METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

METHYLPREDNISOLONE; WATER

זמין מ:

HOSPIRA HEALTHCARE ULC

קוד ATC:

H02AB04

INN (שם בינלאומי):

METHYLPREDNISOLONE

כמות:

1G; 20ML

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

METHYLPREDNISOLONE 1G; WATER 20ML

מסלול נתינה (של תרופות):

INTRAMUSCULAR

יחידות באריזה:

16ML

סוג מרשם:

Prescription

איזור תרפויטי:

ADRENALS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2019-04-05

מאפייני מוצר

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_Methylprednisolone Sodium Succinate for Injection, USP- Product
Monograph _
_Page 1 of 35_
PRODUCT MONOGRAPH
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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
...