FrancophonIA/ELRC3.0 huggingface dataset:
English: Possible side effects Like all medicines, Celvapan can cause side effects, although not everybody gets them.
Danish: Celvapan kan som al anden medicin have bivirkninger, men ikke alle får bivirkninger.
English: Immune response against A/California/07/2009(H1N1)v
Danish: Immunrespons mod A/California/07/2009(H1N1)v
English: Dispose of in accordance with local requirements.
Danish: Bør destrueres i henhold til lokale bestemmelser.
English: Alterations in calcium metabolism have not been examined in human clinical studies.
Danish: Forandringer i calciummetabolismen er ikke blevet undersøgt i kliniske studier med mennesker.
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
Danish: • Minimummængde af data, der skal indsendes ved individuelle patientsikkerhedsrapporter, for at lette evaluering og identifikation af vaccinen, indgivet til hver enkel person, inklusive lægemidlets navn, fremstiller og
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or fetal or neonatal toxicity.
Danish: Data fra gravide kvinder vaccineret med forskellige inaktiverede, non-adjuverede influenzavacciner tyder ikke på malformationer eller føtal eller neonatal toksicitet.
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: Derfor skal sundhedspersonalet vurdere fordele og eventuelle risici i forbindelse med at anvende denne vaccine til personer med trombocytopeni eller blødningsforstyrrelse, der kan kontraindicere intramuskulær injektion, med mindre den mulige fordel opvejer risikoen for blødninger.
English: Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte vacciner samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by influenza vaccines.
Danish: De fleste bivirkninger var af mild karakter, af kort varighed og på niveau med dem, der fremkaldes af influenzavacciner.
English: Side effects from clinical studies in adults and older people
Danish: Bivirkninger i kliniske studier hos voksne og ældre
English: • severe stabbing or throbbing pain along one or more nerves • low blood platelet count which can result in bleeding or bruising
Danish: • alvorlig stikkende eller dunkende smerte langs en eller flere nerver • lavt blodpladeantal, som kan give blødninger eller blå mærker
English: System Organ Class (SOC)
Danish: Systemorganklasse (SOK)
English: • The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/(H1N1)v 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 aftale forholdsregler med medlemsstaterne for at lette identifikation og sporbarhed af vaccinen A/(H1N1)v indgivet til hver enkel patient, for at minimere medicineringsfejl og for at hjælpe patienter og sundhedspersonale med indrapportering af bivirkninger.
English: Celvapan is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus When a person is given the vaccine, the immune system (the body's natural defense system) will produce its own protection (antibodies) against the disease.
Danish: Celvapan er en vaccine mod influenza forårsaget af A(H1N1)v 2009 virus Når en person får vaccinen, producerer immunsystemet (kroppens eget forsvarssystem) sin egen beskyttelse (antistoffer) mod sygdommen.
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 influenzavaccination er der set falsk positive resultater i serologitests med ELISA-metoden for antistoffer mod human immundefektvirus-1 (HIV-1), hepatitis C virus og især HTLV-1.
English: 2nd Dose
Danish: 2. dosis
English: METABOLISM AND NUTRITION DISORDERS
Danish: METABOLISME OG ERNÆRING
English: If you are not sure, talk to your doctor or nurse before having this vaccine.
Danish: Hvis du er usikker, skal du tale med din læge eller sygeplejerske, før du får vaccinen.
English: Your doctor will discuss with you whether you should be given Celvapan.
Danish: Din læge bør diskutere med dig, om du skal vaccineres med Celvapan.
English: When Celvapan is given for the first dose, it is recommended that Celvapan (and not another vaccine against (H1N1)v) be given for the complete vaccination course.
Danish: Når Celvapan er givet som første dosis, anbefales det, at Celvapan (og ingen anden vaccine mod (H1N1)v) gives for at færdiggøre vaccinationsforløbet.
English: Younger children 6 months to 9 years received Celvapan, while older children from 9 to 18 years of age received an adjuvanted split pandemic vaccine.
Danish: Små børn i alderen fra 6 måneder til 9 år fik Celvapan, mens større børn i alderen 9-18 år fik en adjuveret pandemisk splitvaccine.
