CEFEPIME FOR INJECTION POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
20-04-2020

유효 성분:

CEFEPIME (CEFEPIME HYDROCHLORIDE)

제공처:

APOTEX INC

ATC 코드:

J01DE01

INN (국제 이름):

CEFEPIME

복용량:

2G

약제 형태:

POWDER FOR SOLUTION

구성:

CEFEPIME (CEFEPIME HYDROCHLORIDE) 2G

관리 경로:

INTRAVENOUS

패키지 단위:

IV:10ML/IV INF.:SEE PM

처방전 유형:

Prescription

치료 영역:

FOURTH GENERATION CEPHALOSPORINS

제품 요약:

Active ingredient group (AIG) number: 0150504005; AHFS:

승인 상태:

APPROVED

승인 날짜:

2009-02-16

제품 특성 요약

                                PRODUCT MONOGRAPH
Cefepime for Injection
(cefepime hydrochloride)
1 g and 2 g cefepime per vial
Orchid Standard
Antibiotic
_Manufactured by: _
ORCHID HEALTHCARE
(A Division of Orchid Chemicals & Pharmaceuticals Ltd.)
Plot No: B3-B6 & B11-B14, SIPCOT Industrial Park,
Irungattukottai- 602 105, Sriperumbudur P.O.,
Kancheepuram District, INDIA.
_Manufactured for: _
APOTEX INC.
150 Signet Drive
Weston, ON, M9L 1T9
DATE OF PREPARATION
April 20, 2020
Control #: 234594
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................. 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL
USE...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
5
WARNINGS AND PRECAUTIONS
......................................................................................
5
ADVERSE REACTIONS
........................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................
10
DOSAGE AND ADMINISTRATION
...................................................................................
10
OVERDOSAGE
.....................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 15
STORAGE AND STABILITY
..............................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
............................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 19
PART II: SCIENTIFIC INFORMATION
.........................................................
                                
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