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Vaqta

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Vaqta

Vaqta

INDICATIONS

VAQTA (hepatitis a vaccine, inactivated) is indicated for active immunization against disease caused by hepatitis A virus in persons 12 months of age and older. Primary immunization should be given at least 2 weeks prior to expected exposure to HAV.

The Advisory Committee on Immunization Practices (ACIP) has issued recommendations for hepatitis A vaccination for persons who are at increased risk for infection and for any person wishing to obtain immunity.7 Please consult the Centers for Disease Control and Prevention for updates to those recommendations (www.cdc.gov).

If passive protection against hepatitis A is required either following exposure to hepatitis A virus or in persons in need of combined immediate and long-term protection, VAQTA (hepatitis a vaccine, inactivated) may be administered along with immune globulin at a separate site with a separate syringe.

Revaccination

See DOSAGE AND ADMINISTRATION, Dosage.

DOSAGE AND ADMINISTRATION

Do not inject intravascularly, intradermally, or subcutaneously.

VAQTA (hepatitis a vaccine, inactivated) is for intramuscular injection. The deltoid muscle is the preferred site for intramuscular injection.

Dosage

The vaccination regimen consists of one primary dose and one booster dose for healthy children, adolescents, and adults, as follows:

Children/Adolescents

Individuals 12 months through 18 years of age should receive a single 0.5 mL (~25U) dose of vaccine at elected date and a booster dose of 0.5 mL (~25U) 6 to 18 months later.

Adults

Adults 19 years of age and older should receive a single 1.0 mL (~50U) dose of vaccine at elected date and a booster dose of 1.0 mL (~50U) 6 to 18 months later. For all age groups, a booster dose is recommended anytime between 6 and 18 months after the administration of the primary dose in order to elicit a high antibody titer.

Interchangeability of the Booster Dose

A booster dose of VAQTA (hepatitis a vaccine, inactivated) may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines (e.g., HAVRIX). (See CLINICAL PHARMACOLOGY, Interchangeability of Booster Dose.)

Use With Other Vaccines

VAQTA (hepatitis a vaccine, inactivated) may be given concomitantly with typhoid and yellow fever vaccines. The GMTs for hepatitis A when VAQTA (hepatitis a vaccine, inactivated) , typhoid, and yellow fever vaccines were administered concomitantly were reduced when compared to VAQTA (hepatitis a vaccine, inactivated) alone. Following receipt of the booster dose of VAQTA (hepatitis a vaccine, inactivated) , the GMTs for hepatitis A in these two groups were observed to be comparable. VAQTA (hepatitis a vaccine, inactivated) may be given concomitantly with M-M-R II. Data on concomitant use with other vaccines are limited. Separate injection sites and syringes should be used for concomitant administration of injectable vaccines. (See CLINICAL PHARMACOLOGY, Use With Other Vaccines.)

Use With Immune Globulin

VAQTA (hepatitis a vaccine, inactivated) may be administered concomitantly with immune globulin (IG) using separate sites and syringes. The vaccination regimen for VAQTA (hepatitis a vaccine, inactivated) should be followed as stated above. Consult the manufacturer's product circular for the appropriate dosage of IG. A booster dose of VAQTA (hepatitis a vaccine, inactivated) should be administered at the appropriate time as outlined above.

Administration

Known or Presumed Exposure to HAV/Travel to Endemic Areas

For individuals requiring either post-exposure prophylaxis or combined immediate and longer term protection (e.g., travelers departing on short notice to endemic areas), VAQTA (hepatitis a vaccine, inactivated) may be administered concomitantly with IG using separate sites and syringes (see CLINICAL PHARMACOLOGY).

The following are the ACIP and American Academy of Family Physicians (AAFP) recommendations for all intramuscular injections: "For administration of VAQTA (hepatitis a vaccine, inactivated) for children and adolescents (persons 12 months to 18 years), the deltoid muscle can be used if the muscle mass is adequate. The needle size can range from 22 to 25 gauge and from 7/8 to 1 ¼ inches, on the basis of the size of the muscle. For toddlers, the anterolateral thigh can be used, but the needle should be longer, usually 1 inch.

For adults (persons aged > 18 years) the deltoid muscle is recommended for routine intramuscular vaccinations. The anterolateral thigh can be used. The suggested needle size is 1 – 1 ½ inches and 22-25 gauge.”8

The vaccine should be used as supplied; no reconstitution is necessary.

Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine. Discard if the suspension does not appear homogenous.

Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit. After thorough agitation, VAQTA (hepatitis a vaccine, inactivated) is a slightly opaque, white suspension.

A separate sterile syringe and sterile disposable needle or a sterile disposable unit should be used for each individual patient to prevent transmission of hepatitis or other infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.

Prefilled Syringe Use with and without Needle Guard (Safety) Device
Prefilled Syringe with Needle Guard (Safety) Device

Instructions for using the prefilled single-dose syringes preassembled with needle guard device

 Prefilled Syringe - Illustration

NOTE: Please use the enclosed needle for administration. If a different needle is chosen, it should fit securely on the syringe and be no longer than 1 inch to ensure proper functioning of the needle guard device. Two detachable labels are provided which can be removed after the needle is guarded.

At any of the following steps, avoid contact with the Trigger Fingers to keep from activating the safety device prematurely.

Remove Syringe Tip Cap and Needle Cap. Attach Luer Needle bypressing both Anti-Rotation Tabs to secure syringe and by twisting the Luer Needle in a clockwise direction until secured to the syringe. Remove Needle Sheath. Administer injection per standard protocol as stated above under DOSAGE AND ADMINISTRATION. Depress the Plunger while grasping the Finger Flange until the entire dose has been given. The Needle Guard Device will NOT activate to cover and protect the needle unless the ENTIRE dose has been given. While the Plunger is still depressed, remove needle from the vaccine recipient. Slowly release the Plunger and allow syringe to move up until the entire needle is guarded. For documentation of vaccination, remove detachable labels by pulling slowly on them. Dispose in approved sharps container.

Prefilled Syringe without Needle Guard (Safety) Device

This package does not contain a needle guard (safety device) or a needle. Shake well before use. Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. Administer the entire dose as per standard protocol.

HOW SUPPLIED

Pediatric/Adolescent Formulation

Vials

No. 4831 — VAQTA (hepatitis a vaccine, inactivated) for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose vial, NDC 0006-4831-00.

No. 4831 — VAQTA (hepatitis a vaccine, inactivated) for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose vial, in a box of 10 single-dose vials, NDC 0006-4831-41.

Syringes

No. 4095 — VAQTA (hepatitis a vaccine, inactivated) for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose prefilled Luer Lock syringe, preassembled with UltraSafe Passive®§§§delivery system in a box of 6 single-dose prefilled syringes. Six one-inch 23 gauge needles are provided separately in the package, NDC 0006-4095-06.

No. 4095 — VAQTA (hepatitis a vaccine, inactivated) for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a carton of 6 0.5 mL prefilled single-dose Luer Lock syringes with tip caps, NDC 0006-4095-09.

Asult Formulation

Vials

No. 4841 — VAQTA (hepatitis a vaccine, inactivated) for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose vial, NDC 0006-4841-00.

No. 4841 — VAQTA (hepatitis a vaccine, inactivated) for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose vial, in a box of 10 single-dose vials, NDC 0006-4841-41.

Syringes

No. 4096 — VAQTA (hepatitis a vaccine, inactivated) for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose prefilled Luer Lock syringe, preassembled with UltraSafe Passive® delivery system. A one-inch 23 gauge needle is provided separately in the package, NDC 0006-4096-31.

No. 4096 — VAQTA (hepatitis a vaccine, inactivated) for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose prefilled Luer Lock syringe, preassembled with UltraSafe Passive® delivery system in a box of 6 single-dose, prefilled syringes. Six one-inch 23 gauge needles are provided separately in the package, NDC 0006-4096-06.

No. 4096 — VAQTA (hepatitis a vaccine, inactivated) for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a carton of 6 1 mL prefilled single-dose Luer Lock syringes with tip caps, NDC 0006-4096-09.

Storage

Store vaccine at 2-8°C (36-46°F).

DO NOT FREEZE since freezing destroys potency.

§§§ UltraSafe Passive® delivery system is a Trademark of Safety Syringes, Inc.

REFERENCES

7. Recommendations of the Advisory Committee on Immunization Practices (ACIP); Prevention of Hepatitis A Through Active or Passive Immunization, MMWR 48(RR-12): 1-37, 1999.

8. Recommendations of the Advisory Committee on Immunization Practices (ACIP); General Recommendations on Immunization, MMWR 51(RR-2): 1-35, 2002.

Manufactured amd Dist by: MERCK & CO., INC, Whitehouse Station, NJ 08889, USA. Issued December 2007.

Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.

A A A

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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