FrancophonIA/ELRC3.0 huggingface dataset:
English: This may include the provision by the MAH of stickers with invented name and batch number with each pack of the vaccine.
Danish: En sådan aftale kan eventuelt omfatte, at indehaveren af markedsføringstilladelsen forsyner hver enkelt pakke vaccine med en mærkat med produktnavn og batchnummer.
English: 1 x single dose of 0.5 ml pre-filled syringe 10 x single dose of 0.5 ml pre-filled syringes
Danish: 1 x enkeltdosis på 0,5 ml fyldt injektionssprøjte 10 x enkeltdosis på 0,5 ml fyldte injektionssprøjter
English: A/California/07/2009 (H1N1)-derived strain used NYMC X-181 7.5 micrograms haemagglutinin
Danish: A/California/07/2009 (H1N1)-deriveret stamme fra NYMC X-181 7,5 mikrogram hæmagglutinin
English: Children (3-8 years)
Danish: Børn (3-8 år)
English: Prophylaxis of influenza caused by A (H1N1v) 2009 virus (see section 4.4).
Danish: Profylakse mod influenza forårsaget af A(H1N1v) 2009-virus (se pkt.
English: Palpitation, tachycardia.
Danish: Palpitationer, takykardi.
English: • Safety and immunogenicity data in healthy children and adolescents aged from 6 months to 17 years and in adults, including the elderly
Danish: • Sikkerheds- og immunogenicitetsdata hos raske børn og unge i alderen fra 6 måneder til 17 år,
English: (Manufacturer responsible for final filtration of monovalent pooled harvest): Novartis Vaccines and Diagnostics S.r.l.
Danish: (Fremstiller ansvarlig for endelig filtrering af monovalent poolet høst): Novartis Vaccines and Diagnostics S.r.l.
English: Vial containing ten doses (0.5 ml each) for injection:
Danish: Hætteglas, der indeholder ti doser (hver på 0,5 ml) til injektion:
English: Allergic reactions possibly with shortness of breath, wheezing, swelling of the throat, or leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Danish: Allergiske reaktioner, der resulterer i et farligt fald i blodtrykket, og som kan føre til shock, hvis det ikke behandles.
English: Focetria can be given at the same time as non-adjuvanted seasonal influenza vaccines, with injections made into separate limbs.
Danish: Focetria kan gives samtidig med en type vaccine mod sæsonbetinget influenza, som kaldes en ikke-adjuveret subunit-vaccine, med indsprøjtning i separate lemmer.
English: (Manufacturer responsible for monovalent pooled harvests, before final filtration): Novartis Vaccines and Diagnostics S.r.l.
Danish: (Fremstiller ansvarlig for monovalente, poolede høster, inden endelig filtrering): Novartis Vaccines and Diagnostics S.r.l.
English: Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Danish: Neurologiske lidelser som neuralgi, paraestesi, kramper og neuritis.
English: The majority of febrile convulsions occurred in paediatric subjects.
Danish: Hovedparten af de febrile kramper forekom hos børn.
English: If a second dose is administered there should be an interval of at least three weeks between the first and second dose.
Danish: Hvis der administreres endnu en dosis bør der være et interval på mindst tre uger mellem første og anden dosis.
English: Adverse reactions in the week following vaccination from 87 children 3-8 years old and 95 children and adolescents 9-17 years old receiving the 7.5 µg formulation were reported as follows:
Danish: Bivirkninger i ugen efter vaccineringen hos 87 børn i alderen 3 til 8 år og 95 børn og unge i alderen 9-17 år, der modtog 7,5 µg-formuleringen blev rapporteret som følger:
English: Rare (affects 1 to 10 users in 10,000): Convulsion, eye swelling and anaphylaxis
Danish: Sjælden (forekommer hos 1 til 10 brugere ud af 10.000): Kramper, hævede øjne, allergisk reaktion
English: • The correct way to prepare the vaccine prior to administration.
Danish: • Instruktion i korrekt klargøring af vaccinen til indgivelse
English: (see section 6.
Danish: (se pkt.
English: Blood and lymphatic system disorders Lymphadenopathy.
Danish: Blod og lymfesystem Lymfadenopati.
English: Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems), exudative erythema multiforme.
