PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on
Fentanyl Transdermal Systems (Patches)

SUBJECT: New Changes to the Dosage Guidelines for Fentanyl Transdermal Systems (Patches)

TORONTO, March 10 /CNW/ - The manufacturers of Fentanyl Transdermal Systems, in collaboration with Health Canada, would like to inform Canadians of important new changes made to the Dose Conversion Guidelines in the Product Monograph. These guidelines are used to help determine what dosage of Fentanyl Transdermal Systems is appropriate for each individual patient.

Fentanyl Transdermal Systems are skin patches that contain a high concentration of fentanyl. Fentanyl is a very strong opioid narcotic used to help control chronic (long-lasting) pain.

Fentanyl Transdermal Systems (patches) are only intended for use in patients who require continuous around-the-clock pain relief with strong narcotic pain relievers for an extended period of time and who already are taking narcotic pain relievers at a total daily dose of at least 60 mg/day oral Morphine Equivalents.

    
    -   Health Care Professionals and hospitals have been informed of the new
        changes made to the Dose Conversion Guidelines. These new Guidelines
        will allow them to adjust doses appropriately.
    -   The dosage of Fentanyl Transdermal Systems must be calculated using
        the new conversion table, and must not be higher than the dose
        recommended.
    -   Patients using Fentanyl Transdermal Systems should not stop or change
        their dosage without first consulting with their doctor. This
        medicine should always be used exactly as prescribed.
    

Fentanyl is a very strong opioid narcotic pain medicine that can cause serious and life-threatening breathing problems if the dosage used is too high. Fentanyl Transdermal Systems should not be used in patients who are not already receiving opioid narcotic drugs.

Patients using a Fentanyl Transdermal Systems should seek emergency medical help immediately if they:

    
    -   have trouble breathing, or have slow or shallow breathing
    -   have a slow heartbeat
    -   have severe sleepiness
    -   have cold, clammy skin
    -   feel faint, dizzy, confused, or cannot think, walk, or talk normally
    -   have a seizure
    -   have hallucinations
    

The letters to health care professionals and the notice to hospitals have been posted on the Health Canada website and can be accessed by means of the link below:

http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index-eng.php

Manufacturers of all fentanyl transdermal patches are working with Health Canada to include this safety information in the Dosing and Administration section in all Canadian Product Monographs for Fentanyl Transdermal Systems:

    
    DURAGESIC(R) (fentanyl                 DURAGESIC(R) MAT (fentanyl
    transdermal system)                    transdermal system)
    TEVA-fentanyl                          ratio-FENTANYL Transdermal System
    RAN-FENTANYL TRANSDERMAL SYSTEM        RAN-FENTANYL MATRIX PATCH
    CO Fentanyl                            PMS-FENTANYL MTX
    Sandoz Fentanyl MTX Patch
    

Managing product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any serious or unexpected adverse reactions in patients receiving Fentanyl Transdermal Systems should be reported to the manufacturers or Health Canada at the following addresses:

    
    Janssen-Ortho Inc.                    Cobalt Pharmaceuticals Inc.
    Drug Safety Department                6500 Kitimat Road
    19 Green Belt Drive                   Mississauga, Ontario L5N 2B8
    Toronto, Ontario M3C 1L9              Telephone: (866) 254-6111
    Telephone: (800) 567-3331             Fax: (905) 542-0478
    Fax: (866) 767-5865
    E-mail: dsscan@joica.jnj.com

    Teva Canada Limited                   Ranbaxy Pharmaceuticals Canada Inc.
    Pharmacovigilance and Drug Safety     2680 Matheson Blvd. East, Suite 200
    30 Novopharm Court                    Mississauga, Ontario L4W 0A5
    Toronto, Ontario M1B 2K9              Telephone: (866) 840-1340
    Telephone: (416) 291-8888 ext. 5005   Fax: (905) 602-4216
    Fax: (416) 335-4472
    E-mail: PhV@tevacanada.com

    ratiopharm inc.                       Sandoz Canada Inc.
    17800 Lapointe                        Pharmacovigilance General Contact
    Mirabel, Québec J7J 1P3               145 rue Jules-Léger
    Telephone: (800) 337-2584             Boucherville, Québec J4B 7K8
    Fax: (800) 313-7673                   Tel: (800) 343-8839 ext 4636
    www.ratiopharm.ca                     Fax: (450) 641-6408
    E-mail: drugsafety@ratiopharm.ca   Email:
                                          drugsafety.canada@sandoz.com

    Pharmascience Inc.
    Medical Information Dept.
    6111 Royalmount Ave., Suite No.100
    Montreal, Quebec H4P 2T4
    Telephone: (514) 344-0764 or (888) 550-6060
    Fax: (514)340-0164
    E-mail: adr@pharmascience.com

    Any suspected adverse reaction can also be reported to:
    Canada Vigilance Program
    Marketed Health Products Directorate
    HEALTH CANADA
    Address Locator: 0701C
    Ottawa, Ontario, K1A 0K9
    Tel: (613) 957-0337 or Fax: (613) 957-0335
    To report an Adverse Reaction, consumers and health professionals may
    call toll free:
    Tel: (866) 234-2345
    Fax: (866) 678-6789
    CanadaVigilance@hc-sc.gc.ca

    The AR Reporting Form and the AR Guidelines can be found on the Health
    Canada web site or in The Canadian Compendium of Pharmaceuticals and
    Specialties.

   
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/form/ar-ei_form_e.html
   
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/guide/ar-ei_guide-ldir_e.html

    Authorized by:

    Janssen-Ortho Inc.
    Cobalt Pharmaceuticals Inc.
    Teva Canada Limited
    Ranbaxy Pharmaceuticals Canada Inc.
    ratiopharm inc.
    Sandoz Canada Inc.
    Pharmascience Inc.
    

SOURCE JANSSEN-ORTHO INC.

For further information: For further information: For other inquiries related to this communication, please contact Health Canada at: Marketed Health Products Directorate, E-mail: mhpd_dpsc@hc-sc.gc.ca, Tel: (613) 954-6522, Fax: (613) 952-7738

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JANSSEN-ORTHO INC.

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Teva Canada Limited

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