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SPC, UK: Maxidex (2010)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Alcon Laboratories (U.K) Limited
Διεύθυνση :
Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 7UD
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Name of the medicinal product

MAXIDEX 0.1% w/v, eye drops, suspension.

Qualitative and quantitative composition

Dexamethasone 0.1% w/v For excipients, see 6.1.

Pharmaceutical form

Eye drops, suspension.

Therapeutic indications

Indicated for treatment of steroid responsive inflammatory conditions of the conjunctiva, cornea and anterior segment of the eye such as: anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, ...

Posology and method of administration

Adults, adolescents, and children (above 2 years of age) The frequency of instillation of drops and the duration of treatment will vary depending upon the severity of the underlying condition and the response ...

Contraindications

Vaccinia, varicella, or other viral diseases of cornea and conjunctiva (except herpes zoster keratitis) Ocular herpes simplex Fungal diseases of ocular structures Mycobacterial ocular infections Acute, ...

Special warnings and precautions for use

For ocular use only. Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity, visual field defects and ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered ...

Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of MAXIDEX in pregnant woman. Studies in animals have shown reproductive toxicity (see section 5.3). Even though, the maximum daily dose (2x ...

Effects on ability to drive and use machines

MAXIDEX has no or negligible influence on the ability to drive and use machines. As with any topical ophthalmic medicinal product, temporary blurred vision or other visual disturbances may affect the ability ...

Undesirable effects

Summary of the safety profile In clinical trials, the most common adverse reaction was ocular discomfort. Tabulated list of adverse reactions The following adverse reactions are classified according to ...

Overdose

Long-term intensive topical use may lead to systemic effects. Oral ingestion of the contents of the bottle (up to 10 mls) is unlikely to lead to any serious adverse effects. An ocular overdose of Maxidex ...

Pharmacodynamic properties

Pharmacotherapeutic Group: Ophthalmologicals: Anti-inflammatory Agents ATC Code: S01BA01 Dexamethasone has been demonstrated by animal and human studies based on oral application to possess approximately ...

Pharmacokinetic properties

Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. ...

Preclinical safety data

Repeat dose topical ocular safety studies with dexamethasone in rabbits have shown systemic corticosteroid effects. Such effects are considered to be unlikely when MAXIDEX is used as recommended. Dexamethasone ...

List of excipients

Sodium phosphate Polysorbate 80 Disodium edetate Sodium chloride Benzalkonium chloride Hypromellose Citric acid Purified water

Incompatibilities

None known.

Shelf life

20 months (unopened), 1 month (after first opening).

Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze Keep container tightly closed. Discard 1 month after first opening. Store in the original package.

Nature and contents of container

Drop-Tainer 5ml and 10ml Natural Low Density Polyethylene Bottles and Plugs. Polystyrene or Polypropylene cap.

Special precautions for disposal and other handling

Do not touch dropper tip to any surface as this may contaminate the contents. If the drop of medication is not retained in the eye upon dosing for any reason then instill another drop.

Marketing authorization holder

Alcon Laboratories (UK) Ltd. Pentagon Park Boundary Way Hemel Hempstead HP2 7UD

Marketing authorization number(s)

PL 0649/5914R

Date of first authorization / renewal of the authorization

28/09/1990 / 17/09/2003

Date of revision of the text

20/07/2010