Fosfontsiale Mono solution for intravenous administration 250mg / 5ml, No. 5

Fatty liver degeneration, acute and chronic hepatitis, cirrhosis of the liver, hepatic coma and prcoma. pre- and postoperative treatment for surgical interventions in the hepatobiliary zone, toxic liver damage, pregnancy toxicosis, psoriasis (as an auxiliary therapy), radiation syndrome.

Only a clear solution should be used.

The drug should not be administered intramuscularly due to the possible occurrence of a local reaction.

The drug is administered intravenously slowly 5-10 ml per day, in severe cases from 10 to 20 ml per day. It is allowed to inject 10 ml of the drug at a time. For dilution of the drug, it is recommended to use the patient's own blood in a 1: 1 ratio. The course of treatment is up to 10 days, followed by the transition to oral forms of phosphatidylcholine. Treatment for psoriasis begins with oral phosphatidylcholine for 2 weeks. After that, 10 intravenous injections of 5 ml each are recommended with the simultaneous appointment of PUVA therapy. After the end of the course of injections, oral forms of phosphatidylcholine are resumed. In cases where it is impossible to use the patient's own blood to dilute the drug, electrolyte-free solutions should be used - 5% or 10% glucose solution, 5% xylitol solution in a 1: 1 ratio.

1 ampoule contains:

active substance: phospholipids (Lipoid C 100 *) - 266.00 mg, in terms of phosphatidylcholine - 250.00 mg;

excipients: gasoline alcohol - 45.00 mg, deoxycholic acid - 126.50 mg, sodium hydroxide - 13.40 mg, sodium chloride - 12.00, riboflavin - no more than 0.50 mg, water for injection - up to 5 ml ...

* Lipoid C 100 contains no more than 0.25% a-tocopherol and no more than 0.2% ethanol.

• Hypersensitivity to the components of the drug. Soy intolerance.

• Children under 12 years of age.

Carefully

Pregnancy, children over 12 years of age.

Trade name:

FosfonzialeЃ Mono

International non-proprietary or group name:

phospholipids

Dosage form:

solution for intravenous administration.

Composition

1 ampoule contains:

active substance: phospholipids (Lipoid C 100 *) - 266.00 mg, in terms of phosphatidylcholine - 250.00 mg;

excipients: gasoline alcohol - 45.00 mg, deoxycholic acid - 126.50 mg, sodium hydroxide - 13.40 mg, sodium chloride - 12.00, riboflavin - no more than 0.50 mg, water for injection - up to 5 ml ...

* Lipoid C 100 contains no more than 0.25% a-tocopherol and no more than 0.2% ethanol.

Description:

Transparent yellow solution with a characteristic odor.

Pharmacotherapeutic group:

hepatoprotective agent.

Pharmacological properties

Pharmacodynamics

The phospholipids contained in the preparation are similar in their chemical structure to endogenous phospholipids, but they are much higher in terms of the content of polyunsaturated (essential) fatty acids. These high-energy molecules are incorporated predominantly into the structures of cell membranes and facilitate the repair of damaged liver tissue. Phospholipids affect disturbed lipid metabolism by regulating lipoprotein metabolism, as a result of which neutral fats and cholesterol are converted into forms suitable for transport. especially due to an increase in the ability of high density lipoproteins (HDL) to bind cholesterol, and are intended for further oxidation. During the excretion of phospholipids through the biliary tract, the lithogenic index decreases and bile stabilizes.

Pharmacokinetics

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

The half-life of the cholipic component is 66 hours, for unsaturated fatty acids - 32 hours.

Indications for use

Fatty liver degeneration, acute and chronic hepatitis, cirrhosis of the liver, hepatic coma and prcoma. pre- and postoperative treatment for surgical interventions in the hepatobiliary zone, toxic liver damage, pregnancy toxicosis, psoriasis (as an auxiliary therapy), radiation syndrome.

Contraindications

• Hypersensitivity to the components of the drug. Soy intolerance.

• Children under 12 years of age.

Carefully

Pregnancy, children over 12 years of age.

Application during pregnancy and during breastfeeding

During pregnancy, due to the presence of benzyl alcohol in the composition of the drug, which can penetrate the placental barrier (the use of drugs containing benzyl alcohol in newborns born at term or premature newborns was associated with the development of dyspnea syndrome with a fatal outcome), the use of the drug is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

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

Method of administration and dosage

Only a clear solution should be used.

The drug should not be administered intramuscularly due to the possible occurrence of a local reaction.

The drug is administered intravenously slowly 5-10 ml per day, in severe cases from 10 to 20 ml per day. It is allowed to inject 10 ml of the drug at a time. For dilution of the drug, it is recommended to use the patient's own blood in a 1: 1 ratio. The course of treatment is up to 10 days, followed by the transition to oral forms of phosphatidylcholine. Treatment for psoriasis begins with oral phosphatidylcholine for 2 weeks. After that, 10 intravenous injections of 5 ml each are recommended with the simultaneous appointment of PUVA therapy. After the end of the course of injections, oral forms of phosphatidylcholine are resumed. In cases where it is impossible to use the patient's own blood to dilute the drug, electrolyte-free solutions should be used - 5% or 10% glucose solution, 5% xylitol solution in a 1: 1 ratio.

Side effect

From the gastrointestinal tract: epigastric discomfort, loose stools, nausea, gastralgia.

From the immune system:

allergic reactions (rash, exanthema, urticaria, pruritus).

Overdose

There were no reports of overdose.

Interaction with other medicinal products

Interaction with other drugs has not been studied. The drug is not compatible with electrolyte solutions. Do not inject the drug together with other drugs in the same syringe.

special instructions

Only clear solution should be used! Caution: the solution contains gasoline alcohol. For intravenous use only. Children. The drug is used to treat children over 12 years of age.

Influence on the ability to drive vehicles and mechanisms

Not identified.

Release form

Solution for intravenous administration 50 mg / ml.

5 ml in ampoules for medicines made of dark medical glass of the NS-1 or NS-3 brands or of the 1st hydrolytic class according to ISO 9187.

5 or 10 ampoules in a blister made of polyvinyl chloride film.

1, 2 blister packs and 5 ampoules of ILTGTKG I 'blister packs of 10 ampoules, together with instructions for use, are placed in a cardboard box. It is allowed to put a scarifier in a pack.

Storage conditions

At temperatures from 2 ? C to 8 ? C in the manufacturer's packaging. Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiration date.

Vacation conditions

Dispensed by prescription.