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Corvitin 0.5g 5’s lyophilized powder for solution for injection




The instruction for medical use of Corvitin Torgovoye medicine a name Corvitin Mezhdunarodnoye the unlicensed name Is not present the Dosage form Powder the Structure lyophilized for preparation of solution for injections of 0.5 g 1 bottle contains active agents: meletin (in terms of 100% dry matter) 0.05 g, povidone with a molecular weight of 7100 ± 11000, (in terms of without – water substance) 0.45 g, excipient – sodium hydroxide. The description Dry porous weight from color, light yellow to yellow with a greenish shade, hydroscopic. Pharmacotherapeutic group Vasoprotectives. The drugs reducing permeability of capillaries. The other drugs reducing permeability of capillaries. The ATX C05CX code the Pharmacological Pharmacokinetics At properties of one-time intravenous infusion of drug quickly raises concentration of meletin in blood. After administration of drug in a dose of 10 mg/kg the maximum concentration of meletin is observed in 50 sec. after the beginning of introduction and makes 123 mkg/ml, of them 75 mkg/ml – in cellular elements of blood and 48 mkg/ml – in blood plasma. Elimination half-life of meletin of blood, plasma and uniform elements of blood makes, respectively, 0.73±0.03, 0.85±0.01, 0.77±0.02 minutes. It is removed mainly with urine. The pharmacodynamics meletin shows properties of the modulator of activity of various enzymes which are taking part in degradation of the phospholipids (phospholipases, fosfogenaz, cyclooxygenases) influencing free radical processes and which are responsible for cellular biosynthesis of nitrogen oxide, proteinases. Inhibiting effect of meletin on membranotropny enzymes and, first of all, on 5 lipoxygenase affects slowing down of synthesis of LTC4 and LTV4 leukotrienes Along with it meletin dozozavisimo increases nitrogen oxide level in endothelial cells that explains its cardiotyre-tread action at ischemic and reperfusion damages of heart. Drug shows also antioxidant and immunomodulatory properties, reduces development cytotoxic anion superoxide, normalizes activation of subpopulation structure of lymphocytes and reduces the level of their activation. Braking products of anti-inflammatory SILT-1b cytokines, SILT-8, effect of drug positively affects reduction of volume of a nekrotizirovanny myocardium and strengthening of reparative processes. The protective mechanism of effect of drug is connected also with prevention of increase in concentration of intracellular calcium in thrombocytes and activation of aggregation, with slowing down of processes of a trombogenez. Drug restores a regional blood stream and microcirculation without noticeable changes of a tone of vessels, increasing reactivity of microvessels. Long pharmacological effect of drug can be connected with pharmacological active metabolites, in particular with chalcone that considerably increases the fluidity of lipids of cellular membranes. Indications – as a part of complex therapy in an acute disorder of coronary circulation and a myocardial infarction – treatment and prevention of a reperfusion syndrome at surgical treatment of patients with obliterating atherosclerosis of a ventral aorta and peripheral arteries. The route of administration and doses enter Normal saline solution of sodium of chloride of 0.9% in number of 15 ml the syringe into a bottle with Corvitin, stir up a bottle before full dissolution of the lyophilized powder. Solution which was formed in a bottle transfer to the container with normal saline solution of sodium of chloride 0.9%, total amount of normal saline solution – 50 ml. In need of introduction of 1 g of Corvitin initially divorced drug from two bottles to transfer to capacity from 0.9% chloride sodium solution, the total amount of ready solution – 50-100 ml. Not to mix with other solutions and drugs! Not to use syringes and systems to intravenous administration which were applied to other medicines before. Corvitin it is necessary to part just before introduction! It is not recommended to apply solvent of more than 100 ml as with increase in volume of solvent the potential risk of reduction of stability of the prepared solution increases. In an acute myocardial infarction in complex therapy for fast influence on the damaged sites of a muscle of heart of Corvitin in the first day it is entered intravenously in a dose of 0.5 g of the drug dissolved in 50 ml of isotonic solution of sodium of chloride right after hospitalization in 2 hours and in 12 hours. For the second and third day Corvitin enter in a dose 0.5 g two