PENDO-PREGABALIN CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

PREGABALIN

Pieejams no:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATĶ kods:

N02BF02

SNN (starptautisko nepatentēto nosaukumu):

PREGABALIN

Deva:

150MG

Zāļu forma:

CAPSULE

Kompozīcija:

PREGABALIN 150MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

MISCELLANEOUS ANTICONVULSANTS

Produktu pārskats:

Active ingredient group (AIG) number: 0151121005; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2014-07-31

Produkta apraksts

PRODUCT MONOGRAPH
Pr
PENDO-PREGABALIN
Pregabalin capsules
50 mg &150 mg
ANALGESIC AGENT
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Av. Royalmount, Suite 100
June 02, 2009
Montréal, Canada
H4P 2T4
Date of Revision:
June 13, 2016
Submission Control No: 194692
_ _
_pendo-PREGABALIN Product Monograph _
_Page 2 of 67 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
15
DRUG INTERACTIONS
.................................................................................................
36
DOSAGE AND ADMINISTRATION
.............................................................................
38
OVERDOSAGE
...............................................................................................................
41
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 42
STORAGE AND STABILITY
.........................................................................................
45
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 45
PART II: SCIENTIFIC INFORMATION
..............................................................................
47
PHARMACEUTICAL INFORMATION
.........................................................................
47
CLINICAL TRIALS
.........................................................................................................
48
DETAILED PHARMACOLOGY
...................................