【药品名称】
通用名：流行性感冒病毒裂解疫苗
商品名：凡尔灵VAXIGRIP
英文名：Inactivated Split Influenza Vaccine
汉语拼音：Liuxingxing Ganmao Bingdu Liejie Yimiao
【成份和性状】
本品为乳白色液体，主要成份：
每0.5g含：
【性状】
每人份0.5 mL含有 ：在鸡胚中培养的流感病毒，用Octoxynol裂解，福尔马林灭活、纯化，含有抗原 ：A/莫斯科/10/99（H3N2）；A/新喀里多尼亚/20/99（H1N1）- 15 ug血凝素 ；B/香港/330/2001 - 15 ug血凝素。疫苗采用世界卫生组织推荐2000/2001季节流行株。此外，尚含有非活性成分 ：钠盐（氯化钠、磷酸氢二钠）或钾盐（氯化钾、磷酸钾）。
【适应症】
该疫苗用作预防流行性感冒，尤其是易发生相关并发症人群：体弱多病的儿童 ；65岁以上老年人 ；慢性心脏病或支气管－肺病患者 ；慢性肾功能不全 ；糖尿病患者 ；免疫缺陷患者 ；以及危险职业人群，如医护工作者、保育员，群居人群，如敬老院、军队，或其他自愿接种者。
【用法用量】
6-36个月儿童：步又?次，每次0.25 mL(间隔4周)。成人及36个月以上儿童：.5 mL/次，肌注或皮下注射。
【不良反应】
局部反应如红、肿、硬结 ；全身反应如发热、肌痛、乏力。上述反应无需治疗，一般1～2天会自然消失。罕见速发型过敏反应。神经系统紊乱与疫苗注射的因果关系尚未被证实。
【禁忌症】
对疫苗中任何一种成分，尤其是卵蛋白过敏者。
【警告】
发热或急性感染期患者最好推迟接种。
【注意事项】
由于流感呈季节性发病，建议每年接种流感疫苗，温带地区干燥季节前接种，热带地区流行高峰来临前接种。免疫功能低下者，对新霉素过敏者(疫苗生产过程中使用该物质)慎用。
【孕妇及哺乳期妇女用药】
怀孕和哺乳期妇女慎用。
【药物相互作用】
免疫抑制剂的应用可降低疫苗接种后的免疫应答。
【用药须知】
用前充分摇匀，肌注或皮下注射。包装瓶有断裂出现或液体有颜色变化时，严禁使用。可与其他疫苗同时接种，但应接种在不同部位。
【贮藏/有效期】
该疫苗需贮存在2-8°C冰箱内，避光保存，严禁冰冻。
【制造商】
安万特·巴斯德
Sanofi Pasteur introduces flu vaccine, Vaxigrip
Sanofi Pasteur, the global leader in vaccines recently introduced Vaxigrip, its global preventive vaccine against influenza for the season 2005-06 in India. Vaxigrip is the leading protection against influenza in the world. Vaxigrip is a suspension for injection in prefilled syringe of 0.5m in a box of one or 20 or in an ampoule of 0.5ml. Vaxigrip is produced by Sanofi Pasteur in Lyon, France and is marketed in India by Sanofi Pasteur and Ranbaxy.
Vaxigrip has proven to have a good safety profile, immunogenicity and has more than 30 years of experience in Influenza immunization. Vaxigrip should be administered by an intramuscular or deep subcutaneous injection.
A Sanofi Pasteur spokesperson said, “Influenza is a more serious condition than a cold and can be life threatening for some people showing a high risk of associated complications. Vaxigrip can be administered to young children, working adults, pilgrims, elderly and patients suffering from diabetes, asthma, cardiac and pulmonary disorders.”
Due to constant genetic changes in the surface antigens of the influenza virus, the composition of the vaccine must be adapted each year to match the most virulent circulating influenza A viruses (H3N2 and H1N1) and influenza B viruses.
Sanofi Pasteur’s flu vaccines are registered in more than 150 countries. The vaccine is well tolerated and very effective, leading to a 70 to 90 percent reduction in flu-morbidity among healthy adults.
