PREGABALIN CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

PREGABALIN

から入手可能:

RANBAXY PHARMACEUTICALS CANADA INC.

ATCコード:

N02BF02

INN（国際名）:

PREGABALIN

投薬量:

300MG

医薬品形態:

CAPSULE

構図:

PREGABALIN 300MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS ANTICONVULSANTS

製品概要:

Active ingredient group (AIG) number: 0151121008; AHFS:

認証ステータス:

APPROVED

承認日:

2013-11-07

製品の特徴

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_Pr_
_RAN_
_™_
_-PREGABALIN (Pregabalin Capsules) Product Monograph_
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_Page 1 of 61_
PRODUCT MONOGRAPH
Pr
RAN
™
-PREGABALIN
Pregabalin Capsules
25 mg, 50 mg, 75 mg, 150 mg, 225 mg, 300 mg
ANALGESIC AGENT
Ranbaxy Pharmaceuticals Canada Inc.,
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
March 24, 2020
Submission Control No: 237057
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
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_Pr_
_RAN_
_™_
_-PREGABALIN (Pregabalin Capsules) Product Monograph_
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_Page 2 of 61_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
.................................................................................................4
ADVERSE REACTIONS
..................................................................................................15
DRUG INTERACTIONS
................................................................................................33
DOSAGE AND ADMINISTRATION
...........................................................................35
OVERDOSAGE
...............................................................................................................37
ACTION AND CLINICAL PHARMACOLOGY
............................................................38
STORAGE AND
STABILITY........................................................................................41
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................41
PART II: SCIENTIFIC INFORMATION
...............................................................................43
PHARMACEUTICAL INFORMATION
..........................................................................43
CLINICAL TRIALS
........................................................................................................44
D