Land: Canada
Taal: Engels
Bron: Health Canada
CLINDAMYCIN (CLINDAMYCIN PHOSPHATE)
SANDOZ CANADA INCORPORATED
J01FF01
CLINDAMYCIN
12MG
SOLUTION
CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 12MG
INTRAVENOUS
50ML
Prescription
LINCOMYCINS
Active ingredient group (AIG) number: 0105830009; AHFS:
APPROVED
2013-07-10
_ _ _Clindamycin IV Infusion (clindamycin phosphate) _ _Page 1 of 38_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR CLINDAMYCIN IV INFUSION Clindamycin Injection in 5% Dextrose w/v Minibags, clindamycin 12 mg/mL (600 mg/50 mL) and 18 mg/mL (900 mg/50 mL) (as clindamycin phosphate) Sterile Solution Antibiotic Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, QC, Canada J4B 1E6 Date of Initial Authorization: July 10, 2013 Date of Revision: July 26, 2023 Submission Control Number: 272119 _ _ _Clindamycin IV Infusion (clindamycin phosphate) _ _Page 2 of 38_ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 07/2023 7 WARNINGS AND PRECAUTIONS, Renal 07/2023 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 ................................................................................................. 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 4.1 Dosing Considerations ............................................................................................... 6 4.2 Recommended Dose and Dosage Adjustment ...................................................... Lees het volledige document