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:

125MG

Farmaceutski oblik:

KIT

Sastav:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 125MG

Administracija rute:

INTRAMUSCULAR

Jedinice u paketu:

25X2ML

Tip recepta:

Prescription

Područje terapije:

ADRENALS

Proizvod sažetak:

Active ingredient group (AIG) number: 0106290004; AHFS:

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2005-08-05

Svojstava lijeka

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_Page 1 of 25_
PRODUCT MONOGRAPH
Pr
SOLU-MEDROL*
Methylprednisolone Sodium Succinate for Injection USP
Sterile Powder
40 mg, 125 mg, 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
Glucocorticoid
Pfizer Canada Inc
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Preparation:
September 23, 2003
Date of Revision:
May 15, 2006
Submission Control No: 097578
*
TM Pfizer Enterprises SARL
Pfizer Canada Inc, Licensee
†
TM Pharmacia & Upjohn Company LLC
Pfizer Canada Inc., Licensee

Pfizer Canada Inc 2006
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_Page 2 of 25_
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND
PRECAUTIONS..................................................................................5
ADVERSE
REACTIONS....................................................................................................8
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND
ADMINISTRATION..............................................................................11
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND
STABILITY..........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
.......................