PRO-DILTIAZEM CD CAPSULE (CONTROLLED-DELIVERY)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DILTIAZEM HYDROCHLORIDE

Disponible depuis:

PRO DOC LIMITEE

Code ATC:

C08DB01

DCI (Dénomination commune internationale):

DILTIAZEM

Dosage:

300MG

forme pharmaceutique:

CAPSULE (CONTROLLED-DELIVERY)

Composition:

DILTIAZEM HYDROCHLORIDE 300MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Descriptif du produit:

Active ingredient group (AIG) number: 0115863008; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2023-08-30

Résumé des caractéristiques du produit

_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
...........................................