BACLOFEN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

BACLOFEN

متاح من:

APOTEX INC

ATC رمز:

M03BX01

INN (الاسم الدولي):

BACLOFEN

جرعة:

10MG

الشكل الصيدلاني:

TABLET

تركيب:

BACLOFEN 10MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100/250/500/1000

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS

ملخص المنتج:

Active ingredient group (AIG) number: 0113246001; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2014-08-23

خصائص المنتج

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
...................................................................................................