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FML Eye drops, suspension (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

FML Liquifilm Ophthalmic 1 mg/ml eye drops, suspension.

Qualitative and quantitative composition

One millilitre contains 1 mg Fluorometholone. For a full list of excipients, see section 6.1.

Pharmaceutical form

Eye drops, suspension. A white, microfine suspension.

Therapeutic indications

For corticosteroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Posology and method of administration

FML is for topical ophthalmic use only, applied as drops into the conjuctival sac. Shake FML well before use. Instil 1–2 drops into the conjunctival sac 2–4 times daily. During the first 24 to 48 hours ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. FML is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic ...

Special warnings and precautions for use

Eye drops containing corticosteroids should not be used for longer than a week except under an eye specialists careful surveillance combined with regular measurement of intraocular pressure. Prolonged ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should ...

Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of fluorometholone in pregnant women. Studies in animals have shown reproductive toxicity. FML is not recommended during pregnancy. Lactation ...

Effects on ability to drive and use machines

FML has no influence on the ability to drive or use machines. However, instillation of any eye drop could result in transient blurring of vision. If this occurs, the patient should wait for the blurring ...

Undesirable effects

Class effects Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids. The following undesirable effects have been ...

Overdose

Overdosage by the topical ophthalmic route will not ordinarily cause acute problems. If accidental overdosage occurs in the eye, the eye should be flushed with water or normal saline. If accidentally ingested, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, plain ATC code: S01BA07 Fluorometholone is a synthetic corticosteroid (glucocorticoid), a derivative of desoxyprednisolone. It is a member of the group of universally ...

Pharmacokinetic properties

When tritium-labelled 0.1% fluorometholone suspension was administered locally, the peak concentration of the radioactive substance in aqueous humour was achieved 30 minutes after administration. A rapidly ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose ocular toxicity and repeated dose systemic toxicity.

List of excipients

Polyvinyl alcohol Benzalkonium chloride Edetate disodium Sodium chloride Disodium phosphate, heptahydrate Sodium dihydrogen phosphate, monohydrate Polysorbate 80 Sodium hydroxide (for pH adjustment) Purified ...

Incompatibilities

None known.

Shelf life

Shelf life 36 months unopened. Discard 28 days after first opening.

Special precautions for storage

Do not store above 25°C. Do not freeze.

Nature and contents of container

A bottle and an applicator tip of low density polyethylene (LDPE). A screw cap of polystyrene (MIPS). The bottle contains 5 ml or 10 ml of suspension. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the applicator tip to the eye or to any other surface. The use of the product by more than one person ...

Marketing authorization holder

Allergan Limited, Marlow International, The Parkway, Marlow, Bucks, SL7 1YL, UK

Marketing authorization number(s)

PL 00426/0028

Date of first authorization / renewal of the authorization

15<sup>th</sup> July 2003

Date of revision of the text

September 2017

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