FrancophonIA/ELRC3.0 huggingface dataset:
English: Rabbits dams dosed with vaccine pre-mating and during gestation did not show any effects on embryofetal development.
Danish: Kaninmoderdyr, som blev givet doser af vaccine inden parring og under drægtighed, viste ingen indvirkning på embryo-føtal udvikling.
English: Children 3 to 8 years of age
Danish: Børn mellem 3 og 8 år
English: PACKAGE LEAFLET: INFORMATION FOR THE USER HUMENZA Suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN HUMENZA Suspension og emulsion til injektionsvæske, emulsion Pandemisk influenzavaccine (H1N1) (split virion, inaktiveret, adjuveret)
English: Children and adolescents (from 3 to 17 years of age):
Danish: Børn og unge (mellem 3 og 17 år):
English: The vaccine is mixed by withdrawing with a sterile syringe and needle the entire content of the antigen vial and adding it into the adjuvant vial.
Danish: Vaccinen blandes ved at trække hele indholdet af hætteglasset med antigen op vha. en steril injektionssprøjte og kanyle og tilsætte dette til hætteglasset med adjuvans.
English: One dose of 0.5 ml of the vaccine will be given.
Danish: Der gives en dosis på 0,5 ml af vaccinen.
English: Common: injection site warmth.
Danish: Almindelig: varme på injektionsstedet.
English: - Vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems.
Danish: - Betændelse i blodkar (vaskulitis), som kan resultere i hududslæt og i meget sjældne tilfælde i
English: METHOD OF ADMINISTRATION Mix into the adjuvant vial before use.
Danish: ANVENDELSESMÅDE Sammenblandes i hætteglasset med adjuvans inden brug.
English: One half-dose of 0.25 ml of the vaccine will be given.
Danish: Der gives en halv dosis på 0,25 ml af vaccinen.
English: For the dose to be administered, see recommended posology in section 3
Danish: For dosen, som skal indgives, se anbefalet dosering i afsnit 4.2.
English: No data have been generated in pregnant or lactating women with the vaccine HUMENZA or with any other vaccine containing adjuvant AF03.
Danish: Der foreligger ingen data for anvendelse af vaccinen HUMENZA eller nogen anden vaccine, som indeholder adjuvans AF03.
English: The other ingredients are: thiomersal (11.3 micrograms per 0.5 ml dose), sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Danish: Øvrige indholdsstoffer: thiomersal (11,3 mikrogram pr. 0,5 ml dosis), natriumklorid, kaliumklorid, dinatriumfosfatdihydrat, kaliumdihydrogenfosfat og vand til injektioner.
English: 21 days after 2nd dose Seroprotection rate* % [95% CI]
Danish: 21 dage efter 2. dosis Seroprotektion srate* % [95 % KI]
English: Children from 3 to 8 years old:
Danish: Børn mellem 3 og 8 år:
English: Children from 12 to 23 months old:
Danish: Børn mellem 12 og 23 måneder:
English: AF03 adjuvant composed of squalene, sorbitan oleate, polyoxyethylene cetostearyl ether and mannitol
Danish: AF03 adjuvans bestående af squalen, sorbitanoleat, polyoxyethylencetostearylether og mannitol
English: Pharmacovigilance The MAH commits to submit the data from pregnancy
Danish: Lægemiddelovervågning MAH forpligter sig til at fremsende data fra sit interne
English: The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.
Danish: Resultaterne af disse undersøgelser vil danne grundlaget for den årlige revurdering af risk/benefit-forholdet.
English: After mixing, store in a refrigerator and use within 24 hours.
Danish: Opbevares efter sammenblanding i køleskab og skal anvendes inden for 24 timer.
English: INSTRUCTIONS ON USE
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSE
English: Musculoskeletal and connective tissue disorders - Very common: myalgia
Danish: Knogler, led, muskler og bindevæv - Meget almindelig: Myalgi
English: For the most up-to-date information please consult the website of the European Medicines Agency : http://www.ema.europa.eu/.