Danish: Vaskulitis (betændelse i blodkarrene, hvilket kan forårsage hududslæt, ledsmerter og nyreproblemer), Væskende hudreaktioner.
English: 0.5 ml in pre-filled syringe (type I glass) with plunger-stopper (bromo-butyl rubber).
Danish: 0,5 ml i fyldt injektionssprøjte (type I-glas) med stempelprop (bromobutylgummi).
English: Multidose vial:
Danish: Flerdosishætteglas:
English: Very commonly reported reactions in both children and adolescents were pain, hardening of the skin at the injection site, injection site redness, generally feeling unwell, muscle ache, headache and fatigue.
Danish: Meget almindeligt rapporterede reaktioner hos både børn og unge var smerter, fortykkelse af huden ved injektionsområdet, rødmen ved injektionsområdet, generel følelse af ubehag, muskelsmerter, hovedpine og træthed.
English: Data in children and adolescents 3-17 years suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Danish: Data for børn og unge i alderen 3 til 17 år indikerer et let fald i reaktogenicitet efter den anden dosis, uden øgning af tilfælde af feber.
English: Via Fiorentina, 1 - Siena, Italy.
Danish: Via Fiorentina 1, - Siena,
English: Adverse reactions in the week following vaccination from 80 infants 6-11 months old and 82 toddlers 12-35 months old, receiving the 7.5 µg formulation were reported as follows:
Danish: Følgende bivirkninger blev rapporteret i ugen efter vaccinationen hos 80 spædbørn i alderen 6-11 måneder og 82 børn i alderen 12-35 måneder, som modtog formuleringen med 7,5 µg:
English: Fever 39°C to 39.9°C
Danish: Feber 39° C til 39,9° C
English: Immune system disorders
Danish: Immunsystemslidelser
English: General side effects reported very commonly in the 6 months-35 months of age group per dose were irritability, unusual crying, sleepiness, diarrhoea and change in eating habits.
Danish: Hyppigt rapporterede bivirkninger per dosis for aldersgruppen 6 til 35 måneder var irritabilitet, usædvanlig gråd, døsighed, diarré og ændret appetit.
English: Seroconversion or Significant Increase (95% CI) * measured by HI assay ** geometric mean ratios of HI
Danish: Serumkonvertering eller markant øgning (95 % CI) * Målt med HI-assay ** Geometriske middelratios for HI
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: You should discuss with your doctor whether you should receive Focetria taking into consideration official recommendation based on post-marketing reported adverse events during second and third trimesters of pregnancy.
Danish: Der skal tages hensyn til de officielle anbefalinger, som er baseret på rapporterede bivirkninger efter markedsføringen blandt gravide kvinder, der blev vaccineret i andet eller tredje semester af graviditeten.
English: GMR (95% CI) Seroconversion or Significant Increase (95% CI)
Danish: Serumkonvertering eller markant øgning (95 % CI)
English: Any adverse reaction Local
Danish: Enhver bivirkning Lokal
English: Children and adolescents aged 3-17 years:
Danish: Børn og teenagere i alderen 3-17 år:
English: Fever ≥38°C to 38.9°C
Danish: Feber ≥ 38° C til 38,9° C
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 10-DOSE VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAPÆSKE TIL 10-DOSIS HÆTTEGLAS
English: What Focetria looks like and contents of the pack Focetria is a milky-white liquid.
Danish: Focetria er en mælkehvid væske.
English: Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Danish: Knogler, led, muskler og bindevæv Muskelsvaghed, smerte i ekstremiteter.
English: General disorders and administration site conditions Asthenia.
Danish: Almene symptomer og reaktioner på administrationsstedet Asteni.
English: 5.0 ml in 10-dose vial (type I glass) with stopper (halo-butyl rubber).
Danish: 5,0 ml i 10-dosis hætteglas (type I-glas) med prop (halobutylgummi).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/07/2009 (H1N1)-derived strain used NYMC X-181 7.5 micrograms** per 0.5 ml dose * propagated in eggs ** expressed in microgram haemagglutinin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Influenzavirus overfladeantigen (hæmagglutinin og neuraminidase)* af følgende stamme: A/California/07/2009 (H1N1)-deriveret stamme fra NYMC X-181 7,5 mikrogram** pr. 0,5 ml dosis * dyrket i æg ** udtrykt i mikrogram hæmagglutinin.
