Adacel

Adacel

Manufacturer:

Kalventis Sinergi Farma
Concise Prescribing Info
Contents
Per 0.5 mL Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, component pertussis (pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbrial agglutinogens 2+3 5 mcg, pertactin 3 mcg)
Indications/Uses
Active booster immunization for the prevention of tetanus, diphtheria & pertussis (whooping cough) in childn 4-6 yr & ≥10 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 (DTaP) vaccine in childn 4-6 yr. Tetanus prophylaxis in wound management.
Dosage/Direction for Use
IM 0.5 mL as a booster inj preferably in the deltoid muscle. Redosing can be used at 5‐10 yr interval. May be administered to pregnant women from 24-36 wk gestation to provide passive protection of infants against pertussis.
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 following previous vaccination of pertussis-containing vaccine.
Special Precautions
Hypersensitivity. Syncope. Do not administer intravascularly, intradermally, SC or into the buttocks. Not to be used for diseases caused by Bordetella pertussis, Corynebacterium diphtheriae or Clostridium tetani infections. Do not give fractional doses (<0.5 mL). Postpone vaccination in patients w/ acute or febrile disease. 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. Delay vaccination in immunocompromised patients until after any immunosuppressive treatment completion. Carefully consider use if Guillain-Barré syndrome occurred w/in 6 wk of receipt of prior tetanus-toxoid containing vaccine. Lactation. Not indicated for use in childn <4 yr.
Adverse Reactions
Inj site pain, swelling & erythema; fever (≥38°C), headache, nausea, diarrhea, vomiting, anorexia, rash, body ache or muscle weakness, sore or swollen joints, tiredness, 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
Interfered expected immune response development w/ immunosuppressants. 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 vaccine (inj)
Packing/Price
(vial) 0.5 mL x 1's (Rp447,552/boks)
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