Gene-HBvax
RECOMBINANT HEPATITIS B VACCINE

1.0 ml of dose contains:

• Purified Hepatitis B surface antigen ………………………….~ 20 µg
• Aluminium hydroxyde (as Aluminium)……………………… ≤ 600 µg
• Thimerosal……………………………………………………….. ≤ 0.012% (w/v)

0.5 ml of dose contains:

• Purified Hepatitis B surface antigen ………………………….~ 10 µg
• Aluminium hydroxyde (as Aluminium)……………………… ≤ 300 µg
• Thimerosal……………………………………………………….. ≤ 0.012% (w/v)

Gene-HBvax is indicated for active immunization against hepatitis B virus infection. This vaccine will not prevent hepatitis infection caused by other agents as hepatitis A, C…

Healthy high risk groups

• Medical employees (Doctor, dentist, surgeon, nursing, paramedical personnel… )
• Hospital staff are often exposed to blood.
• Laboratory staff.
• Person whose family menbers are infected with the hepatitis B virus, especially baby was born from HBsAg and HBeAg positive mothers.

Patients

• Patients who are frequently have blood transfusions or blood products  which is potentially infected with hepatitis B.
• Immunocompromised patients.
• Patients on heamodialysis.

Others

• Administrative staff, soldiers, prisoners.
• Homosexuals, addicts and injecting drug user.
• Residents and tourists who travele into the high prevalence areas such as: Mediterranean, Cental Europe, South America, Africa and some Asian countries.

• Do not use Gene-HBvax in person with hypersensitivity to any component of the vaccine.
• Congenital diseases.
• Tiredness, high fever or systematic reaction with any acute infectious diseases.
• Heart, kidney, liver diseases.
• Diabetes, malnutritions.
• Leucemia cancer and other malignant diseases in general.
• Hypersensitivity disease.

The most reactions are soreness, erythema, swelling at the injection site as all adsorbed vaccines. These reactions will be disappeared within 2 days after vaccination. Systematic reactions such as fever, headache, nausea, dizziness, fatigue have been observed in some persons but the cause related with the vaccination has been unknown.

Cautions
As an injectable vaccine, always must have epinephrine ready to use for the case of rare anaphylactic shock may occur.

For pregnant women and breast-feeding women

The effect of the antigen on foetal development is unknown, therefore, vaccination for pregnant women is not recommended in general. As all inactivated viral vaccines, the risk to the fetus is considered negligible. Immuno response on breast-feeding women has not studied yet. Thus, the vaccine does not indicate for this subject.

Warnings
Because of the long incubation period of hepatitis B, subject has been exposed with infectious disease at the time of vaccination without clinical symptom has been observed. The vaccine can not prevent the vaccinees in such cases.

Gene-HBvax should not be administrated in the gluteal region or intradermally because of the administration may not obtain a optimum immune response.

Do not inject intravenously

In heamodialysis patients who have an imbalance of the immune system because adequate antibody concentrations may not be obtained after the usual immunization schedule so such patients must require booster doses.

Administration: Administration by intramuscularly route only.

Do not administrate intravenously and subcutaneously. Adults: The vaccine should be injected in the deltoid region, Children: It is recommended better to administrate the vaccine in the outer thighs region is better because the deltoid is still small. Subcutaneous administration is exception for hemophiliacs. The vials should be well shaken before use.

Dosage

• Adults: 20 µg/dose 1 ml (over 10 years old).
• Children: 10 µg/dose 0.5 ml (under 10 years old).

Schedule: Immunization schedule consists of 3 doses with intramuscularly as follow:

(1)   1^st dose: Injection of first time. For the newborns it is the best vaccination within the first 24 hours after birth.

2^nd dose: 1 month after the first injection.

3^rd dose: 2 months after the first injection.

A booster dose: 1 year after the first injection.

(2)   1^st dose: Injection of first time. For the new borns it is best vaccination within the first 24 hours after birth.

2^nd dose: 1 month after the first injection.

3^rd dose: 6 months after the first injection.

A booster dose: 5 years after the first injection.

Gene-HBvax may be administrated with Hepatitis B immunoglobulin at the same time but at different injection sites. Hepatitis B Immunoglobulin and hepatitis B vaccine must be injected together in case as follow:

• Risk of exposure to blood infected with hepatitis B (needle, knife,etc…).
• Newborns of HBsAg and HBeAg positive mothers (the best time is within 24 hours after birth).

Gene-HBvax can be given concurrently with diphtheria, tetanus, pertussis vaccines (DPT); polio, BCG vaccine without affecting to efficiency. However, the vaccine should be given with different syringes and at different sites.

Overdose research is unfeasible. However, there is not any official report from user about overdose. However as the other vaccines the overdose should be avoided.

Further more Gene-HBvax is inactivated purified vaccine so it is quite safety.

Transportation and Store at from +2^oC to +8^oC. Do not freeze.

The expiry is 36 months from manufacturing date at +2^oC to +8^oC.

1.0 ml/vial x 10 vials/box.

0.5ml/vial x 10 vials/box.

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