Rx Item-Varivax varicella vaccine live/P W/DL 10X0.5 ML SDV KEEP FROZEN by Merck

Rx Item-Varivax Ds W/DL 10X0.5 ML Single Dose Vial -KEEP FROZEN by Merck & Co Pharma USA , Clinical Information:
Generic Code And Description: 60760 Varicella Vaccine Live/Pf Preservative Free Subcutaneous Vial 1350 Unit
Strength: 1 350 Unit/0.5 Ml
Dose Form: Vial (Ea)
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 80120000 Vaccines
Active Ingredients: 3023 Varicella Virus Vaccine Live
9870 Preservative Free
Inactive Ingredients: 2549 Gelatin 9000708
2598 Sucrose 57501
3785 Edetic Acid 60004
9283 Beef Derived (Bovine) Drug Class: Drug Class: 80120000 Vaccines , OMP Family: , Temparature Zone: 40 Keep Frozen, Unit Dose Indicator: NO, Item Size: 10X0.5ML, Brand Label Flag: BRAND , Storage Temperature Zone: 40 Keep Frozen, Item Size Code: 10X0.5ML, Item Strength Code:W/DL , Item Abbreviation: Varivax Ds , Generic Form: Vial

These highlights do not include all the information needed to use VARIVAX safely and effectively. See full prescribing information for VARIVAX.

VARIVAX®
Varicella Virus Vaccine Live
Suspension for intramuscular or subcutaneous injection
Initial U.S. Approval: 1995
RECENT MAJOR CHANGES
Dosage and Administration
Dose and Schedule (2.1) 02/2023
Administration (2.3) 02/2023
INDICATIONS AND USAGE

VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older. (1)
DOSAGE AND ADMINISTRATION

For intramuscular or subcutaneous injection only. (2.1, 2.3)
A single dose is approximately 0.5 mL.

Children (12 months to 12 years of age)

The first dose is administered at 12 to 15 months of age. (2.1)
The second dose is administered at 4 to 6 years of age. (2.1)
There should be a minimum interval of 3 months between doses. (2.1)

Adolescents (≥13 years of age) and Adults

Two doses are administered at a minimum interval of 4 weeks. (2.1)

DOSAGE FORMS AND STRENGTHS

Suspension for injection (approximately 0.5 mL dose) supplied as a lyophilized vaccine to be reconstituted using the accompanying sterile diluent. (2.2, 3, 16)
CONTRAINDICATIONS

History of severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of varicella vaccine. (4.1)
Immunosuppression. (4.2)
Moderate or severe febrile illness. (4.3)
Active untreated tuberculosis. (4.4)
Pregnancy. (4.5, 8.1, 17)

WARNINGS AND PRECAUTIONS

Evaluate individuals for immune competence prior to administration of VARIVAX if there is a family history of congenital or hereditary immunodeficiency. (5.1)
Avoid close contact with high-risk individuals susceptible to varicella because of possible transmission of varicella vaccine virus. (5.3)
Immune Globulins (IG) and other blood products should not be given concomitantly with VARIVAX. (5.4, 7.2)
Avoid use of salicylates for 6 weeks following administration of VARIVAX to children and adolescents. (5.5, 7.1)

ADVERSE REACTIONS

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% (6.1)
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% (6.1)
Other reported adverse reactions in all age groups include:
varicella-like rash (injection site)
varicella-like rash (generalized) (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov .
DRUG INTERACTIONS

Reye syndrome has been reported in children and adolescents following the use of salicylates during wild-type varicella infection. (5.5, 7.1)
Administration of immune globulins and other blood products concurrently with VARIVAX vaccine may interfere with the expected immune response. (5.4, 7.2)
VARIVAX vaccination may result in a temporary depression of purified protein derivative (PPD) tuberculin skin sensitivity. (7.3)

USE IN SPECIFIC POPULATIONS

Pregnancy: Do not administer VARIVAX to females who are pregnant. Pregnancy should be avoided for 3 months following vaccination with VARIVAX. (4.5, 8.1, 17)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2023

Rx Item-Varivax Ds W/DL 10X0.5 ML Single
Item No. RX039321, 039321, NDC No.: 00006-4827-00, 00006-827-00, 0000682700, 00006482700, 4827-00, 482700 UPC No. 3-00064-82700-2, 300064-827002, 300064827002

Varivax varicella vaccine
Item No. RX039321, 039321, NDC No.: 00006-4827-00, 00006-827-00, 0000682700, 00006482700, 4827-00, 482700 UPC No. 3-00064-82700-2, 300064-827002, 300064827002

Rx Item-Varivax Ds W/DL 10X0.5 ML Single
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica

Rx Item-Varivax Ds W/DL 10X0.5 ML Single
Item No. RX039321, 039321, NDC No.: 00006-4827-00, 00006-827-00, 0000682700, 00006482700, 4827-00, 482700 UPC No. 3-00064-82700-2, 300064-827002, 300064827002