Transcription of N BEL UCA - purdue.ca
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N BEL UCA - purdue.ca
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION NBELBUCA Buprenorphine Buccal Soluble Film 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg and 900 mcg of buprenorphine as buprenorphine hydrochloride. Opioid Analgesic Purdue Pharma 575 Granite Court Pickering, Ontario L1W 3W8 Date of Preparation: February 15, 2018 Submission Control No: 210011 BELBUCA is a registered trademark of BioDelivery Sciences International, Inc., used with permission by Purdue Pharma. BELBUCA Product Monograph Page 2 of 57 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ..3 SUMMARY PRODUCT INFORMATION ..3 INDICATIONS AND CLINICAL USE ..3 CONTRAINDICATIONS ..4 WARNINGS AND PRECAUTIONS ..4 ADVERSE REACTIONS ..17 DRUG INTERACTIONS ..22 DOSAGE AND ADMINISTRATION ..26 OVERDOSAGE ..31 ACTION AND CLINICAL PHARMACOLOGY ..32 STORAGE AND STABILITY ..35 SPECIAL HANDLING INSTRUCTIONS ..35 DOSAGE FORMS, COMPOSITION AND PACKAGING ..35 PART II: SCIENTIFIC INFORMATION.
Addiction, Abuse, and Misuse: BELBUCA. poses risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Each patient’s risk should be assessed prior to pBELBUCArescribing , and all
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