English: Data in children and adolescents suggest a slight decrease in reactogenicity after the second dose of the vaccine, with no increase in rates of fever.
Danish: Data for børn og unge antyder et svagt fald i vaccinations bivirkninger efter den anden dosis af vaccinen, uden øgning i forekomsten af feber.
English: It is provided in: - a ready-to-use syringe, containing a single dose of 0.5 ml for injection; - vial containing ten doses of 0.5 ml each for injection.
Danish: Focetria findes: - i en injektionssprøjte klar til brug med en enkelt dosis på 0,5 ml til injektion - i et hætteglas med ti doser på 0,5 ml til injektion.
English: Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Danish: Hud og subkutane væv Generaliserede hudreaktioner, herunder pruritus, nældefeber eller uspecifikt udslæt, angioødem.
English: Muscoskeletal, connective tissue and bone disorders Very common: myalgia
Danish: Knogler, led, muskler og bindevæv Meget almindelig: myalgi Almindelig: atralgi
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Danish: Hvis det overvejes at administrere en anden vaccine på samme tid, skal denne vaccine gives i andre lemmer.
English: Nervous system disorders
Danish: Nervesystemslidelser
English: Cardiac disorders Palpitation, tachycardia.
Danish: Hjerte Palpitationer, takykardi.
English: In the first few weeks after vaccination with Focetria the results of these tests may not be correct.
Danish: Resultaterne af disse blodprøver vil muligvis ikke være korrekte i de første uger, efter at du er blevet vaccineret med Focetria.
English: Children (3 to 8 years of age)
Danish: Børn (i alderen 3 til 8 år)
English: Uncommon: influenza like illness
Danish: Ikke almindelig: influenzalignende symptomer
English: Very common reactions reported in children and adolescents 3 to 17 years of age: Pain, induration and erythema, malaise, myalgia, headache and fatigue.
Danish: Ofte rapporterede reaktioner i børn og unge i alderen 3 til 17 år: Smerte, induration og rødme ved injektionsstedet, utilpashed, myalgi, hovedpine og træthed.
English: Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Danish: Pandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret).
English: There are no data on co-administration of Focetria with other vaccines.
Danish: Der er ingen tilgængelige data for samtidig indgivelse af Focetria og andre vacciner.
English: Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Danish: Gastrointestinale lidelser Gastrointestinale lidelser som kvalme, opkast, mavesmerter og diarré.
English: A dose (0.5 ml) of the vaccine will be given.
Danish: En dosis på 0,5 ml af vaccinen anbefales.
English: Swollen lymph nodes, palpitations, weakness, pain in the extremities and cough.
Danish: Hævede lymfekirtler, hjertebanken, svaghed, smerte i ekstremiteter og hoste.
English: METHOD OF ADMINISTRATION Shake before use.
Danish: ANVENDELSESMÅDE Omrystes før brug.
English: Pregnancy and breast-feeding
Danish: Graviditet og amning og frugtbarhed
English: Clinical trials with Focetria H1N1v
Danish: Kliniske studier med Focetria H1N1v
English: Excipients: thiomersal
Danish: Hjælpestoffer: thiomersal
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Injektionsvæske, suspension.
English: Pre-filled syringe:
Danish: Fyldt sprøjte:
English: Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or use machines.
Danish: 4 ”Bivirkninger”, kan muligvis påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Common: injection site ecchymosis and fever
Danish: Almindelig: ekkymose ved injektionsstedet
English: Please consult the Product Information of: Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Danish: Se produktinformationen for Pandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret).
English: Immune response to Focetria H1N1v
Danish: Immunresponse på Focetria H1N1v
English: Ready-to-use syringe, containing a single dose of 0.5 ml for injection:
Danish: Injektionssprøjte, der er klar til brug og indeholder en enkelt dosis (0,5 ml) til injektion.
English: The other ingredients are: thiomersal (multidose vial only), sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Danish: De øvrige indholdsstoffer er: thiomersal (kun flerdosis-hætteglas), natriumchlorid, kaliumchlorid, kaliumdihydrogenfosfat, dinatriumfosfatdihydrat, magnesiumchloridhexahydrat, calciumchloriddihydrat, natriumcitrat, citronsyre og vand til injektioner.
