FrancophonIA/ELRC3.0 huggingface dataset:
English: • The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Focetria.
Danish: • Indehaveren af markedsføringstilladelsen skal sammen med medlemslandene aftale tiltag, der sikrer, at patienter og sundhedspersoner altid har adgang til opdaterede oplysninger om Focetria.
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: • Bivirkninger, som skal prioriteres i forhold til indberetning, dvs. dødelige eller livstruende bivirkninger, uventede alvorlige bivirkninger, bivirkninger af særlig interesse.
English: Packs of 10.
Danish: Pakninger med 10.
English: The same study demonstrated that previous administration of adjuvanted or unadjuvanted seasonal influenza vaccines to adults and elderly does not interfere with the immune response to Focetria.
Danish: Samme studie demonstrerede, at tidligere administration af adjuverede eller ikke-adjuverede sæsonbetingede influenza vacciner til voksne og ældre ikke indvirker på immunresponset på Focetria.
English: Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Danish: Fortæl din læge eller sygeplejerske, hvis du nemt kommer til at bløde eller nemt får blå mærker.
English: Do not use Focetria after the expiry date which is stated on the carton and the label.
Danish: Brug ikke Focetria efter den udløbsdato, der står på pakningen og etiketten efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Clinical studies in which a version of Focetria containing HA derived from A/Vietnam/1194/2004 (H5N1) was administered at day 1 and at day 22 provide:
Danish: Kliniske studier, hvor en version af Focetria indeholdende hæmagglutinin udledt af A/Vietnam/1194/2004 (H5N1) blev administreret på dag 1 og dag 22, leverer:
English: A protective response may not be elicited in all vaccinees (see section 5.1).
Danish: Et beskyttende respons kan ikke med sikkerhed fremkaldes hos alle vaccinerede (se pkt.
English: Some cases were observed in subjects with a history of epilepsy.
Danish: Nogle tilfælde blev observeret hos personer med epilepsi i anamnesen.
English: 21 days after 1st dose(day 22)
Danish: 21 dage efter 1. dosis (dag 22)
English: SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSERNE
English: Warning: Do not inject intravascularly.
Danish: Advarsel: Må ikke injiceres intravaskulært.
English: Anti-HA antibody
Danish: Anti-HA-antistof
English: In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with Focetria H1N1v:
Danish: Udover de rapporterede bivirkninger i de kliniske studier er følgende rapporteret efter markedsføringen af Focetria H1N1v:
English: The safety profile of Focetria was similar to that of the H5N1 mock up vaccines.
Danish: Sikkerhedsprofilen for Focetria var identisk med H5N1-mock-up-vaccinen.
English: Grounds recommending the variation to the terms of the Marketing Authorisation On the basis of the scientific conclusions for Focetria, the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing the active substance influenza vaccine h1n1v (surface antigen, inactivated, adjuvanted) is favourable subject to the proposed changes to the product information.
Danish: Begrundelser for at anbefale ændring af betingelserne for markedsføringstilladelsen På baggrund af de videnskabelige konklusioner for Focetria er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel, der indeholder det aktive stof influenzavaccine H1N1v (overfladeantigen, inaktiveret, adjuveret), er gunstigt under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Allergic reactions may occur following vaccination, in rare cases leading to shock.
Danish: Der kan opstå bivirkninger efter vaccinationen, som i sjældne tilfælde kan medføre shock.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Focetria injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Focetria injektionsvæske
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 kan der forekomme falske positive resultater i serologiske test, som har anvendt ELISA-metoden til at påvise antistoffer mod Human Immundefekt Virus-1 (HIV-1), hepatitis C-virus og specielt HTLV-1.
English: Paediatric population Children and adolescents 6 months to 17 years of age
Danish: Pædiatrisk population Børn og unge i alderen 6 måneder til 17 år
English: Focetria should under no circumstances be administered intravascularly.
Danish: Focetria må under ingen omstændigheder gives intravaskulært.
English: Although Focetria in multidose vials contains a preservative that inhibits microbial growth, minimisation of the risk of contamination of the multidose vial during withdrawal of each dose is the responsibility of the user.
