REGULAR STRENGTH ANALGESIC & MUSCLE RELAXANT CAPLETS TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

IBUPROFEN; METHOCARBAMOL

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

M03BA53

INN (Διεθνής Όνομα):

METHOCARBAMOL, COMBINATIONS EXCL PSYCHOLEPTICS

Δοσολογία:

200MG; 500MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

IBUPROFEN 200MG; METHOCARBAMOL 500MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

18/40

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

CENTRALLY ACTING SKELETAL MUSCLE RELAXANTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0248961001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2015-11-25

Αρχείο Π.Χ.Π.

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........................................