English: Rare (1/10,000 to <1/1,000),
Danish: Ikke almindelig (1/1000 til <1/100), Sjælden (1/10.000 til <1/1.000), Meget sjælden (<1/10.000).
English: Tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescriptionor have recently been given any other vaccine.
Danish: Fortæl det altid til lægen eller sygeplejersken, hvis du bruger anden medicin eller har brugt det for nylig.
English: Infants (6 to 11 months of age)
Danish: Spædbørn (6-11 måneder)
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE
Danish: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG
English: METHOD OF ADMINISTRATION Gently shake before use.
Danish: ANVENDELSESMÅDE Omrystes forsigtigt før brug.
English: Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Danish: Generaliserede hudreaktioner, herunder pruritus, nældefeber eller uspecifikt udslæt, angioødem.
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Danish: Dette lægemiddel indeholder thiomersal (en organisk kviksølvforbindelse) som konserveringsmiddel.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Novartis Vaccines and Diagnostics S.r.l.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Novartis Vaccines and Diagnostics S.r.l.
English: Adults (18-60 years):
Danish: Voksne i alderen 18-60 år:
English: Very common reactions reported in 233 infants and toddlers 6 to 35 months of age: Tenderness, erythema, irritability, unusual crying, sleepiness, diarrhoea and change in eating habits.
Danish: Data for spædbørn og børn i alderen 6-35 måneder antyder et svagt fald i vaccinations bivirkninger efter den anden dosis af vaccinen, uden øgning i forekomsten af feber Meget almindelige reaktioner hos 233 spædbørn og børn mellem 6 og 35 måneder: Ømhed, erytem, irritabilitet, usædvanlig gråd, søvnighed, diarre og ændringer i spisevaner.
English: Data in infants and toddlers 6-35 months of age suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Danish: Data for spædbørn og børn i alderen 6-35 måneder antyder et svagt fald i vaccinations bivirkninger efter den anden dosis af vaccinen, uden øgning i forekomsten af feber.
English: Pain, hardening of the skin at the injection site, injection site redness, injection site swelling, pain at the site of injection, aching muscles, headache, sweating, fatigue, generally feeling unwell and shivering
Danish: Meget almindelig (forekommer hos flere end 1 bruger ud af 10): Smerte, hårdhed på injektionsstedet, rødmen på injektionsstedet, hævelse på injektionsstedet eller smerte på injektionsstedet, muskelsmerter, hovedpine, svedtendens, træthed, generelt ubehag og rystelser.
English: Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Danish: Gastrointestinale lidelser som kvalme, opkast, mavesmerter og diarré.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR SYRINGE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAPÆSKE TIL INJEKTIONSSPRØJTE
English: However, if this cannot be avoided, the vaccines should be injected into separate limbs.
Danish: Hvis en anden vaccine er nødvendig på samme tid, skal de to vacciner indsprøjtes i forskellige lemmer.
English: Breast-feeding Focetria may be administered to lactating women.
Danish: Amning Focetria kan anvendes under amning.
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)) of this vaccine.
Danish: Anamnese med anafylaktisk (dvs. livstruende) reaktion på ethvert indholdsstof eller sporstoffer (af ægge- og kyllingeproteiner, ovalbumin, kanamycin- og neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid (CTAB) i denne vaccine.
English: Seronegative at baseline N=51
Danish: Serumnegativ baseline N=51
English: Fever ≥38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE
Danish: Feber ≥ 38° C til 38,9° C Feber 39° C til 39,9° C Feber ≥ 40° C Enhver anden bivirkning
English: How to store FOCETRIA
Danish: Sådan skal du bruge FOCETRIA
English: Seronegative at baseline N=48
Danish: Serumnegativ baseline N=48
English: Seronegative at baseline N=46
Danish: Serumnegativ baseline N=46
English: Generalised skin reactions including itching, urticaria (hives), rash or swelling of the skin and mucous membranes.
Danish: Generelle hudreaktioner inklusive kløe, nældefeber, udslæt eller hævelse af hud og slimhinder.
