Regevac^® B (Suspension) Instructions for Use

ATC Code

J07BC01 (Hepatitis B virus purified antigen)

Active Substance

Hepatitis B vaccine (rDNA) (Ph.Eur.)

Clinical-Pharmacological Group

Vaccine for the prevention of hepatitis B

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Hepatitis B vaccine. Promotes the development of immunity against the hepatitis B virus. It is a purified major surface antigen of the hepatitis B virus (HBsAg), obtained using recombinant DNA technology and adsorbed onto aluminum hydroxide.

The antigen is produced by a culture of yeast cells (Saccharomyces cerevisiae), obtained by genetic engineering and having a gene encoding the major surface antigen of the hepatitis B virus. HBsAg is purified from yeast cells using several sequentially applied physicochemical methods.

HBsAg spontaneously transforms into spherical particles with a diameter of 20 nm, containing non-glycosylated HBsAg polypeptides and a lipid matrix consisting mainly of phospholipids. Studies have shown that these particles possess properties characteristic of natural HBsAg.

It causes the formation of specific HBs-antibodies, which at a titer of 10 IU/L prevent hepatitis B disease.

Indications

For active immunization of children and adults against hepatitis B, primarily individuals at risk of hepatitis B virus infection.

Active immunization against hepatitis B in areas with low incidence is recommended for newborns and adolescents, as well as individuals at increased risk of infection, which include:

• Children born to mothers who are carriers of the hepatitis B virus;
• Staff of medical and dental institutions, including employees of clinical and serological laboratories;
• Patients who are undergoing or planning blood and blood component transfusions, scheduled surgical interventions, invasive therapeutic and diagnostic procedures;
• Individuals whose increased risk of disease is associated with their sexual behavior;
• Drug addicts;
• Persons traveling to regions with widespread hepatitis B;
• Children in regions with widespread hepatitis B;
• Patients with chronic hepatitis C and carriers of the hepatitis C virus;
• Patients with sickle cell anemia;
• Patients for whom organ transplantation is planned;
• Persons who abuse alcohol;
• Persons who have close contact with patients or carriers of the virus, and all persons who, due to work or for any other reason, may be infected with the hepatitis B virus.

Active immunization against hepatitis B in areas with moderate or high frequency of hepatitis B incidence, where there is a risk of infection for the entire population, vaccination is necessary (in addition to all the groups listed above) for all children and newborns, as well as adolescents and young adults.

ICD codes

Dosage Regimen

Suspension

The vaccine is administered intramuscularly into the deltoid muscle; to newborns and young children – into the anterolateral surface of the thigh. Administration at another site reduces the effectiveness of vaccination. The ampoule should be shaken before administration.

A single dose for newborns and children and adolescents under 19 years of age is 0.5 ml (10 mcg HBsAg).

A single dose for patients over 19 years of age is 1 ml (20 mcg HBsAg).

For patients in hemodialysis units, the vaccine is administered in a double dose of 2 ml (40 mcg HBsAg).

The vaccination course consists of three intramuscular injections of the vaccine according to the scheme: 0 – 1 – 6 months. If the interval between vaccine injections is extended, the next injection should be carried out as soon as possible, determined by the health status of the vaccinated person. Children over 13 years of age, not previously vaccinated, are vaccinated according to the standard scheme.

For children born to mothers who are carriers of the hepatitis B virus or who had viral hepatitis B in the third trimester of pregnancy, vaccination against viral hepatitis B is carried out according to the scheme 0 (on the day of birth) – 1 – 2 – 12 months.

Vaccination of previously unvaccinated individuals who have had contact with material infected with the hepatitis B virus is carried out according to the scheme 0 – 1 – 2 months.

For patients in hemodialysis units, the vaccine is administered four times with a one-month interval between injections.

Vaccination against hepatitis B can be carried out simultaneously (on the same day) with the administration of vaccines from the national preventive vaccination calendar and inactivated vaccines from the preventive vaccination calendar for epidemic indications. The injections are administered with different syringes into different parts of the body.

Only a disposable syringe is used for injection. The injection site is treated with 70% alcohol before and after the injection. Opening of ampoules and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis.

Ampoules with physical defects that lead to a violation of their tightness must not be used.

The vaccine must not be administered intravenously.

The drug in an opened ampoule must not be stored.

Adverse Reactions

Local reactions slight soreness, erythema and induration at the injection site.

General disorders rarely – weakness, fever, malaise, flu-like symptoms; in some cases – lymphadenopathy.

Nervous system disorders rarely – headache, dizziness, paresthesia; in some cases – neuropathy, paralysis, neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis, convulsions, although a causal relationship of these complications with vaccination has not been established.

Gastrointestinal disorders rarely – nausea, vomiting, diarrhea, abdominal pain, changes in liver function parameters.

Musculoskeletal and connective tissue disorders rarely – arthralgia, myalgia; in some cases – arthritis.

Allergic reactions rarely – rash, itching, urticaria; in some cases – anaphylaxis, serum sickness, angioedema, erythema multiforme.

Cardiovascular disorders in some cases – syncope, arterial hypotension, vasculitis.

Other in some cases – thrombocytopenia, bronchospasm.

Adverse reactions are mild and transient. In many cases, a causal relationship between adverse events and vaccine administration has not been established.

Contraindications

Acute and severe diseases, as well as severe infectious diseases accompanied by fever; manifestation of a hypersensitivity reaction to previous administration of hepatitis B vaccines.

Use in Hepatic Impairment

The drug is used for active immunization of children and adults against hepatitis B. The vaccine does not prevent infections caused by other pathogens, such as hepatitis A, hepatitis C and hepatitis E, as well as pathogens causing other liver diseases.

Geriatric Use

Usually, in people over 40 years of age, the humoral immune response is less pronounced, so such patients may require the administration of additional doses of the vaccine.

Special Precautions

Due to the long incubation period of hepatitis B, a latent hepatitis B virus infection may be present during the vaccination course. In such cases, the use of the vaccine cannot prevent hepatitis B disease.

The vaccine does not prevent infections caused by other pathogens, such as hepatitis A, hepatitis C and hepatitis E, as well as pathogens causing other liver diseases.

The immune response to vaccination is associated with various factors, including age, sex, obesity, smoking and the method of vaccine administration. Usually, in people over 40 years of age, the humoral immune response is less pronounced, so such patients may require the administration of additional doses of the vaccine.

In patients on hemodialysis, in HIV-infected patients and in individuals with other immune disorders, an adequate titer of HBs-antibodies may not be achieved after the main immunization course, so additional vaccine administration may be required.

When administering the vaccine, it is necessary to have available means that may be required in case of anaphylactic reactions. Allergic reactions may develop immediately after vaccine administration, therefore vaccinated patients should remain under medical supervision for 30 minutes.

In the presence of an infectious disease in a mild form, vaccination can be carried out immediately after the temperature normalizes.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.