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DROPODEX Eye drops, solution (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Dropodex 0.1% w/v Eye Drops, solution.

Qualitative and quantitative composition

Dexamethasone sodium phosphate Ph Eur equivalent to 0.1% w/v dexamethasone. Each ml of solution contains 1 mg dexamethasone phosphate (as dexamethasone sodium phosphate). Each individual single-dose unit ...

Pharmaceutical form

Eye drops, solution. Single-use eye drops which are sterile and preservative free. A colourless solution when examined under suitable conditions of visibility, clear and free from particles.

Therapeutic indications

Dropodex 0.1% w/v Eye Drops are indicated for inflammatory conditions of the anterior segment of the eye, such as marginal keratitis, stromal oedema in keratitis, anterior uveitis, episcleritis (if NSAIDs ...

Posology and method of administration

Posology Adults (including the elderly) The usual dose in adults, including the elderly, is 1 drop, 4 to 6 times daily. In severe conditions, the treatment can be used more frequently at first (1 drop ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use is contra-indicated in herpes simplex and other viral diseases of the cornea and conjunctiva, fungal disease, ...

Special warnings and precautions for use

For ocular use only. Not for injection into the eye. Care should be taken to ensure that the eye is not infected before Dropodex 0.1% w/v Eye Drops are used. In those diseases causing thinning of the cornea ...

Interaction with other medicinal products and other forms of interaction

The risk of increased intraocular pressure associated with prolonged corticosteroid therapy may be more likely to occur with concomitant use of anticholinergics, especially atropine and related compounds, ...

Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of dexamethasone eye drops in pregnant women. Studies in animals have shown that topically applied steroids can be absorbed systemically and ...

Effects on ability to drive and use machines

Dropodex 0.1% w/v Eye Drops have no or negligible influence on the ability to drive and use machines; however, instillation of eye drops may cause transient blurring of vision. Warn patients not to drive ...

Undesirable effects

The following undesirable effects are classified according to the following convention: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1000), very rare ...

Overdose

Overdose is unlikely to occur as Dropodex 0.1% w/v Eye Drops are single-dose units. Excess Dropodex 0.1% w/v Eye Drops may be wiped away with a clean tissue.

Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, plain ATC code: S01BA01 Dexamethasone is a highly potent and long-acting glucocorticoid. It has an approximately 7 times greater anti-inflammatory potency than ...

Pharmacokinetic properties

Absorption When given topically to the eye, dexamethasone is absorbed into the aqueous humour, cornea, iris, choroid, ciliary body and retina. Systemic absorption occurs but may be significant only at ...

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 dexamethasone eye drops are used as recommended. ...

List of excipients

Sodium chloride Disodium edetate Disodium phosphate dodecahydrate (E339) Water, purified

Incompatibilities

None known. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life Unopened: 30 months. After opening the sachet: use contents within 28 days. After opening the single-dose unit: use immediately after opening the single-dose unit. Discard any unused content. ...

Special precautions for storage

Keep out of sight and reach of children. Do not store above 25°C. Do not refrigerate or freeze. Store in original package. Discard any remaining single-dose units 28 days after opening the sachet.

Nature and contents of container

Dropodex 0.1% w/v Eye Drops are available in 0.4 ml transparent low density polyethylene single-dose units. Each pre-formable PET metal/PE transparent and PET metal/PE peelable sachet contains 5 single-dose ...

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Rayner Pharmaceuticals Ltd, 10 Dominion Way, Worthing, West Sussex, BN14 8AQ, United Kingdom

Marketing authorization number(s)

PL 47069/0003

Date of first authorization / renewal of the authorization

Date of first authorisation: 30 January 2013 Date of latest renewal: 28 September 2017

Date of revision of the text

28 September 2017

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