METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

H02AB04

INN (nume internaţional):

METHYLPREDNISOLONE

Dozare:

5G

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 5G

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

80ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ADRENALS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED PRE MARKET

Data de autorizare:

2015-10-16

Caracteristicilor produsului

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