Danish: Den mest opdaterede information kan findes på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: Children from 24 to 35 months old:
Danish: Børn mellem 24 og 35 måneder:
English: NAME OF THE MEDICINAL PRODUCT Antigen for HUMENZA suspension for injection Pandemic influenza vaccine (H1N1)
Danish: Antigen til HUMENZA injektionsvæske, suspension Pandemisk influenzavaccine (H1N1)
English: For further information, see section 5.1.
Danish: For yderligere information, se pkt.
English: Children from 6 to 11 months old:
Danish: Børn fra 6 til 11 måneder:
English: Children (6 to 11 months of age)
Danish: Børn (mellem 6 og 11 måneder)
English: Children (12 to 35 months of age)
Danish: Børn (mellem 12 og 35 måneder)
English: 1st dose
Danish: 1. dosis
English: After mixing HUMENZA should be stored in a refrigerator (2°C-8°C) (never place in the freezer) and should be used within 24 hours.
Danish: Efter sammenblanding skal HUMENZA opbevares i køleskab (2° C-8° C) (må aldrig anbringes i en fryser) og bruges inden for 24 timer.
English: 21 days after 1st dose Seroprotection rate* % [95% CI]
Danish: 21 dage efter 1. dosis Seroprotektion srate* % [95 % KI]
English: Suspension for injection 10 vials
Danish: Injektionsvæske, suspension 10 hætteglas
English: Very rare: - Skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), rash.
Danish: Meget sjælden: - Hudreaktioner, som kan sprede sig over hele kroppen, inklusive kløende hud (kløe, nældefeber),
English: Immunisation should be carried out by intramuscular injection (IM) preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Danish: Det foretrukne injektionssted er i musculus deltoideua eller i det øvre anterolaterale område på låret (afhængig af muskelmasse).
English: 21 days after 2nd dose
Danish: 21 dage efter 2. dosis
English: In an open-label clinical trial, two half-doses (0.25 ml) of HUMENZA have been administered at a 3-week interval in 48 children from 6 to 11 months of age and in 48 children from 12 to 35 months.
Danish: I en åben klinisk undersøgelse blev to halve doser (0,25 ml) HUMENZA indgivet med tre ugers mellemrum til 48 børn mellem 6 og 11 måneder og til 48 børn mellem 12 og 35 måneder.
English: Intramuscular use Read the package leaflet before use
Danish: Intramuskulær brug Læs indlægssedlen inden brug.
English: Allergic reactions may occur following vaccination, in rare cases leading to shock.
Danish: Overfølsomhedsreaktioner, som i sjældne tilfælde kan føre til shock, kan forekomme efter vaccinationen.
English: Prior to each administration, the multidose vial should be gently shaken by at least 5 rotating movements.
Danish: Inden hver indgivelse skal hætteglasset med flere doser forsigtigt omrystes ved at vende det mindst 5 gange.
English: After mixing, HUMENZA should be stored in a refrigerator (2°C-8°C) and should be used within 24 hours.
Danish: Efter sammenblanding skal HUMENZA opbevares i køleskab (2° C-8° C) og anvendes inden for 24 timer.
English: One half-dose of 0.25 ml at an elected date.
Danish: En halv dosis på 0,25 ml gives på en bestemt dato.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK CONTAINING 1 PACK OF 10 VIALS OF SUSPENSION (ANTIGEN) AND 1 PACK OF 10 VIALS OF EMULSION (ADJUVANT)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING MED 1 PAKKE MED 10 HÆTTEGLAS MED SUSPENSION (ANTIGEN) OG 1 PAKKE MED 10 HÆTTEGLAS MED EMULSION (ADJUVANS)
English: One pack contains: - One pack containing 10 vials of 1.5 ml of suspension (antigen).
Danish: En pakke indeholder: - En pakke med 10 hætteglas med 1,5 ml suspension (antigen).
