SOLU-MEDROL KIT

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)

Διαθέσιμο από:

PFIZER CANADA ULC

Φαρμακολογική κατηγορία (ATC):

H02AB04

INN (Διεθνής Όνομα):

METHYLPREDNISOLONE

Δοσολογία:

40MG

Φαρμακοτεχνική μορφή:

KIT

Σύνθεση:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 40MG

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

10X1ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ADRENALS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0106290002; AHFS:

Καθεστώς αδειοδότησης:

MARKETED

Ημερομηνία της άδειας:

2012-01-11

Αρχείο Π.Χ.Π.

_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
.........................................