Danish: Selv om Focetria i multidosishætteglas indeholder et konserveringsmiddel der hæmmer mikrobiel vækst, påhviler det brugeren at minimere risikoen for kontaminering af multidosishætteglas ved hver optrækning af en dosis.
English: The incidence of symptoms observed in subjects over 60 years of age was generally lower as compared to the 18-60 years old population.
Danish: Forekomsten af symptomerne, der blev observeret hos personer på mere end 60 år, var generelt mildere end hos populationen i alderen 18-60 år.
English: Additional information is available from the studies conducted with a vaccine similar in composition to Focetria but containing antigen derived from H5N1 viruses.
Danish: Yderligere oplysninger er tilgængelige fra studier, udført med en vaccine med en sammensætning, der svarer til Focetria, men som indeholder antistof, der er deriveret fra H5N1-vira.
English: Available clinical data suggest that a single dose may be sufficient.
Danish: Tilgængelige kliniske data viser, at en enkelt dosis kan være tilstrækkelig.
English: “Possible side effects” may affect the ability to drive or use machines.
Danish: ”Bivirkninger”, kan muligvis påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Local
Danish: Lokal
English: Focetria is a vaccine to prevent influenza (flu) caused by A(H1N1v) 2009 virus.
Danish: Focetria er en vaccine, der er udviklet til at forebygge influenza, forårsaget af A(H1N1v) 2009-virus.
English: Therefore, the relevant SmPC wording currently stating the limited availability of clinical data in pregnant women, is recommended to be changed to reflect the newly available information.
Danish: Derfor anbefales det, at den relevante formulering i det gældende produktresume, som angiver at der er utilstrækkelige data fra anvendelse til gravide kvinder, ændres til at afspejle den nyligt tilgængelige information.
English: Rare: anaphylaxis
Danish: Sjælden: anafylaksi
English: Common (1/100 to <1/10)
Danish: Almindelig (1/100 til <1/10),
English: Most of the reactions were mild in nature and of short duration.
Danish: De fleste bivirkninger var milde og af kort varighed.
English: When Focetria is given for the first dose, it is recommended that Focetria (and not another vaccine against H1N1v) be given for the complete vaccination course.
Danish: Hvis der ved første dosis gives Focetria, anbefales det, at man også i anden omgang får Focetria (og ikke en anden vaccine mod H1N1v) for at fuldføre vaccinationsprogrammet.
English: Focetria H1N1v may be co-administered with a non adjuvanted seasonal influenza vaccine.
Danish: Focetria H1N1v kan administreres samtidig med en ikke-adjuveret sæsonbetinget vaccine.
English: Influenza vaccine H1N1v
Danish: Influenzavaccine H1N1v
English: The MAH shall perform the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use CHMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelovervågningsaktiviteter, som er beskrevet i lægemiddelovervågningsplanen (ifølge aftalen i RMP, modul 1.8.2 i markedsføringstilladelsen), og enhver efterfølgende opdatering af RMP, som er godkendt af Udvalget for Lægemidler til Mennesker (CHMP).
English: There are no data with Focetria using the subcutaneous route.
Danish: Der er ingen data med Focetria givet subkutant.
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Danish: Vaccinen skal helst injiceres intramuskulært i musculus deltoideus eller i det anterolaterale lår (afhængigt af muskelmasse).
English: Infants 6-11 months
Danish: Spædbørn 6-11 måneder
English: 1.175 milligrams
Danish: 1,175 milligram
English: MF59C.1 is an oil/water emulsion containing 9.75 mg squalene, 1.175 mg polysorbate 80 and 1.175 mg sorbitan trioleate in a citrate buffer.
Danish: MF59C.1 er en olie-vand-emulsion, der indeholder 9,75 mg squalen; 1,175 mg polysorbat 80 og 1,175 mg sorbitantrioleat i en citratbuffer.
English: Tell the doctor requesting these tests that you have recently been given Focetria.
Danish: Hvis lægen foreslår disse blodprøver, skal du fortælle ham eller hende, at du for nylig har fået Focetria.
