TEVA-RISEDRONATE/CALCIUM KIT

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE); CALCIUM (CALCIUM CARBONATE)

MAH:

TEVA CANADA LIMITED

ATC_code:

M05BB02

INN:

RISEDRONIC ACID AND CALCIUM, SEQUENTIAL

dosage:

35MG; 500MG

pharmaceutical_form:

KIT

composition:

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

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

BONE RESORPTION INHIBITORS

leaflet_short:

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

authorization_status:

CANCELLED PRE MARKET

authorization_date:

2021-07-29

SPC

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICIATION INFORMATION
PR
TEVA-RISEDRONATE/CALCIUM
Risedronate Sodium (as the monohydrate) 35 mg Tablets
Bone Metabolism Regulator
and
Calcium Carbonate 1250 mg Tablets, Teva Standard
500 mg elemental calcium
Mineral Supplement
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
March 29, 2018
Toronto, Ontario
M1B 2K9
Control Number: 124986, 153581, 197103
_TEVA-RISEDRONATE/CALCIUM Product Monograph _
2_ _
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...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
10
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE........................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL
INFORMATION.....................................