Advise the patient to read the FDA-approved patient labeling (Patient Information).

Risk of Hemorrhage including Spinal/Epidural Hematomas

If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet inhibitors, or other anticoagulants, inform the patients to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness (especially in the lower limbs) and muscular weakness. If any of these symptoms occur the patient should contact his or her physician immediately.

Additionally, the use of aspirin and other NSAIDs may enhance the risk of hemorrhage. Discontinue their use prior to FRAGMIN therapy whenever possible; if co-administration is essential, the patient's clinical and laboratory status should be closely monitored [see Drug Interactions (7)].

Inform Patients:

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of the instructions for injecting FRAGMIN if their therapy is to continue after discharge from the hospitals.

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it may take them longer than usual to stop bleeding.

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they may bruise and/or bleed more easily when they are treated with FRAGMIN.

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they should report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician [see Warnings and Precautions (5.1, 5.2)].

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to tell their physicians and dentists they are taking FRAGMIN and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken [see Warnings and Precautions (5.1)].

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to tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs [see Drug Interactions (7)].

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Risks are associated with benzyl alcohol in neonates, infants, and pregnant women [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)].

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to tell their physicians and care givers if they are allergic to natural rubber latex [see Dosage and Administration (2.7)].