Menactra

Dosage Forms And Strengths

Menactra vaccine is a liquid solution supplied in 0.5 mL single-dose vials. [See DESCRIPTIONfor a complete listing of ingredients.]

Vial, 1 Dose (NDC 49281-589-58) supplied as a package of 5 vials (NDC 49281-589-05).

Storage And Handling

Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Frozen/previously frozen product should not be used. Do not use after the expiration date.

Manufactured by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA

You should not receive this vaccine if you have ever had an allergic reaction to a meningococcal or a diphtheria vaccine, if you are allergic to latex, or if you have a history of Guillain-Barre syndrome.

To make sure you can safely receive this vaccine, tell your doctor if you have any of these other conditions:

• a bleeding or blood clotting disorder, such as hemophilia;
• any condition that weakens the immune system (such as HIV, AIDS, or cancer); or
• if you are receiving steroids, chemotherapy, or radiation treatments.

If you have any of these conditions, you may not be able to receive meningococcal conjugate vaccine, or you may need to wait until your condition changes or you have completed your treatments.

FDA pregnancy category C. It is not known whether meningococcal conjugate vaccine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant soon after receiving this vaccine.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of meningococcal conjugate vaccine on the baby.

It is not known whether this vaccine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The Menactra brand of this vaccine should not be given to anyone younger than 9 months or older than 55 years of age. The Menveo brand should not be given to anyone younger than 2 years or older than 55 years of age.

• Vaccination and Immunization Safety Information

You should not receive this vaccine if you have ever had an allergic reaction to a meningococcal or diphtheria vaccine.

For all patients taking Menactra:

• Tell all of your health care providers that you take Menactra. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may not protect all people who use it. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Children:

• Some children may need to have more than 1 dose of this vaccine. Talk with your child's doctor.
• If your child was born premature, talk with the doctor. Trouble breathing has happened in these children after getting some vaccines.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Data not available

Data not available

Benefit should outweigh risk. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -It is considered unlikely that vaccinating a breast-feeding mother with this product would be harmful to the infant.