DROPODEX Eye drops, solution (2017)
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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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