RAN-GABAPENTIN CAPSULE
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
17-06-2020
该产品的某些文档当前不可用，您可以向我们的客户服务发送请求，我们将在获得它们后尽快通知您。
发送请求。
发送请求。
有效成分:
GABAPENTIN
可用日期:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC代码:
N02BF01
INN（国际名称）:
GABAPENTIN
剂量:
300MG
药物剂型:
CAPSULE
组成:
GABAPENTIN 300MG
给药途径:
ORAL
每包单位数:
100/500
处方类型:
Prescription
治疗领域:
MISCELLANEOUS ANTICONVULSANTS
產品總結:
Active ingredient group (AIG) number: 0125929003; AHFS:
授权状态:
CANCELLED POST MARKET
授权日期:
2023-02-06
产品特点
Page 1 of 33
PRODUCT MONOGRAPH
PR
RAN™-GABAPENTIN
Gabapentin Capsules, Mfr. Std
100 mg, 300 mg, and 400 mg
Antiepileptic Agent
Ranbaxy Pharmaceuticals Canada Inc.
Date of Revision
126 East Drive
June 17, 2020
Brampton, Ontario
L6T 1C1
Submission Control No.: 239409
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
Page 2 of 33
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
3
ADVERSE REACTIONS
...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................
15
OVERDOSAGE
........................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
17
STORAGE AND STABILITY
.................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
...................................
阅读完整的文件
