MEFENAMIC CAPSULE
Nazione: Canada
Lingua: inglese
Fonte: Health Canada
Scheda tecnica
(SPC)
10-04-2019
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Principio attivo:
MEFENAMIC ACID
Commercializzato da:
AA PHARMA INC
Codice ATC:
M01AG01
INN (Nome Internazionale):
MEFENAMIC ACID
Dosaggio:
250MG
Forma farmaceutica:
CAPSULE
Composizione:
MEFENAMIC ACID 250MG
Via di somministrazione:
ORAL
Confezione:
100/500
Tipo di ricetta:
Prescription
Area terapeutica:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Dettagli prodotto:
Active ingredient group (AIG) number: 0102336001; AHFS:
Stato dell'autorizzazione:
APPROVED
Data dell'autorizzazione:
2010-12-08
Scheda tecnica
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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