"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
It is a contraindication to use this vaccine after an immediate anaphylactic reaction temporally associated with a previous dose. Because of uncertainty as to which component of the vaccine might be responsible, no further vaccination with any diphtheria, tetanus or pertussis component should be carried out. Alternatively, because of the importance of tetanus vaccinations, such individuals may be referred for evaluation by an allergist. 3
The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their etiology. Although a moderate or severe febrile illness is sufficient reason to postpone vaccinations, minor illnesses such as mild upper-respiratory infections with or without low-grade fever are not contraindications. 3, 19, 20, 21, 22 Elective immunization procedures should be deferred during an outbreak of poliomyelitis. 23 Data on the use of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM in children for whom whole-cell pertussis vaccine is contraindicated are not available. Until such data are available, it would be prudent to consider CDC Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) contraindications to pertussis-containing vaccines as contraindications to Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM. 3, 20, 21
- An immediate anaphylactic reaction.
- Encephalopathy not attributable to another identifiable cause (e.g., an acute, severe central nervous system disorder occurring within 7 days after vaccination and generally consisting of major alterations in consciousness, unresponsiveness, or generalized or focal seizures that persist more than a few hours, without recovery within 24 hours). In such cases, DT vaccine should be administered for the remaining doses in the vaccination schedule to ensure protection against diphtheria and tetanus.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Certiva Information
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