Health Canada Endorsed Important Information on FLOLAN® (epoprostenol sodium)

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


 
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