Product Information by Manufacturer

AVENTIS PASTEUR / CONNAUGHT

DPT Polio Vaccine - 1983  1984 - Connaught

Indications: To prevent diphtheria, tetanus, whooping cough and poliomyelitis; only for use with infants and pre-school children.

Contraindications: DPT Polio 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 40ºC; convulsion(s) with or without accompanying fever; alterations of consciousness; focal neurologic signs; screaming episodes; shock; collapse; thrombocytopenia purpura.

DPT Polio 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 Polio Vaccine are contraindicated and active immunization against diphtheria, tetanus and poliomyelitis should be completed with Diphtheria Toxoid and Tetanus Toxoid (Combined), or with Diphtheria and Tetanus Toxoids Adsorbed and Poliomyelitis vaccine. 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 (1:1,000) 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 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 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 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.)

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 >38ºC, 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 or 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.)

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: Inject s.c. near the insertion of the deltoid muscle. 3 doses of 1 ml each at intervals of 4 weeks beginning at 3 to 6 months of age. Reinforcing doses: 1 ml 6 to 12 months after the third dose, and 1 ml at 5 years of age. During school age, additional reinforcing doses against diphtheria, tetanus and poliomyelitis are recommended. At this age pertussis should be omitted, use Diphtheria-Tetanus-Polio vaccine at intervals of about 5 years. In the event of a person being exposed to the risk of tetanus, see "Procedure at Time of Injury" under Tetanus Immune Globulin (Human). Supplied

Supplied: Each ml contains: purified and concentrated trivalent formalin-inactivated poliomyelitis vaccine containing diphtheria toxoid 40 Lf, tetanus toxoid 8 Lf, and 4.7 protective units of pertussis vaccine. The preparations is cherry-red in color due to the presence of a small amount of phenol red indicator and is slightly turbid because of the pertussis component. Available in 10 ml vials and 5 x 1 ml ampoules. Store at 2º to 5ºC. Do not freeze.

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DPT Polio Vaccine 1982  Connaught

Indications: To prevent diphtheria, tetanus, whooping cough and poliomyelitis; only for use with infants and pre-school children.

Contraindications: Children with fever or other evidence of acute illness, or with a history of convulsions.

Precautions: Should not be used in older children and adults. Discontinue inoculations if severe reactions or convulsions occur. Proceed with caution in cases with evidence of hypersensitive reactions. Epinephrine HCI 1:1000 should be available for immediate use in case of anaphylactic or acute hypersensitivity reaction occurs.

Adverse Effects: Mild local reactions consisting of pain, redness, tenderness and swelling at the injection side are common and may be associated with systemic reactions including mild to moderate fever, chills, malaise and irritability. More marked reactions such as fever over 40°C, drowsiness, convulsions, excessive screaming and/or transient shock-like episodes may occur. The occurrence of high fever (over 40°C) pronounced drowsiness, convulsions, excessive screaming or a shock like episode within 24 to 48 hours following administration is a contraindication to further injections containing the pertussis component. Neurological disorders, such as encephalopathy have been reported and are believed related to the pertussis component.

Dosage: Inject s.c. near the insertion of the deltoid muscle. 3 doses of 1 ml each at intervals of 4 weeks beginning at 3 to 6 months of age. Reinforcing doses: 1 ml 6 to 12 months after the third dose, and 1 ml at 5 years of age. During school age, additional reinforcing doses are recommended. At this age pertussis should be omitted, use Diphtheria-Tetanus-Polio vaccine at intervals of about 5 years. In the event of a person being exposed to the risk of tetanus, see "Procedure at Time of Injury" under Tetanus Immune Globulin (Human).

Supplied: Each ml contains: purified and concentrated trivalent formalin-inactivated poliomyelitis vaccine containing diphtheria toxoid 40 Lf, tetanus toxoid 8 Lf, and 4.7 protective units of pertussis vaccine. The preparations is cherry-red in color due to the presence of a small amount of phenol red indicator and is slightly turbid because of the pertussis component. Available in 10 ml vials and 5 x 1 ml ampoules. Store at 2° to 5°C. Do not freeze.

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DPT Polio Vaccine 1981  Connaught

Indications: To prevent diphtheria, tetanus, whooping cough and poliomyelitis; only for use with infants and pre-school children.

Contraindications: Children with fever or other evidence of acute illness, or with a history of convulsions.

Precautions: Should not be used in older children and adults. Discontinue inoculations if severe reactions or convulsions occur. Proceed with caution in cases with evidence of hypersensitive reactions.

Adverse Effects: Mild local reactions consisting of pain, redness, tenderness and swelling at the injection side are common and may be associated with systemic reactions including mild to moderate fever, chills, malaise and irritability. More marked reactions such as fever over 40°C, drowsiness, convulsions, excessive screaming and/or transient shock-like episodes may occur. The occurrence of high fever (over 40°C) pronounced drowsiness, convulsions, excessive screaming or a shock like episode within 24 to 48 hours following administration is a contraindication to further injections containing the pertussis component. Neurological disorders, such as encephalopathy have been reported and are believed related to the pertussis component.

Dosage: Inject s.c. near the insertion of the deltoid muscle. 3 doses of 1 ml each at intervals of 4 weeks beginning at 3 to 6 months of age. Reinforcing doses: 1 ml 6 to 12 months after the third dose, and 1 ml at 5 years of age. During school age, additional reinforcing doses are recommended. At this age pertussis should be omitted, use Diphtheria-Tetanus-Polio vaccine at intervals of about 5 years. In the event of a person being exposed to the risk of tetanus, see "Procedure at Time of Injury" under Tetanus Immune Globulin (Human).

Supplied: Each ml contains: purified and concentrated trivalent formalin-inactivated poliomyelitis vaccine containing diphtheria toxoid 40 Lf, tetanus toxoid 8 Lf, and 4.7 protective units of pertussis vaccine. The preparations is cherry-red in color due to the presence of a small amount of phenol red indicator and is slightly turbid because of the pertussis component. Available in 10 ml vials and 5 x 1 ml ampoules. Store at 2° to 5°C. Do not freeze.