METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

지금 구매하세요

제품 특성 요약 제품 특성 요약 (SPC)
06-05-2014

유효 성분:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)

제공처:

TEVA CANADA LIMITED

ATC 코드:

H02AB04

INN (International Name):

METHYLPREDNISOLONE

복용량:

5G

약제 형태:

POWDER FOR SOLUTION

구성:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 5G

관리 경로:

INTRAMUSCULAR

패키지 단위:

80ML

처방전 유형:

Prescription

치료 영역:

ADRENALS

제품 요약:

Active ingredient group (AIG) number: 0106290010; AHFS:

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2015-10-16

제품 특성 요약

                                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
                                
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