Evadelit^® (Solution) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

A05BA10 (Phospholipids)

Active Substance

Phospholipids (Grouping name)

Dosage Form

Evadelit®

Solution for intravenous administration 250 mg/5 ml: amp. 5 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration yellow or greenish-yellow in color, transparent, with a faint characteristic odor.

Excipients: benzyl alcohol – 9 mg, deoxycholic acid – 25.3 mg, sodium hydroxide – 2.68 mg, sodium chloride – 2.4 mg, riboflavin sodium phosphate (calculated as riboflavin) – 0.1 mg, water for injections – up to 1 ml.

5 ml – glass ampoules (5) – contour cell packs (1) – cardboard boxes.
5 ml – glass ampoules (5) – contour cell packs (2) – cardboard boxes.
5 ml – glass ampoules (10) – contour cell packs (1) – cardboard boxes.

Clinical-Pharmacological Group

Hepatoprotective agent

Pharmacotherapeutic Group

Hepatoprotective agent

Pharmacological Action

Hepatoprotective agent; the Phospholipids included in the composition are the main elements in the structure of the cell membrane and mitochondria.

It regulates lipid and carbohydrate metabolism, improves the functional state of the liver and its detoxification function, promotes the preservation and restoration of the structure of hepatocytes; inhibits the formation of connective tissue in the liver.

Pharmacokinetics

Binding mainly to high-density lipoproteins, phosphatidylcholine enters, in particular, into liver cells.

The T_1/2 of the choline component is 66 hours, and that of unsaturated fatty acids is 32 hours.

Indications

Fatty liver dystrophy (including in diabetes mellitus); acute and chronic hepatitis, liver cirrhosis, liver cell necrosis, hepatic coma and precoma, toxic liver lesions; toxicosis of pregnancy; pre- and postoperative treatment, especially for operations in the hepatobiliary area; psoriasis (as an auxiliary therapy); radiation syndrome.

ICD codes

Dosage Regimen

Administer intravenously only; do not administer intramuscularly or subcutaneously.

For slow intravenous injection, dilute the contents of one 5 ml ampoule (250 mg) with the patient’s blood in a 1:1 ratio.

Inject no more than 5 ml of the diluted solution per minute.

For intravenous infusion, dilute the contents of one or two 5 ml ampoules (250-500 mg) in 250-500 ml of a compatible infusion solution, such as dextrose 5% or 10%.

Infuse the total volume at a rate not exceeding 30-40 drops per minute

The usual adult daily dose is 250-500 mg (5-10 ml).

In severe cases, increase the daily dose to 500-1000 mg (10-20 ml).

Administer the initial dose as a slow intravenous injection; subsequent doses may be given as an intravenous infusion.

Transition to an oral hepatoprotective formulation for maintenance therapy as the patient’s condition improves.

The duration of treatment is determined by the severity of the condition and the clinical response.

Adverse Reactions

From the digestive system when used in high doses – diarrhea.

From the immune system hypersensitivity reactions, incl. skin allergic reactions: skin rash, skin itching, exanthema or urticaria.

Contraindications

Age under 18 years; soy intolerance; hypersensitivity to the active substance.

Use in Pregnancy and Lactation

Use during pregnancy is possible only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

It is not recommended for use during breastfeeding due to the lack of safety data.

Special Precautions

As the patient’s condition improves, parenteral administration is replaced by oral administration of a drug containing Phospholipids in the appropriate dosage form.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.