FrancophonIA/ELRC3.0 huggingface dataset:
English: On the basis of the scientific conclusions for Pumarix, the CHMP is of the opinion that the benefitrisk balance of the medicinal product containing the active substance purified antigen fractions of inactivated split virion A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2 is favourable subject to the proposed changes to the product information.
Danish: På grundlag af de videnskabelige konklusioner for Pumarix, er CHMP af den opfattelse, at forholdet mellem fordele og ricisi for lægemidlet, der indeholder det aktive stof oprensede antigen fraktioner af inaktiveret split virion A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2, er gunstigt, underlagt de
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG
English: In a consistency study (Q-Pan-H5N1-002), the anti-haemagglutinin (anti-HA) antibody responses twenty-one days and six months after the second dose were as follows:
Danish: I et konsistensstudie (Q-Pan-H5N1-002) var anti-hæmagglutinin (anti-HA)-antistofresponset henholdsvis 21 dage og 6 måneder efter anden dosis følgende:
English: No post-marketing surveillance data are available following Pumarix administration.
Danish: Der findes ingen data fra overvågning efter markedsføring for Pumarix.
English: Immune response to A/Indonesia/5/2005 Day 42 N=145
Danish: Immunrespons mod A/Indonesia/5/2005 dag 42 n = 145
English: The vaccine should be administered in accordance with the recommended posology (see section 3.
Danish: Vaccinen skal administreres i overensstemmelse med den anbefalede dosering (se pkt.
English: Adverse Events of Special Interest (PTs)
Danish: Særlige bivirkninger af speciel interesse (foretrukne termer) 3.
English: Adjuvants are used to improve the body's response to the vaccine.
Danish: Adjuvans bruges til at øge kroppens
English: In a clinical study (Q-Pan-H5N1-010), a booster dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 was given 15 months after primary vaccination.
Danish: I et klinisk studie (Q-Pan-H5N1-010) blev en boosterdosis AS03-adjuveret vaccine indeholdende 3,75 µg HA fra A/Turkey/Turkey/1/2005 administreret 15 måneder efter den primære vaccination.
English: Your doctors know that this might happen and will have emergency treatment
Danish: Din læge er opmærksom på dette og har et nødberedskab klart i sådanne
English: This is because the vaccination may not be recommended, or may need to be delayed.
Danish: Det er ikke sikkert, at du skal vaccineres, eller måske skal
English: In the first few weeks after vaccination with Pumarix 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 Pumarix.
English: A 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was achieved in 44.7% of subjects at day 21, 53.2% at day 42 and 38.3% at day 180.
Danish: En firdobbelt stigning i serum-neutraliserende antistof mod A/Vietnam/1194/2004 blev opnået hos 44,7 % af personerne på dag 21, hos 53,2 % af personerne på dag 42 og hos 38,3 % af personerne på dag 180.
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) manufactured using a different process and on administration of half a dose of the same 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 tilgængelig for administration af AS03adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) (fremstillet ved en anden proces) og for administration af en halv voksendosis af samme vaccine (1,875 μg HA og halv mængde AS03-adjuvans) på dag 0 og dag 21 til børn i aldersgruppen 3-9 år.
English: • They will give Pumarix as an injection into a muscle
Danish: Lægen eller sygeplejersken vil give Pumarix som en indsprøjtning i en muskel.
English: Grounds recommending the variation to the terms of the Marketing Authorisation
Danish: Begrundelser for at anbefale variationen af markedsføringstilladelsen
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Danish: Vaccinationen skal gives som intramuskulær injektion fortrinsvis i musculus deltoideus eller i det
English: In subjects > 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (58.0%), muscle aches (19.7%), fatigue (13.5%), headache (12.4%) and joint pain
Danish: Hos personer over 64 år var de hyppigst rapporterede bivirkninger efter vaccination smerter på injektionsstedet (58,0 %), muskelsmerter (19,7 %), træthed (13,5 %), hovedpine (12,4 %) og ledsmerter
English: It is recommended to equip the syringe with a needle gauge not larger than 23
Danish: Det anbefales, at bruge en kanylestørrelse der ikke er større end 23-G.
English: Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 (H5N1):
Danish: Krydsreaktions-immunrespons fremkaldt af AS03-adjuveret vaccine, som indeholder 3,75 μg HA fra A/Indonesia/05/2005 (H5N1):
English: In the consistency study (Q-Pan-H5N1-002), a 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was at day 42 achieved in 65.5% of subjects aged 18-60 years and in 24.1% of subjects over 60 years of age.
Danish: I konsistensstudiet (Q-Pan-H5N1-002) blev der på dag 42 opnået en firdobbelt stigning i serumneutraliserende antistof mod A/Vietnam/1194/2004 hos 65,5 % af personerne i alderen 18-60 år og hos 24,1 % af personerne over 60 år.
