ACTONEL TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Saadav alates:

WARNER CHILCOTT CANADA CO

ATC kood:

M05BA07

INN (Rahvusvaheline Nimetus):

RISEDRONIC ACID

Annus:

75MG

Ravimvorm:

TABLET

Koostis:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 75MG

Manustamisviis:

ORAL

Ühikuid pakis:

2

Retsepti tüüp:

Prescription

Terapeutiline ala:

BONE RESORPTION INHIBITORS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0135301004; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2016-08-05

Toote omadused

PRODUCT MONOGRAPH
Pr
ACTONEL
®
Risedronate Sodium (as the hemi-pentahydrate) Tablets, USP
5 mg, 30 mg, 35 mg, 75 mg and 150 mg
Pr
ACTONEL DR
®
Risedronate Sodium (as the hemi-pentahydrate) Delayed-Release Tablets
35 mg
Bisphosphonates
Warner Chilcott Canada Co.
Mississauga, Ontario
L5N 6J5
Date of Revision:
February 29, 2016
Submission Control No: 188707
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
......................................................................................................14
DOSAGE AND
ADMINISTRATION...................................................................................16
OVERDOSAGE
.....................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
.................................................................19
STORAGE AND STABILITY
..............................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................26
PART II: SCIENTIFIC INFORMATION
................................................................................27
PHARMACEUTICAL INFORMATION
..............................................................................27
CLINICAL TRIALS
..................................................................