TARO-IMIPENEM-CILASTATIN POWDER FOR SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

から入手可能:

SUN PHARMA CANADA INC

ATCコード:

J01DH51

INN（国際名）:

IMIPENEM AND CILASTATIN

投薬量:

250MG; 250MG

医薬品形態:

POWDER FOR SOLUTION

構図:

IMIPENEM 250MG; CILASTATIN (CILASTATIN SODIUM) 250MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

30ML

処方タイプ:

Prescription

治療領域:

CARBAPENEMS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2021-01-19

製品の特徴

_ _
_ _
_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.