English: In another clinical study (Q-Pan-H5N1-001), anti-HA responses against A/Vietnam/1194/2004 following administration of AS03-adjuvanted vaccine containing 3.75 µg derived from A/Indonesia/5/2005 were as follows:
Danish: I et andet klinisk studie (Q-Pan-H5N1-001) var anti-HA-responset mod A/Vietnam/1194/2004 efter administration af AS03-adjuveret vaccine, som indeholder 3,75 µg HA fra A/Indonesia/05/2005 følgende:
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Danish: Hvis samtidig administration af andre vacciner påtænkes, skal det ske i anden ekstremitet.
English: There is no information available on use in children aged less than 3 years or aged from 10-17 years.
Danish: Der findes ikke nogen information om vaccination af børn under 3 år eller i
English: 4.7 Effects on ability to drive and use machines Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner Nogle af de bivirkninger, der er nævnt i pkt.
English: Common: redness at the injection site, swelling at the injection site, fever, shivering Uncommon: injection site reactions (such as bruising, induration, pruritus, warmth), asthenia, chest
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: smerter ved administrationsstedet, træthed Almindelig: rødme ved administrationsstedet, hævelse ved administrationsstedet, feber, kuldegysninger Ikke almindelig: reaktioner ved administrationsstedet (f.eks. blå mærker, induration, kløe, varme),
English: Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) manufactured using a different process Paediatric population
Danish: Administration af AS03-adjuveret vaccine, som indeholder 3,75 µg HA fra A/Vietnam/1194/2004 (H5N1), som er fremstillet ved en anden proces
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 another Pandemic influenza 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 to voksendoser (a 0,5 ml med 21 dages mellemrum) eller to halve voksendoser (a 0,25 ml med 21 dages mellemrum) af en anden pandemisk vaccine (H5N1 A/Vietnam/1194/2004 fremstillet i Dresden, Tyskland).
English: See section 6.5 for the
Danish: 5.1 for
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), hvert indeholdende 2,5 ml suspension og forsynet med prop (butylgummi).
English: The suspension and emulsion, once mixed, form a multidose vaccine in a vial.
Danish: Når suspension og emulsion er sammenblandet, fås en flerdosisvaccine i et hætteglas.
English: Fainting can occur following, or even before, any needle injection.
Danish: Besvimelse kan opstå (overvejende hos unge) efter og endda før vaccination med nål.
English: However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be
Danish: Hvis samtidig vaccination med andre vacciner er nødvendigt, vil vaccinerne blive givet i hver sin arm. Du skal være opmærksom på, at
English: In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing four different doses of H5N1 antigen (3.75, 1.5, 0.6 and 0.24 µg of HA antigen) adjuvanted with half dose of AS03.
Danish: I dette forsøg, omhandlende beskyttelse, blev fritter (seks fritter pr. gruppe) immuniseret intramuskulært med en vaccinekandidat, som indeholder fire forskellige doser H5N1-antigen (3,5, 1,5, 0,6 og 0,24 µg HA-antigen) adjuveret med halv dosis AS03.
English: In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing three different doses of H5N1 antigen (7.5, 3.8 and 1.9 µg of HA antigen) adjuvanted with the standard dose or half dose of AS03.
Danish: I dette forsøg, omhandlende beskyttelse, blev fritter (seks fritter pr. gruppe) immuniseret intramuskulært med en vaccinekandidat, som indeholder tre forskellige doser H5N1-antigen (7,5; 3,8 og 1,9 µg HAantigen) adjuveret med standarddosis eller halv dosis AS03.
English: When a dose of 0.5 ml of a similar vaccine was given to children aged 3-9 years, fever occurred more often than when half of this dose (0.25 ml of vaccine) was given.
Danish: Hos børn i alderen 3-9 år var feber mere udbredt ved vaccination med en voksendosis (0,5 ml) end ved vaccination med en halv voksendosis (0,25 ml).
English: Clinical studies have evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 in subjects from the age of 18 years onwards following a 0, 21 days schedule.
Danish: Kliniske studier har vurderet immunogeniciteten af AS03-adjuveret vaccine, som indeholder 3,75 µg HA fra A/Indonesia/05/2005 hos personer i alderen 18 år og derover, efter vaccination på dag 0 og dag
English: During the pandemic, the applicant will conduct a surveillance on the safety of the vaccine during
Danish: Under en pandemi er ansøgeren af markedsføringstilladelsen forpligtet til at overvåge sikkerheden af den pandemiske vaccine ved brug under graviditet ved hjælp af et graviditetsregister
English: Clinical studies have evaluated the incidence of adverse reactions in approximately 4,500 subjects 18 years old and above who received Pumarix or placebo.
