FrancophonIA/ELRC3.0 huggingface dataset:
English: Packs of 1 or 10 pre-filled syringes.
Danish: Pakninger med 1 eller 10 fyldte injektionssprøjter.
English: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare
Danish: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000).
English: Up to 50% (n=33) of the elderly subjects aged 62 to 88 years immunised with AFLUNOV in trial V87P1 were seroprotected at six months.
Danish: Op til 50 % (N=33) af de ældre forsøgspersoner i alderen 62 til 88 år, der blev immuniseret med AFLUNOV i studie V87P1, udviste seroprotektion ved 6 måneder.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Danish: Kendetegnene ved en allergisk reaktion kan være kløende hududslæt, åndenød og hævet ansigt eller tunge.
English: Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Danish: Allergiske reaktioner, anafylaksi inklusive dyspnø, bronkospasme, larynxødem, som i sjældne tilfælde fører til shock
English: • Low blood platelet count which can result in bleeding or bruising.
Danish: • Lavt blodpladeantal, som kan medføre blødning eller blå mærker
English: • Erythema multiforme (type of allergic skin reaction that occurs in response to medications,
Danish: • Erythema multiforme (en slags allergisk hudreaktion, der forekommer som respons på lægemidler, infektioner eller sygdomme)
English: “Possible side 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: • Swollen lymph nodes, palpitations (irregular or forceful heart beat), tachycardia (faster than normal heart beat), weakness, pain in the extremities, cough and asthenia (unusual weakness).
Danish: • Hævede lymfekirtler, hjertebanken (uregelmæssige eller kraftige hjerteslag), takykardi (hurtigere hjerteslag end normalt), svaghed, smerte i arme/ben og hoste, asteni (usædvanlig kraftesløshed)
English: • Anaphylaxis (severe allergic reactions).
Danish: • Anafylaktisk shock (kraftig allergisk reaktion)
English: AFLUNOV may be co-administered with non-adjuvanted seasonal influenza vaccines, and immunisation should be carried out on separate limbs.
Danish: AFLUNOV kan administreres samtidig med ikke-adjuverede sæsoninfluenzavacciner, og immunisering skal udføres på forskellige ekstremiteter.
English: Water for injections.
Danish: Vand til injektionsvæsker
English: Based on humoral immune responses to the vaccine strain A/turkey/Turkey/1/2005 after two doses of AFLUNOV, a protective immune response may not be elicited in all vaccinees.
Danish: På baggrund af humorale immunresponser på vaccinestammen A/turkey/Turkey/1/2005 efter to doser AFLUNOV er det muligt, at der ikke fremkaldes et beskyttende immunrespons hos alle vaccinerede.
English: SRH results after the first dose, that mimic prepandemic priming plus single heterologous booster dose, revealed seroprotection and seroconversion rates of 100% (74100) and an 18-fold increase in SRH area (GMR).
Danish: SRH-resultater efter den første dosis, som efterligner præpandemisk priming plus en enkelt heterolog boosterdosis, viste seroprotektions- og serokonverteringsrater på 100 % (74-100) og en 18 gange stigning i SRH-areal (GMR).
English: In the elderly, the reported reactions increased with the third booster dose only when compared with the second dose.
Danish: Hos ældre var de indberettede bivirkninger ved den tredje boosterdosis kun hyppigere ved sammenligning med den anden dosis.
English: SRH seroprotection rates ranged from 86% to 98%, seroconversion rated from 64% to 90%, and GMR ranged from 2.92 to 4.57.
Danish: SRH-seroprotektionsrater lå i intervallet fra 86 % til 98 %, serokonverteringsrater fra 64 % til 90 %, og GMR lå i intervallet fra 2,92 til 4,57.
English: However, it is estimated that during the 2009 H1N1 pandemic more than 90,000 women were vaccinated during pregnancy with Focetria (an H1N1 pandemic vaccine similar to AFLUNOV) which contains the same amount of adjuvant MF59C.1 as AFLUNOV.
