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HAVAX®
HEPATITIS A VACCINE
Hepatitis A virus (HM 175 hepatitis A strain) is propagated on primary monkey kidney cell cultures to produce this vaccine. Aer purification from cell lysates, the HAV preparation is formaldehyde-inactivated. The vaccine is adjuvanted by adsorption to aluminum hydroxide. HAVAX is used for the prevention of Hepatitis A virus infection.
Vaccine information
Description
HAVAX®, hepatitis A vaccine is a sterile suspension containing inactivated hepatitis A virus (HM175 hepatitis A strain) absorbed onto aluminium hydroxyde.
The virus is propagated in primary monkey kidney cells Maccaca mulatta. The virus suspension is purified by concentration and ultracentrifuge. The hepatitis A virus is inactivated by formaldehydem.
HAVAX® comply with the World Health Organization requirements for this product.
COMPOSITION
1.0 ml contains:
– Protein contains purified hepatitis A antigen ……………….………………˂ 200µg
– Aluminium hydrowyde (as Aluminium)……………………………………………≤ 500µg
– 2-phenoxyethanol ……………………………….….……………………………….≤ 0.6% (w/v)
0.5ml contains:
– Protein contains purified hepatitis A antigen …………………..……………˂ 100µg
– Aluminium hydrowyde (as Aluminium ………………………………………………≤ 250µg
– 2-phenoxyethanol …………………………………………………………….…….≤ 0.6% (w/v)
INDICATION
– HAVAX® is indicated for active immunization against hepatitis A virus infection in subiects over 2 years old (over 24 months).
– HAVAX® is indicated for active immunization against hepatitis A virus infection in subjects at risk of exposure to HAV:
- Unvaccinated persons travelling to areas where the prevalence of hepatitis A is high.
- Persons for whom there is an increased risk of transmision. These include employees in day care chitdrens centers, paramedtical personnel, rursing, meticat empioyee, sewage workers, food handlers.
- Person who has particularly at risk of infection (Hemophiliacs, frequent blood transfusions, injectable drugs, homosexuals..).
– HAVAX® will not prevent hepatitis infection caused by other agents.
CONTRA-INDICATIONS
- Do not use in person with hypersensitivity to any component of the vaccine.
- Children under 2 vears old (24 months)
- Congenital diseases
-
Tiredness, fever or intensive infectious diseases.
- Heart, kidney, liver diseases.
- Diabetes, malnutritions.
-
Leucemia cancer and other malignant diseases in general.
- Hypersensitivity disease
ADVERSE REACTIONS
The most reactions are soreness, erythema, swelling at the iniection site as all adsorbed vaccines, These reactions will disappear within 2 days after vaccination. Several reactions such as fever, headache, nausea, dizziness, fatique have been observed in some person but the cause related with the vaccination has been unknown.
CAUTIONS AND WARNINGS
Cautions
As a injectable vaccine, always must have epinephrine to use for the case of rare anaphylactic shock may occur
For pregnant women and breast-teeding 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. However, pregnant women can be injected this vaccine in the case of high-risk hepatitis A infection.
Warnings
HAVAX® should not be administrated to hepatitis patients. Because of the long incubation period of hepatitis A, subject has been exposed with infectious disease at the time of vaccination but no clinical symptom has been observed. The vaccine can not prevent in such cases.
HAVAX® should not be administrated in the gluteal region or intradermally because of the administration may not obtain a good immune response.
Do not inject intravenously in dialysis 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.
DOSAGE ADMINISTRATION
Administration: Only inject intramuscular.
– Adults: The vaccine should be injected in the deltoid region.
– Children: The vaccine should be injected in the outside of thigh 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 (over 18 years old): 1ml
– Children (from 2 to under 18 years old): 0.5ml
Schedule: Immunization schedule consists of 2 doses with intramuscularly as follow:
–1st dose: Injection of first time.
– 2nd dose: A booster 6-12 months later.
OVERDOSE AND SOLVENT
Overdose research is unfeasible. However, there is no official report from user about overdose. Further more HAVAX® is inactivated purified vaccine so it is quite safe.
PHARMACODYNAMIC
Clinical research on children 2-5 years & adults
- Adults group with anti HAV(-) before vaccination: after 3 doses following scedule 0-1-6 with injection 150 µg, 70 µg and 50 µg immune response is 100%, 94.1%, 84.2% respectively and the rate is 92.9 %, 100%, 75% for 0-1-2 schedule (one month interval).
- Children group with anti HAV(-) before vaccination: after 3 doses following schedule 0-1-6 with injection 75 ug, 50 ug and 25 µg immune response is 100%,100%, 90.2% respectively and the rate is 92.9 %, 84.8%, 91.7% respectively for 0-1-2 schedule (one month interval).
- Antibody titer GMT after 3 dose 75 µg, 50 µg and 25 µg of schedule 0-1-6 is 720.5; 695 and 315.4 mIU/ml respectively higher than antibody titer GMT of other groups of schedule 0-1-2 is 307.8; 152.4; 82.3 mlU/ml (p<0.01) respectively.
- Response immunity: Hepatitis A vaccine is produced by VABIOTECH has induced a good immune response for both groups: adults and children. Antibody titer after HAVAX® vaccination of both groups is much higher than WHO requirement (Anti-HAV protective level ≥ 20mIU).
DRUG INTERACTIONS
HAVAX® may be administrated with immunoglobulin at the same time and at different iniection sites. HAVAX® can be given concurrently with diphtheria, tetanus, pertussis vaccines(DPT); polio, Hib, Measles-Mumps-Rubella (MMR), hepatitis B vaccine without affecting to efficiency. However, the vaccine should be given with different syringes and at dilferent sites.
STORAGE
Transport and Store from +2°C to +8°C. Do not freeze.
SHELF LIFE
The expiry is 24 months from manufacturing date at +2°C to +8°C.
PACKING SIZE
1.0 ml/vial x 10 vials/box.
0.5 ml/vial x 10 vials/box.
SPECIFICATION
Manufacturer
NOTICE
- SHAKE WELL BEFORE USE
- KEEP OUT OF REACH OF CHILDREN
- READ THE LEAFLET CAREFULLY BEFORE USE
*** All complaints about this vaccine must be reported directly, with information about series number, expiration date and relevant evidence (if any) to the manufacturer: Company for Vaccines and Biological Production No.1 (VABIOTECH). Address: No. 1 Yersin, Pham Đinh Ho Ward, Hai Ba Trung District, Hanoi. Phone: +84-24-39717710
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