FrancophonIA/ELRC3.0 huggingface dataset:
English: The Western Blot technique disproves the results.
Danish: Western Blot-teknik kan i sådanne tilfælde konfirmere, at der er tale om falsk-positive resultater.
English: narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
Danish: snæver SMF ”Anafylaktisk reaktion” og snæver SMF ”Angioødem”
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome Reporting of suspected adverse reactions
Danish: Neurologiske sygdomme, f.eks. encefalomyelitis, neuritis og Guillain-Barré syndrom.
English: Allergic reactions, including sudden and life-threatening allergic reactions (anaphylaxis), have been reported with a similar H1N1 influenza vaccine (swine flu vaccine) given during a pandemic period.
Danish: Allergiske reaktioner, herunder livstruende allergiske reaktioner (anafylaksi), er rapporteret med tilsvarende H1N1-influenzavaccine (vaccine mod svineinfluenza) indgivet under en pandemisk periode.
English: Rare: neuralgia, transient thrombocytopenia
Danish: Sjælden: Neuralgi, forbigående trombocytopeni.
English: Animal reproductive and developmental toxicity studies with H5N1 strain vaccines (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 development (see section 5.3).
Danish: Dyrestudier af reproduktions- og udviklingstoksicitet med H5N1-vaccinestammer (A/Vietnam/1203/2004 og A/Indonesien/05/2005) indikerer hverken direkte eller indirekte skadelige virkninger hvad angår fertilitet hos hunner, drægtighed, embryonal/føtal udvikling, fødsel eller postnatal udvikling (se pkt.
English: The vaccine should never be given into a vein.
Danish: Denne vaccine må aldrig gives i en vene.
English: If it is necessary to provide immediate protection, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be given at the same time as normal or specific immunoglobulin.
Danish: Hvis dette er nødvendigt for at give omgående beskyttelse, kan PANDEMIC INFLUENZA VACCINE H5N1 BAXTER gives samtidig med normal eller specifik immunoglobulin.
English: • irritation or itching at the injection site, bruising or stiff arm
Danish: • irritation eller kløe på injektionsstedet, blå mærker eller stiv arm
English: Similarly, the A/lndonesia/05/2005 vaccine was efficacious against a heterologous challenge, showing a vaccine dose-dependent survivorship in the vaccinated cohorts as compared to the control cohort.
Danish: A/Indonesien/05/2005-vaccinen var ligeledes effektiv ved heterolog eksponering med en vaccine-dosisafhængig overlevelse hos de vaccinerede kohorter sammenlignet med kontrolkohorten.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 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 PANDEMIC INFLUENZA VACCINE H5N1 BAXTER takes due account of the officially declared pandemic strain.
Danish: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER må kun markedsføres, når der er udstedt en officiel WHO/EU-erklæring om en pandemisk influenza, og på de betingelser som markedsføringstilladelsesindehaveren for PANDEMIC INFLUENZA VACCINE H5N1 BAXTER skal opfylde som følge af den officielt erklærede pandemiske vaccinestamme
English: Month 24 * SRH area ≥ 25 mm² ** MN titre ≥ 20
Danish: Måned 24 * SRH-område ≥ 25 mm² ** MN-titer ≥ 20
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given as an injection into the muscle (usually in the upper arm or upper thigh, depending on the muscle mass).
Danish: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER gives som en injektion i musklen (som regel i overarmen eller øverst på låret afhængigt af muskelmassen).
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)
Danish: Meget almindelig (≥1/10) Almindelig (≥1/100 til <1/10) Ikke almindelig (≥1/1.000 til <1/100) Sjælden (≥1/10.000 til <1/1000)
English: The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80.
Danish: Øvrige indholdsstoffer: Trometamol, natriumchlorid, vand til injektionsvæsker, polysorbat 80.
English: Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed).
Danish: Bivirkninger af speciel interesse, opdelt efter rapporttype (medicinsk bekræftet eller ikke-medicinsk bekræftet).
English: Skin and subcutaneous tissue disorders: angioedema Musculoskeletal and connective tissue disorders: pain in extremity Trivalent seasonal influenza vaccines
Danish: Knogler, led, muskler og bindevæv: Ekstremitetssmerter Trivalente, sæson-influenzavacciner
English: After shaking, the vaccine is an off-white, opalescent, translucent suspension.
Danish: Efter omrystning er vaccinen en råhvid, opaliserende, gennemskinnelig suspension.
