SOLU-MEDROL KIT

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)

Disponibil de la:

PFIZER CANADA ULC

Codul ATC:

H02AB04

INN (nume internaţional):

METHYLPREDNISOLONE

Dozare:

500MG

Forma farmaceutică:

KIT

Compoziție:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 500MG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

5X4ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ADRENALS

Rezumat produs:

Active ingredient group (AIG) number: 0106290005; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2015-09-15

Caracteristicilor produsului

PRODUCT MONOGRAPH
Pr
SOLU-MEDROL
®
Methylprednisolone Sodium Succinate for Injection USP
Sterile Powder
500 mg, 1 g Vials
Pr
SOLU-MEDROL
® ACT-O-VIALS
®
Methylprednisolone Sodium Succinate for Injection USP
Sterile Powder and Diluent
40 mg, 125 mg, 500 mg, 1 g Act-O-Vials with preservative
40 mg, 125 mg, 500 mg, 1 g Act-O-Vials without preservative
Glucocorticoid
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Revision:
11 February 2015
Submission Control No: 178081
®
TM Pfizer Enterprises SARL
Pfizer Canada Inc., Licensee
®
TM Pharmacia & Upjohn Company LLC
Pfizer Canada Inc., Licensee
Pfizer Canada Inc. 2014
_ _
_SOLU-MEDROL (methylprednisolone sodium succinate) Product Monograph _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND
PRECAUTIONS..................................................................................
5
ADVERSE REACTIONS
.................................................................................................
14
DRUG INTERACTIONS
..................................................................................................
17
DOSAGE AND ADMINISTRATION
..............................................................................
24
OVERDOSAGE
................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 27
STORAGE AND
STABILITY..........................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................