METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP POWDER FOR SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

METHYLPREDNISOLONE; WATER

متاح من:

HOSPIRA HEALTHCARE ULC

ATC رمز:

H02AB04

INN (الاسم الدولي):

METHYLPREDNISOLONE

جرعة:

1G; 20ML

الشكل الصيدلاني:

POWDER FOR SOLUTION

تركيب:

METHYLPREDNISOLONE 1G; WATER 20ML

طريقة التعاطي:

INTRAMUSCULAR

الوحدات في الحزمة:

16ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ADRENALS

ملخص المنتج:

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

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2019-04-05

خصائص المنتج

_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
...