Danish: Det anslås imidlertid, at mere end 90.000 kvinder under 2009-H1N1-pandemien blev vaccineret under graviditet med Focetria (en H1N1-pandemivaccine tilsvarende AFLUNOV), som indeholder samme mængde adjuvans MF59C.1 som AFLUNOV.
English: Name and address of the manufacturer responsible for batch release Seqirus Vaccines Ltd
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Seqirus Vaccines Ltd
English: The vaccine contains per 0.5 ml 9.75 mg squalene, 1.175 mg polysorbate 80, 1.175 mg sorbitan trioleate.
Danish: Vaccinen indeholder pr. 0,5 ml 9,75 mg squalen, 1,175 mg polysorbat, 1,175 mg sorbitantrioleat.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL INJEKTIONSSPRØJTE
English: Children (3-<9 years)
Danish: Børn (3-< 9 år)
English: A slight increase in reactions in adults was reported when a booster dose was administered 18 months after the initial dosing series.
Danish: En let øget bivirkningsfrekvens hos voksne blev indberettet, når en boosterdosis blev administreret 18 måneder efter den første dosis-serie.
English: V87P11 Adults (18-60 years) N=186
Danish: V87P11 Voksne (18-60 år) N=186
English: In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Danish: Hvis noget af ovenstående gælder for dig, SKAL DU FORTÆLLE DET TIL LÆGEN ELLER SUNDHEDSPERSONALET, da det kan være, at vaccination ikke anbefales, eller at den skal udskydes.
English: Limited data were obtained from women who became pregnant during the course of clinical trials with AFLUNOV or similar pandemic H1N1v vaccines adjuvanted with MF59C.1.
Danish: Der er opnået begrænsede data fra kvinder, der blev gravide under kliniske studier med AFLUNOV eller tilsvarende pandemiske H1N1v-vacciner adjuveret med MF59C.1.
English: One dose of 0.5 ml contains: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in fertilised hens' eggs from healthy chicken flocks, of strain:
Danish: En dosis på 0,5 ml indeholder: Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase) formeret i befrugtede hønseæg fra sunde hønsehold fra stammen:
English: Active immunisation against H5N1 subtype of Influenza A virus.
Danish: Aktiv immunisering mod H5N1-undertypen af influenza A-virus.
English: Across studies V87_25 and V87_26, the safety of AFLUNOV in healthy adult and elderly subjects was consistent with existing safety data from previous clinical trials.
Danish: I studierne V87_25 and V87_26 var sikkerheden for AFLUNOV hos raske voksne og ældre forsøgspersoner i overensstemmelse med eksisterende sikkerhedsdata fra tidligere kliniske studier.
English: In these trials, lower levels of antibodies and reduced seroprotection rates against homologous H5N1 A/turkey/Turkey/1/2005 were also measured in healthy elderly subjects, as compared to healthy adults, though previous studies showed induction of sufficiently immunogenic responses against H5N1 strains (see above for information on elderly).
Danish: I disse studier blev der også målt lavere niveauer af antistoffer og reducerede seroprotektionsrater mod homolog H5N1 A/turkey/Turkey/1/2005 hos raske ældre forsøgspersoner sammenlignet med raske voksne, selvom tidligere studier har vist induktion af tilstrækkeligt immunogene responser mod H5N1-stammer (se ovenfor vedrørende information om ældre).
English: There is limited experience in elderly over 70 years of age (see section 5.1).
Danish: Erfaringerne hos ældre over 70 år er begrænsede (se pkt.
English: AFLUNOV injection H5N1 Zoonotic influenza vaccine IM
Danish: AFLUNOV injektionsvæske H5N1 zoonotisk influenzavaccine i.m.
English: The following additional adverse events were reported from post-marketing surveillance with seasonal non-adjuvanted trivalent vaccines in all age groups and a seasonal trivalent MF59-adjuvanted subunit influenza vaccine approved for use in elderly subjects 65 years of age and older:
Danish: Følgende yderligere bivirkninger er indberettet fra overvågning efter markedsføring med ikke-adjuverede trivalente sæsonvacciner i alle aldersgrupper og en trivalent MF59-adjuveret subunitinfluenzasæsonvaccine, som er godkendt til brug hos ældre forsøgspersoner på 65 år og derover.
