ACTONEL PLUS CALCIUM TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

RISEDRONATE SODIUM; CALCIUM (CALCIUM CARBONATE)

Διαθέσιμο από:

WARNER CHILCOTT CANADA CO

Φαρμακολογική κατηγορία (ATC):

M05BB02

INN (Διεθνής Όνομα):

RISEDRONIC ACID AND CALCIUM, SEQUENTIAL

Δοσολογία:

35MG; 500MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

RISEDRONATE SODIUM 35MG; CALCIUM (CALCIUM CARBONATE) 500MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

7/28

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

BONE RESORPTION INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0251633001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2015-11-19

Αρχείο Π.Χ.Π.

_ _
PRODUCT MONOGRAPH
Pr
ACTONEL PLUS CALCIUM
Risedronate Sodium (as the hemi-pentahydrate) 35 mg Tablets
USP
Bone Metabolism Regulator
and
Calcium Carbonate 1250 mg Tablets
USP
Mineral Supplement
Warner Chilcott Canada Co.
PO Box 4367, Station A
Toronto, ON
M5W 3N7
Marketed with sanofi-aventis Canada Inc.
Laval, QC H7L 4A8
Date of Revision:
February 19, 2013
SUBMISSION CONTROL NO: 160238
2
TABLE OF CONTENTS
PAGE
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
............................................................................3
INDICATIONS AND CLINICAL USE
..................................................................................3
CONTRAINDICATIONS
.......................................................................................................4
WARNINGS AND PRECAUTIONS
......................................................................................4
ADVERSE REACTIONS
........................................................................................................7
DRUG INTERACTIONS
......................................................................................................10
DOSAGE AND ADMINISTRATION
..................................................................................13
OVERDOSAGE
.....................................................................................................................14
ACTION AND CLINICAL
PHARMACOLOGY.................................................................15
STORAGE AND STABILITY
..............................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................20
PHARMACEUTICAL INFORMATION
..............................................................................20
CLINICAL TRIALS
.......................................