CLARITIN RAPID DISSOLVE TABLET (ORALLY DISINTEGRATING)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

LORATADINE

Saatavilla:

BAYER INC

ATC-koodi:

R06AX13

INN (Kansainvälinen yleisnimi):

LORATADINE

Annos:

5MG

Lääkemuoto:

TABLET (ORALLY DISINTEGRATING)

Koostumus:

LORATADINE 5MG

Antoreitti:

ORAL

Kpl paketissa:

5/10

Prescription tyyppi:

OTC

Terapeuttinen alue:

SECOND GENERATION ANTIHISTAMINES

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2014-12-18

Valmisteyhteenveto

_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