CEFTRIAXONE SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Sẵn có từ:

STERIMAX INC

Mã ATC:

J01DD04

INN (Tên quốc tế):

CEFTRIAXONE

Liều dùng:

250MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 250MG

Tuyến hành chính:

INTRAMUSCULAR

Các đơn vị trong gói:

15ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

THIRD GENERATION CEPHALOSPORINS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0117292001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2010-11-10

Đặc tính sản phẩm

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFTRIAXONE SODIUM FOR INJECTION BP
Sterile Powder for Solution, 250 mg, 500 mg, 1 g, 2 g and 10 g
ceftriaxone (as ceftriaxone
sodium) per vial,
Intravenous or Intramuscular
BP
Antibiotic
SteriMax Inc.
2770 Portland Drive,
Oakville, ON
L6H 6R4
Control No. 259108
Date of Initial Authorization:
November 19, 2010
Date of Revision:
July 6, 2022
Page 2 of 55
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 PEDIATRICS
12/2021
1 INDICATIONS, 1.2 GERIATRICS
12/2021
4 DOSAGE AND ADMINISTRATION, 4.1 DOSING CONSIDERATIONS
12/2021
4 DOSAGE AND ADMINISTRATION, 4.2 RECOMMENDED DOSE
AND DOSAGE ADJUSTMENT
12/2021
4 DOSAGE AND ADMINISTRATION, 4.3 RECONSTITUTION
12/2021
4 DOSAGE AND ADMINISTRATION, 4.4 ADMINISTRATION
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 PREGNANT WOMEN
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.2 BREAST-FEEDING
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.3 PEDIATRICS
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.4 GERIATRICS
12/2021
TABLE OF CONTENTS
SECTION 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
4
DOSAGE AND ADMINISTRATION
.........................................................................