Dropodex 0.1% w/v Eye Drops, solution

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

DEXAMETHASONE PHOSPHATE

Доступна с:

Rayner Pharmaceuticals Limited

код АТС:

S01BA; S01BA01

ИНН (Международная Имя):

DEXAMETHASONE PHOSPHATE

дозировка:

0.1 percent weight/volume

Фармацевтическая форма:

Eye drops, solution

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Corticosteroids, plain; dexamethasone

Статус Авторизация:

Not marketed

Дата Авторизация:

2013-05-03

Характеристики продукта

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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