Instruction for use: The hepatitis B recombinant (rDNA)

Dosage form: Suspension for intramuscular injection

Active substance: Vaccinum ad prophylaxim hepatitis epidemicae B

ATX

J07BC01 Hepatitis B virus inactivated whole

Pharmacological group:

Vaccines, serums, phages and toxoids

Composition and release form

Suspension for intramuscular administration (for children and adolescents under 19 years) 1 dose (0.5 ml)

Purified surface antigen of hepatitis B virus 10 μg

Aluminum hydroxide (Al +++) 0.25-0.4 mg

Thiomersal 0.025 mg

In glass bottles (type 1, USP) or glass ampoules of 0.5 ml (1 infant dose) or 5 ml (10 children's doses), or 10 ml (20 children's doses); In a box of cardboard 10, 25 and 50 bottles or 50 ampoules.

Suspension for intramuscular administration (for adults aged 19 years) 1 dose (1 ml)

Purified Hepatitis B Virus Surface Antigen 20 μg

Aluminum hydroxide (Al +++) 0.5-0.8 mg

Thiomersal 0.05 mg

In glass bottles (type 1, USP) or glass ampoules of 1 ml (1 adult dose) or 5 ml (5 adult doses), or 10 ml (10 adult doses); In a box of cardboard 10, 25 and 50 bottles or 50 ampoules.

Dosing and Administration

IM, adults, older children and adolescents - in the deltoid muscle;

Newborns and young children - in anterolateral lateral surface of the thigh.

In no case should the vaccine be administered IV.

Patients with thrombocytopenia and hemophilia should be given the vaccine sc.

Before use, the vial or ampoule with the vaccine should be shaken several times until a homogeneous suspension is obtained. The vaccination procedure should be carried out with strict adherence to aseptic and antiseptic rules. The drug from the opened multi-dose vial should be used within one day.

A single dose of vaccine for children and adolescents under the age of 19 is 0.5 ml (10 μg HBsAg);

For adults from 19 years - 1 ml (20 mcg HBsAg);

For hemodialysis patients, 2 ml (40 μg HBsAg).

The vaccine can be administered concomitantly (on the same day) with the vaccines of the National Immunization Calendar, with the exception of BCG, as well as the yellow fever vaccine. In this case, the vaccines should be injected in different places with different syringes.

Immunization schedule

To achieve the optimal level of protection against hepatitis B, IM injections are needed according to the following schemes:

Vaccination of children in the National calendar of preventive vaccinations

Newborns are vaccinated three times according to the scheme: 0-1-6 months. The first injection of the vaccine is on the child's birthday. For newborns whose mothers are carriers of hepatitis B virus, a vaccination schedule of 0-1-2-12 months is recommended. Simultaneously with the first inoculation, an immunoglobulin against hepatitis B can be injected into / in another thigh.

Children, adolescents and adults not previously vaccinated against hepatitis B are vaccinated according to the following pattern: 0-1-6 months.

Accelerated

In emergency cases, accelerated vaccination is carried out according to the scheme:

1st dose: on the selected day;

2nd dose: 1 month after the first dose;

3rd dose: 2 months after the first dose;

4th dose: 12 months after the first dose.

Such vaccination results in a rapid development of protection against hepatitis B, but antibody titers may be at a lower level of vaccine levels than with standard immunization.

Hemodialysis vaccination

Patients undergoing hemodialysis are recommended an additional dosage indicated below:

1st dose 40 μg (2 ml): on the selected day;

2nd dose 40 mcg (2 ml): 30 days after the 1st dose;

3rd dose 40 mcg (2 ml): 60 days after the 1st dose;

The 4th dose of 40 mcg (2 ml): 180 days after the 1st dose.

Vaccination with established or suspected contact with the hepatitis B virus

When exposed to a material infected with the hepatitis B virus (eg a needle contaminated needle), the first dose of hepatitis B vaccine should be administered concomitantly with immunoglobulin against hepatitis B (injections at different locations). Further vaccinations are recommended for accelerated immunization.

Revaccination

With primary immunization at 0, 1, 6 months, a second vaccination may be needed 5 years after the initial course.

For primary immunization at 0, 1, 2 months, a second immunization is recommended after 12 months after the first dose. The next vaccination may be needed after 8 years.

Precaution measures

You cannot enter IV or IV. Caution should be exercised in cardiopulmonary failure and in patients at high risk of adverse effects in developing a febrile or systemic reaction. In the case of severe acute infection, it is advisable to postpone vaccination, except in situations where delay is a great danger. Against the background of immunodeficiency and the appointment of immunosuppressive therapy requires a higher dose of vaccine.

Storage conditions of the drug The hepatitis B recombinant (rDNA)

At a temperature of 2-8 ° C. Short-term (not more than 72 hours) transportation at a temperature of 9 to 20 ° C is allowed.

Keep out of the reach of children.

Shelf life of the drug The hepatitis B recombinant (rDNA)

2 years.

Do not use after the expiry date printed on the package.