CEFTRIAXONE FOR INJECTION POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

제공처:

FRESENIUS KABI CANADA LTD

ATC 코드:

J01DD04

INN (International Name):

CEFTRIAXONE

복용량:

2G

약제 형태:

POWDER FOR SOLUTION

구성:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 2G

관리 경로:

INTRAMUSCULAR

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

THIRD GENERATION CEPHALOSPORINS

제품 요약:

Active ingredient group (AIG) number: 0117292006; AHFS:

승인 상태:

APPROVED

승인 날짜:

2015-04-07

제품 특성 요약

Ceftriaxone for Injection – Product Monograph_ _Page 1 of 58
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFTRIAXONE FOR INJECTION
Sterile Powder for Solution, 250 mg, 500 mg, 1 g, 2 g ceftriaxone (as
ceftriaxone sodium) per vial
Pharmacy Bulk Package 10 g ceftriaxone (as ceftriaxone sodium) per
vial
100 g ceftriaxone (as ceftriaxone sodium) in SmartPak® Pharmacy Bulk
Package
Intravenous or Intramuscular
USP
Antibiotic
FRESENIUS KABI CANADA LTD. Date of Initial Authorization:
165 Galaxy Blvd. Suite 100 DEC 16, 2006
Toronto, ON M9W 0C8 Date of Revision:
JAN 05, 2022
Submission Control No.: 255106
Ceftriaxone for Injection – Product Monograph_ _Page 2 of 58
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General, Severe Cutaneous Adverse
Reactions
01/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................
4
1
INDICATIONS
......................................................................................................................
4
1.1 Pediatrics
.....................................................................................................................
5
1.2 Geriatrics
.....................................................................................................................
5
2
CONTRAINDICATIONS
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5
4
DOSAGE
AND
ADMINISTRATION
...........................................................................................
5
4.1 Dosing Considerations
...................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
................................................................... 6