安律平新型流感疫苗

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

有效成分:

A/California/7/2009(H1N1)v-like virus;;SQUALENE;;TOCOPHEROL ALPHA DL- (EQ TO DL-ALPHA TOCOPHEROL);;TWEEN 80 (EQ TO POLYSORBATE 80)

可用日期:

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)

ATC代码:

J07BB02

药物剂型:

懸浮注射劑

组成:

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

每包单位数:

小瓶裝

类:

菌　疫

处方类型:

須由醫師處方使用

厂商:

BAXTER PHARMACEUTICAL SOLUTIONS LLC 927 SOUTH CURRY PIKE, BLOOMINGTON, IN 47403 USA US

治疗领域:

influenza, inactivated, split virus or surface antigen

疗效迹象:

預防新型流感。

產品總結:

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

授权状态:

已註銷

授权日期:

2012-02-17

资料单张

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