METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP POWDER FOR SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

METHYLPREDNISOLONE; WATER

可用日期:

HOSPIRA HEALTHCARE ULC

ATC代码:

H02AB04

INN（国际名称）:

METHYLPREDNISOLONE

剂量:

1G; 20ML

药物剂型:

POWDER FOR SOLUTION

组成:

METHYLPREDNISOLONE 1G; WATER 20ML

给药途径:

INTRAMUSCULAR

每包单位数:

16ML

处方类型:

Prescription

治疗领域:

ADRENALS

產品總結:

Active ingredient group (AIG) number: 0232014003; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2019-04-05

产品特点

_Pr_
_Methylprednisolone Sodium Succinate for Injection, USP- Product
Monograph _
_Page 1 of 35_
PRODUCT MONOGRAPH
Pr
Methylprednisolone Sodium Succinate for Injection, USP
Sterile Powder for Solution
500 mg, 1 g Vials
Glucocorticoid
Hospira Healthcare Corporation
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Revision: August 03, 2018
Submission Control No: 218009
_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
...