服樂維靈流感疫苗

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)

资料单张 资料单张 (PIL)
04-07-2020
公众评估报告 公众评估报告 (PAR)
11-04-2020

有效成分:

A/California/7/2009(H1N1);;A/Victoria/361/2011(H3N2);;B/Massachusetts/02/2012

可用日期:

台灣諾華股份有限公司 台北市中正區仁愛路二段99號11、12、13樓 (01516589)

ATC代码:

J07BB02

药物剂型:

懸浮注射劑

组成:

A/California/7/2009(H1N1) (8012002475) pdm09-like strainug haemagglutinin; B/Massachusetts/02/2012 (8012002700) like strainug haemagglutinin; A/Victoria/361/2011(H3N2) (8012016000) like strainug haemagglutinin

每包单位数:

針筒裝;;盒裝

类:

菌 疫

处方类型:

須由醫師處方使用

厂商:

NOVARTIS VACCINES AND DIAGNOSTICS S.R.L. BELLARIA ROSIA 53018 SOVICILLE (SIENA), ITLAY IT

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: 2017/08/15; 註銷理由: 自請註銷; 有效日期: 2019/08/12; 英文品名: Fluvirin Suspension for injection

授权状态:

已註銷

授权日期:

2009-08-12

资料单张

                                3. HOW TO USE FLUVIRIN
DOSAGE
Adults receive one 0.5ml dose
Use in children
Children from 48 months and older receive one 0.5ml dose.
If your child has not been previously vaccinated against flu, a second
dose should be given after at least 4 weeks.
METHOD AND/OR ROUTE(S) OF ADMINISTRATION
Your doctor will administer the recommended dose of the vaccine as
an injection into the muscle or deep under the skin.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fluvirin can cause side effects, although not
everybody gets them.
During clinical trials, the following side effects have been observed.
Their
frequencies have been estimated as Common: affects 1 to 10 users in
100.
• headache
• sweating
• muscular pain (myalgia), joint pain (arthralgia)
• fever, generally feeling unwell (malaise), shivering, fatigue
• local
reactions:
redness,
swelling,
pain,
bruising
(ecchymosis),
hardness (induration) around the area where the vaccine is injected.
These reactions usually disappear within 1-2 days without treatment.
Next to the above common side effects, the following side effects
occurred after the vaccine came on the market:
•
allergic reactions:
- leading to medical emergency with a failure of the circulatory
system to maintain adequate blood flow to the different organs
(shock) in rare cases,
- swelling most apparent in the head and neck, including the face,
lips, tongue, throat or any other part of the body (angioedema)
in very rare cases.
•
skin reactions that may spread throughout the body including
itchiness of the skin (pruritus, urticaria), rash.
•
blood
vessel
inflammation
which
may
result
in
skin
rashes
(vasculitis) and in very rare cases in temporary kidney problems.
•
pain situated on the nerve route (neuralgia), anomalies in the
perception
of
touch,
pain,
heat
and
cold
(paraesthesia),
fits
(convulsions) associated with fever, neurological disorders that
may result in stiff neck, confusion, numbness, pain a
                                
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