Aminoplasmal E15 - instructions for use, dose, side effects, contraindications

Active substances:
Isoleucine	5.850 grams
Leucine	11,400 grams
Lysine monohydrate	3,000 grams
(corresponds to lysine)	2.670 g
Lysine hydrochloride	6.600 grams
(corresponds to lysine)	5.280 g
Methionine	5,700 g
Phenylalanine	5,700 g
Threonine	5,400 grams
Tryptophan	2,100 g
Valine	7,200 g
Arginine	16,050 g
Histidine	5.250 g
Alanin	22,350 g
Glycine	19,200 g
Aspartic acid	7.950 g
Glutamic acid	16,200 grams
Proline	7,350 g
Serin	3,000 grams
Tyrosine	0.500 grams
Acetylcysteine	0.500 grams
(corresponding to cysteine)	0.370 g
Potassium acetate	2.945 g
Magnesium acetate tetrahydrate	0.558 g
Sodium dihydrogen phosphate dihydrate	1.404 g
Excipients:
Sodium hydroxide	1.651 grams
Citric acid monohydrate	0.200-0.400 g
Water for injections	up to 1000 ml

Concentration of electrolytes:

Sodium 50 mmol / l

Potassium 30 mmol / l

Magnesium 2.6 mmol / l

Chloride 36 mmol / l

Acetates 35 mmol / l

Dihydrogen phosphates 9 mmol / l

Amino acid content 150 g / l

Total nitrogen 24 g / l

The energy value of 835 kJ / l (200 kcal / l)

Physico-chemical characteristics:

Theoretical osmolality 588 mOsm / l

pH from 5.7 to 6.3

Description:A clear, colorless or pale yellow solution.

Pharmacotherapeutic group:nutrition parenteral remedy

ATX: & nbsp

B.05.B.A Solutions for parenteral nutrition

Pharmacodynamics:

Mechanism of action

The task of parenteral nutrition is the supply of all nutrients necessary for the growth, functioning and regeneration of body tissues, etc.

Amino acids are especially important, as some of them are indispensable for protein synthesis. Intravenously introduced amino acids are included in the appropriate intravascular and intracellular amino acid pools. Exogenous, as well as endogenous amino acids, are a substrate for the synthesis of functional and structural proteins.

To prevent the inclusion of amino acids in metabolism as a source of energy, as well as providing other body processes, simultaneous administration of 15 energy donors, such as fat emulsions and carbohydrate solutions, is necessary with the preparation of Aminoplasmal.

Pharmacokinetics:

Suction

Bioavailability of all components of the drug Aminoplasmal E 15 with intravenous administration is 100%.

Distribution

Amino acids are included in the structure of proteins of various body tissues. In addition, each amino acid is present in a free form in the blood and inside the cells.

The composition of the amino acid solution is based on the results of clinical studies of the metabolism of intravenously administered amino acids.The content of amino acids in the solution is selected in such a way that when the drug is administered, a uniform increase in the concentrations of all amino acids in the plasma is achieved. Thus, during the infusion of the drug, the physiological ratio of amino acids in the plasma is maintained, i.e. amino acid homeostasis.

Normal growth and development of the fetus depends on the continuous supply of amino acids from the mother. The placenta is responsible for the transfer of amino acids from the mother to the fetus.

Biotransformation

Amino acids not involved in the synthesis of proteins are metabolized as follows: as a result of transamination, the amino groups are separated from the carbon skeleton, then the carbon chains or oxidized to CO₂, or used as a substrate in the reaction of gluconeogenesis in the liver. Amino groups of metabolic are erysed in the liver to urea.

Excretion

Small amounts of amino acids are excreted unchanged in the urine.

Indications:The introduction of amino acids and a limited number of electrolytes for parenteral nutrition, when normal food intake or enteral nutrition is not possible, insufficient or contraindicated.

Contraindications:

Hypersensitivity to active ingredients or any of the excipients;
Congenital disorders of amino acid metabolism;
Severe hepatic impairment;
Severe renal failure in the absence of hemofiltration or hemodialysis;
High and uncorrectable concentration in the blood plasma of any of the electrolytes that make up the drug;
Children under 2 years.

General contraindications for parenteral nutrition:

Severe circulatory disorders with a life threat (eg, shock);
Severe hypoxia;
Pronounced metabolic acidosis;
Decompensated heart failure;
Pulmonary edema;
Hyperhydration.

Carefully:

For violations of the amino acid metabolism, which are not congenital, the drug should be prescribed only in cases where the expected benefit of the treatment exceeds the possible risk of complications.

Care should be taken when infusing large volumes of fluid to patients with heart failure.

Caution should be exercised in patients with increased plasma osmolality.

Pregnancy and lactation:

Pregnancy

Sufficient clinical data on the use of Aminoplasmal E 15 during pregnancy is not available. The use of the drug during pregnancy is possible if the expected benefit to the mother exceeds the risk to the fetus.

Breastfeeding period

Amino acids / metabolites of the drug Aminoplasmal E15 penetrate into breast milk, but if the dosage regimen is not observed, effects on the newborn / infants are not expected. Nevertheless, when carrying out parenteral nutrition, breast-feeding is not recommended.

Dosing and Administration:

Mode of application

Intravenously.

Only for insertion into the central veins.

