ALLERGY CONTROL DESLORATADINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DESLORATADINE

Tersedia dari:

PHARMASCIENCE INC

Kode ATC:

R06AX27

INN (Nama Internasional):

DESLORATADINE

Dosis:

5MG

Bentuk farmasi:

TABLET

Komposisi:

DESLORATADINE 5MG

Rute administrasi :

ORAL

Unit dalam paket:

10/20/30/50/100/120/180

Jenis Resep:

OTC

Area terapi:

SECOND GENERATION ANTIHISTAMINES

Ringkasan produk:

Active ingredient group (AIG) number: 0143961001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2013-11-26

Karakteristik produk

PRODUCT MONOGRAPH
ALLERGY CONTROL DESLORATADINE
Desloratadine tablets
5 mg
Histamine H
1
-Receptor Antagonist
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite 100
Montréal, Canada
H4P 2T4
Date of Preparation:
November 5, 2013
Submission Control No: 169400
_ _
_ALLERGY CONTROL DESLORATADINE Product Monograph _
_Page 2 of 33_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
..........................................................................................11
SPECIAL HANDLING INSTRUCTIONS
.......................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
...............................................................................12
PHARMACEUTICAL INFORMATION
..........................................................................12
CLINICAL TRIALS
....................................................