FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common (affects more than 1 user in 10): • pain at the injection site
Danish: Meget almindelig (forekommer hos flere end 1 ud af 10 brugere): • smerte på injektionsstedet
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Danish: Under pandemien gennemfører ansøgeren et prospektivt kohortestudie som nævnt i lægemiddelovervågningsplanen.
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity.
Danish: Data fra gravide kvinder vaccineret med forskellige inaktiverede, ikke-adjuverede sæson-vacciner antyder ikke misdannelser eller føtal/neonatal toksicitet.
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 ved alle andre injicerbare vacciner bør passende medicinsk behandling og overvågning altid være til stede i tilfælde af sjælden anafylaktisk reaktion ved indgift af vaccinen.
English: Month 12-15
Danish: Måned 12-15
English: 6 - 35 months
Danish: 6-35 måneder
English: Adults and children from 6 months onwards: One dose of 0.5 ml at an elected date.
Danish: Voksne og børn fra 6-månedersalderen og ældre: En dosis a 0,5 ml på en valgt dato.
English: • if you have a bleeding problem or bruise easily.
Danish: • hvis du har et problem med blødninger eller let får blå mærker.
English: 7.5 microgram**
Danish: 7,5 mikrogram**
English: - Rapporteur's assessment report is circulated to CHMP members on Day 50.
Danish: - Evalueringsrapporten fra Rapporteur cirkuleres til CHMP-medlemmer på dag 50.
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 blandt andet være kløende hududslæt, vejrtrækningsbesvær og hævelse i ansigt eller tunge.
English: This section describes the clinical experience with the mock-up vaccine following a two-dose administration.
Danish: Dette afsnit beskriver den kliniske erfaring med mock-up-vacciner efter indgift af to doser.
English: • if you have a poor immune response (for example because of immunosuppressive therapy, e.g. corticosteroid treatments or chemotherapy for cancer);
Danish: • hvis du har et dårligt immunforsvar (det kan være på grund af immunhæmmende behandling som f.eks. behandlinger med binyrebarkhormoner (kortikosteroider) eller kemoterapi for kræft);
English: During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Danish: Under pandemien indsamler ansøgerne data om klinisk sikkerhed og effektivitet for den pandemiske vaccine og indsender disse oplysninger til CHMP til vurdering.
English: - CHMP report is circulated to the vaccine manufacturer on Day 55.
Danish: - CHMP-rapporten cirkuleres til vaccinefremstilleren på dag 55.
English: 18 - 59 years
Danish: 18-59 år
English: Such reactions occurred both in patients with a history of multiple allergies and in patients with no known allergy.
Danish: Sådanne reaktioner opstod både hos patienter med flere allergier i anamnesen og patienter uden kendt allergi.
English: Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Danish: Mock-up-vacciner indeholder influenzaantigener, som er anderledes end antigenerne i de aktuelt cirkulerende influenzavira.
English: A 12 to 24 months heterologous booster has also been administered in a phase 3 study in immunocompromised subjects and patients with chronic disease conditions.
Danish: En 12 til 24 måneder heterolog booster er også blevet administreret i et fase 3-studie med immunokompromitterede personer og patienter med kroniske sygdomme.
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI.
Danish: Uden for en pandemiperiode vil den normale periodicitet og format for PSUR bibeholdes med speciel gennemgang af bivirkninger med speciel interesse (AESI).
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Patients with chronic disease conditions
Danish: Patienter med kroniske sygdomme
English: Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines.
Danish: Data fra mock-up-vaccinen støtter den vaccinationsstrategi, der sandsynligvis vil blive anvendt med den pandemiske vaccine: Klinisk immunogenicitets-, sikkerheds- og reaktogenicitetsdata fra mock-up-vacciner er relevante i forbindelse med de pandemiske vacciner.
