LIVOSTIN SUS NAS 0.5MG/ML SUSPENSION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

LEVOCABASTINE (LEVOCABASTINE HYDROCHLORIDE)

Sẵn có từ:

JANSSEN INC

Mã ATC:

R01AC02

INN (Tên quốc tế):

LEVOCABASTINE

Liều dùng:

0.05MG

Dạng dược phẩm:

SUSPENSION

Thành phần:

LEVOCABASTINE (LEVOCABASTINE HYDROCHLORIDE) 0.05MG

Tuyến hành chính:

NASAL

Các đơn vị trong gói:

15 ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTIALLERGIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0124244002; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2020-12-22

Đặc tính sản phẩm

LIVOSTIN 163978 APM.doc
Page 1 of 22
PRODUCT MONOGRAPH
PR
LIVOSTIN
®
levocabastine Nasal Spray
0.5 mg/mL as levocabastine hydrochloride
Histamine H
1
-antagonist
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.ca
Date of Revision:
July 15, 2013
SUBMISSION CONTROL NO: 163978
© 2013 Janssen Inc.
All trademarks used under license.
LIVOSTIN 163978 APM.doc
Page 2 of 22
PRODUCT MONOGRAPH
PR
LIVOSTIN
®
levocabastine Nasal Spray
0.5 mg/mL as levocabastine hydrochloride
Histamine H
1
-antagonist
CLINICAL PHARMACOLOGY
LIVOSTIN
®
levocabastine hydrochloride is a potent, fast-acting and highly
selective histamine
H
1
-antagonist with a sustained duration of action.
Within 10 minutes of topical application to the nose, levocabastine
inhibits sneezing, itchy nose
and rhinorrhea induced by nasal provocation with allergens.
Orally administered levocabastine provides a dose-dependent inhibition
of skin reactions to
intradermal histamine. After repeated topical application to the nose,
topical and systemic
antihistamine effects contribute to overall clinical outcome. Although
systemic effects may
contribute to the therapeutic effects of levocabastine nasal spray,
this is not accompanied by any
sedative effects.
Levocabastine nasal spray (2 sprays/nostril t.i.d.), under acute and
steady-state conditions, is
devoid of CNS effects, as evaluated by objective and subjective
psychoperformance tests and
measures of general CNS activity.
Following topical application to the nose, the absorption of
levocabastine was incomplete and the
absolute bioavailability of levocabastine administered in the nose
could be estimated at 60-80% in
healthy volunteers and in patients with allergic rhinitis.
INDICATIONS AND CLINICAL USE
LIVOSTIN
®
levocabastine hydrochloride nasal spray is indicated for the
symptomatic treatment
of allergic rhinitis (sneezing, itchy nose, runny nose) in patients 12
years of age and older.
CONTRAINDICATIONS
LIVOSTIN
®
levocabastine hydrochloride nasal spray is contraindicated in patients
with
hyper