RISEDRONATE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)

제공처:

SANIS HEALTH INC

ATC 코드:

M05BA07

INN (International Name):

RISEDRONIC ACID

복용량:

35MG

약제 형태:

TABLET

구성:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 35MG

관리 경로:

ORAL

패키지 단위:

4

처방전 유형:

Prescription

치료 영역:

BONE RESORPTION INHIBITORS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2011-09-22

제품 특성 요약

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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RISEDRONATE
Risedronate sodium (as the monohydrate)
35 mg Tablets
Manufacturer’s Standard
Bisphosphonates
Sanis Health Inc.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
www.sanis.com
Date of Revision:
March 6, 2019
Submission Control No: 224337
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TABLE OF CONTENTS
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
.........................................................................................................
12
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
..............................................................................