Properties
What is it?
Composition: 5ml of the preparation contains: active substance: dried soybean phosphatidycholine substance, containing 93% (3-sn-phosphatidyl) choline: synonyms - essential phospholipids, EPL-250mg. Excipients: deoxycholic acid-126.50mg; sodium hydroxide-13.40mg; benzyl alcohol-45.00mg, sodium chloride-12.00mg, riboflavin-0.50mg; water for injection-up to 5ml. Indications: fatty degeneration of the liver (including in diabetes mellitus): acute and chronic hepatitis, liver cirrhosis, liver cell necrosis, hepatic coma and precoma, toxic liver damage; pregnancy toxemia; pre- and postoperative treatment, especially during surgery in the hepatobiliary system; psoriasis; radiation syndrome. Contraindications: hypersensitivity to any ingredient of the preparation. Age up to 3 years. Precautions: during pregnancy, due to the presence of benzyl alcohol in the preparation, which can cross the placental barrier (the use of preparations containing benzyl alcohol in full-term or premature newborns has been associated with the development of respiratory distress syndrome with a fatal outcome). Method of administration and dosage: the preparation is used for intravenous injection, it cannot be administered intramuscularly due to possible local irritant reactions. If not otherwise prescribed by a doctor, administer slowly intravenously 1-2 ampoules (5-10ml) or in severe cases-2-4 ampoules (10-20ml) per day. The contents of two ampoules can be administered simultaneously. Do not mix with other preparations in the same syringe. It is recommended to dilute the solution with the patient's blood in a 1:1 ratio. If dilution of the preparation is necessary, use only 5% or 10% dextrose solution for infusion, and the diluted preparation solution must be clear during administration. Do not dilute the preparation with electrolyte solutions (isotonic solution, Ringer's solution)! It is recommended to supplement parenteral administration of the preparation as soon as possible with oral intake. Possible side effects: in rare cases, due to the presence of benzyl alcohol in the preparation, hypersensitivity reactions may develop. In very rare cases, allergic skin reactions (rash, exanthema, or urticaria) may occur. In case of any side effects, including those not listed in this instruction, consult your doctor or pharmacist. Dosage form: solution for intravenous injection. Description: clear yellow solution. Special instructions: use only a clear solution! Release form: solution for intravenous administration 250mg-5ml. 5ml of the preparation in narrow dark glass ampoules. 5 ampoules in a PVC contour pack. Each contour pack is placed in a cardboard box with instructions for use. Storage conditions: store the preparation at temperatures of 2C-8C, out of reach of children. List B. Shelf life: 3 years. Do not use after the expiry date. Dispensing from pharmacy: by prescription. Manufacturer: FAMAR HEALTH CARE SERVICES MADRID, S.A.U., Spain