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Elfunat 50 mg / ml solution 2ml 10s intravenously. and intramuscularly. introduction in vials




The instruction for medical use of ELFUNAT medicine the Trade name Elfunat Mezhdunarodnoye the unlicensed name Is not present the Dosage form Solution for intravenous and intramuscular administration Structure 1 ml of drug contains active agent – ethylmethylhydroxypyridine succinate – 50 mg, excipients: water for injections the Description Transparent colourless or yellowish solution Pharmacotherapeutic group Other drugs for treatment of diseases of nervous system the ATX N07XX Code the Pharmacological Pharmacokinetics At properties intramuscular introduction is defined in blood plasma for 4 hours after introduction. Time of achievement of the maximum concentration in blood serum is 0.45-0.50 hours. The maximum concentration at introduction in doses of 400 – 500 mg makes 3.5-4.0 mkg/ml. Quickly passes from the blood course into bodies and fabrics and it eliminirutsya quickly from an organism. The average time of deduction of drug in an organism is 0.7-1.3 hours. It is brought out of an organism with urine, generally in the form of glucuronic conjugates, and in insignificant quantities – in an invariable look. The pharmacodynamics Elfunat renders antioxidant, anti-hypoxemic, membranoprotektorny, nootropic, anticonvulsant, anxiolytic and hypolipidemic action. Resistance of an organism to a stress and influence of various disturbing factors, such as shock, hypoxia, ischemia, disturbances of cerebral circulation, intoxication alcohol and antipsychotic drugs (neuroleptics) raises. Improves metabolism and blood supply of a brain. Stabilizes membrane structures of blood cells, prevents hemolysis. Possesses hypolipidemic action, reduces the level of the general cholesterol and lipoproteids of low density. Reduces an enzymatic toxaemia and endogenous intoxication in acute pancreatitis. The mechanism of effect of drug is caused by its antioxidant and membranoprotektorny activity. Inhibits processes of peroxide oxidation of lipids, increases activity of a superoksidoksidaza, the lipid protein raises a ratio, improves structure and function of a cell membrane. Modulates activity of membrane-bound enzymes (kaltsiynezavisimy phosphodiesterase, adenylatecyclase, acetylcholinesterase), receptor complexes (benzodiazepine, piperidic acid, atsetilkholinovy) that enhances their ability to contact ligands, promotes restoration of the structurally functional organization of biomembranes therefore transport of neurotransmitters and, respectively, synoptic transfer improves. Elfunat increases concentration in a dopamine brain. Strengthens compensatory activation of aerobic glycolysis and reduces extent of oppression of oxidizing processes in a tricarbonic acid cycle in the conditions of a hypoxia with increase in adenosine triphosphate and creatine phosphate, activates the power synthesizing function of mitochondrions, stabilization of cellular membranes. Elfunat normalizes metabolic processes in an ischemic myocardium, reduces a necrosis zone, restores and improves electric activity and contractility of a myocardium and also increases a coronary blood stream in an ischemia zone, reduces consequences of a reperfusion syndrome at acute coronary insufficiency. Increases anti-anginal activity of nitrodrugs. Promotes preservation of ganglionic cells of a retina and fibers of an optic nerve at the progressing neuropathy which reasons chronic ischemia and a hypoxia are. Improves functional activity of a retina and optic nerve, increasing visual acuity. Indications – acute disorders of cerebral circulation, – a craniocereberal injury, consequences of craniocereberal injuries, – distsirkulyatorny encephalopathy, – vegeto-vascular (neurocirculatory) dystonia, – the disturbances of functions of a brain caused by atherosclerosis (slight cognitive disorders) – anxiety disorders at neurotic and neurosis-like states, – an acute myocardial infarction (from first day) as a part of complex therapy, – an abstinence syndrome in alcoholism with prevalence in a clinical picture of neurotic and vegeto-vascular disorders, – acute intoxication neuroleptics, – acute pyoinflammatory processes of an abdominal cavity (acute necrotic pancreatitis, peritonitis) as a part of complex therapy, – primary open angle glaucoma of various stages as a part of complex therapy Elfunat apply the Route of administration and doses to intramuscular or intravenous administration (struyno or by drop infusion). The maximum daily dose should not exceed 1200 mg. At an infusional method of administration drug should be dissolved in 0.9% chloride sodium solution. Struyno the drug is administered slowly within 5-7 minutes, by drop infusion – with a speed of 40-60 thaws a minute. In acute disorders of cerebral circulation – intravenously by drop infusion on 200-500 mg 2-4 times a day in the first 10-14 days, then – intramusculary on 200-250 mg 2-3 times a day for 2 weeks. In a craniocereberal injury and consequences of craniocereberal injuries – intravenously by drop infusion on 200-500 mg 2-4 times a day for 10-15 days. In distsirkulyatorny encephalopathy in a decompensation phase – intravenously struyno or by drop infusion on 200-500 mg 1-2 times a day for 14 days, then – intramusculary on 100-250 mg a day for the next 2 weeks. For course prevention of distsirkulyatorny encephalopathy – intramusculary on 200-250 mg 2 times a day for 10-14 days. In vegeto-vascular dystonia and anxiety disorders at neurotic and neurosis-like states – intramusculary on 50-400 mg a day for 14 days. In slight cognitive disorders – intramusculary on 100-300 mg a day for 14-30 days. In an acute myocardial