Страна: Канада
мова: англійська
Джерело: Health Canada
CEFTRIAXONE (CEFTRIAXONE SODIUM)
FRESENIUS KABI CANADA LTD
J01DD04
CEFTRIAXONE
250MG
POWDER FOR SOLUTION
CEFTRIAXONE (CEFTRIAXONE SODIUM) 250MG
INTRAMUSCULAR
100
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0117292001; AHFS:
CANCELLED PRE MARKET
2022-08-17
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 .......................................................................................................... 5 4 DOSAGE AND ADMINISTRATION ........................................................................................... 5 4.1 Dosing Considerations ................................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ................................................................... 6 Прочитайте повний документ