Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
CEFTRIAXONE (CEFTRIAXONE SODIUM)
SANDOZ CANADA INCORPORATED
J01DD04
CEFTRIAXONE
250MG
POWDER FOR SOLUTION
CEFTRIAXONE (CEFTRIAXONE SODIUM) 250MG
INTRAMUSCULAR
1ML(IM)-2.5ML(IV)
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0117292001; 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 ..................................................................................... Baca dokumen lengkap