MUSCLE AND BACK PAIN PLATINUM RELIEF TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
13-01-2020
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Aktívna zložka:
METHOCARBAMOL; IBUPROFEN
Dostupné z:
VITA HEALTH PRODUCTS INC
ATC kód:
M03BA53
INN (Medzinárodný Name):
METHOCARBAMOL, COMBINATIONS EXCL PSYCHOLEPTICS
Dávkovanie:
500MG; 200MG
Forma lieku:
TABLET
Zloženie:
METHOCARBAMOL 500MG; IBUPROFEN 200MG
Spôsob podávania:
ORAL
Počet v balení:
18/40
Typ predpisu:
OTC
Terapeutické oblasti:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0248961001; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2014-03-11
Súhrn charakteristických
Page 1 of 41
PRODUCT MONOGRAPH
MUSCLE AND BACK PAIN PLATINUM RELIEF
Methocarbamol and Ibuprofen Caplets
500mg/200mg
Muscle Relaxant/Analgesic
VITA HEALTH PRODUCTS INC. Date of Preparation:
150 Beghin Avenue March 4, 2014
Winnipeg, MB
R2J 3W2 Date of Revision:
December 2, 2019
Control Number 231400
Page 2 of 41
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................3
SUMMARY PRODUCT INFORMATION
...................................................................................3
INDICATIONS AND CLINICAL
USE..........................................................................................3
CONTRAINDICATIONS
..............................................................................................................3
ADVERSE
REACTIONS..............................................................................................................11
DRUG
INTERACTIONS..............................................................................................................13
DOSAGE AND
ADMINISTRATION..........................................................................................16
OVERDOSAGE
...........................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................18
STORAGE AND
STABILITY......................................................................................................20
SPECIAL HANDLING INSTRUCTIONS
..................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................21
PART II: SCIENTIFIC
INFORMATION................................................................................22
PHARMACEUTICAL
INFORMATION......................................................................................22
CLINICAL
TRIALS..................................................
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