Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
CEFTRIAXONE (CEFTRIAXONE SODIUM)
PFIZER CANADA ULC
J01DD04
CEFTRIAXONE
500MG
POWDER FOR SOLUTION
CEFTRIAXONE (CEFTRIAXONE SODIUM) 500MG
INTRAMUSCULAR
10X10 ML VIALS
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0117292005; AHFS:
CANCELLED PRE 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 ...................... Belgenin tamamını okuyun