English: In children aged 6 to 35 months disturbed sleep and fever were very common, and decreased appetite, restlessness, irritability, crying and drowsiness were common.
Danish: Hos børn i alderen fra 6 måneder til 35 måneder var søvnforstyrrelse og feber meget almindelige reaktioner, og appetitløshed, rastløshed, irritabilitet, gråd og søvnighed var almindelige reaktioner.
English: Pain in extremity (in the majority of cases reported as pain in the injection site arm) General disorders and administration site conditions:
Danish: Ekstremitetssmerter (i de fleste tilfælde rapporteret som smerte i armen med injektionsstedet) Almene symptomer og reaktioner på administrationsstedet:
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Danish: Antistofdannelse hos patienter med endogen eller iatrogen immunosuppression kan være
English: There are no safety, immunogenicity or efficacy data to support interchangeability of Celvapan with other (H1N1)v vaccines.
Danish: Der findes ingen sikkerheds-, immunogenicitets- eller effektdata, der understøtter skift mellem Celvapan og andre (H1N1)v-vacciner.
English: * propagated in Vero cells (continuous cell line of mammalian origin)
Danish: * dyrket i vero-celler (kontinuerlig cellelinje fra pattedyr)
English: Adults aged 18 years and older
Danish: Voksne i alderen fra 18 år og ældre
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Danish: Lægerne er opmærksomme på risikoen for dette og har en nødbehandling klar til brug, hvis det skulle ske.
English: The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)v-like strains.
Danish: Det kan kun forventes, at vaccinen beskytter mod influenza, der er forårsaget af A/California/07/2009 (H1N1)v-lignende stammer.
English: • Safety and immunogenicity data in special risk groups (immunocompromised and
Danish: • Sikkerheds- og immunigenicitetsdata hos særlige risikogrupper (immunsvækkede og kronisk
English: Name and address of the manufacturers of the biological active substance(s)
Danish: Navn og adresse på fremstillerne af det (de) biologisk aktive stof(fer)
English: This leaflet was last revised in {month/YYYY}
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}
English: The vaccine is a clear to opalescent, translucent suspension.
Danish: Vaccinen er en klar til opaliserende, gennemsigtig suspension.
English: Some effects mentioned under section 4.
Danish: Nogle bivirkninger nævnt i pkt.
English: Children and adolescents aged 3 to 17 years One dose of 0.5 ml at an elected date.
Danish: Børn og unge i alderen fra 3 til 17 år En dosis på 0,5 ml på en fastlagt dato.
English: For further information, see sections 4.8 and 5.1.
Danish: 4.4, 4.8 og 5.1).
English: From post-marketing surveillance with egg-derived trivalent seasonal influenza vaccines, the following serious adverse reactions have been reported:
Danish: I forbindelse med bivirkningsovervågningen efter markedsføringen af æggebaserede, trivalente, sæsonbetingede influenzavacciner er følgende alvorlige bivirkninger indberettet.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
Danish: Læger og sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Neuralgia, paraesthesia, transient thrombocytopenia.
Danish: Neuralgi, paræstesi, forbigående trombocytopeni.
English: Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Danish: Hver vaccinedosis på 0,5 ml trækkes op i en injektionssprøjte.
English: • Post-marketing surveillance
Danish: • Bivirkningsovervågning efter markedsføringen
English: • vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney
Danish: • vasculitis (betændelse i blodkar, der kan give hudkløe, smerte i led og nyreproblemer)
English: Uferstrasse 15
Danish: Baxter AG Uferstrasse 15
English: See section 4.4 for Special warnings and special precautions for use.
Danish: 4.4 for særlige advarsler og forsigtighedsregler vedrørende brugen.
English: Pandemic vaccine effectiveness against the medically-attended influenza like illness (ILI) with laboratory-confirmation as A(H1N1)v, was assessed for the vaccination campaign in Jersey 2009/2010 in a case control study (test-negative design).
Danish: Effektiviteten af pandemisk vaccine mod medicinsk behandlet influenzalignende sygdom (ILI), der er laboratoriebekræftet som A(H1N1)v, blev bedømt i forbindelse med vaccinationskampagnen på Jersey i 2009/2010 i et case-kontrol studie (testnegativt).