English: Cross-reactive immune response against related H5N1 strains In a phase 3 study in adults (N=270) and older subjects (N=272) after vaccination with the A/Vietnam/1203/2004 strain vaccine the rate of subjects with cross-neutralising antibodies as measured by MN (titre ≥ 20) was as follows:
Danish: Krydsreaktivt immunrespons mod beslægtede H5N1-stammer I et fase 3-studie hos voksne (N=270) og ældre personer (N=272) efter vaccination med A/Vietnam/1203/2004-stammen var andelen af personer med krydsneutraliserende antistoffer, målt med MN (titer ≥ 20), følgende:
English: Immune response against the vaccine strain contained in PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (A/Vietnam/1203/2004)
Danish: Immunrespons mod vaccinestammen i PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (A/Vietnam/1203/2004)
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Danish: Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: All ferrets were challenged intranasally on day 35 with a high dose of the highly virulent H5N1 virus strain A/Vietnam/1203/2004 and monitored for 14 days.
Danish: Alle fritter blev eksponeret intranasalt på dag 35 med en stor dosis af den stærkt virulente H5N1 virusstamme A/Vietnam/1203/2004 og overvåget i 14 dage.
English: The vaccine should not be administered intravascularly.
Danish: Vaccinen må ikke gives intravaskulært.
English: The safety of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in pregnancy and lactation has not been assessed in clinical trials.
Danish: Sikkerhed ved PANDEMIC INFLUENZA VACCINE H5N1 BAXTER under graviditet og amning er ikke vurderet i kliniske forsøg.
English: Influenza-like illness
Danish: Influenza-lignende sygdom Brystubehag
English: • if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) contained in the vaccine.
Danish: • hvis du er overfølsom (allergisk) over for et af indholdsstofferne eller sporrester (formaldehyd, benzonase, saccharose) i vaccinen.
English: The vaccine is available as 1 pack containing 20 multidose vials (type I glass) of 5 ml suspension (10 doses).
Danish: Vaccinen fås som 1 pakke med 20 multidosis-hætteglas (type I-glas) a 5 ml suspension (10 doser).
English: 20 multidose vials (10 doses per vial - 0.5 ml per dose)
Danish: 20 multidosishætteglas (10 doser pr. hætteglas - 0,5 ml pr. dosis)
English: • decreased appetite
Danish: • manglende appetit
English: ** ≥ 4-fold increase in MN titer *** geometric mean increase
Danish: ** ≥ 4-dobbelt stigning i MN titer *** geometrisk middelstigning
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, suspension.
English: In a second study, sixty-six ferrets were divided into 6 cohorts of 11 ferrets and were immunized on days 0 and 21 with 3.75 µg or 7.5 µg of the Indonesia vaccine or were sham vaccinated.
Danish: I det andet forsøg blev 66 fritter opdelt i 6 kohorter a 11 fritter og enten immuniseret på dag 0 og dag 21 med 3,75 µg eller 7,5 µg med Indonesien-vaccinen, eller vaccination blev imiteret.
English: 12 - 24 months booster * MN titre ≥ 20
Danish: 12-24 måneders booster * MN-titer ≥ 20
English: PT “Bell's palsy”
Danish: FT ”Bells parese”
English: The A/lndonesia/05/2005 vaccine was shown to be efficacious with 100% survival, reduced incidence of fever, reduced weight loss, reduced virus burden, and reduced haematological (leukopenia and lymphopenia) changes in the vaccinated cohorts following homologous challenge.
Danish: Efter homolog eksponering viste A/Indonesien/05/2005-vaccinen sig at være effektiv med 100 % overlevelse, reduceret forekomst af feber, reduceret vægttab, reduceret virusbyrde og nedsat hæmatologiske (leukopeni og lymfopeni) ændringer hos de vaccinerede kohorter som følge af den homologe eksponering.
English: 21 Days after
Danish: Efter 21 dage
English: - Guillain-Barré syndrome:
Danish: - Guillain-Barré syndrom (GBS):
English: One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber).
Danish: En pakke med 20 multidosishætteglas (type I glas) a 5 ml suspension (10 x 0,5 ml doser) med en prop (brombutylgummi).
English: In the event of either being observed, discard the vaccine.
Danish: Hvis dette forekommer, skal vaccinen kasseres.
English: • Immunoglobulin is not to be given with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Danish: • Immunoglobulin må ikke gives sammen med PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
English: EAR AND LABYRINTH DISORDERS
Danish: ØRE OG LABYRINT Vertigo
English: SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Danish: HUD OG SUBKUTANE VÆV
English: Clinical trials were conducted with this H5N1 vaccine (see section 5.1 for more information on the H5N1 vaccines) in approximately 3500 subjects (ranging in age groups from 18 to 59 years and 60 years and above) and special risk groups of approximately 300 subjects each, consisting of immunocompromised subjects and patients with chronic disease conditions.
