TARO-IMIPENEM-CILASTATIN POWDER FOR SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

可用日期:

SUN PHARMA CANADA INC

ATC代码:

J01DH51

INN（国际名称）:

IMIPENEM AND CILASTATIN

剂量:

500MG; 500MG

药物剂型:

POWDER FOR SOLUTION

组成:

IMIPENEM 500MG; CILASTATIN (CILASTATIN SODIUM) 500MG

给药途径:

INTRAVENOUS

每包单位数:

30ML

处方类型:

Prescription

治疗领域:

CARBAPENEMS

產品總結:

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

授权状态:

APPROVED

授权日期:

2021-01-19

产品特点

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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
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6
4.