Product Information by Manufacturer

AVENTUS PASTEUR / CONNAUGHT

DPT Polio Adsorbed - 1986 to 1990 - Connaught

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

Contraindications: Should not be administered to infants or children with fever, other evidence of acute illness or infection. The presence of 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:

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

DPT Polio Adsorbed 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 immunosuppressive 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 Reactions.) If any are reported, further doses of DPT Polio Vaccine are contraindicated and active immunization against diphtheria and tetanus and poliomyelitis should be completed with Diphtheria and Tetanus Toxoids Adsorbed (DT Adsorbed) and Poliomyelitis Vaccine using separate injections.

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.

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.

DPT Polio Adsorbed should only be used for infants and children through 6 years of age.

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 (6-10 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 > 38 degrees 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 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: For primary immunization of infants and children through 6 years of age, it is recommended that 3 i.m. injections of 0.5 ml to be administered with an interval of 8 weeks between doses followed by a reinforcing dose 12 months after the initial dose of vaccine.

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 up to the sixth birthday.

A reinforcing injection of 0.5 ml i.m. should be administered between 4 and 6 years of age (i.e. at the time of school entry). the booster dose is not necessary if the fourth primary immunizing dose has been administered after the fourth birthday. Shake the container vigorously before each withdrawal of vaccine. The vaccine should be administered by i.m. injection. The vastus lateralis (mid-thigh laterally) is the preferred injection site for infants. The deltoid muscle may be used as the injection site in children where the muscle has developed sufficiently to accommodate the vaccine. The site of injection should be prepared with a suitable antiseptic. Do not inject s.c. or i.v. In order to avoid i.v. injection, pull back the plunger of the syringe to make certain that no blood is withdrawn before injecting the desired dose.

Each injection of the primary immunization series should be made into a different site.

If sterile disposable syringes and needles are not used, syringes and needles should be sterilized in an autoclave at 121 degrees C for 30 minutes. Failing that, they should be boiled for at least 20 minutes. Care should be taken to maintain sterility until used.

Note: Once the ampul has been opened, any of its contents not used immediately should be discarded.

Supplied: Each single dose (0.5mL ) contains purified poliomyelitis vaccine, diphtheria toxoid (25 Lf), tetanus toxoid (5 Lf), pertussis vaccine (4-12 Protective Units) (P.U.) and aluminum phosphate (1.5 mg). Each 0.5 mL of the vaccine contains not more than 100 µg streptomycin and 4 µg neomycin and 2-phenoxyethanol 0.375% added as a preservative. Multiple-dose rubber stoppered vials of 5 ml and single-dose glass ampuls of 0.5 ml. Store at 2 to 8°C. Do not freeze. Products exposed to freezing should not be used.

Reviewed 1986