English: Very rare (<1/10,000) Not known (cannot be estimated from the available data)
Danish: Meget sjælden (<1/10.000) Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01
Danish: Farmakoterapeutisk klassifikation: Influenzavacciner, ATC-kode: J07BB01
English: Such reactions have happened both in people who have allergies and in those who do not;
Danish: Sådanne reaktioner er opstået både hos personer med og uden allergier;
English: • Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Danish: • Efter influenzavaccination er der set falske positive resultater i serologitests med ELISA-metoden i forbindelse med antistoffer mod HIV1, hepatitis C og især HTLV1.
English: This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for lægemidlet af videnskabelige årsager.
English: 3 - 8 years
Danish: 3-8 år
English: Strain A/Indonesia/05/2005
Danish: Stamme A/Indonesien/05/2005
English: Vaccine distribution report
Danish: Vaccinedistributionsrapport
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu/
Danish: Yderligere information om dette produkt findes på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/
English: To put the safety report into context, a summary of vaccine distribution should be included and should provide details of the number of doses of vaccine distributed in i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world.
Danish: Denne bør give nærmere oplysninger om antallet af distribuerede vaccinedoser i: i) EU's medlemsstater i rapporteringsperioden pr. batchnummer ii) EU's medlemsstater kumuleret, og iii) resten af verden
English: Once the needle is attached, the vaccine must be administered immediately.
Danish: Efter isætning af nålen skal vaccinen administreres straks.
English: The MAH shall perfom the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Danish: Under en pandemi kan det være relevant at give vaccinen under forudsætning af, at der er genoplivningsudstyr inden for rækkevidde.
English: - Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
Danish: - Indehaveren af markedsføringstilladelsen og (Co-)Rapporteur bør evaluere hyppigheden med 6 måneders mellemrum.
English: • crying
Danish: • gråd
English: METHOD OF ADMINISTRATION Shake before use
Danish: ADMINISTRATIONSMETODE Omrystes før brug
English: The side-effects are generally similar to those related to the influenza vaccine.
Danish: Bivirkningerne ligner generelt bivirkningerne af influenzavaccinen.
English: Prophylaxis of influenza in an officially declared pandemic situation.
Danish: Profylakse mod influenza i en officielt erklæret pandemisk situation.
English: Marketing Authorisation Holder: Ology Bioservices Ireland LTD Wilton Park House Wilton Place
Danish: Indehaver af markedsføringstilladelsen: Ology Bioservices Ireland LTD Wilton Park House
English: Sensory disturbance (paresthesia, dysesthesia, oral dysesthesia, hypoesthesia, dysgeusia, and burning sensation)
Danish: Sensoriske forstyrrelser (paræstesi, dysæstesi, oral dysæstesi, hypæstesi, dysguesi, brændende fornemmelse)
English: Immunization should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh, depending on the muscle mass.
Danish: Immunisering bør foretages ved intramuskulær injektion i musculus deltoideus eller anterolateralt i låret afhængigt af muskelmasse.
English: 9 - 17 years
Danish: 9-17 år
English: If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can still be given but your response to the vaccine may be poor.
Danish: Hvis du tager medicin, der nedsætter immuniteten over for infektioner, eller du får en anden type behandling (som strålebehandling), der påvirker immunforsvaret, kan PANDEMIC INFLUENZA VACCINE H5N1 BAXTER stadig gives, men din respons på vaccinen kan være ringe.
English: - Except for Table 1, all tables will be based on number of reactions (presented on PT level, sorted by System Organ Class [SOC] and High Level Term [HLT]) and not number of cases.
Danish: - Med undtagelse af Tabel 1 skal alle tabeller være baseret på antal reaktioner (angivet i FT, sorteret efter organklasse [SOC] og Højt Niveau Term [HNT]) og ikke på antal hændelser.
English: Clinically significant alterations in liver enzymes and calcium levels have not been seen to date in human clinical studies.
Danish: Klinisk signifikante ændringer i leverenzymer og calciumniveauer er til dato ikke iagttaget i kliniske studier med mennesker.
