"The European Medicines Agency (EMA) has launched a review of the six direct-acting antivirals approved for use in the European Union for treating chronic hepatitis C virus infection, the agency said today.
They are daclatasvir (Dak"...
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR ADMINISTRATION ONLY.
Dosage And Schedule
Children/Adolescents (12 Months Through 18 Years Of Age)
The vaccination schedule consists of a primary 0.5-mL dose administered intramuscularly, and a 0.5-mL booster dose administered intramuscularly 6 to 18 months later.
Adults ( ≥ 19 Years Of Age)
The vaccination schedule consists of a primary 1-mL dose administered intramuscularly, and a 1-mL booster dose administered intramuscularly 6 to 18 months later.
Booster Immunization Following Another Manufacturer's Hepatitis A Vaccine
Preparation And Administration
Shake the single-dose vial or single-dose prefilled syringe well to obtain a slightly opaque, white suspension before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Discard if the suspension does not appear homogenous or if extraneous particulate matter remains or discoloration is observed.
For single-dose vials, withdraw and administer entire dose of VAQTA intramuscularly using a sterile needle and syringe.
For single-dose prefilled syringes, securely attach a needle by twisting in a clockwise direction and administer dose of VAQTA intramuscularly.
For adults, adolescents, and children older than 2 years of age, the deltoid muscle is the preferred site for intramuscular injection. For children 12 through 23 months of age, the anterolateral area of the thigh is the preferred site for intramuscular injection.
Dosage Forms And Strengths
Suspension for injection available in four presentations:
- 0.5-mL pediatric dose in single-dose vials and prefilled syringes
- 1-mL adult dose in single-dose vials and prefilled syringes
[See DESCRIPTION for listing of vaccine components and Storage and Handling]
Storage And Handling
VAQTA is available in single-dose vials and prefilled Luer Lock syringes.
25U/0.5 mL in single-dose vials and prefilled Luer Lock syringes.
NDC 0006-4831-41 – box of ten 0.5-mL single dose vials.
NDC 0006-4095-09 – carton of six 0.5-mL prefilled single-dose Luer Lock syringes with tip caps.
50U/1-mL in single-dose vials and prefilled Luer Lock syringes.
NDC 0006-4841-00 – 1-mL single dose vial.
NDC 0006-4841-41 – box of ten 1-mL single dose vials.
NDC 0006-4096-09 – carton of six 1-mL prefilled single-dose Luer Lock syringes with tip caps.
Store vaccine at 2-8°C (36-46°F).
DO NOT FREEZE since freezing destroys potency.
Manuf. and Dist. by : Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USAThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/1/2015
Additional Vaqta Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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