Complivit aqua q3 dropwise to vn.pr. 15000me / ml-10ml vial cap. 1 PC

$3.88

Complivit aqua q3 dropwise to vn.pr. 15000me / ml-10ml vial cap. 1 PC

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Description

Composition
Active substance:
1 ml of solution contains: Kolekaltsiferol (vitamin D3) – 0,375 * mg (15,000 IU)
Excipients:
macrogol glitserilritsinoleat – 75,000 mg; sucrose (white sugar) – 250,000 mg; sodium hydrogenphosphate dodecahydrate – 7,000 mg; citric acid (citric acid monohydrate) – 0,430 mg; anethole – 0.825 mg; benzyl alcohol –
15,000 mg; Purified water to 1 ml.
* 1 mg kolekaltsiferola corresponds to 40000 IU of vitamin D3 activity.
Description:
Complivit Aqua D3 – is a new modern water-soluble form of vitamin D.
Suitable for children from 4 weeks of life!
The special technology of its production allows the fat-soluble vitamin D3 translate into micellar (water-soluble) form, where the hydrophobic ends of the molecules moved inwards and the hydrophilic – out. Such a form is ready for absorption in the small intestine, regardless of ZHKT3 function.
Compared with the usual oil-release form, aqueous form Complivit® Aqua D3 has a number of benefits and features:
better absorbed from the gastrointestinal tract;
absorption is not affected by formation of bile is insufficient (e.g., preterm children);
produced in a convenient dosage form: in the form of drops for oral administration.
Product form:
Drops for oral administration, 15,000 IU / ml.
10 ml vials dropper dark (amber) glass, capped, stoppered polyethylene dropper and a polypropylene caps control the first opening.
One vial-IV together with instructions for use placed in a pile of cardboard.
Contraindications
Increased sensitivity to the drug, especially benzyl alcohol.
Deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption.
Hypervitaminosis of vitamin D.
Elevated blood levels of calcium (hypercalcemia), increased excretion of calcium in the urine (hypercalciuria), urolithiasis (formation of calcium oxalate stones), including a history of renal osteodystrophy with hyperphosphatemia, pseudohypoparathyreosis.
Sarcoidosis.
Acute and chronic liver and kidney disease, renal failure.
The active form of tuberculosis.
Children up to age of 4 weeks of life.
Carefully.
Patients are able to immobilize.
Patients taking thiazide diuretics, as well as in patients with cardiovascular disease taking cardiac glycosides (see. See “The interaction with other drugs”).
During pregnancy and breastfeeding (cm. “Pregnancy and lactation” section).
In infants with a predisposition to early overgrown fontanelle (when installed from birth the small size of the front temechku).
Upon receiving the additional amounts of vitamin D and calcium (e.g., as part of other drugs), breach of calcium and phosphate excretion in the urine, the treatment of benzothiadiazine derivatives and immobilized patients (risk of hypercalcemia and hypercalciuria) (see. Specific guidance section).
Patients with the following concomitant diseases: atherosclerosis, heart disease, organic heart disease, granulomatosis, hyperphosphatemia, phosphate nefrourolitiaz, diseases of the gastrointestinal tract, gastric ulcer and duodenal ulcers, hypothyroidism.
In the presence of one or more of the following diseases and conditions prior to administration of the drug need to consult with a physician.
Dosage
15000 IU / ml
Indications
Prevention of vitamin D deficiency diseases and related to its failure (rickets, osteomalacia).
Treatment of rickets.
Complex therapy of osteoporosis of various genesis.
Interaction with other drugs
Antiepileptics (especially phenytoin and phenobarbital, primidone), rifampicin, colestyramine reduce reabsorption of vitamin D3.
Application together with thiazide diuretics increases the risk of hypercalcemia. In such cases, continuous monitoring of blood calcium concentration should be carried out.
In hypervitaminosis D3 possible potentiation of cardiac glycosides and increased risk of arrhythmias caused by the development of hypercalcemia (suitable control of calcium concentration in blood, electrocardiogram, as well as dose correction cardiac glycoside).
corticosteroids Concomitant therapy may reduce the effectiveness of vitamin D3.
Prolonged use of antacids containing aluminum and magnesium, in combination with vitamin D3 may promote increased concentrations of aluminum and magnesium in the blood and as a consequence – toxic effects of aluminum on bone and hypermagnesemia in renal failure patients.
Cholestyramine, colestipol and mineral oils reduce absorption in the gastrointestinal tract of fat-soluble vitamins and require increase of their doses.
Concomitant use of benzodiazepines increases the risk of hypercalcemia.
Formulations containing high concentrations of calcium and phosphorus, increase the risk of developing hyperphosphatemia.
While the use of sodium fluoride interval between doses should be at least 2 hours; forms with oral tetracyclines – at least 3 hours.
