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|Cathflo Activase

Cathflo Activase

Cathflo Activase is used for:

Restoring function to central venous access devices that have become clogged with clotted blood. It may also be used for other conditions as determined by your doctor.

Cathflo Activase is a tissue plasminogen activator (tPA). It works by helping to break down unwanted blood clots.

Do NOT use Cathflo Activase if:

• you are allergic to any ingredient in Cathflo Activase

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

Before using Cathflo Activase :

Tell your health care provider 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 active internal bleeding
• if you have had any type of surgery or medical procedure or have undergone childbirth within the past 48 hours
• if you have blood problems (eg, thrombocytopenia, blood clotting problems) or severe liver or kidney disease
• if you have an increased risk for complications due to clotting (eg, blood clot near the catheter)
• if you have a known or suspected infection at the catheter site

Some MEDICINES MAY INTERACT with Cathflo Activase . Tell your health care provider if you are taking any of the following medicines.

• Abciximab, anticoagulants (eg, warfarin, heparin), aspirin, or dipyridamole because the risk of serious side effects, such as bleeding, may be increased
• Nitrates (eg, nitroglycerin, isosorbide dinitrate) because the effectiveness of Cathflo Activase may be decreased

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

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

• Cathflo Activase is usually administered at your doctor"s office, hospital, or clinic. If you are using Cathflo Activase at home, carefully follow the procedures taught to you by your health care provider.
• If Cathflo Activase contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Mix Cathflo Activase by swirling gently. Do not shake.
• Throw away any unused medicine left in the vial.
• Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.
• If you miss a dose of Cathflo Activase , contact your doctor right away.

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

Important safety information:

• Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Cathflo Activase . Using Cathflo Activase alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Be sure you know why the catheter is not functioning before using Cathflo Activase . If the catheter is not functioning due to a reason other than clotted blood, contact your doctor before using Cathflo Activase .
• Contact your doctor if the catheter remains blocked after using this product as directed.
• If redness, swelling, or pain develops at the catheter site, contact your doctor immediately.
• Cathflo Activase may reduce the number of cells in your blood that help your blood clot (platelets). To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• If serious bleeding occurs while you are using Cathflo Activase , contact your doctor immediately.
• Additional monitoring of your dose or condition may be needed if you are taking warfarin or aspirin.
• Use Cathflo Activase with caution in the ELDERLY because they may be more sensitive to its effects.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using this product during pregnancy. It is unknown if Cathflo Activase is excreted in breast milk. If you are or will be breast-feeding while you are using Cathflo Activase , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Cathflo Activase :

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; bloody vomit; calf pain or tenderness; changes in vision; chest pain; chills; coughing up blood; difficulty breathing or sudden shortness of breath; fast, slow, or irregular heartbeat; fever; one-sided weakness; redness, swelling, or pain at the catheter site; severe bleeding; severe stomach pain; speech problems or changes; unusual or easy bleeding or bruising.

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. Symptoms may include unusual bleeding.

Store Cathflo Activase in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Store away from heat, moisture, and light. Keep Cathflo Activase , as well as syringes and needles, out of the reach of children and away from pets.

General information:

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