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 2.5 mcg, filamentous haemagglutinin 5 mcg, pertactin 3 mcg, fimbriae types 2 & 3 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 administered w/ inactivated poliomyelitis vaccine. Tetanus prophylaxis in wound management.
Dosage/Direction for Use
IM 0.5 mL as booster dose preferably into the deltoid muscle. Re-dosing: 5-10 yr intervals.
Contraindications
Hypersensitivity. Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) w/in 7 days of previous dose of pertussis-containing vaccine not attributable to another identifiable cause.
Special Precautions
Evaluate possibility of allergic reactions in persons sensitive to the components of the vaccine. Not to be administered intravascularly, intradermally, SC or into the buttocks. Not to be used for treatment of disease caused by Bordetella pertussis, Corynebacterium diphtheriae or Clostridium tetani infections. Not to be given as fractional doses (<0.5 mL). Syncope may occur; place procedures to prevent falling injury & manage syncopal reactions. May not protect 100% of vaccinated persons. Postpone vaccination in case of 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. Vaccination of persons w/ chronic immunodeficiency (eg, HIV) is recommended even if immune response might be limited. Not to be administered to individuals w/ progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy until treatment regimen has been established & condition has stabilized. Carefully consider use if Guillain-Barré syndrome occurred w/in 6 wk of receipt of prior tetanus toxoid containing vaccine. Possible CNS demyelinating diseases, peripheral & cranial mononeuropathies. Pregnancy; may be administered during 2nd or 3rd trimester. Lactation. Not indicated for immunization of childn <4 yr.
Adverse Reactions
Inj site pain; 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. Use separate syringes at separate inj sites when administering vaccines simultaneously. Not to be mixed in the same syringe w/ other parenterals.
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 susp for inj
Packing/Price
(single-dose vial) 0.5 mL x 1's
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