APO-VERAP TAB 80MG TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Compra

Scarica Scheda tecnica (SPC)
12-05-2022

Principio attivo:

VERAPAMIL HYDROCHLORIDE

Commercializzato da:

APOTEX INC

Codice ATC:

C08DA01

INN (Nome Internazionale):

VERAPAMIL

Dosaggio:

80MG

Forma farmaceutica:

TABLET

Composizione:

VERAPAMIL HYDROCHLORIDE 80MG

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: 0113846002; AHFS:

Stato dell'autorizzazione:

MARKETED

Data dell'autorizzazione:

1989-12-31

Scheda tecnica

                                PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-VERAP
Verapamil Hydrochloride
Tablets, 80 mg and 120 mg, oral
BP
Antianginal / Antiarrhythmic / Antihypertensive Agent
APOTEX INC.
150 Signet Drive,
Weston, Ontario
M9L 1T9.
Date of Initial Authorization:
JUN 30, 1989
Date of Revision:
MAY 12, 2022
www.apotex.ca/products
Submission Control Number: 258995
_ _
_VERAPAMIL HYDROCHLORIDE TABLETS (verapamil hydrochloride) _
_Page 2 of 48_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.1 Pediatrics
05/2022
1 Indications, 1.2 Geriatrics
05/2022
2 Contraindications
05/2022
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
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7 Warnings and Precautions, Cardiovascular
05/2022
7 Warnings and Precautions, Hepatic/Biliary/Pancreatic
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7 Warnings and Precautions, Monitoring and Laboratory tests
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7 Warnings and Precautions, Neurologic
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7 Warnings and Precautions, 7.1.1 Pregnant Women
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7 Warnings and Precautions, 7.1.3 Pediatrics
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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
.......................................................................5
1
INDICATIONS
................................................................................................................5
1.1
Pediatrics
............................................................................................................5
1.2
Geriatrics.............................................................................................................5
2
CONTRAINDICATIONS
...................................................................................................5
4
DOSAGE AND
ADMINISTRATION..........................................
                                
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