English: - Demyelination:
Danish: - Demyelinisering:
English: From post-marketing surveillance with a whole virion, Vero cell derived, H1N1 vaccine, the following adverse reactions have been reported (the frequency of these adverse reactions is not known as it cannot be estimated from the available data):
Danish: I forbindelse med bivirkningsovervågning efter markedsføringen af hel virion, verocelle-afledt H1N1-vaccine er følgende bivirkninger indberettet (hyppigheden af disse bivirkninger er ikke kendt og kan ikke vurderes ud fra de tilgængelige data):
English: It is used to prevent influenza (flu) in an officially declared pandemic.
Danish: Den bruges til at forebygge influenza i en officielt erklæret pandemi.
English: Infants, children, and adolescents
Danish: Spædbørn, børn og unge
English: Adverse Reactions (Adults and Older People)
Danish: Bivirkninger (voksne og ældre personer)
English: You should be aware that the side effects may be intensified.
Danish: Vær opmærksom på, at bivirkningerne herved kan forstærkes.
English: 21 Days After
Danish: 21 dage efter
English: Health care providers should carefully consider the potential risks and benefits for each specific patient before administering PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Danish: Sundhedspersonalet bør nøje overveje de potentielle risici og fordele individuelt for hver patient før administration af PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
English: Immunogenicity in immunocompromised subjects (N=122) and in patients with chronic disease conditions (N=123)
Danish: Immunogenicitet hos immunokompromitterede personer (N=122) og hos patienter med kroniske sygdomme (N=123)
English: A second dose of vaccine should be given after an interval of at least 3 weeks.
Danish: Endnu en dosis skal gives efter et interval på mindst 3 uger.
English: Some undesirable effects mentioned under section 4.8 such as dizziness and vertigo may affect the ability to drive or use machines.
Danish: 4.8, såsom svimmelhed og vertigo kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: • pain in mouth and throat
Danish: • smerter i mund og hals
English: Post-marketing surveillance
Danish: Bivirkningsovervågning efter markedsføringen
English: Very rare: vasculitis with transient renal involvement.
Danish: Meget sjælden: Vasculitis med forbigående påvirkning af nyrerne.
English: Animal reproductive and developmental toxicity studies do not indicate direct or indirect harmful effects with respect to female fertility, pregnancy, embryonal/ foetal development parturition or post natal development.
Danish: Dyrestudier af reproduktions- og udviklingstoksicitet indikerer hverken direkte eller indirekte skadelige virkninger hvad angår fertilitet hos hunner, drægtighed, embryonal/føtal udvikling, fødsel eller postnatal udvikling.
English: Adverse reactions are listed according to the following frequency below.
Danish: Bivirkninger er angivet i henhold til hyppighed som anført herunder.
English: • if you previously had a serious allergic reaction (i.e. life-threatening) to PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Danish: • hvis du tidligere har haft en alvorlig allergisk reaktion (dvs. livstruende) over for PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
English: narrow SMQ “Non-infectious encephalitis”
Danish: snæver SMF ”Ikke-infektiøs encefalitis”
English: Shake before use.
Danish: Rystes før brug.
English: The vaccine should never be given into a blood vessel.
Danish: Vaccinen må aldrig gives i et blodkar.
English: The European Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om lægemidlet, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: If your are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice if you should receive PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, om du skal have PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
English: PT “Vaccination failure”.
Danish: FT ”Vaccinationssvigt”
English: However, if this cannot be avoided, the immunoglobulins should be injected into the other limb.
Danish: Hvis dette imidlertid ikke kan undgås, bør immunoglobulinerne injiceres i det andet lem.
English: The safety profile in immunocompromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy adults and older people subjects.
Danish: Sikkerhedsprofilen hos immunokompromitterede personer og patienter med kroniske sygdomme er den samme som sikkerhedsprofilen hos raske voksne og ældre personer.
English: • Hypersensitivity reactions, including anaphylaxis, have been reported following use of a similar whole virion, Vero cell derived H1N1 influenza vaccine administered during a pandemic period.
Danish: • Overfølsomhedsreaktioner, herunder anafylaksi, er rapporteret efter brug af tilsvarende hel virion, verocelleafledt H1N1-influenzavaccine administreret under en pandemisk periode.