English: A/California/7/2009 (H1N1)-like strain (NYMC X-179A)...........................................3.8 micrograms**
Danish: A/California/7/2009 (H1N1)-lignende stamme (NYMC X-179A)...............................3,8 mikrogram**
English: NAME OF THE MEDICINAL PRODUCT Adjuvant for HUMENZA emulsion for injection
Danish: LÆGEMIDLETS NAVN Adjuvans til HUMENZA injektionsvæske, emulsion
English: There are no data with HUMENZA using the subcutaneous route.
Danish: Der findes ingen data for subkutan administration af HUMENZA.
English: Very common: appetite lost, irritability, drowsiness, fever, abnormal crying.
Danish: Meget almindelig: appetitløshed, irritabilitet, døsighed, feber, anormal gråd.
English: NAME OF THE MEDICINAL PRODUCT HUMENZA suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Danish: HUMENZA suspension og emulsion til injektionsvæske, emulsion Pandemisk influenzavaccine (H1N1) (split virion, inaktiveret, adjuveret)
English: Adolescent from 9 to 17 years old:
Danish: Unge mellem 9 og 17 år:
English: Danmark Sanofi Pasteur MSD Tlf: +45 23 32 69 29
Danish: Sanofi Pasteur MSD Tlf: +45 23 32 69 29
English: The use of a second half-dose should take into consideration the information provided in sections 4.4, 4.8 and 5.1.
Danish: 4.4, 4.8 og 5.1. skal tages i betragtning ved indgivelse af en endnu en halv dosis.
English: - Temporary reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia), temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy).
Danish: Et lavt antal af disse kan føre til voldsom blodudtrædning eller blødning (transitorisk trombocytopeni), midlertidig hævelse af kirtlerne i halsen, armhulen eller lysken (transitorisk lymfadenopati).
English: Very common: headache, muscular pain, injection site pain.
Danish: Meget almindelig: hovedpine, muskelsmerter, smerter på injektionssstedet.
English: One dose of 0.5 ml at an elected date.
Danish: En dosis på 0,5 ml gives på en bestemt dato.
English: 21 days after 1st dose
Danish: 21 dage efter 1. dosis
English: Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently been given any other vaccine.
Danish: Fortæl det altid til din læge eller sygeplejerske, hvis du tager anden medicin eller har gjort det for nylig.
English: - One pack containing 10 vials of 4.5 ml of emulsion (adjuvant).
Danish: - En pakke med 10 hætteglas med 4,5 ml emulsion (adjuvans).
English: Sanofi Pasteur SA 2, avenue Pont Pasteur F-69007 Lyon France
Danish: Sanofi Pasteur SA 2, avenue Pont Pasteur F-69007 Lyon Frankrig
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant for HUMENZA emulsion for injection IM
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Adjuvans til HUMENZA injektionsvæske, emulsion IM
English: If a second dose is administered there should be an interval of at least three weeks between the first and second dose.
Danish: Gives yderligere en dosis, skal der være et interval på mindst 3 uger mellem første og anden dosis.
English: The seroconversion rate corresponds to the proportion of subjects with a pre-vaccination titer <1:10 achieving a post-vaccination titer ≥1:40, or the proportion of subjects with a ≥four-fold increase from pre- to post-vaccination titer.
Danish: Serokonversionsraten tilsvarer andelen af personer med en titer inden vaccinination <1:10 og som opnår en titer efter vaccination ≥1:40, eller andelen af personer med en ≥firedobbelt stigning af titer fra før og efter vaccination.
English: A single administration of a human dose of HUMENZA elicited HI titers ≥ 80 and MN (Microneutralization) titers ≥ 160 specific to the vaccinal strain in 100% of vaccinated animals and a two-dose administration regimen markedly increased (at least a 5-fold increase) HI and MN antibody titers.
Danish: En enkelt administration af en human dosis HUMENZA frembragte HI-titre ≥ 80 og MN-titre (mikroneutralisering) ≥ 160, som var specifikke for vaccinestammen i 100 % af de vaccinerede dyr.
