TARO-IMIPENEM-CILASTATIN POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Dostopno od:

SUN PHARMA CANADA INC

Koda artikla:

J01DH51

INN (mednarodno ime):

IMIPENEM AND CILASTATIN

Odmerek:

500MG; 500MG

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

IMIPENEM 500MG; CILASTATIN (CILASTATIN SODIUM) 500MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

30ML

Tip zastaranja:

Prescription

Terapevtsko območje:

CARBAPENEMS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2021-01-19

Lastnosti izdelka

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_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.