JAMP-CETIRIZINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CETIRIZINE HYDROCHLORIDE

Tersedia dari:

JAMP PHARMA CORPORATION

Kode ATC:

R06AE07

INN (Nama Internasional):

CETIRIZINE

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

CETIRIZINE HYDROCHLORIDE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

OTC

Area terapi:

SECOND GENERATION ANTIHISTAMINES

Ringkasan produk:

Active ingredient group (AIG) number: 0122686001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2016-02-19

Karakteristik produk

JAMP-Cetirizine - Product Monograph
Page 1 of 34
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
JAMP-CETIRIZINE
Cetirizine Hydrochloride Tablets
Tablets, 5 mg, 10 mg, Oral
Histamine H
1
Receptor Antagonist
JAMP Pharma Corporation
1310 rue Nobel,
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
February 19, 2016
Date of Revision:
June 09, 2023
Submission Control Number: 274964
JAMP-Cetirizine - Product Monograph
Page 2 of 34
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
.............................................................................................2
TABLE OF CONTENTS
...............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
...............................................................................................................4
1.1
Pediatrics
...........................................................................................................4
1.2
Geriatrics............................................................................................................4
2
CONTRAINDICATIONS
..................................................................................................4
4
DOSAGE AND ADMINISTRATION
..................................................................................4
4.1
Dosing
Considerations.........................................................................................4
4.2
Recommended Dose and Dosage
Adjustment......................................................4
4.4
Administration....................................................................................................5
4.5
Missed Dose
.......................................................................................................5
5
OVERDOSAGE
.....