Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
RIZATRIPTAN (RIZATRIPTAN BENZOATE)
NATCO PHARMA (CANADA) INC
N02CC04
RIZATRIPTAN
10MG
TABLET (ORALLY DISINTEGRATING)
RIZATRIPTAN (RIZATRIPTAN BENZOATE) 10MG
ORAL
6
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0137841002; AHFS:
APPROVED
2015-01-27
_NAT-Riztriptan ODT_ _Page 1 of 38_ PRODUCT MONOGRAPH PR NAT-RIZATRIPTAN ODT Rizatriptan Benzoate Orally Disintegrating Tablets 5 mg and 10 mg Rizatriptan (as Rizatriptan Benzoate) 5-HT 1 Receptor Agonist MIGRAINE THERAPY Natco Pharma (Canada) Inc. Date of Preparation: 2550 Argentia Road, Suite # 116 January 22, 2015 Mississauga, ON, L5N 5R1 CONTROL# 172717 _NAT-Riztriptan 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 .............................................................................................................. 11 DRUG INTERACTIONS ............................................................................................................... 17 DOSAGE AND ADMINISTRATION ........................................................................................... 19 OVERDOSAGE ............................................................................................................................. 20 ACTION AND CLINICAL PHARMACOLOGY ......................................................................... 21 STORAGE AND STABILITY ...................................................................................................... 24 SPECIAL HANDLING INSTRUCTIONS .................................................................................... 24 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................... 25 PART II: SCIENTIFIC INFORMATION ................... Đọc toàn bộ tài liệu