CLARITIN RAPID DISSOLVE TABLET (ORALLY DISINTEGRATING)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
30-04-2020

Viambatanisho vya kazi:

LORATADINE

Inapatikana kutoka:

BAYER INC

ATC kanuni:

R06AX13

INN (Jina la Kimataifa):

LORATADINE

Kipimo:

5MG

Dawa fomu:

TABLET (ORALLY DISINTEGRATING)

Tungo:

LORATADINE 5MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

5/10

Dawa ya aina:

OTC

Eneo la matibabu:

SECOND GENERATION ANTIHISTAMINES

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2014-12-18

Tabia za bidhaa

                                _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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