NIFEDIPINE CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

NIFEDIPINE

Disponibil de la:

AA PHARMA INC

Codul ATC:

C08CA05

INN (nume internaţional):

NIFEDIPINE

Dozare:

5MG

Forma farmaceutică:

CAPSULE

Compoziție:

NIFEDIPINE 5MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

DIHYDROPYRIDINES

Rezumat produs:

Active ingredient group (AIG) number: 0115253003; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2010-06-14

Caracteristicilor produsului

_NIFEDIPINE (Nifedipine Capsules) _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NIFEDIPINE
Nifedipine Capsules
Capsules, 5 mg and 10 mg, Oral
USP
Anti-Anginal Agent
AA PHARMA INC.
1165 Creditstone Road Unit # 1
Vaughan, Ontario
L4K 4N7
www.aapharma.ca/en/
Date of Initial Authorization:
JUN 16, 2010
Date of Revision:
DEC 01, 2023
Submission Control Number: 271662
_NIFEDIPINE (Nifedipine Capsules) _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
None
N/A
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
.........................................................................................................
5
4.5
Missed Dose
...............................................................................