Eltair Forte Aqueous

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Budesonide 100ug

זמין מ:

Douglas Pharmaceuticals Limited

INN (שם בינלאומי):

Budesonide 100 µg

כמות:

100 mcg/dose

טופס פרצבטיות:

Nasal spray solution

הרכב:

Active: Budesonide 100ug Excipient: Butylated hydroxyanisole Citric acid monohydrate Disodium edetate dihydrate Hydrochloric acid Hypromellose Macrogol 400 Microcrystalline cellulose Potassium sorbate Purified water Sodium citrate dihydrate Sodium laurilsulfate

יחידות באריזה:

Spray bottle, glass, metered, 200 dose units

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

Sicor (Societa Italiana Corticosteroidi) Srl

leaflet_short:

Package - Contents - Shelf Life: Spray bottle, glass, metered, - 200 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 3 months opened stored at or below 25°C protect from light

תאריך אישור:

1989-02-27

מאפייני מוצר

DATA SHEET 

ELTAIR FORTE AQUEOUS 
BUDESONIDE 
100 ΜG/DOSE 
PRESENTATION 

ELTAIR FORTE AQUEOUS
 nasal spray is a uniform, white, liquid suspension packed in a 
12mL amber glass bottle fitted with a metered dose pump. 
USES 
_ACTIONS _

Budesonide is a non-halogenated corticosteroid. In investigations in
animals and man, 
budesonide has shown a favourable relationship between local
anti-inflammatory activity and 
systemic glucocorticoid side effects over a wide dose range. This
favourable relation between 
therapeutic effect and systemic side effects is due to budesonide's
high glucocorticoid receptor 
affinity and high first-pass metabolism with a short half-life. 

The mechanism of action of intranasally administered budesonide has
not yet been completely 
defined, however, budesonide has been shown to counteract the mainly
IgE mediated lung 
anaphylaxis in guinea pigs. 

Pre-treatment for one week with intranasal budesonide 400mcg daily in
asymptomatic patients 
with seasonal rhinitis significantly inhibited the immediate reaction
to allergen challenge. 
_PHARMACOKINETICS _

Due to extensive first pass metabolism in the liver, the oral
bioavailability of budesonide is low 
(approximately 10%). After nasal administration of a
large dose (1mg) of budesonide from a 
metered dose aerosol the systemically available fraction is
approximately 15%. 

Negligible biotransformation occurs in human nasal mucosa. 

After nasal application of 100mcg, budesonide peak plasma
concentrations of approximately 
1nmol/L were observed with 45 minutes.  

The volume of distribution of budesonide
in adult man is 301.3   41.7L and in children is 3.1 to 
4.8L/kg indicating a high tissue affinity. Plasma protein binding is
88.3   1.5% in humans. 

Budesonide is metabolised in the liver to
more polar metabolites with low glucocorticoid activity 
(ie. 100 fold lower than the parent compound). 

The plasma half-life of budesonide in humans