NITRO-DUR 0.2 PATCH (EXTENDED RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

NITROGLYCERIN

Disponible depuis:

USPHARMA LTD

Code ATC:

C01DA02

DCI (Dénomination commune internationale):

GLYCERYL TRINITRATE

Dosage:

0.2MG

forme pharmaceutique:

PATCH (EXTENDED RELEASE)

Composition:

NITROGLYCERIN 0.2MG

Mode d'administration:

TRANSDERMAL

Unités en paquet:

30X10CM SQ

Type d'ordonnance:

Ethical

Domaine thérapeutique:

NITRATES AND NITRITES

Descriptif du produit:

Active ingredient group (AIG) number: 0103615026; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2011-02-11

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
NITRO-DUR
®
0.2
NITRO-DUR
®
0.4
NITRO-DUR
®
0.6
NITRO-DUR
®
0.8
Nitroglycerin Transdermal Sy
stem
NITRO-DUR 0.2 (Rated release in vivo 0.2 mg/hour, 10 cm
2
)
NITRO-DUR 0.4 (Rated release in vivo 0.4 mg/hour, 20 cm
2
)
NITRO-DUR 0.6 (Rated release in vivo 0.6 mg/hour, 30 cm
2
)
NITRO-DUR 0.8 (Rated release in vivo 0.8 mg/hour, 40 cm
2
)
Antianginal A
gent
DIN Owner:
USPHARMA LTD.
13900 NW 57th Court
Miami Lakes, FL 33014, USA
Imported by:
DR. REDDY'S LABORATORIES
CANADA INC.
5580 Explorer Drive, Suite 204,
Mississauga, ON L4W 4Y1
CANADA
Date of Revision:
March 26, 2019
Submission Control No: 223266
_NITRO-DUR (Nitroglycerin Transdermal System) _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFOR
M
ATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE
REACTIONS....................................................................................................6
DRUG
INTERACTIONS
....................................................................................................7
DOSAGE AND
ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................9
STORAGE AND STAB
IL
I
T
Y
............................................................................................9
SPECI