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GAMUNEX
IMMUNE GLOBULIN IV HUMAN (GAMUNEX)
BOXED WARNING: ACUTE RENAL DYSFUNCTION and FAILURE; RISK OF THROMBOSIS See full prescribing information for complete boxed warning. • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may be associated with Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMUNEX does not contain sucrose. • Administer IGIV products at the minimum concentration available and the minimum infusion rate practicable. • FDA has analyzed recent data that has strengthened the association between the use of intravenous, subcutaneous and intramuscular human immune globulin products and the risk of thrombosis. Additional caution regarding the use of these products is warranted. • FDA is requiring manufacturers to add information on thrombosis to the current boxed warning in the labels of all intravenous human immune globulin products and to add a boxed warning to the labels of all subcutaneous and intramuscular human immune globulin products to highlight the risk of thrombosis and to add information on its mitigation.
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Use this medicine exactly as directed on the label, unless instructed differently by your doctor * This medicine is given as an IV INFUSION at a constant rate over a period of time as recommended by manufacturer.
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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.
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Severe allergic reaction.
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Severe skin itching with patches.
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Dizziness; Stomach discomfort or pain; Itching; Joint pain; Injection site pain; Nausea; Vomiting; Fever; Headache.
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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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