Pertagen 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 Purified Bordetella pertussis antigens (recombinant pertussis toxin 5 mcg, filamentous haemagglutinin 5 mcg)

Indications/Uses

Active booster immunization against 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 0.5 mL as single dose.

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Overdosage

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

Contraindications

Individuals w/ past experience or signs of severe allergic reaction or any encephalopathy w/ unknown origin following pertussis vaccination; 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. Postpone immunosuppressive treatment or immunodeficiency vaccination in case acute severe febrile illness occurs. Consider vaccination in HIV-infected persons or those w/ chronic immunodeficiency disorder. Subjects who had high body temp (≥40°C) w/o any identifiable cause w/in 48 hr after previous immunization w/ any pertussis vaccines. Individuals receiving anticoagulant therapy, those w/ thrombocytopenia or any coagulation disorder. Pregnancy; may be considered in 2nd or 3rd trimester preferably at least 15 days before end of pregnancy. Lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Inj site pain, malaise, fatigue; headache; myalgia, arthralgia. Inj site redness & induration, chills, fever; vomiting, nausea. Men, non-pregnant women & childn 3-7 yr: Inj site swelling. Pregnant women & childn 3-7 yr: Inj site pruritus. Adolescent 12-17 yr: Pain in extremity.

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Storage

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

Description

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

Action

View pertagen mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07AJ02 - pertussis, purified antigen ; Belongs to the class of pertussis bacterial vaccines.

Regulatory Classification

POM

Presentation/Packing

Form

pertagen susp for inj

Packing/Price

0.5 mL x 1's

pertagen

Manufacturer:

Bionet-Asia

Distributor:

Novem Healthcare

Marketer:

Novem Healthcare