Boostrix Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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.

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Dosage/Direction for Use

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.

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Overdosage

View Boostrix overdosage for action to be taken in the event of an overdose.

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.

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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. Thrombocytopenia or bleeding disorders. Immunosuppressed patients. Syncope (fainting) may occur. Protective immune response may not be elicited in all vaccinees. Lactation. Defer pertussis immunization in childn w/ progressive neurological disorders including infantile spasms, uncontrolled epilepsy or progressive encephalopathy.

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Use In Pregnancy & Lactation

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Adverse Reactions

Inj site reactions eg, pain, redness & swelling, fatigue. Fever ≥37.5°C; 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.

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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.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Boostrix detailed prescribing information

Storage

View Boostrix storage conditions for details to ensure optimal shelf-life.

Description

View Boostrix description for details of the chemical structure and excipients (inactive components).

Action

View Boostrix mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07AJ52 - pertussis, purified antigen, combinations with toxoids ; Belongs to the class of pertussis bacterial vaccines.

Regulatory Classification

Presentation/Packing

Form

Boostrix susp for inj

Packing/Price

(pre-filled syringe) 0.5 mL x 1's

Boostrix

Manufacturer:

GlaxoSmithKline Indonesia