APO-DILTIAZ CD CAPSULE (CONTROLLED-DELIVERY)

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DILTIAZEM HYDROCHLORIDE

Commercializzato da:

APOTEX INC

Codice ATC:

C08DB01

INN (Nome Internazionale):

DILTIAZEM

Dosaggio:

120MG

Forma farmaceutica:

CAPSULE (CONTROLLED-DELIVERY)

Composizione:

DILTIAZEM HYDROCHLORIDE 120MG

Via di somministrazione:

ORAL

Confezione:

100/500

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

1997-03-26

Scheda tecnica

_APO-DILTIAZ CD (Diltiazem Hydrochloride) Product Monograph _
_page 1 of 47 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DILTIAZ CD
Diltiazem Hydrochloride Controlled Delivery Capsules
Controlled Delivery Capsules, 120 mg, 180 mg, 240 mg and 300 mg, Oral
Apotex Standard
Antihypertensive Agent_ _
Antianginal Agent
APOTEX INC
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
SEP 16, 1996
Date of Revision:
JUL 24, 2023
Submission Control Number: 272276
_Pr_
_APO-DILTIAZ CD (Diltiazem Hydrochloride) Product Monograph _
_page 2 of 47 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2023
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
...................................................................................
5
4.1
Dosing Considerations
...........................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................................. 5
4.4
Administration
..........