Instructions Nephrotect solution for infusions bottle 250 ml No. 10
Composition
1000 ml of solution contain:
L-isoleucine - 5.80 g,
L-leucine - 12.80 g,
L-lysine monoacetate = 16.90 g,
in terms of L-lysine - 12.00 g,
L-methionine - 2.00 g,
L-phenylalanine - 3.50 g,
L-threonine - 8.20 g,
L-tryptophan - 3.00 g,
L-valine - 8.70 g,
L-arginine - 8.20 g,
L-histidine - 9.80 g,
L-alanine - 6.20 g,
N-acetyl-L-cysteine - 0.54 g,
in terms of L-cysteine - 0.40 g,
glycine - 5.305 g,
L-proline - 3.00 g,
L-serine - 7.60 g,
L-tyrosine - 0.60 g,
glycyl-L-tyrosine - 3.155 g;
Excipients: glacial acetic acid, malic acid, water for injection.
The total amount of amino acids is 100.0 g/l.
Total nitrogen - 16.3 g/l
Total energy value - 1600 kJ/l (=400 kcal/l).
Titratable acidity - 60 mM NaOH/L.
Osmolarity - 960 mOsmol/L.
Dosage form
Solution for infusion.
Main physicochemical properties: clear solution from colorless to pale yellow.
Pharmacotherapeutic group
Solutions for parenteral nutrition. Amino acids. ATX code B05B A01.
Pharmacological properties
Pharmacodynamics
Nephrotect is a solution of amino acids necessary for protein synthesis during parenteral nutrition of patients with renal failure. The bioavailability of Nephrotect when administered intravenously is 100%. The amino acid solution is intended for patients with impaired renal function.
Pharmacokinetics
Since tyrosine is poorly soluble in water, but is an essential amino acid in renal dysfunction, the dipeptide glycyl-L-tyrosine was included in the composition of Nephrotect as an additional source of L-tyrosine. This dipeptide is rapidly metabolized after administration (half-life approximately 5 minutes) and its constituent components are released even in patients with renal failure. The released amino acids accumulate together with other amino acids and are used in the body for protein synthesis.
Indication
For parenteral nutrition of patients when oral or enteral nutrition is impossible, insufficient or contraindicated, patients with impaired renal function, patients with acute and chronic renal failure, including patients on dialysis, including during the dialysis procedure itself.
Contraindication
Hypersensitivity to any component of the drug; congenital disorders of amino acid metabolism; severe renal failure without access to hemofiltration or dialysis; acute stage of shock. General contraindications for infusion therapy: acute pulmonary edema, hyperhydration, decompensated heart failure and hypotonic dehydration. Severe hepatic failure.
Interaction with other medicinal products and other types of interactions
Currently unknown.
Application features
When using the drug, you must adhere to the following recommendations:
The drug should be used immediately after opening the vial; The drug is intended for single use only; Do not use the drug after the expiration date has passed; Use the drug only from an undamaged container that contains a clear solution without foreign impurities; Any unused solution in the vial and any mixture remaining after infusion of the drug should be disposed of. The drug can be mixed under sterile conditions with other parenteral nutrition drugs, such as fat emulsions, carbohydrates, and electrolytes.
Any infusion into a peripheral vein may cause irritation of the vessel walls and thrombophlebitis. Therefore, it is recommended to inspect the catheter site daily. If the patient is also prescribed a fat emulsion, it should be administered simultaneously with Nephrotect, if possible, to reduce the risk of phlebitis.
The choice of catheter placement site (central or peripheral vein) is determined by the final osmolarity of the mixture: for infusion into a peripheral vein, the osmolarity limit is 800–900 mOsmol/L. It is necessary to take into account the age, clinical condition of the patient, and the condition of his peripheral veins.
It is necessary to strictly follow the rules of asepsis, especially when inserting a catheter into a central vein.
The drug should be used with caution in patients with hyponatremia or increased plasma osmolarity.
During therapy, it is necessary to monitor fluid balance, serum electrolyte levels, acid-base balance, urea levels, and ammonia levels.
In the presence of hypotonic dehydration, the body should be provided with fluids and electrolytes before starting parenteral nutrition.
The administration of any amino acid solutions can provoke acute folate deficiency, so patients should be given folic acid daily.
Caution should be exercised when infusing large volumes of fluid to patients with heart failure.
