Land: Kanada
Språk: engelska
Källa: Health Canada
HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE)
PFIZER CANADA ULC
H02AB09
HYDROCORTISONE
250MG
POWDER FOR SOLUTION
HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE) 250MG
INTRAMUSCULAR
2ML-VIAL
Prescription
ADRENALS
Active ingredient group (AIG) number: 0106344004; AHFS:
APPROVED
2001-04-10
_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 ........................................................................................... 2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics ................................................................................................................... 6 1.2 Geriatrics ................................................................................................................... 6 2 CONTRAINDICATIONS ................................................................................................. 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 7 4.1 Dosing Considerations .............................................................................................. 7 4.2 Recom Läs hela dokumentet