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Компливит® D3 Calcium for kids

Препарат Компливит® Кальций Д3 для малышей. ОАО "Фармстандарт" Россия


Producer: JSC Pharmstandart Russia

Code of automatic telephone exchange: A12AX

Release form: Firm dosage forms. Powder for oral administration.

Indications to use: Deficit of calcium.


General characteristics. Structure:

Active agents: carbonate calcium (in terms of calcium) – 4,0 g; a kolekaltsiferola (in terms of 100% колекальциферол) - 0,027 mg (1000 ME), in the form of the granulate containing: cholecalciferol, d, l - alpha tocopherol, triglycerides from the remains of fatty acids of average length, sucrose, acacia gum, corn starch, calcium phosphate, water.
Excipients: sorbitol (sorbite), starch prezhelatinizirovanny (преджель), silicon dioxide colloid (aerosil), fragrance orange.

Structure on 5 ml of suspension:
Active agents: carbonate calcium (in terms of calcium) - 200 mg / 5 ml; a kolekaltsiferola (in terms of 100% колекальциферол) - 0,00135 mg (50 ME)/5 ml, in the form of the granulate containing: cholecalciferol, d, l - alpha tocopherol, triglycerides from the remains of fatty acids of average length, sucrose, acacia gum, corn starch, calcium phosphate, water.
Excipients: sorbitol (sorbite), starch prezhelatinizirovanny (преджель), silicon dioxide colloid (aerosil), fragrance orange.

Opisaniye:poroshok white or almost white color with a characteristic smell of orange.

The description of the prepared suspension: homogeneous suspension of white or almost white color with a characteristic smell of orange.




Pharmacological properties:

The combined drug intended for completion of deficit of calcium and D3 vitamin in an organism.

Pharmacodynamics. Calcium participates in formation of a bone tissue, increases its density, participates in a mineralization of teeth, in regulation of nerve conduction and muscular contractions, in maintenance of stability of cordial activity, in the course of a blood coagulation.

D3 vitamin (колекальциферол) regulates exchange of calcium and phosphorus in an organism, increases absorption of calcium in intestines, promotes a mineralization of bones, formation of a bone skeleton and teeth at children.

Drug reduces production of parathyroid hormone which is a stimulator of the raised bone resorption.


Indications to use:

Prevention of deficit of calcium and D3 vitamin at children of early age.


Route of administration and doses:

Drug is accepted inside, during food.
The dosage form is specially developed for children of early age up to 3 years.

Preparation of suspension from powder:
To add prokipyachenny and chilled water to the bottle containing powder on 

2/3 volumes of a bottle, carefully to mix (within 1-2 minutes). To add prokipyachenny and chilled water up to the volume of 100 ml (to a bottle mouth) and to mix repeatedly. Before each reception to shake up bottle contents.

In 5 ml of the received suspension contains carbonate calcium in terms of elementary calcium – 200 mg, a kolekaltsiferola – 50 ME.

To children 1 years – 5-10 ml of 1 times a day are aged more senior; to children till 1 year - on 5 ml of suspension of 1 times a day, according to the recommendation of the doctor. Purpose of drug to other age groups is carried out in need of corresponding doses according to the recommendation of the doctor.

Prevention course duration - 1 month, more long course - on doctor's orders.


Features of use:

In order to avoid overdose not to apply along with vitamin complexes, calciferous and D3 vitamin.

At preventive use of D3 vitamin it must be kept in mind a possibility of overdose, especially at children (it is not necessary to appoint more than 10-15 mg a year). Long use in high doses leads to a chronic hypervitaminosis of D3. At prolonged treatment it is necessary to control concentration of Ca2 + in blood and urine (especially at a combination to thiazide diuretics).

It must be kept in mind that sensitivity to vitamin D at different patients is individual and reception even of therapeutic doses can cause the hypervitaminosis phenomena in a number of patients.

