SUMATRIPTAN INJECTION SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE)

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

N02CC01

INN (Tên quốc tế):

SUMATRIPTAN

Liều dùng:

12MG

Dạng dược phẩm:

SOLUTION

Thành phần:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 12MG

Tuyến hành chính:

SUBCUTANEOUS

Các đơn vị trong gói:

0.5ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

SELECTIVE SEROTONIN AGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0123238006; AHFS:

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2021-07-29

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
SUMATRIPTAN INJECTION
(sumatriptan succinate)
6 mg sumatriptan
Subcutaneous Injection (Autoinjector)
12 mg/mL (6 mg/0.5 mL)
Teva Standard
5-HT
1
Receptor Agonist
Migraine Therapy
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control No: 147860
Date of Preparation:
June 20, 2011
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT
INFORMATION.........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS....................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE
REACTIONS..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE.................................................................................................................15
ACTION AND CLINICAL
PHARMACOLOGY.............................................................16
STORAGE AND STABILITY
..........................................................................................17
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................18
PART II: SCIENTIFIC INFORMATION
...............................................................................19
PHARMACEUTICAL
INFORMATION..........................................................................19
CLINICAL TRIALS
..........................................................................................................20
DETAILED PHARMACOLOGY
....