SOLU-MEDROL KIT

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)

Dostupné z:

PFIZER CANADA ULC

ATC kód:

H02AB04

INN (Medzinárodný Name):

METHYLPREDNISOLONE

Dávkovanie:

1G

Forma lieku:

KIT

Zloženie:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 1G

Spôsob podávania:

INTRAMUSCULAR

Počet v balení:

1X8ML

Typ predpisu:

Prescription

Terapeutické oblasti:

ADRENALS

Prehľad produktov:

Active ingredient group (AIG) number: 0106290001; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2015-09-15

Súhrn charakteristických

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
..................