CLARITIN KIDS RAPID DISSOLVE TABLET (ORALLY DISINTEGRATING)
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
30-04-2020
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Werkstoffen:
LORATADINE
Beschikbaar vanaf:
BAYER INC
ATC-code:
R06AX13
INN (Algemene Internationale Benaming):
LORATADINE
Dosering:
5MG
farmaceutische vorm:
TABLET (ORALLY DISINTEGRATING)
Samenstelling:
LORATADINE 5MG
Toedieningsweg:
ORAL
Eenheden in pakket:
15G/50G
Prescription-type:
OTC
Therapeutisch gebied:
SECOND GENERATION ANTIHISTAMINES
Product samenvatting:
Active ingredient group (AIG) number: 0120416003; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2020-11-27
Productkenmerken
_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
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