Boostagen Dosage & Drug Information

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 Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per 0.5 mL Tetanus toxoid 7.5 Lf, diphtheria toxoid 2 Lf, purified Bordetella pertussis antigens (recombinant pertussis toxin 5 mcg, filamentous haemagglutinin 5 mcg)

Indications/Uses

Active booster immunization against tetanus, diphtheria & pertussis in individuals ≥3 yr. Maternal immunization in pregnant women for pertussis prevention in infants too young to be vaccinated.

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Dosage/Direction for Use

IM Booster vaccination & maternal immunization in 2nd or 3rd trimester at least 15 days before end of pregnancy, protection of infant against pertussis; tetanus prophylaxis in wound management 0.5 mL as a single dose.

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Overdosage

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

Contraindications

Hypersensitivity or life-threatening reaction following administration. Any encephalopathy w/ unknown aetiology (eg, coma, prolonged seizures or decreased consciousness level w/in 7 days following previous vaccination w/ any whooping cough vaccine). Progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy.

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Special Precautions

Appropriate medical care should be readily available in case of rare anaphylactic reaction after vaccination. Not indicated for primary immunization. Postpone vaccination to subjects suffering from acute severe febrile illness. Subjects who had any adverse events (eg, high temp ≥40°C w/o any identifiable cause, convulsion & collapse or shock-like state) w/in 48 hr after previous immunization w/ any pertussis vaccines. Recipient w/ any bleeding disorders, thrombocytopenia or anticoagulant therapy. Postpone vaccination in case of immunosuppressive treatment or immunodeficiency until end of treatment or disease resolution. Vaccination is recommended even if response may be limited in case of chronic immunodeficiency including HIV-infected persons.

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Use In Pregnancy & Lactation

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Adverse Reactions

Fatigue; headache; myalgia. Vomiting. Pregnant women: Inj site pain; arthralgia. Redness, induration & pruritus at inj site, malaise, fever ≥38°C; nausea. Adults (including non-pregnant women): Pain, redness & induration at inj site, malaise; arthralgia. Inj site swelling, chills, fever ≥38°C; headache; nausea; arthralgia. Adolescents 12-17 yr: Pain, redness & induration at inj site, malaise; arthralgia. Chills, fever ≥37.5°C; pain in extremity. Childn 3-7 yr: Pain, malaise, fever ≥38°C. Redness, swelling, induration & pruritus at the inj site, chills; headache; nausea; arthralgia.

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Storage

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

Description

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

Action

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MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

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

Regulatory Classification

POM

Presentation/Packing

Form

boostagen susp for inj

Packing/Price

0.5 mL x 1's

boostagen

Manufacturer:

Bionet-Asia

Distributor:

Novem Healthcare

Marketer:

Novem Healthcare