MINT-ALENDRONATE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ALENDRONIC ACID (ALENDRONATE SODIUM)

제공처:

MINT PHARMACEUTICALS INC

ATC 코드:

M05BA04

INN (국제 이름):

ALENDRONIC ACID

복용량:

10.0MG

약제 형태:

TABLET

구성:

ALENDRONIC ACID (ALENDRONATE SODIUM) 10.0MG

관리 경로:

ORAL

패키지 단위:

28

처방전 유형:

Prescription

치료 영역:

BONE RESORPTION INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0150323003; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2018-08-01

제품 특성 요약

_Product Monograph – _
MINT-ALENDRONATE
_ _
_ Page 1 of 47 _
PR O D U CT MON OGR A PH
MINT-ALENDRONATE
ALENDRONATE SODIUM TABLETS
5 MG, 10 MG AND 70 MG
Bone Metabolism Regulator
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit 1
Mississauga, Ontario
L5T 1J6
Date of Revision:
April 19, 2018
SUBMISSION CONTROL NO.: 214834
_Product Monograph – _
MINT-ALENDRONATE
_ _
_ Page 2 of 47 _
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
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
......................................................................................
14
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
.................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
............................................... 22
PHARMACEUTICAL INFORMATION
.................................................................................
22
CLINICAL TRIALS
.........................................................