Indications: For secondary immunization in children aged 7 years and older and adults who have been previously immunized against tetanus and diphtheria. Tetanus and Diphtheria Toxoids Adsorbed may also be used for primary immunization of older children (7 years of age and over) and of adults who have not been previously immunized against tetanus and diphtheria.
Contraindications: Elective immunization should be deferred in the presence of any acute illness, including febrile illness, and during an outbreak of poliomyelitis.
Warnings: Individuals receiving corticosteroids or other immunosuppressive drugs may not develop an optimum immunologic response.
Precautions: Epinephrine HCl 1:1 000 should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.
The possibility of allergic reactions in individuals sensitive to the components of the vaccine should be borne in mind.
Frequent booster doses of tetanus toxoid in the presence of adequate or excessive serum levels of tetanus antitoxin have been associated with increased incidence and severity of reactions and should be avoided. If hypersensitivity to the diphtheria component is suspected, tetanus toxoid should be used for reinforcing doses.
A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent the transmission of hepatitis or other infectious agents from one person to another.
Adverse Effects: Localized reactions consisting of discomfort, pain, swelling and redness at the injection site may occur. These are usually of low frequency and transient in duration. Persistent nodules at the site of injection have occurred following the use of adsorbed vaccine, but this complication is unusual.
Generalized reactions may develop and may take the form of allergic reactions including urticaria and less commonly, angioneurotic edema. Influenza like symptoms may occur within 12 hours of vaccination. Neurological complications such as peripheral neuropathies have been documented but are rare. The incidence of reactions to toxoids (especially to tetanus toxoid) rises according to the number of previously administered doses. This incidence in adults is unlikely to exceed 1% and occurs mainly inthe overimmunized.
Dosage: For individuals who have previously been immunized against tetanus and diphtheria, a dose of 0.5 mL should be administered i.m. as a reinforcing dose at approximately 10 year intervals.
For primary immunization of individuals 7 years or older a series of three (0.5 mL) injections is required with the first 2 injections being administered 2 months apart followed by the third injection 6 to 12 months later. Thereafter reinforcing doses are recommended at approximately 10 year intervals.
Tetanus Prophylaxis in Wound Management: Table I summarizes the recommended use of immunizing agents in wound management. If not clearly documented, a history of immunization should be regarded as uncertain. If a tetanus booster is required it is often appropriate to choose a combined preparation such as Tetanus and Diphtheria Toxoids Adsorbed (for 7 years and older) containing 5 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. Appropriate cleansing and debridement of the wound is imperative.Booster doses given more frequently than recommended above may lead to adverse local and systemic reactions.
Note: Diphtheria and Tetanus Toxoid Adsorbed, containing 25 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid per 0.5 mL dose, should not be administered as a tetanus booster to children over 7 years of age or adults due to the risk of reaction to the high diphtheria toxoid component in this vaccine.
Note: Tetanus toxoid, or a combined vaccine containing tetanus toxoid, and tetanus immune globulin should be administered in separate syringes at different sites.
Supplied: Each dose (0.5 mL) contains: tetanus toxoid (5 Lf.), diphtheria toxoid (2 Lf.) and aluminum phosphate 1.5 mg. Thimerosal 0.01% is added as a preservative. Rubber stoppered vials of 5 mL, and glass ampuls of 0.5 mL (1 dose). Store at 2 to 8C. Do not freeze. Product exposed to freezing should not be used.