English: Total enrolled subjects N= 48
Danish: Inkluderede forsøgspersoner i alt N= 48
English: You should not receive HUMENZA: - if you have previously had a sudden life-threatening allergic reaction to any ingredient of HUMENZA (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: ovalbumin, egg and chicken proteins, neomycin, octoxinol-9, formaldehyde.
Danish: Du må ikke få HUMENZA: - hvis du tidligere har haft en pludselig, livstruende allergisk reaktion over for et eller flere af indholdsstofferne i HUMENZA (disse er anført i slutningen af denne indlægsseddel), eller over for nogle af følgende stoffer, der kan findes spor af i vaccinen: ovalbumin, ægge- og kyllingeproteiner, neomycin, octoxinol-9, formaldehyd.
English: OTHER SPECIAL WARNING(S), IF NECESSARY MIX THE ANTIGEN INTO THE ADJUVANT VIAL BEFORE USE
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER SAMMENBLANDES I HÆTTEGLASSET MED ADJUVANS INDEN BRUG
English: The seroprotection rate corresponds to the proportion of subjects achieving a post-vaccination titer
Danish: Seroprotektionsraten tilsvarer andelen af personer, som opnåede en titer efter vaccination > 1:40.
English: In a clinical trial, the immunogenicity 21 days after each injection of HUMENZA given 21 days apart has been assessed in 50 children from 3 to 8 years of age and 49 adolescents from 9 to 17 years of age.
Danish: Immunogeniciteten 21 dage efter hver indgivelse af HUMENZA med 21 dage mellemrum blev undersøgt i en klinisk undersøgelse med 50 børn mellem 3 og 8 år og 49 unge mellem 9 og 17 år.
English: The adjuvant is a white opaque emulsion.
Danish: Adjuvansen er en hvid, uigennemsigitg emulsion.
English: Adolescents 9 to 17 years of age
Danish: Ældre børn mellem 9 og 17 år
English: The seroprotection rate, the seroconversion rate and the seroconversion factor, using HI method, were as follows:
Danish: Seroprotektionsraten, serokonversionsraten og serokonversionsfaktoren ved anvendelse af HI metoden var som følger:
English: Total enrolled subjects N= 50
Danish: Inkludere forsøgspersoner i alt N= 50
English: Sanofi Pasteur SA - 2, avenue Pont Pasteur - F-69007 Lyon - France
Danish: Sanofi Pasteur SA - 2, avenue Pont Pasteur - F-69007 Lyon - Frankrig
English: The adjuvant (AF03) is composed of squalene (12.4 milligrams), sorbitan oleate (1.9 milligrams), polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3 milligrams), per 0.5 ml dose
Danish: Adjuvans (AF03) består af squalen (12,4 milligram), sorbitanoleat (1,9 milligram), polyoxyethylencetostearylether (2,4 milligram), og mannitol (2,3 milligram), pr. 0,5 ml dosis
English: The seroprotection rate, the seroconversion rate and the seroconversion factor, using haemagglutination inhibiting (HI) method, were as follows:
Danish: Seroprotektionsraten, serokonversionsraten og serokonversionsfaktoren ved brug af hæmagglutinationshæmningsmetoden (HI) var som følger:
English: A second dose of vaccine should be given after an interval of at least 3 weeks.
Danish: En anden dosis af vaccinen bør gives mindst 3 uger senere.
English: Number of doses after mixing the content of antigen vial into the adjuvant vial: 10 doses of 0.5 ml.
Danish: Antal doser efter sammenblanding af indholdet af hætteglasset med antigen i hætteglasset med adjuvans: 10 doser af 0,5 ml
English: Total enrolled subjects N= 49
Danish: Inkluderede forsøgspersoner i alt N= 49
English: After mixing the content of antigen vial into the adjuvant vial, HUMENZA is an emulsion for injection in a multidose vial containing 10 doses of 0.5 ml.
