ALLERTIN TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

LORATADINE

Verfügbar ab:

APOTEX INC

ATC-Code:

R06AX13

INN (Internationale Bezeichnung):

LORATADINE

Dosierung:

10MG

Darreichungsform:

TABLET

Zusammensetzung:

LORATADINE 10MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

2,6,10,12,18,20,24,30,36,48,72,100

Verschreibungstyp:

OTC

Therapiebereich:

SECOND GENERATION ANTIHISTAMINES

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2014-01-06

Fachinformation

Page 1 of 22
PRODUCT MONOGRAPH
ALLERTIN®
LORATADINE TABLETS USP
10 MG
HISTAMINE H
1 RECEPTOR ANTAGONIST
APOTEX INC.
DATE OF REVISED:
150 SIGNET DRIVE
January 03, 2014
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 169172
Page 2 of 22
TABLET 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
.................................................................. 4
DRUG INTERACTIONS
................................................................... 6
DOSAGE AND ADMINISTRATION
................................................ 6
OVERDOSAGE
.................................................................................
7
ACTION AND CLINICAL PHARMACOLOGY ................................ 7
STORAGE AND STABILITY
........................................................... 10
SPECIAL HANDLING INSTRUCTIONS
......................................... 10
DOSAGE FORMS, COMPOSITION AND PACKAGING .............. 10
PART II: SCIENTIFIC INFORMATION
..................................................... 11
PHARMACEUTICAL
INFORMATION............................................. 11
CLINICAL TRIALS
............................................................................
12
DETAILED PHARMACOLOGY
....................................................... 12
MICROBIOLOGY
..............................................................................
15
TOXICOLOGY
..................................................................................
16
REFERENCES
..................................................................................
19
PART III: CONSUMER INFORMATION
.................................................... 20
Page 3 of 22
ALLERTIN®
LORATADINE TABLETS USP
10 MG
PART I: HEA