Diphtheria and Tetanus Toxoids Adsorbed and Poliomyelitis Vaccine

Diphtheria and Tetanus Toxoids Adsorbed and Poliomyelitis Vaccine (DT Polio Adsorbed)

Connaught

Vaccine

Indications And Clinical Uses: For the primary immunization of infants and of children at or above the age of 2 months through 6 years of age (prior to the seventh birthday) against diphtheria, tetanus, and poliomyelitis in whom simultaneous immunization against pertussis is not indicated.

DT Polio Adsorbed may be administered simultaneously with Hib conjugate vaccines and/or MMR at separate sites with separate syringes.

Contra-Indications: Immunization with DT Polio Adsorbed should be deferred in the presence of any acute illness, including febrile illness.

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

DT Polio Adsorbed should not be administered to children on or after the seventh birthday and to adults because of possible reactions to the pediatric dosage of diphtheria toxoid.

Allergic reaction to any component of DT Polio Adsorbed is a contraindication to vaccination.

Human Immunodeficiency Virus (HIV) Infected Persons: HIV-infected individuals, both asymptomatic and symptomatic, should be immunized with DT Polio Adsorbed according to standard schedules.

Manufacturers’ Warnings In Clinical States: If DT Polio Adsorbed is used in persons with malignancies, receiving immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, or who are otherwise immunocompromised, the expected immune response may not be obtained.

Corticosteroid therapy can result in immunosuppression although the exact dose and duration of therapy required to suppress the immune system is not well defined. Persons treated with high doses of systemic steroids, e.g., ³2 mg/kg/day of prednisone orally for more than 2 weeks, should be considered to have a compromised immune system.

As with any vaccine, immunization with DT Polio Adsorbed may not protect 100% of susceptible individuals.

Precautions: The possibility of allergic reactions in individuals sensitive to components of the vaccine should be evaluated. Epinephrine HCl solution (1:1 000) and other appropriate agents should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

Before an injection of any vaccine, appropriate precautions should be taken to prevent adverse reactions. This includes a review of the patient’s history with respect to possible hypersensitivity to the vaccine or similar vaccine, determination of previous immunization history, and the presence of any contraindications to immunization.

Since the vaccine contains 2-phenoxyethanol and may contain trace amounts of polymyxin B and neomycin, the possibility of allergic reactions in individuals sensitive to these substances should be borne in mind when considering the use of this vaccine.

Any febrile illness or acute infection is reason to delay the use of DT Polio Adsorbed.

Special care should be taken to ensure that the product is not injected into a blood vessel.

A separate, sterile syringe and needle, or a sterile disposable unit, must be used for each individual patient to prevent the transmission of infectious agents. There have been case reports of transmission of HIV and hepatitis by failure to scrupulously observe sterile technique.

Do not recap needles.

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.

Children with Symptomatic HIV Infection: Available data suggest that routine childhood immunizations are not hazardous to HIV-infected children. Furthermore, there is no evidence that immunization with routine vaccines leads to deterioration of the clinical condition of HIV-infected persons.

Immunization with DPT (Diphtheria, Pertussis and Tetanus), IPV (Inactivated Poliomyelitis Vaccine) and Haemophilus b Conjugate Vaccine is recommended, although immunization may be less effective than it would be for immunocompetent children.

Adverse Reactions: Mild local reactions consisting of pain, erythema, tenderness 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.

Physicians, nurses and pharmacists should report any adverse occurrences temporally related to the administration of the product in accordance with local requirements and report to the Medical Director at Connaught Laboratories Limited, 1755 Steeles Avenue West, Toronto, Ontario, Canada, M2R 3T4.

Dosage And Administration: For primary immunization of infants, the following routine DT Polio Adsorbed immunization schedule is recommended: one 0.5 mL dose administered at 2, 4, 6 and 18 months of age.

If for any reason this schedule is delayed, it is recommended that 3 doses of 0.5 mL be administered with an interval of 4 to 8 weeks between doses, followed by a fourth dose of 0.5 mL administered approximately 1 year after the third dose. The same schedule may be used through 6 years of age (prior to the seventh birthday).

A booster dose of 0.5 mL should be administered between 4 and 6 years of age (i.e., at the time of school entry). This booster dose is unnecessary if the fourth primary immunizing dose has been administered after the fourth birthday.

Administration: Parenteral biological products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration. If these conditions exist, the product should not be administered.

Shake ampul well to uniformly distribute the suspension before withdrawing each dose. Before withdrawing a dose from an ampul, tap the container first to ensure that all the vaccine is in the lower portion. Once the ampul has been opened, any of its contents not used immediately should be discarded. Aseptic technique must be used for withdrawal of each dose.

Administer the vaccine i.m. The preferred site is into the anterolateral aspect of the mid-thigh (vastus lateralis muscle) or into the deltoid muscle. The former is the site of choice for infants 1 year of age, the deltoid is the preferred site since use of the anterolateral thigh results in frequent complaints of limping due to muscle pain.

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.

Do not inject i.v.

Each person who is immunized should be given a permanent personal immunization record. In addition, it is essential that the physician or nurse record the immunization history in the permanent medical record of each patient. This permanent office record should contain the name of the vaccine, date given, dose, manufacturer and lot number.

Availability And Storage: Each single human dose (0.5 mL) of sterile, cloudy, uniform suspension contains: purified poliomyelitis vaccine type 1 (Mahoney), type 2 (M.E.F.1) and type 3 (Saukett), diphtheria toxoid (25 Lf), tetanus toxoid (5 Lf) and aluminum phosphate (1.5 mg). Trace amounts of polymyxin B and neomycin may be present from the cell growth medium. Formaldehyde (27 ppm) and 2-phenoxyethanol (0.5%) are added as a preservative. Ampuls of 0.5 mL, boxes of 5. Store at a temperature between 2 and 8°C. Do not freeze. Product which has been exposed to freezing should not be used. Once an ampul is opened, any contents not used immediately should be discarded.

Diphtheria and Tetanus Toxoids Adsorbed and Poliomyelitis Vaccine (DT Polio Adsorbed) Connaught Vaccine

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