"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
The ACIP and AAP state that if any of the following events occur in temporal relation to receipt of DTP or DTaP, the decision to give subsequent doses of vaccine containing the pertussis component should be carefirlly considered. There may be circumstances, such as a high incidence of pertussis, in which the potential benefits outweigh possible risks, particularly because these events have not been proven to cause permanent sequelae. The following events were previously considered contraindications and are ACIP22:
- Temperature of ³105° F (³40.5° C) within 48 hours, cause.
- Collapse or shock-like state (hypotonic hyporesponsive episode) within 48 hours.
- Persistent crying lasting 23 hours, occurring within 48 hours.
- Convulsions with or without fever, occurring within 3 days.
Data on the use of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM in children with a personal history of convulsion or an evolving or changing disorder of the central nervous system are not available. In the opinion of the manufacturer, the presence of a personal history of convulsion or an evolving or changing disorder of the central nervous system is considered a warning against further immunization with this vaccine.
The ACIP and AAP recommend considering deferral of immunization against pertussis in children with progressive neurologic disorder, personal history of convulsion, and known or suspected neurologic conditions which predispose to seizures or neurologic deterioration until now considered precautions by the not attributable to another identifiable the childs health status has been fully assessed, a treatment regimen established and the condition stabilized. 3, 20, 21, 22
Children with a personal or family history of convulsion may have an increased risk of seizure following DTP vaccination compared with children without such histories. 24, 25 However, the ACIP recognizes in certain instances that infants and children with stable neurologic conditions, including well-controlled seizures, may be vaccinated and that the occurrence of single seizures (temporally unassociated with D.P. does not contraindicate DTP vaccination if the seizures can be satisfactorily explained. In addition, the ACIP does not consider a family history of convulsions or other central nervous system disorders to be a contraindication to pertussis vaccination. 20, 22, 25 Data on the use of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM in these infants and children are not available. The decision to administer a pertussis-containing vaccine to children with stable central nervous system disorders, such as well-controlled seizures or satisfactorily explained single seizures, must be made by the attending physician on a case-by-case basis, taking into account all relevant factors and an assessment of the potential risks and benefits for each child. The physician should review the full text of the ACIP and AAP guidelines prior to considering vaccination for such children. In addition, the parent or guardian should be advised of the potential increased risk involved (See PATIENT INFORMATION). For children at higher risk of seizures than the general population, the ACIP recommends that acetaminophen or ibuprofen may be administered at the time of DTaP vaccination and for 24 hours thereafter (using an age-appropriate dose and dosing interval) to reduce the possibility of post-vaccination fever.22
A committee from the Institute of Medicine (IOM) has concluded that evidence is consistent with a causal relationship between whole-cell DTP and acute neurologic illness, and under special circumstances, between whole-cell DTP and chronic neurologic disease in the context of the National Childhood Encephalopathy Study (NCES) report. 26, 27 However, the IOM committee concluded that evidence was insufficient to indicate whether or not whole-cell DTP vaccine increased the overall risk of chronic neurological disease.27 The ACIP indicated that the results of the NCES were insufficient to determine whether DTP administration before the acute neurological event influenced the potential for neurologic dysfunction 10 years later. 20 Acute encephalopathy or permanent neurological injury have not been reported in clinical trials after administration of CertivaTM, but experience with this vaccine is insufficient to rule this out (See ADVERSE REACTIONS).
Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration. If the decision is made to administer CertivaTM to children with coagulation disorders, it should be given with caution (See DRUG lNTERACTIONS).19
Care is to be taken by the physician for the safe and effective use of this vaccine.
- Prior to administration of any dose of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM, the physician should review the childs medical history. The physician should also review the childs previous immunization history for possible vaccine sensitivity and occurrence of any symptoms or signs of an adverse event after immunization, in order to determine the existence of any contraindication to immunization with CertivaTM and to allow an assessment of benefits and risks (See CONTRAINDICATIONS and ADVERSE REACTIONS).
- Before the injection of any biological, the physician should take all precautions known for the prevention of allergic or any other side reactions, including understanding the use of the biological concerned and the nature of the side effects and adverse reactions that may follow its use. Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.
- Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced immune response to active immunization procedures. Deferral of immunization may be considered in individuals receiving immunosuppressive therapy. Other groups should receive this vaccine according to the usual recommended schedule (See DRUG INTERACTIONS).28
- Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM is not contraindicated based on the presence of HIV infection. 3
- Special care should be taken to ensure that the injection does not enter a blood vessel.
- A separate, sterile syringe and needle or a sterile disposable unit should be used for each subject to prevent transmission of hepatitis or other infectious agents from person to person. Needles should not be recapped but should be disposed of properly.
Caution: the packaging stopper of this product contains natural rubber latex which may cause allergic reactions.
Information for Vaccine Recipients and Parents
Parents or guardians of infants and children to be vaccinated should be fully informed of the benefits and risks of vaccination with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM and the importance of completing the immunization series, unless contraindicated.
The physician should inform the parents or guardians about the potential for adverse reactions that have been temporally associated with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM and other pertussis vaccine administrations. The parents or guardians of infants and children with family history of convulsions or other central nervous system disorders should be advised of the potential increased risk of seizures following DTP vaccinations.
Prior to each immunization, the parent or guardian should be provided with the Vaccine Information Materials (VIMs), as required by the National Childhood Vaccine Injury Act of 1986. 26 Parents or guardians should be instructed to report any severe or unusual reactions to their health-care provider.
The U. S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including, but not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. 29, 30 The toll-free number for VAERS forms and information is 1-800-822-7967.
See DRUG INTERACTIONS section.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) m has not been evaluated for its carcinogenic or mutagenic potentials or impairment of fertility.
Reproductive Studies: Pregnancy Category C:Animal reproduction studies have not been conducted with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM. It is not known whether Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM is NOT recommended for use in a pregnant woman. This vaccine is not recommended for persons 7 years of age or older (See Pediatric Use below).
SAFETY AND EFFECTIVENESS OF CertivaTM IN INFANTS BELOW 6 WEEKS OF AGE HAVE NOT BEEN ESTABLISHED (SEE DOSAGE AND ADMINISTRATION).
THIS VACCINE IS NOT RECOMMENDED FOR PERSONS 7 YEARS OF AGE AND OLDER
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
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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