ACTONEL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Tersedia dari:

ALLERGAN PHARMA CO.

Kode ATC:

M05BA07

INN (Nama Internasional):

RISEDRONIC ACID

Dosis:

5MG

Bentuk farmasi:

TABLET

Komposisi:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 5MG

Rute administrasi :

ORAL

Unit dalam paket:

28

Jenis Resep:

Prescription

Area terapi:

BONE RESORPTION INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0135301002; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2019-01-04

Karakteristik produk

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ACTONEL
®
Risedronate Sodium (as the hemi-pentahydrate) Tablets, USP
5 mg, 30 mg, 35 mg, and 150 mg
Pr
ACTONEL DR
®
Risedronate Sodium (as the hemi-pentahydrate) Delayed-Release Tablets
35 mg
Bisphosphonates
Allergan Pharma Co.
Markham, Ontario
L6G 0B5
Date of Preparation:
August 3, 2017
Submission Control No: 205107
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
......................................................................................................13
DOSAGE AND ADMINISTRATION
..................................................................................16
OVERDOSAGE
.....................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
................................................................18
STORAGE AND STABILITY
..............................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................24
PART II: SCIENTIFIC INFORMATION
................................................................................26
PHARMACEUTICAL INFORMATION
..............................................................................26
CLINICAL TRIALS
...............................................