RISEDRONATE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)

Tilgjengelig fra:

SANIS HEALTH INC

ATC-kode:

M05BA07

INN (International Name):

RISEDRONIC ACID

Dosering :

35MG

Legemiddelform:

TABLET

Sammensetning:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 35MG

Administreringsrute:

ORAL

Enheter i pakken:

4

Resept typen:

Prescription

Terapeutisk område:

BONE RESORPTION INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0135301003; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2011-09-22

Preparatomtale

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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RISEDRONATE
Risedronate sodium (as the monohydrate)
35 mg Tablets
Manufacturer’s Standard
Bisphosphonates
Sanis Health Inc.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
www.sanis.com
Date of Revision:
March 6, 2019
Submission Control No: 224337
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_Page 2 of 51_
TABLE OF CONTENTS
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
.........................................................................................................
12
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
..............................................................................