FLIXONASE Nasal drops (2019)
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
Flixonase Nasule Drops 400 micrograms (1 mg/ml), nasal drops suspension.
2. Qualitative and quantitative composition
<u>Each single dose of Flixonase Nasule Drops contain:</u> Fluticasone propionate 400 micrograms (1 mg/ml). For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Nasal drops. Single dose aqueous suspension.
4.1. Therapeutic indications
Flixonase Nasule Drops are indicated for the regular treatment of nasal polyps and associated symptoms of nasal obstruction.
4.2. Posology and method of administration
Posology The dose should be titrated to the lowest dose at which effective control of disease is maintained. For full therapeutic benefit regular usage is essential. The absence of an immediate effect ...
4.3. Contraindications
Flixonase Nasule Drops are contra-indicated in patients with a history of hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
<u>Local infection:</u> Infections of the nasal airways should be appropriately treated but do not constitute a specific contra-indication to treatment with Flixonase Nasule Drops. Unilateral polyposis ...
4.5. Interaction with other medicinal products and other forms of interaction
Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after intranasal dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome ...
4.6. Pregnancy and lactation
The use of Flixonase Nasule Drops during pregnancy and lactation requires that the benefits be weighed against possible risks associated with the product or with any alternative therapy. Pregnancy There ...
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) ...
4.9. Overdose
There are no data available from patients on the effects of acute or chronic overdosage with Flixonase Nasule Drops. In healthy volunteers, intranasal administration of 2 milligrams fluticasone propionate ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Nasal preparations, Corticosteroids <b>ATC code:</b> R01AD08 Fluticasone propionate has potent anti-inflammatory activity when used topically on the nasal mucosa. Fluticasone ...
5.2. Pharmacokinetic properties
Absorption After recommended doses of intranasal fluticasone propionate plasma levels are low. Systemic bioavailability for the nasal drop formula is extremely low (mean value 0.06%). Following intravenous ...
5.3. Preclinical safety data
At doses in excess of those recommended for therapeutic use, only class effects typical of potent corticosteroids have been shown in repeat dose toxicity tests, reproductive toxicology and teratology studies. ...
6.1. List of excipients
Polysorbate 20 Sorbitan laurate Sodium dihydrogen phosphate dihydrate Disodium phosphate anhydrous Sodium chloride Water for injections
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. After removal of foil: 28 days.
6.4. Special precautions for storage
Do not freeze. Keep the containers in the outer carton. Store upright. Do not store above 30°C.
6.5. Nature and contents of container
Strips of polyethylene single dose (400 micrograms) containers, within foil wrapping are available in the following pack sizes: 28 containers (4 strips of 7 Nasules) 84 containers (12 strips of 7 Nasules) ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Glaxo Wellcome UK Limited, trading as Allen & Hanburys, 980 Great West Road, Brentford, Middlesex, TW8 9GS
8. Marketing authorization number(s)
PL 10949/0323
9. Date of first authorization / renewal of the authorization
27 January 1999 / 04 December 2008
10. Date of revision of the text
18 November 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
