xunke ormutivimab injection 200 iu (1ml) vial

Description

Indication & Scope

Ormutivimab is a rabies passive immunization agent for adults and children aged ≥2 years with Grade III rabies exposure or managed as Grade III exposure, applied in emergency prevention of rabies after animal bites/scratches and must be combined with rabies vaccine.

Mechanism
As fully human anti-rabies IgG1 monoclonal antibody, it specifically binds and neutralizes rabies virus glycoprotein to block virus invasion into host cells, providing immediate passive antibody protection during vaccine immune window.
Drug class
Class 1 therapeutic biological product, recombinant human monoclonal antibody, rabies passive immunotherapeutic.
Clinical use
Phase III clinical trials verified its favorable safety and efficacy combined with rabies vaccine with low immunogenicity; clinically administered via wound infiltration and intramuscular injection at single dose of 20IU/kg body weight, the first domestic fully human anti-rabies mAb approved for children over 2 years old.

Specification

Generic Name	Ormutivimab Injection
Brand Name	XunKe®
Ingredient	Ormutivimab
Dosage Form	Solution for injection
Package	200iu(1ml)/vial
Conditions Treated	Passive immunization for rabies virus exposure in adults and children aged ≥2 years, indicated for Grade III rabies exposure or cases managed as Grade III rabies exposure, to be used in combination with rabies vaccine
Taboos	Contraindicated for patients with hypersensitivity to the active ingredient or any excipients of this product, or those with severe allergic history
Place of origin	Hebei, China
Priscription Type	Prescription drug (Rx)
Storage Conditions	Store at 2–8℃, avoid freezing and light
Manufacturer	NCPC Jintan Biotechnology Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA)
Approval number	S20220003
Date of Revision	May 13, 2024
Shelf Life	24 months

How to use ?

Recommended Dose: 20 IU/kg single dose. Divide evenly for wound infiltration; residual dose injected intramuscularly away from vaccine site.
Time: Give within 24h post exposure; usable up to 7 days after first rabies vaccine shot.
Interaction: For wound infiltration & intramuscular injection only, IV injection forbidden. Calculate dose by weight, disinfect wounds first. Must be combined with rabies vaccine.
Side effects: Mild, temporary reactions common: injection pain, redness, swelling, itch, fever, fatigue, headache, muscle ache. Rare allergy, urticaria; severe anaphylaxis very rare.

Important Notice

This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support