DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS VACCINE ADSORBED (DPT Adsorbed)

Connaught

Vaccine

Indications: The primary immunization of infants, at or above the age of 2 months, and of children through 6 years of age against diphtheria, tetanus and whooping cough.

Contraindications: Infants or children with fever, other evidence of acute illness or infection. The presence of an evolving or changing neurologic disorder is a contraindication to receipt of this vaccine.

Recent data suggest that infants and young children who have previously had convulsions (whether febrile or non-febrile) are more likely to have seizures following pertussis vaccination than those without such histories. In infants and young children who have a history of seizures before receiving vaccine or who develop seizures before the primary series is completed, initiation or continuation of pertussis immunization should be deferred until an evolving neurological disorder can be excluded.

Occurrence of any of the following signs, symptoms or conditions following administration is a contraindication to further use of this product and/or pertussis vaccine as the single antigen: fever over 40°C; convulsion(s) with or without accompanying fever; alterations of consciousness; focal neurologic signs; screaming episodes; shock; collapse; thrombocytopenia purpura.

Elective immunization of individuals over 6 months of age should be deferred during an outbreak of poliomyelitis.

DPT Vaccine should not be administered to children over 6 years of age or to adults because of the danger of reactions to diphtheria toxoid or to pertussis vaccine and because pertussis is less severe in these age groups than in infants and young children.

Warnings: Individuals receiving corticosteroids or other immunosupressive drugs may not develop an optimum immunologic response.

Precautions: This product should be used only for infants and children from 2 months through 6 years of age.

When an infant or child returns for the next dose in the series of injections, the parent should be questioned about the occurrence of any severe adverse reaction after the previous dose (see Contraindications and Adverse Effects). If any are reported, further doses of DPT Vaccine are contraindicated and active immunization against diphtheria and tetanus should be completed with Diphtheria and Tetanus Toxoids Adsorbed.

The possibility of allergic reactions in individuals sensitive to the components of the vaccine should be borne in mind.

Before the injection of any biological product, the physician should take all precautions known for the prevention of allergic or any other side reactions. These should include - a review of the patient's history regarding possible sensitivity; the immediate availability of epinephrine HCl solution (1:1 000) and other appropriate agents used for control of immediate allergic reactions; and a knowledge of the recent literature relating to the use of the biological product concerned, including thenature of side effects and adverse reactions that may follow its use.

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.

Note: 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 erythema, pain and tenderness, swelling and induration at the injection site are common, usually self-limited and subside without treatment.

Persistent nodules at the site of injection have occurred following the use of an adsorbed vaccine, but this complication is unusual. Abscess at the site of injection has been reported (6 to 10 per million doses).

Mild to moderate systemic reactions occur frequently following injections of this vaccine. These usually consist of one or more of the following symptoms and signs: temperature elevation³38°C, drowsiness, fretfulness, anorexia, vomiting, irritability, persistent or unusual crying. These symptoms are most frequent during the first 24 hours following vaccine injection and may persist for one to two days.

The adverse reactions listed below, which can be serious and occasionally fatal, have been reported following administration of preparations containing pertussis vaccine. The incidence of these reactions is unknown, but they seem to be exceedingly rare. If any of these reactions occur, further immunization against pertussis is contraindicated (see also Contraindications and Precautions).

1. High fever-40.5°C.

2. Collapse with rapid recovery.

3. Collapse followed by prolonged prostration and a shock-like state.

4. Screaming episodes, usually a prolonged period of peculiar crying during which the infant can not be comforted.

5. Isolated convulsion(s) with or without fever.

6. Frank encephalopathy with changes in the level of consciousness, focal neurologic signs and convulsions with or without permanent neurological and/or mental deficit.

7. Thrombocytopenia purpura.

Sudden-infant-death-syndrome (SIDS) has been reported following administration of vaccines containing diphtheria and tetanus toxoids and pertussis vaccine. The significance of these reports is not clear. It should be borne in mind that the three primary immunizing doses of these vaccines are usually administered to infants between the age of 2 and 6 months and that approximately 85% of SIDS cases occur in the period from 1 through 6 months of age with the peak incidence at age 2 to 4 months.

Dosage: Primary immunization of infants and preschool children. Three i.m. injections of 0.5 mL with an interval of 4 to 8 weeks between doses. Each injection of the primary immunization series should be made into a different site. The vastus lateralis (mid-thigh laterally) is the preferred injection site for infants. For a lasting immunization effect a fourth injection of 0.5 mL approximately 1 year following the 3rd dose is considered essential.

Although it is recommended that immunization be started at 2 to 6 months of age, if for any reason it is delayed, the same schedule may be used throughout the preschool period.

Reinforcing Dose: 0.5 mL i.m. between 4 and 6 years of age (i.e., at the time of school entry).This dose 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.), pertussis vaccine (4 to 12 Protective Units) and aluminum phosphate 1.5 mg. Thimerosal 0.01% is added as a preservative. Multidose rubber stoppered vials of 5 mL and glass ampuls of 0.5 mL (1 dose). Store at 2 to 8°C. Do not freeze. Product exposed to freezing should not be used.