MYLAN-PREGABALIN CAPSULE

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PREGABALIN

Verfügbar ab:

MYLAN PHARMACEUTICALS ULC

ATC-Code:

N02BF02

INN (Internationale Bezeichnung):

PREGABALIN

Dosierung:

25MG

Darreichungsform:

CAPSULE

Zusammensetzung:

PREGABALIN 25MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

60/500

Verschreibungstyp:

Prescription

Therapiebereich:

MISCELLANEOUS ANTICONVULSANTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0151121001; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2018-07-12

Fachinformation

_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 _
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PR MYLAN-PREGABALIN
P
REGABALIN CAPSULES
PART I: HEALTH PROFESSIONAL IN