Alpha Lipon Aristo 600 mg concentrate for solution for infusion, 5X24 ml

Alpha Lipon Aristo® 600 mg concentrate for preparation of an infusion solution

Alpha Lipon Aristo® 600 mg concentrate for the preparation of an infusion solution is used in the initial treatment of abnormal sensations in diabetic polyneuropathy.If the discomfort is severe, intravenous administration is recommended in adults at a dosage of 24 ml injection solution per day.Each ampoule with 24 ml of concentrate contains 600 mg of the active ingredient thioctic acid.

The concentrate is mixed with 250 ml of sodium chloride solution 0.9% to prepare a solution for infusion.The intravenous administration is then given as a short infusion over at least 30 minutes by the treating doctor.The injection solution is administered over a period of two to four weeks in the initial phase of treatment.

In order to stabilize the effect of the infusion in the long term, long-term therapy with Alpha Lipon Aristo® film-coated tablets makes sense.No prescription is required for this product.

Active ingredients / ingredients / ingredients

774.77 mg alpha-lipoic acid, ethylenediamine salt, 600 mg DL-alpha-lipoic acid, argon as an excipient, nitrogen as an excipient and water for injection purposes as an excipient.

Area of application

Alpha-lipoic acid is a substance formed in the body's metabolism that influences certain metabolic processes in the body.It also has antioxidant properties that protect the nerve cell from reactive degradation products.The medicine is used for abnormal sensations caused by diabetic nerve damage (polyneuropathy).

Contraindications

The medicine must not be used if you are hypersensitive to alpha-lipoic acid or any of the other ingredients.

Dosage

Always use the medicine exactly as directed.Please ask your doctor or pharmacist if you are not sure.Unless otherwise prescribed by the doctor, the usual dose for severe abnormal sensations of diabetic polyneuropathy in adults is the infusion of 1 ampoule, equivalent to 600 mg alpha-lipoic acid, in isotonic saline once a day.

The intravenous administration should be given as a short infusion over at least 30 minutes after the contents have been mixed with 250 ml of isotonic saline solution.Because the active ingredient is sensitive to light, the short infusion should only be prepared shortly before use.The infusion solution must be protected from light with aluminum foil.The light-protected infusion solution has a shelf life of approximately 6 hours.It must be ensured that the minimum infusion time of 30 minutes is adhered to.

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 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 have the impression that the effect is too strong or too weak.

If you use more than you should, you may experience nausea, vomiting and headaches.In individual cases, severe, sometimes life-threatening symptoms of poisoning have been observed when taking more than 10 g of alpha-lipoic acid, especially when accompanied by heavy alcohol consumption.Therefore, if a significant overdose is suspected, immediate hospitalization and the initiation of measures in accordance with the general principles of treatment of cases of poisoning are necessary.

If you have any further questions about using the medicine, ask your doctor or pharmacist.

Intake

The preparation may only be administered as an infusion in isotonic saline solution.

Patient information

Particular caution is required when using it, as allergic reactions including life-threatening shock have been observed.Your doctor will monitor you for early symptoms during use.If these occur, therapy should be stopped immediately.Alpha-lipoic acid is incompatible with glucose solution, Ringer's solution and with solutions that react with SH-groups or disulfide bridges.Only isotonic saline solution should be used as a carrier solution for infusion use.

Children and adolescents should be excluded from treatment as there is no clinical experience for this age group.No special precautions are required regarding the ability to drive and use machines.

Pregnancy

Pregnant and breastfeeding women should only undergo treatment with alpha-lipoic acid after careful recommendation and monitoring by a doctor, as there is currently no experience with this patient group.Special studies on animals have shown no evidence of fertility disorders or teratogenic effects.Nothing is known about the possible excretion of alpha-lipoic acid into breast milk.

Notes

For information about risks and side effects, read the package leaflet and ask your doctor or pharmacy.

Ingredients

Active ingredient per ampoule with 24 ml concentrate for preparing an infusion solution: 600 mg thioctic acid.The other ingredients are water for injections, nitrogen and argon.

Address of the provider/manufacturer

Aristo Pharma GmbH, Wallenroder Str. 8-10, 13435 Berlin

Important information (mandatory information)

Alpha-Lipon Aristo 600 mg, concentrate for preparing an infusion solution.Active ingredient: thioctic acid [als Ethan-1,2-diamin-Salz (1:1)].Areas of application: For the treatment of abnormal sensations caused by diabetic nerve damage (polyneuropathy).