Нефротект

General characteristics. Structure:

Active ingredients: 5,8 g of L-izoleytsina, 12,8 g of a L-leucine, 16,925 g of a L-lysine of monoacetate that corresponds to 12 g of a L-lysine, 2 g of L-methionine, 3,5 g of L-phenylalanine, 8,2 g of L-threonine, 3 g of L-tryptophane, 8,7 g of L-valine, 8,2 g of L-arginine, 9,8 g of a L-histidine, 6,2 g of L-alanine, 540 mg N-acetyl-L-cysteine that corresponds to 400 mg of L-cysteine, 5,305 g of glycine, 3 g of L-proline, 7,6 g of L-serine, 600 mg of L-tyrosine, 3,155 g of glycyl-N-tyrosine (anhydrous); the general content of amino acids is 100 g/l, the general content of nitrogen is 16.3 g/l, theoretical osmolarity 935 ¼Äß¼/l, рН - 5.5-6.5.

Excipients: acetic acid ice, malic acid, water for injections.

Pharmacological properties:

Pharmacodynamics. Нефротект - solution of the irreplaceable and replaceable amino acids necessary for synthesis of protein in an organism and achievements of positive balance of nitrogen at parenteral food and completion of losses of amino acids at dialysis. It is developed especially for patients with a renal failure.

Pharmacokinetics. Distribution. At in administration of drug the amino acids coming to an organism anabolic are utilized and included organism proteins at availability of power substrates. Bioavailability at in introduction makes 100%.

Distribution of amino acids at in introduction is identical to that at intake of amino acids from a GIT at hydrolysis of proteins of food.

Metabolism and removal. Glycyl - L - the tyrosine included in Nefrotekt's list as an additional source of L-tyrosine is hydrolyzed with the subsequent utilization of amino acids of L-tyrosine and glycine right after in/in introductions, including at patients with a renal failure. T1/2 makes 3.44 min.

At administration of drug with the recommended speed only an insignificant part of the arrived amino acids is lost with urine.

Indications to use:

— administration of amino acids at full or partial parenteral food of patients with renal failures, including parenteral food at an acute and chronic renal failure, including the patients who are on haemo - or peritoneal dialysis;

— completion of losses of amino acids at haemo - or peritoneal dialysis.

Route of administration and doses:

The drug is administered in / century. The dose should be selected depending on individual need of the patient.

To the patients with an acute and chronic renal failure who are not receiving haemo - or peritoneal dialysis: 0.6-0.8 of amino acids on body weight kg in days = 6-8 ml/kg/days.

To the patients with an acute and chronic renal failure who are on haemo - or peritoneal dialysis: 0.8-1.2 of amino acids on body weight kg in days = 8-12 ml/kg/days.

For completion of loss of amino acids at haemo - or peritoneal dialysis: 0.5-0.8 of amino acids on body weight kg in days = 5-8 ml/kg/days.

The maximum recommended daily dose for adults and children: 0.8-1.2 of amino acids on body weight kg in days = 8-12 ml/kg/days. It corresponds to about 560-840 ml/days for patients with the body weight of 70 kg.

The maximum recommended rate of administering for adults and children: parenteral food - 0.1 g of amino acids on body weight kg an hour = 1 ml/kg/h; completion of losses of amino acids at haemo - or peritoneal dialysis - 0.2 g of amino acids on body weight kg an hour = 2.0 ml/kg/h.

Usually when carrying out parenteral food any amino-acid solutions are appointed in a combination with drugs energy sources: solutions of glucose and/or fatty emulsions. When carrying out full parenteral food of Nefrotekt it is used together with energy sources, electrolytes, water-soluble and fat-soluble vitamins and microelements. Нефротект in combination with other drugs for parenteral food it is possible to enter into the central or peripheral veins depending on final osmolarity.

Нефротект it can be entered through separate infusional system or can be mixed in aseptic conditions with other components of parenteral food and it is entered into a container.

For completion of loss of amino acids at dialysis of Nefrotekt it is possible to enter without solutions of glucose and fatty emulsions directly into a venous trap of the dialysis device.

Нефротект it is possible to apply until the patient needs parenteral food or there is a need for completion of loss of amino acids.

Features of use:

Use at pregnancy and feeding by a breast. Administration of amino acids at parenteral food to patients with renal failures can be vital. If necessary it is possible to appoint solutions of amino acids at pregnancy and during breastfeeding, at the same time it is necessary to estimate the expected advantage and possible risk of therapy. Adverse and side effects were not noted at use of drug for this category of patients. Teratogenic effects are not revealed.

Special instructions. It is recommended to control water and electrolytic balance, indicators of an acid-base state, level of urea and ammonium when performing therapy.

Нефротект it is possible to mix or enter in parallel with energy carriers, electrolytes, in the quantities necessary for the specific patient.

Use in pediatrics. At parenteral food children with renal failures can have the vital administration of amino acids, in this case use for children is possible. Tyrosine is irreplaceable amino acid for children. Before Nefrotekt's appointment children should estimate a ratio of advantage and risk of therapy.

Side effects:

Side effects were not observed at observance of the technology of introduction, the recommended doses and contraindications.

In rare instances at administration of any amino-acid solutions: increase in level of eosinophils, muscular pains, scleroderma, puffiness of extremities, breath difficulty.

Interaction with other medicines:

Solutions of amino acids can be mixed in aseptic conditions only with the drugs intended for parenteral food including with fatty emulsions, solutions of glucose, electrolytes.

Joint introduction with other groups of drugs because of risk of incompatibility is not recommended.

Contraindications:

— inborn disturbances of amino-acid exchange;

— acute phase of shock;

— the general contraindications for infusional therapy: acute fluid lungs, overhydratation, dekompensirovanny heart failure, dekompensirovanny hypotonic dehydration;

— hypersensitivity to drug components.

With care it is necessary to use drug at patients with the hyponatremia raised by osmolarity of blood.

Overdose:

Data on overdose of drug of Nefrotekt are not provided.

Storage conditions:

Drug should be stored in the unavailable to children, protected from light place at a temperature not above 25 °C; not to freeze. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

250 ml - bottles of colourless glass (10) - a box cardboard.
250 ml - bottles of colourless glass with holders plastic (10) - boxes cardboard.
500 ml - bottles of colourless glass (10) - a box cardboard.
500 ml - bottles of colourless glass with holders plastic (10) - boxes cardboard.