FLIXONASE Nasal spray (2020)
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 Aqueous Nasal Spray.
2. Qualitative and quantitative composition
Aqueous suspension of 0.05% w/w micronised fluticasone propionate. Each metered dose contains 50 micrograms of fluticasone propionate. <u>Excipient with known effect:</u> Benzalkonium Chloride For the ...
3. Pharmaceutical form
Aqueous suspension for intranasal inhalation via metered dose atomising pump.
4.1. Therapeutic indications
The prophylaxis and treatment of seasonal allergic rhinitis (including hay fever) and perennial rhinitis. Fluticasone propionate has potent anti-inflammatory activity but when used topically on the nasal ...
4.2. Posology and method of administration
Flixonase Aqueous Nasal Spray is for administration by the intranasal route only. Contact with the eyes should be avoided. Adults and children over 12 years of age For the prophylaxis and treatment of ...
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
<u>Local infections:</u> infections of the nasal airways should be appropriately treated but do not constitute a specific contra-indication to treatment with Flixonase Aqueous Nasal Spray. The full benefit ...
4.5. Interaction with other medicinal products and other forms of interaction
Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome ...
4.6. Pregnancy and lactation
There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intra-uterine ...
4.7. Effects on ability to drive and use machines
None reported.
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 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) ...
4.9. Overdose
There are no data from patients available on the effects of acute or chronic overdosage with Flixonase Aqueous Nasal Spray. Intranasal administration of 2 mg fluticasone propionate twice daily for seven ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Decongestants and other nasal preparations for topical use Corticosteroids <b>ATC Code:</b> R01AD08 Fluticasone propionate causes little or no hypothalamic-pituitary-adrenal ...
5.2. Pharmacokinetic properties
Absorption Following intranasal dosing of fluticasone propionate, (200mcg/day) steady-state maximum plasma concentrations were not quantifiable in most subjects (<0.01ng/mL). The highest C<sub>max</sub> ...
5.3. Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6.1. List of excipients
Glucose (anhydrous) Cellulose microcrystalline Carmellose sodium Phenylethyl alcohol Benzalkonium chloride Polysorbate 80 Water purified
6.2. Incompatibilities
None reported.
6.3. Shelf life
36 months
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
Flixonase Aqueous Nasal Spray is supplied in an amber glass bottle fitted with a metering, atomising pump. Pack size of 120 and 150 metered sprays. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Shake gently before use.
7. Marketing authorization holder
Glaxo Wellcome UK Limited trading as: GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS
8. Marketing authorization number(s)
PL 10949/0036
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 08<sup>th</sup> March 1990 Date of latest renewal: 13<sup>th</sup> September 2005
10. Date of revision of the text
19 October 2020
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