English: You should tell your doctor before vaccination
Danish: Før vaccinationen skal du fortælle din læge
English: A minor infection such as a cold should not be a problem, but your doctor should advise whether you could still be vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
Danish: En mindre infektion som en forkølelse bør ikke være noget problem, men din læge vil vejlede dig med hensyn til, om du kan vaccineres med PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
English: In the first few weeks after vaccination with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER the results of these tests may not be correct.
Danish: I de første par uger efter vaccination med PANDEMIC INFLUENZA VACCINE H5N1 BAXTER er resultaterne af disse tests muligvis ikke korrekte.
English: The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme.
Danish: Bivirkningerne anført herunder er forekommet med en tilsvarende influenzavaccine (Celvapan) hos voksne og børn i forbindelse med et H1N1-pandemisk influenza-vaccinationsprogram.
English: Heterologous booster vaccinations
Danish: Heterologe boostervaccinationer
English: Uncommon: generalised skin reactions
Danish: Ikke almindelig: Generaliserede hudreaktioner
English: However, if this cannot be avoided, the other vaccine should be injected into the other limb.
Danish: Hvis dette imidlertid ikke kan undgås, bør den anden vaccine injiceres i et andet lem.
English: • conjunctivitis (an inflammation of the eye), eye irritation
Danish: • konjunktivitis (øjenbetændelse), øjenirritation
English: narrow SMQ “Vasculitis”
Danish: snæver SMF ”Vasculitis”
English: • swelling of tissue just below the skin
Danish: • hævelse i vævet under huden
English: A/Vietnam A/Indonesia
Danish: A/Vietnam A/Indonesien
English: Two studies have been performed using either the H5N1 A/Vietnam/1203/2004 or the A/Indonesia/05/2005 vaccine.
Danish: Der er udført to forsøg med enten H5N1 A/Vietnam/1203/2004- eller A/Indonesien/05/2005-vaccinen.
English: Male fertility was not investigated in the reproductive and developmental toxicity studies, however there were no findings in the repeat-dose toxicity studies to indicate any vaccine-related changes to the tissues of the male reproductive tract.
Danish: Fertilitet hos hanner blev ikke undersøgt i studierne af reproduktions- og udviklingstoksicitet, men studier af toksicitet efter gentagne doser indikerede ikke vaccine-relaterede ændringer i vævet i forplantningsorganerne hos mænd.
English: • malaise (generally feeling unwell)
Danish: • ubehag (generel følelse af utilpashed)
English: Tell the doctor requesting these tests that you have recently received PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
Danish: Fortæl den læge, der ønsker disse tests, at du for nylig har fået PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
English: Infants and children aged 6 to 35 months: In a clinical trial the H5N1 vaccine was administered to 36 infants and children aged 6 to 35 months.
Danish: Spædbørn og børn i alderen 6 til 35 måneder: I et klinisk forsøg blev H5N1-vaccinen givet til 36 spædbørn og børn i alderen fra 6 til 35 måneder.
English: In the clinical studies conducted in infants, children and adolescents, the incidence and nature of symptoms after the first and second vaccination were similar to those occurred in adults and older people.
Danish: I de kliniske forsøg, der er blevet udført hos spædbørn, børn og unge, svarede forekomsten og arten af bivirkninger efter den første og anden vaccination til dem, der blev set hos voksne og ældre personer.
English: A second dose of 0.5 ml should be given after an interval of at least three weeks.
Danish: Endnu en dosis på 0,5 ml skal gives efter et interval på mindst 3 uger.
English: Seroneutralisation rate* Immunocompromised subjects
Danish: Seroneutraliseringsværdi* Immunokompromitterede personer
English: The incidence and nature of symptoms after the first and second vaccination were similar to those observed in the healthy adults and older subjects.
Danish: Forekomsten og arten af bivirkninger efter den første og anden vaccination svarede til dem, der blev set hos raske voksne og ældre personer.
