Tubersol

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tuberculin injection in children.

Geriatric

Although appropriate studies on the relationship of age to the effects of tuberculin injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Extensive skin burns or eczema (skin disease) or
• Tuberculosis, active or history of—Should not be given to patients with these conditions.

• HIV infection or AIDS or
• Organ transplant, history of or
• Weak immune system—May increase your risk of developing active tuberculosis.

This section provides information on the proper use of a number of products that contain tuberculin. It may not be specific to Tubersol. Please read with care.

A nurse or other trained health professional will give you this medicine in a hospital or clinic. This medicine is injected into the skin on your forearm.

Your skin may become red and swollen in the area where the medicine was given.

You must return to your doctor's office 2 or 3 days after receiving tuberculin. This is to check at the way your skin has reacted to the medicine.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Fainting may occur after receiving this test. It may occur with other symptoms including: lightheadedness, muscle weakness, or seizures.

False positive or negative tuberculin skin test reaction may occur in some patients. This may occur if you have received a vaccine against tuberculosis (eg, BCG) or if you have been exposed to other mycobacteria.

Make sure your doctor knows if you are using a medicine that weakens your immune system, such as a steroid or cancer treatment.

Tuberculin skin test should not be given within 1 month to patients who have received live vaccines. These vaccines include measles, mumps, rubella, oral polio, yellow fever, and varicella.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Bleeding at the injection site (occurring up to 3 days after the skin test)
• blistering, crusting, or scabbing at the injection site
• cough
• deep, dark purple bruise at the injection site (occurring up to 3 days after the skin test)
• difficult or labored breathing
• dizziness
• fainting
• fast heartbeat
• fever
• hard lump at the injection site
• hives
• itching, pain, redness, or swelling at the injection site
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• scar at the injection site
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Pain, discomfort, or itching at the injection site
• redness or rash at the injection site (occurring within 12 hours after skin test)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tuberculin Purified Protein
Derivative (Mantoux)
Tubersol®

5 mL (50 Tests)

Test dose: 5 TU/0.1 mL ID.

Rx only

Protect from light.

Discard opened product after 30 days.

Sanofi Pasteur Limited

Date opened