PMS-RISEDRONATE PLUS CALCIUM TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE); CALCIUM (CALCIUM CARBONATE)

Διαθέσιμο από:

PHARMASCIENCE INC

Φαρμακολογική κατηγορία (ATC):

M05BB02

INN (Διεθνής Όνομα):

RISEDRONIC ACID AND CALCIUM, SEQUENTIAL

Δοσολογία:

35MG; 500MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

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

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

BONE RESORPTION INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2011-02-17

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR PMS-RISEDRONATE PLUS CALCIUM
Risedronate Sodium (as the hemi-pentahydrate) 35 mg Tablets, House
Standard
BONE METABOLISM REGULATOR
and
Calcium Carbonate 1250 mg Caplets, House Standard
(Equivalent to 500 mg elemental calcium)
MINERAL SUPPLEMENT
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100,
June 08, 2016
Montreal QC, H4P 2T4
www.pharmascience.com
Control Number: 195294
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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...........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
10
DOSAGE AND ADMINISTRATION
.....................................................................................
13
OVERDOSAGE
.......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 15
STORAGE AND STABILITY
.................................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
....................................................................................
21
PHARMACEUTICAL
INFORMA