APO-LORATADINE TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

LORATADINE

Disponibbli minn:

APOTEX INC

Kodiċi ATC:

R06AX13

INN (Isem Internazzjonali):

LORATADINE

Dożaġġ:

10MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

LORATADINE 10MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

12/18/100

Tip ta 'preskrizzjoni:

OTC

Żona terapewtika:

SECOND GENERATION ANTIHISTAMINES

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2010-10-08

Karatteristiċi tal-prodott

Page 1 of 20
PRODUCT MONOGRAPH
APO-LORATADINE
LORATADINE TABLETS USP
10 MG
HISTAMINE H
1 RECEPTOR ANTAGONIST
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
AUGUST 26, 2019
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO: 229215
Page 2 of 20
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
...........................................................................................................................
4
DRUG INTERACTIONS
............................................................................................................................
6
DOSAGE AND ADMINISTRATION
...........................................................................................................
6
OVERDOSAGE
.........................................................................................................................................
6
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................................
7
STORAGE AND STABILITY
.....................................................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................................................
9
PART II: SCIENTIFIC INFORMATION
.......................................................................................................
10
PHARMACEUTICAL INF