VACCINE RISK AWARENESS NETWORK -"DPT: Polio Combined Vaccine 1984

Indications: Prevention of diphtheria, whooping cough and tetanus. For administration to infants and preschool children only.

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:

**Signs &/or Symptoms**
fever over 40 degrees C. convulsion(s) with or without accompanying fever alterations of consciousness focal neurologic signs screaming episodes shock collapse thrombocytopenia purpura

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

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 Reactions). If any are reported, further doses of DPT Vaccine are contraindicated and active immunization against diphtheria and tetanus should be completed with Diphtheria Toxoid and Tetanus Toxoid (Combined), or 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 HCI solution (1:1000) 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 the nature 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.

Adverse Reactions: 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.

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 elevation >38°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 1to 2 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.)

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: Administer s.c., 3 doses of 1 ml each at intervals of 4 weeks, beginning at 3 to 6 months of age. Reinforcing doses: 1 ml at 6 to 12 months after third dose, 1 ml between 4 and 6 years of age (i.e. at time of school entry.)

Supplied: Each ml contains: 40 Lf of diphtheria toxoid, 8 Lf of tetanus toxoid, and 4 protective units of pertussis vaccine. Available in 1 ml ampoules, boxes of 5; and 10 ml vials. Store at 2° to 8°C. Do not freeze.

Indications: Prevention of diphtheria, whooping cough and tetanus. For administration to infants and preschool children only.

Contraindications: DPT Vaccine should not be administered to 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. While data to support exclusion of pertussis immunization because of a family history of convulsive or other neurologic disorders are scarce, a personal or family history of CNS disease or convulsions is considered a contraindication to use of this vaccine. 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. DPT Vaccine should not be administered to children over 6 years of age or to adults because of the danger of reactions due to diphtheria toxoid or to pertussis vaccine and because pertussis is less severe in these age groups than in infants and young children.

Adverse Reactions: 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 side 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 (6-10 per million doses.)

Dosage: Administer s.c., 3 doses of 1 ml each at intervals of 4 weeks, beginning at 3 to 6 months of age. Reinforcing doses: 1 ml at 6 to 12 months after third dose, 1 ml at 5 years of age.

Indications: Prevention of diphtheria, whooping cough and tetanus. For administration to infants and preschool children only.

Contraindications: Do not give to children with fever or other evidence of acute illness, or with a history of convulsions. Precautions: Proceed with caution when there is evidence of cerebral damage and of previous hypersensitive reactions. Discontinue vaccination series if severe reactions or convulsions occur. Epinephrine HCI 1:1000 should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

Adverse Effects: Local: Some redness and swelling at the site of injection may occur and are usually of short duration.

General: Mild febrile responses occur frequently. More marked febrile response (39°C or over), uncontrollable screaming, drowsiness and convulsions are infrequent. Convulsions have been reported to be followed by neurological complications in rare instances.

Dosage: Administer subcutaneously, 3 doses of 1 ml each at intervals of 4 weeks, beginning at 3 to 6 months of age. Reinforcing doses: 1 ml at 6 to 12 months after third dose, 1 ml at 5 years of age.