Td ADSORBED

Product Information

• Name: Td ADSORBED
• Type: Tetanus and Diphtheria Toxoids Adsorbed
• Form: Suspension for injection
• Manufacturer: Sanofi Pasteur Limited

Indications and Clinical Use

• Indication: Active primary and booster immunization for the prevention of tetanus and diphtheria in individuals 7 years of age and older.
• Use:
• Primary Immunization: Recommended series of three doses.
• Booster Immunization: Single dose for previously immunized individuals, typically at 10-year intervals.
• Tetanus Prophylaxis in Wound Management: Based on wound condition and patient’s vaccination history.

Contraindications

• Hypersensitivity: Known systemic hypersensitivity to any component or life-threatening reaction after previous administration of the vaccine or similar vaccines.

Warnings and Precautions

• General: Inform recipient of benefits and risks, review health status and immunization history, avoid intravascular injection, and postpone vaccination in cases of acute or febrile disease.
• Hematologic: Caution in individuals with bleeding disorders or on anticoagulant therapy; intramuscular injections may cause hematoma.
• Immune Response: May be suboptimal in immunocompromised individuals; hypersensitivity reactions are possible.
• Neurologic: Potential association with Guillain-Barré syndrome and brachial neuritis; careful consideration needed if these conditions occurred after previous tetanus toxoid vaccination.
• Pregnant Women: Use only if clearly needed.
• Nursing Women: Safety not fully assessed, but risk is considered improbable.

Adverse Reactions

• Common: Pain, redness, swelling at the injection site, fever, irritability, drowsiness, loss of appetite.
• Severe: Anaphylactic reactions, Guillain-Barré syndrome, extensive limb swelling.
• Clinical Trials: No serious adverse events reported; common reactions included injection site pain, swelling, and redness.

Drug Interactions

• Vaccine-Drug Interactions: Immunosuppressive treatments may interfere with immune response.
• Concomitant Vaccine Administration: Can be administered with other vaccines using separate syringes and sites.

Dosage and Administration

• Primary Immunization:
• Series of Three Doses: First two doses 4-8 weeks apart, third dose 6-12 months after the second.
• No need to restart the series if interrupted.
• Booster Immunization: Single dose every 10 years for previously immunized individuals.
• Administration: Intramuscular injection, preferably in the deltoid muscle.

Storage and Stability

• Storage: Store at 2°C to 8°C. Do not freeze. Discard if exposed to freezing.

Clinical Trials and Efficacy

• Immunogenicity: High protective antibody levels against tetanus and diphtheria achieved in clinical trials.
• Safety: Generally well-tolerated with mild to moderate adverse reactions; severe reactions are rare.