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Cervarix

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Cervarix

Indications
Dosage
How Supplied

INDICATIONS

Indications

CERVARIX® is indicated for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18 [see Clinical Studies]:

Limitations Of Use And Effectiveness

CERVARIX does not provide protection against disease due to all HPV types [see Clinical Studies].

CERVARIX has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity [see Clinical Studies].

Females should continue to adhere to recommended cervical cancer screening procedures [see PATIENT INFORMATION].

Vaccination with CERVARIX may not result in protection in all vaccine recipients.

DOSAGE AND ADMINISTRATION

Preparation For Administration

Shake syringe well before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered. With thorough agitation, CERVARIX is a homogeneous, turbid, white suspension. Do not administer if it appears otherwise.

Attach a sterile needle and administer intramuscularly.

Do not administer this product intravenously, intradermally, or subcutaneously.

Dose And Schedule

Immunization with CERVARIX consists of 3 doses of 0.5-mL each, by intramuscular injection according to the following schedule: 0, 1, and 6 months. The preferred site of administration is the deltoid region of the upper arm.

HOW SUPPLIED

Dosage Forms And Strengths

CERVARIX is a suspension for intramuscular injection available in 0.5-mL single-dose prefilled TIP-LOK® syringes.

Storage And Handling

CERVARIX is available in 0.5-mL single-dose disposable prefilled TIP-LOK syringes (packaged without needles):

NDC 58160-830-05 Syringe in Package of 1: NDC 58160-830-34

NDC 58160-830-43 Syringe in Package of 10: NDC 58160-830-52

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen. Upon storage, a fine, white deposit with a clear, colorless supernatant may be observed. This does not constitute a sign of deterioration.

Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License 1617. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709

Last reviewed on RxList: 9/8/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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