H-B-Vax II (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. It promotes the development of immunity against the hepatitis B virus.

It is a purified main surface antigen of the hepatitis B virus (HBsAg), obtained using recombinant DNA technology and adsorbed on aluminum hydroxide. The antigen is produced by a culture of yeast cells (Saccharomyces cerevisiae), obtained by genetic engineering and having a gene encoding the main 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

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

Conducting active immunization against hepatitis B in areas with low incidence is recommended for newborn children and adolescents, as well as individuals with an 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 transfusions and its components, planned 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 a wide spread of hepatitis B;
• Children in regions with a wide spread of 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.

Conducting active immunization against hepatitis B in areas with medium 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

Administer the vaccine by intramuscular injection into the deltoid muscle for adults and older children, or into the anterolateral thigh for neonates and infants.

Do not administer intravenously, intradermally, or subcutaneously. Do not inject into the gluteal region.

For adults and children over 16 years, the standard dose is 10 mcg per injection.

For children and adolescents 11-15 years old, the standard dose is 10 mcg; an alternative two-dose schedule using the 20 mcg adult formulation is also approved for this age group.

For neonates, infants, and children up to 11 years, the standard dose is 5 mcg per injection.

For predialysis and dialysis patients and other immunocompromised individuals, use a 40 mcg dose per injection.

Follow the standard three-dose schedule: administer the initial dose on an elected date, the second dose one month later, and the third dose six months after the first dose.

Adhere to the accelerated schedule for rapid immunity induction: administer doses at 0, 1, and 2 months, with a fourth booster dose at 12 months.

For the two-dose schedule in adolescents 11-15 years, administer the first 20 mcg dose on an elected date and the second 20 mcg dose 4 to 6 months later.

Complete the vaccination course to ensure seroprotection. If a scheduled dose is missed, administer the next dose as soon as possible; do not restart the series.

Assess anti-HBs antibody titers 1 to 2 months after the final dose for individuals at high risk or with potential suboptimal response.

Consider administering a booster dose if post-vaccination testing reveals antibody titers below 10 IU/L.

Shake the vial or pre-filled syringe well before use to obtain a slightly opaque, white suspension. Discard the product if it appears otherwise.

Adverse Reactions

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

From the body as a whole: rarely – weakness, fever, malaise, flu-like symptoms; in some cases – lymphadenopathy.

From the CNS and peripheral nervous system: 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.

From the digestive system: rarely – nausea, vomiting, diarrhea, abdominal pain, changes in liver function parameters.

From the musculoskeletal system: rarely – arthralgia, myalgia; in some cases – arthritis.

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

From the cardiovascular system: 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 that cause 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 infection with the hepatitis B virus may be present during the course of vaccination. 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 that cause 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 course of immunization, so additional vaccine administration may be required.

When administering the vaccine, it is necessary to have available the means that may be required in case of anaphylactic reactions. Allergic reactions may develop immediately after vaccine administration, therefore vaccinated patients should be 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 25°C (77°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.