DIPHTHERIA AND TETANUS TOXOIDS ADSORBED
DIPHTHERIA AND TETANUS TOXOIDS ADSORBED- corynebacterium diphtheriae toxoid antigen and clostridium tetani toxoid antigen injection, suspension
Sanofi Pasteur Inc.
Diphtheria and Tetanus Toxoids Adsorbed is a vaccine indicated for active immunization against diphtheria and tetanus. Diphtheria and Tetanus Toxoids Adsorbed is approved for use in children from 6 weeks through 6 years of age
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine (DTaP) or a DTaP-containing vaccine is recommended for immunization of infants and children 6 weeks through 6 years of age. Diphtheria and Tetanus Toxoids Adsorbed should be used in instances where the pertussis vaccine component is contraindicated.
Diphtheria and Tetanus Toxoids Adsorbed is not to be used for treatment of diphtheria or tetanus infection.
Dosage and Schedule
Diphtheria and Tetanus Toxoids Adsorbed is approved for administration as a 5 dose series at 2, 4, 6, 15-18 months, and 4-6 years. The first dose of Diphtheria and Tetanus Toxoids Adsorbed may be administered as early as 6 weeks of age.
Diphtheria and Tetanus Toxoids Adsorbed is a suspension for injection in 0.5 mL single dose vials.
DESCRIPTION
Diphtheria and Tetanus Toxoids Adsorbed is a sterile, cloudy, white, uniform suspension of diphtheria and tetanus toxoids adsorbed on aluminum phosphate and suspended in isotonic sodium chloride solution for intramuscular injection only. Diphtheria and Tetanus Toxoids Adsorbed vaccine does not contain a preservative.
Each 0.5 mL dose is formulated to contain: 25 Lf diphtheria toxoid and 5 Lf tetanus toxoid. Other ingredients per 0.5 mL dose include: 1.5 mg aluminum phosphate and <100 mcg free formaldehyde.
Diphtheria toxoid is prepared from the toxin produced during the growth of a selected strain of Corynebacterium diphtheriae grown with aeration in submerged culture. The toxin is purified by precipitation, converted to toxoid by the addition of formalin and concentrated by ultrafiltration. The culture medium consists of a tryptic digest of casein, supplemented with cystine, maltose, uracil, inorganic salts and vitamins.
Tetanus toxoid is prepared from the toxin produced during the growth of a selected strain of Clostridium tetani. The toxin is converted to toxoid by the addition of formalin, concentrated and then purified. The culture medium consists of a tryptic digest of casein, supplemented with cystine, dextrose, uracil, inorganic salts and vitamins.
When tested in guinea pigs, the tetanus and diphtheria components induce at least 2 neutralizing units/mL of serum.
The vial stopper is not made with natural rubber latex.
Diphtheria and Tetanus Toxoids Adsorbed is supplied in:
a 0.5 mL single dose vial: NDC No. 49281-225-58;
in packages of 10 vials: NDC No. 49281-225-10.
The vial stopper is not made with natural rubber latex.
Diphtheria and Tetanus Toxoids Adsorbed should be stored at 2� to 8�C (35� to 46� F). Do not freeze. Product which has been exposed to freezing should not be used. Do not use vaccine beyond the expiration date.
PATIENT COUNSELING INFORMATION
Inform the parent or guardian of the following:
It is important to complete the immunization series for maximum protection against diphtheria and tetanus.
Common adverse reactions include local redness, swelling, and tenderness at the injection site, fever, crying, and loss of appetite.
Other adverse reactions can occur. Call your healthcare provider with any adverse reactions of concern.
Provide the Vaccine Information Statements (VIS), which are required by the National Childhood Vaccine Injury Act of 1986.