times a day with an interval of 12 hours. For the fourth and fifth day Corvitin enter in a dose 0.5 g into 50 ml of isotonic solution of sodium of chloride once a day. To enter within 15-20 minutes. Duration of treatment is 5 days. At surgical treatment of patients with obliterating atherosclerosis of a ventral aorta and peripheral arteries, at a reperfusion syndrome in 10 minutes before declamping from an aorta enter intravenously 0.5 g of the drug dissolved in 100 ml of isotonic solution of sodium of chloride. The subsequent introduction in a similar dose is repeated in 12 hours. On the second – the fifth day – enters in a dose 0.5 g two times a day. To enter within 15-20 minutes. Duration of treatment is 5 days. Side effects – dizziness, a headache, sonitus, a tremor – feeling of fatigue, lability of mood, excitement, the general weakness, confusion of consciousness – dry cough, breath difficulty, dryness in a mouth, numbness of language – nausea, an abdominal pain, diarrhea – orthostatic hypotonia, an asthenia – skin rash of allergic genesis, a small tortoiseshell, an itching, a Quincke’s disease, an acute anaphylaxis – hyperaemia of the person, pain behind a breast, tachycardia – a renal failure, a hyperpotassemia, development of an acute renal failure – impotence – increase in activity of hepatic transaminases, increase in concentration of bilirubin in blood – a neutropenia, an agranulocytosis, decrease in level of hemoglobin and erythrocytes – arthralgias, myalgias – development of a feverish condition of the Contraindication – arterial hypotension – individual sensitivity to drug – hypersensitivity to drugs with R-vitamin activity – pregnancy and the period of a lactation. Medicinal interactions In a complex with organic nitrates Corvitin can cause hypotension. Combined use of drug from fibrinolitika leads to increase in efficiency of thrombolytic therapy. At drug use: – with drugs of ascorbic acid the summation of effects is observed, – with non-steroidal anti-inflammatory drugs strengthens anti-inflammatory action of the last at decrease in ulcerogenic action, – with digoxin – the maximum concentration in blood serum and total area under a curve concentration time of digoxin increases, – with cyclosporine – the bioavailability and concentration in cyclosporine blood, – with paklitaksely – influence on metabolism of the last increases, – with verapamil – the bioavailability of the last increases, – with tamoxifen – the bioavailability increases, metabolism and removal of the last decreases. It is not recommended to use as solvent drug solutions of glucose, a reopoliglyukin and other solutions. As solvent is applied only 0.9% chloride sodium solution. Special instructions Enter intravenously slowly. Drug is used in a combination with other anti-anginal, antiarrhythmic, antithrombocytic and fibrinolytic means. Corvitin it is impossible to enter at the same time with other solutions of medicines! Use in pediatrics is not recommended to use Drug at children and teenagers up to 18 years. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. There are no data on influence of drug on ability to run the vehicle or potentially dangerous mechanisms. The overdose is not described. Strengthening of manifestations of side reactions is possible. A form of release and packing the powder lyophilized for preparation of solution for injections of 0.5 g. On 0.5 g of drug in the brown bottles from glass with a capacity of 20 ml which are hermetically corked by rubber bungs and pressed out by aluminum caps. On 5 bottles place in the cartridge for packing of bottles. On one cartridge together with the instruction for medical use in the state and Russian languages place in a case from cardboard. Storage conditions In original packing at a temperature not higher than 25 wasps. To store out of children’s reach! The period of storage Drug should not be used 2 years after an expiration date. Prescription status According to the prescription the Public joint stock company Producer Research and production center the Borshchagovsky chemical and pharmaceutical plant’. Ukraine, 03134, Kiev, Mira St., 17. The name and the country of the owner of the registration certificate Borshchagovsky Chemical and Pharmaceutical Plant research and production center Public joint stock company, Ukraine the Address of the organization accepting in the territory of claim RK from consumers on quality of the Representative Office of PJSC NPC Borshchagovskiy HFZ product in the territory of the Republic of Kazakhstan 050063, Almaty, Auezovsky district, mdt. Zhetysu-3
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