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active ingredients: 1 liter of solution for infusion contains L-alanine 15.5 g, glycine to 7.55 g, L-aspartic acid of 1.91 g of L-arginine 9.66 as per g, L - glutamic acid 5 g; L-histidine 3.3 g, L-isoleucine 5,85 g; acetylcysteine 0,673 g; acetyltyrosine 2 g; lysine to monoacetate 10,02 g; L-methionine to 4.68 g, L-leucine for 6.24 g; L-treanna 5 g; L-valine (5 g, L-tryptophan 2 g; L-phenylalanine 5.4 g, ornithine hydrochloride and 2.42 g; L-Proline 7.5 g; L-serine 4.3 g of sodium chloride 0.625 g of sodium hydroxide 1,324 g; sodium acetate NO 3,456 g; potassium chloride 3,355 g; magnesium chloride NO 1,017 g; calcium chloride 2H2O 0,735 g; malic acid 3 g;
excipient: water for infusion.
A dosage form. Solution for infusion.
Means for parenteral nutrition. Code ATC VV a10.
The clinical features.
Parenteral nutrition in the composition of appropriate therapy in case of simultaneous use of infusion solutions containing carbohydrates.
Unstable circulation with life-threatening (shock); acute pulmonary edema, tissue hypoxia.
Method of application and doses.
The dosage depends on the clinical condition of the patient and his needs amino acids, electrolytes and fluid. During conditions when catabolism prevails, it is recommended to use the upper range of doses. Infusion was started very slowly and in an hour the speed is adjusted to the desired value.
Adults. Daily dose: 10 - 20 ml/kg of body weight, equivalent to 1 to 2 g of amino acids/kg of body weight (70 -140 g of amino acids and 700 - 1400 ml for body weight of 70 kg). Maximum daily dose: 20 ml/kg of body weight, equivalent to 2 g of amino acids/kg body weight (140 g amino acid and 1400 ml for body weight of 70 kg). Maximum infusion rate: 1 ml/kg of body weight per hour, which is equal to 0.1 g amino acids/kg of body weight per hour 7 g of amino acid and 70 ml for body weight of 70 kg). Using this the maximum dosage should not exceed the following allowable limits: daily dose of 2 g/kg of body weight per day, speed – 0.1 g/kg of body weight per hour for amino acids. When parenteral nutrition consisting of appropriate therapy in adults the total amount of fluid injected should not exceed 40 ml/kg of body weight per day.
Children. These data are indicative average value and should be determined individually according to age, level of development of the child and the presenting condition. Children over 2 years to 5 years: daily dose of 15 ml/kg of body weight (1.5 g amino acids/kg body weight). Children from 5 to 14 years: daily dose of 10 ml/kg of body weight (1 g amino acids/kg body weight). Maximum infusion rate: 1 ml/kg of body weight per hour (0.1 g amino acids/kg of body weight per hour). Інфезолâ100 is injected intravenous drip. At low speed the introduction of the components of the drug are utilized better than with the rapid introduction. Duration – time to full enteral or oral feeding.
Within the General framework of the use of parenteral nutrition, especially in the beginning of therapy, the possible side effects: in rare cases (≥1/1000 to ≤1/100): nausea, vomiting, headache, fever, fever, skin rash. For very rapid infusion may cause irritation of the venous walls.
At a sufficiently rapid introduction reaction can occur intolerance (nausea, vomiting, fever), and excretion of amino acids by the kidneys. Overdose can lead to amino acid intoxication, overhydration and electrolyte disturbances. First of all, it concerns the possible development of hyperkalemia. The concentration of potassium in the serum of more than 6.5 mmol/l represents a threat to the patient. Hyperkalemia may occur with symptoms such as muscle weakness, impaired sensation, disorders of cardiac activity (ECG recorded, sinus bradycardia, arrhythmia, conduction disturbance, widening of the QRS complex until the development of the blockade feet beam Guisa, the sharpening of the T wave). Treatment. Decrease the rate of infusion and, if necessary, termination of the infusion, appropriate restoration of electrolyte balance, osmotic diuresis. Possible dialysis, if necessary.
Use during pregnancy or breastfeeding.
