ประเทศ: แคนาดา
ภาษา: อังกฤษ
แหล่งที่มา: Health Canada
CEFTRIAXONE (CEFTRIAXONE SODIUM)
PFIZER CANADA ULC
J01DD04
CEFTRIAXONE
250MG
POWDER FOR SOLUTION
CEFTRIAXONE (CEFTRIAXONE SODIUM) 250MG
INTRAMUSCULAR
10X10ML VIAL
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0117292001; AHFS:
CANCELLED POST MARKET
2023-07-17
_Product Monograph - _ _Pr_ _Ceftriaxone Sodium for Injection BP _ _Page 1 of 63 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR CEFTRIAXONE SODIUM FOR INJECTION BP Sterile Powder for Solution, 250 mg, 500 mg, and 1 g ceftriaxone (as ceftriaxone sodium) per vial, Pharmacy Bulk Vials 10 g ceftriaxone (as ceftriaxone sodium) per vial Intravenous or Intramuscular BP Antibiotic Pfizer Canada ULC 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Initial Authorization: September 20, 2006 Date of Revision: March 09, 2022 Submission Control Number: 256934 _Product Monograph - _ _Pr_ _Ceftriaxone Sodium for Injection BP _ _Page 2 of 63 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, General, Severe Cutaneous Adverse Reactions 03/2022 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 4 DOSAGE AND ADMINISTRATION .................................................................................. 5 4.1 Dosing Considerations ......................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ...................... อ่านเอกสารฉบับเต็ม