Adacel

Adacel

Manufacturer:

sanofi pasteur

Distributor:

DKSH
Concise Prescribing Info
Contents
Per 0.5 mL Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, acellular pertussis [pertussis toxoid (PT) 2.5 mcg, filamentous haemagglutinin (FHA) 5 mcg, pertactin (PRN) 3 mcg, fimbriae types 2 & 3 (FIM) 5 mcg]
Indications/Uses
Active booster immunization for the prevention of tetanus, diphtheria & pertussis in persons ≥4 yr. Alternative for the 5th dose of tetanus, diphtheria & acellular pertussis vaccine (DTaP) in childn 4-6 yr concomitantly w/ inactivated poliomyelitis vaccine. Tetanus prophylaxis in wound management.
Dosage/Direction for Use
IM 0.5 mL as a booster dose preferably in the deltoid muscle. Re-dosing: 5-10 yr interval.
Contraindications
Hypersensitivity. Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) w/in 7 days of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause.
Special Precautions
Hypersensitivity. Not for treatment of Bordetella pertussis, Corynebacterium diphtheriae or Clostridium tetani infections. Do not administer intravascularly, intradermally, SC, or into the buttocks. Syncope. May not protect 100% of vaccinated persons. Postpone vaccination in case of an acute or febrile disease. Possible inj site hematoma in persons w/ any bleeding disorders (eg, hemophilia or thrombocytopenia) or in persons on anticoagulant therapy). Immunocompromised persons. Not to be administered to individuals w/ progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen has been established & condition has stabilized. Guillain-Barré syndrome that has occurred w/in 6 wk of receipt of prior tetanus-toxoid containing vaccine. Possible demyelinating diseases of the CNS, peripheral & cranial mononeuropathies. Pregnancy (1st trimester); may be administered during 2nd or 3rd trimester. Lactation. Not indicated for immunization of childn <4 yr.
Adverse Reactions
Pain at the inj site; tiredness (childn); headache (adolescent & adult 18-64 yr); myalgia (adult ≥65 yr). Potentially, severe migraine w/ unilateral facial paralysis, & nerve compression diagnosis in the neck & left arm.
Drug Interactions
Development of the expected immune response may be interfered by immunosuppressive treatments.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AJ52 - pertussis, purified antigen, combinations with toxoids ; Belongs to the class of pertussis bacterial vaccines.
Presentation/Packing
Form
Adacel vaccine inj
Packing/Price
(single-dose vial) 0.5 mL x 1's
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