Ê¡õѺ«½® 100
Producer: Berlin-Chemie AG/Menarini Group (Berlin-Hemi AG/Menarini Group) Germany
Code of automatic telephone exchange: B05BA01
Release form: Liquid dosage forms. Solution for infusions.
General characteristics. Structure:
Active ingredients:
L-izoleytsin of 5,850 g
L-leucine of 6,240 g
Lysine monoacetate (there correspond 7,100 g of a L-lysine) 10,020 g
L-methionine of 4,680 g
Acetylcysteinum (there correspond 0,500 g of L-cysteine) 0,673 g
L-phenylalanine of 5,400 g
Atsetiltirozin (there correspond 1,620 g of L-tyrosine) 2,000 g
L-threonine of 5,000 g
L-tryptophane of 2,000 g
L-valine of 5,000 g
L-arginine of 9,660 g
Ornithine a hydrochloride (there correspond 1,900 g of L-ornithine) 2,420 g
L-histidine of 3,300 g
L-alanine of 15,500 g
L-aspartic acid of 1,910 g
L-glutaminic acid of 5,000 g
Glycine of 7,550 g
L-proline of 7,500 g
L-serine of 4,300 g
Malic acid of 3,000 g
Acetate sodium trihydrate of 3,456 g
Sodium chloride of 0,625 g
Sodium hydroxide of 1,324 g
Potassium chloride of 3,355 g
Calcii chloridum dihydrate of 0,735 g
Chloride magnesium hexahydrate of 1,017 g
Excipient:
Water for injections of 921,735 g
Content of the general nitrogen: 15,6 g
General content of amino acids: 100,0 g
Energy value: 1700 kJ / 400 kcal
Value рН: 5,9-6,3
Theoretical osmolarity: 1145 ¼Äß¼«½ý/l
Pharmacological properties:
Pharmacodynamics. Amino acids represent the components necessary for protein synthesis. The solutions containing amino acids enter within parenteral food together with other components (fats, carbohydrates), electrolytes and liquid. Concentration of free amino acids in plasma is subject to considerable fluctuations, it belongs as to separate amino acids, and their total concentration. Ê¡õѺ«½® 100 enter intravenously and therefore its bioavailability is equal to 100%.
Pharmacokinetics. Amino acids are completely used for protein synthesis. Amino acids which are not required for synthesis of proteins do not collect as a reserve like fatty acids and glucose. Splitting of amino acids happens by deamination and - the amino group which is metabolized to urea which is removed through kidneys. The remained carbon skeleton gets to a cycle of citric acid where it passes in atsetil-KOA, atsetoatsetil-KOA and pyruvate. A part of amino acids (to 5%) is removed in an invariable look.
Indications to use:
• Parenteral food
• Liquid loss completion
• Prevention and therapy of proteinaceous deficit of various genesis (at burns, operations, losses of blood, etc.).
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. It is necessary to begin infusion with slower rate of administering and within the first hour to bring rate of administering to necessary value.
Adults:
Daily dose: 10-20 ml/kg of body weight ~ 1,0-2,0 g of amino acids/kg of body weight
Maximum daily dose: 20 ml/kg of body weight ~ 2,0 g of amino acids/kg of body weight.
Maximum speed of infusion: 1 ml/kg of body weight an hour ~ 0,1 g of amino acids/kg of body weight an hour.
At parenteral food within the corresponding therapy at adults total quantity of the entered liquid should not exceed 40 ml/kg of body weight a day.
Children:
Data on a dosage at children represent average values and have to will be defined individually according to age, level of physical development and disease severity.
Daily dose for children from 2 to 6 years: 10 ml/kg of body weight of 1,0 g of amino acids/kg of body weight.
Daily dose for children from 6 to 14 years: 15 ml/kg of body weight of 1,5 g of amino acids/kg of body weight.
Maximum speed of infusion: 1 ml/kg of body weight an hour ~ 0,1 g of amino acids/kg of body weight.
The maximum daily dose is calculated proceeding from daily requirement of protein.
Drug is used before full transition to an enteral way of food.
Features of use:
Control of a water balance, blood serum ionogramma, concentration of glucose in blood and acid-base structure is necessary. To be careful at the increased osmolarity of blood serum! Full parenteral food requires at the same time addition of substances - fats, carbohydrates, electrolytes, vitamins, microelements.
Side effects:
Usually Инфезол® 100 it is well transferred. When using drug of by-effects usually it is not observed. Emergence of allergic reactions (a small tortoiseshell, anaphylactic reactions) is possible. Very seldom the increased perspiration, nausea, vomiting, a fever, tachycardia can take place, as a rule, at too high rate of administering.
Influence of drug on ability to driving of motor transport and to control of mechanisms is not known.
Interaction with other medicines:
Interactions are unknown so far.
Due to the increased risk of microbic contamination and incompatibility, the solutions containing amino acids should not be mixed with other medicines.
Contraindications:
Absolute contraindications:
• acute disorder of a hemodynamics (including shock)
• acute left ventricular failure
• total fabric hypoxia
• children's age up to 2 years
• craniocereberal injury
• intoxication methanol
• heavy liver failure.
With care after assessment of a ratio of the expected advantage and possible risk at the following states:
• disturbances of exchange of amino acids
• overhydratation
• hyperpotassemia
• hyponatremia
• acidosis
• diseases of kidneys
• chronic heart failure of I-II And degrees.
At a liver and renal failure the individual dosage is required (is selected the doctor under control of biochemical indicators of blood).
Use at pregnancy and a lactation
It is applied in the presence of indications.
Overdose:
At too bystry intravenous injection there can be reactions of intolerance (nausea, vomiting, a fever), and also losses of amino acids through kidneys.
The overdose can lead to amino-acid intoxication, an overhydratation and disturbance of electrolytic balance.
At administration of kaliysberegayushchy solutions too bystry infusion or introduction of excessive quantities can lead to a hyperpotassemia. The maximum potassium concentration in serum makes> 6,5 mmol/l. Symptoms of a hyperpotassemia can be: muscular weakness, sensitivity disturbance, disturbance of a cordial rhythm and conductivity.
Therapy at overdose:
• Reduction of speed of infusion and, if necessary, introduction interruption.
• Corresponding recovery of electrolytic balance
• Osmotic diuresis
• In the cases posing a threat for life, dialysis.
Storage conditions:
At a temperature not above 25 °C in the place protected from light.
To store medicine in the place, unavailable to children!
Period of validity 2 years. Not to apply after expiry date.
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 250 or 500 ml of drug in bottles from transparent glass like II (Evr. T.), closed a brombutilovy rubber stopper (Evr. T.) for piercing and a plastic cover under an aluminum running in, with the plastic holder. On a bottle paste the label.
On 10 bottles on 250 ml or 500 ml together with the application instruction in a cardboard box (for hospitals).