AA-RISEDRONATE DR TABLET (DELAYED-RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Sẵn có từ:

AA PHARMA INC

Mã ATC:

M05BA07

INN (Tên quốc tế):

RISEDRONIC ACID

Liều dùng:

35MG

Dạng dược phẩm:

TABLET (DELAYED-RELEASE)

Thành phần:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

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:

2023-09-08

Đặc tính sản phẩm

_Page 1 of 42_
_AA-RISEDRONATE DR (Risedronate Sodium Delayed-Release Tablets)_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AA-RISEDRONATE DR
Risedronate Sodium Delayed-Release Tablets
Delayed-Release Tablets, 35 mg (as the hemi-pentahydrate), Oral
Bisphosphonates (ATC Code: M05BA07)
Submission Control Number:
278226
AA PHARMA INC.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
SEP
08, 2023
_AA-RISEDRONATE DR (Risedronate Sodium Delayed-Release Tablets) _
_Page 2 of 42 _
RECENT MAJOR LABEL CHANGES
Not Applicable
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
........................................................................................................
4
1.1
Pediatrics
..............................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
...........................................................................................
4
4
DOSAGE AND ADMINISTRATION
...........................................................................
5
4.1
Dosing Considerations
...........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration.......................................................................................................
5
4.5
Missed Dose
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