Phosphonciale^® Mono (Solution) Instructions for Use

Marketing Authorization Holder

Kronopharm, LLC (Russia)

Manufactured By

Grotex, LLC (Russia)

Or

FSBI Russian Cardiology Research And Production Complex Of The Ministry Of Health Of Russia – Epmbp (Russia)

ATC Code

A05BA10 (Phospholipids)

Active Substance

Phospholipids

Dosage Form

Phosphonciale® Mono

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

Dosage Form, Packaging, and Composition

Solution for intravenous administration yellow in color, transparent, with a characteristic odor.

* Lipoid C100 contains not more than 0.25% α-tocopherol and not more than 0.2% ethanol.

Excipients : benzyl alcohol – 45 mg, deoxycholic acid – 126.5 mg, sodium hydroxide – 13.4 mg, sodium chloride – 12 mg, riboflavin – not more than 0.5 mg, water for injection – up to 5 ml.

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

Clinical-Pharmacological Group

Hepatoprotective agent

Pharmacotherapeutic Group

Means for the treatment of diseases of the liver and biliary tract; agents for the treatment of liver diseases, lipotropic agents

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; pregnancy toxicosis; pre- and postoperative treatment, especially for operations in the hepatobiliary zone; 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 or two ampoules (5-10 ml) in the patient’s blood at a 1:1 ratio.

Alternatively, administer by slow intravenous infusion. Dilute the solution in 250-500 ml of dextrose 5% or 10% solution; the use of electrolyte solutions (e.g., Ringer’s, sodium chloride) is prohibited due to potential precipitation.

The recommended daily adult dose is 500-1000 mg (10-20 ml) of phosphatidylcholine.

In severe cases, the daily dose may be increased to 1500 mg (30 ml).

Administer the initial dose of 500 mg (10 ml) intravenously; subsequent doses may be adjusted based on clinical response.

Transition to oral Phospholipid formulations as the patient’s condition improves to complete the course of therapy.

Adverse Reactions

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

From the immune system hypersensitivity reactions, including 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 to 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.