Adacel®, Suspension for Injection

INJECTION, SUSPENSION

**DOSAGE AND ADMINISTRATION** **Recommended Dose** The immunization schedule with ADACEL® should follow local recommendations. ADACEL® may be administered to pregnant women during the second or third trimester to provide passive immunization of infants against pertussis (see sections INDICATIONS AND CLINICAL USE, WARNINGS AND PRECAUTIONS and Special Populations-Pregnant Women – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). ADACEL® (0.5 mL) should be administered as a booster dose by the intramuscular route. Re-dosing with ADACEL® can be used to boost immunity to diphtheria, tetanus and pertussis at 5- to 10-year intervals. The preferred site is into the deltoid muscle. Fractional doses (doses < 0.5 mL) should not be given. The effect of fractional doses on the safety and efficacy has not been determined. The use of ADACEL® in management of tetanus-prone wounds should follow local recommendations. Canada’s National Advisory Committee on Immunization (NACI) and US Advisory Committee on Immunization Practices (ACIP) have issued guidelines for tetanus prophylaxis in routine wound management as shown in Table 3.  A thorough attempt must be made to determine whether a patient has completed primary immunization. Persons who have completed primary immunization against tetanus and who sustain wounds that are minor and uncontaminated, should receive a booster dose of a tetanus toxoid-containing preparation if they have not received tetanus toxoid within the preceding 10 years. For tetanus-prone wounds (e.g., wounds contaminated with dirt, feces, soil and saliva, puncture wounds, avulsions and wounds resulting from missiles, crushing, burns or frostbite), a booster is appropriate if the patient has not received a tetanus toxoid-containing preparation within the preceding 5 years. **Administration** Inspect for extraneous particulate matter and/or discolouration before use. (See DESCRIPTION – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) If these conditions exist, the product should not be administered. **Shake the vial well** until a uniform, cloudy, suspension results. Cleanse the vial stopper with a suitable germicide prior to withdrawing the dose. Do not remove either the stopper or the metal seal holding it in place. Aseptic technique must be used. Use a separate sterile needle and syringe, or a sterile disposable unit for each individual recipient, to prevent disease transmission. Needles should not be recapped but should be disposed of according to biohazard waste guidelines. (See WARNINGS AND PRECAUTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.) Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. Administer the total volume of 0.5 mL **intramuscularly** (IM). The preferred site of injection is the deltoid muscle.