English: Clinical studies with Focetria H1N1v currently provide:
Danish: Kliniske studier med Focetria H1N1v leverer aktuelt:
English: Clinical data suggest that a single dose may be sufficient.
Danish: Kliniske studier viser, at en enkelt dosis kan være tilstrækkelig.
English: This vaccine in a multi-dose vial contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Danish: Denne vaccine, som leveres i et flerdosis-hætteglas, indeholder thiomersal, der er et konserveringsmiddel, som kan fremkalde en allergisk reaktion.
English: Data on co-administration of Focetria H1N1v with a non-adjuvanted seasonal influenza subunit vaccine in healthy adults aged 18-60 years of age did not suggest any interference in the immune response to Focetria.
Danish: Data fra samtidig administration af Focetria H1N1v med en ikke-adjuveret, sæsonbetinget influenza subunit-vaccine hos raske voksne i alderen 18-60 år ikke indikerer interferens med immunresponset over for Focetria.
English: Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du vaccineres.
English: Rare: Low blood platelet count which can result in bleeding or bruising.
Danish: Sjælden: Blodplademangel, som kan medføre blødning eller blå mærker.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/385/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/07/385/001
English: See section 6.5 for the number of doses per vial.
Danish: 6.5 vedrørende antal doser pr. hætteglas.
English: Neurological disorders, such as encephalomyelitis and Guillain Barré syndrome.
Danish: Neurologiske forstyrrelser, såsom encefalomyelitis og Guillain Barré-syndrom.
English: Gastrointestinal disorders Common: nausea
Danish: Gastrointestionale lidelser Almindelig: kvalme
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12 August 2010
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: • Clinical trials
Danish: • Kliniske studier
English: In the event that a second dose is to be administered it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of Focetria with other H1N1v vaccines.
Danish: Hvis endnu en dosis skal administreres, skal det bemærkes, at der ikke foreligger data om sikkerhed, immunogenicitet eller virkning, der understøtter muligheden for at erstatte Focetria med andre H1N1v-vacciner.
English: Tenderness, erythema, irritability, unusual crying, sleepiness, diarrhoea and change in eating habits.
Danish: Ømhed, erytem, irritabilitet, usædvanlig gråd, søvnighed, diarre og ændringer i spisevaner.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)v-like strains.
Danish: Vaccinen kan kun forventes at beskytte mod influenza, forårsaget af A/California/07/2009 (H1N1)v-lignende stammer.
English: The multidose vial should preferably be used within 24 hours after first withdrawal.
Danish: Flerdosis-hætteglas bør benyttes inden for 24 timer fra første udtrækning.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMA) hjemmeside: http://www.ema.europa.eu/.
English: Seroprotection rate (95% CI)
Danish: Serumbeskyttelsesrate (95 % CI)
English: Adverse reactions from clinical trials with the mock-up vaccine are listed below.
Danish: De bivirkninger, der er observeret i kliniske studier med mock-up-vaccinen er opført nedenfor.
English: METHOD AND ROUTE(S) OF ADMINISTRATION To be administered intramuscularly into the deltoid muscle.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Administreres intramuskulært i deltamusklen.
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 lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMA) hjemmeside: http://www.ema.europa.eu/.
English: In a clinical trial 131 adults and 123 elderly were exposed to two doses of the 7.5 µg Focetria.
Danish: I et klinisk studie blev 131 voksne og 123 ældre tildelt to doser af Focetria.
English: In clinical trials with different formulations (H5N3, H9N2 and H5N1) approximately 3400 subjects were exposed to the candidate vaccine.
Danish: I kliniske studier med forskellige formuleringer (H5N3, H9N2 og H5N1) fik ca. 3400 personer kandidatvaccinen.
English: Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Danish: Allergiske reaktioner, anafylaksi inklusive dyspnø, bronkospasme, larynxødem, i sjældne tilfælde førende til shock.
English: It is recommended that subjects who receive a first dose of Focetria, should complete the vaccination course with Focetria H1N1v (see section 4.4).
