平流感疫苗

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)-like virus;;A/Perth/16/2009 (H3N2)-like virus;;B/Brisbane/60/2008-like virus

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)-like virus (8012002471) MCG; A/Perth/16/2009 (H3N2)-like virus (8012005730) MCG; B/Brisbane/60/2008-like virus (8012006510) MCG

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:

ID BIOMEDICAL CORPORATION 2323 PARC TECHNOLOGIQUE BLVD. SAINTE-FOY, QUEBEC, CANADA, G1P 4R8 CA

治疗领域:

influenza, inactivated, split virus or surface antigen

疗效迹象:

預防流感

產品總結:

註銷日期: 2015/10/07; 註銷理由: 自請註銷; 有效日期: 2016/03/22; 英文品名: FluLaval

授权状态:

已註銷

授权日期:

2011-03-22

资料单张

1
FLULAVAL™
INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
QUALITATIVE AND QUANTITATIVE COMPOSITION
_FLULAVAL™_
is an inactivated influenza vaccine (split virion), containing
antigens (propagated in embryonated
eggs) equivalent to the following types and subtypes:
A/California/7/2009 (H1N1)-like strain [variant A/California/7/2009
(NYMC X-181)]
A/Perth/16/2009 (H3N2)-like strain [variant A/Victoria/210/2009 (NYMC
X-187)]
B/Brisbane/60/2008-like strain
This vaccine complies with the WHO recommended strains (Northern
Hemisphere) for the season 2010/2011.
Each 0.5 ml vaccine dose (
_FLULAVAL™_
) contains 15 µg haemagglutinin of each of the recommended strains.
_FLULAVAL™_
meets the WHO requirements for biological substances and influenza
vaccines and the US
Pharmacopoeia requirements for influenza vaccines.
PHARMACEUTICAL FORM
Suspension for injection
CLINICAL PARTICULARS
INDICATIONS
_PREVENTION OF INFLUENZA. _
_FLULAVAL™_
is indicated for active immunization of adults (18 years of age and
older) against influenza disease
caused by influenza virus subtypes A and type B contained in the
vaccine.
This indication is based on immune response elicited by FLULAVAL, and
there have been no controlled trials
demonstrating a decrease in influenza disease after vaccination with
FLULAVAL
_[see Clinical Studie _
DOSAGE AND ADMINISTRATION
_FLULAVAL™_
should be administered as a single 0.5-mL injection by the
intramuscular route preferably in the
region of the deltoid muscle of the upper arm.
Do not administer this product intravenously, intradermally or
subcutaneously.
CONTRAINDICATIONS
_FLULAVAL™_
should not be administered to subjects with known hypersensitivity to
the active substances, to any
of the excipients or to any of the residues such as egg proteins and
formaldehyde or a life-threatening reaction
to previous administration of any influenza vaccination
WARNINGS AND PRECAUTIONS
It is good clinical practice to precede vaccination by a review of the
medical history (especially with regard to
previous vaccinat