Maa: Kanada
Kieli: englanti
Lähde: Health Canada
METHYLPREDNISOLONE; WATER
HOSPIRA HEALTHCARE ULC
H02AB04
METHYLPREDNISOLONE
500MG; 10ML
POWDER FOR SOLUTION
METHYLPREDNISOLONE 500MG; WATER 10ML
INTRAMUSCULAR
8ML
Prescription
ADRENALS
Active ingredient group (AIG) number: 0232014001; AHFS:
CANCELLED POST MARKET
2019-04-05
_Pr_ _Methylprednisolone Sodium Succinate for Injection, USP- Product Monograph _ _Page 1 of 35_ PRODUCT MONOGRAPH P R M ETHYLPREDNISOLONE S ODIUM S UCCINATE FOR I NJECTION USP Sterile Powder 500 mg, 1 g Vials Glucocorticoid Hospira Healthcare Corporation 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Revision: October 18, 2017 Submission Control No: 209610 _Pr_ _Methylprednisolone Sodium Succinate for Injection, USP- Product Monograph _ _Page 2 of 35_ 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 ................................................................................................. 15 DRUG INTERACTIONS .................................................................................................. 18 DOSAGE AND ADMINISTRATION ............................................................................. 25 OVERDOSAGE ................................................................................................................ 28 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 29 STORAGE AND STABILITY ......................................................................................... 31 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 31 PART II: SCIENTIFIC INFORMATION ............................................................................... 34 PHARMACEUTICAL INFORMATION ......................................................................... 34 CLINICAL TRIALS .......... Lue koko asiakirja