ROBAXISAL C 1/2 TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
05-03-2024
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Aktiva substanser:
METHOCARBAMOL; ACETYLSALICYLIC ACID; CODEINE PHOSPHATE
Tillgänglig från:
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
ATC-kod:
N02AA59
INN (International namn):
CODEINE, COMBINATIONS EXCL. PSYCHOLEPTICS
Dos:
400MG; 325MG; 32.4MG
Läkemedelsform:
TABLET
Sammansättning:
METHOCARBAMOL 400MG; ACETYLSALICYLIC ACID 325MG; CODEINE PHOSPHATE 32.4MG
Administreringssätt:
ORAL
Enheter i paketet:
24/250
Receptbelagda typ:
Narcotic (CDSA I)
Terapiområde:
OPIATE AGONISTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0301256001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2010-11-08
Produktens egenskaper
Page 1 of 37
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
ROBAXISAL
®
C ½
(methocarbamol, codeine phosphate and acetylsalicylic acid)
400 mg/32.4 mg/325 mg: per tablet
Skeletal Muscle Relaxant/Analgesic
GlaxoSmithKline Consumer Healthcare ULC
55 Standish Court, suite 450
Mississauga, ON
L5R 4B2
Date of Revision:
March 5, 2024
Submission Control No: 277714
Page 2 of 37
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...........................................................................................
16
DRUG INTERACTIONS
...........................................................................................
18
DOSAGE AND ADMINISTRATION
........................................................................
19
OVERDOSAGE
........................................................................................................
21
ACTION AND CLINICAL
PHARMACOLOGY........................................................
21
STORAGE AND STABILITY
...................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 22
PART II: SCIENTIFIC INFORMATION
..........................................................................
24
PHARMACEUTICAL INFORMATION
....................................................................
24
PATIENT MEDICATION INFORMATION
.....................................................................
27
Page 3 of 37
N
ROBAXISAL
® C ½
(methocarbamol, codeine phosphate and acetylsali
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