ALLERTIN CAPSULE

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

LORATADINE

Disponible des:

APOTEX INC

Codi ATC:

R06AX13

Designació comuna internacional (DCI):

LORATADINE

Dosis:

10MG

formulario farmacéutico:

CAPSULE

Composición:

LORATADINE 10MG

Vía de administración:

ORAL

Unidades en paquete:

12/24

tipo de receta:

OTC

Área terapéutica:

SECOND GENERATION ANTIHISTAMINES

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2012-08-02

Fitxa tècnica

Page 2 of 20
PRODUCT MONOGRAPH
ALLERTIN
LORATADINE CAPSULES, 10 MG
HISTAMINE H
1 RECEPTOR ANTAGONIST
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
SEPTEMBER 25, 2019
TORONTO, ONTARIO
CANADA M9L 1T9
CONTROL #: 231181
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
.....................................................................