CLARITIN KIDS RAPID DISSOLVE TABLET (ORALLY DISINTEGRATING)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

LORATADINE

Disponible desde:

BAYER INC

Código ATC:

R06AX13

Designación común internacional (DCI):

LORATADINE

Dosis:

5MG

formulario farmacéutico:

TABLET (ORALLY DISINTEGRATING)

Composición:

LORATADINE 5MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

OTC

Área terapéutica:

SECOND GENERATION ANTIHISTAMINES

Resumen del producto:

Active ingredient group (AIG) number: 0120416003; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2020-11-27

Ficha técnica

_CLARITIN ALLERGY, CLARITIN RAPID DISSOLVE, CLARITIN KIDS RAPID
DISSOLVE & CLARITIN KIDS_
_Page 1 of 40_
PRODUCT MONOGRAPH
CLARITIN
®
ALLERGY
Loratadine Tablets USP 10 mg
CLARITIN
®
RAPID DISSOLVE™
Loratadine Orally Disintegrating Tablets USP 10 mg
Loratadine Orally Disintegrating Tablets USP 5 mg
CLARITIN
®
KIDS RAPID DISSOLVE™
Loratadine Orally Disintegrating Tablets USP 5 mg
CLARITIN KIDS
®
Loratadine Oral Solution USP 1 mg/mL
Histamine H
1
receptor antagonist
Bayer Inc.
2920 Matheson Blvd. E
Mississauga, ON
L4W 5R6
Date of Revision:
April 30
th
, 2020
Submission Control No: 228699
® TM see www.bayer.ca/tm-mc
_CLARITIN ALLERGY, CLARITIN RAPID DISSOLVE, CLARITIN KIDS RAPID
DISSOLVE & CLARITIN KIDS_
_Page 2 of 40_
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
...........................................................................................................9
DOSAGE AND
ADMINISTRATION.......................................................................................9
OVERDOSAGE
.......................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
...................................................................11
STORAGE AND
STABILITY.................................................................................................15
SPECIAL HANDL