvandt de anførte bivirkninger som regel uden behandling i løbet af 1 til 3 dage.
English: • Post-marketing surveillance
Danish: • Overvågning efter markedsføringen
English: Instructions for the administration of the vaccine:
Danish: Instruktioner i administration af vaccinen:
English: Overall, reactions were more frequent in adults than in elderly and less frequent after the second dose in both age groups.
Danish: Generelt forekom reaktioner hyppigere hos voksne end hos ældre og mindre hyppigt efter den anden dosis hos begge aldersgrupper.
English: All children aged from 6 to 35 months were seronegative prior to vaccination.
Danish: Alle børn mellem 6 og 35 måneder var seronegative inden vaccination.
English: From post marketing surveillance with interpandemic trivalent vaccines, the following adverse events have been reported very rarely, even if an exact incidence rate cannot be precisely calculated:
Danish: Under overvågningen efter markedsføring er følgende bivirkninger i meget sjældne tilfælde blevet rapporteret i forbindelse med anvendelse af interpandemiske trivalente vacciner, omend en præcis incidensrate ikke kan beregnes nøjagtigt:
English: For adjuvant, see section 2.
Danish: Se afsnit 2 for adjuvans.
English: BATCH NUMBER Lot
Danish: PRODUCENTENS BATCHNUMMER Lot
English: Repeated injections of the vaccine induced moderate local inflammation in rabbits and no exacerbation of pneumonia after exposure to the parental wild-type virus in monkeys.
Danish: Gentagne injektioner af vaccinen fremkaldte moderat lokal inflammation hos kaniner og ingen forværring af pneumoni efter eksponering for den parentale vildtype-virus hos aber.
English: Immunogenicity data obtained at three weeks after administration of Humenza in clinical studies suggest that a single dose may be sufficient.
Danish: Immunogenicitetsdata indsamlet tre uger efter indgivelse af Humenza i kliniske undersøgelser, tyder på, at en enkelt dosis kan være tilstrækkelig.
English: Split influenza virus*, inactivated, containing antigen equivalent to:
Danish: Split influenzavirus*, inaktiveret, indeholdende antigen svarende til:
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Danish: Dette lægemiddel indeholder thiomersal (en organisk kviksølvforbindelse) som et konserveringsmiddel, og det er derfor muligt, at der kan forekomme overfølsomhedsreaktioner (se pkt.
English: Very common (≥1/10) 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: 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: Clinical
Danish: Klinisk
English: Fever (≥ 38°C) Headache Malaise
Danish: Feber (≥38°C) Hovedpine Utilpashed Myalgi
English: Before injection the vaccine should be allowed to reach room temperature by gently swirling the vial between hands (not more than 5 minutes).
Danish: Inden injektion bør vaccinen få lov at nå stuetemperatur ved forsigtigt at rulle hætteglasset mellem hænderne (i højst 5 minutter).
English: All children aged from 3 to 8 years were seronegative prior to vaccination.
Danish: Alle børn mellem 3 og 8 år var seronegative inden vaccination.
English: Overall, local and systemic reactions were less frequently observed in children from 6 to 35 months of age than in children from 3 to 8 years, except fever which was more frequently observed in children from 6 to 23 months.
Danish: Generelt blev lokale og systemiske reaktioner observeret mindre hyppigt hos børn mellem 6 og 35 måneder end hos børn mellem 3 og 8 år, med undtagelse af feber, som blev observeret mere hyppigt hos børn fra 6 til 23 måneder.
English: Before use, the two components should be mixed.
Danish: De to komponenter skal sammenblandes inden brug.
English: However, in a pandemic situation, it may be appropriate for you to have the vaccine provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Danish: I tilfælde af en pandemi kan det være hensigtsmæssigt at blive vaccineret alligevel, under forudsætning af at medicinsk behandling er umiddelbart tilgængelig i tilfælde af en allergisk reaktion.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanofi Pasteur SA
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Sanofi Pasteur SA
English: The rate of grade 3 (severe) reactions was overall low (≤ 2%).
Danish: Hyppigheden af grad 3 (svære) reaktioner var generelt lav (≤ 2 %).
English: A higher frequency of headache was reported in this age group compared to the children, adults and elderly.
Danish: Hovedpine blev rapporteret hyppigere for denne aldersgruppe sammenlignet med hos børn, voksne og ældre.
English: Not computed
Danish: Ikke beregnet
English: Very common (affects more than 1 user in 10) Common (affects 1 to 10 users in 100) Uncommon (affects 1 to 10 users in 1,000) Rare (affects 1 to 10 users in 10,000) Very rare (affects less than 1 user in 10,000)
Danish: Meget almindelig (påvirker mere end 1 af 10 brugere) Almindelig (påvirker 1 til 10 af 100 brugere) Ikke almindelig (påvirker 1 til 10 af 1000 brugere) Sjælden (påvirker 1 til 10 af 10.000 brugere) Meget sjælden (påvirker færre end 1 af 10.000 brugere)
English: Adults 18 to 60 years of age Total enrolled subjects N= 99
Danish: Voksne mellem 18 og 60 år Inkluderede forsøgspersoner i alt N= 99
English: The MAH shall submit on a monthly basis a simplified periodic safety update report with the timelines, format and content as defined in the CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine (EMA/359381/2009) and any subsequent update.
