D3-VIT drops for oral administration 15000 IU/ml 10ml №1

Name D3-VIT (Pharm technology) The main active ingredient is Cholecalciferol. Release form Drops for oral administration. Colorless or yellowish, clear or slightly opalescent solution with a slight anise odor. Special instructions The degree of vitamin D deficiency can be determined on the basis of measuring the level of 25-hydroxyvitamin D. In adults, the level of 25-hydroxyvitamin D in the blood serum should not exceed 80 ng / ml. Values above 150 ng/ml are indicative of a health-threatening overdose. The interpretation of the results of the analysis should be carried out by a doctor. With prolonged use of the drug, it is recommended to periodically check the levels of calcium in the blood serum and in the urine. If necessary, the doctor will adjust the dose of D3-VIT depending on the level of calcium in the blood serum. In the event of hypercalcemia or signs of impaired renal function, the doctor may decide to reduce the dose of D3-HIT or stop the use of the drug. With prolonged use of the drug, renal function should be monitored by measuring the level of creatinine in the blood serum. D3-HIT should be used with caution in patients with impaired renal function; the effect of the drug on calcium and phosphate levels should be regularly assessed. The risk of developing soft tissue calcification should be taken into account. In case of severe renal insufficiency, the use of the drug is contraindicated (see section “Contraindications”). If vitamin D is required in patients with severe renal insufficiency, other vitamin D-based drugs should be used. Cholecalciferol should be used with caution in patients: – with sarcoidosis due to the risk of increased metabolism of vitamin D with the formation of its active form in excess; – with osteoporosis caused by immobilization, due to an increased risk of developing hypercalcemia; – concomitantly taking cardiac glycosides or thiazide diuretics (see section “Interaction with other medicinal products and other forms of interaction”). Additional doses of vitamin D should be used under close medical supervision; in this case, it is necessary to frequently monitor the levels of calcium in the blood serum and the excretion of calcium in the urine. Children Concomitant use of other products containing vitamin D should be avoided, especially in children under 1 year of age. The decision on the additional use by children of food fortified with vitamin D or other vitamin D-containing products while taking D3-VIT drops is made by the doctor. Auxiliary components D3-VIT contains benzyl alcohol in the amount of 15 mg / ml (corresponding to 0.5 mg in 1 drop), which can cause the development of allergic reactions. Young children are at risk of developing severe respiratory problems (gasping syndrome) due to exposure to benzyl alcohol; therefore, do not use D3-HIT in newborns (under 28 days of age) without first consulting a doctor. Also, D3-HIT should not be used for more than 1 week in children under 3 years of age without first consulting a doctor due to a possible increased risk of adverse reactions due to the accumulation of benzyl alcohol. Before using D3-VIT drops, seek the advice of a doctor if you are pregnant or breastfeeding, as benzyl alcohol is capable of gradually accumulating in large quantities in the body and can cause the development of metabolic acidosis. Before using D3-VIT drops, seek the advice of a doctor if you have liver or kidney disease, as benzyl alcohol is capable of gradually accumulating in large quantities in the body and can cause the development of metabolic acidosis. The composition of the drug includes white crystalline sugar (sucrose). If you have an intolerance to some sugars, you should consult your doctor before taking this medicine. With prolonged use (2 weeks or more), sugar can damage the teeth. Pharmacological actionD3-WIT contains cholecalciferol (vitamin D3) as an active ingredient. Vitamin D3 increases the absorption of calcium and phosphate from the gastrointestinal tract, stimulates the reabsorption of calcium and phosphate in the kidneys, and promotes bone mineralization. With a lack of vitamin D in children, bone calcification is disturbed and rickets develop, in adults, there is a loss of calcium from the bones and osteomalacia develops. Since the intake of cholecalciferol with food or as part of drugs does not inhibit the physiological production of vitamin D3 in the skin, an overdose of vitamin D3 and the development of intoxication are possible. Indications for use – Prevention and treatment of vitamin D deficiency. – Treatment of rickets. – As an adjunct to the specific therapy of osteoporosis in patients who have risk factors for vitamin D deficiency. Dosage and administration Before use, the integrity of the first opening ring should be checked; if it is broken, this vial cannot be used – it must be returned to the pharmacy. Method of application For oral administration. To accurately measure the number of drops and, accordingly, the dose of the drug, the vial should be held vertically (at an angle of 90 °; see figure). The dose should be measured immediately before use. Due to the risk of overdose, it is not allowed to count the number of drops from the vial directly into the oral cavity! The drug is taken in 1 spoonful of liquid. When used in a small child, you can add the required number of drops to a small portion of baby food, however, in this case, you need to make sure that the child takes the entire portion of food, otherwise you cannot guarantee the required dose of vitamin D3. It is not allowed to store the unaccepted portion of a serving of food containing D3-HIT in order to consume it later. Doses When selecting a dose of D3-VIT, all other sources of vitamin D intake into the body should be taken into account. 1 ml (= 30 drops) of the drug contains 15,000 IU (375 µg) of cholecalciferol (vitamin D3) as an active ingredient. 