FrancophonIA/ELRC3.0 huggingface dataset:
English: Potassium chloride (E508) Potassium dihydrogen phosphate (E340) Disodium phosphate dihydrate (E339) Magnesium chloride hexahydrate (E511) Calcium chloride dihydrate (E 509) Sodium citrate (E311) Citric acid (E330)Water for injections.
Danish: Kaliumchlorid (E508) Kaliumdihydrogenphosphat (E340) Dinatriumphosphatdihydrat (E339) Magnesiumchloridhexahydrat (E511) Calciumchloriddihydrat (E509) Natriumcitrat (E311) Citronsyre (E330)
English: Immunocompromised N=139
Danish: Immunsvækkede N = 139
English: AFLUNOV may contain trace residues of egg and chicken proteins, ovalbumin, kanamycin, neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide which are used during the manufacturing process (see section 4.3).
Danish: AFLUNOV kan indeholde spor af ægge- og hønseprotein, ovalbumin, kanamycin, neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid, som anvendes i fremstillingsprocessen (se pkt.
English: Other medicines and AFLUNOV
Danish: Brug af anden medicin sammen med AFLUNOV
English: These side effects may occur with AFLUNOV.
Danish: Disse bivirkninger kan forekomme med AFLUNOV.
English: Immunogenicity of AFLUNOV (A/turkey/Turkey/1/2005) in adults (18 to 60 years) and elderly (>61 years) subjects with underlying medical conditions (Study V87_25) or immunosuppressive conditions (mainly HIV-infected subjects) (Study V87_26) in comparison to healthy adults (18-60 years) and elderly (>61 years), was evaluated in two randomised, phase III controlled clinical trials (with a seasonal trivalent inactivated MF59-adjuvanted subunit influenza vaccine approved for use in elderly subjects 65 years of age and older as a comparator).
Danish: Immunogeniciteten af AFLUNOV (A/turkey/Turkey/1/2005) hos voksne (18 til 60 år) og ældre (≥ 61 år) forsøgspersoner med underliggende medicinske tilstande (studie V87_25) eller immunsuppressive tilstande (overvejende HIV-inficerede personer) (studie V87_26) sammenlignet med raske voksne (18 til 60 år) og ældre (≥ 61 år) blev evalueret i to randomiserede, kontrollerede fase III-kliniske studier (med en trivalent inaktiveret MF59-adjuveret subunit influenzasæsonvaccine godkendt til brug hos ældre personer i alderen 65 år og derover som komparator).
English: In a phase I clinical trial (V87P3) adult subjects aged 18-65 years primed 6-8 years previously with 2 doses of MF59-adjuvanted H5N3 vaccine/A/Duck/Singapore/97, were administered 2 booster doses of AFLUNOV (A/Vietnam/1194/2004).
Danish: I et fase I-klinisk studie (V87P3) fik voksne forsøgspersoner i alderen 18-65 år, der var primet 6-8 år tidligere med 2 doser MF59-adjuveret H5N3-vaccine/A/Duck/Singapore/97, administreret 2 boosterdoser af AFLUNOV (A/Vietnam/1194/2004).
English: Toddlers (6-<36 months)
Danish: Småbørn (6-< 36 måneder)
English: 1.175 milligrams per 0.5 ml sorbitan trioleate
Danish: 1,175 milligram pr. 0,5 ml sorbitantrioleat
English: If administration of AFLUNOV with other vaccines can not be avoided, the vaccines should be injected into separate limbs.
Danish: Hvis det ikke kan undgås at give AFLUNOV samtidig med andre vacciner, skal vaccinerne indsprøjtes i to forskellige lemmer.
English: AFLUNOV is a suspension for injection in a pre-filled syringe.
Danish: AFLUNOV er en injektionsvæske, suspension i fyldt injektionssprøjte.
English: Do not throw any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Medical Conditions N=143
Danish: Medicinske tilstande N = 143
English: Excipient with known effect: The vaccine contains 1.899 milligrams of sodium and 0.081 milligrams of potassium per 0.5 ml dose.
Danish: Vaccinen indeholder 1,899 mg natrium og 0,081 mg kalium pr. 0,5 ml dosis.
