Country: Тајван
Језик: Кинески
Извор: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
A/California/7/2009(H1N1)v-like virus;;SQUALENE;;TOCOPHEROL ALPHA DL- (EQ TO DL-ALPHA TOCOPHEROL);;TWEEN 80 (EQ TO POLYSORBATE 80)
荷商葛蘭素史克藥廠股份有限公司台灣分公司 台北市中正區忠孝西路一段66號23-24樓 (86927438)
J07BB02
懸浮注射劑
A/California/7/2009(H1N1)v-like virus (8012002473) ug HA; TOCOPHEROL ALPHA DL- (EQ TO DL-ALPHA TOCOPHEROL) (8820000113) MG; TWEEN 80 (EQ TO POLYSORBATE 80) (9600023580) MG; SQUALENE (9600030000) MG
小瓶裝
菌 疫
須由醫師處方使用
BAXTER PHARMACEUTICAL SOLUTIONS LLC 927 SOUTH CURRY PIKE, BLOOMINGTON, IN 47403 USA US
influenza, inactivated, split virus or surface antigen
預防新型流感。
註銷日期: 2015/10/06; 註銷理由: 自請註銷; 有效日期: 2017/02/17; 英文品名: Arepanrix TM H1N1
已註銷
2012-02-17
AREPANRIX TM H1N1 PANDEMIC INFLUENZA VACCINE (H1N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) TITLE Influenza vaccine (H1N1) (split virion, inactivated, AS03 adjuvanted) _Arepanrix™ H1N1 _ PHARMACEUTICAL FORM Suspension and emulsion for emulsion for injection. FORMULATION AND STRENGTH Each 0.5 ml vaccine dose contains 3.75 micrograms 1 of A/California/7/2009 (H1N1) 2 and is adjuvanted with AS03 3 . 1 haemagglutinin 2 propagated in eggs 3 The GlaxoSmithKline proprietary AS03 adjuvant system is composed of squalene (10.69 milligrams), DL- -tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams) EXCIPIENTS Thiomersal Sodium chloride Sodium phosphate dibasic Potassium phosphate monobasic Potassium chloride Water for injections RESIDUES Egg residues including ovalbumin Formaldehyde Sucrose Sodium deoxycholate CLINICAL INFORMATION INDICATIONS Prophylaxis of influenza caused by A (H1N1). Arepanrix (H1N1) should be used according to official guidance. DOSAGE AND ADMINISTRATION The development of pandemic influenza vaccine can be conducted by establishing the efficacy and safety of the mock-up vaccine before replacing the virus strain for the pandemic influenza vaccine; this product is developed as described above. This product Arepanrix H1N1 (manufactured in Quebec, also known as Q-Pan H1N1) is manufactured by replacing the virus strain of mock-up vaccine, Arepanrix H5N1 (manufactured in Quebec, also known as Q-Pan H5N1). The main efficacy and safety data are from Arepanrix H5N1. Relatively less data are available for Arepanrix H1N1. In addition, another product manufactured by Dresden with the same amount of antigen and adjuvant (D-Pan H1N1, also known as Pandemrix H1N1) also provided some of the safety data. Adults aged 18 years and older, children and adolescents aged 10-17 years will receive one 0.5ml dose of Arepanrix™H1N1; Children aged 6 months to 9 years will receive two doses, 0.25ml for each dose. There should be an interval of at least 3 weeks between doses. The vaccine should be administered Прочитајте комплетан документ