TARO-IMIPENEM-CILASTATIN POWDER FOR SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Tillgänglig från:

SUN PHARMA CANADA INC

ATC-kod:

J01DH51

INN (International namn):

IMIPENEM AND CILASTATIN

Dos:

250MG; 250MG

Läkemedelsform:

POWDER FOR SOLUTION

Sammansättning:

IMIPENEM 250MG; CILASTATIN (CILASTATIN SODIUM) 250MG

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

30ML

Receptbelagda typ:

Prescription

Terapiområde:

CARBAPENEMS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2021-01-19

Produktens egenskaper

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_Pr_
_TARO-Imipenem-Cilastatin (Imipenem and Cilastatin for Injection, USP)
Page 1 of 57 _
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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_Pr_
_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
...............................................................................................................
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......................................................................
5
4 DOSAGE AND ADMINISTRATION
..........................................................................................
6
4.