AVAMYS Nasal spray, suspension (2022)
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
Name of the medicinal product
AVAMYS 27.5 micrograms/spray, nasal spray suspension.
Qualitative and quantitative composition
Each spray actuation delivers 27.5 micrograms of fluticasone furoate. <u>Excipient with known effect:</u> One actuation delivers 8.25 micrograms of benzalkonium chloride. For the full list of excipients, ...
Pharmaceutical form
Nasal spray, suspension. White suspension.
Therapeutic indications
Avamys is indicated in adults, adolescents and children (6 years and over). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.
Posology and method of administration
Posology Adults and adolescents (12 years and over) The recommended starting dose is two spray actuations (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Systemic corticosteroid effects Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral ...
Interaction with other medicinal products and other forms of interaction
Interaction with CYP3A inhibitors Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4. Based on data with another glucocorticoid (fluticasone propionate), ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of fluticasone furoate in pregnant women. In animal studies glucocorticoids have been shown to induce malformations including cleft palate and intra-uterine ...
Effects on ability to drive and use machines
Avamys has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions during treatment with fluticasone furoate are epistaxis, nasal ulceration and headache. The most serious undesirable effects are ...
Overdose
In a bioavailability study, intranasal doses of up to 2640 micrograms per day were administered over three days with no adverse systemic reactions observed (see section 5.2). Acute overdose is unlikely ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Nasal preparations, corticosteroids <b>ATC code:</b> R01AD12 Mechanism of action Fluticasone furoate is a synthetic trifluorinated corticosteroid that possesses a very ...
Pharmacokinetic properties
Absorption Fluticasone furoate undergoes incomplete absorption and extensive first-pass metabolism in the liver and gut resulting in negligible systemic exposure. The intranasal dosing of 110 micrograms ...
Preclinical safety data
Findings in general toxicology studies were similar to those observed with other glucocorticoids and are associated with exaggerated pharmacological activity. These findings are not likely to be relevant ...
List of excipients
Glucose anhydrous Dispersible cellulose Polysorbate 80 Benzalkonium chloride Disodium edetate Purified water
Incompatibilities
Not applicable.
Shelf life
3 years. <u>In-use shelf life:</u> 2 months.
Special precautions for storage
Do not refrigerate or freeze. Store upright. Always keep the cap on.
Nature and contents of container
14.2 ml Type I or Type III amber bottle (glass) fitted with a metering spray pump. The medicinal product is available in three pack sizes: 1 bottle of 30, 60 or 120 sprays. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
EU/1/07/434/001 EU/1/07/434/002 EU/1/07/434/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 January 2008 Date of latest renewal: 17 December 2012
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
