MEROPENEM FOR INJECTION POWDER FOR SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

MEROPENEM (MEROPENEM TRIHYDRATE)

可用日期:

JAMP PHARMA CORPORATION

ATC代码:

J01DH02

INN（国际名称）:

MEROPENEM

剂量:

500MG

药物剂型:

POWDER FOR SOLUTION

组成:

MEROPENEM (MEROPENEM TRIHYDRATE) 500MG

给药途径:

INTRAVENOUS

每包单位数:

100

处方类型:

Prescription

產品總結:

Active ingredient group (AIG) number: 0128599001; AHFS:

授权状态:

APPROVED

授权日期:

2023-03-21

产品特点

_ Meropenem for Injection Product Monograph Page 1 of 38 _
PRODUCT MONOGRAPH
PR MEROPENEM FOR INJECTION
500 mg / vial and 1 g / vial
Meropenem (as meropenem trihydrate)
Manufacturer’s Standard
For Intravenous Use
ANTIBIOTIC
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Date of Preparation:
March 20, 2023
Submission Control No.: 261951
_ Meropenem for Injection Product Monograph Page 2 of 38 _
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
...............................................................................................11
DOSAGE
AND
ADMINISTRATION.............................................................................12
OVERDOSAGE
............................................................................................................15
ACTION
AND
CLINICAL
PHARMACOLOGY
............................................................16
STABILITY
AND
STORAGE
RECOMMENDATIONS.................................................23
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..............................................23
PART II: SCIENTIFIC
INFORMATION..................................................................................24
PHARMACEUTICAL
INFORMATION
........................................................................24
CLINICAL
TRIALS..................................................................................................