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Diteper Anatoxal


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A vaccine indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis.Approved for use as a three-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).


Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, pertussis, hepatitis B, or poliovirus-containing vaccine, or to any component of vaccine) • Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine. (4.2) • Progressive neurologic disorders.

Adverse reactions:

Common solicited adverse events following any dose (?25%) included local injection site reactions (pain, redness, and swelling), fever (?100.4°F), drowsiness, irritability/fussiness and loss of appetite.


Do not mix with any other vaccine in the same syringe or vial.


In clinical trials, vaccine was associated with higher rates of fever, relative to separately administered vaccines. If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give vaccine should be based on potential benefits and risks. The needleless prefilled syringes contain dry natural latex rubber and may cause allergic reactions. If specified adverse events (i.e., temperature ≥105oF, collapse or shock-like state, or inconsolable crying lasting ≥3 hours, within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred following a pertussis-containing vaccine, the decision to give the vaccine should be based on potential benefits and risks. For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, to infants born prematurely should be based on consideration of the individual infant’s medical status, and the potential benefits and possible risks of vaccination.


Suspension for injection in 0.5 mL single-dose via

Dosage and Administration

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