DESLORATADINE ALLERGY CONTROL TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

DESLORATADINE

Dostupné s:

DOMINION PHARMACAL

ATC kód:

R06AX27

INN (Mezinárodní Name):

DESLORATADINE

Dávkování:

5MG

Léková forma:

TABLET

Složení:

DESLORATADINE 5MG

Podání:

ORAL

Jednotky v balení:

10/20/30/50/70

Druh předpisu:

OTC

Terapeutické oblasti:

SECOND GENERATION ANTIHISTAMINES

Přehled produktů:

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

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2020-05-06

Charakteristika produktu

PRODUCT MONOGRAPH
DESLORATADINE ALLERGY CONTROL
Desloratadine tablets
5 mg
Histamine H
1
-Receptor Antagonist
DOMINION PHARMAC
A
L
6111 Royalmount Avenue, Suite 100
Montreal, Quebec
H4P 2T4
Date of Preparation:
July 10, 2017
Submission Control No.: 206132
_DESLORATADINE ALLERGY CONTROL _
_Page 2 of 36_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
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
...........................................................................