1 drop contains about 500 IU (12.5 micrograms) of cholecalciferol (vitamin D3). The abbreviation IU stands for “international units”; they measure the activity of vitamin D3. The dose of the drug D3-VIT is determined by the doctor on an individual basis. Use during pregnancy and lactation If you are pregnant or breastfeeding, if you do not exclude the possibility of pregnancy at the moment or if you are planning a pregnancy, please consult your doctor before starting the use of the drug. If during the use of the drug D3-VIT you suspect or find that you are pregnant, consult with your doctor about the possibility of continuing to use this drug. Pregnancy Daily dose up to 500 IU There are currently no known risks associated with this dose. During pregnancy, prolonged use of excessive doses of vitamin D should be avoided, since hypercalcemia caused by such use can lead to mental and physical retardation, supravalvular aortic stenosis and retinopathy in the child. A daily dose of more than 500 IU of D3-HIT should be administered with caution during pregnancy and only if the expected benefit outweighs the potential risks. An overdose of vitamin D during pregnancy is not allowed, since prolonged hypercalcemia can lead to mental and physical retardation, supravalvular aortic stenosis and retinopathy in the child. Breast-feeding Vitamin D and its metabolites are excreted in breast milk. In children, there were no cases of overdose induced by breastfeeding. However, the possibility of an overdose should be taken into account if the child is simultaneously receiving vitamin D from other sources (for example, vitamin D-containing medicines or a diet fortified with vitamin D). Fertility There are no data on the effect on fertility. Interaction with other drugs Influence of other drugs on cholecalciferol Inducers of enzymes of the cytochrome P450 system, such as rifampicin, carbamazepine, phenytoin, barbiturates (for example, phenobarbital, primidone) and glucocorticosteroids, can reduce the effectiveness of vitamin D due to its enhanced inactivation. With the simultaneous use of these drugs, it may be necessary to increase the dose of the drug D3-VIT. Isoniazid may reduce the effectiveness of vitamin D3 by inhibiting the metabolic activation of vitamin D. Concomitant use with agents that cause fat malabsorption (eg, cholestyramine, orlistat) may lead to impaired absorption of vitamin D from the gastrointestinal tract. Elevated levels of parathyroid hormone can increase the metabolism of vitamin D and thus increase the need for vitamin D. When used simultaneously with cardiac glycosides, their toxic effect due to hypercalcemia may increase (risk of developing arrhythmias increases). Careful medical supervision and, if necessary, monitoring of ECG and serum calcium levels is required. With simultaneous use with thiazide and thiazide-like diuretics, the risk of developing hypercalcemia increases, since these drugs reduce the excretion of calcium in the urine. With simultaneous use, regular monitoring of calcium levels in the blood serum is necessary. The simultaneous use of magnesium-containing products (for example, antacids) and the drug D3-HIT is not recommended, as this may lead to an increase in the level of magnesium in the blood. Effects of cholecalciferol on other medicinal products Vitamin D3 may increase the absorption of aluminum from the intestine. Contraindications – Hypersensitivity to the active substance or to any of the excipients that make up the medicinal product (see section “Composition”). – Hypervitaminosis D. – Conditions leading to elevated levels of calcium in the blood and / or urine (for example, impaired excretion of calcium and phosphate through the kidneys, immobilization of the patient, use of benzothiadiazine derivatives (thiazide diuretics). – Kidney stones containing calcium. – Severe arteriosclerosis – Severe renal insufficiency. Excipients: macroglycerol ricinoleate (Kolliphor®EL), white crystalline sugar (sucrose), benzyl alcohol, anise flavor, disodium phosphate dodecahydrate, citric acid monohydrate, purified water. Hypervitaminosis is manifested by non-specific symptoms, such as headache, loss of appetite, weakness b, weight loss, gastrointestinal disorders (nausea, vomiting, constipation), growth disorders. Persistent hypercalcemia can lead to such phenomena as an increased volume of urine excreted (polyuria), severe thirst (polydipsia), nausea, vomiting, constipation, muscle weakness, paresis, weakness, the predominance of nighttime diuresis over daytime (nocturia), the appearance of protein in the urine ( proteinuria), anorexia, increased blood cholesterol (hypercholesterolemia), elevated transaminase levels, cardiac arrhythmias, hypertension, soft tissue calcification, determined by X-ray examination. In severe overdose, vitamin D has the opposite effect. Bone tissue decalcifies, calcium levels in the blood and urine increase. Calcification of tissues, blood vessels, and kidneys may occur. There may be changes in the psyche, up to psychosis. In case of an overdose, the use of vitamin D should be stopped immediately. In case of intoxication, the state of dehydration should be corrected. Other possible measures: the appointment of a diet low in calcium, the use of calcitonin, glucocorticoids. Side effects Like other medicines, D3-VIT can cause side effects, although not everybody gets them. The frequency of adverse reactions with cholecalciferol cannot be determined from the available data (frequency unknown). Cholecalciferol can cause the following adverse reactions, especially in case of overdose (see also section “Overdose”): – metabolic and nutritional disorders: increased blood calcium levels (hypercalcemia), increased calcium levels in the urine (hypercalciuria); – disorders of the gastrointestinal tract: constipation, increased gas formation in the intestines (flatulence), nausea, pain in the stomach or in the stomach area, diarrhea. Reporting Suspected Adverse Reactions If you develop an adverse reaction, tell your doctor. This also applies to any adverse reactions not listed in this package insert. You can report adverse reactions to the information database on adverse reactions (actions) to medicines, including reports of drug failure (UE Center for Expertise and Testing in Healthcare of the Ministry of Health of the Republic of Belarus, https://www.rceth.by ). By reporting adverse reactions, you help to get more information about the safety of the medicine. Storage conditions Store in the original package to protect from light at a temperature not exceeding 25 °C. Keep out of the reach of children! Buy D3-VIT drops for oral administration 15000 IU/ml 10ml №1 Price for D3-VIT drops for oral administration 15000 IU/ml 10ml /ml 10ml №1