SOLU-MEDROL KIT

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)

Dostupno od:

PFIZER CANADA ULC

ATC koda:

H02AB04

INN (International ime):

METHYLPREDNISOLONE

Doziranje:

1G

Farmaceutski oblik:

KIT

Sastav:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 1G

Administracija rute:

INTRAMUSCULAR

Jedinice u paketu:

1X8ML

Tip recepta:

Prescription

Područje terapije:

ADRENALS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2015-09-15

Svojstava lijeka

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