TARO-IMIPENEM-CILASTATIN POWDER FOR SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Предлага се от:

SUN PHARMA CANADA INC

АТС код:

J01DH51

INN (Международно Name):

IMIPENEM AND CILASTATIN

дозиране:

250MG; 250MG

Лекарствена форма:

POWDER FOR SOLUTION

Композиция:

IMIPENEM 250MG; CILASTATIN (CILASTATIN SODIUM) 250MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

30ML

Вид предписание :

Prescription

Терапевтична област:

CARBAPENEMS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2021-01-19

Данни за продукта

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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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_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.