The simultaneous use of other analogues of vitamin D increases the risk of hypervitaminosis of vitamin D.
Ketoconazole can inhibit biosynthesis and the catabolism of 1.25 (OH) 2-kolekaltsiferola.
Vitamin D is an antagonist drugs used in hypercalcaemia:
calcitonin, etidronate, pamidronate, plikamitsin, gallium nitrate.
Isoniazid and rifampicin can reduce the effect of the drug due to increased rate of biotransformation.
Vitamin D3 does not interact with food
Overdose
Symptoms of an acute overdose of vitamin D3:
early manifestations (due to hypercalcemia) – constipation or diarrhea, dryness of the oral mucosa, headache, thirst, pollakiuria, nocturia, polyuria, anorexia, metallic taste in the mouth, nausea, vomiting, weakness and fatigue, hypercalcemia, hypercalciuria, dehydration;
later manifestations – bone pain, blurred urine (in urine hyaline casts, proteinuria, leukocyturia), increased blood pressure, itching, eye photosensitivity, conjunctival hyperemia, arrhythmia, drowsiness, myalgia,
nausea, vomiting, pancreatitis, gastralgia, weight loss, rarely – psychosis (mental changes), and mood changes.
Symptoms of chronic overdose of vitamin D3 (at reception for several weeks or months to adults in doses 20000-60000 IU / day, children – 2000-4000 IU / day): soft tissue calcification, kidney, lungs, blood vessels, hypertension, renal and chronic heart failure (these effects occur most frequently during the accession of hypercalcaemia hyperphosphataemia), impaired growth in children (long-term use at a dose of 1800 IU / day).
Treatment: When above symptoms you should stop to use the drug and consult a doctor. Shows a diet low in calcium (for several weeks), the consumption of large quantities of liquid, diuresis with furosemide, electrolytes, and appointment glucocorticosteroids calcitonin. When kidney calcium level proper functioning can be significantly reduced by infusion of isotonic sodium chloride solution (6.3 liters in 24 hours) with the addition of furosemide, and in some cases also sodium edetate 15 mg / kg / h, while continuously monitoring of calcium levels and the electrocardiogram data. When oligoanuria contrast, hemodialysis is necessary (without calcium dialysate). A specific antidote is not known.
To prevent overdoses in some cases, it is recommended the control of calcium concentration in the blood.
pharmachologic effect
Pharmacological group:
Calcium-phosphorus metabolism regulator.
Pharmacodynamics:
Vitamin D3 is an active antirahiticheskim factor. The most important function of vitamin D3 is the regulation of calcium and phosphate metabolism, which contributes to proper growth and mineralization of skeleton.
Vitamin D3 is a natural form of vitamin D, which is formed in a person’s skin under the action of sunlight. By comparison with vitamin D2 is characterized by 25% higher activity. Kolekaltsiferol plays a substantial role in calcium and phosphate absorption from the intestine, transport and mineral salts in the process of bone calcification, regulates calcium phosphate excretion and kidney.
The concentration of calcium ions in the blood causes the maintenance of skeletal muscle tone of muscles, myocardium function, promotes nerve excitation, regulate the clotting process. Vitamin D is essential for normal function of the parathyroid glands, also participates in the functioning of the immune system, affecting the production of lymphokines.
Lack of vitamin D in the diet, a violation of his intake, calcium deficiency, and insufficient exposure to sunlight causes: children in the intensive growth period – to rickets in adults – to osteomalacia, pregnant women may experience tetany symptoms in newborns – violation process of calcification of bone tissue. Increased need for vitamin D occurs in women during menopause due to the development of hormonal imbalance, leading to osteoporosis.
Pharmacokinetics:
The aqueous solution of vitamin D3 is absorbed better than the oil solution. Premature babies occurs lack of education and the flow of bile into the intestine, which violates the absorption of vitamins in the form of oil solutions. After oral administration Kolekaltsiferol absorbed in the small intestine. It is metabolized in the liver and kidneys. The half-life kolekaltsiferola from the blood of a few days and can be extended in cases of renal insufficiency. The drug crosses the placenta and the mother’s milk. Vitamin D3 has the property of accumulation.
Excreted from the body by the kidneys in small amounts, most excreted in the bile.
Pregnancy and breast-feeding
During pregnancy should not use the drug in doses exceeding recommended for the prevention of deficiency of vitamin D (see. The section “Method of administration and dose”), because of the potential existence of teratogenic effects in overdose. Precautions should be prescribed vitamin D3 in women, breast-feeding, because drug, taken in high doses, the mother, can cause symptoms of overdose in children.
