When This Medicine Should Not Be Used:
You should not receive this vaccine if you have had an allergic reaction to smallpox vaccine, or if you are pregnant. You should not receive this vaccine if you have problems with your immune system, or if you have leukemia, lymphoma, cancer, HIV or AIDS. You should not receive this vaccine if you have had a bone marrow transplant or an organ transplant. You should not receive this vaccine if you are using medicines that weaken your immune system, such as steroids, radiation, or cancer medicines. Children younger than 16 years of age should not receive this vaccine.

How to Use This Medicine:
Injectable

• A nurse or other health provider will give you this medicine.
• Your doctor will prescribe your exact dose. This vaccine is given by using a needle to poke or jab the skin on your upper arm.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using a steroid eye drop or ointment, such as dexamethasone (TobraDex®).
• Do not use creams, ointments, or other skin care products on the vaccination site.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Make sure your doctor knows if you are breastfeeding, or if you have any heart disease. This includes a history of heart attack, stroke, chest pain, or congestive heart failure. Also tell your doctor if you have high blood pressure, high cholesterol, diabetes, a close family member with heart disease, or if you smoke cigarettes. Tell your doctor if you are using a steroid eye drop or ointment, or if you have any skin conditions such as eczema, dermatitis, burns, psoriasis, impetigo, chickenpox, or shingles.
• This vaccine contains neomycin and polymyxin B. Make sure your doctor knows if you have had an allergic reaction to these medicines.
• This vaccine contains a live virus. The virus can cause an infection in other parts of your body or in other people if you touch the vaccination site and then touch your body or other people. Always cover the vaccination site with a bandage. Wash your hands thoroughly after changing the bandage or after touching the vaccination site. Your doctor will tell you how to care for the vaccination site. Make sure you understand the directions and follow them carefully. Avoid contact with people who are sick or have infections until the scab falls off (usually 2 to 4 weeks after vaccination). Talk to your doctor about this if you have concerns.
• You must wait at least 30 days before you can donate blood, use a hot tub or swim, handle a baby, breastfeed, or get a tuberculin (TB) skin test.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash.
• Changes in vision or eye pain.
• Chest pain or shortness of breath.
• Confusion, irritability, headache, seizures, or stiff neck.
• Fast or irregular heartbeat.
• Fever or chills.
• Swollen, painful, or tender glands in the neck, armpit, or groin.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, nausea, or vomiting.
• Mild skin rash or redness.
• Muscle pain.
• Pain, itching, swelling, or redness where the shot is given.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088