REGULAR STRENGTH ANALGESIC & MUSCLE RELAXANT CAPLETS TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
22-03-2013
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Aktiva substanser:
IBUPROFEN; METHOCARBAMOL
Tillgänglig från:
TEVA CANADA LIMITED
ATC-kod:
M03BA53
INN (International namn):
METHOCARBAMOL, COMBINATIONS EXCL PSYCHOLEPTICS
Dos:
200MG; 500MG
Läkemedelsform:
TABLET
Sammansättning:
IBUPROFEN 200MG; METHOCARBAMOL 500MG
Administreringssätt:
ORAL
Enheter i paketet:
18/40
Receptbelagda typ:
OTC
Terapiområde:
CENTRALLY ACTING SKELETAL MUSCLE RELAXANTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0248961001; AHFS:
Bemyndigande status:
CANCELLED PRE MARKET
Tillstånd datum:
2015-11-25
Produktens egenskaper
IMPORTANT: PLEASE READ
1 | P a g e
PRODUCT MONOGRAPH
REGULAR STRENGTH ANALGESIC & MUSCLE
RELAXANT CAPLETS
METHOCARBAMOL AND IBUPROFEN TABLETS
500 MG/200 MG
THERAPEUTIC CLASSIFICATION
MUSCLE RELAXANT / ANALGESIC
TEVA CANADA LIMITED,
Date of Preparation:
30 Novopharm Court
March 5, 2013
Toronto, Canada
M1B 2K9
Control# 161027
IMPORTANT: PLEASE READ
2 | P a g e
TABLE
OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................3
SUMMARY PRODUCT INFORMATION
.......................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
..................................................................................................3
ADVERSE
REACTIONS..................................................................................................10
DRUG
INTERACTIONS..................................................................................................12
DOSAGE AND
ADMINISTRATION..............................................................................15
OVERDOSAGE
...............................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
...........................................................18
STORAGE AND
STABILITY.........................................................................................22
SPECIAL HANDLING INSTRUCTIONS
......................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................22
PART II: SCIENTIFIC
INFORMATION....................................................................21
PHARMACEUTICAL
INFORMATION..........................................................................21
CLINICAL
TRIALS..........................................................................................................23
DETAILED
PHARMACOLOGY........................................
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