English: A phase II clinical trial (V87P1) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 312 healthy adults.
Danish: Der blev udført et fase II-klinisk studie (V87P1) med AFLUNOV (A/Vietnam/1194/2004) hos 312 raske voksne.
English: Uncommon (≥1/1,000 to
Danish: Ikke almindelig (≥ 1/1.000 til
English: Cross-reactive immune response elicited by A/turkey/Turkey/1/2005 against A/Indonesia/5/2005 and A/Vietnam/1194/2004
Danish: Krydsreaktivt immunrespons fremkaldt af A/turkey/Turkey/1/2005 mod A/Indonesia/5/2005 og A/Vietnam/1194/2004
English: A clinical trial (V87P6) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 471 children from 6 months to 17 years of age.
Danish: Der er udført et klinisk studie (V87P6) med AFLUNOV (A/Vietnam/1194/2004) til 471 børn i alderen 6 måneder til 17 år.
English: Adults (18-59 years)a
Danish: Voksne (18-59 år)a
English: Injection site swelling, Injection site pain, Injection site induration, Injection site redness, Fatigue
Danish: Hævelse på injektionsstedet , smerter på injektionsstedet , induration på injektionsstedet , rødme på injektionsstedet , træthed
English: Clinical trials with AFLUNOV have been conducted with either the former A/Vietnam/1194/2004 (H5N1) (clade 1) or the current A/turkey/Turkey/1/2005 (H5NI) vaccine strain (clade 2.2.1).
Danish: Der er udført kliniske studier med AFLUNOV med enten den tidligere A/Vietnam/1194/2004 (H5N1) (clade 1) eller den aktuelle A/turkey/Turkey/1/2005 (H5N1)-vaccinestamme (clade 2.2.1).
English: Immune response to AFLUNOV A/Vietnam/1194/2004 (H5N1) and A/turkey/Turkey/1/2005 (H5NI)
Danish: Immunrespons på AFLUNOV A/Vietnam/1194/2004 (H5N1) og A/turkey/Turkey/1/2005 (H5N1)
English: AFLUNOV is a vaccine for use in adults from 18 onwards, intended to be given in the context of outbreaks of zoonotic influenza viruses (coming from birds) with pandemic potential to prevent flu caused by H5N1 viruses similar to the vaccine strain reported in section 6.
Danish: Den er beregnet til at blive givet i forbindelse med udbrud af zoonotiske influenzavira (der kommer fra fugle) med pandemisk potentiale til forebyggelse af influenza forårsaget af H5N1-vira, der svarer til vaccinestammen, der er anført i punkt 6.
English: Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Danish: Zoonotisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret).
English: In a third clinical trial (V87P11) 194 adult subjects were enrolled and received two doses of AFLUNOV (A/turkey/Turkey/1/2005) administered three weeks apart.
Danish: I et tredje klinisk studie (V87P11) blev der indrulleret 194 voksne forsøgspersoner, som fik to doser AFLUNOV (A/turkey/Turkey/1/2005) med tre ugers mellemrum.
English: MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58).
Danish: MN-resultater mod en A/Vietnam/1194/2004 tyder på en seroprotektionsrate på 99 % (95 % CI: 94-100), en serokonverteringsrate i området 97 % (95 % CI: 91-99) til 99 % (95 % CI: 96-100) og en GMR i området fra 29 (95 % CI: 25-35) til 50 (95 % CI: 44-58).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAPÆSKE
English: Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Danish: Zoonotisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret)
English: In the first few weeks after vaccination with AFLUNOV 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 AFLUNOV.
English: MN results for A/Vietnam/1194/2004 revealed a seroprotection rate of 10% (6-16) in adults (18-60 years) and 6% (3-11) in elderly (>61 years); a seroconversion rate of 19% (13-25) in adults and 7% (4-13) in elderly and finally a GMR of 1.86 (1.63-2.12) in adults and 1.33 (1.17-1.51) in elderly.
Danish: MN-resultater for A/Vietnam/1194/2004 viste en seroprotektionsrate på 10 % (6-16) hos voksne (18-60 år) og 6 % (3-11) hos ældre (≥ 61 år); en serokonverteringsrate på 19 % (13-25) hos voksne og 7 % (4-13) hos ældre samt en GMR på 1,86 (1,63-2,12) hos voksne og 1,33 (1,17-1,51) hos ældre.
