Basic Information
ADACEL®-POLIO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
INJECTION, SUSPENSION
Regulatory Information
SIN15479P
May 8, 2018
Prescription Only
Therapeutic
INTRAMUSCULAR
August 10, 2023
May 30, 2025
XJ07CA02
Company Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Active Ingredients
Strength: 2Lf
Strength: 5Lf
Strength: 40 D-Antigen Units
Strength: 5 µg/ 0.5 ml
Strength: 3 µg/0.5 ml
Strength: 2.5 µg/ 0.5 ml
Strength: 8 D-antigen units
Strength: 32 D-antigen units
Strength: 5 µg/0.5 ml
Detailed Information
Contraindications
**CONTRAINDICATIONS** **Hypersensitivity** Known systemic hypersensitivity reaction to any component of ADACEL®-POLIO 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. 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 that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including ADACEL®-POLIO.
Indication Information
**INDICATIONS AND CLINICAL USE** ADACEL®-POLIO is indicated for active booster immunization for the prevention of tetanus, diphtheria, pertussis (whooping cough) and poliomyelitis in persons 4 years of age and above. In children 4 to 6 years of age, ADACEL®-POLIO may be considered as an alternative for the fifth dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (DTaP-IPV). 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®-POLIO is not to be used for the treatment of disease caused by _Bordetella pertussis_, _Corynebacterium diphtheriae_, _Clostridium tetani_ or poliomyelitis infections. **Pediatrics** ADACEL®-POLIO has been used in clinical studies in children as young as 3 years of age. **Geriatrics** ADACEL®-POLIO has been used in clinical studies in persons up to 91 years of age. **Tetanus Prophylaxis in Wound Management** The need for active immunization with a tetanus toxoid-containing preparation (such as Td Adsorbed vaccine, ADACEL® or ADACEL®-POLIO) 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.)