TARO-MEROPENEM POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEROPENEM (MEROPENEM TRIHYDRATE)

Available from:

SUN PHARMA CANADA INC

ATC code:

J01DH02

INN (International Name):

MEROPENEM

Dosage:

500MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

MEROPENEM (MEROPENEM TRIHYDRATE) 500MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

CARBAPENEMS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2020-12-22

Summary of Product characteristics

_Pr_
_TARO-MEROPENEM (Meropenem For Injection USP, 500 mg, 1 g per vial)
Product Monograph _
Page 1 of 36
PRODUCT MONOGRAPH
PR
TARO-MEROPENEM
Meropenem For Injection USP, 500 mg, 1 g per vial
(as meropenem trihydrate)
For intravenous use
Antibiotic
Sun Pharma Canada Inc.
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
December 18, 2020
Submission Control No: 243010
_Pr_
_TARO-MEROPENEM (Meropenem For Injection USP, 500 mg, 1 g per vial)
Product Monograph _
Page 2 of 36
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
.......................................................................................
11
OVERDOSAGE
.........................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
15
STORAGE AND STABILITY
..................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................... 22
PART II: SCIENTIFIC INFORMATION
......................................................................................
23
PHAR