reteplase-injection, Retavase (cont.)

SIDE EFFECTS: Nausea or dizziness may occur. If either of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: bleeding (e.g., from injection site, gums, or wounds), unusual fatigue or weakness, irregular heartbeat, blood in your urine or stool. Tell your doctor immediately if any of these unlikely but serious side effects occur: changes in amount of urine, discoloration of the skin, severe stomach pain, muscle pain, chest pain, slurred speech, mental/mood changes, severe headache, eye pain or vision changes. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: This medication is not recommended for use if you have the following medical conditions: active internal bleeding (e.g., ulcer, trauma), history of stroke, recent surgery of the brain or spine, blood vessel problems (e.g., aneurysms), severe high blood pressure (uncontrolled). Tell your doctor your medical history, especially of: bleeding or blood problems, high blood pressure, diabetes, high cholesterol, blood clots (e.g., thrombophlebitis), recent surgery or injury, heart problems/infections (e.g., arrhythmias, endocarditis, mitral valve stenosis), eye problems, kidney or liver disease. This medication may cause you to bleed easily. Use caution with sharp objects like safety razors or nail cutters and avoid activities which that may increase your chance of getting cut, bruised, or injured. Also, avoid unnecessary injections into the muscles (IM). Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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