Indications: For the primary immunization of infants, at or above the age of 2 months, and of preschool children against diphtheria and tetanus in whom simultaneous immunization against pertussis is not indicated.
Contraindications: Infants or children with fever, or other evidence of acute illness.
Elective immunization of individuals over 6 months of age should be deferred during an outbreak of poliomyelitis.
The vaccine should not be administered to older children (after 6 years of age) nor to adults because of the danger of reactions to diphtheria toxoid.
Warnings: Individuals receiving corticosteroids or other immunosuppressive drugs may not develop an optimum immunologic response.
Precautions: The possibility of allergic reactions in individuals sensitive to the components of the product should be borne in mind.
Epinephrine HCl solution 1:1 000 should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.
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.
Adverse Effects: Mild local reactions consisting of pain, erythema, tenderness and induration at the injection site are common, and may be associated with systemic reactions including mild to moderate transient fever and irritability.
Persistent nodules at the site of injection have occurred following the use of an adsorbed product, but this complication is unusual.
Dosage: For primary immunization of infants, it is recommended that 3 i.m. injections of 0.5 mL be administered at 2, 4 and 6 months of age, followed by a fourth dose (0.5 mL) 1 year after the third dose, or at 18 months of age.
Although it is recommended that immunization be started at 2 to 6 months of age, if for any reason it is delayed, a similar schedule (3 doses with an interval of 2 months between doses, followed by a fourth dose 1 year after the third dose), may be used throughout the preschool period.
A reinforcing injection of 0.5 mL i.m. should be administered between 4 and 6 years of age (i.e., at the time of school entry). This booster is not necessary if the fourth primary immunizing dose has been administered after the fourth birthday.
Supplied: Each 0.5 mL dose contains: diphtheria toxoid (25 Lf.) tetanus toxoid (5 Lf.) and aluminum phosphate 1.5 mg. Thimerosal 0.01% is added as a preservative. Rubber stoppered vials of 5.0 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.