English: Headache, dizziness, somnolence, syncope.
Danish: Hovedpine, svimmelhed, somnolens, synkope.
English: Method of administration Immunisation should be carried out by intramuscular injection into the deltoid muscle.
Danish: Administration Immunisering skal udføres ved intramuskulær injektion i m. deltoideus.
English: The other ingredients are: 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: Øvrige indholdsstoffer: natriumchlorid, kaliumchlorid, kaliumdihydrogenphosphat, dinatriumphosphatdihydrat, magnesiumchloridhexahydrat, calciumchloriddihydrat, natriumcitrat, citronsyre og vand til injektioner.
English: In the event of an officially declared influenza pandemic due to A/H5N1 virus, persons previously vaccinated with one or two doses of AFLUNOV that contained haemagglutinin (HA) antigen derived from a different clade of the same influenza subtype as the influenza pandemic strain may receive a single dose of AFLUNOV instead of two doses that are required in previously unvaccinated individuals (see section 5.1).
Danish: I tilfælde af en officielt erklæret influenzapandemi forårsaget af A/H5N1-virus kan personer, der tidligere er vaccineret med en eller to doser AFLUNOV indeholdende hæmagglutinin (HA-) antigen udvundet af en anden clade af den samme influenza-undertype som influenzapandemi-stammen, få en enkelt dosis AFLUNOV i stedet for de to doser, der kræves til hidtil uvaccinerede personer (se pkt.
English: Vascular disorders Vasculitis with transient renal involvement.
Danish: Vaskulære sygdomme Vasculitis med forbigående nyrepåvirkning
English: • Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
Danish: • Vaskulitis (betændelse i blodkarrene, hvilket kan forårsage hududslæt, ledsmerter og nyreproblemer)
English: Tell the doctor requesting these tests that you have recently been given AFLUNOV.
Danish: Hvis lægen foreslår disse blodprøver, skal du fortælle ham eller hende, at du for nylig har fået AFLUNOV
English: The vaccine will be injected into the muscles of the upper arm (deltoid muscle).
Danish: Vaccinen vil blive sprøjtet ind i overarmsmusklen (deltamusklen).
English: 9.75 milligrams per 0.5 ml polysorbate 80
Danish: 9,75 milligram pr. 0,5 ml polysorbat 80
English: Based on data obtained from trials V87P1, V87P11 and V87_13, persistence of antibodies after primary vaccination in elderly subjects as assessed by HI, SRH, and MN tests reduced from 1/2 to 1/5th of their post-vaccination level at day 202 as compared to day 43 after completion of primary schedules.
Danish: Baseret på data opnået fra studierne V87P1, V87P11 and V87_13 var persistens af antistoffer efter primær vaccination hos ældre forsøgspersoner målt ved HI-, SRH- og MN-test reduceret til 1/2 til 1/5 i forhold til post-vaccinationsniveauet ved dag 202 sammenlignet med dag 43 efter gennemførelse af de primære vaccinationsprogrammer.
English: In toddlers, erythema and tenderness were the most commonly reported solicited local reactions; irritability and unusual crying were the most commonly reported solicited systemic reactions.
Danish: Hos småbørn var rødme og ømhed de mest almindeligt rapporterede forventelige lokale reaktioner, mens irritabilitet og usædvanlig gråd var de mest almindeligt rapporterede forventelige systemiske reaktioner.
English: Data on safety of a booster dose of AFLUNOV are limited to three trials (V87P1, V87P2 and V87P1E1) that included 116 adults (18-60 years) and 56 elderly subjects (>61 years).
Danish: Data for sikkerhed i forbindelse med en boosterdosis af AFLUNOV er begrænset til tre studier (V87P1, V87P2 og V87P1E1), som inkluderede 116 voksne (18-60 år) og 56 ældre forsøgspersoner (≥ 61 år).
