ACH-METFORMIN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

METFORMIN HYDROCHLORIDE

제공처:

ACCORD HEALTHCARE INC

ATC 코드:

A10BA02

INN (International Name):

METFORMIN

복용량:

500MG

약제 형태:

TABLET

구성:

METFORMIN HYDROCHLORIDE 500MG

관리 경로:

ORAL

패키지 단위:

100/500

처방전 유형:

Prescription

치료 영역:

BIGUANIDES

제품 요약:

Active ingredient group (AIG) number: 0101773001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2021-03-01

제품 특성 요약

PRODUCT MONOGRAPH
PR
ACH-METFORMIN
Metformin Hydrochloride Tablets, Mfr Std
500 mg and 850 mg tablets
Oral Antihyperglycemic Agent
Accord Healthcare Inc.
3535 Boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
DATE OF REVISION:
FEBRUARY 23, 2021
SUBMISSION CONTROL NO.: 244440
_Page 2 of 37_
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
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
......................................................................................
17
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
19
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL
INFORMATION..................................................................................
21
CLINICAL TRIALS
........................................................................................