NRA-AMLODIPINE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

AMLODIPINE (AMLODIPINE BESYLATE)

Pieejams no:

NORA PHARMA INC

ATĶ kods:

C08CA01

SNN (starptautisko nepatentēto nosaukumu):

AMLODIPINE

Deva:

5MG

Zāļu forma:

TABLET

Kompozīcija:

AMLODIPINE (AMLODIPINE BESYLATE) 5MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100/250

Receptes veids:

Prescription

Ārstniecības joma:

DIHYDROPYRIDINES

Produktu pārskats:

Active ingredient group (AIG) number: 0131437002; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2023-12-05

Produkta apraksts

1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
NRA-AMLODIPINE
Amlodipine BesylateTablets
Tablets,2.5 mg,5 mgand 10mgamlodipine(asamlodipinebesylate), Oral
HouseStd.
Antihypertensive-AntianginalAgent
Nora Pharma Inc.
1565 Lionel-BouletBlvd,
Varennes,Quebec,J3X 1P7
DateofInitial Authorization:
MAY 30,2018
DateofRevision:
DEC05,2023
SubmissionControlNumber: 279870
2
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
Sections or subsections that are not applicable at
thetimeofauthorizationare not listed.
RECENTMAJOR 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 Doseand Dosage Adjustment
........................................................ 5
4.4
Administration
.........................................................................................................
5
4.5
Missed Dose
.............................................................................................................
5
5
OVERDOSAGE...................................................................