Active ingredients

• 774.77 mg α-lipoic acid, ethylenediamine salt (1:1)

Excipients

• Water for injections
• Nitrogen
• argon

• Alpha-lipoic acid is a substance produced in the body's metabolism in higher organisms that influences certain metabolic functions. Alpha-lipoic acid also has antioxidant properties that protect nerve cells from reactive breakdown products.
• The medicine is used for
  • Paraesthesia in diabetic nerve damage (polyneuropathy)

• Always use this medicine exactly as directed. If you are unsure, please ask your doctor or pharmacist.
• Unless otherwise prescribed by your doctor, the usual dose is
  • In cases of severe discomfort due to diabetic polyneuropathy, an infusion of 1 ampoule (equivalent to 600 mg alpha-lipoic acid) in isotonic saline solution once daily is recommended for adults.
  • The intravenous administration should be administered as a short infusion over at least 30 minutes, after the contents have been mixed with 250 ml of isotonic saline solution. Due to the light sensitivity of the active ingredient, the short infusion should be prepared shortly before use. The infusion solution should be protected from light with aluminum foil. The light-protected infusion solution is stable for approximately 6 hours. It is important to ensure that the minimum infusion time of 30 minutes is observed.
  • The medicine is administered as an infusion with isotonic saline solution over a period of 2-4 weeks in the initial phase of treatment.
  • As a further therapy, 300 - 600 mg of alpha-lipoic acid should be taken daily in the form of capsules, tablets or coated tablets.
  • Please talk to your doctor or pharmacist if you feel that the effect is too strong or too weak.

• If you have used more than you should
  • In case of overdose, nausea, vomiting and headache may occur.
  • In isolated cases, severe, sometimes life-threatening, symptoms of poisoning have been observed when more than 10 g of alpha-lipoic acid was taken, particularly when heavy alcohol was consumed at the same time (such as generalized seizures, disruption of the acid-base balance with lactic acidosis, severe blood clotting disorders).
  • Therefore, if a significant overdose is suspected, immediate hospitalization and the initiation of measures in accordance with the general principles of treatment for poisoning cases are required.

• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

• Special care is required when using
  • Allergic reactions (hypersensitivity reactions up to life-threatening shock (sudden circulatory failure)) have been observed in connection with the use of alpha-lipoic acid as an injection or infusion solution. Therefore, your doctor will monitor you for the occurrence of early symptoms (e.g., itching, nausea, malaise, etc.) during use. If these occur, therapy must be discontinued immediately; further therapeutic measures may be necessary.
  • Alpha-lipoic acid reacts in vitro with metal ion complexes (e.g., cisplatin); alpha-lipoic acid forms poorly soluble complexes with sugar molecules (e.g., levulose solution). The drug is incompatible with glucose solution, Ringer's solution, and solutions known to react with SH groups or disulfide bridges. Only isotonic saline solution should be used as a carrier solution for infusion.
  • Children
    • Children and adolescents should be excluded from treatment as there is no clinical experience for this age group.

• Ability to drive and operate machinery
  • No special precautions are required.