Danish: Det anbefales, at personer, som får den første dosis Focetria, fuldfører det planlagte vaccinationsprogram med Focetria H1N1v (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/385/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/07/385/004
English: Children 6 months to 35 months:
Danish: Børn i alderen 6 måneder til 35 måneder:
English: Neurological disorders such as severe stabbing or throbbing pain along one or more nerves, tingling, fits, and neuritis (inflammation of nerves).
Danish: Neurologiske lidelser som stikkende eller pulserende smerte langs en eller flere nerver, prikken, krampe og neuritis (nervebetændelse).
English: If you get any side effects, talk to your doctor or nurse.
Danish: Hvis du får en af disse bivirkninger, skal du straks fortælle det til din læge eller på apoteket
English: Skin and subcutaneous tissue disorders Common: sweating Uncommon: urticaria Rare: eye swelling
Danish: Hud og subkutane væv Almindelig: svedtendens Ikke almindelig: urticaria Sjælden: hævelse af øjne
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the marketing authorisation, 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 det lægemiddelovervågningssystem, som er beskrevet i modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer, før og under markedsføringen af lægemidlet.
English: The incidence of symptoms observed in subjects over 60 years of age was lower as compared to the 18-60 years old population.
Danish: Hyppigheden af bivirkninger blandt personer over 60 år var lavere end blandt de 18 til 60 årige.
English: • If a specific notification system has been put in place, how to report adverse reactions.
Danish: • Information om indberetning af bivirkninger, såfremt der er oprettet et særligt indberetningssystem.
English: Therefore the data indicate that Focetria may be co-administered with non adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Danish: Data indikerede derfor, at Focetria kan administreres samtidig med ikke-adjuverede sæsoninfluenza-vacciner (med injektion i modsatte lemmer).
English: Non-clinical data obtained with the mock-up vaccine (MF59C.1-adjuvanted H5N1 vaccine) and with seasonal vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of efficacy, repeated dose toxicity, and reproductive and developmental toxicity.
Danish: Ikke-kliniske data indhentet for mock-up-vaccinen (MF59C.1-adjuveret H5N1-vaccine) og sæsonbestemt vaccine, der indeholder MF59C.1-adjuvans, viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af virkning, toksicitet efter gentagne doser, reproduktionstoksicitet og udviklingstoksicitet.
English: What Focetria is and what it is used for What you need to know before you receive Focetria How Focetria is given
Danish: Virkning og anvendelse Det skal du vide, før du får Focetria Sådan får du Focetria
English: Among the adolescents the very common events were: sweating, nausea and chills.
Danish: Blandt unge var de meget almindelige bivirkninger: Tendens til at svede, kvalme og kulderystelser.
English: Common (affects 1 to 10 users in 100): Bruising of the skin at the injection site, fever and nausea
Danish: Almindelig (forekommer hos 1 til 10 brugere ud af 100): Blå mærker ved injektionsstedet, feber og kvalme
English: Children and Adolescents (9-17 years)
Danish: Børn og unge (9-17 år)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (5 ml)
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Flerdosis-hætteglas (5 ml)
English: Elderly (>60 years):
Danish: Ældre (>60 år):
English: 0.05 milligrams
Danish: 0,05 milligram
English: No data are available in children aged less than 6 months (see sections 4.8 and 5.1).
Danish: Der foreligger ingen data vedrørende børn under 6 måneder (se pkt.
English: Very common: pain, induration and erythema, myalgia, headache, sweating, malaise and fatigue
Danish: Meget almindelig: Smerte, induration og erytem, myalgi, hovedpine, svedsekretion, ubehag og træthed.
English: including the elderly.
Danish: og hos voksne, inklusive ældre.
English: What you need to know before you receive FOCETRIA
Danish: Det skal du vide, før du begynder at bruge FOCETRIA
English: Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate in a citrate buffer.
Danish: Adjuvans: MF59C.1 olie i vand-emulsion indeholdende squalen som oliefase stabiliseret med polysorbat 80 og sorbitantrioleat i en citratbuffer.
English: Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barré Syndrome.
Danish: Neurologiske lidelser som encefalomyelitis (betændelse i centralnervesystemet), neuritis (nervebetændelse) og en type af lammelse, som kaldes Guillain-Barré syndrom.
English: There is a further immune response to a second dose of 0.5 ml administered after an interval of three weeks.
