HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION USP POWDER FOR SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE)

Dostupno od:

HIKMA CANADA LIMITED

ATC koda:

H02AB09

INN (International ime):

HYDROCORTISONE

Doziranje:

250MG

Farmaceutski oblik:

POWDER FOR SOLUTION

Sastav:

HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE) 250MG

Administracija rute:

INTRAMUSCULAR

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

ADRENALS

Proizvod sažetak:

Active ingredient group (AIG) number: 0106344004; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2022-05-04

Svojstava lijeka

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
...........................................................................................................