MYLAN-PREGABALIN CAPSULE
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
14-03-2017
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ingredients actius:
PREGABALIN
Disponible des:
MYLAN PHARMACEUTICALS ULC
Codi ATC:
N02BF02
Designació comuna internacional (DCI):
PREGABALIN
Dosis:
300MG
formulario farmacéutico:
CAPSULE
Composición:
PREGABALIN 300MG
Vía de administración:
ORAL
Unidades en paquete:
100
tipo de receta:
Prescription
Área terapéutica:
MISCELLANEOUS ANTICONVULSANTS
Resumen del producto:
Active ingredient group (AIG) number: 0151121008; AHFS:
Estat d'Autorització:
CANCELLED POST MARKET
Data d'autorització:
2018-07-12
Fitxa tècnica
_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
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