Țară: Canada
Limbă: engleză
Sursă: Health Canada
METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)
TEVA CANADA LIMITED
H02AB04
METHYLPREDNISOLONE
500MG
POWDER FOR SOLUTION
METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 500MG
INTRAMUSCULAR
8ML
Prescription
ADRENALS
Active ingredient group (AIG) number: 0106290005; AHFS:
APPROVED
2014-04-02
_Methylprednisolone Sodium Succinate for Injection Page 1 of 42 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION Methylprednisolone Sodium Succinate for Injection Sterile Powder for Solution, 40mg, 125mg, 500 mg, 1 g Vials, intravenous or intramuscular USP Glucocorticoid Teva Canada Limited Date of Initial Authorization: 30 Novopharm Court MAY 06, 2014 Toronto, ON M1B 2K9 Date of Revision: Canada September 23, 2022 www.tevacanada.com Submission Control Number: 263266 _Methylprednisolone Sodium Succinate for Injection Page 2 of 42 _ RECENT MAJOR LABEL CHANGES WARNINGS AND PRECAUTIONS, SPECIAL POPULATIONS, PEDIATRICS 09/2022 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 ........................................................................................................................ 5 1.2 Geriatrics ........................................................................................................................ 5 2 CONTRAINDICATIONS............................................................................................................ 5 4 DOSAGE AND ADMINISTRATION ........................................................................................... 6 4.1 Dosing Considerations ..................................................................................................... 6 4.2 Recommended Dose and Dosage Adjustment ............................... Citiți documentul complet