Shanvac-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 main 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 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

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

Active immunization against hepatitis B in areas with low incidence is recommended for newborns 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 and blood component transfusions, 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.

Active immunization against hepatitis B in areas with a 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 in adults and older children, or into the anterolateral thigh in neonates and infants.

Do not administer intravenously, intradermally, or subcutaneously. Avoid gluteal injection due to risk of reduced immunogenicity.

The standard three-dose schedule (0, 1, and 6 months) is recommended for most individuals. Administer the second dose at least one month after the first; administer the third dose at least two months after the second and at least four months after the first.

An accelerated schedule (0, 1, 2, and 12 months) may be used for individuals requiring rapid protection.

For neonates born to HBsAg-positive mothers, administer the first dose within 24 hours of birth, concurrently with Hepatitis B Immune Globulin (HBIG) at a separate injection site.

The single-dose volume is 10 mcg/0.5 mL for children and adolescents under 20 years of age. The single-dose volume is 20 mcg/1 mL for adults 20 years of age and older.

For immunocompromised individuals, such as those on hemodialysis or with HIV, administer a double adult dose (40 mcg) or use a specialized formulation. Perform post-vaccination serologic testing 1-2 months after the final dose to confirm adequate anti-HBs response.

Revaccinate with a second complete series if the anti-HBs level is less than 10 mIU/mL. For those with an adequate initial response but subsequent loss of antibody, administer a single booster dose.

Adverse Reactions

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

Whole body reactions: rarely – weakness, fever, malaise, flu-like symptoms; in some cases – lymphadenopathy.

Central and peripheral nervous system reactions: 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.

Digestive system reactions: rarely – nausea, vomiting, diarrhea, abdominal pain, changes in liver function parameters.

Musculoskeletal system reactions: rarely – arthralgia, myalgia; in some cases – arthritis.

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

Cardiovascular system reactions: 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 be under medical supervision for 30 minutes.

In the presence of a mild infectious disease, 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.