Thiogamma solution for infusion

Երկիր: Հայաստան

Լեզու: անգլերեն

Աղբյուրը: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ակտիվ բաղադրիչ:

thioctic acid

Հասանելի է:

Solupharm Pharmazeutische Erzeugnisse GmbH

ATC կոդը:

A16AX01

INN (Միջազգային անվանումը):

thioctic acid

Դոզան:

12mg/ml

Դեղագործական ձեւ:

solution for infusion

Միավորները փաթեթում:

(1) glass vial 50ml, (10) glass vial 50ml

Ռեկվիզորի տեսակը:

Prescription

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2022-05-11

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT THIOGAMMA®
Active ingredient: alpha-lipoic acid meglumin salt 1167.70 mg
(corresponding to 600 mg of
aipha-lipoic acid)
Solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
An injection bottle of 50 ml of solution for infusion contains 1167.70
mg of alpha-lipoic acid
meglumine salt (corresponding to 600 mg of alpha-lipoic acid).
Other constituents:
For a complete list of other constituents see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sensory disturbances in cases of diabetic and alcoholic polyneuropathy
4.2 DOSAGE, METHOD AND LENGTH OF ADMINISTRATION
Individual and Daily Doses
In very pronounced paraesthesias in diabetic and alcoholic
polyneuropathy in adults the
intravenous administration of a dose of 600 mg α-liponic acid / day
(equivalent of 1 injection
bottle Thiogamma®) is recommended.
Method and Length of Administration
The injection solution is applied intravenously over a period of 2 to
4 weeks during the initial
phase of treatment.
The intravenous application should be carried out slowly by
administering the contents over a
period of at least 30 minutes in the form of a short infusion. The
infusion is performed directly
from the bottle using standard infusion equipment and the enclosed
light protection bag. As the
active ingredient is sensitive to light the injection bottle should
only be taken out of the folding
box immediately before use. It should be ensured that the minimum
infusion period of 30
minutes is complied with.
Further therapy should involve 300 mg to 600 mg of alpha-lipoic acid
in pharmaceutical forms
suitable for oral administration.
A fundamental requirement of diabetic polyneuropathy therapy is
optimum adjustment of the
diabetes.
4.3 CONTRAINDICATIONS
Thiogamma® is totally contraindicated in patients with known
hypersensitivity to alpha-lipoic
acid or any of the other constituents of Thiogamma®.
Note:
Children and a