MEFENAMIC CAPSULE
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
10-04-2019
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ingredients actius:
MEFENAMIC ACID
Disponible des:
AA PHARMA INC
Codi ATC:
M01AG01
Designació comuna internacional (DCI):
MEFENAMIC ACID
Dosis:
250MG
formulario farmacéutico:
CAPSULE
Composición:
MEFENAMIC ACID 250MG
Vía de administración:
ORAL
Unidades en paquete:
100/500
tipo de receta:
Prescription
Área terapéutica:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Resumen del producto:
Active ingredient group (AIG) number: 0102336001; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2010-12-08
Fitxa tècnica
Page 1 of 32
_ _
PRESCRIBING INFORMATION
PRODUCT MONOGRAPH
PR
MEFENAMIC
MEFENAMIC ACID CAPSULES
250 MG
USP
ANALGESIC
AA PHARMA INC.
1165 CREDITSTONE ROAD, UNIT #1
VAUGHAN, ONTARIO
L4K 4N7
DATE OF REVISION:
April 10, 2019
CONTROL NO.: 226522
Page 2 of 32
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
15
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
......................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
23
DETAILED PHARMA
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