ENTOCORT ENEMA

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

BUDESONIDE

可用日期:

TILLOTTS PHARMA GMBH

ATC代码:

A07EA06

INN（国际名称）:

BUDESONIDE

剂量:

2.3MG

药物剂型:

ENEMA

组成:

BUDESONIDE 2.3MG

给药途径:

RECTAL

每包单位数:

7 TABLETS, 7 SOLUTIONS

处方类型:

Prescription

治疗领域:

ANTI-INFLAMMATORY AGENTS

產品總結:

Active ingredient group (AIG) number: 0116807015; AHFS:

授权状态:

APPROVED

授权日期:

2016-07-13

产品特点

_ENTOCORT_
_®_
_ ENEMA (Budesonide dispersible tablets) _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ENTOCORT® ENEMA
Budesonide dispersible tablets
Enema, 0.02 mg/mL budesonide (when reconstituted), Rectal use
Glucocorticosteroid Enema
Tillotts Pharma GmbH
Warmbacher Strasse 80
79618 Rheinfelden
Germany
Date of Initial Authorization:
NOV 25, 1994
Date of Revision:
MAR 31, 2023
Importer/Distributor:
C.R.I.
Burlington, ON
L7N 3G2
Control Number: 268828
_ _
_ENTOCORT_
_®_
_ ENEMA (Budesonide dispersible tablets) _
_Page 2 of 26_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hypersensitivity
03/2023
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
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.3
Reconstitution
............................................................