DESLORATADINE ALLERGY CONTROL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Beli Sekarang

Unduh Karakteristik produk (SPC)
12-09-2023

Bahan aktif:

DESLORATADINE

Tersedia dari:

PHARMASCIENCE INC

Kode ATC:

R06AX27

INN (Nama Internasional):

DESLORATADINE

Dosis:

5MG

Bentuk farmasi:

TABLET

Komposisi:

DESLORATADINE 5MG

Rute administrasi :

ORAL

Unit dalam paket:

10/20/30/50

Jenis Resep:

OTC

Area terapi:

SECOND GENERATION ANTIHISTAMINES

Ringkasan produk:

Active ingredient group (AIG) number: 0143961001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2009-11-06

Karakteristik produk

                                _DESLORATADINE ALLERGY _CONTROL page 1 of 37
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
DESLORATADINE ALLERGY CONTROL
Desloratadine
Tablet, 5mg, Oral
House Standard
Histamine H1-Receptor Antagonist
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite 100
Montréal, Canada
H4P 2T4
Date of initial Authorization:
SEP 22, 2011
Date of Revision:
SEP 12, 2023
Submission Control Number: 272961
_DESLORATADINE ALLERGY _CONTROL page 2 of 37
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................................................
4
1
INDICATIONS
....................................................................................................................................
4
1.1
PEDIATRICS
....................................................................................................................................
4
1.2
GERIATRICS
....................................................................................................................................
4
2
CONTRAINDICATIONS
.......................................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..................................................................................
4
4
DOSAGE AND ADMINISTRATION
.......................................................................................................
4
4.1
DOSING CONSIDERATIONS
................................................................................................................
4
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
.............................................................................
5
4.3
ADMINISTRATION
............................................................................................................................
5
4.4
MISSED DOSE
................................................................................................................................
5
5
OVERDOSAGE
......................................
                                
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