PRO-DILTIAZEM CD CAPSULE (CONTROLLED-DELIVERY)

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DILTIAZEM HYDROCHLORIDE

Доступно од:

PRO DOC LIMITEE

АТЦ код:

C08DB01

INN (Међународно име):

DILTIAZEM

Дозирање:

120MG

Фармацеутски облик:

CAPSULE (CONTROLLED-DELIVERY)

Састав:

DILTIAZEM HYDROCHLORIDE 120MG

Пут администрације:

ORAL

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Резиме производа:

Active ingredient group (AIG) number: 0115863004; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2023-08-30

Карактеристике производа

_PRO-DILTIAZEM CD (Diltiazem Hydrochloride) Product Monograph _
_page 1 of 47 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRO-DILTIAZEM CD
Diltiazem Hydrochloride Controlled Delivery Capsules
Controlled Delivery Capsules, 120 mg, 180 mg, 240 mg and 300 mg, Oral
Manufacturer’s Standard
Antihypertensive Agent_ _
Antianginal Agent
PRO DOC LTEE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Submission Control Number: 277917
Date of Initial Authorization:
AUG 30, 2023
_Pr _
_PRO-DILTIAZEM CD (Diltiazem Hydrochloride) Product Monograph _
_page 2 of 47 _
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
...................................................................................................
4
4
DOSAGE AND ADMINISTRATION
...................................................................................
5
4.1
Dosing Considerations
...........................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................................. 5
4.4
Administration
...........................................