English: Clinical studies in which a version of Celvapan containing HA derived from A/Vietnam/1203/2004 (H5N1) was administered at day 0 and at day 21 provide:
Danish: Kliniske studier, hvor en version af Celvapan indeholdende HA stammende fra A/Vietnam/1203/2004 (H5N1) blev indgivet på dag 0 og dag 21, giver:
English: 3 to 8 years
Danish: 3 til 8 år
English: Crude vaccine effectiveness of one dose of pandemic vaccine among children was 100% (95%
Danish: Råvaccineeffektiviteten af én dosis pandemisk vaccine hos børn var 100 % (95 % CI: 70-100 %).
English: Very common: Feeling tired, headache
Danish: Meget almindelig: Træthed, hovedpine
English: 6 to 11 months
Danish: 6 til 11 måneder
English: Allergic reactions, including anaphylactic reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock.
Danish: Allergiske reaktioner, inklusive anafylaktiske reaktioner, der kan medføre alvorligt blodtryksfald og eventuelt shock, hvis det ikke behandles.
English: The safety profile in healthy subjects > 60 years of age, in immune-compromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy subjects.
Danish: Sikkerhedsprofilen hos raske personer over 60 år, hos immunkompromitterede personer og hos patienter med kroniske sygdomstilstande svarer til sikkerhedsprofilen hos raske personer.
English: One pack of Celvapan contains 20 multidose vials of 5 ml suspension for injection for 10 doses.
Danish: En pakning Celvapan indeholder 20 multidosis-hætteglas à 5 ml suspension til injektion af 10 doser.
English: One dose of 0.5 ml at an elected date.
Danish: En dosis på 0,5 ml på en fastlagt dato.
English: Celvapan should under no circumstances be administered intravascularly.
Danish: Celvapan må under ingen omstændigheder indgives intravaskulært.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR 10-DOSE VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL HÆTTEGLAS MED 10 DOSER
English: *Such reactions have been manifested by respiratory distress, hypotension, tachycardia, tachypnea, cyanosis, pyrexia, flushing, angioedema, and urticaria Musculoskeletal and connective tissue disorders:
Danish: *Sådanne reaktioner er kommet til udtryk ved respiratorisk lidelse, hypotension, takykardi, takypnø, cyanose, feber, rødmen, angioødem og urticaria
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Celvapan suspension for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Celvapan injektionsvæske, suspension
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Danish: Neurologiske sygdomme, f.eks. encefalomyelitis, neuritis og Guillain-Barré syndrom.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: The vaccine should be allowed to reach room temperature before use.
Danish: Vaccinen bør have stuetemperatur før brug.
English: Trivalent seasonal influenza vaccines
Danish: Trivalente, årlige influenzavacciner.
English: In an observational safety study including 3216 subjects aged 6 months to 60 years and older, the nature of adverse events was consistent with those observed in other clinical studies in adults and children.
Danish: I et pandemisk observationssikkerhedsstudie med 3.216 personer i alderen 6 måneder til 60 år og derover var beskaffenheden af bivirkninger i overensstemmelse med de bivirkninger, der er set hos voksne og børn i andre kliniske studier.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV
English: • The MAH shall agree with Member States on the provision of a targeted communication to health care professionals which should address the following:
Danish: • Indehaveren af markedsføringstilladelsen skal aftale betingelserne med medlemsstaterne for en målrettet kommunikation til sundhedspersonale omhandlende følgende:
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
Danish: • Prioritering af bivirkningsindrapportering, dvs. fatale og livstruende bivirkninger, uventede alvorlige bivirkninger, bivirkninger med speciel interesse (AESI).
English: 12 to 35 months
Danish: 12 til 35 måneder
English: Vasculitis with transient renal involvement.
Danish: Vasculitis med forbigående påvirkning af nyrerne.
English: In a study with a similar influenza vaccine (containing a H5N1 vaccine strain) that included healthy adults and older people, subjects with a weakened immune system and patients with long-term conditions, the safety profile was similar to that in healthy adults.