English: The safety profile across clinical studies using AFLUNOV containing either the A/turkey/Turkey/1/2005 or the A/Vietnam/1194/2004 strain is comparable.
Danish: Sikkerhedsprofilen i kliniske studier, der har anvendt AFLUNOV, som enten indeholdt A/turkey/Turkey/1/2005- eller A/Vietnam/1194/2004-stammen, er sammenlignelige.
English: The following adverse events were reported from post-marketing surveillance with Focetria (an H1N1 pandemic vaccine similar to AFLUNOV) which contains the same amount of adjuvant MF59C.1 as AFLUNOV, approved for use in children 6 months of age and above, adults and the elderly:
Danish: Følgende utilsigtede hændelser er indberettet fra overvågning efter markedsføring af Focetria (en H1N1-pandemivaccine tilsvarende AFLUNOV), som indeholder den samme mængde adjuvans MF59C.1 som AFLUNOV, der er godkendt til brug hos børn på 6 måneder og derover, voksne og ældre:
English: A single vaccination with AFLUNOV (A/Vietnam/1194/2004) induced high and rapid serological response in subjects primed 6-8 years previously with two doses of a different surrogate H5N vaccine, having same formulation as AFLUNOV but using the strain H5N3.
Danish: En enkelt vaccination med AFLUNOV (A/Vietnam/1194/2004) fremkaldte et højt og hurtigt serologisk respons hos forsøgspersoner, der var blevet primet 6-8 år tidligere med to doser af en anden H5N-surrogatvaccine med samme formulering som AFLUNOV men ved anvendelse af stammen H5N3.
English: • extensive swelling of injected limb lasting more than one week.
Danish: • Kraftig hævelse af armen eller benet, der er injiceret, som varer mere end én uge
English: 1 pre-filled syringe (0.5 ml) 10 pre-filled syringes (0.5 ml)
Danish: 1 fyldt injektionssprøjte (0,5 ml) 10 fyldte injektionssprøjter (0,5 ml)
English: Adults (18-60 years)
Danish: Voksne (18-60 år)
English: Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Danish: Hud og subkutane væv Generaliserede hudreaktioner, inklusive pruritus, urticaria eller uspecifikt udslæt, angioødem
English: Neurological disorders such as
Danish: • Neurologiske lidelser som
English: Medical Conditions N=140
Danish: Medicinske tilstande N = 140
English: Two doses of AFLUNOV were administered three weeks apart and a third dose 12 months following the first dose.
Danish: Der blev administreret to doser AFLUNOV med tre ugers mellemrum samt en tredje dosis 12 måneder efter den første dosis.
English: Information from non-clinical studies
Danish: Oplysninger fra prækliniske studier
English: In trial V87_25 and V87_26, 96 and 67 subjects, respectively, were over the age of 70 years.
Danish: I studie V87 25 og V87 26 var henholdsvis 96 og 67 forsøgspersoner over 70 år.
English: There is limited experience in children between 6 months and 17 years of age.
Danish: Erfaringerne hos børn i alderen 6 måneder til 17 år er begrænsede.
English: General disorders and administration site conditions Extensive swelling of injected limb lasting more than one week, injection-site cellulitis-like reaction (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week).
Danish: Almene symptomer og reaktioner på admnistrationsstedet Kraftig hævelse af injiceret ekstremitet, som varer i mere end 1 uge, cellulitislignende reaktion på injektionsstedet (nogle tilfælde af hævelse, smerter og rødme, der dækker mere end 10 cm og varer mere end 1 uge).
English: • Headache, dizziness, drowsiness, fainting.
Danish: • Hovedpine, svimmelhed, døsighed, besvimelse
English: Package leaflet: information for the user AFLUNOV suspension for injection in pre-filled syringe
Danish: Indlægsseddel: information til brugeren AFLUNOV injektionsvæske, suspension i fyldt injektionssprøjte
English: Heterologous immune response against A/Indonesia/5/2005 (clade 2.1) was detectable in study V87P11 after the second vaccination, indicating cross-reactivity of the clade 2.2.1 vaccine against clade 2.1 strains.
