Aminoplasmal Hepa
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Aminoplasmal Hepa is a drug for parenteral nutrition in liver failure, normalizing Fisher's coefficient, the level of aromatic and branched-chain amino acids, reducing the severity of symptoms of hepatic encephalopathy, reducing blood ammonia concentration.
Release form and composition
Dosage form of the drug - solution for infusion 10%: clear, colorless or pale yellow liquid (500 ml each in 2 class hydrolytic glass bottles, sealed with a brick-colored rubber stopper, brick-red aluminum cap and gray plastic plug; for hospitals - 10 bottles in a cardboard box).
1 ml of solution contains active ingredients:
- Alanine - 8.3 mg;
- Arginine - 8.8 mg;
- Asparagine monohydrate - 0.55 mg (equivalent to 0.48 mg of asparagine);
- Aspartic acid - 2.5 mg;
- Acetyltyrosine - 0.86 mg (equivalent to 0.7 mg of tyrosine);
- Acetylcysteine - 0.8 mg (equivalent to 0.59 mg of cysteine);
- Valine - 10.6 mg;
- Histidine - 4.7 mg;
- Glycine - 6.3 mg;
- Glutamic acid - 5.7 mg;
- Isoleucine - 8.8 mg;
- Leucine - 13.6 mg;
- Lysine monoacetate - 10.6 mg (equivalent to 7.15 mg of lysine);
- Methionine - 1.2 mg;
- Ornithine hydrochloride - 1.66 mg (equivalent to 1.3 mg of ornithine);
- Proline - 7.1 mg;
- Serine - 3.7 mg;
- Threonine - 4.6 mg;
- Tryptophan - 1.5 mg;
- Phenylalanine 1.6 mg
Auxiliary components: sodium hydroxide or hydrochloric acid (from 0 to 2.0 mmol), disodium edetate dihydrate, water for injection.
Concentration of electrolytes in solution (mmol / l):
- Acetates - 51;
- Chlorides - 10.
Physicochemical characteristics:
- pH - from 5.5 to 6.5;
- Caloric content - 1675 kJ / l (400 kcal / l);
- Total nitrogen - 15.3 g / l;
- Amino acid content - 100 g / l;
- The theoretical osmolarity is 875 mOsm / L.
Indications for use
Aminoplasmal Hepa is used for parenteral nutrition in case of a violation of the amino acid balance, which occurs in chronic or acute liver diseases, as well as for the prevention and treatment of hepatic encephalopathy.
Given the specificity of the amino acid composition, the solution must be used exclusively for the indicated indications. The use of the drug in other cases can lead to disorders of amino acid metabolism.
Contraindications
- Severe acidosis;
- Hyperhydration;
- Severe hypokalemia;
- Severe hyponatremia;
- Severe circulatory disorders (shock);
- Disorders of amino acid metabolism of extrahepatic etiology;
- Pulmonary edema;
- Pregnancy and breastfeeding period;
- Children under 2 years old;
- Hypersensitivity to any of the components.
The solution is used with caution in patients with an increased level of plasma osmolarity.
Method of administration and dosage
Aminoplasmal Hepa solution is intended for intravenous administration using a central venous catheter.
It is required to observe the following rules for using the drug:
- The dose of solution contained in 1 bottle is calculated for a single use;
- Any unused volume of the drug is not subject to further storage and must be disposed of;
- The preparation is not suitable for use if there are obvious traces of damage on the bottle, the tightness is broken, the solution is not transparent.
If there are no other prescriptions, taking into account the individual needs of patients, it is recommended to use the solution in the following doses:
- Adults, standard dose: per kg of body weight per day - 7-10 ml, which corresponds to 700-1000 mg of amino acids;
- Adults, maximum dose: per kg of body weight per day - 15 ml, which corresponds to 1500 mg of amino acids;
- Children from 2 years old, standard dose: per kg of body weight per day - 7-10 ml, which corresponds to 700-1000 mg of amino acids.
In the case of prescribing Aminoplasmal Hepa solution to children, the child's age, nutritional status and main diagnosis are especially carefully considered.
If it is necessary to switch to complete parenteral nutrition, carbohydrates, trace elements, vitamins and essential fatty acids should also be administered.
In patients with hepatic encephalopathy, at the beginning of therapy, it is recommended to inject the solution at a high rate, until a clinically significant improvement occurs.
The recommended infusion rate for a patient weighing 70 kg:
- The first 2 hours: 50 drops / min, which corresponds to ~ 150 ml / h or 2 ml / kg / h;
- 3rd-4th hour: 25 drops / min, which corresponds to ~ 75 ml / h or 1 ml / kg / h;
- From the 5th hour: 15 drops / min, which corresponds to ~ 45 ml / h or 0.6 ml / kg / h;
- Parenteral nutrition, supportive therapy: 15-25 drops / min, which corresponds to ~ 45-75 ml / h or 0.6-1 ml / kg / h.
The drug is used for parenteral nutrition until the threat of hepatic encephalopathy is eliminated.
Side effects
In the case of strict adherence to the rate of administration of the solution, the dosage of the drug and the recommended precautions during the infusion, there are no side effects, but the possibility of developing hypersensitivity reactions cannot be ruled out.
In case of an overdose or exceeding the recommended infusion rate, there may be observed: nausea, vomiting, chills, increased renal excretion of amino acids. In this case, the administration of the drug must be stopped immediately and resumed after a while, reducing the infusion rate.
special instructions
It is forbidden to inject Aminoplasmal Hepa solution into peripheral veins.
In renal failure, the amino acid dose is adjusted according to the serum creatinine and urea levels.
The use of amino acid solutions for the treatment of hepatic encephalopathy does not exclude other established therapeutic measures.
The complex use of other nutrients simultaneously with the infusion of the amino acid composition has been shown: the introduction of an adequate amount of carbohydrates, the use of electrolytes in accordance with the needs, etc.
During therapy, it is necessary to control the concentration of glucose in the blood, water-electrolyte balance, plasma osmolarity, acid-base balance and liver function. The method of control and the frequency of its implementation depend on the severity of the patient's condition and the severity of the course of the disease.
The duration of infusion of a solution from one bottle should not exceed 24 hours.
Drug interactions
At the moment, there is no data on the drug interaction of the amino acid complex with other substances / drugs.
Due to the danger of physicochemical incompatibility and bacterial contamination, it is not recommended to add drugs to the Aminoplasmal Hepa solution, it is preferable to include them in standard solutions of electrolytes or carbohydrates. This does not exclude the possibility of mixing other solutions for parenteral nutrition with Aminoplasmal Hepa after testing for their compatibility.
Analogs
Analogs of the drug Aminoplasmal Hepa are: Hymix, Dipeptiven, Aminoven, Aminoven Infant, Nephrotect.
Terms and conditions of storage
Store in a dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children. Do not freeze!
The shelf life is 3 years.
Terms of dispensing from pharmacies
Released for hospitals.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