Danish: Der ses en yderligere immunrespons ved endnu en dosis på 0,5 ml, som administreres efter et interval på 3 uger.
English: In clinical trials with different formulations (H5N3, H9N2 and H5N1) approximately 3400 subjects were exposed to the mock-up vaccines.
Danish: I kliniske studier med forskellige formuleringer (H5N3, H9N2 og H5N1) fik ca. 3400 personer mock-up-vaccinen.
English: The vaccine may be used during breast-feeding.
Danish: Vaccinen kan anvendes under amning.
English: There is no information on administration of the vaccine Focetria with any other vaccines.
Danish: Der foreligger ingen oplysninger om indgivelse af Focetria-vaccinen samtidig med andre vacciner.
English: Other medicines and Focetria
Danish: Brug af anden medicin sammen med Focetria
English: In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Danish: Hvis noget af ovenstående gælder for dig, SKAL DU FORTÆLLE DET TIL LÆGEN ELLER SYGEPLEJERSKEN, da det kan være, at du ikke skal vaccineres eller skal vaccineres på et senere tidspunkt.
English: Fertility An animal study with H5N1 mock-up vaccine did not indicate reproductive toxicity (see section 5.3).
Danish: Fertilitet Et dyrestudie med H5N1 mock-up-vaccine indikerede ikke reproduktionstoksicitet (se pkt.
English: Uncommon (affects 1 to 10 users in 1,000): Flu like symptoms
Danish: Ikke almindelig (forekommer hos 1 til 10 brugere ud af 1.000): Influenzalignende symptomer
English: Immunogencity results with two doses of 7.5 µg Focetria H1N1v vaccine from the ongoing clinical trial in adults and elderly are shown below.
Danish: Immunogenicitetsresultater fra det aktuelt igangværende kliniske studier med administration af to doser på 7,5 µg Focetria H1N1v vaccine til voksne og ældre er vist herunder.
English: The vaccine should not be administered intravascularly.
Danish: Vaccinen må ikke indgives intravaskulært.
English: Elderly (>60 years)
Danish: Ældre (>60 år)
English: In addition, from Post-marketing surveillance with seasonal trivalent vaccines in all age groups and with the MF59 adjuvanted seasonal trivalent vaccine with the similar composition of Focetria (surface antigen, inactivated, adjuvanted with MF59C.1), licensed for use in elderly subjects above 65 years of age, the following adverse events have been reported:
Danish: Herudover har bivirkningsovervågning efter markedsføring af sæsonbestemte trivalente vacciner i alle aldersgrupper og med MF59 adjuverede, sæsonbestemte trivalente vacciner med lignende sammensætning som Focetria (overfladeantigen, inaktiveret, adjuveret med MF59C.1) godkendt til ældre forsøgspersoner i alderen 65 år eller derover, rapporteret følgende bivirkninger:
English: • The MAH shall agree with Member States on the provision of a targeted communication to healthcare professionals which should address the following:
Danish: • Indehaveren af markedsføringstilladelsen skal sammen med medlemslandene lave en aftale om informationsmateriale målrettet sundhedspersoner, som skal inkludere:
English: For the adjuvant, see section 2.
Danish: 2 vedrørende adjuvanset.
English: H1N1v to healthy children and adolescents aged 6 months-17 years and to healthy adults,
Danish: H1N1v til raske børn og unge i alderen 6 måneder til 17 år og til raske voksne, inklusive ældre.
English: Lymphadenopathy.
Danish: Lymfadenopati.
English: Quantities are expressed per 0.5 ml vaccine dose.
Danish: Mængderne er angivet pr. 0,5 ml dosis.
English: One dose of 0.5 ml contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in eggs, and adjuvanted with MF59C.1, of strain:
Danish: En dosis på 0,5 ml indeholder: Aktive stoffer: Influenzavirus overfladeantigener (hæmagglutinin og neuraminidase), dyrket i æg og adjuveret med MF59C.1 af følgende stamme:
English: Headache, dizziness, drowsiness, fainting.
Danish: Hovedpine, svimmelhed, sløvhed, besvimelse.