Boostrix

Boostrix

Manufacturer:

GlaxoSmithKline Indonesia
Concise Prescribing Info
Contents
Per 0.5 mL dose Diphtheria toxoid not <2 IU, tetanus toxoid not <20 IU, Bordetella pertussis antigens (pertussis toxoid 8 mcg, filamentous haemagglutinin 8 mcg, pertactin 2.5 mcg)
Indications/Uses
Booster vaccination against diphtheria, tetanus & pertussis for individuals from ≥4 yr. Passive protection against pertussis in early infancy following maternal immunization during pregnancy.
Dosage/Direction for Use
A single 0.5 mL dose by deep IM inj preferably in the deltoid region. Can be administered to pregnant women between 27 & 36 wk of pregnancy in accordance w/ official recommendations.
Contraindications
Hypersensitivity to any component of Boostrix or after previous administration of diphtheria, tetanus or pertussis vaccines. Encephalopathy of unknown etiology occurring w/in 7 days following previous vaccination w/ pertussis-containing vaccine. Transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria &/or tetanus.
Special Precautions
Do not administer IV. Postpone administration in patients w/ acute severe febrile illness. Temp ≥40°C; collapse or shock-like state; persistent, inconsolable crying lasting ≥3 hr, occurring w/in 48 hr of vaccination or convulsions w/ or w/o fever, occurring w/in 3 days of vaccination. Progressive neurological disorders including infantile spasms, uncontrolled epilepsy or progressive encephalopathy. Thrombocytopenia or bleeding disorders. Immunosuppressed patients. Syncope (fainting) may occur. A protective immune response may not be elicited in all vaccinees. Can be used between 27 & 36 wk of pregnancy. Lactation.
Adverse Reactions
Inj site reactions eg, pain, redness & swelling, fatigue. Fever; GI disorders. Adults, adolescents & childn ≥10 yr: Headache; malaise. Dizziness; nausea; inj site mass, abscess sterile. Childn 4-9 yr: Irritability; somnolence. Anorexia; headache; diarrhoea, vomiting.
Drug Interactions
If to be given at the same time as other vaccines or Ig, the products should be administered at different sites. Adequate response may not be achieved w/ immunosuppressive therapy & patients w/ immunodeficiency.
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
Boostrix vaccine (inj)
Packing/Price
(pre-filled syringe) 0.5 mL x 1's
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