Polydexa 1g(650000U) /100ml+ 1000000U/100ml+0,1g/100ml drops ear (solution)

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

neomycin (neomycin sulfate), polymyxin B (polymyxin B sulfate), dexamethasone (dexamethasone sodium metasulphobenzoate)

Доступна с:

Laboratoires Bouchara-Recordati

код АТС:

S02CA06

ИНН (Международная Имя):

neomycin (neomycin sulfate), polymyxin B (polymyxin B sulfate), dexamethasone (dexamethasone sodium metasulphobenzoate)

дозировка:

1g(650000U) /100ml+ 1000000U/100ml+0,1g/100ml

Фармацевтическая форма:

drops ear (solution)

Штук в упаковке:

bottle-dropper 10,5ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2016-09-13

Характеристики продукта

APPENDIX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
POLYDEXA EAR DROPS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Neomycin sulphate .............................................
650,000 UI
Polymyxin B sulphate ..........................................
1,000,000 UI
Dexamethasone (sodium metasulphobenzoate) ...........
0.100 g
Excipient
q.s. 100 ml
Composition of the excipient:
Sodium mercurothiolate ..........................................
0.003 g
Citric acid ..........................
0.282 g
Sodium hydroxide (1 M) .................................
2.5 ml
Macrogol 400 ................................................
10.00 g
Polysorbate 80
....................................................................
2.00 g
Distilled water
............................................................
q.s. 100 ml
3.
PHARMACEUTICAL FORM
Ear drops; 10.5 ml bottle.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Topical treatment of otitis externa due to bacterial infection (in
particular infectious eczema of the
external auditory canal) as long as the tympanic membrane is intact.
This product must never be used if the tympanic membrane is perforated
(due to a risk of ototoxicity).
The official guidelines pertaining to the appropriate use of
antibiotics should always be followed.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY: _
Every morning, instil the drops into the auditory canal of the
affected ear; repeat in the evening.
. In adults, the dosage is 1-5 drops in the affected ear, twice a day,
6-10 day.
. In children, the dosage (depending on the age of the child) is 1-2
drops in the affected ear, twice a
day, 6-10 day.
The usual duration of the course of treatment is 7-10 days.
_METHOD OF ADMINISTRATION: _
Topical application. Auricular instillation.
Before use, warm the bottle up by holding it in the palm of the hand
for a few minutes in order to
avoid the unpleasant sensation associated with contact between the ear
and a cold solution.
With the head inclined, instil the solution, p