Clinical trials Інфезолуâ 100 in pregnant women and in women who are breastfeeding has not been conducted. However, the available clinical experience with the use of compared amino acid solutions for parenteral nutrition does not give reason to assume any kind of threat for women in the periods indicated. Before using this drug in women during pregnancy and lactation should weigh the expected benefits and possible risks.
Research on the use of nimesulide in children under the age of 2 years is insufficient, so it is not recommended. When using in children aged 2 years it is necessary to determine the dosage according to age, weight and underlying disease, and if necessary to apply for oral and enteral administration other drugs containing proteins. With the introduction of the drug required to use vials with a volume which corresponds to a daily dose. In addition, the introduction of additional sources of energy, vitamins and minerals with the use of paediatric formulations.
Specific security measures.
Use only clear solutions in unopened vials. The vial should be used immediately after opening! In any case, do not store an open bottle for further use! Solutions containing amino acids, should not be mixed with other drugs because of high risk of microbial contamination and incompatibility.
The application features.
Інфезолâ 100 used with great caution and only after careful evaluation of the balance of expected benefits and possible risk in patients with impaired metabolism of amino acids, of fluid overload, hyperkalemia, hypernatremia. With adrenal insufficiency, hepatic, renal, cardiac and pulmonary insufficiency require individual determination of dosage. During the application Інфезолуâ 100, it is necessary to control water and electrolyte balance, plasma osmolarity, acid-base status, blood sugar levels and liver function parameters. The frequency of clinical and laboratory examination of the patient depends on the severity of the disease and its clinical condition. Especially often such a survey is recommended in the following conditions: disorders of amino acid metabolism, liver failure, through the risk of occurrence or worsening of existing neurological disorders associated with grermany; renal failure, especially in the presence of hyperkalemia, risk factors contributing to the emergence or intensification of metabolic acidosis and azotemia due to impaired real clearance. You have to be careful at high osmolarity of the serum of the patient. It should be borne in mind that Інфезолâ 100 is only one of the components of parenteral nutrition to full enteral nutrition should the simultaneous use of other energy sources (taking into account the needs of essential fatty acids), electrolytes, vitamins and trace elements. With prolonged use of the drug (a few weeks), you should carefully monitor blood parameters and coagulation factors. Інфезолâ 100 contains 5.4 g/l of phenylalanine and may be harmful to patients with phenylketonuria.
Influence on velocity reactions in driving motor transport or operating other mechanisms.
Up to this time is not known. The drug is used only in a hospital environment
Interaction with other medicinal products and other forms of interaction.
Prior to this time are not known.
Pharmacodynamics. Amino acids are the components necessary for protein synthesis. Solutions containing amino acids, used for parenteral therapy together with native energy, electrolytes and fluid to maintain or improve the condition of the body or, under certain conditions, to minimize the loss of body weight. In pathological conditions in the absence of exogenous administration of amino acids, there are significant and typical changes of the set of amino acids in plasma, while this applies to both the absolute concentrations of individual amino acids and their percentage composition in the plasma.
The pharmacokinetics. Amino acids used for protein synthesis. Excess amino acids that are not required for the synthesis of proteins and other biomolecules, can be accumulated as a reserve like fatty acids and glucose. Only 5% of the amino acids can be inferred from the body in an unchanged state. Cleavage of amino acids occurs by design a-amino group, converted to urea, which, in turn, excreted by the kidneys. Carbohydrate skeleton that is left is included in the citric acid cycle, where it goes into acetyl-Co-A, acetone acetyl Co-A, pyruvate or an intermediate product.
Basic physical and chemical properties: clear, almost colourless or yellowish liquid, containing no particles.
1 l solution for infusion contains: amino acids – 100 g; total nitrogen – 15.6 g; total energy – 1700 kJ/400 kcal. a pH of 5.9 to 6.3. Theoretical osmolarity – 1145 mOsm.
Pesol® 100 should not be mixed with other drugs or solutions for parenteral nutrition, because there is no solid data as to their compatibility.
The expiration date.
Do not use the drug after the expiry date printed on the package!
The storage conditions.
Store at temperature not exceeding 25 °C, protected from light place!
The bottle is made of transparent glass contains 250 or 500 ml of solution for infusion; 10 bottles in a carton.
Category of leave.
According to the recipe.
BERLIN-CHEMIE AG (MENARD GROUPS).
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