Gep's aminoplasmal

Gep's aminoplasmal – the drug for parenteral food at a liver failure normalizing Fischer's coefficient, level of aromatic amino acids and amino acids with a branched chain reducing expressiveness of symptoms of hepatic encephalopathy, reducing concentration of ammonia in blood.

Form of release and structure

Dosage form of drug – solution for infusions of 10%: transparent, colourless or pale yellow liquid (on 500 ml in bottles of hydrolytic glass 2 classes corked brick color by a rubber bung, brick-red color an aluminum cap and gray color a plastic cap; for hospitals – on 10 bottles in a box cardboard).

1 ml of solution contain active ingredients:

• Alanine – 8,3 mg;
• Arginine – 8,8 mg;
• Asparagine monohydrate – 0,55 mg (0,48 mg of asparagine are equivalent);
• Aspartic acid – 2,5 mg;
• Atsetiltirozin – 0,86 mg (0,7 mg of tyrosine are equivalent);
• Acetylcysteinum – 0,8 mg (0,59 mg of cysteine are equivalent);
• Valine – 10,6 mg;
• Histidine – 4,7 mg;
• Glycine – 6,3 mg;
• Glutaminic acid – 5,7 mg;
• Isoleucine – 8,8 mg;
• Leucine – 13,6 mg;
• Lysine monoacetate – 10,6 mg (7,15 mg of a lysine are equivalent);
• Methionine – 1200 mg;
• Ornithine a hydrochloride – 1,66 mg (1,3 mg of ornithine are equivalent);
• Proline – 7,1 mg;
• Serine – 3,7 mg;
• Threonine – 4600 mg;
• Tryptophane – 1500 mg;
• Phenylalanine – 1600 mg.

Auxiliary components: sodium hydroxide or Acidum hydrochloricum (from 0 to 2,0 mmol), dinatrium of an edetat a dihydrate, water for injections.

Concentration of electrolytes in solution (mmol/l):

• Acetates – 51;
• Chlorides – 10.

Physical and chemical characteristics:

• pH – from 5,5 to 6,5;
• Caloric content – 1675 kJ/l (400 kcal/l);
• The general nitrogen – 15,3 g/l;
• Content of amino acids – 100 g/l;
• Theoretical osmolarity – 875 ¼Äß¼/l.

Indications to use

Gep's aminoplasmal is used for parenteral food in case of disturbance of amino-acid balance which arises at chronic or acute diseases of a liver, and also for the purpose of the prevention and therapy of hepatic encephalopathy.

Considering specifics of amino-acid structure, solution is required to be applied only according to the listed indications. Use of drug in other cases can lead to disturbances of amino-acid exchange.

Contraindications

• The expressed acidosis;
• Overhydratation;
• The expressed hypopotassemia;
• The expressed hyponatremia;
• Disturbances of blood circulation of heavy degree (shock);
• Disturbances of exchange of amino acids of an extrahepatic etiology;
• Fluid lungs;
• Pregnancy and period of breastfeeding;
• Children's age up to 2 years;
• Hypersensitivity to any of components.

With care solution is applied at patients with the increased level of osmolarity of plasma.

Route of administration and dosage

Solution Aminoplazmal Gepa is intended for intravenous administration with use of the central venous catheter.

It is required to follow the following rules of use of drug:

1. The solution dose which is contained in 1 bottle is counted on single use;
2. Any unused volume of drug is not subject to further storage and has to be utilized;
3. Drug is not suitable for use if on a bottle explicit traces of damages are visible, tightness is broken, solution is not transparent.

If there are no other instructions, taking into account individual needs of patients, it is recommended to use solution in the following doses:

• Adults, standard dose: on body weight kg a day – 7-10 ml that corresponds to 700-1000 mg of amino acids;
• Adults, maximum dose: on body weight kg a day – 15 ml that corresponds to 1500 mg of amino acids;
• Children since 2 years, a standard dose: on body weight kg a day – 7-10 ml that corresponds to 700-1000 mg of amino acids.

In case of purpose of solution Aminoplazmal Gepa to children is especially carefully considered age of the child, his nutritsionny status and the main diagnosis.

In need of transition to full parenteral food it is also necessary to enter carbohydrates, microelements, vitamins and irreplaceable fatty acids.

Patients with hepatic encephalopathy at the beginning of therapy are recommended to enter solution with a high speed, before clinically significant improvement.

The recommended infusion speed for the patient weighing 70 kg:

• First 2 hours: 50 caps/min. that there correspond ~ 150 ml/h or 2 ml/kg/h;
• 3-y-4-y hour: 25 caps/min. that there correspond ~ 75 ml/h or 1 ml/kg/h;
• From the 5th o'clock: 15 caps/min. that there correspond ~ 45 ml/h or 0,6 ml/kg/h;
• Parenteral food, maintenance therapy: 15-25 caps/min. that there correspond ~ 45-75 ml/h or 0,6-1 ml/kg/h.

Use drug for parenteral food up to elimination of threat of development of hepatic encephalopathy.

Side effects

In case of strict observance of rate of administering of solution, a dosage of drug and the recommended precautionary measures when performing infusion, side effects are absent, but it is impossible to exclude a possibility of development of reactions of hypersensitivity.

At overdose or exceeding of the recommended speed of infusion can be observed: nausea, vomiting, fever, increase in excretion of amino acids kidneys. In that case administration of drug is required to be stopped and resumed immediately after a while, having reduced infusion speed.

Special instructions

It is forbidden to enter solution Aminoplazmal Gepa into peripheral veins.

At a renal failure the dose of amino acids korrigirutsya depending on the level of creatinine and urea in serum.

Use for treatment of hepatic encephalopathy of solutions of amino acids does not exclude other established therapeutic measures.

Complex use of other nutrients along with infusion of amino-acid structure is shown: introduction of adequate amount of carbohydrates, use of electrolytes according to requirements, etc.

In the course of therapy control of concentration of glucose in blood, water and electrolytic balance, osmolarity of plasma, acid-base balance and function of a liver is necessary. The way of control and frequency of its carrying out depend on weight of a condition of the patient and sharpness of course of a disease.

Duration of infusion of solution from one bottle should not be more than 24 hours.

Medicinal interaction

At the moment there are no data on medicinal interaction of a complex of amino acids with other substances / drugs.

Because of danger of physical and chemical incompatibility and bacterial contamination Aminoplazmal Gepa is not recommended to add to solution medicines, it is preferable to include them in standard solutions of electrolytes or carbohydrates. It does not exclude a possibility of mixing of other solutions for parenteral food with Aminoplazmal Gepa after conducting check on their compatibility.

Terms and storage conditions

To store in the dark place, at a temperature not above 25 °C. To protect from children. Not to freeze!

Period of validity – 3 years.