FrancophonIA/ELRC3.0 huggingface dataset:
English: There are very limited safety and immunogenicity data available on the administration of an AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) and on administration of half a dose of the vaccine (i.e. 1.875 µg HA and half the amount of AS03 adjuvant) at 0 and 21 days in children aged 3 to 9 years.
Danish: Der er meget begrænsede sikkerheds- og immunogenicitetsdata tilgængelige for administration af en AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) og for administration af halv vaccinedosis (dvs. 1,875 μg HA og halv mængde AS03-adjuvans) på dag 0 og dag 21 til børn i alderen 3-9 år.
English: Very limited data in seronegative subjects >80 years of age (N=5) showed that no subject achieved seroprotection following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1).
Danish: Meget begrænsede data for seronegative personer > 80 år (n = 5) viste, at ingen personer opnåede serobeskyttelse efter administration af to enkeltdoser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1).
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Danish: Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
English: An extended dosing interval was investigated in study D-H5N1-012 in which a group of subjects 1860 years of age received two doses of Prepandrix containing the A/Vietnam/1194/2004 strain 6 months or 12 months apart.
Danish: Et forlænget doseringsinterval blev undersøgt i studie D-H5N1-012, i hvilket en gruppe personer i alderen 18-60 år modtog to doser af Prepandrix, som indeholdt A/Vietnam/1194/2004 virusstammen, med 6 måneders eller 12 måneders interval.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN GlaxoSmithKline Biologicals s.a.
English: The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections
Danish: Polysorbat 80, octoxinol 10, thiomersal, natriumchlorid, dinatriumhydrogenphosphat, kaliumdihydrogenphosphat, kaliumchlorid, magnesiumchlorid, vand til injektionsvæsker
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Split influenzavirus, inaktiveret, indeholdende antigen* svarende til 3,75 mikrogram hæmagglutinin/dosis *Antigen: A/Indonesia/05/2005 (H5N1)-lignende stamme (PR8-IBCDC-RG2)
English: 2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
Danish: 2 firdobbelt stigning i serumneutraliserende antistoftiter 3 andel af personer, som opnåede en serumneutraliserende antistoftiter på mindst 1:80
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Prepandrix
Danish: LÆGEMIDLETS NAVN Emulsion til Prepandrix injektionsvæske, emulsion
English: Seroprotection rate
Danish: Seroprotektionsrate1
English: One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
Danish: En pakke indeholder: - en pakke med 50 hætteglas (type I-glas) hver indeholdende 2,5 ml suspension og forsynet med prop (butylgummi).
English: The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
Danish: Seroprotektionsraten mod A/Indonesia var 92 % 21 dage efter boostervaccination og 69,2 % på dag
English: 21 days after 2nd dose N=48
Danish: 21 dage efter anden dosis n = 48
English: It is recommended to equip the syringe with a 23-G needle.
Danish: Det anbefales at bruge en 23-G kanyle på sprøjten.
English: In a clinical study, children 3 to 9 years of age have received either two adult (0.5 ml) or two half adult (0.25 ml) doses of a similar vaccine containing A/Vietnam/1194/2004.
Danish: Børn i alderen 3-9 år har i et klinisk studie fået enten to voksendoser (0,5 ml) eller to halve voksendoser (0,25 ml) af en tilsvarende vaccine indeholdende A/Vietnam/1194/2004.
English: What Prepandrix is and what it is used for What you need to know before you receive Prepandrix How Prepandrix is given
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Prepandrix Sådan får du Prepandrix Bivirkninger
English: After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25°C.
Danish: Efter sammenblandingen, skal den færdige vaccine indspøjtes inden for 24 timer og må ikke opbevares over 25 °C.
English: Double dose (N=131)
Danish: dosis (n = 131)
English: The anti-HA and neutralising antibody responses to A/Indonesia/05/2005 elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from this same strain have been shown to be comparable with the immune responses to A/Vietnam/1194/2004 elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from this same strain.
Danish: Anti-HA og neutraliserende antistofrespons mod A/Indonesia/05/2005 fremkaldt af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra den samme stamme er vist at være sammenlignelig med immunresponset mod A/Vietnam/1194/2004 fremkaldt af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra denne samme stamme.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Prepandrix
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Adjuvans, emulsion til Prepandrix i.m.
