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|Pulmozyme

Pulmozyme

Pulmozyme is used for:

Improving lung function and reducing the risk of respiratory tract infections in patients with cystic fibrosis.

Pulmozyme is an enzyme. It works by decreasing the thickness and stickiness of mucus secretions in the airways of cystic fibrosis patients.

Do NOT use Pulmozyme if:

• you are allergic to any ingredient in Pulmozyme
• you are allergic to Chinese hamster ovary cell products

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

Before using Pulmozyme :

Some medical conditions may interact with Pulmozyme . 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

Some MEDICINES MAY INTERACT with Pulmozyme . However, no specific interactions with Pulmozyme are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pulmozyme 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 Pulmozyme :

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

• Discuss with your doctor what type of nebulizer is appropriate to use with Pulmozyme . Follow the directions provided by your doctor or other health care provider for using your nebulizer.
• Do not mix Pulmozyme with any other medicine in the nebulizer. Do not use Pulmozyme if it is cloudy or discolored.
• Before each use, squeeze the vial you will be using to make sure that it is not leaking.
• To use Pulmozyme , twist open the top of the vial and pour the entire contents into the nebulizer reservoir, unless directed otherwise by your doctor.
• Connect the nebulizer reservoir to the mouthpiece or face mask. Connect the nebulizer to the compressor.
• Sit in a comfortable, upright position. Place the mouthpiece in your mouth (or put on the face mask) and turn on the compressor.
• Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes).
• Use the contents of the vial as soon as it is opened. Discard any unused medicine.
• Clean the nebulizer according to the instructions. Failure to properly clean the nebulizer could lead to bacterial contamination and you may get an infection. To avoid contamination, throw away any unused medicine after the vial has been opened.
• If you miss a dose of Pulmozyme , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

• Do not dilute or mix Pulmozyme with other medicines before using it.
• Pulmozyme should be used in combination with standard therapies for cystic fibrosis.
• Use Pulmozyme with extreme caution in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pulmozyme , discuss with your doctor the benefits and risks of using Pulmozyme during pregnancy. It is unknown if Pulmozyme is excreted in breast milk. If you are or will be breast-feeding while you are using Pulmozyme , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pulmozyme :

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:

Changes in voice; fever; indigestion; itching; mild sore throat; redness around the eyes; sinus inflammation; temporary loss of voice or hoarseness; throat inflammation.

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

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.

Store Pulmozyme in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep Pulmozyme out of the reach of children and away from pets.

General information:

• If you have any questions about Pulmozyme , please talk with your doctor, pharmacist, or other health care provider.
• Pulmozyme 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 Pulmozyme . 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.