Product name: Novamin
Dosage form: solution for infusion
1000 ml of solution contain:
L-proline – 1 g
L-serine – 1 g
L-alanine – 2 g
L-isoleucine – 3.52 g
L-leucine – 4.9 g
aspartic acid – 2.5 g
tyrosine – 0.25 g
L-glutamic acid – 0.75 g
L-phenylalanine – 5.33 g
L-arginine hydrochloride – 5 g
L-litsinmonogidrohlorid – 4.3 g
L-histidine hydrochloride – 2.5 g
L-Valine – 3.6 g
L-Threonine – 2.5 g
L-Tryptophan – 0.9 g
L-methionine – 2.25 g
L-cysteine - 0.1 g
glycine – 7.6 g
sorbitol – 50 g
Sodium hydrogensulfite – 0.5 g
excipient: water for injection.
Description: transparent colorless or nearly colorless liquid colors.
Pharmacotherapeutic group: Plasma substitutes and perfusion solutions. Preparations for parenteral nutrition.
Dosage form: 250 ml or 500 ml of the product in a glass vial.
Storage conditions: In a dry, dark place at a temperature not vyshe25oC
Use only clear solutions in intact vials.
After opening the vial the drug should be used immediately.
Shelf life: 2 Years
Conditions of supply of pharmacies: With recipe
Solution for parenteral nutrition. The structure includes all necessary essential, conditionally-essential (L-arginine and L-histidine) and nonessential amino acids in a ratio giving the possibility of complete protein synthesis in the body. Amino acids contained in the product are mainly in the L-form that enables their direct role in the biosynthesis of proteins. Sorbitol is the source of energy in the body and metabolized without insulin. The amount of electrolytes that are part of the preparation, covers the normal needs of the body. The optimum ratio of essential and all the essential amino acids provides a good environment for the relief of inflammatory processes of reparative regeneration of damaged tissue, to improve the functional state of life-support systems, as well as the prevention of azotemia and uremia. Parenteral administration of amino acids solution for conditions involving protein deficiency catabolism and leads to the restoration of normal blood protein composition. Aminoselmen maintains homeostasis and does not disturb the balance of the body’s amino acids even in the case of metabolic stress. The drug is clinically well tolerated.
Aminoselmen bioavailability of the drug is 100%.
The concentration of free amino acids in the plasma is subject to significant fluctuations, this applies to both individual amino acids and their total concentration. After administration of the drug immediately amino acids are included in the process of protein synthesis and metabolic processes in the body. Excessive amounts of amino acids are not included in the synthesis of proteins and other biomolecules, is not accumulated (as distinct from fatty acids and glucose), and cleaved by dezaminirovaniyaα-amino group which is metabolized to form urea which is excreted by the kidneys. Only a small part of the amino acid (5%) is excreted unchanged. Sorbitol is independent of the source of insulin uglevodov.Natriya acetate, potassium acetate, magnesium acetate and sodium dihydrogen dissotsiiruya in solution cations and anions, hyperosmolarity provide a solution, as elements to maintain homeostasis.
• Full or partial parenteral nutrition;
• replenishment of protein, loss of fluid and electrolytes in the impossibility of enteral nutrition;
• prevention and treatment of protein deficiency of various origins (for burns, surgery, blood loss);
• severe cases of gastrointestinal diseases (intestinal obstruction, peritonitis, malabsorption syndrome, intestinal fistulas, inflammatory intestinal diseases, pancreatitis);
• other cases requiring parenteral nutrition (malignant tumor before and after surgery).
Dosing and Administration
The drug is administered intravenously, slowly, carefully monitoring the patient’s condition. Novamin Dose selected individually for each patient according to the age, body weight and severity of the patient’s condition.
Novamin assigned based adults: amino acids 100-150 mg / kg of patient weight per hour, which corresponds to 20-30 ml / kg / day. injection speed: 60 drops per minute, which corresponds to 180 mL / h. The maximum daily dose of 2 g amino acid / kg (corresponding to 40 ml / kg / day).
In hepatic and renal failure requiring correction mode: protein requirement is 0.8-1.1 g / kg / day (16-22 ml / kg / day) .Prodolzhitelnost applications: to complete the transition to the oral or enteral nutrition.
• sanguinis, vel bacterial fungal thrombophlebitis per damnum ad venis insertionem per foramen acus;
• arcent, anaphylactic reactiones.
• sudor augebat, nausea, vomitus, gelat, Tachycardia (praesertim Lorem iniectio);
• penuria of folate (folic acid quotidie attractio sit necessaria);
• incrementum in iecur enzymes;
• hemorrhage, bacterial or fungal thrombophlebitis caused by damage to the veins during insertion of the needle;
• hives, anaphylactic reactions.
• increased sweating, nausea, vomiting, chills, tachycardia (especially at high speed injection);
• shortage of folate (folic acid is needed daily intake);
• increase in liver enzymes;
• Preparation incompatible with other drugs (not to be confused with other uncontrolled drugs).
• Simultaneous administration of arginine with thiazide diuretics and aminophylline increases the amount of insulin in the blood.
• With simultaneous use of arginine with spironolactone may develop tyazheloygiperkaliemii.
• Estrogen and oral contraceptives, while the use Aminoselmen can strengthen increase growth hormone levels caused by arginine, and reduce glucagon and insulin response to arginine. Insulin prevents hyperkalemia, which can cause arginine.
• With the introduction of the drug should be taken into account that arginine is incompatible with sodium thiopental.
• Caution should be used should be carried out slowly with increased osmolarity syvorotki.Inektsiyu as the rapid introduction of amino acids leads to a rapid excretion of unchanged in the body and their effect is lost.
• It is necessary to control the water and electrolyte balance of the blood, the concentration of glucose in the blood, acid-base composition and condition of the liver and kidneys.
• For a complete parenteral nutrition is necessary the simultaneous addition of vitamins and minerals.
• Caution should be exercised when using the drug in patients with liver disease, in which the introduction of large amounts of amino acids can cause the development of hepatic encephalopathy; in sepsis; hyperthermia of unknown etiology; patients who need to limit fluid intake, including those with hypertension; while the use of sodium thiopental, spironolactone, thiazide diuretics, aminophylline.
• Due to the high risk of microbial contamination of solutions containing amino acids, should not be mixed with other drugs.
• Use only clear solution from the bottle intact.
• Features of influence on the ability to drive a vehicle and potentially dangerous machinery
• The drug is used only in a hospital.
• The product should be stored out of reach of children and do not use after the expiry date!
• Symptoms: The administration of high doses or too fast skorostinfuzii drug can lead to acidosis, impaired liver and kidney function, acute failure of the left ventricle of the heart, pulmonary edema, hyperammonemia, hyperkalemia.
• Treatment: the introduction of the drug should be discontinued. Treatment is symptomatic. No specific antidote. To eliminate the need to enter hyperkalemia 200-500 ml of 10% glucose solution with 1.3 units of insulin per 3.5 g of glucose. In life-threatening conditions, should undertake dialysis.
• Hemodynamic instability with life-threatening (shock);
• heart failure decompensation stage;
• severe renal and hepatic failure;
• amino acid metabolism disorders;
• metabolic acidosis;
• pregnancy and lactation;
• Children up to age 18 years.