SIBBORAN POWDER FOR SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

LANDIOLOL HYDROCHLORIDE

Доступно од:

TRIMEDIC THERAPEUTICS INC.

АТЦ код:

C07AB14

INN (Међународно име):

LANDIOLOL

Дозирање:

300MG

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

LANDIOLOL HYDROCHLORIDE 300MG

Пут администрације:

INTRAVENOUS

Јединице у пакету:

100

Тип рецептора:

Prescription

Резиме производа:

Active ingredient group (AIG) number: 0165341001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2023-11-20

Карактеристике производа

_Pr_
_SIBBORAN (landiolol hydrochloride) _
_Page 1 of 37_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SIBBORAN
Landiolol Hydrochloride for Injection
Powder for Solution, 300 mg/vial, Intravenous
Beta-Adrenergic Receptor Blocking Agent
Trimedic Therapeutics Inc.
116 Viceroy Rd, Unit 1, Building B
Concord, ON, L4K 2M2
Canada
Date of Initial Authorization:
November 17, 2023
Submission Control Number: 259953
_Pr_
_SIBBORAN (landiolol hydrochloride) _
_Page 2 of 37_
RECENT MAJOR LABEL CHANGES
_None at time of authorization _
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.3
Reconstitution
................................................................