TARO-IMIPENEM-CILASTATIN POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Available from:

SUN PHARMA CANADA INC

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:

30ML

Prescription type:

Prescription

Therapeutic area:

CARBAPENEMS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2021-01-19

Summary of Product characteristics

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_TARO-Imipenem-Cilastatin (Imipenem and Cilastatin for Injection, USP)
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-IMIPENEM-CILASTATIN
Imipenem and Cilastatin for Injection
250 mg imipenem and 250 mg cilastatin (as cilastatin sodium) per vial
500 mg imipenem and 500 mg cilastatin (as cilastatin sodium) per vial
Sterile powder for solution, I.V. Infusion
USP
ANTIBIOTIC
Sun Pharma Canada Inc.,
126 East Drive
Brampton, ON
L6T 1C1
Date of Initial Authorization:
MAY 20, 2010
Date of Revision:
JULY 22, 2022
Submission Control Number: 260927
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_TARO-Imipenem-Cilastatin (Imipenem and Cilastatin for Injection, USP)
Page 2 of 57 _
RECENT MAJOR LABEL CHANGES
4. DOSAGE AND ADMINISTRATION
07/2022
7. WARNINGS AND PRECAUTIONS
01/2021
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........................................................................................................................
4
1.1 PEDIATRICS
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5
1.2 GERIATRICS
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5
2 CONTRAINDICATIONS
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5
3 SERIOUS WARNINGS AND PRECAUTIONS
BOX......................................................................
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4 DOSAGE AND ADMINISTRATION
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4.