MYLAN-PERINDOPRIL/INDAPAMIDE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

INDAPAMIDE; PERINDOPRIL ERBUMINE

제공처:

MYLAN PHARMACEUTICALS ULC

ATC 코드:

C09BA04

INN (국제 이름):

PERINDOPRIL AND DIURETICS

복용량:

0.625MG; 2MG

약제 형태:

TABLET

구성:

INDAPAMIDE 0.625MG; PERINDOPRIL ERBUMINE 2MG

관리 경로:

ORAL

패키지 단위:

30/100

처방전 유형:

Prescription

치료 영역:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0248401002; AHFS:

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2023-06-07

제품 특성 요약

_Product Monograph _
_–_
_ Mylan-Perindopril/Indapamide _
_ Page 1 of 63_
PRODUCT MONOGRAPH
Pr
MYLAN-PERINDOPRIL/INDAPAMIDE
(2 mg/0.625 mg) tablets
Pr
MYLAN-PERINDOPRIL/INDAPAMIDE
(4 mg/1.25 mg) tablets
Pr
MYLAN-PERINDOPRIL/INDAPAMIDE
(8 mg/2.5 mg) tablets
(perindopril erbumine/indapamide)
Angiotensin Converting Enzyme Inhibitor / Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Initial Approval:
March 07, 2018
Date of Revision:
July 5, 2022
Submission Control No.: 265136
_Product Monograph _
_–_
_ Mylan-Perindopril/Indapamide _
_ Page 2 of 63_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 3
SUMMARY PRODUCT INFORMATION
......................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................
3
CONTRAINDICATIONS
.............................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................................
5
ADVERSE REACTIONS
...........................................................................................................
16
DRUG INTERACTIONS
...........................................................................................................
23
DOSAGE AND ADMINISTRATION
..........................................................................................
29
OVERDOSAGE
........................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
31
STORAGE AND STABILITY
....................................................................................................
36
SPECIAL HANDLING INSTRUCTIONS
.............................................................