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Aplisol is used for:

Detecting tuberculosis (TB) infection.

Aplisol is a diagnostic agent. It works by causing a mild, delayed allergic reaction in patients infected with TB or who have had a past infection, which allows for detection of TB.

Do NOT use Aplisol if:

• you are allergic to any ingredient in Aplisol or you have previously had a severe reaction (eg, sores, skin wasting) to Aplisol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aplisol :

Some medical conditions may interact with Aplisol . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a viral infection (eg, HIV, chickenpox), known TB infection or a previous positive tuberculin skin test, another bacterial infection (eg, strep throat), cancer, or severe protein deficiency
• if you have recently been given a live vaccine (eg, measles, flu)

Some MEDICINES MAY INTERACT with Aplisol . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Corticosteroids (eg, prednisone), immunosuppressives (eg, certain cancer medicines, cyclosporine), or live vaccines (eg, measles) because the effectiveness of Aplisol may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aplisol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aplisol :

Use Aplisol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Aplisol is usually administered as an injection at your doctor's office, hospital, or clinic.
• If Aplisol contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• The result is read 48 to 72 hours after administration. Be sure to keep your appointment to have the result read. It may be necessary to have a follow-up test done, depending on your potential to come in contact with TB.
• If you miss a dose of Aplisol , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Aplisol .

Important safety information:

• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Aplisol during pregnancy. If you are or will be breast-feeding while you are using Aplisol , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Aplisol :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Pain, itching, or redness at the injection site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters; open sores.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Aplisol is usually handled and stored by a health care provider. If you are using Aplisol at home, store Aplisol as directed by your pharmacist or health care provider. Keep this medicine out of the reach of children and away from pets.

General information:

• If you have any questions about Aplisol , please talk with your doctor, pharmacist, or other health care provider.
• Aplisol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Aplisol . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.