Adacel

Adacel

Manufacturer:

Sanofi Pasteur

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 0.5 mL Tetanus toxoid 5 Lf, reduced diphtheria toxoid 2 Lf, acellular pertussis vaccine adsorbed (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 DPT in persons ≥4 yr. Passive protection against pertussis in early infancy following maternal immunization during pregnancy. Alternative for the 5th dose of tetanus, diphtheria & acellular pertussis vaccine (DTaP) in childn 4-6 yr. Tetanus prophylaxis in wound management.
Dosage/Direction for Use
IM Administer 0.5 mL as booster dose. Preferred site is into deltoid muscle. Re-dosing may be used at 5- to 10-yr intervals. May be administered to pregnant women during 2nd or 3rd trimester.
Contraindications
Hypersensitivity. Life-threatening reaction after previous administration of the vaccine or a vaccine containing ≥1 of the same components. Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) w/in 7 days of previous dose of any pertussis-containing vaccine.
Special Precautions
Hypersensitivity reactions. Do not administer by intravascular, intradermal or SC route or into the buttocks. Do not use for the treatment of disease caused by Bordetella pertussis, Corynebacterium diphtheriae or Clostridium tetani infections. Postpone vaccination in case of acute or febrile disease. Should not be administered in patients w/ any bleeding disorders eg, hemophilia or thrombocytopenia, or on anticoagulant therapy. Delay vaccination in immunocompromised patients until after any immunosuppressive treatment completion. Should not be administered to individuals w/ progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy until treatment regimen is established. Guillain-Barré syndrome w/in 6 wk prior to vaccination. Pregnancy & lactation. Infants born to women vaccinated w/ Adacel during pregnancy. Childn <4 yr.
Adverse Reactions
Pain, swelling, erythema; fever (≥38°C), headache, nausea, diarrhea, vomiting, anorexia, rash, body ache or muscle weakness/myalgia, sore or swollen joints, tiredness/malaise, chills, axillary lymph node swelling. Hypersensitivity reaction (anaphylactic, angioedema, edema, hypotension); paraesthesia, hypoesthesia, Guillain-Barré syndrome, brachial neuritis, facial palsy, convulsion, syncope, myelitis; myocarditis; pruritus, urticaria; myositis, muscle spasm; large inj site reactions (>50 mm), extensive limb swelling, inj site bruising, sterile abscess.
Drug Interactions
May interfere the development of expected immune response w/ immunosuppressants.
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
0.5 mL x 1's
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