País: Canadá
Idioma: inglés
Fuente: Health Canada
CEFTRIAXONE (CEFTRIAXONE SODIUM)
STERIMAX INC
J01DD04
CEFTRIAXONE
1G
POWDER FOR SOLUTION
CEFTRIAXONE (CEFTRIAXONE SODIUM) 1G
INTRAMUSCULAR
10X1G
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0117292007; AHFS:
APPROVED
2010-11-10
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 ......................................................................... Leer el documento completo