METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

H02AB04

INN (International Nazwa):

METHYLPREDNISOLONE

Dawkowanie:

5G

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 5G

Droga podania:

INTRAMUSCULAR

Sztuk w opakowaniu:

80ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ADRENALS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2015-10-16

Charakterystyka produktu

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