AG-ALENDRONATE SODIUM TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ALENDRONIC ACID (ALENDRONATE SODIUM)

Boleh didapati daripada:

ANGITA PHARMA INC.

Kod ATC:

M05BA04

INN (Nama Antarabangsa):

ALENDRONIC ACID

Dos:

70MG

Borang farmaseutikal:

TABLET

Komposisi:

ALENDRONIC ACID (ALENDRONATE SODIUM) 70MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

BONE RESORPTION INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0150323002; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2020-10-08

Ciri produk

_AG-Alendronate Sodium (alendronate sodium) _
_Page 1 of 42_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-ALENDRONATE SODIUM
Alendronate Sodium Tablets
tablet, 70 mg of alendronic acid (as sodium alendronate), Oral
USP
Bone Metabolism Regulator
Angita Pharma Inc.
1310, rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Submission Control Number: 275527
Date of Initial Authorization:
OCT
08, 2020
Date
of
Revision:
JUN
15, 2023
_AG-Alendronate Sodium (alendronate sodium) _
_Page 2 of 42_
_ _
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
........................................................................................................
5
4.5
Missed Dose
...........................................................................................................
5
5
OVERDOSAGE
.................................