English: Cross-reactive immune response elicited by A/Vietnam/1194/2004 against A/turkey/Turkey/1/2005 and A/Indonesia/5/2005
Danish: Krydsreaktivt immunrespons fremkaldt af A/Vietnam/1194/2004 mod A/turkey/Turkey/1/2005 og A/Indonesia/5/2005
English: Adolescents(9-<18 years)
Danish: Unge (9-< 18 år)
English: In Study V87P11 MN results against homologous A/turkey/Turkey/1/2005) indicate a seroprotection and seroconversion rate of 85% (79-90) and 93% (89-96), respectively.
Danish: I Studie V87P11 tyder MN-resultater mod homolog A/turkey/Turkey/1/2005 på en seroprotektions- og serokonverteringsrate på henholdsvis 85 % (79-90) og 93 % (89-96).
English: Common (≥1/100 to <1/10)
Danish: Almindelig (≥ 1/100 til
English: • Flu like symptoms
Danish: • Influenzalignende symptomer
English: MN results for A/Indonesia/5/2005 revealed a seroprotection rate of 38% (31-45) in adults (18-60 years) and 14% (8-20) in elderly (>61 years); a seroconversion rate of 58% (50-65) in adults and 30% (23-38) in elderly and finally a GMR of 4.67 (3.95-5.56) in adults and 2.19 (1.86-2.58) in elderly.
Danish: MN-resultater for A/Indonesia/5/2005 viste en seroprotektionsrate på 38 % (31-45) hos voksne (18-60 år) og 14 % (8-20) hos ældre (≥ 61 år); en serokonverteringsrate på 58 % (50-65) hos voksne og 30 % (23-38) hos ældre samt en GMR på 4,67 (3,95-5,56) hos voksne og 2,19 (1,86-2,58) hos ældre.
English: There are no data with AFLUNOV using the subcutaneous route of administration.
Danish: Der foreligger ingen data for subkutan administration af AFLUNOV.
English: • Pain at the site of injection
Danish: • Smerter på injektionsstedet
English: Milky-white liquid.
Danish: Mælkehvid væske.
English: V87P11 Elderly (>61-89 years)a N=142
Danish: V87P11 Ældre (6189 år)a N=142
English: Some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or operate machinery.
Danish: 4.8, kan muligvis påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Gently shake before use.
Danish: Omrystes forsigtigt før brug.
English: Immunocompromised
Danish: Immunsvækkede
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB) (see section 6.
Danish: • hvis du har haft en allergisk reaktion, som ikke er en pludselig, livstruende allergisk reaktion, over for en af de ingredienser, der findes i vaccinen, ægge- og kyllingeprotein, ovalbumin, formaldehyd, kanamycin og neomycinsulfat (antibiotika) eller cetyltrimethylammoniumbromid (CTAB) (se pkt.
English: • Disorders of the gut such as
Danish: • Mave-tarmlidelser såsom:
English: % SP (95% CI) Day 43
Danish: % SP (95 % CI) Dag 43
English: Elderly (>61 years)
Danish: Ældre (≥ 61 år)
English: Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Danish: Fortæl det altid til lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har brugt det for nylig.
English: Adults (19- 60 years)a
Danish: Voksne (19-60 år)a
English: What AFLUNOV is and what it is used for What you need to know before you receive AFLUNOV How AFLUNOV is given
Danish: Virkning og anvendelse Det skal du vide, før du får AFLUNOV Sådan får du AFLUNOV Bivirkninger
English: Currently available data in subjects aged 6 months to 18 years of age are described in section 5.1 but no recommendation on a posology can be made.
Danish: De foreliggende data for børn mellem 6 måneder og 18 år er beskrevet i pkt.
English: In phase III clinical trial (V87P13) 2693 adult subjects were enrolled and 2566 received two doses of AFLUNOV (A/Vietnam/1194/2004) administered three weeks apart.
