Heberbiovac-HB

Hepatitis B Recombinant Vaccine.

Each vial of 10 μg/0.5 mL, or 20 μg/1.0 mL contains: (See table.)

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Heberbiovac HB. Hepatitis B Recombinant vaccine (CIGS), contains a preparation of the surface antigen of the hepatitis B virus (HBV) obtained from cultures of a transformed yeast by the insertion in its genome of the gene coding for the antigen using recombinant DNA procedures.
The expression product of this gene is extracted and purified by a combination of physical, chemical and biochemical procedures. The purified surface antigen, obtained as an aggregate, forming particles of approximately 22 nm, is finally adsorbed in an aluminium hydroxide gel (0.5 mg. Al3+/dose of 20 μg) to which thiomersal is added as a preservative (0.05 mg/dose of 20 μg). The final product has the appearance of a white-gray material which sediments on the bottom of the container defining two phase: a clear supernatant, essentially protein-free composed of phosphate buffered saline (PBS) with the preservative substance dissolved, plus a precipitated aluminium-hydroxide gel with more than 98% of the antigen adsorbed. When shaken, an opaque gray suspension, takes place, lasting for some minutes, which is the form in which the product should be administered. Fermentation and purification processes have been optimized, scaled-up and standardized to maintain consistency and reproducibility from batch to batch.

EFFECTIVENESS AND SAFETY: As early as 15 to 30 days after the first dose of the vaccine has been administered, a significant number of vaccinated persons may already present specific antibodies. At 60 day (after second dose), more than 65 percent of all vaccinated persons have attained seroconversion, and 15 days after having received the third dose, almost 100 percent of these persons remain completely protected for long periods of time. The most appropriate moment for a booster or reactivation dose after having received the full vaccination protocol has not yet been established with complete accuracy, yet this booster shot should always be administered when specific antibody levels drop below 10 IU/liter or from 1 to 2 years after the third dose. For haemodialysis and other immunocompromised patients, booster dose are recommended in order to ensure an antibody level of ≥10 IU/L. The vaccine's high level of purity and the fact that it has been produced from a recombinant yeast source guarantee the absence of any risk of contamination from infective blood agents or other sources of infection. Various studies show that close to 90 percent of all new-born children from infected mothers, vaccinated immediately after birth, remain protected. It has been proven that this vaccine meets the Hepatitis B prevention requirements established by the World Health Organization (WHO).
This vaccine does not prevent hepatitis caused by other agents different from HBV (as virus A, C and E), but it is considered effective to prevent hepatitis caused by the delta agent.

For active immunization against infection by HBV and prevention of its potential consequences such as acute or chronic hepatitis, liver cirrhosis and primary carcinoma. Specially recommended for the following high-risk population groups: Health workers in direct contact with patients. Morgue, funeral parlor and forensic-service staff.
Students in medical and nursing schools and related technical schools in contact with patients.
Persons who work with blood and blood derivatives.
Travelers going to or coming from high-risk countries or regions.
Household contacts with positive cases.
Handicapped persons receiving social service, persons living in institutions and community homes, and the staff of these institutions.
Patients who have received a number of blood transfusions or those affected with oncological disorders, nephropathies, cirrhosis or receiving hemodialysis or plasmapheresis, among others.
New-born children of infected mothers or all new-born children in high or medium-risk countries or regions.
Patients who will undergo elective surgery with sufficient time for seroconversion.
Receptors of transplanted organs.
Hemophiliacs and other systematic blood receptors.
Soldiers and other military personnel on active duty.
Prisoners, prison guards and other prison employees.
Persons at risk of sexual contamination (e.g. promiscuous persons, male homosexuals, prostitutes and venereal-disease patients) and drug addicts.

Intramuscular injection.
DOSAGE: Adults and children of 10 years and older: A dose of 20 μg.
Neonates, and children under 10 years: A dose of 10 μg.
There are two different schedules: 2 doses at 1 month interval, followed by a third dose 6 months after the first (0-1-6).
3 doses all month interval, followed by a reactivation booster dose a year later (0-1-2+12). This schedule is recommended in cases where there is an immediate risk of infection.
The preparation should be administered by deep intramuscular injection in the deltoid region, or in the anterolateral region of the thigh in neonates. Other forms of administration are not recommended.
In immunodepressed patients, protective levels of antibodies may not be attained and higher doses (usually twice the normal dose) could be necessary.
Patients with renal insufficiency including patients undergoing haemodialysis 16 years of age and above: The primary immunisation schedule for patients with renal insufficiency including patients undergoing haemodialysis is four doses of 40 μg (2 ml) at 0, 1, 2 and 6 months from the date of the first dose. The immunisation schedule should be adapted in order to ensure that the anti-HBs antibody titre remains equal to or higher than the accepted protective level of 10 IU/L.
SHAKE WELL BEFORE USE.

The vaccine should not be administered to persons with feverish states due to severe infections or to persons allergic to any of its components.

Due to long incubation period of Hepatitis B (up to 6 months or more). If the disease is being incubated when the vaccine is administered, vaccination may not be effective.
DO NOT ADMINISTER INTRAVENOUSLY.

Vaccination of pregnant is not recommended but in case of high risk or other special situations, the physician could consider it justified. Abortion is not required in the case of unconscious vaccination.
As with any type of vaccine, a 1:1000 adrenaline solution must be immediately available ready for use in an unexpected and rare case of anaphylactic reaction.

The performed trials demonstrated the very low reactogenicity of the vaccine. Only slight local reactions such as a limited induration, erythema and pain at the site of the injection may appear in some cases, possibly due to the aluminium hydroxide adjuvant. Systemic reactions such as fever, headache, nausea and weakness appeared in a few subjects, but their linkage to vaccination is doubtful and difficult to demonstrate or reject.

STABILTY, EXPIRATION DATE AND STORAGE REQUIREMENTS: This vaccine preparation will remain stable for three years if stored at +2 °C to + 8 °C.
Short exposures to room temperature (25-30 °C) do not affect the vaccine's life, but storage and transportation should be carried out at +2 °C to +8 °C.
DO NOT FREEZE.

Vaccines, Antisera & Immunologicals

J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.

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