TARO-IMIPENEM-CILASTATIN POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Disponibbli minn:

SUN PHARMA CANADA INC

Kodiċi ATC:

J01DH51

INN (Isem Internazzjonali):

IMIPENEM AND CILASTATIN

Dożaġġ:

500MG; 500MG

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

IMIPENEM 500MG; CILASTATIN (CILASTATIN SODIUM) 500MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

30ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

CARBAPENEMS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0218820001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2021-01-19

Karatteristiċi tal-prodott

_ _
_ _
_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
_ _
_ _
_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.