Danish: I et fase III-klinisk studie (V87P13) blev der indrulleret 2693 voksne forsøgspersoner, og 2566 fik to doserAFLUNOV (A/Vietnam/1194/2004) med tre ugers mellemrum.
English: Contents of the pack and other information What AFLUNOV contains
Danish: Pakningsstørrelser og yderligere oplysninger AFLUNOV indeholder
English: Undesirable effects in patients with underlying long term medical problems such as diabetes, lung disease or heart problems and weakened immune systems (immunocompromised) such as HIV patients
Danish: Birvirkninger hos patienter med underliggende langvarige medicinske problemer, såsom diabetes, lungesygdom eller hjerteproblemer, og svækket immunforsvar, såsom HIV-patienter Kvalme, ledsmerter, diarré og appetitløshed er meget hyppigt rapporterede bivirkninger i denne population.
English: Adults (20- 60 years)a
Danish: Voksne (20-60 år)a
English: Immunocompromised N=143
Danish: Immunsvækkede N = 143
English: In Study V87P11, MN results against homologous A/turkey/Turkey/1/2005 indicate a seroprotection and seroconversion rate of 68% (59-75) and 81% (74-87), respectively.
Danish: I Studie V87P11 tyder MN-resultater mod homolog A/turkey/Turkey/1/2005 på en seroprotektions- og serokonverteringsrate på henholdsvis 68 % (59-75) og 81 % (74-87).
English: MN results against homologous A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69), respectively.
Danish: MN-resultater mod homolog A/Vietnam/1194/2004 tyder på en seroprotektions- og serokonverteringsrate i området fra henholdsvis 57 % (50-64) til 79 % (68-87) og 55 % (48-62) til 58 % (47-69).
English: Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Danish: Mave-tarm-kanalen Mave-tarmlidelser, såsom kvalme, opkastning, mavesmerter og diarré
English: Rare (affects 1 to 10 users in 10.000):
Danish: Sjælden (forekommer hos 1 til 10 brugere ud af 10.000):
English: • Rash or swelling of the skin and mucous membranes
Danish: • Udslæt eller hævelse af hud og slimhinder
English: For the adjuvant, see section 2
Danish: 2 vedrørende adjuvanset
English: Elderly (61-79 years)a
Danish: Ældre (61-79 år)a
English: Elderly (61-84 years)a
Danish: Ældre (61-84 år)a
English: Common (affects 1 to 10 users in 100):
Danish: Almindelig (forekommer hos 1 til 10 brugere ud af 100):
English: MicroNeutralisation (MN) results against homologous A/Vietnam/1194/2004) indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively.
Danish: Mikroneutraliserings (MN)-resultater mod homolog A/Vietnam/1194/2004 tyder på en seroprotektions- og serokonverteringsrate i området fra henholdsvis 67 % (60-74) til 85 % (78-90) og 65 % (58-72) til 83 % (77-89).
English: Seroconversion rates against homologous A/turkey/Turkey/1/2005 ranged from 37.50% to 43.10% in healthy adults, and from 19.18% to 26.47% in adults with immunosuppressive or underlying medical conditions, respectively; seroconversion rates ranged from 21.43% to 30.65% in healthy elderly subjects, and from 24.49% to 27.86% in elderly subjects with immunosuppressive or underlying medical conditions.
Danish: Serokonverteringsrater mod homolog A/turkey/Turkey/1/2005 lå i henholdsvis intervallet fra 37,50 % til 43,10 % hos raske voksne og i intervallet fra 19,18 % til 26,47 % hos voksne med immunsuppressive eller underliggende medicinske tilstande.
English: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms haemagglutinin
Danish: A/turkey/Turkey/1/2005 (H5N1)-lignende stamme (NIBRG-23) (clade 2.2.1)
English: In a clinical trial evaluating 4 different vaccination schedules in 240 subjects 18 to 60 years of age, where the second dose occurred either 1, 2, 3 or 6 weeks after the first AFLUNOV
Danish: I et klinisk studie, hvor 4 forskellige vaccinationsprogrammer blev evalueret hos 240 forsøgspersoner i alderen 18 til 60 år, og hvor den anden dosis blev givet enten 1, 2, 3 eller 6 uger efter den første AFLUNOV (A/Vietnam/1194/2004) dosis, opnåede alle vaccinationsprogramgrupper fra 3 uger efter den 2. vaccination høje niveauer af antistoffer evalueret med SRH.
