ERTAPENEM FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ERTAPENEM (ERTAPENEM SODIUM)

Available from:

AURO PHARMA INC

ATC code:

J01DH03

INN (International Name):

ERTAPENEM

Dosage:

1G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

ERTAPENEM (ERTAPENEM SODIUM) 1G

Administration route:

INTRAMUSCULAR

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

CARBAPENEMS

Product summary:

Active ingredient group (AIG) number: 0149104002; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-09-11

Summary of Product characteristics

ERTAPENEM FOR INJECTION PRODUCT MONOGRAPH
PAGE 1 OF 81
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ERTAPENEM FOR INJECTION
Ertapenem for Injection
Powder for Solution, 1 g/vial ertapenem (as ertapenem monosodium), for
Intravenous or
Intramuscular Use
Antibiotic
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Initial Authorization:
September 11, 2019
Date of Revision:
January 17, 2023
Submission Control Number: 266851
ERTAPENEM FOR INJECTION PRODUCT MONOGRAPH
PAGE 2 OF 81
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Skin
01/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF
CONTENTS.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 5
1 INDICATIONS
.....................................................................................................................
5
1.1
Pediatrics...................................................................................................................
6
1.2 Geriatrics
...................................................................................................................
6
2 CONTRAINDICATIONS
........................................................................................................
7
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................... 7
4 DOSAGE AND ADMINISTRATION
........................................................................................
8
4.2 Recommended Dose and Dosage
Adjustment.............................................................
8
4.3 Reconstitution
...................................................................................