Diphtheria and Tetanus Toxoids Adsorbed: Suspension for Intramuscular Injection: patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Diphtheria and Tetanus Toxoids Adsorbed safely and effectively. See full prescribing information for Diphtheria and Tetanus Toxoids Adsorbed.

Diphtheria and Tetanus Toxoids Adsorbed

Suspension for Intramuscular Injection

Initial U.S. Approval: 1997

INGREDIENTS AND EXCIPIENTS

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.

INDICATIONS AND USAGE

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 (prior to 7th birthday). (1)

DOSAGE AND ADMINISTRATION

The five dose immunization series consists of an injection administered at 2, 4, 6, 15-18 months and between 4 and 6 years of age. (2.1)

DOSAGE FORMS AND STRENGTHS

Suspension for injection, supplied in single dose (0.5 mL) vials (3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of Diphtheria and Tetanus Toxoids Adsorbed or any other diphtheria toxoid or tetanus toxoid-containing vaccine, or any other component of this vaccine. (4)

WARNINGS AND PRECAUTIONS

If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following Diphtheria and Tetanus Toxoids Adsorbed vaccine. (5.2)

Apnea following intramuscular vaccination has been observed in some infants born prematurely.The decision about when to administer an intramuscular vaccine, including Diphtheria and Tetanus Toxoids Adsorbed, to an infant born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination. (5.5)

Syncope (fainting) has been reported following vaccination with Diphtheria and Tetanus Toxoids Adsorbed vaccine. Procedures should be in place to prevent falling injury and manage syncopal reactions. (5.6)

ADVERSE REACTIONS

The most common adverse reactions (≥5%) were crying, fever, and loss of appetite. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 and http://vaers.hhs.gov.

USE IN SPECIFIC POPULATIONS

Pregnancy Category C

Animal reproduction studies have not been conducted with Diphtheria and Tetanus Toxoids Adsorbed. It is also not known whether Diphtheria and Tetanus Toxoids Adsorbed can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity

Pediatric Use

Diphtheria and Tetanus Toxoids Adsorbed is not indicated for infants below 6 weeks of age or children 7 years of age or older. Safety and effectiveness of Diphtheria and Tetanus Toxoids Adsorbed in these age groups have not been established.

Revised: [06/2013]

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