M-AZITHROMYCIN TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
24-07-2020
이 제품에 대한 일부 문서는 현재 사용할 수 없습니다. 고객 서비스에 요청을 보내면 가능한 빨리 알려 드리겠습니다.
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유효 성분:
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)
제공처:
MANTRA PHARMA INC
ATC 코드:
J01FA10
INN (국제 이름):
AZITHROMYCIN
복용량:
250MG
약제 형태:
TABLET
구성:
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 250MG
관리 경로:
ORAL
패키지 단위:
15G/50G
처방전 유형:
Prescription
치료 영역:
OTHER MACROLIDES
제품 요약:
Active ingredient group (AIG) number: 0126072001; AHFS:
승인 상태:
APPROVED
승인 날짜:
2020-07-28
제품 특성 요약
PRODUCT MONOGRAPH
Pr
M-AZITHROMYCIN
Azithromycin Dihydrate Tablets
250 mg and 600 mg Azithromycin (supplied as azithromycin dihydrate),
manufacturer’s standard
Antibacterial Agent
Mantra Pharma Inc. Date of Revision:
9150 Leduc BLVD, Suite 201, Brossard July 24, 2020
Quebec, Canada
J4Y 0E3
Control Submission #: 240728
Pr
M-Azithromycin (as azithromycin dihydrate) Product Monograph
Page 2 of 62
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
.........................................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................................
14
DOSAGE AND ADMINISTRATION
...................................................................................................
19
OVERDOSAGE
......................................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
20
STORAGE AND STABILITY
...............................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 23
PART II: SCIENTIFIC INFORMATION
......................
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