Country: Կանադա
language: անգլերեն
source: Health Canada
BETAMETHASONE ACETATE; BETAMETHASONE (BETAMETHASONE SODIUM PHOSPHATE)
ORGANON CANADA INC.
H02AB01
BETAMETHASONE
3MG; 3MG
SUSPENSION
BETAMETHASONE ACETATE 3MG; BETAMETHASONE (BETAMETHASONE SODIUM PHOSPHATE) 3MG
INTRA-ARTICULAR
15G/50G
Prescription
ADRENALS
Active ingredient group (AIG) number: 0206301001; AHFS:
APPROVED
2011-02-15
_CELESTONE_ _®_ _ SOLUSPAN_ _®_ _ (Betamethasone Sodium Phosphate and Betamethasone Acetate) _ _Page 1 of 25_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR CELESTONE® SOLUSPAN® Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Injectable Suspension, 3 mg/mL Betamethasone Sodium Phosphate and 3 mg/mL Betamethasone Acetate, intra-articular, intrabursal, intradermal, intramuscular USP Injectable Glucocorticoid Organon Canada Inc. 16766, route Trans-Canadienne Kirkland, QC, Canada, H9H 4M7 www.organon.ca Date of Initial Authorization: DEC 31, 1965 Date of Revision: MAY 19, 2022 Submission Control Number: 259866 _®_ _ N.V. Organon. Used under license. _ _© 2022 Organon group of companies. All rights reserved. _ _ _ _CELESTONE_ _®_ _ SOLUSPAN_ _®_ _ (Betamethasone Sodium Phosphate and Betamethasone Acetate) _ _Page 2 of 25_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 05/2022 8 ADVERSE REACTIONS, 8.1 Adverse Reaction Overview 05/2022 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 .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION.................... read_full_document