Tiomax 600 (conc. sol. perf.)

Acidum thiocticum

Each 24 ml vial of Tiomax 600 concentrate for solution for infusion contains 600 mg thioctic acid in the form of thioctic acid meglumine salt. Each 20 ml vial of concentrate for solution for infusion contains 600 mg thioctic acid in the form of thioctic acid meglumine salt.

Indication: Paraesthesia in diabetic polyneuropathy.

Contraindications (SmPC section 4.3): 4.3 Contraindications - known hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Warnings and precautions (SmPC section 4.4, excerpt): 4.4 Special warnings and precautions for use Hypersensitivity reactions, including up to anaphylactic shock, have been reported in association with parenteral administration of thioctic acid (see Section 4.8). Patients must therefore be monitored appropriately. If symptoms occur early (e.g. pruritus, nausea, general malaise, etc.), treatment must be discontinued immediately, and other therapeutic measures initiated if necessary. Cases of autoimmune insulin syndrome (AIS) have been reported during treatment with thioctic acid. Patients with a certain human leukocyte antigen genotype (HLA-DRB1*04:06 and HLA-DRB1*04:03 alleles) are more predisposed to developing AIS during treatment with thioctic acid. Carriers of the HLA-DRB1*04:03 allele (sensitivity factor for AIS development - 1.6) are particularly widespread among representatives […]