English: 21 days after 1st dose N=55
Danish: 21 dage efter første dosis n = 55
English: Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the seroprotection rates against A/Indonesia were >80% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against A/Vietnam were >90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Danish: Uanset om der var blevet givet en eller to primære vaccinedoser 6 måneder tidligere, var seroprotektionsraterne > 80 % mod A/Indonesia efter en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 og seroprotektionsraterne > 90 % mod A/Vietnam efter en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005.
English: In the first few weeks after vaccination with Prepandrix the results of these tests may not be correct.
Danish: En sådan blodprøve kan vise et forkert resultat i de første få uger efter vaccination med Prepandrix.
English: Immune response to A/Vietnam/1194/2004 3-5 years 21 days after 2nd dose 6 months after vaccination
Danish: Immunrespons mod A/Vietnam/1194/2004 3-5 år 21 dage efter anden dosis 6 måneder efter vaccination
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 May 2008
Danish: DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: How to store Prepandrix
Danish: Sådan får du Prepandrix
English: Tell your doctor if you have any known allergies.
Danish: Fortæl lægen, hvis du ved, at du er overfølsom over for andre ting.
English: Clinical studies have evaluated the incidence of adverse reactions in approximately 5,000 subjects 18 years old and above who received Prepandrix containing A/Vietnam/1194/2004 (H5N1) strain with at least 3.75 µg HA.
Danish: Bivirkninger er blevet vurderet i kliniske studier med ca. 5.000 personer på 18 år og derover, som fik Prepandrix indeholdende mindst 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1)-stammen.
English: There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old children.
Danish: Hverken hos børn, som fik halv voksendosis, eller hos børn, der fik fuld voksendosis, blev der set nogen stigning i forekomsten af bivirkninger efter anden dosis, bortset fra nogle bivirkninger, hvor forekomsten var højere efter anden dosis, især hyppigheden af feber hos børn < 6 år.
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 listed in section 6.1, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Danish: Der skal udvises forsigtighed, når vaccinen gives til personer med kendt overfølsomhed (ud over anafylaktisk reaktion) over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt 6.1, over for thiomersal og reststoffer (æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat og natriumdeoxycholat).
English: Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1)
Danish: Administration af en AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1)
English: Double dose (N=81)
Danish: dosis (n = 81)
English: 2.5 ml After mixing with adjuvant emulsion: 10 doses of 0.5 ml)
Danish: 2,5 ml Efter sammenblanding med adjuvans, emulsion: 10 doser a 0,5 ml
English: Therefore, the data that have been generated with AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 are considered to be relevant to the use of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Danish: Data fra AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 er derfor relevant for anvendelsen af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005.
English: In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) in subjects 18-60 years old, the anti-haemagglutinin (anti-HA) antibody responses were as follows:
Danish: I kliniske immunogenicitetsstudier med AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) hos personer i alderen 18-60 år er følgende anti-hæmagglutinin (antiHA)-antistofrespons set:
English: After two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses to A/Vietnam/1194/2004 were as follows:
Danish: Efter administration af to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 på dag 0 og 21 til 140 personer i alderen 18-60 år var anti-HA-antistof-responset mod A/Vietnam/1194/2004 følgende:
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer):
English: A clinical study (D-H5N1-009) evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of pandemic preparedness vaccine (H5N1 A/Vietnam/1194/2004 manufactured in Dresden, Germany).
Danish: I et klinisk studie (D-H5N1-009) blev reaktogeniciteten evalueret hos børn i alderen 3-5 år og 6-9 år, som havde fået enten to voksendoser (0,5 ml) eller to halve voksendoser (0,25 ml) (med 21 dages interval) af pandemisk beredskabsvaccine (H5N1 A/Vietnam/1194/2004 fremstillet i Dresden, Tyskland).
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts such as: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
Danish: • hvis du tidligere har haft en pludselig, livstruende, overfølsomhedsreaktion mod et af indholdsstofferne i denne vaccine (angivet i punkt 6) eller over for andre stoffer, som kan være til stede i meget små mængder f.eks. æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat (antibiotikum) eller natriumdeoxycholat.
