BACLOFEN TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

BACLOFEN

มีจำหน่ายจาก:

APOTEX INC

รหัส ATC:

M03BX01

INN (ชื่อสากล):

BACLOFEN

ปริมาณ:

20MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

BACLOFEN 20MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

100/250/500/1000

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS

สรุปสินค้า:

Active ingredient group (AIG) number: 0113246002; AHFS:

สถานะการอนุญาต:

CANCELLED POST MARKET

วันที่อนุญาต:

2014-08-23

สรุปลักษณะสินค้า

Page 1 of 27
PRODUCT MONOGRAPH
BACLOFEN
BACLOFEN TABLETS USP
10 MG AND 20 MG
ANTISPASTIC AGENT
APOTEX INC. DATE OF PREPARATION:
150 SIGNET DRIVE August 18, 2014
TORONTO, ONTARIO
M9L 1T9
Control Number: 176430
Page 2 of 27
TABLE OF CONTENT
THERAPEUTIC CLASSIFICATION
...............................................................................................
3
CLINICAL PHARMACOLOGY
......................................................................................................
3
INDICATIONS
..................................................................................................................................
5
CONTRAINDICATIONS
.................................................................................................................
5
WARNINGS
......................................................................................................................................
5
PRECAUTIONS
................................................................................................................................
7
ADVERSE REACTIONS
................................................................................................................
10
SYMPTOMS AND TREATMENT OF OVERDOSAGE
.............................................................. 13
DOSAGE AND ADMINISTRATION
............................................................................................
14
AVAILABILITY
.............................................................................................................................
15
CHEMISTRY AND PHARMACOLOGY
......................................................................................
17
TOXICOLOGY
...............................................................................................................................
18
TERATOLOGY AND REPRODUCTION STUDIES
....................................................................
20
SELECTED BIBLIOGRAPHY
...................................................................................................