Danish: I et studie med en lignende influenzavaccine (som indeholdt en H5N1-vaccinestamme) hos sunde voksne og ældre, personer med et svækket immunforsvar og patienter med kroniske sygdomme, svarede sikkerhedsprofilen til sikkerhedsprofilen hos raske voksne.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling
Danish: Symptomer på en allergisk reaktion kan være kløende hududslæt, vejrtrækningsbesvær og
English: It is recommended that subjects who receive a first dose of Celvapan, complete the vaccination course with Celvapan (see section 4.4).
Danish: Det anbefales, at personer, der får en første dosis af Celvapan, færdiggør vaccinationsforløbet med Celvapan (se pkt.
English: • if you previously had a sudden life-threatening allergic reaction to any ingredient of Celvapan or to any of the substances that may be present in trace amounts as follows: formaldehyde,
Danish: • hvis du tidligere har haft en pludselig, livstruende allergisk reaktion over for indholdsstofferne i Celvapan eller over for de øvrige indholdsstoffer, der kan være til stede som sporrester:
English: Animal reproductive toxicology studies do not indicate harmful effects in regard to female fertility, embryo-foetal and pre- and post-natal toxicity.
Danish: Reproduktionstoksicitetsstudie i dyr viste ingen skadelige virkninger på fertilitet, embryonets/fostrets udvikling, fødslen eller den postnatale udvikling.
English: A second dose of vaccine should be given after an interval of at least three weeks.
Danish: Endnu en dosis skal gives efter et interval på mindst tre uger.
English: The vaccine should not be administered intravascularly.
Danish: Denne vaccine bør ikke gives intravaskulært.
English: Hypersensitivity reactions, including anaphylaxis, have been reported following CELVAPAN vaccination (see section 4.8).
Danish: Der er rapporteret overfølsomhedsreaktioner, inklusive anafylaksi, efter vaccination med Celvapan (se pkt.
English: Generalised skin reactions
Danish: Generalisede hudreaktioner.
English: The seroprotection rates, seroconversion rates and seroconversion factors reported in adults and older subjects were comparable with Celvapan (H1N1)v.
Danish: Seroprotektionsværdier, serokonversionsværdier og serokonversionsfaktorer rapporteret hos voksne og ældre var sammenlignelige med værdierne for Celvapan (H1N1)v.
English: Clinical studies with Celvapan (H1N1)v currently provide:
Danish: Kliniske studier med Celvapan (H1N1)v giver aktuelt:
English: In a clinical trial the 7.5 µg dose of Celvapan (H1N1)v was administered to 69 infants and young represents the highest frequency observed either in the healthy adult or healthy older study population.
Danish: I et klinisk studie blev der givet en dosis på 7,5 µg Celvapan (H1N1)v til 69 spædbørn og yngre børn repræsenterer den højeste observerede hyppighed enten hos raske voksne eller raske ældre.
English: There are no data with Celvapan using the subcutaneous route.
Danish: Der foreligger ingen data om subkutan brug af Celvapan.
English: Celvapan (H1N1)v to healthy children aged 6 months to 17 years.
Danish: (H1N1)v hos raske børn i alderen fra 6 måneder til 17 år.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den fremstiller (de fremstiller), der er ansvarlig(e) for batchfrigivelse
English: Seronegative subjects at baseline (≤ 4mm2)
Danish: Seronegative personer ved basislinje (≤4 mm2)
English: Pandemic Observational Study with Celvapan (H1N1)v
Danish: Pandemisk observationsstudie med Celvapan (H1N1)v
English: The following adverse reactions were reported at a higher frequency category than in the
Danish: Følgende bivirkninger blev rapporteret med en højere hyppighed end i andre kliniske studier:
English: Following a 12-month booster vaccination with a licensed trivalent virosomal influenza vaccine for the 2010/2011 Northern hemisphere influenza season, seroprotection rates, seroconversion rates and serconversion factors (compared to pre-booster antibody levels) for the H1N1 component as measured by SRH and MN assays were as follows:
Danish: Efter en boostervaccination med en godkendt, trivalent virosomal influenzavaccine (for influenzasæsonen 2010/2011 på den nordlige halvkugle) givet 12 måneder senere, var seroprotektionsværdier, serokonversionsværdier og serokonversionsfaktorer (sammenlignet med antistofniveauer før boostervaccination) for H1N1-komponenten, målt med SRH- og MN-analyser,
English: • you have a bleeding condition or a bleeding problem or you bruise easily.
