NRA-RIZATRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

RIZATRIPTAN (RIZATRIPTAN BENZOATE)

Sẵn có từ:

NORA PHARMA INC

Mã ATC:

N02CC04

INN (Tên quốc tế):

RIZATRIPTAN

Liều dùng:

5MG

Dạng dược phẩm:

TABLET (ORALLY DISINTEGRATING)

Thành phần:

RIZATRIPTAN (RIZATRIPTAN BENZOATE) 5MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

SELECTIVE SEROTONIN AGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0137841001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-06-13

Đặc tính sản phẩm

_NRA-Rizatriptan ODT_
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
NRA-RIZATRIPTAN ODT
Rizatriptan Benzoate Orally Disintegrating Tablets
5 mg and 10 mg Rizatriptan (as Rizatriptan Benzoate)
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
DATE OF PREPERATION:
June 12, 2019
Nora Pharma Inc.
205-2900 Boul Cote-Vertu
Saint-Laurent, Quebec
H4R 3E8
Control# 228041
_NRA-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
..............................................................................................................
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
................................