Thioctacid 600 T solution for injection

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

thioctic acid

Доступна с:

MEDA Pharma GmbH & Co. KG

код АТС:

A16AX01

ИНН (Международная Имя):

thioctic acid

дозировка:

25mg/ml

Фармацевтическая форма:

solution for injection

Штук в упаковке:

(5) ampoules 24ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2021-10-22

Характеристики продукта

EXPERT INFORMATION
(SUMMARY OF PRODUCT CHARACTERISTICS/SPC)
MEDA Pharma GmbH & Co. KG
THIOCTACID
® 600 T
LAST REVISED: DECEMBER 2016
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Thioctacid
®
600 T
Solution for Injection, containing 600 mg thioctic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Thioctic acid, Trometamol salt
24 ml of solution for injection contain 952.3 mg of thioctic acid,
Trometamol salt (equivalent to
600 mg of thioctic acid)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of symptoms of peripheral (sensomotor) diabetic
polyneuropathy
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
In cases of symptoms of peripheral (sensomotor) diabetic
polyneuropathy, for adults intravenous
application of a daily dosage of 24 ml of solution for injection
(equivalent to 600 mg of thioctic
acid/day) is recommended.
During the initial phase of treatment, the injection solution shall be
applied intravenously for a period
of 2 to 4 weeks.
Intravenous application may be performed by injecting the undiluted
solution by means of an injection
syringe over a period of not less than 12 minutes.
After the contents of Thioctacid 600 T have been mixed with 100 –
250 mg of 0.9%-conc. Sodium
chloride solution, the product can also be administered in form of a
short-duration infusion over a
period of not less than 12 minutes. Due to the fact that the active
substance is sensitive to light, the
short-duration infusion shall be prepared just shortly before its use.
The infusion solution must be
protected from light (e. g. by means of aluminium foil). When
protected from light, the infusion
solution has a shelf life of about 6 hours. Particular attention shall
be paid to the fact that the DURATION
OF INFUSION MUST NOT BE LESS THAN 12 MINUTES.
It is recommended to continue treatment by taking 300 mg to 600 mg of
thioctic acid daily in form of
oral pharmaceutical forms.
The basis f