Danish: Indehaveren af markedsføringstilladelsen skal på månedlig basis indsende en simplificeret bivirkningsovervågningsrapport i overensstemmelse med tidsplan, format og indhold anført i”CHMP Recommendations for Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccines (EMA/359381/2009)”, med efterfølgende ændringer.
English: Overall, systemic reactions were more frequently reported in children from 6 to 11 months compared to children from 12 to 23 months.
Danish: Generelt blev systemiske reaktioner rapporteret mere hyppigt hos børn fra 6 til 11 måneder sammenlignet med hos børn fra 12 til 23 måneder.
English: Nervous system disorders - Very common: headache
Danish: Nervesystemet - Meget almindelig: hovedpine
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om HUMENZA, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Immune system disorders: Allergic reactions, in rare cases leading to shock, angioedema
Danish: Immunsystemet: Allergiske reaktioner, som i sjældne tilfælde fører til shock, angioødem.
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 opsvulmet ansigt eller tunge.
English: Children below 6 months of age: HUMENZA is not recommended in children below 6 months of age.
Danish: Børn under 6 måneder: HUMENZA anbefales ikke til børn under 6 måneder.
English: In adolescents from 9 to 17 years of age, the most frequent reactions were injection site pain and headache.
Danish: Hos unge mellem 9 og 17 år var de mest almindelige reaktioner smerter på injektionsstedet og hovedpine.
English: • Neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barré Syndrome).
Danish: • Neurologiske sygdomme, som kan resultere i stiv nakke, forvirring, følelsesløshed, smerter og svage lemmer, balancetab, tab af reflekser, paralysering af en del eller hele kroppen (encephalomyelitis, nervebetændelse, Guillain-Barré syndrom).
English: A minor infection such as a cold should not be problem, but your doctor should advise whether you could still be vaccinated with HUMENZA, - if you are having a blood test to look for evidence of infection with certain viruses.
Danish: En mindre infektion, såsom en forkølelse burde ikke være et problem, men din læge skal rådgive dig om, hvorvidt du stadig kan blive vaccineret med HUMENZA.
English: This section describes the clinical experience with HUMENZA following administration of one or two vaccine doses (0.5 ml or 0.25 ml) at a 3-week interval.
Danish: Dette afsnit omhandler de kliniske erfaringer med HUMENZA, efter indgivelse af en eller to vaccinedoser (0,5 ml eller 0,25 ml) med 3 ugers mellemrum.
English: Adverse reactions reported following any vaccination are listed below according to the following frequency:
Danish: De rapporterede bivirkninger efter enhver vaccination er opført nedenfor ud fra følgende hyppighed:
English: However, if co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Danish: Hvis samtidig indgivelse med en anden vaccine overvejes, skal immunisering foretages på forskellige ekstremiteter.
English: The European Medicines Agency will review any new information on the medicine and this package leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil vurdere alle nye informationer vedrørende denne medicin og vil om nødvendigt opdatere denne indlægsseddel
English: • Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions, unexpected severe adverse reactions, adverse events of special interest (AESI).
Danish: • At visse bivirkninger i forbindelse med indberetning skal opprioriteres, dvs. fatale og livstruende bivirkninger, uventede alvorlige bivirkninger, bivirkninger af speciel interese
English: The adjuvant, AF03, was not mutagenic or clastogenic and induced transient inflammatory changes in repeat dose toxicity studies (in rats and rabbits).
Danish: Adjuvansen, AF03, var ikke mutagen eller clastogen og inducerede forbigående inflammatoriske ændringer i toksicitetsundersøgelser med gentagne doser (hos rotter og kaniner).
English: The content of the multidose vial as well as the content of the syringe after withdrawal should be inspected visually.
Danish: Indholdet af hætteglasset med flere doser, og af injektionssprøjten efter udtagningen, skal inspiceres visuelt.
English: There are no data on administration of AF03-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 AF03-adjuverede vacciner før eller efter andre typer af prepandemiske eller pandemiske influenzavacciner.
English: Pharmacovigilance The MAH commits to update the observational study protocol to screen for auto-antibodies those patients presenting visual or ocular events during the study followup.
Danish: Lægemiddelovervågning MAH forpligter sig til at opdatere protokollen for observationsundersøgelsen til at screene for autoantistoffer hos de patienter, som oplever visuelle eller okulære
English: • The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding HUMENZA.
Danish: • Indehaveren af markedsføringstilladelsen skal sammen med medlemslandene aftale en måde, hvorpå patienter og sundhedspersonale vedvarende har tilgang til opdateret information om HUMENZA.
English: • The minimal data elements to be transmitted in individual case safety reports in order to facilitate the evaluation and the identification of the vaccine administered to each subject, including the invented name, the vaccine manufacturer and the batch number.
Danish: • At minimumskriterier for data overført til ”individual case safety reports” giver mulighed for at evaluere og identificere den administrerede vaccine inklusive produktnavn,