Dropodex 0.1% w/v Eye Drops, solution

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

DEXAMETHASONE PHOSPHATE

可用日期:

Rayner Pharmaceuticals Limited

ATC代码:

S01BA; S01BA01

INN（国际名称）:

DEXAMETHASONE PHOSPHATE

剂量:

0.1 percent weight/volume

药物剂型:

Eye drops, solution

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Corticosteroids, plain; dexamethasone

授权状态:

Not marketed

授权日期:

2013-05-03

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dropodex 0.1% w/v Eye Drops, solution.
2 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 contains 0.4 mg dexamethasone
phosphate (as dexamethasone sodium phosphate) in
0.4 ml of solution.
For the full list of excipients, see section 6.1.
3 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.
4 CLINICAL PARTICULARS
4.1 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 are contraindicated or
insufficient), scleritis, acute phase of severe allergic
conjunctivitis not responding to standard therapy.
4.2 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 every hour), and then reduced to 1 drop
every 4 hours as the eye inflammation subsides.
Dexamethasone sodium phosphate dosage should be progressively
reduced.
_Paediatric population_
Use of Dropodex 0.1% w/v Eye Drops, solution in children and
adolescents must be restricted. No data on safety and
efficacy are available for children aged less than 2 years. Currently
available data are described in sections 4.8, 5.1 and
5.2 but no recommendation on a posology can be made. In children,
long-term continuous corticosteroid therapy should
be avoided due to possible adrenal suppression (see section 4.4).
Method of administration
Ocular use.
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