APO-FLUNISOLIDE NASAL SPRAY METERED-DOSE PUMP

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

FLUNISOLIDE

Disponibbli minn:

APOTEX INC

Kodiċi ATC:

R01AD04

INN (Isem Internazzjonali):

FLUNISOLIDE

Dożaġġ:

0.25MG

Għamla farmaċewtika:

METERED-DOSE PUMP

Kompożizzjoni:

FLUNISOLIDE 0.25MG

Rotta amministrattiva:

NASAL

Unitajiet fil-pakkett:

25ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

CORTICOSTEROIDS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0112482001; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2018-02-20

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
PR
APO-FLUNISOLIDE NASAL SPRAY
(FLUNISOLIDE NASAL SOLUTION USP), 0.025%
CORTICOSTEROID FOR NASAL USE
APOTEX INC. DATE OF PREPARATION:
150 SIGNET DRIVE JANUARY 2, 2013
TORONTO, ONTARIO
M9L 1T9
CONTROL NO: 160578
2
PRODUCT MONOGRAPH
NAME OF DRUG
APO-FLUNISOLIDE Nasal Spray
(Flunisolide Nasal Solution USP), 0.025%
THERAPEUTIC CLASSIFICATION
Corticosteroid for Nasal Use
ACTIONS AND CLINICAL PHARMACOLOGY
Flunisolide has demonstrated marked anti-inflammatory and
anti-allergic efficacy in classical
animal test systems. It is a corticosteroid which is several hundred
times more potent in animal
anti-inflammatory assays than the cortisol standard. Clinical studies
with flunisolide have shown
a topical activity on the nasal mucous membrane with minimal
associated systemic activity at the
low spray doses administered. The improvement of symptoms is based on
its direct local effect
rather than on indirect effect through systemic absorption.
INDICATIONS AND CLINICAL USE
Flunisolide nasal solution is indicated for the treatment of perennial
and seasonal allergic rhinitis
when tolerance to or effectiveness of conventional treatment is
unsatisfactory.
CONTRAINDICATIONS
Active or quiescent tuberculosis or untreated fungal, bacterial or
viral infections. Hypersensitivity
to the product. Children under 6 years of age.
WARNINGS
Glucocorticoids may mask some signs of infection, and new infections
may appear during their
use.
3
PREGNANCY
Safety in pregnancy has not been established. Use of flunisolide
during the first 3 months of
pregnancy is not recommended. If used during the second and third
trimester, weigh the expected
benefits against the potential hazards to the fetus.
In patients previously on high doses of systemic corticosteroids,
withdrawal of steroids may cause
symptoms such as tiredness, aches and pains and depression. In severe
cases, adrenal
insufficiency may occur necessitating a temporary resumption of
systemic corticosteroids.
Flunisolide is not recommended for those patients with a history of
recur