The vaccine formula is revised annually in compliance with the World Health Organization recommendations, which update the composition of the vaccine to match the three viral strains in circulation each year.
Vaxigrip® vaccine
Manufacturer:
Aventis Pasteur Ltd
Generic Name:
influenza vaccine
Form:
injection
Route:
i.m. (intramuscular)
Why is it prescribed?
Vaxigrip® vaccine contains influenza vaccine.
Influenza vaccine is indicated for the following groups of people considered to be at high risk of influenza related complications: infants aged 6 to 23 months; adults and children with chronic heart and lung disorders; people of any age who are residents of nursing homes or chronic care facilities; people over the age of 65; adults and children with chronic conditions such as diabetes mellitus, cancer, kidney disease; anemia; immunosuppressed individuals (e.g. HIV infected people); children and adolescents (6 months to 18 years) with conditions treated for long periods with aspirin (e.g. ASA) and people at high risk for complications who are traveling to a destination where the influenza virus will be circulating.
The following people who have potential of transmitting influenza to those at high risk should be vaccinated: health care providers; those who provide services within closed or relatively closed settings to persons at high risk; household contacts of people at high risk; those who provide child care; people who provide essential community services; people in direct contact with poultry infected with avian influenza. Pregnant women should be immunized in their third trimester if they are expected to deliver during the influenza season. In addition, healthy persons aged 2 to 64 years should be encouraged to receive the vaccine.
Side Effects
Vaxigrip® vaccine contains influenza vaccine.
Influenza vaccine is generally well tolerated and most people will experience only minor unwanted effects. The frequency and severity of these effects depends mainly on the individual's susceptibility. Possible unwanted effects include:
soreness at the injection site
fever
feeling unwell
shivering
tiredness
headache
sweating
muscle joint pain
warmth
Rare:
nerve pain
numbness and tingling
seizures
blood disorders
allergic reactions
Precautions and Warnings for Vaxigrip® vaccine
Vaxigrip® vaccine contains influenza vaccine
The influenza vaccine is prepared using eggs. Therefore, it should not be administered to anyone with an allergy to eggs or egg products.
Drug Interactions: It is important to tell your doctor and pharmacist of any prescription or over-the-counter medications you are taking. The following drugs or drug classes have the potential for interaction with the vaccine:
anti-seizure medications (e.g. phenytoin)
corticosteroids (e.g. prednisone)
cyclosporine (e.g. Neoral®)
theophylline
warfarin (e.g. Coumadin®)
Use is not recommended in the following situations:
allergy to any component of the vaccine
allergy to eggs or egg products
allergy to formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin
fever
active infection
respiratory disease with a sudden onset
unstable neurologic disease
Use with caution in the following situations:
people on immunosuppressive therapy (e.g. prednisone)
blood coagulation disorders
Use in pregnancy:The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy. Use while breastfeeding: Evidence indicates that the vaccine is safe for breastfeeding mothers and their infants.
Patient Information
Vaxigrip® is a vaccine that offers protection against those strains of influenza (flu) viruses that are used to prepare the vaccine. This injection is to be administered by a qualified health professional only. Protection from the vaccine usually is obtained within 2 to 3 weeks after the injection and lasts 6 to 12 months. Annual re-vaccination is required for continued protection.
The best time for vaccination is from mid-October, but anytime in the flu season (November to April) is appropriate.
Contrary to popular belief, influenza vaccine cannot cause the flu.
Vaxigrip® may not work for everybody.
Directions for Use
The dose for adults and children 9 years of age or older is 0.5 mL as a single injection.
The dose for children 3 to 8 years of age is 0.5 mL as a single injection and may require a second injection 4 weeks later.
The dose for children 6 to 35 months is 0.25 mL as a single injection and may require a second injection 4 weeks later.
Lung Diseases Treated with this Drug flu influenza
Need More Information?
For more information contact your physician, pharmacist, other health care professional or for general questions call your local lung association.
Last Updated August 2010