CSL Biotherapies' H1N1 and seasonal influenza vaccines approved for children
The FDA has approved the use of CSL Biotherapies' 2009 H1N1 monovalent influenza vaccine for use in infants and children ≥6 months of age.
Theexpanded approval also covers CSL's seasonal influenza vaccine Afluria (trivalent, inactivated, "split virus" influenza vaccine [Types A and B]).
The approval was based on study data in children showing the vaccine's safety and efficacy in inducing antibodies to protect against influenza.
These efficacy findings supported approval under FDA's accelerated approval regulation.

CSL's 2009 H1N1 influenza vaccine and Afluria are already approved for use in adults ≥18 years of age.

Generic Name for AFLURIA

Trivalent, inactivated, "split virus" influenza vaccine (Types A and B); formulation changes annually; susp for IM inj; may contain trace amounts of neomycin sulfate, polymyxin B.

Legal Classification:

Rx

Manufacturer of AFLURIA

CSLBiotherapies

Indications for AFLURIA

Influenza immunization.

Adult dose for AFLURIA

≥18yrs: 0.5mL by IM inj once in deltoid.

Children's dosing for AFLURIA

<18yrs: not recommended.

Contraindications for AFLURIA

Allergy to egg or chicken proteins, neomycin, polymyxin. Life-threatening reaction to any previous flu vaccine.

Precautions for AFLURIA

Use current formulation only. Have epinephrine inj (1:1000) available. Guillain-Barre syndrome within 6weeks of previous flu vaccine. Immunosuppressed. Pregnancy (Cat.C). Nursing mothers.

Interactions for AFLURIA

Concomitant vaccines: insufficient data (see literature). Immunosuppressants (eg, corticosteroids): may get suboptimal response.

Adverse Reactions for AFLURIA

Local reactions (eg, tenderness, redness, swelling, pain), headache, malaise, muscle aches.

How is AFLURIA supplied?

Single-dose prefilled syringe 0.5mL (preservative-free)—10 (without needles)Multi-dose vial 5mL (contains thimerosal)-1

RelatedDisease:

Immunization Influenza~vaccines

Related Resources

AFLURIA - A型流感病毒包括A/Brisbane/59/2007（H1N1）抗原（丙内酯灭活），A型流感病毒a/uruguay/716/2007（H3N2）抗原（丙内酯灭活）和B型流感病毒b/brisbane/60/2008抗原（丙内酯灭活）注射液.
AFLURIA - A型流感病毒包括A/Brisbane/59/2007（H1N1）抗原（丙内酯灭活），A型流感病毒a/uruguay/716/2007（H3N2）抗原（丙内酯灭活）和B型流感病毒b/brisbane/60/2008抗原（丙内酯灭活）注射液.

CSL有限公司
 
AFLURIA®，流感病毒疫苗肌肉注射

最初美国批准：2007

适应症
AFLURIA®是一种灭活的流感病毒疫苗主动免疫的人士表示，年龄在18岁和年龄对A和B型目前该疫苗的亚型流感病毒引起的流感疾病。
这个指示是基于免疫反应引起AFLURIA®;有没有控制展示后与AFLURIA®疫苗减少了流感病的临床研究。
 
剂量和用法
单一剂量为0.5毫升肌肉注射。
 
剂型和优势
肌肉注射的无菌悬浮AFLURIA®：

0.5毫升不含防腐剂，单剂量，预充式注射器。
5毫升多剂量小瓶含10剂量。硫柳汞，汞的衍生物，增加一条，作为防腐剂;每0.5毫升剂量含有汞（微克）24.5微克。
每0.5毫升的剂量含有15微克3株流感病毒血凝素（HA）：包括A/Brisbane/59/2007的IVR-148型（H1N1），A/Uruguay/716/2007 NYMC X - 175C型（H3N2 ）（A/Brisbane/10/2007-like株），并B/Brisbane/60/2008。
 
禁忌
过敏鸡蛋或鸡肉蛋白，新霉素，多粘菌素，或危及生命的反应，以前的流感疫苗接种。
 
注意事项：
如果格林 - 巴利综合症（GBS）发生在6个星期以前的流感疫苗接种，决定给AFLURIA®应慎重考虑的潜在利益和风险的基础上。
免疫功能低下者可能有减弱的免疫反应，以AFLURIA®。
 
不良反应
当地最常见（≥10％）不良反应（注射部位）有压痛，疼痛，发​​红，肿胀。全身不良反应最常见（≥10％），头痛，全身乏力，肌肉酸痛。
 
药物相互作用
切勿与任何其他疫苗在同一注射器或小瓶。
免疫疗法可能会削弱免疫反应AFLURIA®。
 
在特殊人群中使用
安全和有效性AFLURIA®尚未确立，孕妇或哺乳期的母亲和儿童人口。
抗体反应在老年受试者低于年轻受试者。

日期：07/2009