The Only Single Dose Hepatitis A Vaccine

Formulation:

After reconstitution, each dose (0.5mL) contains:

Hepatitis A live attenuated...NLT 6.50LgCCID50/0.5mL

Description:

Hepatitis A vaccine is a freeze-dried, live attenuated vaccine. The vaccine is prepared from the H2 attenuated strain of the Hepatitis A virus (HAV), propagated in human diploid cells through a series of technological process including culture, harvesting, purification, preparation, filling and freeze-drying.

Pharmacology:

Hepatitis A vaccine confers immunity against HAV infection by the induction of specific antibodies against the virus. The vaccine confers immunity against HAV virus by inducing antibody titers greater than those obtained after passive immunization with immunoglobulin.

Indication:

The vaccine is indicated for active immunization against infection caused by HAV in persons over one and half year of age. It can be used for primary immunization. Hepatitis A vaccine is recommended for pre-exposure prophylaxis of individuals at increased risk of infection and post-exposure prophylaxis. Thus the vaccine is indicated in the following conditions.

1. Residents of communities with high endemic rates or recurrent outbreaks of HAV.

2. Travelers to countries where Hepatitis A is endemic especially when the travel involves rural or primitive conditions.

3. Members of the armed forces, emergency relief workers and others likely to be posted abroad at short notice to areas with rates of HAV infection.

4. Residents and staff of institution where there is an ongoing problem with HAV transmission.

5. Inmates of correctional facilities in which there is an ongoing problem with HAV infection.

6. People with lifestyle determined risks of infection including those engaging in oral or intravenous illicit drug use in unsanitary conditions.

7. People with chronic liver disease who maybe at increased risk of fulminant hepatitis A.

8. Zoo-keepers, veterinaries and researchers who handle non-human primates.

Contraindication:

1. Hypersensitivity to the vaccine or any component of the formulation

2. Acute infectious disease or other serious illness.

3. Acute febrile illness with temperature above 37.5 degree centigrade.

4. Immunological deficiency states.

5. A history of anaphylaxis or any other serious allergic reaction to vaccines

6. Patients with Hemophilia A.

A minor afebrile illness or mild upper respiratory tract infection is not usually a reason to defer immunization with the vaccine.

Warnings:

Hepatitis A vaccine does not provide protection against infection caused by hepatitis B virus, hepatitis C virus, delta virus, hepatitis E virus, or by other pathogens.

Immunocompromised persons (from disease or treatment) may not obtain the expected immune response. Because of the incubation period of Hepatitis A, infection maybe present at the time of vaccination; if so, the vaccine maybe ineffective.

Precaution:

1. The product is a live attenuated vaccine, 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 the vial, or unclear label, or turbidity after dissolution or the presence of foreign body.

3. The vaccine should be used completely within 1 hour after the vial is opened.

4. The vaccine should be given more than 3 month after gammaglobulins administration.

5. As with any parenteral vaccine, epinephrine should be available for use in cases of anaphylaxis or anaphylactoid reaction.

6. Prior to injection, with any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient history with respect to possible hypersensitivity to the vaccine.

7. A separate syringe and needle must be used for each patient to prevent the transmission of infectious agents from person to person.

8. Use by pregnant is not recommended.

Adverse Effects:

Adverse events to Hepatitis A vaccine are usually mild and confined to the first few days after vaccination with spontaneous recovery

Local:

Pain at the site of injection, rednes, swelling, hematoma, induration/ edema, pruritis

These usually subside within 72 hours and no specific treatment is needed. Relevant treatment may be given whenever needed

Systemic:

fever (>37.5˚c axillary) asthenia/ drowsiness headache, myalgia/ arthralgia gastrointestinal disorders, behavioural changes, skin disorders

Dosage:

Add 0.5ml sterile water for injection and shake well till the powder completely dissolves (one single dose). Then inject a single dose of 0.5ml subcutaneously (S.C) over the deltoid muscle of upperarm. No booster dose is usually required. After one and half year of age, only one single dose for child and adult.

Administration:

Parenteral biological products should be inspected visually for extraneous particulate matter and or discoloration before administration. If these conditions exist, the product should not be administered.

Before injection the skin over the site to be injected should be cleansed with suitable germicide.

Administer the vaccine subcutaneously. The preferred site is over the deltoid muscle. Do not administer over the buttocks.

After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel. Do not inject intravenously.

Packaging:

1 glass vial of Lyophilized Powder + 0.5mL diluent (Sterile for injection) per box of 1’s.

Storage:

Store at temperatures +2˚C to 8˚C in dark place. Do not use vaccine beyond the expiration date.

 

Manufactured by:

Zhejiang Pukang Biotechnology Co. Ltd.

No. 587 Binkang Road, Binjiang Distict Hangzhou, 310053 China

 

Imported and Distributed in the Philippines only by:

Vaxines Trading, Inc.

Blk. 1 Lot 33 Uranium St., Pilar Village Las Piñas City (1740)