Country: Կանադա
language: անգլերեն
source: Health Canada
METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)
TEVA CANADA LIMITED
H02AB04
METHYLPREDNISOLONE
5G
POWDER FOR SOLUTION
METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 5G
INTRAMUSCULAR
80ML
Prescription
ADRENALS
Active ingredient group (AIG) number: 0106290010; AHFS:
CANCELLED PRE MARKET
2015-10-16
PRODUCT MONOGRAPH METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION USP methylPREDNISolone Sterile Powder 40mg, 125mg, 500 mg, 1 g, 5 g Vials GLUCOCORTICOID/ ANTI-INFLAMMATORY Teva Canada Limited Date of Preparation: 30 Novopharm Court May 5, 2014 Toronto, Ontario M1B 2K9 CONTROL NO.:173204 Page 2 of 29 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION..............................................3 SUMMARY PRODUCT INFORMATION........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS...................................................................................................5 WARNINGS AND PRECAUTIONS..................................................................................5 ADVERSE REACTIONS .................................................................................................10 DRUG INTERACTIONS..................................................................................................11 DOSAGE AND ADMINISTRATION..............................................................................14 OVERDOSAGE ................................................................................................................17 ACTION AND CLINICAL PHARMACOLOGY.............................................................17 STORAGE AND STABILITY..........................................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING.............................................20 PART II: SCIENTIFIC INFORMATION....................................................................21 PHARMACEUTICAL INFORMATION ........................................................................21 CLINICAL TRIALS......................................................................................................... 22 DETAILED PHARMACOLOGY.....................................................................................23 T read_full_document