Form: Solution for Intramuscular Injection, 250 antitoxin units (AU) pre-filled syringes
Manufacturer: Grifols Therapeutics LLC
Imported and Distributed by: Grifols Canada Ltd.
Indications
Prophylaxis: Against tetanus following injury in patients with incomplete or uncertain immunization.
Treatment: Limited evidence for use in treating active cases of tetanus.
Contraindications
Hypersensitivity: Anaphylactic or severe systemic reactions to immunoglobulin (Human) or any ingredient in the formulation.
Conditions: Severe thrombocytopenia or any coagulation disorder contraindicating intramuscular injections. IgA deficient patients with antibodies against IgA and a history of hypersensitivity.
Serious Warnings and Precautions
Administration: For intramuscular injection only; do not give intravenously.
Infectious Agents: Products made from human plasma may contain infectious agents like viruses.
Dosage and Administration
Dosing Considerations: For intramuscular injection only.
Prophylactic Dose: 250 units by deep intramuscular injection for both adult and pediatric patients.
Wound Management: Use in conjunction with tetanus toxoid-containing vaccine based on wound severity and patient's immunization history.
Active Tetanus Treatment: Immediate implementation of standard therapy including HyperTET® with dosage adjusted according to infection severity.
Administration Instructions
Inspect visually for particulate matter and discoloration.
Administer intramuscularly in the anterolateral aspects of the upper thigh or deltoid muscle; avoid the gluteal region to prevent sciatic nerve injury.
Use UltraSafe® needle guard for safety and proper disposal.
Overdosage
No specific data available; potential manifestations include pain and tenderness at the injection site.
Adverse Reactions
Common: Slight soreness at the injection site, slight temperature elevation, rash, and pruritus.
Severe: Rare occurrences of angioneurotic edema, nephrotic syndrome, and anaphylactic shock.
Drug Interactions
Vaccine Interference: Antibodies may interfere with live viral vaccines like measles, mumps, polio, and rubella; defer these vaccines until 3 months post-administration.
Clinical Pharmacology
Mechanism of Action: Supplies passive immunity by neutralizing the tetanus toxin.
Pharmacokinetics: Peak blood levels of IgG obtained approximately 2 days after injection, with a half-life of approximately 23 days.
Storage, Stability, and Disposal
Store at 2°C to 8°C, do not freeze. Discard unused portions.
Patient Medication Information
Usage: Prevents tetanus in people exposed to the bacteria from injury or wound and may treat active tetanus.
Ingredients: Human Tetanus Immunoglobulin and Glycine.
Side Effects: Pain or soreness at the injection site, slight fever, rash, itching, and rare cases of anaphylaxis.
