METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

H02AB04

DCI (Dénomination commune internationale):

METHYLPREDNISOLONE

Dosage:

5G

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 5G

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

80ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ADRENALS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2015-10-16

Résumé des caractéristiques du produit

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