Dosage/Direction for Use
Intramuscular Active immunisation against tetanus Adult: As ≥40 IU/0.5 mL preparation: Primary immunisation: 0.5 mL for 2 doses, given 4-8 weeks apart, followed by a 3rd dose of 0.5 mL 6-12 months after the 2nd dose. Booster dose: 0.5 mL every 10 years. For neonatal tetanus prophylaxis in pregnant women, the 1st dose is preferably administered ≥90 days prior to birth. Child: Neonates, infants, children, and adolescents: Primary immunisation: Same as adult dose. Treatment recommendations may vary per country; refer to local product guidelines and paediatric vaccine schedules for specific recommendations. Intramuscular Prophylaxis of tetanus in wound management Adult: Consider the immunisation status of the patient and the type and condition of the wound. Non-immunised or partially immunised patients, uncertain vaccination history; completely immunised and >10 years since last booster dose: 0.5 mL (≥ 40 IU) to be given immediately. Completely immunised patients with minor, clean wounds who have been vaccinated within the last 5-10 years may not need a prophylaxis dose. Non-immunised or partially immunised patients or those with uncertain vaccination history are recommended to start and complete a primary series. Refer to detailed product or local treatment guidelines for specific dosing recommendations. |
Contraindications
Hypersensitivity. Neurological disorder following a previous dose of vaccine.
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Special Precautions
Patient with bleeding disorders (including thrombocytopenia) or vitamin K deficiency, history of respiratory immaturity. Patient who developed Guillain-Barre syndrome within 6 weeks of receiving tetanus toxoid-containing vaccine. Defer immunisation in patients with acute infection or febrile illness; vaccination may be given in patients with mild acute illness (with or without fever). Consider delaying vaccination in patients with severe immunosuppression (e.g. receiving chemotherapy/radiation therapy or high-dose corticosteroids) until the end of the treatment; vaccination in patients with chronic immunosuppression (e.g. HIV infection) is recommended. Avoid vaccination more frequently than every 10 years in patients who have experienced Arthus-type hypersensitivity reaction following vaccination of tetanus toxoid. Patient receiving anticoagulant therapy. Very premature infants (born ≤28 weeks of gestation); infants and children (particularly if with neurological disease, history of febrile seizure, or cerebral damage). Pregnancy and lactation. Monitoring Parameters Monitor for hypersensitivity reaction and syncope for at least 15 minutes post-vaccination.
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Adverse Reactions
Significant: Anaphylactoid or hypersensitivity reactions (including Arthus-type hypersensitivity), syncope, Guillain-Barre syndrome, brachial neuritis.
Blood and lymphatic system disorders: Lymphadenopathy, thrombocytopenia.
Gastrointestinal disorders: Nausea.
General disorders and administration site conditions: Inj site reactions (e.g. inflammation, warm sensation, pain, rash, induration, oedema; nodules which may develop into aseptic abscess), transient fever, malaise, irritability.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
Nervous system disorders: Dizziness, headache.
Respiratory, thoracic and mediastinal disorders: Apnoea (particularly in very premature infants).
Skin and subcutaneous tissue disorders: Urticaria, erythema nodosum, generalised pruritus, rash.
Vascular disorders: Hypotension.
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Drug Interactions
May decrease therapeutic effect with immunosuppressants. Risk of haematoma or bleeding following IM inj in patients receiving anticoagulant therapy.
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Action
Tetanus toxoid adsorbed vaccine is a preparation of inactivated toxin produced by virulent tetanus bacilli (detoxified growth product of Clostridium tetani). It acts as an antigen and produces active immunity against tetanus.
Duration: Immunity: Approx 10 years. |
Storage
Intramuscular: Store between 2-8°C. Protect from light. Do not freeze. Opened multidose vials may be stored for up to 4 weeks under appropriate cold chain conditions.
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CIMS Class
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