Danish: Heterologt immunrespons mod A/ Indonesia/5/2005 (clade 2.1) kunne måles i Studie V87P11 efter den anden vaccination, hvilket tyder på krydsreaktivitet for clade 2.2.1 vaccinen mod clade 2.1 stammerne.
English: Immune response to vaccination assessed by MN assay is in line with results obtained with SRH.
Danish: Immunrespons på vaccination målt ved MN-analyse er på linje med resultater opnået med SRH.
English: Skin and subcutaneous tissue disorders Erythema multiforme.
Danish: Hud og subkutane væv Erythema multiforme
English: AFLUNOV has been evaluated in healthy adults (18-60 years of age) and healthy elderly (over 60 years of age) following a 1, 22 day primary vaccination schedule, and booster vaccination (see sections 4.8 and 5.1).
Danish: AFLUNOV er blevet evalueret hos raske voksne (18-60 år) og raske ældre (over 60 år) efter et dag 1 - dag 22 primært vaccinationsprogram samt boostervaccination (se pkt.
English: After 3 weeks from the 2nd vaccination (day 43) all age groups (i.e. 6-35 months, 3-8 years and 9-17 years) achieved high levels of antibodies to (A/Vietnam/1194/2004) as evaluated with SRH and HI assays as presented in table below.
Danish: Tre uger efter den 2. vaccination (dag 43) havde alle aldersgrupper (dvs. 6-35 måneder, 3-8 år og 9-17 år) opnået høje antistofniveauer mod (A/Vietnam/1194/2004) evalueret med SRH- og HI-analyser, som vist i nedenstående tabel.
English: Influenza like illness
Danish: Influenzalignen de sygdom
English: administered 12 months following the first dose, was higher than after both first and second doses.
Danish: Reaktogeniciteten efter den tredje dosis administreret 12 måneder efter den første dosis var højere end efter både første og anden dosis.
English: Healthy N=62
Danish: Raske N = 62
English: • Angioedema (abnormal swelling of the skin, usually around the eyes, lips, tongue, hands or feet, due to an allergic reaction).
Danish: • Angioødem (unormal hævelse af huden, sædvanligvis omkring øjne, af læber, tunge,
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 (brombutylgummi).
English: Two doses of AFLUNOV were administered three weeks apart to 156 healthy adultsImmunogenicity was assessed in 149 subjects.
Danish: To doser AFLUNOV blev administreret med tre ugers mellemrum til 156 raske voksne.
English: Cardiac disorders Palpitation, tachycardia.
Danish: Hjerte Palpitation, takykardi
English: • Urticaria (hives)
Danish: • Urticaria (nældefeber)
English: There are no data on co-administration of AFLUNOV with vaccines other than non-adjuvanted seasonal influenza vaccines.
Danish: Der er ingen data vedrørende samtidig administration af AFLUNOV og andre vacciner end ikkeadjuverede sæsoninfluenzavacciner.
English: Seqirus Netherlands B.V. Paasheuvelweg 28
Danish: Seqirus Netherlands B.V.
English: There are no data regarding the use of AFLUNOV during breast-feeding.
Danish: Der foreligger ingen data vedrørende brug af AFLUNOV under amning.
English: Blood and lymphatic system disorders Lymphadenopathy.
Danish: Blod og lymfesystem Lymfadenopati
English: 1.175 milligrams per 0.5 ml
Danish: 1,175 milligram pr. 0,5 ml
English: The incidence of AFLUNOV (A/Vietnam/1194/2004) adverse reactions has been evaluated in one clinical trial (V87P6) in children (6 months to 17 years old).
Danish: Forekomsten af bivirkninger med AFLUNOV (A/Vietnam/1194/2004) er blevet evalueret i et klinisk studie (V87P6) hos børn (6 måneder til 17 år gamle).
