IMIPENEM AND CILASTATIN FOR INJECTION, USP POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-03-2023
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Active ingredient:
CILASTATIN (CILASTATIN SODIUM); IMIPENEM
Available from:
STERIMAX INC
ATC code:
J01DH51
INN (International Name):
IMIPENEM AND CILASTATIN
Dosage:
500MG; 500MG
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
CILASTATIN (CILASTATIN SODIUM) 500MG; IMIPENEM 500MG
Administration route:
INTRAVENOUS
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
CARBAPENEMS
Product summary:
Active ingredient group (AIG) number: 0218820001; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-03-10
Summary of Product characteristics
Page 1 of 50
PRODUCT MONOGRAPH
PR
IMIPENEM AND CILASTATIN FOR INJECTION, USP
Imipenem 250 mg and Cilastatin 250 mg (as cilastatin sodium) per vial
Imipenem 500 mg and Cilastatin 500 mg (as cilastatin sodium) per vial
Sterile Powder for Intravenous Infusion
ANTIBIOTIC
SteriMax Inc.
2770 Portland Drive
Oakville, ON
L6H 6R4
Control No.: 271444
Date of Preparation:
MAR 10, 2023
Page 2 of 50
TABLE OF CONTENTS
PRODUCT MONOGRAPH
..........................................................................................................
1
THERAPEUTIC
CLASSIFICATION
...........................................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.........................................................................................................
3
CONTRAINDICATIONS
..............................................................................................................................
5
WARNINGS
..................................................................................................................................................
5
PRECAUTIONS
............................................................................................................................................
6
OVERDOSAGE
...........................................................................................................................................
12
DOSAGE
AND
ADMINISTRATION
.........................................................................................................
12
PHARMACEUTICAL
INFORMATION
....................................................................................................
16
COMPATIBILITY
AND
STABILITY
........................................................................................................
17
AVAILABILITY
OF
DOSAGE
FORMS
....................................................................................................
18
STORAGE
..................................................................................
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