INSTRUCTIONS FOR MEDICAL USE
INFAZ-40
Trade name of drug: INFAZ-40
Active ingredients (INN): Amino acids: L-Alanine, Glycine, L-Arginine hydrochloride, L-Aspartic acid, L-Glutamic acid, L-Histidine hydrochloride monohydrate, L-Isoleucine, L-Lysine hydrochloride, L-Methionine, L-Leucine, L-Phenylalanine, L-Threonine, L-Tryptophan, L-Valine, Potassium chloride, Magnesium chloride hexahydrate, Xylite.
Dosage form: solution for infusion.
Contents:
100 ml of the solution contains:
Active ingredients:
L-Alanine – 0.4 g
Glycine – 0,7 g
L-Arginine – 0,455 g
L-Aspartic acid – 0,2 g
L-Glutamic acid – 0,5 g
L-Histidine – 0,135 g
L-Isoleucine – 0,210 g
L-Lysine hydrochloride (lysine equivalent) – 0,25 g (0,2 g)
L-Methionine – 0,175g
L-Leucine – 0,275 g
L-Phenylalanine – 0,315g
L-threonine – 0,160g
L-Tryptophan – 0.050g
L-Valine – 0.225g
Potassium chloride – 0.186g
Magnesium chloride hexahydrate – 0.051g
xylitol – 5.0 g
Excipients: Sodium hydroxide, sodium metabisulfite (sodium disulfite), sodium acetate trihydrate, water for injection up to 100 ml.
Description: Transparent liquid of almost colorless to yellow color.
Characteristics:
Sodium ions – 40.2 mmol/L.
Potassium ions – 25.0 mmol/l
Magnesium ions – 2.5 mmol/l
Chloride ions – 43.6 mmol/l
Acetate ions -25.0 mmol/l
Theoretical osmolarity: 801.8 mOsm/L
pH value: 5,7-7,0
titratable acidity max
(recalculated to blood pH value) +11.6 mmol/l
Energy content (total): 1551.0 kJ/l
Total nitrogen: 6.3 g/l
Pharmacotherapeutic group: parenteral nutrition agent, amino acids.
ATX code: B05BA10
Pharmacological properties
Pharmacodynamics
L-amino acid infusion solution for parenteral nutrition. Amino acids are components required for protein synthesis. Amino acids contained in preparation are in L-form, which enables their direct participation in protein biosynthesis. Solutions containing amino acids are used for parenteral nutrition simultaneously with energy carriers, electrolytes and fluids, in order to maintain or improve body condition or minimize weight loss. In pathological conditions in the absence of exogenous administration of amino acids, a typical pronounced change in the set of amino acids in the blood plasma develops, both the absolute concentration of individual amino acids and their percentage ratio in the blood plasma.
The preparation contains all eight essential amino acids as well as conditionally substituted L-arginine and L-histidine. L-arginine promotes the conversion of ammonia into urea and binds toxic ammonium ions, which are formed during protein catabolism in the liver. L-amino acids are involved in anabolic processes (protein synthesis), slow down catabolic processes, accelerate repair processes, are part of the buffer system regulating homeostasis of extra- and intracellular body fluids. Xylitol is a source of calories, its metabolites are involved in glycolysis and gluconeogenesis.
Pharmacokinetics
Bioavailability of the preparation is 100%. After drug administration, amino acids are included in the process of protein synthesis. Excessive amino acids that are not included into synthesis of proteins and other biomolecules are not accumulated (unlike fatty acids and glucose), but are broken down by deamination of α-amino group, which is metabolized to form urea. The latter is excreted by the kidneys. Only a small part of amino acids (5%) is excreted unchanged.
Indications for use
Parenteral protein nutrition for:
- Hypoproteinemia and fluid loss of different genesis;
- Inability or severe limitation of food intake in the usual way in pre- or postoperative periods;
- Extensive deep burns (especially burn exhaustion);
- Trauma, fractures, purulent processes, sepsis;
- inflammatory bowel diseases, cachexia, poisoning;
- malignant tumors of the gastrointestinal tract, permanent febrile states;
- in children with protein dystrophy, hypotrophy, gastrointestinal malformations.
Do not use the drug secondarily from the vial, which has already been used.
Use only clear solution in an undamaged bottle!
Failure to observe storage and transportation conditions may lead to formation of microcracks on the vial, thus increasing the risk of microbial contamination of the solution.
For single-use sampling only!
Do not freeze or heat!
Dosages and methods of administration
The drug is administered intravenously (IV) dropwise, slowly with careful monitoring of the patient’s condition. Dosage is adjusted for the patient’s clinical condition and his requirements for amino acids and fluids, body weight and degree of catabolism.
Adults: 0.6 to 1.0 g amino acids (up to 20 ml of the solution/kg of body weight per day).
In catabolic states: 1.3 to 2 g amino acids (up to 40 ml of solution/kg of body weight per day).
Children aged 2 to 18 years: 1.0 to 2.0 g amino acids (up to 40 ml of solution/kg of body weight per day).
Maximum daily dose is 2.0 g amino acids (up to 40 ml of solution/kg body weight).
Maximum infusion rate: 2 ml/kg body weight per hour, which equals 0.1 g amino acids/kg body weight per hour.
When parenteral nutrition in adults, the total amount of injected fluid should not exceed 40 ml/kg of body weight per day. The drug is used until the patient is fully transferred to enteral or oral feeding.
Side effects
Usually the drug is well tolerated. Nausea, vomiting, chills, phlebitis (especially if administered quickly) may occur in single cases. Due to the drug content of sodium disulfite in single cases (especially in patients with bronchial asthma) hyperergic reactions, vomiting, diarrhea, dyspnea, bronchial asthma attacks, loss of consciousness, shock are possible. In addition, the products of interaction of sodium disulfite with another component of the drug – tryptophan – may increase bilirubin content and activity of liver enzymes in the blood plasma.
Contraindications
- Unstable and life-threatening circulation (shock);
- Hypoxia (insufficient oxygen supply to cells);
- Severe hepatic and renal failure;
- Heart failure in decompensation stage;
- Amino acid metabolism disorders;
- Metabolic acidosis;
- Acute period of craniocerebral trauma;
- Hypersensitivity to the drug components, coma or cerebral dysfunction, which may cause coma.
Drug Interactions
Should not be mixed with other drugs in the same solution.
Special indications
It is possible to use during pregnancy and lactation period as indicated.
The drug is used only under hospital conditions.
Use with caution in case of increased serum osmolarity.
Correction of dosage regimen is required in case of moderate hepatic and renal insufficiency.
Blood water and electrolyte balance, blood glucose concentration and acid-base balance should be controlled.
Complete parenteral nutrition requires simultaneous addition of substances – energy carriers, electrolytes, vitamins and trace elements. After opening the bottle the drug should be used immediately. Do not store opened vial.
If necessary to improve metabolic and reparative processes in the postoperative period.
Replenishment or elimination of protein deficiency resulting from increased need or cost and from protein metabolism disorders during digestion, absorption and excretion.
Overdose
No data on drug overdose are given.
Form of production
Infusion solution in 100 ml, 200 ml and 250 ml vials.
Storage conditions
Store in a dark place at temperatures not exceeding 25°C. Keep out of the reach of children!
Shelf life
2 years. Do not use after the expiration date.
Conditions of dispensing from pharmacies
Released by a doctor’s prescription.