CELESTONE SOLUSPAN SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BETAMETHASONE ACETATE; BETAMETHASONE (BETAMETHASONE SODIUM PHOSPHATE)

Available from:

ORGANON CANADA INC.

ATC code:

H02AB01

INN (International Name):

BETAMETHASONE

Dosage:

3MG; 3MG

Pharmaceutical form:

SUSPENSION

Composition:

BETAMETHASONE ACETATE 3MG; BETAMETHASONE (BETAMETHASONE SODIUM PHOSPHATE) 3MG

Administration route:

INTRA-ARTICULAR

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ADRENALS

Product summary:

Active ingredient group (AIG) number: 0206301001; AHFS:

Authorization status:

APPROVED

Authorization date:

2011-02-15

Summary of Product characteristics

_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....................