国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1)
Novartis Vaccines and Diagnostics S.r.l.
J07BB02
prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Vaccines,
Influenza, Human, Immunization, Disease Outbreaks
Active immunisation against H5N1 subtype of Influenza A virus., 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/Vietnam/1194/2004 (H5N1)-like strain., Prepandemic influenza vaccine (H5N1) Novartis Vaccines and Diagnostic should be used in accordance with official recommendations.,
Revision: 2
Withdrawn
2010-11-29
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ _ _ _ _ _ _ Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics suspension for injection in pre-filled syringe. Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) 7.5 micrograms** per 0.5 ml dose * propagated in eggs ** expressed in microgram haemagglutinin. Adjuvant MF59C.1 containing: squalene 9.75 milligrams per 0.5 ml polysorbate 80 1.175 milligrams per 0.5 ml sorbitan trioleate 1.175 milligrams per 0.5 ml For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. Milky-white liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation against H5N1 subtype of Influenza A virus. 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/Vietnam/1194/2004 (H5N1)-like strain (see section 5.1). Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should be used in accordance with official recommendations. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology:_ Adults and elderly (18 years of age and above): One dose of 0.5 ml at an elected date. A second dose of 0.5 ml should be given after an interval of at least 3 weeks. Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics 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). There is limited experience in elderly over 70 yea 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ _ _ _ _ _ _ Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics suspension for injection in pre-filled syringe. Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) 7.5 micrograms** per 0.5 ml dose * propagated in eggs ** expressed in microgram haemagglutinin. Adjuvant MF59C.1 containing: squalene 9.75 milligrams per 0.5 ml polysorbate 80 1.175 milligrams per 0.5 ml sorbitan trioleate 1.175 milligrams per 0.5 ml For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. Milky-white liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation against H5N1 subtype of Influenza A virus. 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/Vietnam/1194/2004 (H5N1)-like strain (see section 5.1). Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should be used in accordance with official recommendations. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology:_ Adults and elderly (18 years of age and above): One dose of 0.5 ml at an elected date. A second dose of 0.5 ml should be given after an interval of at least 3 weeks. Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics 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). There is limited experience in elderly over 70 yea 完全なドキュメントを読む