English: Adverse reactions in special populations have been evaluated in two clinical trials, V87_25 and V87_26, involving adult (18-60 years) and elderly (≥ 61 years) subjects who were either healthy or with underlying medical conditions or immunosuppressive conditions.
Danish: Bivirkninger i specielle populationer er blevet evalueret i to kliniske studier, V87_25 og V87_26, der inddrog voksne (18-60 år) og ældre (≥ 61 år) forsøgspersoner, som enten var raske eller havde underliggende medicinske tilstande eller immunsuppressive tilstande.
English: Healthy N=57
Danish: Raske N = 57
English: No increase in reactions was reported when a booster dose was administered 6 months-18 months later, after the initial dosing series.
Danish: Der blev ikke rapporteret hyppigere bivirkninger, når en boosterdosis blev administreret 6-18 måneder efter den første dosis-serie.
English: MN results for the three clinical studies in the Table above revealed a seroprotection rate and seroconversion rate against A/turkey/Turkey/2005 ranging from 10% (2-27) to 39% (32-46) and 10% (2-27) to 36% (29-43) respectively.
Danish: MN-resultater for de tre kliniske studier i ovenstående tabel viste en seroprotektionsrate og en serokonverteringsrate mod A/turkey/Turkey/2005 i området fra henholdsvis 10 % (2-27) til 39 % (32-46) og 10 % (2-27) til 36 % (29-43).
English: AFLUNOV(A/Vietnam/1194/2004) and an AFLUNOV-like H5N1 vaccine (A/turkey/Turkey/1/2005-like) were tested.
Danish: AFLUNOV (A/Vietnam/1194/2004) og en AFLUNOV-lignende H5N1-vaccine (A/turkey/Turkey/2005-lignende) blev testet.
English: The side effects listed below have occurred in the days or weeks after vaccination with another vaccine called Focetria H1N1v similar to AFLUNOV.
Danish: Nedenstående bivirkninger er forekommet i dagene og ugerne efter vaccination med Focetria H1N1v-vaccine, som er en anden vaccine, der ligner AFLUNOV.
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Danish: Hvis samtidig administration af andre vacciner overvejes, skal immunisering foretages i forskellige ekstremiteter.
English: Nervous system disorders Neurological disorders, such as encephalomyelitis, and Guillain Barré syndrome.
Danish: Nervesystemet Neurologiske forstyrrelser, såsom encefalomyelitis og Guillain-Barrés syndrom
English: This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/turkey/Turkey/1/2005 (H5N1)-like strain (see sections 4.4 and 5.1).
Danish: Denne indikation er baseret på immunogenicitetsdata fra raske forsøgspersoner fra 18 år og opefter efter administration af to doser af vaccinen indeholdende A/turkey/Turkey/1/2005 (H5N1)-lignende stamme (se pkt.
English: Some heterologous immune response against A/turkey/Turkey/1/2005 (NIBRG23; clade 2.2.1) and A/ Indonesia/5/2005 (clade 2.1) was detectable both after the second and third vaccinations, indicating cross-reactivity of the clade 1 vaccine against clade 2 strains.
Danish: Der kunne detekteres et vist heterologt immunrespons mod A/turkey/Turkey/1/2005 (NIBRG23; clade 2.2.1) og A/Indonesia/5/2005 (clade 2.1) efter både anden og tredje vaccination, hvilket tyder på, at clade 1-vaccine udviser krydsreaktivitet mod clade 2-stammer.
English: Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Danish: Neurologiske lidelser, såsom neuralgi, paræstesi, kramper og neuritis
English: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose
Danish: A/turkey/Turkey/1/2005 (H5N1)-lignende stamme (NIBRG-23) (clade 2.2.1) 7,5 mikrogram** pr. 0,5 ml dosis
English: - Active Substance: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Danish: - Aktivt stof: Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase)* fra stammen:
English: Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Danish: Knogler, led, muskler og bindevæv Muskelsvaghed, smerter i ekstremiteter