MEROPENEM FOR INJECTION POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

MEROPENEM (MEROPENEM TRIHYDRATE)

Sẵn có từ:

STERIMAX INC

Mã ATC:

J01DH02

INN (Tên quốc tế):

MEROPENEM

Liều dùng:

500MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

MEROPENEM (MEROPENEM TRIHYDRATE) 500MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

CARBAPENEMS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-10-23

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
MEROPENEM FOR INJECTION
500 mg/vial and 1 g/vial
(as meropenem trihydrate)
USP
For intravenous use
Antibiotic
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario L6H 6R4
Date of Preparation:
October 22, 2019
Submission Control No: 213538
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_MEROPENEM FOR INJECTION _
_Page 2 of 37 _
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
.......................................................................................................
9
DRUG
INTERACTIONS......................................................................................................
12
DOSAGE AND ADMINISTRATION
.................................................................................
12
OVERDOSAGE
....................................................................................................................
16
ACTIONS AND CLINICAL PHARMACOLOGY
.............................................................. 16
STORAGE AND STABILITY
.............................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 23
PART II:SCIENTIFIC INFORMATION
.........................................................................
24
PHARMACEUTICAL INFORMATION
.............................................................................
24
CLINICAL
TRIALS………………………………………………………………………..25
DETAILED PHARMACOLOGY
...................................