English: Infants, children, and adolescents Immune response against A/Vietnam/1203/2004 (H5N1)
Danish: Spædbørn, børn og unge Immunrespons mod A/Vietnam/1203/2004 (H5N1)
English: Similar to the homologous challenge, vaccination against a heterologous challenge reduced virus burden, and reduced haematological (leukopenia) changes associated with highly pathogenic avian influenza infection.
Danish: I lighed med den homologe eksponering, reducerede vaccination ved heterolog eksponering virusbyrden og nedsatte de hæmatologiske (leukopeni) ændringer, der er forbundet med svær patogen aviær influenzainfektion.
English: Immunogenicity in adults aged 18 to 59 years (N=961) and in subjects aged 60 years and older (N=391)
Danish: Immunogenicitet hos voksne i alderen 18 til 59 (N=961) og hos personer i alderen 60 år (N=391) og derover
English: BLOOD AND LYMPHATIC SYSTEM DISORDERS
Danish: BLOD OG LYMFESYSTEM
English: The following serious adverse reactions have been reported from post-marketing surveillance with egg-derived interpandemic trivalent vaccines:
Danish: Følgende alvorlige bivirkninger er rapporteret i forbindelse med bivirkningsovervågning af ægbaserede, interpandemiske, trivalente vacciner:
English: narrow SMQ “Guillain-Barré syndrome”
Danish: snæver SMF ”Guillain-Barré syndrom”
English: • A protective response may not be induced in all vaccinees (see section 5.1).
Danish: • Det er ikke sikkert, at der opnås beskyttende immunrespons hos alle vaccinerede (se pkt.
English: In addition, the immunogenicity has also been evaluated in a Phase 3 study in specified risk groups of immunocompromised subjects (N=122) and patients with chronic disease conditions (N=123) following a 0, 21 day schedule.
Danish: Derudover er immunogeniciteten vurderet i et fase 3-studie i specificerede risikogrupper med immunkompromitterede personer (N=122) og patienter med kroniske sygdomme (N=123), der blev vaccinert på dag 0 og 21.
English: The A/Vietnam/1203/2004 vaccine afforded protection against homologous challenge as evidenced by full survivorship, reduced weight loss, a less pronounced and shorter increase in temperature, a less marked reduction in lymphocyte counts and in reduction of inflammation and necrosis in brain and olfactory bulb in the vaccinated cohorts as compared to control animals.
Danish: A/Vietnam/1203/2004-vaccinen gav beskyttelse ved homolog eksponering, hvilket manifesterede sig ved fuld overlevelse, reduceret vægttab, en mindre udtalt og mere kortvarig temperaturforøgelse, en mindre markant reduktion af lymfocyttallet samt reduktion af inflammation og nekrose i hjerne og bulbus olfactorius hos den vaccinerede kohorte end hos kontroldyrene.
English: Ferrets vaccinated with the 7.5 µg dose of the A/Vietnam/1203/2004 vaccine demonstrated a high rate of seroconversion.
Danish: De fritter, der var vaccineret med 7,5 µg dosen af A/Vietnam/1203/2004-vaccinen havde en høj serokonversionsværdi.
English: • pain in joint or muscle
Danish: • smerter i led eller muskler
English: In the clinical studies conducted in adults and older people with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, most side effects were mild in nature and short term.
Danish: I kliniske forsøg, der er udført hos voksne og ældre personer, med PANDEMIC INFLUENZA VACCINE H5N1 BAXTER var de fleste bivirkninger milde og kortvarige.
English: The following side effects have been reported in clinical studies in adults and older people.
Danish: Der er set følgende bivirkninger i kliniske forsøg med voksne og ældre personer.
English: • Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to trace residues e.g. formaldehyde, benzonase, or sucrose.
Danish: • Der skal udvises forsigtighed, når vaccinen administreres til personer med kendt overfølsomhed (ud over anafylaktisk reaktion) over for det aktive stof, over for et af hjælpestofferne og over for sporstofferne, f.eks. formaldehyd, benzonase eller saccharose.
English: INFECTIONS AND INFESTATIONS
Danish: INFEKTIONER OG PARASITÆRE SYGDOMME