LORATADINE SOFT GEL CAPSULES

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

LORATADINE

Commercializzato da:

APOTEX INC

Codice ATC:

R06AX13

INN (Nome Internazionale):

LORATADINE

Dosaggio:

10MG

Forma farmaceutica:

CAPSULE

Composizione:

LORATADINE 10MG

Via di somministrazione:

ORAL

Confezione:

6/10/12/18/20/24/30/36/48/72

Tipo di ricetta:

OTC

Area terapeutica:

SECOND GENERATION ANTIHISTAMINES

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2012-02-10

Scheda tecnica

Page 2 of 20
PRODUCT MONOGRAPH
LORATADINE SOFT GEL CAPSULES
LORATADINE CAPSULES, 10 MG
HISTAMINE H
1 RECEPTOR ANTAGONIST
APOTEX INC.
DATE OFREVISION:
150 SIGNET DRIVE
MAY 31, 2019
WESTON, ONTARIO
CANADA M9L 1T9
CONTROL #: 218233
Page 3 of 20
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
SUMMARY PRODUCT INFORMATION
.............................................................................................
4
INDICATIONS AND CLINICAL USE
...................................................................................................
4
CONTRAINDICATIONS
........................................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................................
4
ADVERSE REACTIONS
.........................................................................................................................
5
DRUG INTERACTIONS
.........................................................................................................................
6
DOSAGE AND ADMINISTRATION
.....................................................................................................
7
OVERDOSAGE
.......................................................................................................................................
7
ACTION AND CLINICAL
PHARMACOLOGY....................................................................................
8
STORAGE AND STABILITY
.................................................................................................................
9
SPECIAL HANDLING INSTRUCTIONS
..............................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................................... 9
PART II: SCIENTIFIC INFORMATION
.........................................................