Adacel

Adacel

Manufacturer:

sanofi pasteur

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 0.5 mL Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, pertactin 3 mcg, fimbriae types 2 & 3 5 mcg
Indications/Uses
Active booster immunization for prevention of tetanus, diphtheria & pertussis (whooping cough) in persons ≥4 yr. Passive protection against pertussis in early infancy following maternal immunization during pregnancy. Concomitant w/ inactivated poliomyelitis vaccine as alternative for 5th dose of tetanus, diphtheria & acellular pertussis vaccine (DTaP) in childn 4-6 yr. Tetanus prophylaxis in wound management.
Dosage/Direction for Use
Contraindications
Hypersensitivity to vaccine or after previous inj. Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) w/in 7 days following previous vaccination w/ pertussis-containing vaccine.
Special Precautions
Hypersensitivity. Not to be inj intravascularly, intradermally, SC or into buttocks. Not to be used for diseases caused by Bordetella pertussis, Corynebacterium diphtheriae or Clostridium tetani infections. Not to be administered in persons w/ bleeding disorders eg, hemophilia or thrombocytopenia or those on anticoagulant therapy; progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy. Postpone vaccination in acute or febrile disease. Syncope; Guillain-Barre syndrome. Immunocompromised patients. Pregnancy & lactation. Not to be used for immunization of childn <4 yr.
Adverse Reactions
Inj site pain, swelling & erythema; fever, headache, nausea, diarrhea, vomiting, anorexia, rash, body ache or muscle weakness/myalgia, sore or swollen joints, tiredness/malaise, chills, axillary lymph node swelling.
Drug Interactions
Interfered expected immune response development w/ immunosuppressants. Not to be mixed w/ other parenterally-administered medicinal products.
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 (single-dose vial) 0.5 mL
Packing/Price
(single-dose) 0.5 mL x 1's
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