Health Canada Endorsed Important Information on FLOLAN® (epoprostenol sodium) Subject: Updated Information - Potential for Glass-Related Particles in FLOLAN(®) (epoprostenol sodium) Sterile Diluent and the Essential Use of a Filter with the Administration of the Reconstituted Product (FLOLAN(® )0.5 mg vial, DIN: 02230845; FLOLAN(® )1.5 mg vial, DIN: 02230848; Sterile Diluent DIN: 02230857) TORONTO, April 24, 2013 /CNW/ - GlaxoSmithKline Inc., in consultation with Health Canada, is providing Canadians with updated information on the use of the pulmonary hypertension drug, FLOLAN(®). Some vials of Sterile Diluent for FLOLAN(®) have been found to contain glass-related particles that may not be easily visible under normal lighting conditions. Studies indicate filtration through a 0.22 or 0.2 micron pore size filter is an effective means to remove these glass-related particles. The infusion tubing supplied by your Pharmaprix/Shoppers Drug Mart Specialty Pharmacy already incorporates a 0.2 micron filter. There have been no reports of adverse events that could be definitively attributed to these glass-related particles in GlaxoSmithKline's safety database for FLOLAN(®). Based on this information, GlaxoSmithKline would like to advise you of the following: -- Some vials of Sterile Diluent for FLOLAN(®) have been found to contain glass-related particles -- When administering FLOLAN(®) you must only use the infusion tubing supplied to you by your Pharmaprix/Shoppers Drug Mart Specialty Pharmacy. This tubing already incorporates a 0.2 micron filter. -- FLOLAN(®) Sterile Diluent and reconstituted FLOLAN(®) should be inspected for visible particles prior to use. Product containing visible particles should not be used GlaxoSmithKline has sent a letter to healthcare professionals informing them of this safety information. A copy of that letter will be available on the Health Canada Website. GlaxoSmithKline continues to search for improvements in the manufacturing process of the Sterile Diluent for FLOLAN(®) so that no vials will contain glass particles. Since the continued availability of this product is medically necessary for patients who require FLOLAN(®), the use of a filter with the administration is essential for these patients. For media inquiries, please contact GlaxoSmithKline Communications at (905) 819-3363. Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing side effects are generally presumed to underestimate the risks associated with health product treatments. Any serious or unexpected side effects in patients receiving FLOLAN(®) should be reported to GlaxoSmithKline Inc. or Health Canada. GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 Phone: 1-800-387-7374 You can report any suspected adverse reactions associated with the use of health products to Health Canada by: -- Calling toll-free at 1-866-234-2345; or -- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax For other health product inquiries related to this communication, please contact Health Canada at: Health Products and Food Branch Inspectorate E-mail: DCVIU_UVECM@hc-sc.gc.ca Telephone: 1-800-267-9675 Fax: 1-613-946-5636 Sincerely, Original signed by Dr. Glenn Crater, Vice President, Medical and Chief Medical Officer GlaxoSmithKline Inc. (®)FLOLAN is a registered trademark used under license by GlaxoSmithKline Inc. GlaxoSmithKline Communications at (905) 819-3363 SOURCE: GlaxoSmithKline Inc. To view this news release in HTML formatting, please use the following URL: http://www.newswire.ca/en/releases/archive/April2013/24/c7874.html CO: GlaxoSmithKline Inc. ST: Ontario NI: HEA -0- Apr/24/2013 12:00 GMT
Health Canada Endorsed Important Information on FLOLAN® (epoprostenol sodium)
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