METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

METHYLPREDNISOLONE; WATER

Disponible depuis:

HOSPIRA HEALTHCARE ULC

Code ATC:

H02AB04

DCI (Dénomination commune internationale):

METHYLPREDNISOLONE

Dosage:

500MG; 10ML

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

METHYLPREDNISOLONE 500MG; WATER 10ML

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

8ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ADRENALS

Descriptif du produit:

Active ingredient group (AIG) number: 0232014001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2019-04-05

Résumé des caractéristiques du produit

_Pr_
_Methylprednisolone Sodium Succinate for Injection, USP- Product
Monograph _
_Page 1 of 35_
PRODUCT MONOGRAPH
P
R
M
ETHYLPREDNISOLONE
S
ODIUM
S
UCCINATE FOR
I
NJECTION
USP
Sterile Powder
500 mg, 1 g Vials
Glucocorticoid
Hospira Healthcare Corporation
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision: October 18, 2017
Submission Control No: 209610
_Pr_
_Methylprednisolone Sodium Succinate for Injection, USP- Product
Monograph _
_Page 2 of 35_
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
.................................................................................................
15
DRUG INTERACTIONS
..................................................................................................
18
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 29
STORAGE AND STABILITY
.........................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 31
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
..........