Ê¡õѺ«½® 40

General characteristics. Structure:

Active ingredients:
L-alanine                                                         of 4,00 g
L-arginine                                                       of 4,55 g
L-aspartic acid                                 of 2,00 g
L-glutaminic acid                                   of 5,00 g
L-histidine                                                       of 1,35 g
L-izoleytsin                                                    of 2,10 g
L-leucine                                                         of 2,75 g
L-lysine hydrochloride
(there correspond 2,00 g of a lysine)                           2,50 g
L-methionine                                                     of 1,75 g
L-phenylalanine                                               of 3,15 g
L-threonine                                                       of 1,60 g
L-tryptophane                                                   of 0,50 g
L-valine                                                          of 2,25 g
Glycine                                                           of 7,00 g
Xylitol                                                           of 50,00 g
Sodium acetate                                                of 3,40 g
Potassium chloride                                                of 1,86 g
Magnesium chloride                                               of 0,51 g
Sodium hydroxide                                           of 0,60 g
Excipients:
Water for injections                                       of 931,00 g
Sodium metabisulphite                                   of 0,02 g

Content of the general nitrogen:                             6,3 g/l

The general content of amino acids                     is 40,0 g/l

Theoretical osmolarity:                  801,8 ¼Äß¼«½ý/l

Energy value:                        1551,0 kJ/l

Pharmacological properties:

Ê¡õѺ«½® 40 - the combined drug containing L-amino acids, carbohydrates and electrolytes. The amino acids arriving intravenously serve as links for protein synthesis. Electrolytes are necessary for correction of water and electrolytic balance. Xylitol is a source of calories which in the course of carbohydrate metabolism is split at the level of a liver, at the same time its metabolites enter processes of glycolysis and a gluconeogenesis.

Ê¡õѺ«½® 40 it is entered intravenously therefore its bioavailability is equal to 100%.

Indications to use:

• parenteral food;
• liquid loss completion (at burns, operations, bleedings);
• prevention and therapy of proteinaceous deficit which results from the increased requirement, the raised consumption or disturbance of intake of protein with food, its absorption and removal.

Route of administration and doses:

The drug is administered intravenously, kapelno, slowly at careful observation of a condition of the patient.  The dosage is calculated depending on a clinical condition of the patient and his needs for amino acids, electrolytes and liquid.

Dosing mode:

Adults:
from 0,6 g to 1,0 g of amino acids (to 25 ml of the drug Инфезол® 40 on body weight kg a day).
at states with a catabolism prevalence:
from 1,3 g to 2,0 g of amino acids (to 50 ml of the drug Инфезол® 40 on body weight kg a day).

for children from 2 to 18 years:
from 1,0 g to 2,0 g of amino acids (to 50 ml of the drug Инфезол® 40 on body weight kg a day).

At higher need of an organism for liquid and calories the calculated amount  of the drug Инфезол® 40 can be added with simultaneous or serial administration of solutions of electrolytes, glucose, etc.

 In the presence of a possibility of partial peroral food the amount of the drug Инфезол® 40 arriving parenterally respectively decreases by amount of liquid and the calories entered orally.

At too bystry infusion reactions of intolerance, and also renal losses of amino acids with disturbance of their balance are possible.

At a renal and liver failure the individual dosage is required.

Use duration before full transition to enteral or peroral food.

Features of use:

Regular control of content of electrolytes in blood serum is necessary, for concentration of glucose in blood, acid-base composition, a water balance, crude protein of blood serum, renal and hepatic indicators. It is necessary to observe extra care at patients with heart failure at introduction of large amounts of liquid. To be careful at the increased osmolarity of serum
 blood.

Because of the disulphite sodium (metabisulphite sodium) which is contained in drug in isolated cases, in particular, at the patients having asthma the hypersensitivity reactions which are shown vomiting, diarrheas, discontinuous breath, bad attacks of asthma, disturbance of consciousness or shock can be observed. These reactions in each separate case can proceed very differently and also bring to
 to the states posing a threat for life. Besides, disulphite sodium reaction products (metabisulphite sodium) with other components of drug, in particular, with tryptophane,   can   cause   increase in activity of liver enzymes and concentration of bilirubin.

Influence of drug on ability to driving of motor transport and to control of mechanisms

The drug Инфезол® 40 does not influence ability to driving of motor transport and control of mechanisms.

Side effects:

Usually the drug Infezol®40 is transferred well. When using drug of by-effects usually it is not observed. Seldom or never nausea, vomiting, a headache, a fever, fervescence and irritation of walls of veins can take place, as a rule, at too bystry introduction. In isolated cases emergence of allergic reactions is possible.

Interaction with other medicines:

Due to the increased risk of microbic contamination and incompatibility, the solutions containing amino acids should not be mixed with other medicines. At simultaneous administration of the drug Инфезол® 40 and solution of thiamin (B1 vitamin) there is a thiamin splitting.

Contraindications:

• hypersensitivity to sodium to disulphite (sodium to metabisulphite) and to other components of drug;
• severe damages of a liver;
• disturbance of amino-acid exchange (for example, fenilketonuriya);
• metabolic acidosis;
• acute craniocereberal injury;
• intoxication methanol;
• hyperpotassemia;
• shock;
• hypoxia;
• patholologically the high level of the electrolytes which are contained in this solution in a blood plasma;
• the morbid conditions which are followed by the assumed or established renal  failure  of heavy    severity  (clearance  of creatinine <30 µmol/l);
• dekompensirovanny heart failure;
• acute fluid lungs;
• overhydratation;
• bronchial asthma;
• children's age up to 2 years (for children up to 2 years there are specific requirements to amino acids).

With care
• Pregnancy, lactation period.

Use at pregnancy and a lactation

Use of the drug Инфезол® 40 during pregnancy is possible only if the estimated advantage of therapy for mother exceeds potential risk for a fruit or the child that is estimated by the attending physician, in view of lack of sufficient clinical experience of use of drug at pregnancy and in the period of a lactation.

Overdose:

Symptoms: At overdose or too bystry administration of drug reactions  of intolerance in the form of nausea, vomiting, a fever and renal losses of amino acids are possible.
Too bystry administration or  introduction of excessive amounts of kaliysoderzhashchy solutions, in particular at acidosis and a renal failure, can lead to a hyperpotassemia. The potassium concentration posing a threat in serum makes> 6,5 mmol/l. Can be symptoms of a hyperpotassemia: muscular weakness, disturbances of sensitivity, a cardiac disturbance (a sinus bradycardia, arrhythmia, conductivity disturbances, broadening of the QRS complex up to blockade of legs of a ventriculonector, the T tooth point on an ECG - at the patients accepting drugs of a foxglove, changes of a tooth of T can be veiled).

Therapy: Immediate termination of infusion. Osmotic diuresis. In the cases posing a threat for life - dialysis.

Storage conditions:

To store at a temperature not above 25 °C in the place protected from light. Not to freeze!

To store medicine in the place, unavailable to children!

Period of validity 2 years. Not to apply after the period of validity specified on packaging.

To use only transparent solutions in the unimpaired bottles!

After opening of a bottle drug has to be immediately used!

Issue conditions:

According to the recipe

Packaging:

Solution for infusions.

On   100, 250 or 500 ml of drug in bottles from transparent glass like II,
closed a brombutilovy rubber stopper for piercing and plastic
 cover under an aluminum running in, with the plastic holder.

On 10 bottles together with the application instruction place in a cardboard box
(for hospitals).