PMS-PREDNISOLONE SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

PREDNISOLONE (PREDNISOLONE SODIUM PHOSPHATE)

Dostupno od:

PHARMASCIENCE INC

ATC koda:

H02AB06

INN (International ime):

PREDNISOLONE

Doziranje:

5MG

Farmaceutski oblik:

SOLUTION

Sastav:

PREDNISOLONE (PREDNISOLONE SODIUM PHOSPHATE) 5MG

Administracija rute:

ORAL

Jedinice u paketu:

120 ML

Tip recepta:

Prescription

Područje terapije:

ADRENALS

Proizvod sažetak:

Active ingredient group (AIG) number: 0106287004; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2002-03-08

Svojstava lijeka

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-PREDNISOLONE
Prednisolone Oral Solution
Solution, 5 mg / 5 mL Prednisolone (as Prednisolone Sodium Phosphate),
Oral
House Standard
Glucocorticoid / Anti-Inflammatory
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 265215
Date of Initial Authorization
MAR 8, 2002
Date of Revision:
NOV 30, 2022
_pms-PREDNISOLONE Product Monograph _
_Page 2 of 33_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
12/2020
7 WARNINGS AND PRECAUTIONS
12/2020
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
11/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
11/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
.....................................................................................................................
4
1.1
Pediatrics
................................................................................................................4
2
CONTRAINDICATIONS........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.......................................................................................
4
4.1
Dosing Considerations
.............................................................................................4
4.2
Recommended Dose and Dosage
Adjustment...........................................................4
4.4
Administration.........................................................................................................5
4.5
Missed Dos