Cultural concentrated purified inactivated dried antirabies vaccine (Lyophilisate) Instructions for Use

Marketing Authorization Holder

M.P. Chumakov Institute of Poliomyelitis and Viral Encephalitides Enterprise for the Production of Bacterial and Viral Preparations of the RAMS Federal State Unitary Enterprise (Russia)

ATC Code

J07BG01 (Rabies virus inactivated whole)

Active Substance

Rabies vaccine (USP United States Pharmacopoeia)

Dosage Form

Cultural concentrated purified inactivated dried antirabies vaccine

Lyophilizate for preparation of solution for intramuscular administration 2.5 IU/dose: 1 ml amp. 5 pcs. with solvent

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intramuscular administration in the form of a white, hygroscopic, porous mass.

Excipients: human albumin 5 mg, sucrose 75 mg, gelatin 10 mg.

Solvent: water for injections.

2.5 IU (1 dose) – ampoules (5) in a kit with solvent 1 ml amp. (5) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of rabies

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine induces the development of immunity against rabies.

Indications

Post-exposure and pre-exposure immunization of humans against rabies

• Post-exposure immunization
  • Contact and bites of people by animals with rabies, animals suspected of having rabies, wild or unknown animals.
• Pre-exposure immunization
  • Persons with a high risk of rabies infection (laboratory workers handling street rabies virus; veterinary workers; gamekeepers, hunters, foresters; persons involved in animal capture and keeping, and other professional groups).

ICD codes

Dosage Regimen

The contents of the ampoule with the vaccine should be dissolved in 1.0 ml of water for injections. The dissolution time should not exceed 5 minutes. The dissolved vaccine is a clear or slightly opalescent liquid from colorless to light yellow.

The dissolved vaccine is administered slowly intramuscularly into the deltoid muscle of the shoulder; for children under 5 years old – into the upper part of the anterolateral surface of the thigh.

Administration of the vaccine into the gluteal region is not allowed.

The drug in ampoules with damaged integrity, labeling, as well as with changed color and transparency, with an expired shelf life, or improper storage is not suitable for use.

Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic rules.

Storage of the dissolved vaccine for more than 5 minutes is not allowed.

The vaccinated person must be under medical supervision for at least 30 minutes.

Vaccination sites must be equipped with anti-shock therapy means.

Provision of anti-rabies assistance

Anti-rabies assistance consists of local treatment of wounds, scratches, abrasions, places of saliva exposure and subsequent administration of the anti-rabies vaccine or, if indicated, combined administration of anti-rabies immunoglobulin (RIG) and the anti-rabies vaccine. The interval between the administration of RIG and the anti-rabies vaccine is no more than 30 minutes.

Local treatment of wounds

Local treatment of wounds (bites, scratches, abrasions) and places of saliva exposure should begin immediately or as soon as possible after a bite or injury. It involves copious washing for several minutes (up to 15 minutes) of the wound surface with water and soap or another detergent, or, in the absence of soap or detergent, the injury site is washed with a stream of water. After this, the edges of the wound should be treated with 70% alcohol or a 5% water-alcohol solution of iodine.

Stitching of wounds should be avoided if possible. Suturing is indicated exclusively in the following cases:

• For extensive wounds — several guiding skin sutures after preliminary treatment of the wound;
• For cosmetic reasons (applying skin sutures to facial wounds);
• Suturing of bleeding vessels to stop external bleeding.

If there are indications for the use of anti-rabies immunoglobulin, it is used immediately before suturing (see section Dose of anti-rabies immunoglobulin (RIG)).

After local treatment of wounds (injuries), post-exposure immunization is started immediately.

Post-exposure immunization

Indications: Contact and bites of people by animals with rabies, animals suspected of having rabies, wild or unknown animals.

Contraindications: None. Pregnancy is not a contraindication.

A detailed scheme of post-exposure immunization and notes to the scheme are presented in the table (Scheme of post-exposure vaccinations with anti-rabies vaccine and anti-rabies immunoglobulin (RIG).

All persons at risk of rabies infection are subject to post-exposure immunization. If there are indications for combined treatment, RIG is administered first, and no more than 30 minutes after it, the anti-rabies vaccine is administered.

