البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
RIZATRIPTAN (RIZATRIPTAN BENZOATE)
VANC PHARMACEUTICALS INC
N02CC04
RIZATRIPTAN
5MG
TABLET (ORALLY DISINTEGRATING)
RIZATRIPTAN (RIZATRIPTAN BENZOATE) 5MG
ORAL
6
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0137841001; AHFS:
CANCELLED PRE MARKET
2019-07-31
PRODUCT MONOGRAPH PR VAN-RIZATRIPTAN ODT Rizatriptan Benzoate Orally Disintegrating Tablets 5 mg and 10 mg Rizatriptan (as Rizatriptan Benzoate) 5-HT 1 Receptor Agonist MIGRAINE THERAPY Vanc Pharmaceuticals Inc. Date of Preparation: 210-2639, Viking way 9 November, 2015 Richmond, BC V6V3B7 www.vancpharm.com Submission Control No: 188668 _ _ _VAN-Rizatriptan ODT _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Page 2 of 38_ 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 .............................................................................................................. 12 DRUG INTERACTIONS ............................................................................................................... 18 DOSAGE AND ADMINISTRATION ........................................................................................... 20 OVERDOSAGE ............................................................................................................................. 21 ACTION AND CLINICAL PHARMACOLOGY ......................................................................... 22 STORAGE AND STABILITY ...................................................................................................... 25 SPECIAL HANDLING INSTRUCTIONS .................................................................................... 25 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................................... 26 PART II: SCIENTIFIC INFORMATION اقرأ الوثيقة كاملة