TAD 600

Field of Activity:

Application:

Release form:

Composition:

Trade name TAD 600 Dosage form, dosage Lyophilized powder for the preparation of solution for intravenous administration complete with solvent – ​​water for injection, 600 mg/4 ml Pharmacotherapeutic group Other drugs. All other therapeutic drugs. Antidotes. Glutadione. ATX code V03AB32   Indications for use – prevention of neurotoxicity during chemotherapy with cisplatin or other related […]

Trade name

TAD 600

Dosage form, dosage

Lyophilized powder for the preparation of solution for intravenous administration complete with solvent – ​​water for injection, 600 mg/4 ml


Pharmacotherapeutic group

Other drugs. All other therapeutic drugs. Antidotes. Glutadione.

ATX code V03AB32

 

Indications for use

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

List of information required before use

Contraindications

- hypersensitivity to the active substances or to any of the excipients

 

Necessary precautions for use

In case of adverse reactions during intravenous administration, use of the drug should be discontinued immediately.

Warning: For a drug intended for parenteral use, a visual inspection should be made before use in order to, 
if possible, determine the presence of particles or deviations in the color of the drug. Do not use if there is turbidity or precipitation.

Use in children

Данные по безопасности и эффективности лекарственного средства у детей и подростков до 18 лет отсутствуют.

Special Warnings

Fertility, pregnancy and lactation

Available evidence shows that glutathione, being a substance physiologically present in cells, does not cause adverse effects in women during pregnancy or breastfeeding. Preclinical studies do not indicate direct or indirect harmful effects regarding pregnancy, embryonic/embryonic development, childbirth or postnatal development.
Features of the drug's influence on the ability to drive a vehicle or potentially dangerous mechanisms

TAD 600 has no or negligible effect on performance associated with driving or using machinery.

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

The dose, however, depends on the age, weight and clinical condition of the patient, as well as on the dose and schedule of administration of chemotherapeutic agents.
In the case of simultaneous use of glutathione and a chemotherapy agent, an intravenous infusion of TAD 600 should be performed 15-30 minutes before the start of chemotherapy.
In case of long-term treatment, it is possible to reduce the dose of the drug (600 mg or 300 mg), which can be administered intramuscularly or slowly intravenously.

Method and route of administration

For intravenous administration.

Measures to be taken in case of overdose

Symptoms: no cases of overdose have been reported.

Treatment: if necessary, symptomatic treatment is carried out.
Recommendations for seeking advice from a healthcare professional to explain how to use the drug

Ask your doctor or pharmacist for advice before taking this medicine.

Description of adverse reactions that occur with standard use of drugs and measures that should be taken in this case

Rare cases of skin rash have been reported following intramuscular administration and disappear after discontinuation of treatment.
Mild pain at the injection site has also been reported.

As with all solutions for intravenous infusion, febrile reactions, injection site infections, venous thrombosis or phlebitis, and extravasation may occur.
In the event of an immediate adverse reaction during intravenous infusion, the administration 
of the drug should be interrupted immediately and, if possible, the unused remaining liquid should be saved for examination.
If adverse drug reactions occur, contact your healthcare professional, pharmacist, or directly
to the information database on adverse drug reactions (actions), including reports of drug ineffectiveness
RSE on REM "National Center for Expertise of Medicines and Medical Devices" of the Committee for 
Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan

additional information

Composition of the medicinal product

One bottle contains:

active substance: reduced glutathione sodium salt - 0.646 g, corresponds to 600 mg reduced glutathione

one ampoule with solvent contains: water for injection
Release form and packaging

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

4 ml of solvent are poured into transparent glass ampoules.

Self-adhesive labels are placed on the bottles.

10 bottles of the drug together with 10 ampoules of solvent and instructions for medical use in Kazakh and Russian are placed in a cardboard pack.
Do not use after the expiration date.


Storage conditions

Store at a temperature not exceeding 25ºС.

Keep out of the reach of children!


Conditions for dispensing from a pharmacy

On prescription

 

Manufacturer information

Biomedica Foscama Industria Chimico Farmaceutica S.p.A., Ferentino, Italy

Name, address and contact details (telephone, fax, e-mail) of the organization on the territory of 
the Republic of Kazakhstan that accepts complaints (suggestions) regarding the quality of medicinal
products from consumers and is responsible for post-registration monitoring of the safety of the medicinal product

Representative office of the closed joint stock company "Claus Marsh Ltd" in the Republic of Kazakhstan

Almaty, 050012 Almaly district, Tole Bi street, 83

 

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