Anti-rabies immunoglobulin (RIG) is prescribed as early as possible after contact with a rabid animal or an animal suspected of having rabies, a wild or unknown animal.

Before administration of heterologous (equine) anti-rabies immunoglobulin, it is necessary to check the individual sensitivity of the patient to horse protein (see “Instructions for use of liquid anti-rabies immunoglobulin from horse serum”). Before administration of homologous (human) anti-rabies immunoglobulin, individual sensitivity is not checked.

Heterologous anti-rabies immunoglobulin is administered no later than 3 days after the bite, homologous anti-rabies immunoglobulin is administered no later than 7 days after the bite.

Dose of anti-rabies immunoglobulin (RIG). Heterologous (equine) anti-rabies immunoglobulin is prescribed at a dose of 40 IU per 1 kg of body weight. Homologous (human) anti-rabies immunoglobulin is prescribed at a dose of 20 IU per 1 kg of body weight. The volume of administered heterologous anti-rabies immunoglobulin should not exceed 20 ml.

Administration of anti-rabies immunoglobulin (RIG). As much as possible of the recommended dose of RIG should be infiltrated into the tissues around the wound and into the depth of the wound. The unused part of the drug dose is administered deeply intramuscularly at a site different from the administration of the anti-rabies vaccine.

Pre-exposure immunization

Indications: For prophylactic purposes, persons with a high risk of rabies infection are immunized (laboratory workers handling street rabies virus; veterinary workers; gamekeepers, hunters, foresters; persons involved in animal capture and keeping, and other professional groups).
The vaccine is administered intramuscularly into the deltoid muscle of the shoulder at 1.0 ml on days 0, 7, and 30. Revaccination is carried out as a single dose of 1.0 ml after one year and then every three years.

Scheme of pre-exposure immunization

Pre-exposure immunization of high-risk groups for rabies infection is carried out in vaccination rooms of medical and preventive institutions, where a “Certificate of Preventive Vaccinations” is filled out and issued, which includes all necessary information (names, batches, doses, frequency and dates of receipt of the drugs).

Adverse Reactions

1. Administration of the vaccine may be accompanied by a local or general reaction. The local reaction is characterized by slight swelling, redness, itching, pain at the injection site, and enlargement of regional lymph nodes. The general reaction may manifest as malaise, headache, weakness, and increased body temperature. Symptomatic therapy, the use of hyposensitizing agents and antihistamines is recommended.

In rare cases, neurological symptoms may develop; such a patient should be urgently hospitalized.

2. After administration of anti-rabies immunoglobulin from horse serum, complications may be observed: a local allergic reaction occurring on days 1-2 after administration; serum sickness, which most often occurs on days 6-8; anaphylactic shock. In case of an anaphylactoid reaction, a solution of adrenaline or noradrenaline is administered subcutaneously in an age-specific dosage and 0.2-1.0 ml of 5% ephedrine.

If symptoms of serum sickness appear, parenteral administration of antihistamines, corticosteroids, and calcium preparations is recommended.

Contraindications

Post-exposure immunization

• None.

Pre-exposure immunization

• Acute infectious and non-infectious diseases, chronic diseases in the stage of exacerbation or decompensation – vaccinations are carried out no earlier than one month after recovery (remission);
• Systemic allergic reactions to previous administration of anti-rabies immunoglobulin (generalized rash, Quincke’s edema, etc.);
• Allergic reactions to antibiotics;
• Pregnancy.

Use in Pregnancy and Lactation

Pregnancy is not a contraindication only for post-exposure immunization.

Drug Interactions

During the course of post-exposure vaccination, vaccination with other drugs is prohibited. After the end of rabies vaccination, vaccinations with other vaccines are allowed no earlier than 2 months later.

Pre-exposure vaccination is carried out no earlier than 1 month after vaccination against another infectious disease.

Storage Conditions

The vaccine is stored and transported at a temperature of 2 to 8°C (46.4°F). Transportation of the vaccine at a temperature of 25°C (77°F) for no more than 2 days is allowed. Store in a place inaccessible to children.

Shelf Life

The shelf life of the vaccine is 2 years.

Dispensing Status

For medical and preventive institutions.

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.