ADACEL®-POLIO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

INJECTION, SUSPENSION

**DOSAGE AND ADMINISTRATION** **Recommended Dose** ADACEL®-POLIO should be administered as a single injection of 1 dose (0.5 mL) by the intramuscular route. The preferred site is the deltoid muscle. ADACEL®-POLIO may be administered to pregnant women during the second or third trimester to provide passive immunization of infants against pertussis (see sections WARNINGS AND PRECAUTIONS – Pregnant Women and ACTION AND CLINICAL PHARMACOLOGY – Immunogenicity – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Fractional doses (doses <0.5 mL) should not be given. The effect of fractional doses on safety and efficacy has not been determined. Health-care professionals should refer to the National Advisory Committee on Immunization (NACI) guidelines for tetanus prophylaxis in routine wound management shown in Table 2.  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. For adults who have not previously received a dose of acellular pertussis vaccine, a single Tetanus-diphtheria (Td) booster dose should be replaced by a combined tetanus-diphtheria-acellular pertussis vaccine (Tdap). **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 be discarded. **Shake the vial or syringe well** until a uniform, cloudy, suspension results. When administering a dose from a stoppered vial, do not remove either the stopper or the metal seal holding it in place. Use a separate sterile needle and syringe, or a sterile disposable unit for each individual patient to prevent disease transmission. Needles should not be recapped but should be disposed of according to biohazard waste guidelines. 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.