IMIPENEM AND CILASTATIN FOR INJECTION USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

J01DH51

INN (International Name):

IMIPENEM AND CILASTATIN

Dosage:

250MG; 250MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

IMIPENEM 250MG; CILASTATIN (CILASTATIN SODIUM) 250MG

Administration route:

INTRAVENOUS

Units in package:

20ML

Prescription type:

Prescription

Therapeutic area:

CARBAPENEMS

Product summary:

Active ingredient group (AIG) number: 0218820002; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-10-20

Summary of Product characteristics

_Imipenem and Cilastatin for Injection USP _
_Page 1 of 55_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
IMIPENEM AND CILASTATIN FOR INJECTION USP
500 mg imipenem and 500 mg cilastatin (as cilastatin sodium) per vial
Sterile powder for solution, I.V. Infusion
Antibiotic
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, (Québec), Canada
J4B 1E6
Date of Initial Authorization:
December 21, 2010
Date of Revision:
July 26, 2022
Submission Control Number: 260930
_Imipenem and Cilastatin for Injection USP _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
07/2022
4 DOSAGE AND ADMINISTRATION
07/2022
7 WARNINGS AND PRECAUTIONS
07/2022
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1 PEDIATRICS
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5
1.2 GERIATRICS
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5
2
CONTRAINDICATIONS......................................................................................................
6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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6
4.1 DOSING
CONSIDERATIONS............................................................................................
6
4.2 RECO