Danish: Efter iblanding af hætteglasset med antigenet i hætteglasset med adjuvans fås HUMENZA som en injektionsvæske, emulsion i et hætteglas med 10 doser af 0,5 ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 10 VIALS OF SUSPENSION (ANTIGEN)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKKE MED 10 HÆTTEGLAS MED SUSPENSION (ANTIGEN)
English: In an open-label clinical trial, two doses (0.5 ml) of HUMENZA have been administered at a 3-week interval in 153 subjects (99 adults and 54 elderly).
Danish: To doser (0,5 ml) HUMENZA blev indgivet med tre ugers mellemrum til 153 personer (99 voksne og 54 ældre) i en åben klinisk undersøgelse.
English: Injection site pain/tenderness Injection site erythema Injection site swelling Injection site induration Injection site ecchymosis
Danish: Smerter/ømhed på injektionsstedet Erytem på injektionsstedet Hævelse på injektionsstedet Induration på injektionsstedet Ekkymose på injektionsstedet
English: Very common: irritability, crying abnormal, appetite lost, drowsiness, fever, vomiting.
Danish: Meget almindelig:irritabilitet, unormal gråd, appetitløshed, døsighed, feber, opkastning.
English: Sanofi Pasteur MSD S.A. Tel: +34.91.371.78.00
Danish: Sanofi Pasteur MSD Spa Tel: +34.91.371.78.00
English: AF03 adjuvant composed of squalene (33 mg), sorbitan oleate (4.9 mg), polyoxyethylene cetostearyl ether (6.3 mg), mannitol (6.1 mg) per 1 ml
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER AF03 adjuvans bestående af squalèn (33 mg), sorbitanoleat (4,9 mg), polyoxyethylencetostearylether (6,3 mg), mannitol (6,1 mg) pr. 1 ml
English: Seroprotection rate* % [95% CI]
Danish: Seroprotektionsrate* % [95 % KI]
English: Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Danish: Natriumklorid Kaliumklorid Dinatriumfosfatdihydrat Kaliumdihydrogenfosfat Vand til injektioner
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, to thiomersal, and to residues (ovalbumin, egg and chicken proteins, neomycin, octoxinol-9, formaldehyde).
Danish: Der skal udvises forsigtighed ved indgivelse af vaccinen til personer med kendt overfølsomhed (andet end anafylaktisk reaktion) over for det aktive stof, over for et eller flere af hjælpestofferne, over for thiomersal og over for reststoffer (ovalbumin, ægge- og kyllingeproteiner, neomycin, octoxinol-9, formaldehyd).
English: • If a specific notification system has been put in place, how to report adverse reactions.
Danish: • Instruktion om indberetning af bivirkninger, såfremt der findes et særligt
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere information om HUMENZA på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Children from 6 to 35 months of age:
Danish: Børn mellem 6 og 35 måneder:
English: One pack containing: - One pack of 10 vials (type I glass) of 1.5 ml suspension (antigen) with stopper (chlorobutyl).
Danish: En pakke indeholder: - En pakke med 10 hætteglas (type I-glas), hver indeholdende 1,5 ml suspension (antigen) med
English: Take special care with HUMENZA: - if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, ovalbumin, egg and chicken proteins, neomycin, octoxinol-9, formaldehyde (see section 6.
Danish: Vær ekstra forsigtig med at tage HUMENZA: - hvis du har haft en allergisk reaktion, som ikke var livstruende, over for et eller flere af indholdsstofferne i denne vaccine, over for thiomersal, ovalbumin, ægge- og kyllingeproteiner, neomycin, octoxinol-9, formaldehyd (se afsnit 6 - Yderligere oplysninger).