English: The suspension and emulsion vials once mixed form a multidose container.
Danish: Efter sammenblanding af suspension og emulsion fra hætteglassene fremkommer en vaccine i en flerdosisbeholder.
English: % of subjects reaching a serum neutralising antibody titre of at least 1:80
Danish: andel af personer, som opnåede en serumneutraliserende antistoftiter på mindst 1:80
English: Immune response against A/Indonesia/05/2005 (H5N1) In a clinical study (Q-Pan-H5N1-001) in which two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 were administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses were as follows: anti-HA antibody
Danish: Immunrespons mod A/Indonesia/05/2005 (H5N1) I et klinisk studie (Q-Pan-H5N1-001), hvor 140 personer i alderen 18-60 år fik to doser AS03adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 på dag 0 og 21, var anti-HAantistofresponset følgende: anti-HA-antistof
English: Shivering NA=not available
Danish: Irritabilitet Appetitløshed Kulderystelser - = ikke tilgængelig
English: One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004.
Danish: En dosis AS03-adjuveret vaccine indholdende 3,75 μg HA fra A/Indonesia/05/2005 administreret efter en eller to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004
English: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) I.M.
Danish: A/Indonesia/05/2005 (H5N1)-lignende stamme (PR8-IBCDC-RG2) i.m.
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Danish: Tidligere anafylaktisk (dvs. livstruende) reaktion over for et eller flere af stofferne eller over for spor af reststoffer (æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat og natriumdeoxycholat) i denne vaccine.
English: Seropositivity rate2
Danish: GMT1 Seropositivitetsrate2
English: - two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
Danish: - to pakker med 25 hætteglas (type I-glas) hver indeholdende 2,5 ml emulsion og forsynet med prop (butylgummi)
English: In the subjects aged 3 to 5 and 6 to 9 years old who received two doses of either a full or a half dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1), the anti-HA antibody responses against A/Indonesia/5/2005 at day 42 were as follows:
Danish: Hos børn i aldersgrupperne 3-5 år og 6-9 år, som fik enten to fulde doser eller to halve doser AS03adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1), var anti-HAantistofresponset mod A/Indonesia/5/2005 på dag 42 følgende:
English: Cross-reactive immune response elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1)
Danish: Krydsreaktionsimmunrespons fremkaldt af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 (H5N1)
English: In a second study, 49 subjects aged 18-60 years received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 on days 0 and 21.
Danish: I et andet studie fik 49 personer i alderen 18-60 år to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 på dag 0 og 21.
English: Very rare: may affect up to 1 in 10,000 people
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer):
English: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 3.75 micrograms** per 0.5 ml
Danish: A/Indonesia/05/2005 (H5N1)-lignende stamme (PR8-IBCDC-RG2) 3,75 mikrogram** pr. 0,5 ml
English: Subjects of D-Pan-H5N1-009 were followed up for persistence of the immune response.
Danish: Personerne i studie D-Pan-H5N1-009 blev fulgt og undersøgt for et vedvarende immunrespons.
English: Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Danish: Prepandrix suspension og emulsion til injektionsvæske, emulsion Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
English: • if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Danish: • hvis du har haft andre overfølsomhedsreaktioner end den pludselige, livstruende overfølsomhedsreaktion, over for et af indholdsstofferne i denne vaccine (angivet i punkt 6) eller over for thiomersal, æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat (antibiotikum) eller natriumdeoxycholat.
English: The seroprotection rates 6, 12, 24 and 36 months after the first dose were as follows: anti-HA antibody
Danish: Seroprotektionsraten 6, 12, 24 og 36 måneder efter første dosis var følgende:
English: Rare: may affect up to 1 in 1,000 people
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer):
English: Skin and subcutaneous tissue disorders Common: ecchymosis at the injection site, sweating increased Uncommon: pruritus, rash
Danish: Almindelig: blodudtrædninger i huden ved administrationsstedet, øget svedtendens Ikke almindelig: hudkløe, udslæt
English: Month 6 N=48
Danish: måned n = 48
English: Common: may affect up to 1 in 10 people
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer):
English: GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkusstraße 40, D-01069 Dresden Germany
Danish: KG Zirkusstraße 40, D-01069 Dresden Tyskland
English: Seroprotection rate1 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Danish: Seroprotektionsrate1 1seroprotektionsrate: andelen af personer med hæmagglutinationshæmnings (HI) titer ≥ 1:40
English: In other clinical studies where children 6 months to 17 years received Prepandrix, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
Danish: Stigninger i hyppigheden af visse bivirkninger (herunder smerte ved administrationsstedet, rødme og feber) efter anden dosis til børn under 6 år blev observeret i andre kliniske studier, hvor børn fra 6 måneder til 17 år fik Prepandrix.
