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:

MARKETED

Data de autorizare:

2012-01-18

Caracteristicilor produsului

_SOLU-MEDROL (methylprednisolone sodium succinate) Product Monograph _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SOLU-MEDROL
®
Methylprednisolone Sodium Succinate for Injection USP
Sterile Powder, 500 mg, 1 g Vials, intravenous and intramuscular
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,
intravenous and intramuscular
Glucocorticoid
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
March 20, 1991
Date of Revision:
MAR 14, 2024
Submission Control Number: 280527
® TM Pfizer Enterprises SARL
Pfizer Canada ULC, Licensee
® TM Pharmacia & Upjohn Company LLC
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC 2024
_ _
_SOLU-MEDROL (methylprednisolone sodium succinate) Product Monograph _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
01/2023
8 ADVERSE REACTIONS
03/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
5
1.2
Geriatrics
................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.........................................