Aminoplasmal B. Brown E 10 - instructions for use, dose, side effects, contraindications

Active substances:
Isoleucine	5,000 grams
Leucine	8,900 g
Lysine hydrochloride	8.560 g
(corresponds to lysine)	6,850 g
Methionine	4,400 g
Phenylalanine	4.700 g
Threonine	4,200 g
Tryptophan	1,600 g
Valine	6,200 g
Arginine	11,500 grams
Histidine	3,000 grams
Alanin	10.500 grams
Glycine	12,000 grams
Aspartic acid	5.600 grams
Glutamic acid	7,200 g
Proline	5,500 grams
Serin	2,300 g
Tyrosine	0.400 g
Sodium acetate trihydrate	2.858 g
Sodium hydroxide	0.360 g
Potassium acetate	2.453 g
Magnesium chloride hexahydrate	0.508 g
Sodium hydrophosphate dodecahydrate	3.581 g
Excipients:
Acetyl cysteine	0.200 g
Citric acid monohydrate	0.210-0.420 g
Water for injections	up to 1000 ml

Concentration of electrolytes:

Sodium 50 mmol / l

Potassium 25 mmol / l

Magnesium 2.5 mmol / l

Chloride 52 mmol / l

Acetates 46 mmol / l

Phosphates 10 mmol / l

Citrate 2.0 mmol / l

Physico-chemical characteristics:

Theoretical osmolality 1021 mOsm / l

pH from 5.7 to 6.3

Amino acid content 100 g / l

Total nitrogen 15.8 g / l

Energy value1675 kJ / l (400 kcal / l)

Description:

A clear, colorless or pale yellow solution.

Pharmacotherapeutic group:Parenteral nutrition

ATX: & nbsp

B.05.B.A Solutions for parenteral nutrition

Pharmacodynamics:

The main therapeutic effect of Aminoplasmal B. Brown E 10 is to supply the body with a protein synthesis substrate parenteral nutrition.

The introduction of all the amino acids necessary for protein synthesis (including conditionally replaceable and non-replaceable amino acids) contained in Aminoplasmal B. Brown E 10, provides high nutrient efficiency and reduces the burden on the body during protein synthesis.

To exclude the metabolism of the introduced amino acids as a source of energy, simultaneous administration with Aminoplasmal B. Brown E 10 energy donors, such as fat emulsions and carbohydrate solutions, is necessary.

In addition to amino acids, Aminoplasmal B. Brown E 10 contains the mineral substances necessary to maintain the water-electrolyte and acid-base equilibrium.

Pharmacokinetics:

Intravenous amino acids enter the intravascular and intracellular depots of endogenous free amino acids and, like them, function as a substrate for the synthesis of body proteins. Bioavailability of all components of Aminoplasmal B. Brown E 10 with intravenous administration is 100%.

In Aminoplasmal B, Brown E 10 individual concentrations of amino acids are selected in such a way that when the solution is injected intravenously, the relative increase in the concentration of each amino acid in the plasma does not go beyond the norm, which ensures the maintenance of amino acid homeostasis in plasma.

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

Indications:

Parenteral nutrition in order to prevent and treat the conditions of protein deficiency due to increased loss of proteins and / or increased need for them:

- Severe and severe injuries, polytrauma, burns, peritonitis, sepsis, multiple organ failure in accordance with metabolic needs;

- Conditions after extensive surgical interventions;

- Inflammatory bowel diseases (including Crohn's disease, ulcerative colitis), intestinal fistulas;

- Disturbances in nutrition of different genesis (cachexia).

Contraindications:

- Hypersensitivity to the components of the drug;

- Congenital disorders of amino acid metabolism;

- Severe circulatory disorders (shock);

- Pronounced hypoxia;

- Pronounced metabolic acidosis;

- Progressive liver failure;

- Acute renal failure if hemofiltration or hemodialysis is not possible;

- Exceeding the maximum permissible concentration of electrolytes that make up the drug in the blood plasma;

- Children under 2 years;

- General contraindications for the introduction of infusion therapy (decompensated heart failure, acute pulmonary edema, hyperhydration).

Carefully:

Aminoplasmal B. Brown E 10 can only be used after a thorough assessment of the risk / benefit ratio in the following cases:

- Renal or hepatic insufficiency,

- Increased plasma osmolality,

- Hypotonic dehydration,

as well as in all cases of metabolic disorders of amino acids, caused by causes that are not contraindications to the use of the drug.

