AA-RISEDRONATE DR TABLET (DELAYED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

제공처:

AA PHARMA INC

ATC 코드:

M05BA07

INN (International Name):

RISEDRONIC ACID

복용량:

35MG

약제 형태:

TABLET (DELAYED-RELEASE)

구성:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

BONE RESORPTION INHIBITORS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2023-09-08

제품 특성 요약

_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
............................................................................................................
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
4.1
Dosing Considerations
...........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration.......................................................................................................
5
4.5
Missed Dose
.........................................