Land: Canada
Taal: Engels
Bron: Health Canada
CEFTRIAXONE (CEFTRIAXONE SODIUM)
SANDOZ CANADA INCORPORATED
J01DD04
CEFTRIAXONE
10G
POWDER FOR SOLUTION
CEFTRIAXONE (CEFTRIAXONE SODIUM) 10G
INTRAVENOUS
101ML(PHARMACY BULK VIAL)
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0117292008; AHFS:
APPROVED
2018-03-15
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR CEFTRIAXONE SODIUM FOR INJECTION BP Sterile Powder for Solution, 250 mg, 1 g, 2 g and 10 g ceftriaxone per vial Intravenous or Intramuscular BP Antibiotic Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, (Québec), Canada J4B 1K6 Date of Initial Authorization: August 17, 2006 Date of Revision: January 6, 2022 Submission Control Number: 255080 Ceftriaxone Sodium for Injection BP Page 2 of 58 RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions 01/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. TABLE OF CONTENTS ................................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ............................................................................ 4 1 INDICATIONS..................................................................................................................... 4 1.1 P EDIATRICS ......................................................................................................................... 5 1.2 G ERIATRICS ......................................................................................................................... 5 2 CONTRAINDICATIONS ........................................................................................................ 5 4 DOSAGE AND ADMINISTRATION.......................................................................................... 5 4.1 D OSING C ONSIDERATI ONS ....................................................................................................... 5 4.2 R ECOMMENDED D OSE AND D OSAGE A DJUSTMENT ........................................................................... 6 4.3 R ECONSTI TUTI ON .................................................................................................................. 7 4.4 A DMINISTRATION ..................................................................................... Lees het volledige document