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Health Canada: Important Changes to the Dose Conversion Guidelines for Fentanyl Transdermal Systems OTTAWA, Ontario -- January 7, 2009 -- The manufacturers of Fentanyl Transdermal Systems (FTS), in collaboration with Health Canada are informing healthcare professionals with important information regarding changes to the Dose Conversion Guidelines and to the analgesic equivalency table: Opioid Analgesics: Parenteral/Oral/Rectal Equianalgesic Potency Conversion in the Dosage and Administration section of the Canadian Product Monographs for FTS. The dose conversion guidelines are to be used to convert adult patients from their current oral or parenteral opioid therapy to the fentanyl transdermal patch. The analgesic equivalency table may be used for adult patients taking opioids or doses not listed in Table 1.1, using the conversion methodology outlined for Table 1.1 with Table 1.2 (http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/fentanyl_hpc-cps-eng.php#t1#t1). Serious or life-threatening hypoventilation can result if appropriate conversions are not used. Based on clinical experience in patients with chronic pain: · The conversion from IM/IV morphine to the fentanyl transdermal patch has been revised to reflect a conversion ratio of 1:2 and 1:3 of parenteral morphine to oral morphine. · The conversion from IV hydromorphone to the fentanyl transdermal patch has been revised to reflect a conversion ratio of 1:2 of parenteral hydromorphone to oral hydromorphone. In addition, the analgesic equivalency table 1.2 has been revised to remove the data equating 10 mg parenteral morphine to 60 mg oral morphine derived from single or intermittent dosing studies. Data referring to IM//IV oxycodone and to IM meperidine have been removed from both tables 1.1 and 1.2 as the former drug is not marketed in Canada as an Injectable, and the latter drug causes CNS toxicity if used by the parenteral route chronically. Manufacturers of all fentanyl transdermal patches are working with Health Canada to include this safety information in the Dosage and Administration section in all Canadian Product Monographs for Fentanyl Transdermal Systems including Duragesic® (fentanyl transdermal system), CO Fentanyl, Novo-fentanyl, RAN-fentanyl transdermal system, and ratio-FENTANYL Transdermal System. 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. Drug Safety Department 19 Green Belt Drive Toronto, Ontario M3C 1L9 Telephone: 1-800-567-3331 or Fax: 1-866-767-5865 E-mail: dsscan@joica.jnj.com Cobalt Pharmaceuticals Inc. 6500 Kitimat Road Mississauga, Ontario L5N 2B8 Telephone: 1-866-254-6111 Fax: 905-542-0478 Novopharm Limited Pharmacovigilance and Drug Safety 30 Novopharm Court Toronto, Ontario M1B 2K9 Telephone: 416-291-8888 ext. 5005 Fax: 416-335-4472 E-mail: PhV@Novopharm.com Ranbaxy Pharmaceuticals Canada Inc. 2680 Matheson Blvd. East, Suite 200 Mississauga, Ontario L4W 0A5 Telephone: 1-866-840-1340 Fax: 905-602-4216 ratiopharm inc. 17800 Lapointe Mirabel, Quebec J7J 1P3 Telephone: 1-800-337-2584 Fax: 1-800-313-7673 E-mail: drugsafety@ratiopharm.ca 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: 1-866-234-2345, Fax: 1-866-678-6789 CanadaVigilance@hc-sc.gc.ca SOURCE: Health Canada E-mail this page to a friend or colleague! To print, use this version