METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION USP

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

METHYLPREDNISOLONE ACETATE

Pieejams no:

SANDOZ CANADA INCORPORATED

ATĶ kods:

H02AB04

SNN (starptautisko nepatentēto nosaukumu):

METHYLPREDNISOLONE

Deva:

80MG

Zāļu forma:

SUSPENSION

Kompozīcija:

METHYLPREDNISOLONE ACETATE 80MG

Ievadīšanas:

INTRA-ARTICULAR

Vienības iepakojumā:

1 ML

Receptes veids:

Prescription

Ārstniecības joma:

ADRENALS

Produktu pārskats:

Active ingredient group (AIG) number: 0106292004; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2021-04-16

Produkta apraksts

_Methylprednisolone Acetate Injectable Suspension USP _
_Page 1 of 32 _
PRODUCT MONOGRAPH
PR
METHYLPREDNISOLONE ACETATE INJECTABLE
SUSPENSION USP
40 mg/mL and 80 mg/mL
GLUCOCORTICOID
Sandoz Canada Inc.
Date of Revision: July 20, 2018
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Control No.: 217576
_Methylprednisolone Acetate Injectable Suspension USP _
_Page 2 of 32 _
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
...................................................................................................13
DRUG
INTERACTIONS....................................................................................................15
DOSAGE AND ADMINISTRATION
................................................................................18
OVERDOSAGE
.................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
...............................................................23
STORAGE AND STABILITY
...........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................23
PART II: SCIENTIFIC INFORMATION
...................................................................................25
PHARMACEUTICAL INFORMATION
............................................................................25
TOXICOLOGY
.......................................................................................