CEFPROZIL POWDER FOR ORAL SUSPENSION POWDER FOR SUSPENSION
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
09-10-2019
이 제품에 대한 일부 문서는 현재 사용할 수 없습니다. 고객 서비스에 요청을 보내면 가능한 빨리 알려 드리겠습니다.
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유효 성분:
CEFPROZIL (CEFPROZIL MONOHYDRATE)
제공처:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC 코드:
J01DC10
INN (International Name):
CEFPROZIL
복용량:
250MG
약제 형태:
POWDER FOR SUSPENSION
구성:
CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG
관리 경로:
ORAL
패키지 단위:
50/75/100ML
처방전 유형:
Prescription
치료 영역:
SECOND GENERATION CEPHALOSPORINS
제품 요약:
Active ingredient group (AIG) number: 0127613004; AHFS:
승인 상태:
APPROVED
승인 날짜:
2009-08-20
제품 특성 요약
PRODUCT MONOGRAPH
PR
CEFPROZIL POWDER FOR ORAL SUSPENSION
CEFPROZIL POWDER FOR ORAL SUSPENSION USP
(250 MG/5 ML OF CEFPROZIL AS CEFPROZIL MONOHYDRATE, WHEN
RECONSTITUTED)
USP
ANTIBIOTIC
Ranbaxy Pharmaceuticals Canada Inc.
126 East Drive,
Brampton, Ontario
L6T 1C1
Date of Revision:
October 9, 2019
Submission Control No.: 230902
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 4
SUMMARY PRODUCT INFORMATION
.................................................................................
4
INDICATIONS AND CLINICAL USE
.......................................................................................
4
CONTRAINDICATIONS
............................................................................................................
5
WARNINGS AND PRECAUTIONS
...........................................................................................
5
ADVERSE REACTIONS
.............................................................................................................
7
DRUG INTERACTIONS
.............................................................................................................
9
DOSAGE AND ADMINISTRATION
.........................................................................................
9
OVERDOSAGE
.........................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
11
STORAGE AND STABILITY
...................................................................................................
12
STORAGE OF RECONSTITUTED SUSPENSION
................................................................. 12
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................... 13
PART II: SCIENTIFIC INFORMATION
.....................................................................................
14
PHARMACEUTICAL INFORMATION
...................
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