Rabix VC

Indications

Rabix-VC is recommended for the preventive immunization against rabies and for the treatment of individuals following potential exposure to rabies.

Pre-exposure Immunization:

Rabix-VC is suitable for the following high-risk groups:

• Professionals frequently exposed to rabies
• Veterinary surgeons and veterinary students
• Technical staff collaborating with veterinary teams
• Laboratory personnel handling rabies-contaminated materials
• Workers in abattoirs and knackers’ yards
• Taxidermists
• Gamekeepers, forestry workers, and naturalists in areas with rabies presence
• Infants particularly at risk of rabies exposure

Post-exposure Immunization:

This vaccine is used for:

• Treatment of individuals bitten by suspected rabid animals
• Treatment of individuals who have come into contact with rabid animals

Always consult a registered medical practitioner before use.

Pharmacology

The rabies vaccine for human use is a freeze-dried formulation containing inactivated rabies virus, produced in Vero cells. Upon reconstitution, the vaccine appears as a clear, colorless sterile solution intended for intramuscular administration.

Dosage

To reconstitute the vaccine, add the contents of the supplied diluent to the vial containing the freeze-dried powder. Avoid shaking. After reconstitution, the solution should be clear and free from particles. The vaccine must be injected immediately after preparation, and the syringe should be disposed of after use.

Administration Method for Intramuscular Use:

• For adults: Administer a 1 ml dose intramuscularly into the deltoid muscle.
• For children under 1 year: Inject into the anterolateral thigh muscle. Avoid the gluteal region and intravenous injection.

Pre-exposure Immunization Schedule:

• For adults and children: 1 ml dosage.
• Primary vaccination: As per WHO guidelines, administer one injection intramuscularly on Days 0, 7, and either 21 or 28, followed by a booster after one year.
• Boosters: Thereafter, a single injection every five years or when the antibody titer falls below 0.5 IU/ml.

Post-exposure Immunization Schedule:

• Local wound treatment: Wash the wound gently and thoroughly with soap or detergent, then flush with running tap water for at least 15 minutes. After cleaning, apply disinfectants such as 70% ethanol or iodine tincture. Do not bandage or suture the wound.
• Vaccination for non-immunized individuals:

Intramuscular Regimens:

• Standard schedule (1-1-1-1-1):
  • Day 0: 1 ml injection
  • Day 3: 1 ml injection
  • Day 7: 1 ml injection
  • Day 14: 1 ml injection
  • Day 28: 1 ml injection
• Abbreviated multisite regimen (2-1-1):
  • Day 0: 2 injections of 1 ml at separate sites
  • Day 7: 1 injection of 1 ml
  • Day 21: 1 injection of 1 ml

For severe (WHO category 3) wounds, rabies immunoglobulin should be administered promptly along with the first dose of the rabies vaccine. The immunoglobulin should ideally be given through local wound infiltration, reserving any remaining dose for muscle injection. Ensure the rabies vaccine is injected at a different site.

Vaccination for Previously Immunized Individuals:

If a patient has completed a post-exposure immunization schedule within the past year and is bitten by a suspected rabid animal, they require one dose on Day 0 and another on Day 3.

If it has been over a year since the last immunization, a complete post-exposure regimen is required. Patients who have had a full immunization and booster within the last three years need one dose on Day 0 and another on Day 3 after a rabid animal bite. For patients who received their last booster over three years ago, a complete post-exposure regimen is necessary. Post-exposure vaccination should be based on severity and conducted under medical supervision.

Always consult a registered medical practitioner before use.

Administration

Co-administration: Be cautious with corticosteroids and immunosuppressants, as they may hinder antibody production and reduce vaccination effectiveness. In such cases, titration of neutralizing antibodies is recommended.

Always consult a registered medical practitioner before use.

Interaction

Concurrent administration of immunosuppressants may compromise the efficacy of the rabies vaccine.

Contraindications

The rabies vaccine should not be given in the following cases:

• Pre-exposure: Severe fever, febrile illness, acute diseases, or progressive chronic conditions. Known hypersensitivity to the vaccine or any of its components.
• Post-exposure: There are no absolute contraindications to post-exposure treatment, as rabies is a fatal disease. Any contraindications should be carefully evaluated before deciding against anti-rabies treatment.

Side Effects

Common side effects include mild local reactions such as pain, redness, swelling, itching, and hardness at the injection site, typically lasting 24-48 hours. Other possible side effects may include moderate fever, shivering, dizziness, fatigue, respiratory issues (shortness of breath, wheezing), abdominal discomfort, vomiting, and allergic skin reactions (urticaria, rash, itching).

Pregnancy & Lactation

Pregnancy: The risks associated with rabies vaccination during pregnancy are not fully understood. However, due to the severe nature of rabies, pregnancy is not a contraindication for post-exposure prophylaxis.

Lactation: It is unknown whether the vaccine passes into human breast milk. Nonetheless, due to the critical nature of the disease, breastfeeding is not considered a contraindication.

Precautions & Warnings

• Intravenous injection is strictly prohibited.
• The rabies vaccine and anti-rabies immunoglobulin should never be administered using the same syringe or injection site.
• Before use, ensure to check the package, label, appearance, and expiration date.
• Administer the reconstituted Rabix-VC as soon as possible.
• Store any unused reconstituted vaccine in a refrigerator at 2°C to 8°C and use within 8 hours; otherwise, discard.

Therapeutic Class

Vaccines, Anti-sera & Immunoglobulin.

Storage Conditions

Keep out of reach of children. Store and transport at temperatures between 2°C and 8°C, away from light. Do not freeze.