TAD-600mg/4ml (Glutathione) 10 bottles and 10 vials - Sport and Workout

Dosage form

Powder lyophilized for solution preparation for

intravenous administration of 600 mg together with the solvent– water for

injection 4 ml

 

Composition

One vial with powder contains

active substance - glutathione restored the sodium salt 0,646 g,

 

Description

Crystalline, hygroscopic powder white docelowego color.

The reconstituted solution is clear, colorless elizveta-yellow liquid.

 

Pharmacotherapeutic group

Antidotes.

ATC code V03AB32

 

Pharmacological properties

Pharmacokinetics

After intravenous infusion of 2 g/m2 of glutathione, plasma total glutathione concentrations increased from 17.5 ± 13.4 mmol/l to 823 ± 326 mmol/L. the Volume of distribution of exogenous glutathione 176 ± 107 ml/kg. the half-life of 14.1 ± 9.2 minutes. The concentration of cysteine in plasmatrone increased from 8.9 ± 3.5 m mol/l to 114 ± 45 m/mol after infusion. Despite increases in cysteine, total concentration in plasma total cysteine, cystine and the mixed disulfide is decreased, which indicates an increase of the transport properties of cysteine inside the cell. 

Urinary excretion of glutathione and cysteine were increased by 300% and 10%, respectively, 90 minutes after injection. 

Pharmacodynamics

Glutathione is a physiologic Tripeptide of glutamic acid, cysteine and glycine,which is involved in several biological processes and has an important role in detoxification, protecting cells from the harmful effects of xenobiotics, free radicals and radiation. Preclinical and clinical studies have shown a protective role of glutathione in a number of situations that cause pathological cell damage (poisoning with such substances as ethyl alcohol,paracetamol, salicylates, phenobarbital, tricyclic antidepressants,organophosphorous insecticides, etc.). 

It is also observed that glutathione affects the activity of many chemotherapeutic drugs, reducing tissue levels of endogenous glutathione and reduces oxidative stress caused by tumor process. 

The use of such drugs as cisplatin and its derivatives for the prevention of neurotoxicity induced by chemotherapeutic drugs, was due to the fact that platinum is accumulated in the peripheral nervous system, especially the ganglia back nerve roots. Therefore, using substances such as glutathione, can prevent the initial accumulation of platinum in nerve root ganglia of the rear. 

Clinical studies confirmed that the infusion of glutathione, before the introduction of antineoplastic agents in patients with carcinomas of the ovary, carcinoma of stomach and colorectal cancer provides effective protection from renal failure and neurotoxicity caused by cisplatin and oxaliplatin, which allows,if necessary, to achieve higher cumulative doses of anticancer agents. 

 

Indications for use

- prevention of neurotoxicity associated with chemotherapy cisplatin or other related compounds 

 

Method of application and doses

Daily dose of TAD 600обычно recommended for patients receiving chemotherapy with cisplatin and related compounds is 1.5 g/m2 (corresponding to 2.5 g) by slow intravenous infusion.

The dose, however, depends on age, weight and clinical condition of the patient, and the dose grafica the introduction of chemotherapeutic agents. 

In case of concurrent administration of glutathione and chemotherapeutic agents,intravenous infusion of TAD 600 has to be done 15-30 minutes prior to chemotherapy. 

In the case of long-term treatment, may reduce dose (600 mg or 300mg), which may be administered intramuscularly or slowly intravenously. 

 

Side effects

Possible

- febrile reactions

- venous thrombosis or phlebitis and hemorrhage at the injection site

Rarely

- skin rash, which disappeared after discontinuation of treatment

- mild pain at the injection site

 

Contraindications

- hypersensitivity to the active substance

 

Drug interactions

No reports of pharmacological interactions with glutathione, have been reported in the literature. 

In recommended doses, TAD 600 does not interfere with the therapeutic activity of chemotherapeutic agents. 

 

Special instructions

In the event of adverse reactions when administered intravenously,the use of the drug should be discontinued immediately.

Warning: the preparation is intended for parenteral use, you should make a visual inspection , in order to determine the presence of particles or variations in the color of the drug. Do not use in case of presence of turbidity or precipitation. 

The children

Data on safety and effectiveness of lekarstvennogo in children and adolescents under 18 years no

Pregnancy and lactation

The available data show that glutathione,being a physiological substance, present in cells, does not cause unwanted effects in women during pregnancy or breast-feeding. 

Preclinical studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development,parturition and postnatal development. 

 

Overdose

Symptoms – not a single case of overdose.

Treatment if necessary can be used symptomatic treatment. 

 

Form of release and packing

At 0.646 g of the drug is placed in a transparent glass bottle,sealed with a rubber stopper and sealed with aluminium cap.

For 4 ml of solvent is poured into transparent glass vials, sealed with rubber stopper and sealed with aluminum caps.

The bottles self-adhesive label pasted.

10 vials with the drug together with 10 vials of diluent and instructions for medical use is placed in cardboard pack.

 

Storage conditions

Keep at temperature not above 25 °C .

Keep out of reach of children!

 

Shelf life

5 years. The drug is not used after the term has been expired.

 

Manufacturer

Biomediсa Foscama,Chemical-pharmaceutical company S. p. A., Italy