LORATADINE TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

LORATADINE

Verfügbar ab:

MYLAN PHARMACEUTICALS ULC

ATC-Code:

R06AX13

INN (Internationale Bezeichnung):

LORATADINE

Dosierung:

10MG

Darreichungsform:

TABLET

Zusammensetzung:

LORATADINE 10MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

12/18/24/30

Verschreibungstyp:

OTC

Therapiebereich:

SECOND GENERATION ANTIHISTAMINES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0120416001; AHFS:

Berechtigungsstatus:

CANCELLED PRE MARKET

Berechtigungsdatum:

2016-11-02

Fachinformation

PRODUCT MONOGRAPH
LORATADINE
Loratadine Tablets
10 mg
USP
Histamine H
1
receptor antagonist
Mylan Pharmaceutical ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Revision Date: April 23, 2013
Control Number: 160783
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
4
ADVERSE
REACTIONS
...........................................................................................................
5
DRUG
INTERACTIONS
...........................................................................................................
7
DOSAGE
AND
ADMINISTRATION
.......................................................................................
8
OVERDOSAGE
.........................................................................................................................
8
ACTION
AND
CLINICAL
PHARMACOLOGY
......................................................................
9
STORAGE
AND
STABILITY
.................................................................................................
11
SPECIAL
HANDLING
INSTRUCTIONS
...............................................................................
11
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 11
PART II: SCIENTIFIC INFORMATION
...............................................................................
12
PHARMACEUTICAL
INFORMATION
.................................................................................
12
CLINICAL
TRIALS
............................................................