Danish: 5.1 for yderligere oplysninger vedrørende H5N1-vacciner) hos ca. 3.500 personer (i aldersgrupperne fra 18 til 59 år og fra 60 år og derover) og hos særlige risikogrupper på ca. 300 personer hver, bestående af immunkompromitterede personer og personer med kroniske sygdomme.
English: The vaccine is available in a single dose pre-filled syringe.
Danish: Vaccinen fås i en enkeltdosis fyldt injektionssprøjte.
English: Trometamol, sodium chloride, water for injections, polysorbate 80
Danish: Trometamol, Natriumchlorid, vand til injektionsvæsker, polysorbat 80
English: NERVOUS SYSTEM DISORDERS
Danish: NERVESYSTEMET
English: 2nd Dose 1st Dose
Danish: 2. dosis 1. dosis
English: Microneutralisation Assay Immunocompromised subjects
Danish: Mikroneutraliseringsanalyse Immunkompromitterede personer
English: • stomach pain, indigestion
Danish: • mavepine, fordøjelsesproblemer
English: Vomiting Diarrhoea
Danish: Opkastning Diarré
English: The following side effects have been reported in clinical studies in children aged 3 to 8 years.
Danish: Der er set følgende bivirkninger i kliniske forsøg med børn i alderen fra 3 til 8 år.
English: Seroprotection*/
Danish: Seroprotektion*
English: Insomnia Sleep disorder
Danish: Søvnløshed Søvnforstyrrelser
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a vaccine used in individuals aged 6 months and older.
Danish: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER er en vaccine, som anvendes til personer i alderen fra 6 måneder og derover.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose syringe (0.5ml)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Enkeltdosis injektionssprøjte (0,5 ml)
English: In one study, sixteen ferrets were divided into two cohorts and were vaccinated on days 0 and 21 with 7.5 µg of the A/Vietnam/1203/2004 vaccine or were sham vaccinated.
Danish: I det ene forsøg blev 16 fritter opdelt i to kohorter og enten vaccineret på dag 0 og dag 21 med 7,5 µg af A/Vietnam/1203/2004-vaccinen eller vaccination blev imiteret.
English: • pain in the armpit
Danish: • smerter i armhulen
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL- SINGLE DOSE PRE-FILLED SYRINGE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET - ENKELTDOSIS FYLDT INJEKTIONSSPRØJTE
English: The vaccine is an off-white, opalescent, translucent suspension.
Danish: Vaccinen er en råhvid, opaliserende, gennemsigtig suspension.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 10-DOSE VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - HÆTTEGLAS MED 10 DOSER
English: In a clinical trial 300 adolescents aged 9 to 17 years and 153 children aged 3 to 8 years were administered the H5N1 vaccine.
Danish: I et klinisk forsøg blev H5N1-vaccinen givet til 300 unge i alderen fra 9 til 17 år og til 153 børn i alderen fra 3 til 8 år.
English: per 0.5 ml dose * produced in Vero cells ** haemagglutinin
Danish: pr. 0,5 ml dosis * produceret i vero-celler ** hæmagglutinin
English: The ferrets were challenged intranasally on day 35 with a high dose of either the clade 2 H5N1 virus A/Indonesia/05/2005 or the clade 1 H5N1 virus A/Vietnam/1203/2004 and monitored for 14 days.
Danish: Fritterne blev eksponeret intranasalt på dag 35 med en stor dosis af enten stamme 2 H5N1 virus A/Indonesien/05/2005 eller stamme 1 H5N1-virus A/Vietnam/1203/2004 og overvåget i 14 dage.
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 Multidosishætteglas (10 doser af 0,5 ml per hætteglas)
English: • sleep disorder
Danish: • søvnforstyrrelser
English: Information from non-clinical studies
Danish: Information fra prækliniske forsøg
English: The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years.
Danish: Der er set følgende bivirkninger i kliniske forsøg med unge i alderen fra 9 til 17 år.
English: Seroneutralisation rate* Seroconversion rate** Seroconversion factor*** * MN titre ≥ 20 ** ≥ 4-fold increase in MN titre *** geometric mean increase
Danish: Seroneutraliseringsværdi* Serokonversionværdi** Serokonversionsfaktor*** * MN-titer ≥ 20 ** ≥ 4-dobbelt stigning i MN titer *** geometrisk middelstigning
English: Like all medicines, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can cause side effects, although not everybody gets them.
Danish: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER after the expiry date which is stated on the carton.
