AIRCORT Nasal spray, suspension (2012)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
AIRCORT 100 micrograms/spray, nasal spray, suspension.
2. Qualitative and quantitative composition
<u>AIRCORT 100 micrograms:</u> 1 ml of suspension contains 2 mg of budesonide.
3. Pharmaceutical form
Nasal spray, suspension.
4.1. Therapeutic indications
Seasonal allergic rhinitis, perennial allergic and non-allergic rhinitis. Treatment of nasal polyps. Preventive against nasal polyps after polypectomy.
4.2. Posology and method of administration
Dosage should be individually determined. <u>Treatment of rhinitis:</u> Recommended dose for adults and children 6 years of age or older: two 50 µg administrations (100 micrograms into each nostril) twice ...
4.3. Contraindications
Hypersensitivity to budesonide or to any of the ingredients or chemically related substances.
4.4. Special warnings and precautions for use
Special care is needed in patients with fungal and viral nasal infections. The use of corticosteroids in patients affected by tuberculosis must follow a careful evaluation of therapeutical advantages against ...
4.5. Interaction with other medicinal products and other forms of interaction
The influence of cimetidine on the kinetics and dynamics of budesonide after concomitant oral and intravenous administration is of minor clinical importance.
4.6. Pregnancy and lactation
Administration during pregnancy should be avoided unless there are compelling reasons. In pregnant animals, administration of budesonide causes abnormalities of fetal development. As the relevance of this ...
4.7. Effects on ability to drive and use machines
Aircort does not affect the ability to drive or use machines.
4.8. Undesirable effects
Clinical studies, scientific publications and post marketing experience indicate that the following undesirable effects may occur especially if administered at high dosage and for prolonged time: Frequency ...
4.9. Overdose
Acute overdose with Aircort nasal spray, even in excessive doses, is not a clinical problem.
5.1. Pharmacodynamic properties
<b>ATC Class:</b> R01AD05 Budesonide is a gluco-corticosteroid with high local anti-inflammatory activity. Budesonide has a high (90% ) first pass hepatic degradation rate; its metabolites have low gluco-corticosteroid ...
5.2. Pharmacokinetic properties
The systemic bioavailability of budesonide formulated as an aqueous suspension administered nasally is 33%. The peak plasma concentration of budesonide after nasal administration of 400 microgrammes in ...
5.3. Preclinical safety data
Single dose oral administration showed DL50 values greater than 800 mg/kg in mice and 400 mg/kg in rats. Toxicity studies in dogs using repeated dose of 200 mcg per day administered by inhalation up to ...
6.1. List of excipients
Microcrystalline cellulose Croscarmellose sodium Hypromellose Sodium lauryl sulphate Polyethylene glycol 400 Butylated hydroxyanisole Sodium citrate Citric acid monohydrate Potassium sorbate Disodium edetate ...
6.2. Incompatibilities
None.
6.3. Shelf life
<u>AIRCORT 100 micrograms/spray:</u> 36 months if stored correctly and in the original pack. <u>AIRCORT 50 micrograms/spray:</u> 24 months if stored correctly and in the original pack.
6.4. Special precautions for storage
Store at a temperature below 25°C. Store inside the original carton.
6.5. Nature and contents of container
200 sprays 15 ml amber glass bottle fitted with a 50 microlitre metered dose pump.
6.6. Special precautions for disposal and other handling
Before each administration: Shake vigorously the bottle before use. Remove the dust cap from the nasal applicator. Hold the bottle between your fingers and away from your face. Activate the valve by pressing ...
7. Marketing authorization holder
Italchimici SpA, Via Pontina 5, Km 29, 00040 Pomezia (Rome)
8. Marketing authorization number(s)
MA033/00102
9. Date of first authorization / renewal of the authorization
30th November 2006
10. Date of revision of the text
December 2012
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
