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GAMMAPLEX- human immunoglobulin g solution


Inform Patients To Immediately Report The Following Signs And Symptoms To Their Healthcare Professional:

Inform patients that GAMMAPLEX 5% is made from human plasma and may contain infectious agents that can cause disease. While the risk that GAMMAPLEX 5% can transmit an infection has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating or removing certain viruses during manufacturing, patients should report any symptoms that concern them[seeWarnings and Precautions (5.9)].

Inform patients that GAMMAPLEX 5% can interfere with their immune response to live viral vaccines (e.g. measles, mumps, and rubella), and instruct patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations[seeDrug Interactions (7)].

Instruct patients to immediately report symptoms of thrombosis. These symptoms may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.

Manufactured by:
Bio Products Laboratory Ltd.,
Elstree,
WD6 3BX.
United Kingdom.
US License No. 1811

U.S. Distributor:
BPL Inc.,
302 E. Pettigrew Street,
Suite C-190,
Durham, NC 27701,
U.S.A.

Version 10



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