MEROPENEM FOR INJECTION POWDER FOR SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

MEROPENEM (MEROPENEM TRIHYDRATE)

から入手可能:

AURO PHARMA INC

ATCコード:

J01DH02

INN（国際名）:

MEROPENEM

投薬量:

1G

医薬品形態:

POWDER FOR SOLUTION

構図:

MEROPENEM (MEROPENEM TRIHYDRATE) 1G

投与経路:

INTRAVENOUS

パッケージ内のユニット:

10ML

処方タイプ:

Prescription

治療領域:

CARBAPENEMS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2017-04-06

製品の特徴

MEROPENEM FOR INJECTION_ _
PAGE 1 OF 39
PRODUCT MONOGRAPH
PR
MEROPENEM FOR INJECTION
500 mg and 1 g meropenem (as meropenem trihydrate) per vial
For intravenous use
Sterile
House Std.
Antibiotic
AURO PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite # 402
May 24, 2023
Woodbridge, Ontario, L4L 8K8,
Canada.
Submission Control No: 270535
MEROPENEM FOR INJECTION_ _
PAGE 2 OF 39
TABLE OF CONTENT
TABLE OF CONTENT
............................................................................................................................
2
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
.............................