In the case of the drug during pregnancy and breast-feeding is necessary to consider delivery of vitamin D from other sources of vitamin D daily dose should not exceed 600 ME.
Conditions of supply of pharmacies
Without recipe.
side effects
The frequency of adverse reactions did not determined.
Violations by the Metabolism and nutrition: hypercalcemia and hypercalciuria.
Disorders of the nervous system: headache.
Violations of the cardiovascular system: high blood pressure, arrhythmia.
Violations of the respiratory system, thorax and mediastinum:
worsening of tuberculosis in the lungs.
Disorders of the gastrointestinal tract: loss of appetite, constipation, flatulence, nausea, abdominal pain or diarrhea.
Violations of the skin and subcutaneous tissue disorders: hypersensitivity reactions such as itching, skin rash, and urticaria.
Violations by musculoskeletal and connective tissue disorders: arthralgia, myalgia.
Violations by the kidneys and urinary tract: renal failure,
polyuria.
If you experience side effects, contact your doctor.
special instructions
Avoid overdosing.
Before the drug should be taken into account the amount of vitamin D and of calcium coming from the food and the composition of other drugs.
Too high doses of vitamin D3, applied continuously or shock doses can cause chronic hypervitaminosis D3.
Should not be used simultaneously with vitamin D3 high doses of calcium.
The drug should be used with caution in patients with impaired excretion of calcium and phosphate in the urine, the treatment of benzothiadiazine derivatives and immobilized patients (risk of hypercalcemia and hypercalciuria). These patients should be monitored levels of calcium in the plasma and urine.
It should not take vitamin D3 at pseudohypoparathyreosis, since in this disease need for vitamin D can be reduced, which can lead to long-term risk of overdose.
The main clinical manifestations of rickets include mild nervous irritability, anxiety, startle at sudden sound, a flash of light, rhythm sleep disorders, superficial “disturbing” dream, sweating, itching, alopecia neck, yielding margins of a large fontanelle.
Visible deformation of bone is typical of moderate to severe rickets, which usually require hospitalization and a comprehensive therapy prescribed by the doctor based on test results.
Repetition of courses of therapy for osteoporosis may recommended by the doctor, depending on the results of the evaluation of bone turnover markers, and calcium metabolism. If your doctor has prescribed a longer treatment than recommended in the instructions, you should regularly (at least every three months of therapy) to determine the level of calcium in the blood serum and urine, as well as to assess kidney function by measuring the creatinine level in blood serum. If necessary, the dose may be adjusted by the physician in accordance with the level of calcium in blood serum.
In the case of hypercalcemia or presence of impaired renal function dose should reduce or stop the treatment. If calcium levels in urine exceed 7.5 mmol / 24 hours (300 mg / 24 h), it is advisable to reduce the dose or suspend treatment.
Effects on ability to drive vehicles, machinery data about the possible effects of the drug on the ability to drive and there are no mechanisms.
Storage conditions
The protected from light at a temperature not higher than 25 C. Keep out of reach of children
Dosing and Administration
Orally.
The drug Complivit® Aqua D3 is taken orally in liquid spoon.
1 drop contains 500 ME vitamin D3.
Prevention of rickets:
– term newborns with 4-weeks of age – 1 drop (500 ME) per day;
– Preterm children with 4-weeks of age – 2 drops (1000 IU) per day during the first year of life, followed by 1 drop (500 IU) per day.
The drug is used during the first two years of life, during periods of low insolation (especially in winter).
Treatment of rickets:
If no visible deformation of the skeletal system (mild rickets) – 2-3
drops (1000-1500 ME) per day, the treatment continued for 30 days.
In the presence of bone deformities characteristic of rickets moderate and severe – 4-8 drops (2000-4000 IU) per day, Treatment continued for 30-45 days
the dose and duration of therapy depend on the severity of the changes, and determined by the physician (see. Special instructions).
Prevention of vitamin D deficiency diseases and related to its failure (osteomalacia):
1 drop (500 ME) per day for the entire period, accompanied by a deficiency of vitamin D. Incoming minimum duration of prophylaxis – 1 month.
When the complex treatment of osteoporosis:
1-2 drops (500-1000 ME) per day during 3 months. Repetition of possible courses of therapy on doctor’s recommendations, depending on the results of the evaluation of bone turnover markers, and calcium metabolism (see. Special instructions).
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Complivit

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