infarction as a part of complex therapy Elfunat enter intravenously or intramusculary within 14 days, against the background of the traditional therapy of a myocardial infarction including nitrates, beta blockers, inhibitors of angiotensin-converting enzyme, a trombolitika, anticoagulating and antiagregantny means and also symptomatic means according to indications. In the first 5 days for achievement of the maximum effect it is desirable to administer the drug intravenously, in the next 9 days it can be entered intramusculary. Intravenous administration of drug is made by drop infusion, slowly (in order to avoid side effects) in 0.9% solution of sodium of chloride or 5% solution of a dextrose (glucose) of 100-150 ml within 30-90 minutes. If necessary perhaps slow jet administration of drug lasting not less than 5 minutes. Administration of drug (intravenous or intramuscular) is carried out by 3 times a day, every 8 hours. The daily therapeutic dose makes 6-9 mg/kg of body weight a day, a single dose – 2-3 mg/kg of body weight. The maximum daily dose should not exceed 800 mg, single – 250 mg. In an abstinence alcoholic syndrome – intravenously by drop infusion or intramusculary on 200-500 mg 2-3 times a day for 5-7 days. In acute intoxication antipsychotic means – intravenously on 200-500 mg a day for 7-14 days. At acute pyoinflammatory processes of an abdominal cavity (acute necrotic pancreatitis, peritonitis), drug is appointed in the first day both in preoperative, and in the postoperative period. The entered doses depend on a form and disease severity, prevalence of process, options of a clinical course. Drug withdrawal has to be made gradually, only after steady positive clinical laboratory effect. In acute edematous (interstitial) pancreatitis – on 200-500 mg 3 times a day intravenously by drop infusion (in 0.9% chloride sodium solution) and intramusculary. In necrotic pancreatitis of light severity – on 100-200 mg Z times a day intravenously by drop infusion (in 0.9% chloride sodium solution) and intramusculary. In necrotic pancreatitis of moderate severity – on 200 mg 3 times a day intravenously by drop infusion (in 0.9% chloride sodium solution). In necrotic pancreatitis of a heavy course – intravenously by drop infusion in a dose of 800 mg in the first day, at the double mode of introduction, then – on 200-500 mg 2 times a day with gradual decrease in a daily dose. At extremely severe form of necrotic pancreatitis the initial dose makes 800 mg a day before permanent stopping of manifestations of pankreatogenny shock, at stabilization of a state – on 300-500 mg 2 times a day intravenously by drop infusion (in 0.9% chloride sodium solution) with gradual decrease in a daily dose. In an open angle glaucoma of various stages as a part of complex therapy – intramusculary on 100-300 mg a day, 1-3 times a day for 14 days. Side effects the Used lower than the parameters of frequency of side effects are defined as follows: not specified frequency – parameters of frequency cannot be estimated on the available data. From digestive system: – nausea, dryness in a mouth. Other: – allergic reactions – drowsiness, backfilling process disturbance – a headache, increase or a lowering of arterial pressure (ABP). Contraindications – hypersensitivity – an acute liver and/or renal failure – children’s and teenage age up to 18 years – pregnancy – the lactation period Medicinal interactions Drug strengthens effect of benzodiazepine anxiolytics, antiepileptic (carbamazepine), protivoparkinsonichesky (levodopa) medicines, nitrates. Reduces toxic effects of alcohol. Special instructions In some cases, especially at predisposed patients with bronchial asthma at hypersensitivity to sulfites, development of heavy reactions of hypersensitivity is possible. Patients with the ABP more than 180/100 mm Hg, by a krizovy course of arterial hypertension and the significant affective instability need careful control of the ABP during performing therapy. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Should be careful when driving motor transport and potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions. Overdose Symptoms: – a sleep disorder (insomnia, in certain cases – drowsiness) – insignificant and short-term (till 1.5 – 2 o’clock) increase the ABP Lecheniye: as a rule, it is not required – symptoms disappear independently within a day. In hard cases in insomnia – nitrazepam of 10 mg, oxazepam of 10 mg or diazepam of 5 mg. At excessive increase in the ABP – hypotensive medicines under control of the ABP and/or complement therapy with nitrodrugs. A form of release and packing On 2 ml and/or 5 ml in ampoules from colourless glass. On 5 ampoules from colourless glass in blister strip packaging. On two (for ampoules on 2 ml) and/or one (for ampoules on 5 ml) blister strip packaging together with the instruction for medical use in the state and Russian languages place Storage conditions in a cardboard box to Store at a temperature not over 25 ºС. To store out of children’s reach! A period of storage 3 years not to apply after an expiration date Prescription status According to the prescription the Producer Mefar Ilach Sanayii. A.Sh., Turkey the Owner of the registration certificate of Uorld Meditsin Ltd, Georgia the Name, the address and a contact information of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of medicine of RIN Pharm LLP, Almaty, Turksibsky district, the ave.Suyunby, 222b ph. / fax: 8 (727) 252 90 90 Address of the organization responsible for post-registration observation of safety of medicine of TROKA-S PHARMA LLP, Almaty, Suyunbaya Avenue 222-b mobile phone number +7 701 786 33 98, (24-hour access). e-mail:
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