Thioctacid 600 T solution for injection

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

thioctic acid

Disponible depuis:

MEDA Pharma GmbH & Co. KG

Code ATC:

A16AX01

DCI (Dénomination commune internationale):

thioctic acid

Dosage:

25mg/ml

forme pharmaceutique:

solution for injection

Unités en paquet:

(5) ampoules 24ml

Type d'ordonnance:

Prescription

Statut de autorisation:

Registered

Date de l'autorisation:

2018-02-28

Résumé des caractéristiques du produit

EXPERT INFORMATION
(SUMMARY OF PRODUCT CHARACTERISTICS/SPC)
MEDA Pharma GmbH & Co. KG
THIOCTACID
® 600 T
LAST REVISED: JUNE 2010
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Thioctacid
®
600 T
Solution for Injection contains 600 mg alpha-lipoic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Alpha-lipoic acid, Trometamol salt
24 ml of Solution for Injection contain 952.3 mg of alpha-lipoic acid,
Trometamol salt
(equivalent to 600 mg of alpha-lipoic acid)
For a 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 sysmptoms 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 alpha-lipoic 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
must 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 600 mg of
alpha-lipoic acid daily in form of
oral pharmaceutical forms.
The ba