English: Month 6 N=40
Danish: måned n = 40
English: NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Prepandrix Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Danish: Suspension til Prepandrix injektionsvæske, emulsion Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
English: Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1):
Danish: Krydsreaktionsimmunrespons fremkaldt af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1)
English: Induration
Danish: Amning
English: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30 Finland.tuoteinfo@gsk.com
Danish: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Danish: 1seroprotektionsrate: andelen af personer med hæmagglutinationshæmnings (HI) titer ≥ 1:40
English: In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21.
Danish: I et klinisk studie (D-Pan-H5N1-012) fik personer i alderen 18-60 år en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra enten A/Vietnam/1194/2004 eller Indonesia/05/2005 6 måneder efter administration af en eller to primære doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 på henholdsvis dag 0 eller dag 0 og 21.
English: In another clinical study (D-Pan-H5N1-015), 39 subjects aged 18-60 years received a dose of AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
Danish: I et andet klinisk studie (D-Pan-H5N1-015) fik 39 personer i alderen 18-60 år en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 fjorten måneder efter at have modtaget to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 på dag 0 og 21.
English: If you are not sure, talk to your doctor or nurse before having this vaccine.
Danish: Spørg lægen eller sundhedspersonalet, hvis der er noget, du er i tvivl om, før du får denne vaccine.
English: NAME OF THE MEDICINAL PRODUCT Prepandrix suspension and emulsion for emulsion for injection.
Danish: Prepandrix suspension og emulsion til injektionsvæske, emulsion.
English: • Itching, rash
Danish: • Kløen, udslæt
English: Single dose (N=86)
Danish: (n = 86)
English: In clinical trials in which subjects (N=201) received Prepandrix containing 3.75 microgram HA/AS03 of A/Indonesia/05/2005 (H5N1) strain, the types and frequencies of adverse reactions were comparable with those reported below.
Danish: Tilsvarende bivirkninger og hyppigheder, som anført nedenfor, er set i kliniske studier med personer (n = 201), som fik Prepandrix indeholdende 3,75 μg HA/AS03 fra A/Indonesia/05/2005 H5N1stammen.
English: PHARMACEUTICAL FORM AND CONTENTS Suspension and emulsion for emulsion for injection 50 vials: suspension (antigen)
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Suspension og emulsion til injektionsvæske, emulsion.
English: • Feeling tired
Danish: Induration Smerter
English: In a clinical study (D-Pan-H5N1-009), children aged 3 to 5 and 6 to 9 years old received two doses of either a full (0.5 ml) or a half dose (0.25 ml) of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Danish: I et klinisk studie (D-Pan-H5N1-009) med AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) fik børn i alderen 3-5 år og 6-9 år administreret fuld dosis (0,5 ml) på dag 0 og dag 21 eller administreret halv dosis (0,25 ml) på dag 0 og dag 21.
English: - This vaccine has been prescribed for you only.
Danish: Lægemidlet er receptpligtigt.
English: PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Adjuvans, emulsion til injektionsvæske.
English: 24 months after the 1st dose
Danish: 24 måneder efter første dosis n = 411
English: Uncommon: may affect upt o 1 in 100 people
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer):
English: Tell the doctor requesting these tests that you have recently received Prepandrix.
Danish: - Lægen har ordineret Prepandrix til dig personligt.
English: It should be given at the same time each day.
Danish: Det bør gives samme tid hver dag.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ganfort on 19 May 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ganfort den 19. maj 2006.
English: The values were lowered by about 8-10 mmHg.
Danish: Værdierne blev reduceret med cirka 8-10 mmHg.
English: This is a summary of the European public assessment report (EPAR) for Ganfort.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ganfort.