English: • Aching muscles
Danish: • Muskelsmerter
English: % SP (95% CI) Day 43 GMR Day 43 to Day 1 % SC (95% CI)Day 43
Danish: GMR (95 % CI) dag 43 til dag 1 % SC (95 % CI) dag 43
English: Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=132c
Danish: Studie V87P11 A/turkey/Turkey/1/2005 21 dage efter 2. dosis N=132c
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Danish: Indehaver af markedsføringstilladelsen og fremstiller: Indehaver af markedsføringstilladelsen
English: Study V87P13 21 days after 2nd dose N=197
Danish: Studie V87P13 21 dage efter 2. dosis N=197
English: Study V87P1 Elderly booster after 2nd dose
Danish: Studie V87P1 Ældre booster efter 2. dosis
English: MN results against homologous A/turkey/Turkey/1/2005 indicate a seroconversion rate of 66.67% in healthy adults, and ranging from 33.57% to 54.14% in adults with immunosuppressive or underlying medical conditions, respectively; seroconversion rates ranged from 24.39% to 29.03% in healthy elderly subjects, and from 31.65% to 39.42% in elderly subjects with immunosuppressive or underlying medical conditions.
Danish: MN-resultater mod homolog A/turkey/Turkey/1/2005 tyder på en serokonverteringsrate på henholdsvis 66,67 % hos raske voksne og i intervallet fra 33,57 % til 54,14 % hos voksne med immunsuppressive eller underliggende medicinske tilstande.
English: Study V87P2 Adults booster after 2nd dose
Danish: Studie V87P2 Voksne booster efter 2. dosis
English: Study V87P3 21 days after 2nd dose N=30
Danish: Studie V87P3 21 dage efter 2 dosis N=30
English: AFLUNOV suspension for injection in pre-filled syringe.
Danish: AFLUNOV injektionsvæske, suspension i fyldt injektionssprøjte.
English: There is no information on administration of AFLUNOV with noninfluenza vaccines.
Danish: Der er ingen oplysninger om brug af AFLUNOV sammen med vacciner, som ikke er influenzavacciner.
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)** Seroconversion factor (95%CI)*** a Ages 62-88 years; b Ages 61-68 years; c Ages 61-89 years * Seroprotection: SRH area ≥ 25 mm2
Danish: Seroprotektionsrate (95 % CI)* Serokonverteringsrate (95 % CI)** Serokonverteringsfaktor (95 % CI)*** a 62-88 år, b 61-68 år, c 61-89 år * Seroprotektion: SRH-areal ≥ 25 mm2 ** Serokonvertering blev defineret som et SRH-areal ≥ 25 mm2 for forsøgspersoner, der var seronegative ved baseline (dag 1-SRH-areal ≤ 4 mm2), eller en signifikant (mindst 50 %) stigning i SRH-areal for forsøgspersoner, der var seropositive ved baseline (dag 1-SRH-areal > 4 mm2) *** GMR'er af SRH
English: The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 (A/Vietnam/1194/2004 and to A/ turkey/Turkey/1/2005) in subjects aged 61 years and older (limited number of subjects were above 70 years of age; n=123) measured by SRH assay assessed in three clinical studies were as follows:
Danish: Seroprotektionsrate*, serokonverteringsrate** og serokonverteringsfaktor*** for anti-HA antistof mod H5N1 (A/Vietnam/1194/2004 og mod H5N1 A/turkey/Turkey/1/2005) (V87P11) hos forsøgspersoner i alderen 61 år og derover (et begrænset antal forsøgspersoner var over 70 år, N=123) målt ved SRH-analyse vurderet i to kliniske studier var som følger:
English: The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 measured by SRH assays were as follows:
Danish: Seroprotektionsrate*, serokonverteringsrate** og serokonverteringsfaktor*** for anti-HA antistof mod H5N1 A/Vietnam/1194/2004 målt ved SRH-analyser var som følger:
English: The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 and to H5N1 A/turkey/Turkey/1/2005 in the adults measured by SRH assay was as follows:
Danish: Seroprotektionsrate*, serokonverteringsrate** og serokonverteringsfaktor*** for anti-HA antistof mod H5N1 A/Vietnam/1194/2004 og mod H5N1 A/turkey/Turkey/1/2005 hos de voksne målt ved SRH-analyse var som følger:
English: Study V87P1 Adults booster after 2nd dose
Danish: Studie V87P1 Voksne booster efter 2. dosis
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) of this vaccine.
