Description:

Rabies Antiserum Immunoglobulin 1000 IU/5 mL is a sterile solution containing rabies-specific antibodies. It provides immediate passive immunity by neutralizing the rabies virus at the site of exposure, serving as a critical component in post-exposure prophylaxis (PEP) for individuals potentially exposed to rabies.

Prescription:

• Prescription-only 

 Dosage:

• The recommended dose is 20 IU per kilogram of body weight.
• For a 70 kg adult, this equates to 1,400 IU, or 7 mL of the solution.
• As much of the dose as anatomically feasible should be infiltrated around and into the wound(s).
• Any remaining volume should be administered intramuscularly at a site distant from the vaccine administration site.
• Administration should occur as soon as possible after exposure, ideally within 24 hours, and no later than 7 days after the first dose of rabies vaccine.

 Therapeutic Category:

• Immunoglobulin / Passive Immunization Agent

Active Ingredients/Composition:

• Rabies Immunoglobulin derived from human plasma or equine serum, standardized to 1000 IU per 5 mL vial.

 Variant:

• Available as a 5 mL vial containing 1000 IU of rabies immunoglobulin.

Consume Type:

• Parenteral — Administered via infiltration into and around the wound and intramuscular injection.

Directions/Usage:

1. Wound Care: Immediately and thoroughly cleanse all bite wounds and scratches with soap and water.
2. Administration: Infiltrate as much of the calculated dose as anatomically feasible into and around the wound(s). Any remaining volume should be administered intramuscularly at a site distant from the rabies vaccine injection site.
3. Combination with Vaccine: Rabies immunoglobulin should be used in conjunction with a full course of rabies vaccine.

Common Side Effects:

• Pain at the injection site
• Fever
• Headache
• Nausea
• Allergic reactions, including rash or, rarely, anaphylaxis

Package Type:

• Supplied in glass vials, each containing 5 mL of solution equivalent to 1000 IU of rabies immunoglobulin.

 Storage Advice:

• Store at 2°C to 8°C (36°F to 46°F).
• Do not freeze.
• Protect from light.

 Safety Advice:

• Not recommended for individuals with known hypersensitivity to human immunoglobulins or any component of the formulation.
• Use with caution in individuals with a history of allergic reactions to blood products.
• Not indicated for individuals who have previously received a complete rabies vaccination series and have adequate antibody titers.

Product Substitutes:

• Rabix-IG (Incepta Pharmaceuticals Ltd.)
• Favirab (Synovia Pharma PLC.)
• Rabivax-IG (Popular Pharmaceuticals Ltd.)

Manufacturer/Marketer:

• Bharat Serums & Vaccines Ltd.

 Country of Origin:

• India