Danish: Forekomsten af bivirkninger er evalueret i kliniske studier med ca. 4.500 personer på 18 år eller
English: Ear and labyrinth disorders Uncommon: vertigo
Danish: Ikke almindelig: vertigo
English: This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Danish: Denne adjuvans består af squalen (10,69 mg), DL-αtocopherol (11,86 mg) og polysorbat 80 (4,86 mg).
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 or sodium deoxycholate.
Danish: • hvis du tidligere har haft en pludselig, livstruende overfølsomhedsreaktion (allergisk reaktion) over for det aktive stof eller et af de øvrige indholdsstoffer i denne vaccine (angivet i punkt 6), eller over for andre stoffer, som kan være til stede i meget små mængder: ægge- og kyllingeprotein, ovalbumin, formaldehyd eller natriumdeoxycholat.
English: Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
Danish: Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
English: Pumarix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Danish: Suspension til Pumarix injektionsvæske, emulsion Pandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
English: The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Danish: Sygdomstegnene ved en pandemisk influenza er de samme som ved en almindelig
English: Adverse reactions from clinical trials with the mock-up vaccine are listed here below (see section 5.1 for more information on mock-up vaccines).
Danish: Bivirkninger set i de kliniske studier med mock-up-vaccinen er anført nedenfor (se pkt.
English: One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 administered after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from Indonesia/5/2005
Danish: En dosis AS03-adjuveret vaccine, som indeholder 3,75 μg HA fra A/Turkey/Turkey/1/2005 administreret efter to doser AS03-adjuveret vaccine, som indeholder 3,75 μg HA fra Indonesia/5/2005
English: - Periodicity will be reviewed by the MAH and the (Co)Rapporteur at 3 monthly intervals.
Danish: - Indehaveren af markedsføringstilladelsen og (Co-)Rapporteur evaluerer hyppigheden
English: The per-dose frequency of local and general solicited adverse reactions observed in the groups of children who received two adult (0.5 ml) doses was higher than that observed in the groups of children who received two half adult (i.e. 0.25 ml) doses, except for redness in the 6-9 years of age group.
Danish: Bortset fra rødme i 6-9 års-gruppen var frekvensen for lokale og generelle indsamlede bivirkninger per dosis højere i gruppen af børn, som fik to voksendoser (0,5 ml), end i gruppen af børn, som fik to halve voksendoser (0,25 ml).
English: Uncommon: back pain, musculoskeletal stiffness, neck pain, muscle spasms, pain in extremity
Danish: Ikke almindelig: rygsmerter, muskuloskeletal stivhed, nakkesmerter, muskelkramper, smerter i
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pumarix
Danish: LÆGEMIDLETS NAVN Emulsion til Pumarix injektionsvæske, emulsion
English: A/Indonesia/5/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Danish: A/Indonesia/5/2005 (H5N1)-lignende stamme (PR8-IBCDC-RG2)
English: Immune response to A/Vietnam/1194/2004 3 to 5 years
Danish: Immunerespons mod A/Vietnam/1194/2004 6-9 år dag 42
English: Against A/Indonesia 21 days after boosting with A/Indonesia N=49
Danish: Mod A/Indonesia 21 dage efter boosterdosis A/Indonesia n = 49 efter en primær dosis efter to primære doser
English: If you have previously received one or two doses of a similar H5N1 AS03-containing vaccine
Danish: Hvis du tidligere har fået en eller to vaccinedoser af en tilsvarende H5N1 AS03-adjuveret vaccine Voksne fra 18 år og derover: Du vil få en vaccinedosis Pumarix.
English: 3.75 micrograms* AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80
Danish: AS03-adjuvans bestående af squalen, DL-α-tocopherol og polysorbat 80
English: There are no data with Pumarix using the subcutaneous route.
Danish: Der findes ingen data for subkutan administration af Pumarix.
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2 °C - 8 °C) Må ikke fryses.
English: If any of the side effects below occur, please tell your doctor or nurse immediately:
Danish: Hvis nogen af ovennævnte bivirkninger opstår, skal du straks fortælle det til din læge eller sygeplejerske.
English: A titre of 1:80 was achieved in 84.2% of subjects aged 18-60 years and in 92.6% of subjects aged >60 years.
Danish: 84,2 % af personerne i alderen 18-60 år og 92,6 % af personerne over 60 år opnåede en titer på 1:80.
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), hvert indeholdende 2,5 ml emulsion og forsynet med prop (butylgummi)
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 or to sodium deoxycholate.
Danish: • hvis du har haft en overfølsomhedsreaktion, som ikke var livstruende, over for et eller flere af indholdsstofferne i denne vaccine (angivet i punkt 6) eller over for thiomersal, ægge- og kyllingeprotein, ovalbumin, formaldehyd eller natriumdeoxycholat.
