ERTAPENEM FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ERTAPENEM (ERTAPENEM SODIUM)

Available from:

HIKMA CANADA LIMITED

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:

100

Prescription type:

Prescription

Therapeutic area:

CARBAPENEMS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2020-09-15

Summary of Product characteristics

_Ertapenem for Injection (ertapenem sodium) _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ERTAPENEM FOR INJECTION
Sterile lyophilized powder; 1 g / vial ertapenem (as ertapenem sodium)
for Intravenous or Intramuscular Use
Antibiotic
Hikma Canada Ltd.
5995 Avebury Road, Suite 804
Mississauga, Ontario
Canada L5R 3P9
Date of Initial Approval:
September 15, 2020
Date of Revision:
September 6, 2022
SUBMISSION CONTROL NO.: 266939
_Ertapenem for Injection (ertapenem sodium) _
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RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Skin
12/2020
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
......................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................ 4
1
INDICATIONS....................................................................................................
4
1.1
Pediatrics
...................................................................................................
5
1.2
Geriatrics
...................................................................................................
5
2
CONTRAINDICATIONS
.....................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX............................................ 6
4
DOSAGE AND ADMINISTRATION
.................................................................... 6
4.2
Recommended Dose and Dosage Adjustment
............................................ 6
4.3
Reconstitution
............................................................................................
9
4.4
Administration
..........................................................................................
10
4.5
Missed Dose
............................................................................................
10
5
OVERDOSAGE
...............................................................................................
11
6
DOSAGE FORMS, STRENGTHS, COM