AURO-RISEDRONATE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Sẵn có từ:

AURO PHARMA INC

Mã ATC:

M05BA07

INN (Tên quốc tế):

RISEDRONIC ACID

Liều dùng:

35MG

Dạng dược phẩm:

TABLET

Thành phần:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

4/28

Loại thuốc theo toa:

Prescription

Khu trị liệu:

BONE RESORPTION INHIBITORS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2013-05-08

Đặc tính sản phẩm

Auro-Risedronate Product Monograph
Page 1 of 56
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-RISEDRONATE
Risedronate Sodium Tablets
Tablets, 5 mg, 30 mg, 35 mg and 150 mg
Risedronate sodium (as the hemi-pentahydrate), for oral use
House standard
Bisphosphonates
AURO PHARMA INC.
3700 Steeles Avenue West,
Suite # 402 Woodbridge, Ontario, L4L 8K8,
Canada
Date of Initial Authorization:
May 08, 2013
Date of Revision:
December 21, 2023
Submission Control Number: 278087
Auro-Risedronate Product Monograph
Page 2 of 56
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
12/2023
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
...................................................................................................................
5
1.2 Geriatrics
...................................................................................................................
5
2 CONTRAINDICATIONS
.........................................................................................................
5
4 DOSAGE AND ADMINISTRATION
.........................................................................................
5
4.1 Dosing Considerations
...............................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
........................................................... 5
4.4 Administration
..............................