Form: 1 mL and 5 mL vials, 300 IU/mL solution for infiltration and intramuscular injection
Manufacturer: Grifols Therapeutics LLC
Imported and Distributed by: Grifols Canada Ltd.
Indications and Clinical Use
Indication: For post-exposure prophylaxis along with rabies vaccine for all individuals suspected of exposure to rabies. Administer as promptly as possible, but can be given up to 7 days after the first dose of the rabies vaccine.
Dosage and Administration
Recommended Dose: 20 IU/kg (0.0665 mL/kg) of body weight.
Administration: Preferably at the time of the first vaccine dose. If possible, infiltrate the full dose around the wound; if not, inject the remainder intramuscularly (deltoid or lateral thigh muscle).
Do Not: Administer in the same syringe or anatomical site as the vaccine.
Contraindications
None known.
Warnings and Precautions
Serious Warnings:
Discuss risks and benefits with the patient before administration.
For intramuscular injection only; do not administer intravenously.
Products made from human plasma may carry the risk of transmitting infectious agents.
Adverse Reactions
Common: Injection site pain, headache.
Less Common: Injection site nodule, abdominal pain, diarrhea, flatulence, nasal congestion, oropharyngeal pain.
Interactions: May interfere with the response to live vaccines (e.g., measles, mumps, polio, rubella). Defer live vaccines for 3 months after administration.
Dilution: Do not dilute with normal saline; use dextrose, 5% (D5W) in water if needed.
Storage and Stability
Storage: Store at 2-8°C. Do not freeze. Use immediately after opening or within 48 hours if stored in a refrigerator.
Special Populations
Pregnant Women: Use only if clearly needed.
Breastfeeding: Unknown if excreted in human milk; use with caution.
Pediatrics and Geriatrics: Safety and effectiveness not established.
Clinical Trials and Efficacy
Study Results: Demonstrated detectable titers of antibodies to rabies virus in 12 healthy adults for 21 days after administration.