Danish: Brug ikke PANDEMIC INFLUENZA VACCINE H5N1 BAXTER efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: * produced in Vero cells ** haemagglutinin
Danish: * produceret i vero-celler ** hæmagglutinin
English: Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Danish: Sjælden (≥1/10.000 til <1/1000) Meget sjælden (<1/10.000)
English: Seroneutralisation rate*
Danish: Seroneutraliseringsværdi*
English: There is no information on the use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER under the skin.
Danish: Der findes ingen oplysninger om indgift af PANDEMIC INFLUENZA VACCINE H5N1 BAXTER under huden.
English: PSYCHIATRIC DISORDERS
Danish: PSYKISKE FORSTYRRELSER
English: Trometamol Sodium chloride Water for injections Polysorbate 80
Danish: Natriumchlorid Vand til injektionsvæsker Polysorbat 80
English: The immunogenicity of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain A/Vietnam/1203/2004) has been evaluated in three clinical studies in adults aged 18 - 59 years (N=961) and in older subjects aged 60 years and older (N=391) following a 0, 21 day schedule.
Danish: Immunogeniciteten af PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (stamme A/Vietnam/1203/2004) er blevet vurderet i tre kliniske studier med voksne på 18-59 år (N=961) og ældre personer på 60 år og derover (N=391), der blev vaccineret på dag 0 og dag 21.
English: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Danish: ALMENE SYMPTOMER OG REAKTIONER PÅ ADMINISTRATIONSSTEDET
English: After first opening, the medicinal product should be used immediately.
Danish: Lægemidlet skal anvendes omgående, når hætteglasset først er åbnet.
English: Contents of the pack and other information What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER contains Active substance:
Danish: Pakningsstørrelser og yderligere oplysninger PANDEMIC INFLUENZA VACCINE H5N1 BAXTER indeholder: Aktivt stof:
English: • flu-like illness
Danish: • influenza-lignende sygdom
English: The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in a clinical trial in children and adolescents aged 9 to 17 years (N=288), in children aged 3 to 8 years (N=146) and in infants and children aged 6 to 35 months (N=33) following a 0, 21 day schedule.
Danish: Immunogeniciteten af vaccine med A/Vietnam/1203/2004-stamme er blevet vurderet i et klinisk studie med børn og unge i alderen fra 9 til 17 år (N=288), med børn i alderen fra 3 til 8 år (N=146) og med spædbørn og børn i alderen fra 6 til 35 måneder (N=33), der blev vaccineret på dag 0 og dag 21.
English: The vaccine is available in a multidose container (see section 6.5 for the number of doses per vial).
Danish: Vaccinen fås i et hætteglas med flere doser (se antal doser pr. hætteglas under pkt.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is an off-white, opalescent, translucent liquid.
Danish: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER er en råhvid, opaliserende, gennemsigtig væske.
English: The use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be considered during pregnancy if this is thought to be necessary, taking into account official recommendations.
Danish: Hvis det anses for nødvendigt, kan administration af PANDEMIC INFLUENZA VACCINE H5N1 BAXTER overvejes under graviditet under hensyntagen til de officielle anbefalinger.
English: An overview for all spontaneous cases per country, stratified according to type of report (medically confirmed or non-medically confirmed) and seriousness, for the period covered by the report and cumulatively.
Danish: En oversigt over alle spontane hændelser per land, opdelt efter rapporttype (medicinsk bekræftet eller ikke-medicinsk bekræftet) og alvorlighed, for perioden, som dækkes af rapporten, og kumuleret.
English: Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Danish: Pandemisk influenzavaccine (H5N1) (hel virion, inaktiveret, fremstillet i cellekultur)
English: Antibody persistence after vaccination with the 7.5 µg non-adjuvanted formulation of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain A/Vietnam/1203/2004) has been evaluated in a clinical study in adults aged 18 - 59 years and subjects aged 60 years and above at 6 months, 12 - 15 months and 24 months after the start of the primary vaccination series.
Danish: Antistoffets persistens efter vaccination med 7,5 µg ikke-adjuveret formulering af PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (stamme A/Vietnam/1203/2004) er blevet vurderet i et klinisk studie hos voksne i alderen 18-59 og personer på 60 og derover 6 måneder, 12-15 måneder og 24 måneder efter start af den primære vaccinationsserie.