English: Full dose N=29
Danish: fuld dosis n = 29
English: 3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre
Danish: 3 serokonverteringsfaktor: forholdet mellem post-vaccinationsgeometrisk middeltiter (GMT) og
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
Danish: Hverken hos børn, som fik halv voksendosis, eller hos børn, som 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 for hyppigheden af feber hos
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Danish: 1 seroprotektionsrate: andelen af forsøgspersoner med hæmagglutinationshæmningstiter (HI) ≥ 1:40;
English: All signal evaluation reports should be provided, including those that were subsequently not
Danish: Alle vurderingsrapporter over signalerne skal angives inkl.
English: In addition, from post-marketing surveillance with interpandemic trivalent vaccines, the following
Danish: Angioødem, generaliserede hudreaktioner, nældefeber I forbindelse med overvågning efter markedsføring af interpandemiske, trivalente vacciner er der også
English: It is best to see how Pumarix affects you before you try these activities.
Danish: Du skal derfor være opmærksom på, hvordan vaccinen påvirker dig før du kører eller anvender maskiner.
English: PSURs
Danish: RMP
English: In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted 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 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 fået to doser AS03adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 på dag 0 og 21.
English: One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 manufactured using a different process administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 manufactured using a different
Danish: En dosis AS03-adjuveret vaccine, som indeholder 3,75 μg HA fra A/Indonesia/05/2005 (fremstillet efter en anden proces) administreret efter en eller to doser AS03-adjuveret vaccine, som indeholder 3,75 μg HA fra A/Vietnam/1194/2004 (som er fremstillet ved en anden proces)
English: In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the pandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:
Danish: Indehaveren af markedsføringstilladelsen skal derfor, ved en erklæret pandemisk situation (WHO fase 6) og ved anvendelsen af den pandemiske vaccine indsende PSUR efter den tidsplan og i det
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Danish: seroprotektionsrate: andelen af forsøgspersoner med hæmagglutinationshæmningstiter (HI) ≥ 1:40;
English: The other ingredients are: thiomersal, sodium chloride, disodium hydrogen phosphate,
Danish: Hjælpestoffer: Thiomersal, natriumchlorid, dinatriumhydrogenphosphat, kaliumdihydrogenphosphat,
English: At day 42 and six months after the second dose, the anti-HA antibody responses were as follows:
Danish: På dag 42 og seks måneder efter anden dosis sås
English: Half dose N=44
Danish: halv dosis n = 44
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to
Danish: Ved sammenblanding af 1 hætteglas suspension ( 2,5 ml) og 1 hætteglas emulsion (2,5 ml) fås 10
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION (ADJUVANT)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING MED 25 HÆTTEGLAS INDEHOLDENDE EMULSION
English: 2seroconversion rate (i.e. proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and
Danish: 2 serokonverteringsrate: andelen af forsøgspersoner, som enten var seronegative før vaccination og opnår en beskyttende post-vaccinationstiter på ≥ 1:40, eller som var seropositive før vaccination og
English: If you are not sure, talk to your doctor or nurse before having this vaccine.
Danish: Spørg din læge eller sygeplejerske, hvis der er noget, du er i tvivl om, før du får denne vaccine.
English: This includes any possible side effects not listed in this leaflet.
Danish: Tal med lægen, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel.
English: Full dose N=41
Danish: fuld dosis n = 41
English: In a clinical study (D-Pan-H5N1-009, -023), 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
Danish: I et klinisk studie (D-Pan-H5N1-009, -023), hvor børn i alderen 3-5 år og 6-9 år fik enten to fulde doser (0,5 ml) eller en halv dosis (0,25 ml) AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) på dag 0 og dag 21.
English: Excipient with known effect: the vaccine contains 5 micrograms thiomersal For the full list of excipients see section 6.1.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: vaccinen indeholder 5 mikrogram thiomersal.
English: Tel.: + 36-1-2255300
Danish: Magyarország GlaxoSmithKline Kft. Tel.: + 36-1-2255300
English: NA
Danish: år
English: 4.5 Interaction with other medicinal products and other forms of interaction There are no data on co-administration of Pumarix with other vaccines.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: Split influenza virus, inactivated, containing antigen* equivalent to: *Antigen: A/Indonesia/5/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Danish: Split influenzavirus, inaktiveret, indeholdende antigen* svarende til: A/H5N1/Indonesia/5/2005-lignende stamme (PR8-IBCDC-RG2)
English: Mix into Antigen suspension before use
Danish: Emulsionen skal sammenblandes med antigen, suspension, før administration.
English: Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Danish: Indhold: AS03-adjuvans bestående af squalen (10,69 mg), DL-α-tocopherol (11,86 mg) og polysorbat