METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)

זמין מ:

TEVA CANADA LIMITED

קוד ATC:

H02AB04

INN (שם בינלאומי):

METHYLPREDNISOLONE

כמות:

5G

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 5G

מסלול נתינה (של תרופות):

INTRAMUSCULAR

יחידות באריזה:

80ML

סוג מרשם:

Prescription

איזור תרפויטי:

ADRENALS

leaflet_short:

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

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2015-10-16

מאפייני מוצר

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