English: Name and address of the manufacturers of the biological active substance sanofi pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil France sanofi pasteur
Danish: Sanofi Pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil Frankrig
English: MIX INTO THE ADJUVANT VIAL BEFORE USE
Danish: SAMMENBLANDES I HÆTTEGLASSET MED ADJUVANS INDEN BRUG
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (ovalbumin, egg and chicken proteins, neomycin, octoxinol-9, formaldehyde).
Danish: Anamnese med en anafylaktisk (dvs. livstruende) reaktion over for et eller flere af indholdsstofferne eller reststoffer (ovalbumin, ægge- og kyllingeproteiner, neomycin, octoxinol-9, formaldehyd).
English: Common: injection site bruising, diarrhoea.
Danish: Almindelig: Blå mærker på injektionsstedet, diaré.
English: Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or use machines.
Danish: 4.8, kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 10 VIALS OF EMULSION (ADJUVANT)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKKE MED 10 HÆTTEGLAS MED EMULSION (ADJUVANS)
English: Very common: headache, feeling generally unwell, muscular pain, shivering.
Danish: Meget almindelig: hovedpine, følelse af generelt ubehag, muskelsmerter, kulderystelser.
English: Seronegative subjects prior to vaccination N= 55
Danish: Seronegative forsøgspersoner før vaccination N= 55
English: HUMENZA consists of 2 separate vials: - One vial containing the antigen (suspension) - One vial containing the adjuvant (emulsion) Before use, the two components should be mixed.
Danish: HUMENZA består af 2 særskilte hætteglas: - Et hætteglas med antigen (suspension) - Et hætteglas med adjuvans (emulsion) De to komponenter skal sammenblandes inden brug.
English: Split Influenza virus*, inactivated, containing antigen equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X179A)….....................................3.8 micrograms**
Danish: Split influenzavirus*, inaktiveret indeholdende antigen svarende til: A/California/7/2009 (H1N1)-lignende stamme (NYMC X-179A)…...........3,8 mikrogram**
English: Common: injection site bruising, headache, cough.
Danish: Almindelig: blå mærker på injektionsstedet, hovedpine, hoste.
English: Total enrolled subjects N= 18
Danish: Inkludere de forsøgsper soner i alt N= 18
English: Very common: feeling generally unwell, muscular pain, headache, shivering, fever.
Danish: Meget almindelig: følelse af generelt ubehag, muskelsmerter, hovedpine, kulderystelser, feber.
English: Viral shedding was assessed by measuring viral replication in both nasal and throat swabs and results demonstrated that HUMENZA was able to consistently reduce the viral load in the upper respiratory tract.
Danish: Resultaterne deraf viste, at HUMENZA var i stand til konsekvent at reducere viruskoncentrationen i de øvre luftveje.
English: In order to keep the traceability of the product received by each vaccinee the name of the vaccine and the lot number should be recorded by using the stickers provided in the pack containing both the antigen and adjuvant vials.
Danish: Vaccinens navn og lotnummer skal registreres vha. mærkaterne leveret med pakken, som indeholder hætteglas med både antigen og adjuvans, for at sikre sporbarheden af det produkt den vaccinerede person har fået.
English: Seroconversion factor*** [95% CI]
Danish: Serokonversionsfaktor*** % [95 % KI]
English: Regarding unsolicited reactions after any vaccination, diarrhoea (4.3 %) was reported in children from 6 to 11 months of age and cough (4.2 %) was reported in children from 12 to 35 months of age.
Danish: Hoste (4,2 %) blev rapporteret som spontan reaktioner efter enhver vaccination hos børn mellem 12 og 35 måneder.
English: Common: fever, sore throat, injection site bruising.
Danish: Almindelig: feber, ondt i halsen, blå mærker på injektionsstedet.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: Tal med lægen, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Seronegative subjects prior to vaccination N= 37
Danish: Seronegative forsøgspersoner før vaccination N= 37
English: Excipients: thiomersal, sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Danish: Hjælpestoffer: thiomersal, natriumklorid, kaliumklorid, dinatriumfosfatdihydrat, kaliumdihydrogenfosfat og vand til injektioner.