MEROPENEM FOR INJECTION POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

MEROPENEM (MEROPENEM TRIHYDRATE)

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

J01DH02

INN (국제 이름):

MEROPENEM

복용량:

1G

약제 형태:

POWDER FOR SOLUTION

구성:

MEROPENEM (MEROPENEM TRIHYDRATE) 1G

관리 경로:

INTRAVENOUS

패키지 단위:

20ML

처방전 유형:

Prescription

치료 영역:

CARBAPENEMS

제품 요약:

Active ingredient group (AIG) number: 0128599003; AHFS:

승인 상태:

APPROVED

승인 날짜:

2012-01-26

제품 특성 요약

_ _
_Meropenem for Injection _
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
MEROPENEM FOR INJECTION
(meropenem for injection)
500 mg and 1 g vials
USP
For intravenous use
Antibiotic
Sandoz Canada Inc.
Date of Revision: October 6, 2020
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Submission Control No: 239077
_ _
_Meropenem for Injection _
_Page 2 of 38_
TABLE OF CONTENT
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
.........................................................................................................
11
DOSAGE
AND
ADMINISTRATION
.....................................................................................
12
OVERDOSAGE
.......................................................................................................................
15
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
16
STABILITY AND STORAGE RECOMMENDATIONS
........................................................ 22
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL
INFORMATION
.................................................................................
24
CLINICAL
TRIALS
...................................................................