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Ripronat (Meldonium) 10%/5 ml solution for injection (10 ampoules)




The instruction for medical use of RIPRONAT medicine the Trade name Ripronat Mezhdunarodnoye the unlicensed name Meldonium Dosage Form Solution for intravenous injections of 100 mg/ml, 5 ml Structure of 1 ml of solution contains active agent – meldonium (in the form of dihydrate meldonium) 100 mg excipient: water for injections. The description Transparent colourless solution Pharmacotherapeutic group Other drugs for treatment of heart diseases. Other cardiotonic drugs. Meldonium the ATX C01EB22 Code the Pharmacological Pharmacokinetics Bioavailability properties of drug after intravenous administration it is equal to 100%. The maximum concentration in blood plasma is reached right after its introduction. It is metabolized in an organism with formation of two main metabolites which are removed by kidneys. Elimination half-life makes 3-6 hours. A pharmacodynamics Meldonium (Ripronat) – a structural analog of a γ-butyrobetaine, the predecessor of a carnitine. Drug, oppressing activity of a γ-butyrobetainehydroxylase, reduces biosynthesis of a carnitine and transport of fatty acids with a long chain through cell membranes, prevents accumulation in cells of the activated forms of unoxidized fatty acids – derivatives of an acylcarnitine And, thus preventing their negative action. In case of intense ischemic injury of a myocardium the use of drug slows down formation of a necrotic zone, shortens the rehabilitation period, improves blood circulation in the ischemia center, promotes redistribution of blood in favor of the ischemic site. In heart failure Ripronat increases contractility of a myocardium, increases tolerance to physical activity, reduces the frequency of attacks of stenocardia. In acute and chronic ischemic disorders of cerebral circulation improves blood circulation in the ischemia center, promotes redistribution of blood in favor of the ischemic site. Shows anti-ischemic and cytoprotective effects. Ripronat has tonic effect on the central nervous system, increases physical and intellectual effeciency, eliminates functional disturbances somatic and the autonomic nervous system. Indications In complex therapy in the following cases: – heart disease and vascular system: a stable angina of exertion, chronic heart failure (NYHA I-III a functional class), a cardiomyopathy, functional disturbances of action of the heart and the vascular system – acute and chronic ischemic disorders of cerebral circulation – reduced working capacity, a physical and psychoemotional overstrain – during recovery after cerebrovascular disturbances, injuries of the head and encephalitis the Route of administration and doses Solution for intravenous administration. In view of possible development of exciting effect it is recommended to apply in the first half of day. Heart disease and vascular system and disturbance of cerebral circulation: in/in on 500-1000 mg (5-10 ml) a day, entering all dose for once or dividing it into two single doses. The maximum daily dose – 1000 mg. During recovery after cerebrovascular disturbances, injuries of the head and encephalitis, the lowered working capacity, an overstrain: in/in on 500 mg (5 ml) a day. The maximum daily dose – 500 mg. Duration of a course of treatment is 4-6 weeks. It is possible to repeat a course of treatment 2-3 times a year. Special groups of patients At patients of advanced age with abnormal liver functions and/or kidneys reduction of a dose can be required. Patients with abnormal liver functions and/or kidneys should apply a smaller dose of meldonium (to watch also the section Special Instructions). Use in pediatrics the Data on safety and efficiency of use of drug for children and teenagers up to 18 years are absent therefore use of drug is contraindicated. Side effects Side effects are classified by the systems of bodies and frequency of emergence of MedDRA: often (≥1/100 to & lt, 1/10), it is rare (≥1/10000 to & lt, 1/1000). Side effects which were observed in clinical trials and in the post-registration period: From the immune system Often Seldom Allergic reactions * Hypersensitivity, allergic dermatitis, a small tortoiseshell, a Quincke’s disease, anaphylactic reactions from mentality the Excitement, sensation of fear, the notions of compulsion, sleep disorders from nervous system is rare Often Seldom the Headache * Paresthesias, a tremor, a hypesthesia, sonitus, vertigo, dizziness, disturbance of gait, a preunconscious state, a syncope from heart is rare Change of a heart rhythm, heartbeat, tachycardia / sinus tachycardia, fibrillation of auricles, arrhythmia, sensation of discomfort in a breast/stethalgia from a blood system the Increase/lowering of arterial pressure Is rare, hypertensive crisis, hyperaemia, pallor of integuments from respiratory organs, a thorax and mediastinum the Inflammation of a throat, cough, short wind, an apnoea from digestive tract is rare Often Seldom Dyspepsia * the Dysgeusia (metal taste in a mouth), loss of appetite, nausea, vomiting, a meteorism, diarrhea, abdominal pain, dryness in a mouth or hypersalivation. From skin and hypodermic cellulose Seldom Rashes, the general / makulezno / papular rashes, an itching from the musculoskeletal system and connective tissue Seldom the Dorsodynia, muscle weakness, muscular spasms from kidneys and an urinary system Seldom the Pollakiuria the General disturbances and reactions in the injection site Seldom General weakness, a fever, an asthenia, hypostasis, a face edema, hypostasis of legs, feeling of