PREGABALIN CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

PREGABALIN

זמין מ:

RANBAXY PHARMACEUTICALS CANADA INC.

קוד ATC:

N02BF02

INN (שם בינלאומי):

PREGABALIN

כמות:

225MG

טופס פרצבטיות:

CAPSULE

הרכב:

PREGABALIN 225MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

Active ingredient group (AIG) number: 0151121007; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2013-11-07

מאפייני מוצר

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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.
_ _
_Pr_
_RAN_
_™_
_-PREGABALIN (Pregabalin Capsules) Product Monograph_
_ _
_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