English: PSYCHIATRIC DISORDERS Insomnia
Danish: PSYKISKE FORSTYRRELSER Søvnløshed
English: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Danish: LUFTVEJE, THORAX OG MEDIASTINUM
English: Injection Site Reactions
Danish: Reaktioner på injektionsstedet
English: - Encephalitis:
Danish: - Encefalitis:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE
Danish: MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - FYLDT INJEKTIONSSPRØJTE
English: • pain at the injection site
Danish: • smerte ved injektionsstedet
English: Immune system disorders: anaphylactic reaction, hypersensitivity
Danish: Immunsystemet: Anafylaktisk reaktion, overfølsomhed Nervesystemet: Krampeanfald
English: One single dose pre-filled syringe (containing 0.5ml suspension)
Danish: En fyldt injektionssprøjte med en enkelt injektion (indeholder 0,5 ml suspension)
English: • abnormal, reduced sensation
Danish: • unormal, nedsat følesans
English: Seroneutralization rate* Seroconversion rate** Seroconversion factor***
Danish: Seroneutraliseringsværdi* Serokonversionværdi** Serokonversionsfaktor***
English: The following side effects have been reported in a clinical study in infants aged 6 to 35 months.
Danish: Der er set følgende bivirkninger i kliniske forsøg med spædbørn i alderen fra 6 til 35 måneder.
English: The active substance and other ingredients in PANDEMIC INFLUENZA VACCINE H5N1 BAXTER are listed in section 6 at the end of the leaflet.
Danish: Det aktive stof og de øvrige indholdsstoffer i PANDEMIC INFLUENZA VACCINE H5N1 BAXTER er anført på en liste under pkt.
English: Very common (affects more than 1 in 10 vaccinees):
Danish: Meget almindelig (forekommer hos flere end 1 ud af 10 brugere):
English: • sudden hearing loss, ear pain
Danish: • pludseligt høretab, ørepine
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under ‘exceptional circumstances'.
Danish: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER er godkendt under ”særlige omstændigheder”.
English: One pack of 1 single dose pre-filled syringe (type I glass) containing 0.5 ml suspension for injection, with a latex-free plunger stopper (halogeno-butyl rubber) with or without needles.
Danish: En pakke med 1 fyldt injektionssprøjte (type I glas) med en enkelt dosis a 0,5 ml injektionsvæske, suspension med en latexfri stempelprop (halogenbutylgummi) med eller uden nåle.
English: Common (affects 1 to 10 in 100 vaccinees):
Danish: Almindelig (forekommer hos mellem 1 og 10 ud af 100 brugere):
English: - Bell's palsy:
Danish: - Bells parese:
English: The vaccine is available or as 1 pack of 1 single dose pre-filled syringe (type I glass) containing 0.5 ml suspension for injection with a latex-free plunger stopper (halogeno-butyl rubber) with or without needles.
Danish: Vaccinen fås som 1 pakke med 1 fyldt injektionssprøjte (type I glas) med en enkelt dosis a 0,5 ml injektionsvæske, suspension med en latexfri stempelstopper (halogenbutylgummi) med eller uden nåle.
English: • bruising at the injection site
Danish: • kløe på injektionsstedet
English: • hardness, redness, swelling or minor bleeding at the injection site
Danish: • hårdhed, rødme, hævelse eller mindre blødning ved indsprøjtningsstedet
English: • PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should under no circumstances be administered intravascularly.
Danish: • PANDEMIC INFLUENZA VACCINE H5N1 BAXTER må under ingen omstændigheder indgives intravaskulært.
English: Conjunctivitis Eye irritation
Danish: Konjunktivitis Øjenirritation
English: • reduced blood pressure, feeling faint (syncope)
Danish: • nedsat blodtryk, besvimelse eller følelse af at skulle besvime
English: Non-clinical studies demonstrated minor alterations in liver enzymes and calcium levels in a repeat dose toxicity study in rats.
Danish: I et præklinisk toksicitetsstudie med gentagen dosering hos rotter blev der påvist mindre ændringer i leverenzymer og calciumniveauer.
English: MARKETING AUTHORIZATION HOLDER
Danish: Indehaver af markedsføringstilladelsen:
English: Uncommon (affects 1 to 10 in 1,000 vaccinees):
Danish: Ikke almindelig (forekommer hos mellem 1 og 10 ud af 1000 brugere):
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION PANDEMIC INFLUENZA VACCINE H5N1 BAXTER suspension for injection Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) I.M.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) PANDEMIC INFLUENZA VACCINE H5N1 BAXTER injektionsvæske, suspension Pandemisk influenzavaccine (H5N1) (hel virion, inaktiveret, fremstillet i cellekultur) i.m.
English: What you need to know before you are vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Danish: Det skal du vide, før du vaccineres med PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as immunoglobulins.
Danish: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER bør ikke gives samtidig med immunoglobuliner.