heat, cryesthesia, cold sweat Datas of laboratory and researches Seldom Changes in the electrocardiogram (ECG), acceleration of cardiac performance, an eosinophilia * * Side effects which were observed in earlier carried out uncontrollable clinical trials. Contraindications – hypersensitivity or to any of drug components – a heavy liver and/or renal failure (insufficient amount of data on safety) – increase in intracranial pressure (at disturbance of venous outflow, an intracranial tumor) – pregnancy and the period of a lactation – children’s and teenage age up to 18 years not to apply Medicinal interactions to active agent along with other dosage forms containing meldonium (risk of development of side effects). Drug can be combined with anti-anginal means, anticoagulants, antiagregant, antiarrhytmic means, cardiac glycosides, diuretics. It is necessary to consider that drug can strengthen effect of nitroglycerine, nifedipine, beta blockers, peripheral vazodilatator and other antihypertensive drugs. At the patients with chronic heart failure accepting at the same time for reduction of symptoms meldonium and lisinopril the positive action of combination therapy (vazodilatation of the main arteries, improvement of peripheric circulation and quality of life, reduction of a psychological and physical stress) is revealed. At use of meldonium in a combination with orotovy acid for elimination of the damages caused by ischemia/reperfusion the additional pharmacological action was observed. As a result of simultaneous use of the drug Sorbifer and meldonium for patients with the anemia caused by deficiency of iron the composition of fatty acids in red blood cells improved. Meldonium helps to eliminate the pathological changes of heart caused by azidothymidine (AZT) and indirectly influences the reactions of an oxidizing stress caused AZT leading to dysfunction of mitochondrions. Use of meldonium in a combination with AZT or other drugs for treatment of acquired immunodeficiency syndrome (AIDS) positively influences therapy of AIDS. In the test of the loss of an attitudinal reflex caused by ethanol, meldonium reduced dream duration. During the spasms caused by pentylenetetrazole the significant anticonvulsant effect of meldonium is established. In turn, at use before therapy meldonium α2 adrenoblocker, yohimbine in a dose of 2 mg/kg and inhibitor of the N-(G) nitrogen oxide synthase (NOS) – nitro – L – arginine in a dose of 10 mg/kg, completely blocks anticonvulsant effect of meldonium. The overdose of meldonium can increase the cardiotoxicity caused by cyclophosphamide. The deficit of a carnitine which is formed at use of a D-carnitine (pharmacological inactive isomer) – meldonium, can increase the cardiotoxicity caused ifosfamidy. Meldonium has protective action in case of the cardiotoxicity caused indinaviry and the neurotoxicity caused efavirenzy. Special instructions Patients with abnormal liver functions and/or kidneys easy or moderate severity in the anamnesis at use of drug need to be careful (it is necessary to carry out control of function of a liver and/or kidneys). Ripronat is not drug of the first row at a sharp coronary syndrome. Use in pediatrics Experience of use to children is absent. During pregnancy and the lactation period For assessment of the impact of Ripronat on pregnancy, development of an embryo/fruit, childbirth and postnatal development of researches on animals is not enough use. The potential risk for people is unknown therefore meldonium during pregnancy is contraindicated. Available data on animals confirm penetration of meldonium into mother’s milk. There are no data on penetration of meldonium into breast milk. It is impossible to exclude risk for newborns/babies therefore during feeding by a breast meldonium is contraindicated. Features of influence on ability to run the vehicle or potentially dangerous mechanisms of Researches of meldonium for assessment of the impact on ability to run transport and to work with mechanisms it was not carried out. Considering side effects, it is necessary to be careful when driving and potentially dangerous mechanisms. The overdose Is not present messages about cases of overdose by Ripronat. Drug malotoksichen also does not cause side effects hazardous to health of the patient. Symptoms: the lowering of arterial pressure, a headache, dizziness, tachycardia, the general weakness are possible. Treatment: symptomatic. In case of heavy overdose it is necessary to control function of a liver and kidneys. The form of release and packing On 5 ml of drug spill in ampoules from colourless glass with the line or a point of a break. On 5 ampoules place in blister strip packaging from a film polyvinylchloride. On the 2nd blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not above 25ºС. To store out of children’s reach! Not to freeze! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription Producer A.Sh. Mefar Ilach Sanayii, Turkey (Ramazanolu Makh. Ensar Dzhad. No.: 20, 34906 Kurtkyoy-Pendik / Istanbul) ‘Mefar İlaç Sanayii A.Ş.’, Turkey (Ramazanoğlu Mah. Ensar Cad. No: 20, 34906 Kurtköy-Pendik/İstanbul). The owner of the registration certificate of ROTAFARM ILACHLARY LIMITED of SHIRKETI, TURKEY the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products of TROKA-S PHARMA LLP, RK, Almaty, Turksibsky district, Suyunbaya Ave., 222b Ph. / fax: 8 (7272) 529090 The address of the organization responsible for post-registration observation of safety of medicine of TROKA-S PHARMA LLP acting through Toleuisheva Sandugash, Almaty, Suyunbaya Avenue 222-b
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