HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION USP POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-03-2022
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE)
Available from:
HIKMA CANADA LIMITED
ATC code:
H02AB09
INN (International Name):
HYDROCORTISONE
Dosage:
100MG
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE) 100MG
Administration route:
INTRAMUSCULAR
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ADRENALS
Product summary:
Active ingredient group (AIG) number: 0106344003; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-05-04
Summary of Product characteristics
Page 1 of 38
PRODUCT MONOGRAPH
Pr
HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION USP
Sterile Powder for Solution,
100 mg and 250 mg hydrocortisone per vial
For Intramuscular and Intravenous use
Glucocorticoid
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
Date of Preparation:
March 24, 2022
Control number: 263057
Page 2 of 38
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL
USE...............................................................................
3
CONTRAINDICATIONS
...................................................................................................
6
WARNINGS AND PRECAUTIONS
..................................................................................
6
ADVERSE REACTIONS
..................................................................................................14
DRUG
INTERACTIONS...................................................................................................18
DOSAGE AND
ADMINISTRATION................................................................................22
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
...............................................................25
STORAGE AND
STABILITY...........................................................................................27
DOSAGE FORMS, COMPOSTION AND PACKAGING
..................................................27
PART II: SCIENTIFIC
INFORMATION.........................................................................
28
TOXICOLOGY
.................................................................................................................28
REFERENCES
...........................................................................................................
Read the complete document
