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pertagen

pertagen

Manufacturer:

Bionet-Asia

Distributor:

Novem Healthcare

Marketer:

Novem Healthcare
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 ≥11 yr. May be considered as an alternative to combined tetanus, diphtheria & acellular pertussis vaccines in persons having received multiple & frequent tetanus & diphtheria vaccine doses including those w/ known hypersensitivity to tetanus (Arthus-type hypersensitivity reaction) or diphtheria vaccines.
Dosage/Direction for Use
Contraindications
Signs of hypersensitivity or life-threatening reaction following administration. Encephalopathy w/ unknown aetiology eg, coma, prolonged seizures or decreased level of consciousness w/in 7 days following previous vaccination w/ any whooping cough vaccine. Progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy.
Special Precautions
Appropriate medical care should be readily available in case of rare anaphylactic reaction after vaccination. Not to be administered intravascularly. Not to be given as fractional doses <0.5 mL. Postpone vaccination in subjects suffering from acute severe febrile illness. Administer precautionary measures to subjects who had any adverse events (eg, high temp ≥40°C w/o any identifiable cause, convulsions, collapse or shock-like state) w/in 48 hr after previous immunization w/ any whooping cough vaccines. Recipient w/ any bleeding disorders, thrombocytopenia or anticoagulant therapy. Immune response to the vaccine may be diminished in case of immunosuppressive treatment or immunodeficiency; postpone vaccination until the end of treatment or disease resolution. Vaccination is recommended even if the response may be limited in case of chronic immunodeficiency including HIV-infected persons. Pregnancy; may be considered in 2nd or 3rd trimester & preferably at least 15 days before the end of pregnancy. Lactation.
Adverse Reactions
Inj site pain, malaise, fatigue; headache; myalgia, arthralgia. Inj site redness & induration, chills, fever ≥37.5°C; vomiting.
Drug Interactions
Can be administered simultaneously w/ other inactivated vaccines or Ig at separate inj sites. Development of expected immune response may be interfered by immunosuppressive treatment.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AJ02 - pertussis, purified antigen ; Belongs to the class of pertussis bacterial vaccines.
Presentation/Packing
Form
pertagen susp for inj
Packing/Price
0.5 mL x 1's
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