Farmak A05B A50**
COMPOSITION AND DOSAGE FORM:
Solution for injections 50 mg/ml in 5 ml ampoules No. 5, No. 10
No. UA/12317/01/01 valid from 09/07/2012 till 07/09/2017
Pharmacodynamics. Phospholipids in the drug have a similar chemical structure with endogenous phospholipids, but contain far more polyunsaturated (essential) fatty acids. These high-energy molecules are integrated mostly into the cell membranes and facilitate repairing damaged liver tissue. Phospholipids influence disturbed lipid metabolism by regulating lipoprotein metabolism; as a result, neutral fats and cholesterol are converted to transportable forms, especially due to the increased ability of HDL to attach cholesterol, and are used for further oxidation. During phospholipid excretion through the biliary tract, the lithogenic index decreases, and bile is stabilized.
Pharmacokinetics. Half-life of choline is 66 hours, of saturated fatty acids – 32 hours.
In human kinetics studies, <5% of each of 3H and 14C isotopes were excreted with feces.
fatty liver, acute and chronic hepatitis, liver cirrhosis, pre- and postoperative treatment of a patient in liver and biliary tract surgery, toxic liver damage, toxemia in pregnant women, psoriasis, radiation syndrome.
only transparent solution should be used.
The drug is injected IV slowly. Do not inject the drug IM, a potential local reaction may occur.
Adults and children over 12 are prescribed with IV 5–10 ml/day, and 10–20 ml/day in severe cases. 10 ml of the drug may be injected at a time. For dilution, a 1:1 ratio of the drug and patient’s own blood is recommended. Treatment should last for up to 10 days with the subsequent switching to oral phosphatidylcholine.
Start treatment of psoriasis with administration of oral phosphatidylcholine for 2 weeks. Then, 10 intravenous injections of 5 ml with simultaneous PUVA therapy are recommended. After the course of injections is completed, oral phosphatidylcholine should be continued.
When it is not possible to use patient’s own blood for dilution of the drug, electrolyte-free solutions should be used: 5 or 10% glucose solution, 5% xylitol solution at a 1:1 ratio.
hypersensitivity to any of drug components.
in some cases, higher doses of the drug may cause gastrointestinal disorders (diarrhea). In some cases, hypersensitivity reactions, rash, itching may occur.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
precautions: the solution contains 5.02 mg/ml of alcohol. For IV injections only.
Pregnancy and lactation. The drug is used to treat toxemia in pregnant women.
The drug is not contraindicated during lactation.
Paediatric population. The drug is prescribed for the treatment of children over 12 years.
Effects on ability to drive and use machines. None.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION.
interaction with other drugs has not been studied. The drug is incompatible with electrolyte solutions. Do not administer the drug with other drugs in the same syringe.
No cases of overdose were reported.
Store at 2–8°C. Protect from light.