METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

METHYLPREDNISOLONE; WATER

제공처:

HOSPIRA HEALTHCARE ULC

ATC 코드:

H02AB04

INN (International Name):

METHYLPREDNISOLONE

복용량:

1G; 20ML

약제 형태:

POWDER FOR SOLUTION

구성:

METHYLPREDNISOLONE 1G; WATER 20ML

관리 경로:

INTRAMUSCULAR

패키지 단위:

16ML

처방전 유형:

Prescription

치료 영역:

ADRENALS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2019-04-05

제품 특성 요약

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_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
...