Active immunization against varicella (chickenpox) in healthy individuals from 12 months of age and up.
Immunization of susceptible high-risk patients and their susceptible healthy close contacts.
Specific high-risk groups include patients with acute leukemia, those under immunosuppressive treatment, and patients with planned organ transplantation.
Dosage and Administration
Pediatrics (12 months to 12 years):
Two doses of 0.5 mL each, administered subcutaneously, with a minimum interval of 6 weeks between doses.
Adolescents and Adults (13 years and older):
Two doses of 0.5 mL each, administered subcutaneously, with a minimum interval of 6 weeks between doses.
High-Risk Patients:
Additional doses may be required.
Contraindications
Known hypersensitivity to any component of the vaccine or to neomycin.
Severe humoral or cellular immunodeficiency.
Pregnancy and women planning to become pregnant within one month post-vaccination.
Warnings and Precautions
General: Postpone vaccination in individuals with acute severe febrile illness. Use caution in individuals with a history of anaphylactic reactions to any vaccine component.
Administration: Do not administer intravascularly or intradermally. Allow alcohol and disinfecting agents to evaporate before injection.
Special Populations:
Pregnancy: Contraindicated.
Breastfeeding: Use with caution; unknown if excreted in human milk.
Immunocompromised: Limited data available; use with caution and monitor closely.
Adverse Reactions
Very Common: Pain and redness at the injection site.
Common: Rash, swelling at the injection site, fever.
Immune Globulins and Blood Transfusions: Delay vaccination for at least three months.
Salicylates: Avoid use for 6 weeks post-vaccination due to the risk of Reye’s Syndrome.
Other Vaccines: Can be administered with other vaccines at different injection sites.
Storage and Stability
Storage: Store lyophilized vaccine in a refrigerator at 2°C to 8°C. Do not freeze. Reconstituted vaccine should be used promptly, within 90 minutes at room temperature or within 8 hours if refrigerated.
Clinical Trials and Efficacy
Efficacy: High seroconversion rates observed in children and adults. Protection against varicella maintained for several years post-vaccination.
In children aged 9 months to 12 years, seroconversion rates >98% at 6 weeks post-vaccination.
In adolescents and adults, seroconversion rate 100% at 6 weeks post-second dose.
