מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
PREDNISOLONE (PREDNISOLONE SODIUM PHOSPHATE)
PHARMASCIENCE INC
H02AB06
PREDNISOLONE
5MG
SOLUTION
PREDNISOLONE (PREDNISOLONE SODIUM PHOSPHATE) 5MG
ORAL
120 ML
Prescription
ADRENALS
Active ingredient group (AIG) number: 0106287004; AHFS:
APPROVED
2002-03-08
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PMS-PREDNISOLONE Prednisolone Oral Solution Solution, 5 mg / 5 mL Prednisolone (as Prednisolone Sodium Phosphate), Oral House Standard Glucocorticoid / Anti-Inflammatory PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 www.pharmascience.com Submission Control Number: 265215 Date of Initial Authorization MAR 8, 2002 Date of Revision: NOV 30, 2022 _pms-PREDNISOLONE Product Monograph _ _Page 2 of 33_ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 12/2020 7 WARNINGS AND PRECAUTIONS 12/2020 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 11/2022 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 11/2022 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 2 CONTRAINDICATIONS........................................................................................................ 4 4 DOSAGE AND ADMINISTRATION ....................................................................................... 4 4.1 Dosing Considerations .............................................................................................4 4.2 Recommended Dose and Dosage Adjustment...........................................................4 4.4 Administration.........................................................................................................5 4.5 Missed Dos קרא את המסמך השלם