Hepaval powder for solution for injection 600 mg vial with solvent (water for injection) ampoule 4 ml No. 10

Instructions Hepaval powder for solution for injection 600 mg bottle with solvent (water for injection) ampoule 4 ml No. 10

Composition

active ingredient: glutathione;

1 bottle contains 643 mg of sodium glutathione, which is equivalent to 600 mg of glutathione.

1 ampoule of solvent contains 4 ml of water for injection.

Dosage form

Powder for solution for injection.

Main physicochemical properties: white hygroscopic powder; clear colorless liquid, odorless.

Pharmacotherapeutic group

Antidotes. ATX code V03A B32.

Pharmacological properties

Pharmacodynamics

Glutathione is a tripeptide that is a natural component of cells in all body tissues. Its significant distribution is associated with a wide range of biological functions and is of fundamental importance for numerous biochemical and metabolic processes.

The sulfhydryl groups of cysteine, which are part of glutathione, are powerful nucleophilic agents. In this regard, they become the main target of electrophilic attack of chemicals or their active metabolites, which leads to the inactivation of potentially toxic exogenous substances. Thus, the drug has a protective effect on vital nucleophilic sites, the attack on which initiates the process of cell damage.

In addition, glutathione (GSH), reduced as a result of interaction with a large number of oxidized organic metabolites, forms less toxic conjugated compounds, which are subsequently more easily metabolized and excreted as mercapturic acids.

Given these properties, glutathione is prescribed in case of hepatotoxicity reactions, the mechanisms of development of which may be ethyl or drug hepatotoxicosis or pathogenetically determined hepatotoxicosis associated with violations of detoxification mechanisms.

Pharmacokinetics

After intravenous administration, glutathione is mainly distributed in erythrocytes, while in plasma it is rapidly cleaved by gamma-glutamyl transpeptidase and gamma-glutamyl cyclotransferase. Thus, plasma levels of reduced glutathione (GSH), even after high doses, are negligible (peak plasma concentration of approximately 1 nmol/ml 5 minutes after intravenous administration of 600 mg), while levels of the cysteine metabolite are higher (peak plasma concentration of approximately 17 nmol/ml). Blood concentrations determined on whole blood reach values of approximately 100 nmol/ml 5-10 minutes after intravenous administration of 600 mg glutathione. Blood concentrations of the drug gradually decrease, almost reaching baseline values approximately 60 minutes after administration.

Indication

Prevention of neuropathy induced by chemotherapy with cisplatin or other similar substances.

Contraindication

Hypersensitivity to the active substance or to other components of the drug.

Interaction with other medicinal products and other types of interactions

Unknown.

Ability to influence reaction speed when driving vehicles or other mechanisms

Glutathione does not affect the ability to drive or use other mechanisms.

Use during pregnancy or breastfeeding

Although glutathione has not shown any signs of embryo- and fetotoxicity in experimental studies, its use is not recommended for pregnant and breastfeeding women.

Method of administration and doses

In the most severe degree of damage: 600-1200 mg (1-2 vials) per day by intramuscular or slow intravenous injection.

For moderate severity of lesions: use half the dose indicated above.

Preparation of the drug for administration.

In case of intramuscular administration, the drug must be completely dissolved directly in the vial using the solvent provided in the kit.

For intravenous administration, the drug should be dissolved with the solvent provided (water for injections) and administered either by direct slow injection or by infusion after adding the prepared solution to at least 20 ml of sterile infusion solution.

Children

The possibility of use in children has not been studied.

Overdose

There is no information on overdose.

Adverse reactions

In rare cases, nausea, vomiting, headache, and skin rashes may develop. These reactions usually disappear after discontinuation of therapy.

Expiration date

3 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 ºС.

The reconstituted solution is stable for approximately 2 hours when stored at room temperature and for at least 8 hours when stored at 0° to + 5°C.

Keep out of reach of children.

Packaging

Powder for solution for injection 600 mg in vials No. 10 complete with solvent (water for injection) 4 ml in ampoules No. 10 in a cardboard box.

Vacation category

According to the recipe.

Producer

LABORATORIO ITALIANO BIOCHEMICO PHARMACEUTICO LISAPHARMA S.P.A.

VIA LICINIO, 11 – 22036 ERBA (province of Como), Italy.