drug-information.ru

|Activase

Activase

Activase is used for:

Treating blood clots in the lungs and improving heart function and survival following a heart attack. Activase may also be used to improve recovery and reduce disability in certain patients who have had a stroke. It may also be used for other conditions as determined by your doctor.

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

Do NOT use Activase if:

• you are allergic to any ingredient in Activase
• you have active internal bleeding, history of stroke, recent brain or spinal surgery (within 3 months), a growth in the brain, abnormal formation of blood vessels, or a certain type of bulging blood vessel (aneurysm)
• you have a heart attack or blood clot in the lung and you also have had recent brain or spinal injury, a history of bleeding problems, or severe uncontrolled high blood pressure
• you have a stroke and you also have known or suspected bleeding in the head or brain, a history of bleeding in the brain, a recent serious head injury, uncontrolled high blood pressure, low platelet count, high international normalized ratio (INR) or prothrombin time (PT), or a history of bleeding problems, or if you had a seizure at the onset of the stroke
• you have a stroke and you are taking warfarin, or you have used heparin within the past 48 hours and you currently have a high activated partial thromboplastin time (aPTT)

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

Before using 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 had recent major surgery or have recently undergone childbirth
• if you have a disease of the blood vessels in your brain; recent bleeding of the stomach, bowel, genitals, or urinary tract; a recent injury; high blood pressure; inflammation around the heart; inflammation inside the heart due to an infection; blood problems (including blood clotting problems); moderate to severe liver disease; severe kidney disease; bleeding in the eye due to diabetes or other problems; a serious infection; or blood vessel inflammation
• if you have an increased risk of a blood clot in your heart
• if you are older than 75 years of age

Some MEDICINES MAY INTERACT with 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
• Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril) because the risk of serious side effects, such as severe swelling or trouble breathing, may be increased
• Nitrates (eg, nitroglycerin, isosorbide dinitrate) because the effectiveness of Activase may be decreased

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

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

• Activase is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Activase at home, carefully follow the injection procedures taught to you by your health care provider.
• If Activase contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Mix 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 Activase , contact your doctor right away.

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

Important safety information:

• Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Activase . Using Activase alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• 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 Activase , contact your doctor immediately.
• LAB TESTS, including electrocardiogram (ECG), blood coagulation, and blood pressure, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Activase with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Activase with extreme caution in CHILDREN. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY AND BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using this product during pregnancy. It is unknown if Activase is excreted in breast milk. If you are or will be breast-feeding while you are using Activase , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of 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; change in color of your fingers or toes; changes in vision; chills; coughing up blood; decreased amount of urine produced; difficulty breathing or sudden shortness of breath; difficulty swallowing; fast, slow, or irregular heartbeat; fever; hoarseness; numbness in arm or leg; one-sided weakness; pain, redness, or swelling at the injection site; purple skin color; rectal bleeding; seizures; severe bleeding; severe muscle aches or pain; severe stomach pain; sharp or crushing chest pain; speech problems or changes; sudden arm or leg pain; sudden dizziness, fainting, severe headache, or vomiting; 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 severe bleeding.

Store Activase at room temperature, below 86 degrees F (30 degrees C), or under refrigeration, between 36 and 46 degrees F (2 and 8 degrees C). Store away from heat, moisture, and light. Keep 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 Activase , please talk with your doctor, pharmacist, or other health care provider.
• 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 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.