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Hepatitis A (Live) Vaccine, Freeze-dried

 

Hepatitis A (Live) Vaccine, Freeze-dried Instruction

Pharmaceutical Product Name
General name: Hepatitis A (Live) Vaccine, Freeze-dried
English name: Hepatitis A (Live) Vaccine, Freeze-dried
Pronunciation in Chinese: Donggan Jiaxing Ganyan Jiandu Huoyimiao
Composition and Property
The vaccine was made from the attenuated strain of HAV, inoculated in human diploid cells through culture, harvesting and purification of the extracted preparation, added with adequate stabilizer and through lyophilization. The vaccine is a loose substance with cheese colour and is transparent liquid after re-dissolution.
The main components of subsidiary material and stabilizer: lactose, magnesium sulfate, gelatin, medium balance solution.
Indications
Adults and children over 1.5 years of age susceptible to hepatitis A virus.
Function and application
Hapatitis A vaccine confers immunity against HAV infection by the induction of specific antibodies against the virus. Applied for the prevention of hepatitis A.
Specification
After re-dissolution, a single 0.5mL in vial (one single dose), the live vaccine content should not be less than 6.50 lg CCID50.
Immune procedure and dosage
According to labeled amount add sterile water for injection and shake well till the powder completely dissolves. Then inject a single dose of 0.5mL subcutaneously in the deltoid muscle of upper arm.
 
Adverse reactions
A few people may have local pain, redness and swelling over the injection site and usually subside spontaneously within 72hrs. Skin rash may be noted occasionally and no specific treatment was needed. Relevant treatment may be given whenever needed.
Contraindications
(1) Body discomfort with axillary temperature over 37.5℃.
(2) Acute infectious disease or other serious illness.
(3) Immunological deficiency disease or accepting immunosuppressant treatment.
(4) A history of anaphylaxis.
Precautions
(1) The contact of the vaccine with any disinfectant should be avoided during manipulation.
(2) The product should not be used if it is found to have a crack in vial, or turbidity, or the presence of foreign body after re-dissolution.
(3) The vaccine should be given more than 1 month after gamma globulin administration.
(4) Not recommended to pregnancy woman.
 
Storage
The vaccine should be kept and transported at a temperature between 2℃ to 8 ℃ in a dark place.
 
Package
Vaccine: injection vials made of borosilicate glass tubing +bromobutyl rubber closures; Sterile water for injection: ampoules made of low borosilicate glass tubing. Each small box contain one vial of vaccine and one ampoule of sterile water for injection.
 
Valid period:
18 months
Execution standard:
Pharmacopoeia of P.R.C.(third section, 2005 edition)
Authorized number :
Guo Yao Zhun Zi S 20000063
Manufacturing enterprise :
Zhejiang Pukang Biotechnology Co., Ltd