【Product Instruction】Healive (Hepatitis A) (Vial)

Revised: 26 October, 2010

HEPATITIS A VACCINE (HUMAN DIPLOID CELL),INACTIVATED

【INSTRUCTION】
Name of the Medical Product

Generic Name: Hepatitis A Vaccine(Human Diploid Cell),Inactivated

Trade Name: Healive®

Composition and Description

Healive®, inactivated hepatitis A vaccine is derived from hepatitis A virus cultured in human diploid cell, followed by harvest, purification, inactivation by formaldehyde and aluminium adsorption. Healive® is a purified sterile suspension.

Active Ingredient: Inactivated hepatitis A virus antigen

Excipients: Aluminium hydroxide, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, and water for injection.

No preservative in Healive®.

Target Groups For Vaccination

Susceptible people aged over 12 months.

Therapeutic Indication

Healive® can induce body to generate immunoreaction against hepatitis A virus, and can be used for prevention of infection caused by hepatitis A virus.

Strength

Each package contains 0.5ml or 1.0ml. Single dose of 1.0ml containing 500u is for adult use. Single dose of 0.5ml containing 250u is for junior use.

Administration and Dosage

ADMINISTRATION: Healive® is for intramuscular injection in the deltoid region. The standard primary immunization consists of two doses, the 1st dose is at the selected date, the 2nd dose will be at 6 months later (i.e. 0, 6 month schedule).
DOSAGE: 500u/1.0ml is recommended for adults and adolescents over the age of 16 years; 250u/0.5ml is recommended for children between 1and 15 years old.

Adverse Reactions

A few adverse reactions will happen, including pain, redness, slightly fever after vaccination, which can be self-recovered within 72 hours without any treatment.
Rare adverse reactions:
(1)Local reaction such as nodule will be self-recovered in one or two months.
(2)Erythra could happen seldom, seek medical treatment if necessary.
Extremely rare adverse reactions:

(1) Anaphylactic erythra: Urticaria could happen within 72 hours after vaccination, which needs medical treatment of antianaphylaxis.

(2) Anaphylactic shock: could happen within one hour after vaccination, which need first-aid measures such as the injection of adrenalin.

(3) Allergic purpura: need medical treatment, such as corticosterone for antianaphylaxis. It could induce the associated anaphylactoid purpura nephritis(APN) if no properly treatment.

(4) Thrombocytopenic purpura.

Contraindication

(1) People who is allergic to any component of vaccine, including excipients, formaldehyde and gentamycin sulfate.
(2) Women during pregnancy.
(3) People who suffer acute diseases, serious chronic disease, acute paroxysm of any chronic disease, fever.
(4) People who have un-controlled epilepsy or other nervous system disease.

Precautions

(1) Shake well before use.
(2) The product should be used with caution for people who or whose family has the history of convulsion or epilepsia, chronic disease and allergy symptoms.
(3) Do not use the product if any crack of the container, foreign matter, or out of expiry date.
(4) This product should be used immediately after open.
(5) The people who injected the human immunoglobumin should vaccinate this product one month after the human immunoglobumin injection.
(6) Adrenalin and other first aid medicine should be prepared at the vaccination place, in case of serious allergy reaction. The people after vaccination should not leave until 30 minutes after vaccination.
(7) Must not be frozen.

Storage

Store or transport between +2℃ and +8℃, protected from light.

Package

Pre filled syringe or vial. The package unit is one syringe or one vial.

Shelf Life

42 months.

Authorization Number

Adult:Guo Yao Zhun Zi S20020035
Junior:Guo Yao Zhun Zi S20020069

Manufacturer

SINOVAC BIOTECH CO., LTD.
Add:PKU BioCity, No. 39 Shangdi Xi Rd, Haidian District Beijing
Postal code:100085
Tel:86-10-82890088
Fax:86-10-62966910
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Add: No. 39 Shangdi Xi Road, Haidian District, Beijing, P.R.C. 100085 Supported by elongtian