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RAVICTI PRODUCT MONOGRAPH Page 1 of 28 PRODUCT MONOGRAPH INCLUDING PATIENT medication information Pr RAVICTITM (glycerol phenylbutyrate) Oral Liquid g/mL Alimentary Tract and Metabolism PRODUCT (ATC Code: A16A X09) Horizon Pharma Ireland Ltd. Connaught House, 1st Floor 1 Burlington Road Dublin 4 Ireland Date of Preparation: March 16, 2016 Submission Control No: 174219 RAVICTI PRODUCT MONOGRAPH Page 2 of 28 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 ..5 DRUG INTERACTIONS ..8 DOSAGE AND ADMINISTRATION ..9 OVERDOSAGE ..11 ACTION AND CLINICAL PHARMACOLOGY ..11 STORAGE AND STABILITY ..14 DOSAGE FORMS, COMPOSITION AND PACKAGING ..14 PART II: SCIENTIFIC information ..15 PHARMACEUTICAL information ..15 CLINICAL TRIALS ..15 DETAILED PHARMACOLOGY ..21 TOXICOLOGY ..22 PART III: PATIENT medication information .
RAVICTI Product Monograph Page 1 of 28 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr RAVICTITM (glycerol …
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