Basic Information
Adacel®, Suspension for Injection
INJECTION, SUSPENSION
Regulatory Information
SIN14232P
September 20, 2012
Prescription Only
Therapeutic
INTRAMUSCULAR
August 10, 2023
May 30, 2025
XJ07AJ52
Company Information
Active Ingredients
Strength: 5 Lf
Strength: 2 Lf
Strength: 5 micrograms
Strength: 3 micrograms
Strength: 5 micrograms
Strength: 2.5 micrograms
Detailed Information
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®.
Indication Information
**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.)