Sensitivity of newborns to vitamin D can be various, some of them can be sensitive even to very low doses therefore prevention has to be carried out under control of the doctor.

The newborns who are on breastfeeding, especially born by mothers with dark skin and/or receiving insufficient insolation have high risk of emergence of deficit of vitamin D.


Side effects:

Allergic reactions. At use of drug in the recommended doses of other side effects it is not revealed. At exceeding of the recommended doses or a concomitant use of other drugs, calciferous, development of a hypercalcemia and hypercalcuria is possible (increases in content of calcium in blood and urine).

Also treat possible side effects of D3 vitamin: a loss of appetite, a polyuria, locks, a headache, a mialgiya, an arthralgia, increase in the ABP, arrhythmia, a renal failure, an aggravation of tubercular process in lungs.

Also treat possible side effects of calcium carbonate: gastralgia, locks or diarrhea, meteorism, nausea, secondary strengthening of gastric secretion.


Interaction with other medicines:

Drugs of calcium and D3 vitamin reduce absorption of bisfosfonat, digoxin, iron preparations and antibiotics of a tetracycline row (the interval between administration of drugs of not less than 2-3 hours is necessary).

Strengthening of effect of cardiac glycosides (at a concomitant use control of an ECG and condition of the patient is necessary) is possible.

Phenytoinum, barbiturates, Primidonum reduce effect of D3 vitamin due to strengthening of his metabolism.

Vitamin A, tocopherol, ascorbic acid, pantothenic acid, thiamin, Riboflavinum weaken toxic effect of D3 vitamin.

Glucocorticosteroids reduce absorption of calcium ions in intestines.

Colestyraminum, колестипол and mineral oils reduce absorption of D3 vitamin and demand increase in its dosage.

Thiazide diuretics increase risk of development of a hypercalcemia.

Vitamin D increases absorption of phosphorus drugs and risk of emergence of a hyperphosphatemia. At simultaneous use from sodium fluoride the interval between reception has to make not less than 2 h; with peroral forms of tetracyclines - not less than 3 h.

Long therapy by D3 vitamin against the background of simultaneous use of Al3 + and the Mg2+-containing antacids increases their concentration in blood and risk of developing of intoxication (especially in the presence of HPN).

Simultaneous use with other analogs of vitamin D and drugs of calcium increases risk of development of a hypervitaminosis of D.


Contraindications:

Hypersensitivity, hypercalcemia, hypercalcuria, calcic нефроуролитиаз, a hypervitaminosis D, decalcifying tumors (a myeloma, bone metastasises, a sarcoidosis), the osteoporosis caused by an immobilization, an active form of a pulmonary tuberculosis; deficit of invertase/isomaltase, intolerance of fructose, glyukozo-galaktozny malabsorption.

With care
Renal failure, high-quality granulomatosis, reception of cardiac glycosides and thiazide diuretics.


Overdose:

Symptoms: thirst, polyuria, loss of appetite, nausea, vomiting, locks, dizziness, weakness, headache, faint, coma; at prolonged use calcification of vessels and fabrics.
Laboratory indicators at overdose: hypercalcuria, hypercalcemia.
Treatment: the termination of administration of drug, the address to the doctor, a diet with calcium restriction, a regidratation, diuretics, glucocorticosteroids, in hard cases - a hemodialysis.


Storage conditions:

To store in the place protected from light, at a temperature not above 25 °C.

To store the prepared suspension in the place protected from light, at a temperature not over 15 ºС (in the refrigerator). Not to freeze.

To store in the place, unavailable to children.

Period of validity.
To store powder for preparation of suspension for intake 2 years.

To store the prepared suspension no more than 20 days.
Not to use after the period of validity specified on packaging.


Issue conditions:

Without recipe


Packaging:

Powder for preparation of suspension for intake of 200 mg +50 ME/5 ml.

On 43,0 g in bottles on 100 ml from dark (amber) glass. One bottle together with the application instruction and a measured spoon is placed in a pack from a cardboard.



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