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/07/2009 (H1N1)-derived strain used NYMC X-181
Danish: Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase)* af stammen: A/California/07/2009 (H1N1)-deriveret stamme fra NYMC X-181) 7,5 mikrogram** per 0,5 ml dosis
English: See section 4.4. for special warnings and special precautions for use.
Danish: 4.4. for særlige advarsler og forsigtighedsregler vedrørende brugen.
English: Seronegative at baseline N=37
Danish: Serumnegativ baseline N=37
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 319 to 702 (N=70) and an increase in GMT from 247 to 726 in children who were seronegative at baseline (N=48).
Danish: Data for respons på endnu en dosis administreret efter et interval på tre uger viste en øgning i total GMT fra 319 til 702 (N=70) og en øgning i GMT fra 247 til 726 for børn, der var serumnegative ved baseline (N=48).
English: Possible side effects
Danish: Enhver bivirkning
English: Seronegative at baseline N=25
Danish: Serumnegativ baseline N=25
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of Focetria (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB).
Danish: Du må ikke få Focetria: - hvis du tidligere har haft en pludselig, livstruende allergisk reaktion over for et af indholdsstofferne i Focetria (se nederst i indlægssedlen) eller et af de stoffer, der kan være spor af i vaccinen: ægge- og kyllingeprotein, ovalbumin, formaldehyd, kanamycin og neomycinsulphat (antibiotika) eller cetyltrimethylammoniumbromid (CTAB).
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to residues (eggs and chicken protein, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Danish: Der bør udvises forsigtighed, når denne vaccine gives til personer med kendt overfølsomhed (ud over anafylaktiske reaktioner) over for det aktive stof, over for et eller flere af hjælpestofferne eller sporstoffer (æg og kyllingeprotein, ovoalbumin, kanamycin- og neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid (CTAB)).
English: Seronegative at baseline N=45
Danish: Serumnegativ baseline N=45
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 274 to 1700 (N=57) and an increase in GMT from 162 to 1399 in children who were seronegative at baseline (N=37).
Danish: Data for respons på endnu en dosis, administreret efter et interval på 3 uger, viste en stigning i total GMT fra 274 til 1700 (N=57) og en stigning i GMT fra 162 til 1399 hos børn, der var seronegative ved baseline (N=37).
English: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, thiomersal, water for injections.
Danish: Natriumchlorid, kaliumchlorid, kaliumdihydrogenphosphat, dinatriumphosphatdihydrat, magnesiumchloridhexahydrat, calciumchloriddihydrat, natriumcitrat, citronsyre, thiomersal, vand til injektioner.
English: Disorders of the gut such as nausea, vomiting, abdominal pain and diarrhoea.
Danish: Mave-tarm-lidelser såsom kvalme, opkast, mavesmerter og diarré.
English: PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe.
Danish: Injektionsvæske, suspension i fyldt injektionssprøjte.
English: Caution is needed when administrating 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 (eggs and chicken protein, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Danish: Der bør udvises forsigtighed, når denne vaccine gives til personer med kendt overfølsomhed (ud over anafylaktiske reaktioner) over for det aktive stof, over for et eller flere af hjælpestofferne, thiomersal over for æg, kyllingeproteiner, kanamycin- og neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid (CTAB) og sporstoffer fra (æg og kyllingeprotein, ovoalbumin, kanamycin- og neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid (CTAB)).
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 793 to 1065 (N=88) and an increase in GMT from 522 to 870 in children who were seronegative at baseline (N=51).
Danish: Data for respons på endnu en dosis administreret efter et interval på tre uger viste en øgning i total Geometriske middelværdier fra 793 til 1065 (N=88) og en øgning i Geometriske middelværdier fra 522 til 870 hos børn, der var seronegative ved baseline (N=51)
English: A second dose of vaccine should be given after an interval of at least three weeks.
Danish: En dosis på 0,5 ml på en udvalgt dato Endnu en dosis vaccine bør gives efter et interval på mindst tre uger.
English: Focetria suspension for injection Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Danish: Influenzavaccine H1N1v (overfladeantigen, inaktiveret, adjuveret)
English: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, water for injections.
Danish: Natriumchlorid, kaliumchlorid, kaliumdihydrogenfosfat, dinatriumfosfatdihydrat, magnesiumchloridhexahydrat, calciumchloriddihydrat, natriumcitrat, citronsyre vand til injektioner.