Danish: Anamnese med anafylaktisk (dvs. livstruende) reaktion på et eller flere af indholdsstofferne eller sporstoffer (ægge- og kyllingeproteiner, ovalbumin, kanamycin, neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid) i denne vaccine.
English: Very common (affects more than 1 user in 10):
Danish: Meget almindelig (forekommer hos 1 bruger ud af 10):
English: HI Seroprotection rate (95%CI)°
Danish: Seroprotektionsrate (95 % CI)°
English: Geometric mean area*, seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/turkey/Turkey/1/2005 measured by SRH assays 21 days after the 2nd dose were as follows:
Danish: Geometrisk middelareal*, seroprotektionsrate*, serokonverteringsrate* og serokonverteringsfaktor** for anti-HA-antistof mod H5N1 A/turkey/Turkey/1/2005 målt ved hjælp af SRH-analyse 21 dage efter den 2. dosis var som følger:
English: In this trial no vaccine related SAEs were observed.
Danish: Der sås ingen vaccinerelaterede SAE'er (alvorlige bivirkninger) i dette studie.
English: Uncommon (affects 1 to 10 users in 1.000):
Danish: Ikke almindelig (forekommer hos 1 til 10 brugere ud af 1.000):
English: ** Seroconversion was defined as an SRH area ≥25 mm2 for subjects who were seronegative at baseline (Day 1 SRH area ≤4 mm2) or a significant (at least 50%) increase in SRH area for subjects who were seropositive at baseline (Day 1 SRH area >4 mm2) *** geometric mean ratios (GMRs) of SRH
Danish: a faktisk aldersinterval for inkluderet population * Seroprotektion: SRH-areal ≥ 25 mm2 ** Serokonvertering blev defineret som et SRH-areal ≥ 25 mm2 for forsøgspersoner, der var seronegative ved baseline (dag 1-SRH-areal ≤ 4 mm2), eller en signifikant (mindst 50 %) stigning i SRH-areal for forsøgspersoner, der var seropositive ved baseline (dag 1-SRH-areal > 4 mm2) *** geometriske middelratioer af SRH ° målt ved HI-analyse ≥ 40 °° geometriske middelratioer af HI
English: General disorders and administration site conditions Asthenia.
Danish: Almene symptomer og reaktioner på administrationsstedet Asteni
English: Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/ Indonesia/5/2005 and A/Vietnam/1194/2004 after the 2nd dose in adults (18-60 years) and elderly (> 61years), measured by SRH and HI assays were as follows: Anti-HA antibody
Danish: Seroprotektionsrate*, serokonverteringsrate** og serokonverteringsfaktor*** for anti-HA-antistof mod H5N1 A/Indonesia/5/2005 og A/Vietnam/1194/2004 efter den 2. dosis hos voksne (18-60 år) og ældre (≥ 61 år), målt ved SRH- og HI-analyser var som følger:
English: Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/turkey/Turkey/1/2005 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows:
Danish: Seroprotektionsrate*, serokonverteringsrate** og serokonverteringsfaktor*** for anti-HA antistoffer mod H5N1 A/turkey/Turkey/1/2005 efter den 2. dosis hos voksne på 18-60 år målt ved SRH-analyse og HI-analyse var som følger:
English: Injection site ecchymosis, Fever, Malaise, Shivering
Danish: Ekkymose på injektionsstedet , feber, utilpashed, kulderystelser
English: and a type of paralysis known as Guillain-Barré Syndrome.
Danish: • Neurologiske lidelser som encephalomyelitis (betændelse i centralnervesystemet) og en slags lammelse, som kaldes Guillain-Barrés syndrom
English: (≥1/10,000 to
Danish: Sjælden (≥ 1/10.000 til