TARO-IMIPENEM-CILASTATIN POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Sẵn có từ:

SUN PHARMA CANADA INC

Mã ATC:

J01DH51

INN (Tên quốc tế):

IMIPENEM AND CILASTATIN

Liều dùng:

500MG; 500MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

IMIPENEM 500MG; CILASTATIN (CILASTATIN SODIUM) 500MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

30ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

CARBAPENEMS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2021-01-19

Đặc tính sản phẩm

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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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS........................................................................................................................
4
1.1 PEDIATRICS
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5
1.2 GERIATRICS
..........................................................................................................................
5
2 CONTRAINDICATIONS
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5
3 SERIOUS WARNINGS AND PRECAUTIONS
BOX......................................................................
5
4 DOSAGE AND ADMINISTRATION
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6
4.