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Pronunciation |
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(var
i SEL a VYE rus vak
SEEN) |
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U.S. Brand
Names |
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Varivax® |
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Generic
Available |
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No |
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Synonyms |
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Chicken Pox Vaccine; Varicella-Zoster Virus (VZV) Vaccine |
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Pharmacological Index |
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Vaccine |
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Use |
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The American Association of Pediatrics recommends that the chickenpox vaccine
should be given to all healthy children between 12 months and 18 years; children
between 12 months and 13 years who have not been immunized or who have not had
chickenpox should receive 1 vaccination while children 13-18 years of age
require 2 vaccinations 4-8 weeks apart; the vaccine has been added to the
childhood immunization schedule for infants 12-28 months of age and children
11-12 years of age who have not been vaccinated previously or who have not had
the disease; it is recommended to be given with the measles, mumps, and rubella
(MMR) vaccine |
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Pregnancy Risk
Factor |
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C |
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Pregnancy/Breast-Feeding
Implications |
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Clinical effects on the fetus: Varivax® should not be
administered to pregnant females and pregnancy should be avoided for 3 months
following vaccination
Breast-feeding/lactation: Use during breast-feeding should be avoided
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Contraindications |
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Hypersensitivity to any component of the vaccine, including gelatin; a
history of anaphylactoid reaction to neomycin; individuals with blood
dyscrasias, leukemia, lymphomas, or other malignant neoplasms affecting the bone
marrow or lymphatic systems; those receiving immunosuppressive therapy; primary
and acquired immunodeficiency states; a family history of congenital or
hereditary immunodeficiency; active untreated tuberculosis; febrile illness;
pregnancy; I.V. injection |
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Warnings/Precautions |
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Children and adolescents with acute lymphoblastic leukemia in remission can
receive the vaccine under an investigational protocol (215-283-0897); no
clinical data are available or efficacy in children <12 months of age
Immediate treatment for anaphylactoid reaction should be available during
vaccine use; defer vaccination for at least 5 months following blood or plasma
transfusions, immune globulin (IgG), or VZIG (avoid IgG or IVIG use for 2 months
following vaccination); salicylates should be avoided for 5 weeks after
vaccination; vaccinated individuals should not have close association with
susceptible high risk individuals (newborns, pregnant women, immunocompromised
persons) following vaccination |
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Adverse
Reactions |
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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.
>10%:
Central nervous system: Fever (14.7%)
Local: Induration/stiffness at the injection site (19.3%)
1% to 10%:
Central nervous system: Pain, irritability/nervousness, fatigue, disturbed
sleep, headache, malaise, chills
Dermatologic: Redness, rash (at injection site - 3.4%), pruritus, generalized
varicella-like rash (generalized - 3.8%)
Gastrointestinal: Diarrhea, loss of appetite, vomiting, abdominal pain,
nausea
Hematologic: Hematoma
Neuromuscular & skeletal: Myalgia, arthralgia
Otic: Otitis
Respiratory: Upper respiratory illness, cough
Miscellaneous: Lymphadenopathy, allergic reactions
<1%: Febrile seizures (causality not established), pneumonitis
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Drug
Interactions |
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Clinical studies show that Varivax® can be administered
concomitantly with MMR and limited data indicate that DTP and
PedvaxHIB™ may also be administered together (using
separate sites and syringes)
Increased effect: Salicylates may increase the risk of Reye's following
varicella vaccination |
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Stability |
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Store in freezer (-15°C), store diluent separately at
room temperature or in refrigerator; discard if reconstituted vaccine is not
used within 30 minutes |
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Mechanism of
Action |
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As a live, attenuated vaccine, varicella virus vaccine offers active immunity
to disease caused by the varicella-zoster virus |
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Pharmacodynamics/Kinetics |
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Onset of action: Approximately 4-6 weeks postvaccination
Duration: Lowest breakthrough rates (0.2% to 2.9%) exist in the first 2 years
following postvaccination, with slightly higher rates in the third through the
fifth year |
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Usual Dosage |
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S.C.:
Children 12 years to Adults: 2 doses of 0.5 mL separated by 4-8 weeks
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Administration |
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Inject S.C. into the outer aspect of the upper arm, if
possible |
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Monitoring
Parameters |
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Rash, fever |
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Patient
Information |
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Report any adverse reactions to the healthcare provider or Vaccine Adverse
Event Reporting System (1-800-822-7967); avoid pregnancy for 3 months following
vaccination; avoid salicylates for 5 weeks after vaccination; avoid close
association with susceptible high risk individuals following
vaccination |
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Nursing
Implications |
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Obtain the previous immunization history (including allergic reactions) to
previous vaccines; do not inject into a blood vessel; use the supplied diluent
only for reconstitution; inject immediately after
reconstitution |
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Dosage Forms |
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Powder for injection, lyophilized powder, preservative free: 1350 plaque
forming units (PFU)/0.5 mL (0.5 mL single-dose vials) |
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References |
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Bernstein HH, Rothstein EP, Watson BM, et al,
"Clinical Survey of Natural Varicella Compared With Breakthrough Varicella After Immunization With Live Attenuated Oka/Merck Varicella Vaccine,"
Pediatrics, 1993, 92(6):833-7.
"General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP),"
MMWR Morb Mortal Wkly Rep, 1994, 43(RR-1):1-38.
Kuter BJ, Weibel RE, Guess HA, et al,
"Oka/Merck Varicella Vaccine in Healthy Children: Final Report of a 2-Year Efficacy Study and 7-Year Follow-Up Studies,"
Vaccine, 1991, 9(9):643-7. |
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