Doses

Doses are selected in accordance with the individual need for amino acids, electrolytes and liquid, and also depending on the clinical state of the patient (nutritional status and / or severity of nitric catabolism with concomitant disease).

Adults

Daily dose:

6.7 - 13.3 ml / kg body weight, corresponding to 1.0-2.0 g of amino acid / kg body weight or 469 - 931 ml for a patient with a body weight of 70 kg.

Maximum injection rate:

0.67 ml / kg body weight / hour, corresponding to 0.1 g amino acid / kg body weight / hour or 0.78 ml / min for a patient weighing 70 kg.

Patients of childhood

Aminoplasmal E 15 is contraindicated in children under 2 years of age.

Recommendations for doses for children are based on average needs. The dose should be selected individually depending on the age, stage of development and severity of the disease.

Daily dose:

For children from 2 to 4 years:

10 ml / kg of body weight, corresponding to 1.5 g of amino acids / kg of body weight.

For children from 5 to 13 lay down:

6.7 ml / kg of body weight, which corresponds to 1.0 g of amino acids / kg of body weight.

Patients of childhood in critical condition:

In children of critical age, the recommended dose of amino acids can be increased (up to 3.0 g of amino acids / kg of body weight / day). Maximum injection rate:

0.67 ml / kg body weight / hour, which corresponds to 0.1 g of amino acids / kg body weight / hour.

Patients with renal / hepatic insufficiency

In patients with hepatic or renal insufficiency, doses should be selected individually. Aminoplasmal E 15 is contraindicated in severe hepatic insufficiency and severe renal failure.

Duration of application

Limitations on the duration of drug use have not been identified.

Side effects:

When observing the recommendations for the use of undesired reactions is not observed.

Overdose:

Symptoms

Overdose or too rapid introduction of the drug can lead to such violations as nausea, vomiting, chills, headache, metabolic acidosis and increased excretion of amino acids by the kidneys.

Therapy

In cases of overdose symptoms, the drug infusion should be discontinued and resumed later at a slower rate.

Interaction:

Drug interactions with other drugs are not known.

Aminoplasmal E 15 should not be supplemented with other drugs or components unless compatibility is established. After adding other preparations, the contents of the bottle should be shaken thoroughly. Information on compatibility with other drugs (eg, electrolytes, trace elements, vitamins) and shelf life after mixing can be provided by the manufacturer on request.

Special instructions:

Care should be taken when infusing large volumes of fluid to patients with heart failure.

Caution should be exercised in patients with increased plasma osmolality. Before the onset of parenteral nutrition, such water-electrolyte disorders as hypotonic dehydration, hyponatremia and hypokalemia should be corrected.

Constant monitoring should include water-electrolyte balance, blood glucose concentration, acid-base state and kidney function.

The concentration of the plasma protein of the blood and functional tests of the liver should also be monitored.

In patients with renal failure, the dose of the drug should be carefully selected in accordance with the individual needs of the patient, the severity of renal failure and the type of renal replacement therapy (hemodialysis, hemofiltration, etc.).

In patients with hepatic insufficiency, the dose of the drug should be carefully selected in accordance with the individual needs of the patient and the severity of liver failure.

Amino acid solutions are only one of the components of parenteral nutrition.With full parenteral nutrition, along with amino acids, the introduction of nutrients is necessary to ensure the energy needs of the body, essential fatty acids, electrolytes, vitamins, fluids and microelements.

In terms of microbiological safety, after the addition of other drugs, Aminoplasmal E 15 should be used immediately. If the drug is not used immediately, it can be used no later than 24 hours after the addition of other drugs, while storing it during this period at a temperature of 2 to 8 ° C, only if aseptic conditions are observed during mixing.

Storage at temperatures below 15 ° C can cause the formation of crystals that dissolve when the solution is heated to 25 ° C and shaken lightly.

Only for single use. Remaining unused quantities of the drug are subject to destruction.

Do not reuse bottles with the remaining contents.

Use the solution only if it is clear, colorless or pale yellow, and the bottle and cork are not damaged.

For the introduction of a sterile infusion system.

Effect on the ability to drive transp. cf.and fur:Not applicable.

Form release / dosage:

Solution for infusion.

Packaging:

For 500 ml in bottles of hydrolytic glass class II, meeting the requirements of the European Pharmacopoeia for infusion solutions. The bottle is sealed with a rubber stopper of brick color, meeting the requirements of the European Pharmacopoeia for infusion solutions, an aluminum cap of brick-red color and a plastic plug of gray color.

For 10 bottles of 500 ml, along with instructions for use in a cardboard box (for hospitals).

For 1 bottle of 500 ml together with instructions for use in a cardboard pack.

Storage conditions:

Store at a temperature of no higher than 25 ° C in a dark place. Do not freeze! Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:For hospitals

Registration number:П N012990 / 01

Date of registration:05.11.2008 / 10.06.2015

Expiration Date:Unlimited

The owner of the registration certificate:B. Brown Mehlungen AGB. Brown Mehlungen AG Germany

Manufacturer: & nbsp

B. BRAUN MELSUNGEN, AG Germany

Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company

Information update date: & nbsp08.08.2017

Illustrated instructions

Instructions

Aminoplasmal E15 (Aminoplasmal E15)