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SPC, UK: AVAMYS Nasal spray, suspension (2019)

Αναφορές

Βιβλιογραφική αναφορά

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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. For the full list of excipients, see section 6.1.

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

Pharmacotherapeutic group: Nasal preparations, corticosteroids ATC code: R01AD12 Mechanism of action Fluticasone furoate is a synthetic trifluorinated corticosteroid that possesses a very high affinity ...

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

Shelf life: 3 years. In-use shelf life: 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

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