Danish: • hvis du har en blødningssygdom, let kommer til at bløde eller nemt får blå mærker.
English: Celvapan (H1N1)v to healthy adults aged 18 years and older.
Danish: (H1N1)v hos raske voksne i alderen fra 18 år og ældre.
English: Other medicines and Celvapan
Danish: Brug af anden medicin sammen med Celvapan
English: • you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to formaldehyde, benzonase, or to sucrose.
Danish: • hvis du har haft en allergisk reaktion anderledes end en pludselig, livstruende allergisk reaktion over for indholdsstofferne i denne vaccine, over for formaldehyd, benzonase eller saccharose
English: (A/Vietnam/1203/2004 and A/Indonesia/05/2005) do not indicate direct or indirect harmful effects with respect to female fertility, pregnancy, embryonal/foetal development, parturition or post-natal
Danish: Dyrestudier vedrørende reproduktions- og udviklingstoksicitet med H5N1-vaccinestammer (A/Vietnam/1203/2004 og A/Indonesia/05/2005) indikerer hverken direkte eller indirekte skadelige virkninger hvad angår fertilitet hos hunner, graviditet, embryonal/føtal udvikling, fødsel eller postnatal
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Whole virion influenza vaccine, inactivated containing antigen of strain *:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Influenzavaccine, hele virion, inaktiveret, indeholder antigen fra stamme*:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (10 doses of 0.5 ml per vial)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER MULTIDOSIS hætteglas (10 doser af 0,5 ml per hætteglas)
English: Seroprotection / Seroneutralization rate*
Danish: Seroprotektion /
English: 20 multidose vials (10 doses per vial - 0.5 ml per dose)
Danish: 20 multidosis hætteglas (10 doser pr. hætteglas - 0,5 ml pr. dosis)
English: 1st Dose
Danish: 1. dosis
English: Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently been given any other vaccine.
Danish: Fortæl det altid til lægen eller sygeplejersken, hvis du bruger anden medicin eller har brugt det for nylig.
English: * MN titre ≥ 1:40 ** > 4-fold increase in MN titre *** geometric mean increase
Danish: * MN-titer ≥ 1:40 ** > 4-dobbelt stigning i MN-titer *** geometrisk middelstigning
English: Very common: Pain and redness where the injection was given, aching muscles Uncommon: Influenza like illness
Danish: Meget almindelig: Smerte og rødme det sted, hvor indsprøjtningen blev givet, ømme muskler Ikke almindelig: Influenzalignende sygdom
English: • If a specific notification system has been put in place, how to report adverse
Danish: • Hvordan bivirkninger skal indrapporteres, hvis der er oprettet et specifikt
English: • The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Celvapan.
Danish: • Indehaveren af markedsføringstilladelsen skal aftale en måde med medlemsstaterne, der giver patienter og sundhedspersonale mulighed for kontinuerlig adgang til opdateret
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance(s), to any of the excipients and to trace residues e.g. formaldehyde, benzonase, or sucrose.
Danish: Der skal udvises forsigtighed, når vaccinen gives 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: ** ≥ 4-fold increase in MN titre *** geometric mean increase
Danish: ** ≥ 4-dobbelt stigning i MN-titer *** geometrisk middelstigning
English: However, if this cannot be avoided, the vaccines should be injected into separate limbs.
Danish: Hvis dette imidlertid ikke kan undgås, bør vaccinerne injiceres i hver deres arm. Vær opmærksom på, at bivirkningerne herved kan forstærkes.
English: Non-Clinical data obtained with Celvapan containing a H5N1 vaccine strain demonstrated alterations in liver enzymes and calcium levels in repeat dose toxicity studies in rats.
Danish: Prækliniske toksicitetsdata opnået med Celvapan, som indeholder en H5N1-vaccinestamme ved gentagen dosering hos rotter viste ændringer i leverenzymer og calciumniveauer.
English: A protective response may not be elicited in all vaccinees (see section 5.1).
Danish: Det er ikke sikkert, at alle vaccinerede opnår tilstrækkelig beskyttelse (se pkt.