ADACEL, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 ML [SIN17460P]

Product Info

ADACEL, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 ML

[SIN17460P]

Indication

INDICATIONS AND CLINICAL USE

ADACEL® is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis (whooping cough) in persons 4 years of age and older.

ADACEL® may be considered as an alternative for the fifth dose of tetanus, diphtheria and acellular pertussis vaccine (DTaP) in children 4 through 6 years of age, concomitantly administered with Inactivated Poliomyelitis Vaccine (IPV) at separate sites to complete the vaccination series for this age, when indicated.

Persons who have had tetanus, diphtheria or pertussis should still be immunized since these clinical infections do not always confer immunity. Human Immunodeficiency Virus (HIV)-infected persons, both asymptomatic and symptomatic, should be immunized against tetanus, diphtheria and pertussis according to standard schedules.

ADACEL® is not to be used for the treatment of disease caused by Bordetella pertussis, Corynebacterium diphtheriae or Clostridium tetani infections.

Pediatrics

ADACEL® is not indicated for immunization of children below the age of 4 years.

Tetanus Prophylaxis in Wound Management

The need for active immunization with a tetanus toxoid-containing preparation such as Td Adsorbed vaccine or ADACEL®, with or without passive immunization with Tetanus Immune Globulin, depends on both the condition of the wound and the patient’s vaccination history. (See DOSAGE AND ADMINISTRATION.)

Dosing

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.

Adacel in vials

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.)

Adacel in pre-filled syringe
The vaccine is normally a uniform, cloudy, white suspension that can form a sediment and lumpy or flocculent aggregates during storage. Shake the pre-filled syringe well prior to use to obtain a homogeneous suspension before administering the vaccine. The product may be shaken again if aggregates are present until a uniform suspension is formed.

Preparation for administration
The pre-filled syringe supplied with a luer lock hub and a hard cap (Figure A). The syringe containing the suspension for injection should be visually inspected before administration. The pre-filled syringe must be discarded if foreign particles, leakage, premature activation of the plunger or a defective seal are present. The syringe is meant for single use only and should not be reused.

Instructions for use of pre-filled luer lock syringe:

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.

Contraindications

CONTRAINDICATIONS

Hypersensitivity

Known systemic hypersensitivity reaction to any component of ADACEL® or a life threatening reaction after previous administration of the vaccine or a vaccine containing one or more of the same components are contraindications to vaccination. (See DOSAGE FORMS, COMPOSITION AND PACKAGING – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.)

Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such persons may be referred to an allergist for evaluation if further immunizations are considered.

Acute Neurological Disorders

Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause is a contraindication to vaccination with any pertussis-containing vaccine, including ADACEL®.