SOLU-CORTEF POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE)

Διαθέσιμο από:

PFIZER CANADA ULC

Φαρμακολογική κατηγορία (ATC):

H02AB09

INN (Διεθνής Όνομα):

HYDROCORTISONE

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE) 100MG

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

2ML-VIAL

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ADRENALS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0106344003; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2001-04-10

Αρχείο Π.Χ.Π.

_Solu-Cortef (Hydrocortisone sodium succinate) _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SOLU-CORTEF*
Hydrocortisone sodium succinate for injection USP
Sterile Powder and Diluent
100 mg, 250 mg, 500 mg and 1 g Act-O-Vials†
Glucocorticoid
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Québec H9J 2M5
Date of Initial Authorization:
September 24, 2003
Date of Revision:
September 18, 2023
Submission Control Number: 274957
*
®
Pfizer Enterprises SARL
Pfizer Canada ULC, Licensee
†
®
Pharmacia & Upjohn Company LLC
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC 2023
_ _
_Solu-Cortef (Hydrocortisone sodium succinate) _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, OTHER
09/2023
8 ADVERSE REACTIONS, 8.1 ADVERSE REACTIONS
OVERVIEW
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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6
1.2
Geriatrics
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6
2
CONTRAINDICATIONS
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6
4
DOSAGE AND ADMINISTRATION
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7
4.1
Dosing Considerations
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7
4.2
Recom