Rabineutra Ormutivimab Application Scope

Passive immunization for persons exposed to rabies virus—used in combination with rabies vaccination for post-exposure prophylaxis (PEP) in adults and children aged ≥ 2 years.

Intended for use in Category III rabies exposures (high-risk exposures) and for persons managed as Category III exposures.

Rabineutra Ormutivimab Characteristics

Ingredients: Ormutivimab
Properties: Clear to slightly opalescent, colorless to slightly yellow solution for injection
Packaging Specification: Typically supplied as a 2.5 mL single-use vial or pre-filled syringe, containing 40 IU/mL
Storage: Store at +2°C to +8°C (in a refrigerator)
Expiry Date: Refer to the product carton and vial label for the specific expiration date
Executive Standard: As stated in the official registration documentation and product label
Approval Number: See the official product approval documentation/label
Date of Revision: Refer to the most recent product insert
Manufacturer: Hetero Biopharma Limited

Guidelines for the Use of Rabineutra Ormutivimab

Dosage and Administration:
- Recommended Dose: 20 IU per kilogram of body weight. (Example: A 50 kg person requires 1000 IU, i.e., 10 vials/syringes of 100 IU each).
- Administration: Local infiltration of the wound(s) where feasible; use the remainder by appropriate parenteral route as described on the label. Must be administered together with rabies vaccine according to PEP schedules. See product insert for step-by-step instructions.
- Missed Dose: This product is a single-course passive immunization given at the time of exposure; follow the product insert and the local PEP protocol. For vaccine schedule delays, consult local guidelines—Rabineutra should be given as soon as possible after exposure and per label instructions.
Adverse Reactions:
- Common Adverse Reactions: Generally well-tolerated. Reactions may include mild pain, tenderness, redness, or itching at the injection site. Low-grade fever and headache have also been reported.
- Serious Adverse Reactions: Very rare. Potential for hypersensitivity/allergic reactions (e.g., urticaria, rash, anaphylaxis). No cases of serum sickness have been reported, which is a risk with equine RIG.
Contraindications: A history of severe allergic reaction (e.g., anaphylaxis) to any component of this medicinal product.
Precautions:
- Must NEVER replace the full course of rabies vaccination. It is an adjunct to vaccination.
- For multiple or extensive wounds, the calculated dose may be insufficient for complete infiltration. In such cases, dilute the product with sterile normal saline to ensure all wounds are adequately infiltrated.
- Use with caution in individuals with a history of hypersensitivity to proteins of human or recombinant origin.
- Administer with a separate syringe and at a different site from the rabies vaccine.

Rabineutra Ormutivimab Interactions

No known pharmacological interactions have been identified.
The most important interaction is its synergistic use with rabies vaccine, which is mandatory and not an “interaction” in the adverse sense.
Can be safely administered to individuals receiving other routine medications.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.