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Description
The instruction for medical use of REGIDRON OPTIM medicine the Trade name Regidron Optim the International unlicensed name Is not present the Dosage form Powder for preparation of solution for intake of 10.7 g Structure 1 bag contains active agents: potassium chloride of 0.750 g of sodium chloride of 1.300 g of sodium citrate of 1.450 g glucose of anhydrous 6.750 g, excipients: potassium to atsesulfa, fragrance lemon. The description White or light yellow crystal powder with a characteristic lemon smell Pharmacotherapeutic group Antidiarrheal drugs. Electrolytes with carbohydrates. Regidratanta for oral administration. The ATX A07CA code the Pharmacological Pharmacokinetics Pharmacokinetics properties of water, the electrolytes and glucose which are a part of the drug Regidron Optim corresponds to natural pharmacokinetics of these substances in an organism. The pharmacodynamics Solution of the drug Regidron Optim according to WHO recommendations has reduced osmolarity which is 245 mosm/l, rn – alkalescent. Regidron Optim is applied to correction of losses of electrolytes and liquid in diarrhea and vomiting. Glucose promotes absorption of salts, citrates help to correct balance in a metabolic acidosis. Indications oral rehydration in the acute diarrhea connected with slight and moderate dehydration prevention of dehydration completion of losses of liquid and electrolytes in an organism the Route of administration and doses dissolve Contents of 1 bag in 0.5 liters of the boiled, cooled to room temperature water and accept solution orally. Treatment of slight and moderate dehydration (replacement therapy): The dose of drug depends on the body weight of the patient and degree of dehydration and makes 50-100 ml of solution of drug on body weight kg. For shortage control of liquid in an organism Regidron Optim it is necessary to accept within 4 hours. If after introduction of replacement therapy the symptoms of diarrhea remain, use of Regidron Optim solution continues as maintenance therapy. Adults and children in slight and moderate dehydration should take the drug according to the data provided to the table: The age Is more senior Less than 4 months 4-11 months 12-23 months 2-4 years 5-14 years than 15 years the Body weight Less than 5 kg of 5-7.9 kg 8-10.9 kg 11-15.9 kg 16-29.9 kg More than 30 kg solution Volume in ml 200-400 400-600 600-800 800-1200 of 1200-2200 2200-4000 In nausea and vomiting it is reasonable to accept the cooled solution the small, repeated doses. If necessary at first it is necessary to use a small amount of solution (using, for example, a teaspoon, the syringe or a cup), the dose can be increased gradually, depending on shipping. Fast administration of drug is safe, but there is a probability of developing of vomiting at introduction of a large number. During replacement therapy (first four hours), it is not necessary to give to the patient any other food, however, feeding by a breast should be continued at the request of the baby (as well during oral replacement therapy). During therapy by the drug Regidron Optim it is possible to use other liquids, but it is necessary to avoid liquids which contain a lot of sugar as high concentration of sugar can strengthen diarrhea. If necessary solution can be entered via the nazogastralny probe under supervision of the doctor. Prevention of dehydration (maintenance therapy): From an organism and as maintenance therapy apply lower doses to prevention of loss of liquid. Therapy by the drug Regidron Optim needs to be begun at the beginning of diarrhea. Usually it is necessary to take the drug not longer, than 3-4 days, its reception it is necessary to stop after the termination of diarrhea. The dose of drug depends on body weight. For prevention of dehydration the dose can make 5-15 ml/kg of body weight: children with body weight to 10 kg: 50-100 ml of solution of drug after each liquid depletion, adults and children with body weight from 10 kg: 100-200 ml of solution of drug after each liquid depletion. At use Regidron Optim it is possible to use other liquids and food. Side effects vomiting (at one-stage reception of high doses) the low probability of emergence of a hypernatremia or an overhydratation at patients with normal function of kidneys At observance of the recommended doses the development of side reactions is improbable Contraindications hypersensitivity to any component of drug heavy dehydration hypovolemic shock hemodynamic shock intestinal impassability impetuous vomiting Medicinal interactions Information on interaction of the drug Regidron Optim with other drugs is absent. rn drug solution – alkalescent therefore can influence medicines which absorption depends from rn intestines contents. Also absorption of medicines can be changed in diarrhea, mainly such drugs which are absorbed in a small or large intestine or at their enterohepatic circulation. Special instructions acute diarrhea can cause dehydration and electrolytic disorders In children of chest age that can lead to fast aggravation of symptoms of the patient. It is necessary to inform as soon as possible the doctor on all cases of diarrhea and dehydration at children of chest age. It is necessary to show care at the Regidron Optim drug treatment of patients with diabetes, patients with diseases of a liver or kidneys and also patients who adhere to a diet with the limited content of sodium or potassium. Diarrhea can significantly affect balance of liquid and glucose at patients with diabetes, a renal failure or some other chronic diseases. Therefore while symptoms of diarrhea remain, such patients demand more careful monitoring with laboratory control and hospital rehydration therapy in the conditions of a hospital. Regidron Optim apply with care in cases of impassability of an intestinal path, a renal failure in the period of an oliguria or an anury, in cases of parenteral rehydration therapy or in ongoing vomiting. The situations during use of the drug Regidron Optim demanding medical intervention: – change a mental condition of the patient (irritability, apathy), – fever (temperature is above 39 °C), – blood in Calais, – ongoing vomiting, – diarrhea continues more than 2 days, – severe pains in a stomach. At treatment of the diarrhea caused by cholera and other activators, the amount of salt in drug can be insufficient to replace the excessive loss of salts connected with a disease. Regidron Optim contains potassium (0.41 g on 0.5 l of solution) that it is necessary to take into account at solution use by patients with reduced function of kidneys which are on a diet with potassium use control. Regidron Optim contains glucose. Patients with glyukozo-galaktozny malabsorption should not take this drug. Pregnancy and the period of a lactation Drug during pregnancy and feeding by a breast is allowed for use in the recommended doses. It is possible to continue feeding by a breast so much how many it is necessary, even during oral rehydration. Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms Drug does not influence speed of response at control of motor transport and work with other mechanisms Overdose Symptoms: at introduction of excessive quantity or very strong solution of the drug Regidron Optim at patients with disturbances of functions of kidneys the hypernatremia or a hyperpotassemia Treatment can develop: symptomatic the Form of release and packing On 10.7 g of powder in the laminated package: from the internal and outer side a paper covering, a polyethylene layer, an aluminum layer and an ionomeric covering. On 20 packages together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions at a temperature from 15 °C to 25 °C Ready solution to store at a temperature from 2 °C to 8 °C within 24 hours to Store out of children’s reach! A period of storage 3 years not to apply after the expiration date specified on packing Prescription status Without prescription the Producer of the Ethnoviy Oh, Teolisute 16, FI-60100, Seinajoki, Finland the Owner of the registration certificate Orion Corporation, Finland
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