ALLERGY CONTROL DESLORATADINE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DESLORATADINE

Commercializzato da:

PHARMASCIENCE INC

Codice ATC:

R06AX27

INN (Nome Internazionale):

DESLORATADINE

Dosaggio:

5MG

Forma farmaceutica:

TABLET

Composizione:

DESLORATADINE 5MG

Via di somministrazione:

ORAL

Confezione:

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

Tipo di ricetta:

OTC

Area terapeutica:

SECOND GENERATION ANTIHISTAMINES

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2013-11-26

Scheda tecnica

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
....................................................