Vaqta
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Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
VAQTA® [Hepatitis A Vaccine, Inactivated] is indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV.
History
There is currently no drug history available for this drug.
Other Information
VAQTA is an inactivated whole virus vaccine derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts. It contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, purified by a combination of physical and high performance liquid chromatographic techniques developed at the Merck Research Laboratories, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulfate.
VAQTA is a sterile suspension for intramuscular injection. One milliliter of the vaccine contains approximately 50U of hepatitis A virus antigen, which is purified and formulated without a preservative. Within the limits of current assay variability, the 50U dose of VAQTA contains less than 0.1 mcg of non-viral protein, less than 4 × 10–6 mcg of DNA, less than 10–4 mcg of bovine albumin, and less than 0.8 mcg of formaldehyde. Other process chemical residuals are less than 10 parts per billion (ppb), including neomycin.
Each 0.5-mL pediatric dose contains 25U of hepatitis A virus antigen and adsorbed onto approximately 0.225 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride.
Each 1-mL adult dose contains 50U of hepatitis A virus antigen and adsorbed onto approximately 0.45 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 70 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride.
Sources
Vaqta Manufacturers
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Merck Sharp & Dohme Corp.
![Vaqta (Hepatitis A Vaccine, Inactivated) Injection, Suspension [Merck Sharp & Dohme Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Vaqta | Merck Sharp & Dohme Corp.
FOR INTRAMUSCULAR ADMINISTRATION ONLY.
2.1 Dosage and ScheduleChildren/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 and older): 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: A booster dose of VAQTA may be given at 6 to 12 months following a primary dose of HAVRIX [see Clinical Studies (14.6)].
2.2 Preparation and AdministrationShake 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.
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