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FRAGMIN- dalteparin sodium injection


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[seeDrug Interactions (7)].

Inform Patients:

  • of the instructions for injecting FRAGMIN if their therapy is to continue after discharge from the hospitals.
  • it may take them longer than usual to stop bleeding.
  • they may bruise and/or bleed more easily when they are treated with FRAGMIN.
  • 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[seeWarnings and Precautions (5.1,5.2)].
  • 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[seeWarnings and Precautions (5.1)].
  • to tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs[seeDrug Interactions (7)].
  • Risks are associated with benzyl alcohol in neonates, infants, and pregnant women[seeWarnings and Precautions (5.3)andUse in Specific Populations (8.1)].

This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.

FRAGMIN is a registered trademark of Pfizer Health AB.

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LAB-0058-18.0



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