Pregnancy and lactation:

At present, sufficient clinical data on the use of Aminoplasmal B.Brown E 10 during pregnancy and lactation is not available, therefore it is possible to use it in pregnant and lactating women only in cases when the expected benefit from treatment with the drug exceeds the possible risk of complications.

Dosing and Administration:

Aminoplasmal B. Brown E 10 is introduced into the central veins.

For the introduction of Aminoplasmal B. Brown E 10 it is necessary to use only sterile systems for intravenous infusion.

During the application of the drug, it is necessary to monitor the place of injection (the place of puncture, or catheterization) for signs of inflammation or infection.

The drug is supplied in bottles designed for single use. Any unused volumes of the drug are not subject to storage and must be discarded.

Do not use the drug if the solution is not clear, there are obvious signs of damage on the bottle or leakage is broken.

The dose of Aminoplasmal B. Brown E 10 depends on the nutritional status and individual needs of the patient in amino acids, electrolytes and fluid.

Adults and children from 14 years of age

Average daily dose

10-20 ml / kg of body weight, corresponding to 1-2 g of amino acids / kg of body weight, 700-1400 ml of the preparation for a patient with a body weight of 70 kg.

The highest daily dose

20 ml / kg of body weight, corresponding to 2 g of amino acids / kg of body weight, 140 g of amino acids or 1400 ml of the preparation for a patient with a body weight of 70 kg.

Maximum injection rate

1 ml / kg body weight / hour, corresponding to 0.1 g amino acids / kg body weight / hour, 25 drops / minute or 1.17 ml / min for a patient with a body weight of 70 kg.

Children

The following doses are averaged. The dose should be selected in accordance with the child's age, stage and severity of the disease.

For children from 2 to 5 years:

15 ml / kg of body weight, which corresponds to 1.5 g of amino acids / kg of body weight.

For children from 5 to 14 years:

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

Maximum injection rate

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

Duration of application

Restrictions on the duration of use of the drug is not revealed.

Side effects:

If you follow the recommendations for these precautions, the speed of administration and dosage, no side effects are observed, but the development of allergic reactions is possible.

Rarely occurring side effects (≥1: 1000, <1: 100): nausea, vomiting, headache, chills, fever may be associated with the onset of parenteral nutrition and are not specific for Aminoplasm. B. Brown E 10.

Overdose:

Overdose or too rapid introduction of the drug can cause such things as chills, nausea, vomiting and increased excretion of amino acids by the kidneys. In such cases, the administration of the drug should be discontinued and resumed later with a lower infusion rate.

Interaction:

Drug interactions are not known.

Blending of Aminoplasmal B. Brown E 10 with other components of parenteral nutrition (carbohydrates, fat emulsions, vitamins, trace elements) should be carried out under aseptic conditions. It is necessary to check their compatibility before use.

Special instructions:

To ensure the complete assimilation of amino acids, the introduction of Aminoplasmal B. Brown E 10 should be carried out simultaneously with drugs that provide energy needs of the body (fat emulsions and solutions of carbohydrates), as well as electrolytes, vitamins and trace elements.

During the treatment period, it is necessary to control the water-electrolyte and acid-base balance, serum protein level, serum osmolarity, blood glucose concentration and liver function.

For patients with hepatic, renal, cardiac, pulmonary Inadequate it is necessary to select an individual dosage regimen.

With prolonged administration (within a few weeks), coagulation factors and the cellular composition of the blood should be monitored.

In the case of hypotonic dehydration, first, an adequate balance of water and electrolytes should be restored, and then parenteral nutrition should be started.

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.

Form release / dosage:

Solution for infusion.

Packaging:

For 250 ml, 500 ml and 1000 ml in bottles of class II hydrolytic glass 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 1 bottle of 250 ml, 500 ml or 1000 ml, together with instructions for use in a cardboard bundle.

For hospitals.

For 10 bottles of 250 ml or 500 ml each, 6 bottles of 1000 ml each, along with instructions for use in a cardboard box.

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:On prescription

Registration number:LSR-003844/09

Date of registration:21.05.2009 / 07.07.2016

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: & nbsp07.08.2017

Illustrated instructions

Instructions

Aminoplasmal B. Brown E 10 (Aminoplasmal B. Braun E 10)