Varivax0.5 ml

This is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.

Vaccines, Anti-sera & Immunoglobulin

Live varicella vaccine is used to stimulate active immunity to varicella (chickenpox).

Varivax 0.5 ml is administered as an approximately 0.5-mL dose by subcutaneous injection into the outer aspect of the upper arm (deltoid region) or the anterolateral thigh. Do not administer this product intravascularly or intramuscularly.Children (12 months to 12 years of age): If a second dose is administered, there should be a minimum interval of 3 months between dosesAdolescents ( ≥ 13 years of age) and Adults: Two doses of vaccine, to be administered with a minimum interval of 4 weeks between doses

Each 0.5 mL dose of Varivax 0.5 ml is administered subcutaneously. Inject the vaccine subcutaneously into the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh.Children (12 months to 12 years of age): The first dose is administered at 12 to 15 months of age but may be given anytime through 12 years of age. The second dose is administered at 4 to 6 years of age. At least 3 months should elapse between a dose of varicella-containing vaccine. At least 1 month should elapse between a dose of measles-containing vaccine and a dose of Varivax 0.5 ml if the vaccines are not given concurrently.Adolescents (≥13 years of age) and Adults: Two doses of Varivax 0.5 ml are administered at a minimum interval of 4 weeks.

Reye syndrome has been reported in children and adolescents following the use of salicylates during wild-type varicella infection. Administration of immune globulins and other blood products concurrently with Varivax 0.5 ml vaccine may interfere with the expected immune response. Varivax 0.5 ml vaccination may result in a temporary depression of purified protein derivative (PPD) tuberculin skin sensitivity.

Severe Allergic Reaction: Do not administer Varivax 0.5 ml to individuals with a history of anaphylactic or severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of a varicella-containing vaccine.Immunosuppression: Do not administer Varivax 0.5 ml to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Disseminated varicella disease and extensive vaccine associated rash have been reported in individuals who are immunosuppressed or immunodeficient who were inadvertently vaccinated with a varicella-containing vaccine.Moderate or Severe Febrile Illness: Do not administer Varivax 0.5 ml to individuals with an active febrile illness with fever >38.5°C.Active Untreated Tuberculosis: Do not administer Varivax 0.5 ml to individuals with active, untreated tuberculosis (TB).Pregnancy: Do not administer Varivax 0.5 ml to individuals who are pregnant or planning on becoming pregnant in the next 3 months. Wild-type varicella is known to cause fetal harm.

Frequently reported (≥10%) adverse reactions in children ages 1 to 12 years include: fever ≥102.0°F (38.9°C) oral: 14.7% injection-site complaints: 19.3% Frequently reported (≥10%) adverse reactions in adolescents and adults ages 13 years and older include: fever ≥100.0°F (37.8°C) oral: 10.2% injection-site complaints: 24.4% Other reported adverse reactions in all age groups include: varicella-like rash (injection site) varicella-like rash (generalized)

Pregnancy Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Evaluate individuals for immune competence prior to administration of Varivax 0.5 ml if there is a family history of congenital or hereditary immunodeficiency. Avoid close contact with high-risk individuals susceptible to varicella because of possible transmission of varicella vaccine virus. Immune Globulins (IG) and other blood products should not be given concomitantly with Varivax 0.5 ml. Avoid use of salicylates for 6 weeks following administration of Varivax 0.5 ml to children and adolescents.

Store between 2-8° C. Do not freeze. Protect from light. Keep out of the reach of children.

Pediatric Use: No clinical data are available on safety or efficacy of Varivax 0.5 ml in children less than 12 months of age.Geriatric Use: Clinical studies of Varivax 0.5 ml did not include sufficient numbers of seronegative subjects aged 65 and over to determine whether they respond differently from younger subjects.

Reconstitution Instructions: When reconstituting the vaccine, use only the sterile diluent supplied with Varivax 0.5 ml. The sterile diluent does not contain preservatives or other anti-viral substances which might inactivate the vaccine virus.Use a sterile syringe free of preservatives, antiseptics, and detergents for each reconstitution and injection of Varivax 0.5 ml because these substances may inactivate the vaccine virus.To reconstitute the vaccine, first withdraw the total volume of provided sterile diluent into a syringe. Inject all of the withdrawn diluent into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into the syringe and inject the total volume (approximately 0.5 mL) of reconstituted vaccine subcutaneously. Varivax 0.5 ml, when reconstituted, is a clear, colorless to pale yellow liquid.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if particulates are present or if it appears discolored.To minimize loss of potency, administer Varivax 0.5 ml immediately after reconstitution. Discard if reconstituted vaccine is not used within 30 minutes.Do not freeze reconstituted vaccine.Do not combine Varivax 0.5 ml with any other vaccine through reconstitution or mixing.

Vaccines, Anti-sera & Immunoglobulin

Varivax 0.5 ml induces both cell-mediated and humoral immune responses to varicella-zoster virus. The relative contributions of humoral immunity and cell-mediated immunity to protection from varicella are unknown.

Varivax 0.5 ml is contraindicated for use in pregnant women because the vaccine contains live, attenuated varicella virus, and it is known that wild-type varicella virus, if acquired during pregnancy, can cause congenital varicella syndrome. No increased risk for miscarriage, major birth defect or congenital varicella syndrome was observed in a pregnancy exposure registry that monitored outcomes after inadvertent use. There are no relevant animal data.It is not known whether varicella vaccine virus is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Varivax 0.5 ml, and any potential adverse effects on the breastfed child from Varivax 0.5 ml or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

Pediatric Use: No clinical data are available on safety or efficacy of Varivax 0.5 ml in children less than 12 months of age.Geriatric Use: Clinical studies of Varivax 0.5 ml did not include sufficient numbers of seronegative subjects aged 65 and over to determine whether they respond differently from younger subjects.