Meningococcal group A polysaccharide vaccine (Lyophilisate) Instructions for Use

ATC Code

J07AH01 (Meningococcus A purified polysaccharide antigen)

Active Substance

Meningococcal group A polysaccharide vaccine

Clinical-Pharmacological Group

Vaccine for the prevention of diseases caused by meningococci

Pharmacotherapeutic Group

Vaccines; bacterial vaccines; vaccines against meningococcal infection

Pharmacological Action

Administration of the vaccine leads to an intensive increase in specific antibodies in the blood of vaccinated individuals, providing immunity to meningococcal infection caused by meningococcus serogroup A within 1 week.

Immunity persists for 3 years after vaccination. Revaccination is carried out if necessary no earlier than 3 years after the first immunization.

The vaccine does not provide immunity against infection caused by other serogroups of Neisseria meningitidis, nor against meningitis of other etiologies.

Indications

Vaccination of children over 1 year of age, adolescents, and adults: in foci of meningococcal infection caused by meningococci serogroup A; in endemic areas, as well as in case of an epidemic caused by meningococci serogroup A; vaccination of persons subject to conscription for military service.

ICD codes

Dosage Regimen

Reconstitute the lyophilisate immediately before use with the supplied solvent. Use a single dose of the vaccine.

Administer the vaccine once via the subcutaneous route. The preferred injection sites are the subscapular area or the upper third of the shoulder.

For revaccination, administer a single dose if indicated. Perform revaccination no earlier than 3 years after the initial immunization.

This vaccine is indicated for individuals from 1 year of age through adulthood, including adolescents and adults.

Inspect the reconstituted vaccine visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particles.

Discard any unused vaccine or solvent after the single dose has been withdrawn. Do not store reconstituted vaccine.

Adverse Reactions

Very common pain at the injection site, redness at the injection site, its duration does not exceed 2 days.

Common chills, fever 6-8 hours after vaccination, with subsequent normalization within 24 hours.

Contraindications

Allergic reaction to previous administration of meningococcal vaccine. Acute diseases (infectious and non-infectious); exacerbation of chronic diseases (in these cases, vaccination is carried out 2-4 weeks after recovery or during remission). For non-severe acute respiratory viral infections, acute intestinal diseases, as well as in foci of meningococcal infection, vaccination is allowed after normalization of body temperature. Chronic diseases in the stage of decompensation. Malignant neoplasms, blood diseases. Pregnancy and breastfeeding period. Severe reaction or post-vaccination complication to previous administration of meningococcal vaccine – fever above 40°C (104°F), swelling, redness more than 8 cm in diameter at the injection site.

Use in Pregnancy and Lactation

Administration of the vaccine is contraindicated during pregnancy and breastfeeding (safety of use in pregnant and breastfeeding women has not been studied, no controlled clinical trials have been conducted).

Pediatric Use

Used in children over 1 year of age.

Special Precautions

As with other vaccines, a protective immune response may not occur in all vaccinated individuals.

To identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the person to be vaccinated with mandatory temperature measurement.

Given the possibility of anaphylactic shock, it is necessary to provide medical observation of vaccinated individuals for 30 minutes after administration of the drug. Vaccination sites must be equipped with anti-shock therapy means.

Prophylactic vaccination is carried out by a trained medical professional in a specially equipped vaccination room. During mass immunization in an epidemic situation, vaccination at home by vaccination teams is allowed.

Information about the vaccination performed (date of administration, name of the drug, dose, batch number, expiration date, nature of the reaction to the vaccination) is entered into the established accounting forms.

Effect on ability to drive vehicles and mechanisms

For patients who experienced adverse reactions upon vaccine administration, driving vehicles or moving mechanisms is possible only after the symptoms of adverse reactions have disappeared.

Drug Interactions

Simultaneous administration of this vaccine with other inactivated vaccines of the National Calendar of Preventive Vaccinations and vaccinations for epidemic indications is allowed, provided they are administered with different syringes into different parts of the body. The interval between vaccinations when administering inactivated vaccines separately or when administering live vaccines should be at least 1 month.

Before vaccination, the doctor should be informed about the recent or concurrent use of another (including over-the-counter) medicinal product.

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.