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Description
The instruction for medical use of REGIDRON medicine the Trade name Regidron Mezhdunarodnoye the unlicensed name Is not present the Dosage form Powder for preparation of solution for intake Structure 1 bag (18.9 g of powder) contains active agents: potassium chloride of 2.5 g of sodium chloride of 3.5 g of sodium citrate of 2.9 g glucose of anhydrous 10 g Description White crystal powder. Pharmacotherapeutic group 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 corresponds to natural pharmacokinetics of these substances in an organism. The pharmacodynamics Solution of the drug Regidron is applied to correction of loss of electrolytes and liquid in diarrhea and vomiting. Glucose promotes absorption of salts and citrates that helps to balance acid-base balance of blood. The osmolarity of solution of the drug Regidron is 260 mosm/l, pH alkalescent – 8.2. Solution of the drug Regidron contains (on 1 liter of solution): Sodium chloride of 59.9 mmol of Potassium chloride of 33.5 mmol of Sodium citrate of 11.2 mmol Glucose of 55.5 mmol Na + 71.2 mmol of K+ of 33.5 mmol of Cl-of 93.5 mmol Citrate of 11.2 mmol In comparison with the standard solutions for oral rehydration recommended to WHO, the osmolarity of the drug Regidron and concentration of sodium are lower (it is proved that solutions for rehydration with reduced osmolarity are more effective, reduced concentration of sodium is necessary for prevention of development of a hypernatremia), and potassium content – higher (for faster restoration of level of potassium). According to reduced concentration of sodium, therapy by gipoosmolyarny saline solutions for oral rehydration can be associated with a hyponatremia which usually is symptomless and short-term. Indications – restoration of water and electrolytic balance – correction of acidosis in acute diarrhea (including cholera), diarrhea with slight or moderate dehydration (for example, loss of body weight at children of 3-9%) – a thermal stress with the accompanying disturbance of water and electrolytic balance – in the preventive purposes: the thermal and physical activities leading the Route of administration to intensive sweating and doses dissolve Powder of 1 bag in 1 l of the boiled, cooled to room temperature water. It is impossible to add any other components to solution not to break effect of drug. Solution is accepted orally or entered under supervision of the doctor via the nazogastralny probe. Before an initiation of treatment of the patient it is necessary to weigh for definition of loss of body weight and a measure of dehydration. It is possible to continue feeding by a breast so much how many it is necessary, even during oral rehydration or it it is possible to continue right after rehydration. It is necessary to avoid some greasy food and food with the high content of simple sugars. Ready solution should be accepted after each liquid depletion, small drinks. In 6-10 hours the dose of solution of the drug Regidron can make 30-60 ml/kg of body weight. Therapy by the drug Regidron needs to be begun after the beginning of diarrhea. Usually it is necessary to take the drug not longer, than 3-4 days, use of drug it is necessary to stop after the termination of diarrhea. In nausea and vomiting it is reasonable to accept the cooled solution small doses. Rehydration: for correction of dehydration the drug needs to be taken within the first 6-10 hours in quantity which twice exceeds losses of weight in diarrhea that is if losses are 400 ml, the amount of drug is 800 ml. During therapy by the drug Regidron there is no need for use of other liquids. If diarrhea proceeds, after correction of dehydration within the next 24 hours it is possible to apply Regidron (10-20 ml/kg of body weight) and other liquids (20-100 ml/kg of body weight). Side effects – allergic reactions At observance of the recommended doses the development of side reactions is improbable. The contraindication – hypersensitivity to any component of drug – a loss of consciousness – gastrointestinal impassability (Ilheus) – a renal failure – diabetes Medicinal interactions of Information on interaction of the drug Regidron with other drugs does not exist. 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 Heavy dehydration (loss of weight more than 9% at children, an anury) has to be treated first of all with use of intravenous drugs for rehydration. After that Regidron can be used for therapy continuation. The recommended doses of drug should not be exceeded if need of the patient for additional administration of electrolytes is not confirmed with laboratory researches. Contents of a package of the drug Regidron should be dissolved in 1 l of water. When exceeding a dose at the patient the hypernatremia can develop. Patients at whom dehydration developed against the background of a renal failure of diabetes or other chronic diseases breaking acid-base, electrolytic or carbohydrate balance demand careful monitoring when performing therapy by the drug Regidron and perhaps demand hospitalization. Before using drug to children aged up to 6 months, it is usually necessary to consult with the doctor. The situations during drug Regidron use demanding medical intervention: · the patient has a bradyarthria, there is a drowsiness, he is quickly exhausted and does not answer questions · temperature increases above 39 °C · urine discharge stops · there are liquid bloody excrements · diarrhea lasts more than 5 days · diarrhea suddenly stops, severe pains develop · if treatment is unsuccessful at home or it is impossible. Pregnancy and the period of a lactation Drug during pregnancy and feeding by a breast is allowed for use in the recommended doses of Feature 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 At introduction of very large number or very strong solution of the drug Regidron the development of a hypernatremia is possible. Patients with reduced function of kidneys can have a metabolic alkalosis. Symptoms of a hypernatremia include weakness, neuromuscular excitement, drowsiness, the confused consciousness, the apnoea sometimes is possible. The metabolic alkalosis can be shown in decrease in ventilation of the lungs, neuromuscular excitement and tetanic spasms. In case of heavy overdose with the expressed consequences the administration of the drug Regidron needs to be stopped. Consultation of the doctor is necessary. Correction of balance of electrolytes and liquid has to be carried out on the basis of these laboratory researches. A form of release and packing On 18.9 g of powder in a package. 20 packages together with the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions at a temperature from 15 °C to 25 °C. To store out of children’s reach! To store ready solution in the fridge at a temperature from 2 °C to 8 °C within 24 hours. 3 years not to apply a period of storage after the expiration date specified on packing. Prescription status Without prescription Retsipharm Parets Producer, S.L., Santiago Ramon and Kakhal, 2, put Parets Valles, 08150 Barcelona, Spain. Owner of the registration certificate Orion Corporation, Orionintiye 1, 02200 Espoo, Finland. The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) and responsible for post-registration observation of safety of medicine of limited liability partnership ORION PHARMA EAST (ORIONUM FARMA IST) 050000, Almaty, Tolya Bee St., 69, office 19. Ph.: 8 (727) 272-61-10, 272-61-11 Fax: 8 (727) 272-62-09
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