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XEOMIN
INCOBOTULINUMTOXIN A INJ. (XEOMIN)
BOXED WARNING: Distant Spread of Toxin Effect See full prescribing information for complete boxed warning. The effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
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MYASTHENIA GRAVIS. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use.
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Use this medicine exactly as directed on the label, unless instructed differently by your doctor * This medicine is administered only by or under the supervision of your doctor. * This medication is usually given by injection and administered by a healthcare professional. * PRESERVATIVE FREE formulation: Use immediately after reconstitution.
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* STOP TAKING MEDICINE & GET EMERGENCY HELP IMMEDIATELY IF A HYPERSENSITIVITY OR ANAPHYLACTIC REACTION occurs: (see symptoms below):- * shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching. * Safety of use during pregnancy has not been established. This medicine SHOULD NOT BE USED DURING PREGNANCY unless benefit justifies potential risk to the fetus. CALL YOUR DOCTOR.
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Shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching.
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Spread of toxin effects; Respiratory depression; Involuntary motor activity; Myasthenia gravis; Muscle weakness; Difficulty swallowing.
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Back pain; Cough; Dizziness; Flu-like symptoms; Joint pain; Nausea; Neck pain / stiffness; Nasal congestion; Dry mouth; Indigestion; Generalized pain; Headache; Infection; Injection site pain.
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If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY.
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Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients.
Copyright © CliniDATA Source, Inc. 03/14. All rights reserved
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