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Pronunciation |
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(RAY
beez VYE rus vak
SEEN) |
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U.S. Brand
Names |
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Imovax® Rabies I.D. Vaccine;
Imovax® Rabies
Vaccine |
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Generic
Available |
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No |
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Synonyms |
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HDCV; Human Diploid Cell Cultures Rabies Vaccine; Human Diploid Cell Cultures
Rabies Vaccine (Intradermal use) |
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Pharmacological Index |
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Vaccine |
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Use |
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Pre-exposure immunization: Vaccinate persons with greater than usual risk due
to occupation or avocation including veterinarians, rangers, animal handlers,
certain laboratory workers, and persons living in or visiting countries for
longer than 1 month where rabies is a constant threat.
The Food and Drug Administration has not approved the I.D. use of rabies
vaccine for postexposure prophylaxis (only I.M.). The type of and schedule for
postexposure prophylaxis depends upon the previous rabies vaccination status or
the result of a previous or current serologic test for rabies antibody.
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Pregnancy Risk
Factor |
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C |
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Contraindications |
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Developing febrile illness (during pre-exposure therapy only); allergy to
neomycin, gentamicin, or amphotericin B; life-threatening allergic reactions to
rabies vaccine or its components (however, carefully consider a patient's risk
of rabies before continuing therapy) |
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Warnings/Precautions |
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Report serious reactions to the State Health Department or the
manufacturer/distributor, an immune complex reaction is possible 2-21 days
following booster doses of HDCV; hypersensitivity reactions may be treated with
antihistamines or epinephrine, if severe. |
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Adverse
Reactions |
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Mild systemic reactions occur at an incidence of ~8% to 10% with RVA and 20%
with HDCV. All serious adverse reactions must be reported to the U.S.
Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting
System (VAERS) 1-800-822-7967.
Central nervous system: Dizziness, malaise, encephalomyelitis, transverse
myelitis, fever, pain, headache, neuroparalytic reactions
Dermatologic: Itching, erythema
Gastrointestinal: Nausea, abdominal pain
Local: Local discomfort, pain at injection site
Neuromuscular & skeletal: Myalgia
Note: Serum sickness reaction is much less frequent with RVA (<1%)
vs the HDCV (6%) |
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Drug
Interactions |
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Decreased effect with immunosuppressive agents, corticosteroids, antimalarial
drugs (ie, chloroquine); persons on these drugs should receive RIG (3 doses/1 mL
each) by the I.M. route |
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Stability |
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Refrigerate dried vaccine; HDCV can presumably tolerate 30 days at room
temperature; reconstituted vaccine should be used
immediately |
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Mechanism of
Action |
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Rabies vaccine is an inactivated virus vaccine which promotes immunity by
inducing an active immune response. The production of specific antibodies
requires about 7-10 days to develop. Rabies immune globulin or antirabies serum,
equine (ARS), is given in conjunction with rabies vaccine to provide immune
protection until an antibody response can occur. |
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Pharmacodynamics/Kinetics |
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Onset of effect: I.M.: Rabies antibody appears in the serum within 7-10 days
Peak effect: Within 30-60 days and persists for at least 1 year
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Usual Dosage |
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Pre-exposure prophylaxis: 1 mL I.M. or 0.1 mL I.D. on days 0, 7, and
21 to 28. Note: Prolonging the interval between doses does not interfere
with immunity achieved after the concluding dose of the basic series.
Postexposure prophylaxis: All postexposure treatment should begin
with immediate cleansing of the wound with soap and water
Persons not previously immunized as above: Rabies immune globulin 20 units/kg
body weight, half infiltrated at bite site if possible, remainder I.M.; and 5
doses of rabies vaccine, 1 mL I.M., one each on days 0, 3, 7, 14, 28
Persons who have previously received postexposure prophylaxis with rabies
vaccine, received a recommended I.M. pre-exposure series of rabies vaccine, or
have a previously documented rabies antibody titer considered adequate: 1 mL of
either vaccine I.M. only on days 0 and 3; do not administer RIG
Booster (for occupational or other continuing risk): 1 mL I.M. or 0.1 mL I.D.
every 2-5 years or based on antibody titers |
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Reference Range |
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Antibody titers greater than or equal to 115 as determined by rapid
fluorescent-focus inhibition test are indicative of adequate response; collect
titers on day 28 postexposure |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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Refrigerate |
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Nursing
Implications |
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For intramuscular injection only; this rabies vaccine product must not be
administered intradermally; in older children and adults it should be given in
deltoid area for best response |
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Dosage Forms |
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Injection:
Imovax® rabies I.D. vaccine: Rabies antigen 0.25
units/0.1 mL (1 mL)
Rabies vaccine (adsorbed): 1 mL |
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References |
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"A New Rabies Vaccine," Med Lett Drugs Ther, 1998, 40(1029):64-5.
Dreesen DW and Hanlon CA,
"Current Recommendations for the Prophylaxis and Treatment of Rabies,"
Drugs, 1998, 56(5):801-9.
Lang J and Plotkin SA, "Rabies Risk and Immunoprophylaxis in Children,"
Adv Pediatr Infect Dis, 1997, 13:219-55.
Strady A, Lang J, Lienard M, et al,
"Antibody Persistence Following Pre-exposure Regimens of Cell-Culture Rabies Vaccines: 10-Year Follow-up and Proposal for a New Booster Policy,"
J Infect Dis, 1998, 177(5):1290-5.
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