MYLAN-PREGABALIN CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PREGABALIN

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

N02BF02

INN (Nama Internasional):

PREGABALIN

Dosis:

75MG

Bentuk farmasi:

CAPSULE

Komposisi:

PREGABALIN 75MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS ANTICONVULSANTS

Ringkasan produk:

Active ingredient group (AIG) number: 0151121003; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-07-12

Karakteristik produk

_MYLAN-PREGABALIN (PREGABALIN) PRODUCT MONOGRAPH_
_PAGE 1 _
_OF 81_
PRODUCT MONOGRAPH
PR
MYLAN-PREGABALIN
PREGABALIN CAPSULES
25 MG, 50 MG, 75 MG, 150 MG, 225 MG, 300 MG
ANALGESIC AGENT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision: March 1, 2017
_SUBMISSION CONTROL NO: _202862
_MYLAN-PREGABALIN (PREGABALIN) PRODUCT MONOGRAPH_
_PAGE 2 _
_OF 81_
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
......................................................... 19
DRUG
INTERACTIONS
......................................................... 41
DOSAGE
AND
ADMINISTRATION
................................................. 44
OVERDOSAGE
................................................................ 48
ACTION
AND
CLINICAL
PHARMACOLOGY
.......................................... 49
STORAGE
AND
STABILITY
..................................................... 54
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
................................... 54
PART II: SCIENTIFIC INFORMATION ............................................ 56
PHARMACEUTICAL
INFORMATION
................................................ 56
CLINICAL
TRIALS
........................................................... 57
DETAILED
PHARMACOLOGY
..................................................... 68
TOXICOLOGY
................................................................ 71
REFERENCES
................................................................ 75
PART III: CONSUMER INFORMATION ............................................. 78
_MYLAN-PREGABALIN (PREGABALIN) PRODUCT MONOGRAPH_
_PAGE 3 _
_OF 81_
PR MYLAN-PREGABALIN
P
REGABALIN CAPSULES
PART I: HEALTH PROFESSIONAL IN