Careful clinical and laboratory monitoring during the use of the drug is recommended for patients with the following conditions: hepatic insufficiency, risk of onset or worsening of pre-existing neurological disorders associated with hyperammonemia; renal insufficiency, especially in the presence of hyperkalemia, the presence of risk factors contributing to the onset or worsening of metabolic acidosis, and azotemia due to impaired renal clearance. With prolonged use of the drug (several weeks), blood parameters and coagulation factors should be carefully monitored.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug should only be used in a hospital setting.
Use during pregnancy or breastfeeding
No specific studies have been conducted to determine the safety of Nephrotect during pregnancy or breastfeeding. Before prescribing Nephrotect to pregnant or breastfeeding women, the benefit/risk ratio should be assessed.
Method of administration and doses
Nephrotect is intended for intravenous administration. The dosage should be selected individually.
Unless otherwise prescribed, patients with acute and chronic renal failure should be administered:
for patients not on dialysis:
0.6–0.8 g of amino acids per 1 kg of body weight per day, which corresponds to 6–8 ml per 1 kg of body weight per day;
for patients on dialysis:
0.8–1.2 g of amino acids per 1 kg of body weight per day, which corresponds to 8–12 ml per 1 kg of body weight per day;
for parenteral nutrition during long-term hemodialysis:
0.5–0.8 g of amino acids per 1 kg of body weight/dialysis, which corresponds to 5–8 ml per 1 kg of body weight/dialysis.
Maximum recommended daily dose: 0.8–1.2 g of amino acids per 1 kg of body weight, which corresponds to 8–12 ml per 1 kg of body weight, or 560–840 ml per day for patients weighing 70 kg.
Maximum recommended injection speed:
parenteral nutrition:
0.1 g of amino acids per 1 kg of body weight per hour, which corresponds to 1 ml per 1 kg of body weight per hour;
Parenteral nutrition during hemodialysis:
0.2 g of amino acids per 1 kg of body weight per hour, which corresponds to 2 ml per 1 kg of body weight per hour. In general, when carrying out parenteral nutrition, amino acids should be administered in combination with infusion solutions that are sources of energy. When carrying out total parenteral nutrition, Nephrotect should be used together with electrolytes, sources of energy, vitamins and trace elements. Nephrotect together with other nutrients can be administered into central or peripheral veins.
Nephrotect can be administered through a separate infusion system or can be mixed under aseptic conditions with other solutions.
When used during the dialysis procedure itself, Nephrotect can be injected directly into the injection port of the dialysis machine.
Amino acid solutions, including Nephrotect, should generally be used in combination with carbohydrates and lipids. The exception is the use of amino acid supplements during the dialysis procedure itself, during which a dialysate containing glucose may be used. The duration of use depends on the clinical condition of the patient.
Children
Currently, there is no clinical experience with the use of Nephrotect in children.
Overdose
If the dosage or rate of administration of Nephrotect is exceeded, the following may occur: nausea, chills, vomiting, fever, hyperammonemia, hyperaminoacidemia and acidosis; in some patients, an increase in the excretion of amino acids by the kidneys is possible. In this case, the administration of the drug must be stopped immediately. Therapy is symptomatic.
If signs of overdose appear, the infusion should be stopped immediately. It may be resumed at a reduced dosage. Too rapid an infusion may cause fluid overload and electrolyte imbalance.
There is no specific antidote for overdose. Emergency treatment should be general supportive with special attention to respiratory and cardiovascular functions. Monitoring of biochemical parameters and appropriate treatment of identified abnormalities are essential.
Adverse reactions
No adverse reactions have been observed when used correctly. Administration of the drug into a peripheral vein may cause irritation of the venous walls and thrombophlebitis.
In case of an overdose of the drug, general weakness, headache, increased body temperature sometimes occur; tachycardia, increased heartbeat; hypersensitivity reactions, including rash, skin hyperemia, itching; bronchospasm, shortness of breath, decreased blood pressure up to shock; reactions at the injection site; feeling of chills, nausea, vomiting, increased excretion of amino acids through the urinary tract; these phenomena disappear when the drug is discontinued.
Expiration date
2 years.
Do not use after the expiration date.
Storage conditions
Keep out of the reach of children. Store at a temperature not exceeding 25 °C.
Do not freeze!
Packaging
Solution for infusion in glass bottles of 250 ml.
Vacation category
According to the recipe.
Producer
Location of the manufacturer and its business address
Hafnerstrasse 36, 8055 Graz, Austria.
