Solution for infusions "Sterofundin ISO" is applied to substitution of losses of intercellular liquid in case of isotonic dehydration at existence or threat of acidosis.

Structure

1000 ml of solution contain (active ingredients):

• sodium of chloride - 6.80 g;
• potassium of chloride - 0.30 g;
• magnesium of chloride of hexahydrate - 0.20 g;
• Calcii chloridum a dihydrate - 0.37 g;
• sodium of acetate of trihydrate - 3.27 g;
• acid L-low-new - 0.67 g

Concentration of electrolytes (mmol/l): sodium - 145; potassium - 4; magnesium - 1; calcium - 2.5; chlorides - 127; acetates - 24; malates - 5.

Excipients: water for injections, sodium hydroxide.

Contraindication

• hypersensitivity to any acting or to excipient, the medicament which is a part;
• overhydratation;
• heavy stagnant heart failure;
• a renal failure with an oliguria or an anury;
• heavy general hypostasis;
• a hyperpotassemia in a severe form;
• hypercalcemia;
• metabolic alkalosis;
• heavy metabolic acidosis.

Route of administration

Dose should be determined by

depending on the real need for replenishment of water level and electrolytes.

Adult

Maximum daily dose. The volume of the entered solution should not exceed 40 ml/kg of body weight a day (that corresponds to 5.8 mmol of sodium on one kg of body weight and 0.16 mmol of potassium on one kg of body weight). Additional losses of liquid (for example, in connection with fever, diarrhea, vomiting and so on) should be compensated depending on the volume and composition of the lost liquid. In case of dehydration the dose of 40 ml/kg of body weight a day can be exceeded. The dose should be calculated taking into account weight of dehydration and a clinical condition of the patient. At treatment of acute shortage of liquid, namely the expressed or life-threatening, hypovolemic shock, use of high doses, for example, by fast infusion is allowed (under pressure).

Maximum speed of infusion. Speed of infusion of medicine should not exceed 100 ml/hour. At treatment of dehydration the maximum speed of infusion is 5 ml/kg of body weight an hour that corresponds to 0.7 mmol of sodium on one kg of body weight an hour and 20 µmol of potassium on one kg of body weight an hour. At short-term replenishment of intravascular volume the maximum speed of infusion depends on a clinical situation of the patient. In situations, life-threatening, it is possible to enter quickly 500 ml of medicament under manual pressure.

Solvent. At use of solution for infusions "Sterofundin ISO" as solvent of dosing and the speed of infusion is defined mainly on the basis of characteristics and the mode of dosing of soluble means.

Pediatric population. The dose is appointed by the doctor. The dose depends on age, body weight, laboratory indicators, a clinical condition and the accompanying therapy of the patient.

Maximum daily dose. It is not necessary to exceed the following daily doses:

• aged from 28 days of life - 160 ml/kg of body weight a day;
• 2 months - 150 ml/kg of body weight a day;
• 1-2 years - 120 ml/kg of body weight a day;
• 3-5 years - 100 ml/kg of body weight a day;
• 6-12 years - 80 ml/kg of body weight a day;
• 13-18 years - 70 ml/kg of body weight a day.

Additional losses of liquid (for example, in connection with fever, diarrhea, vomiting and so on) should be compensated to

depending on the volume and composition of the lost liquid. In case of dehydration or at short-term replenishment of intravascular volume the above-stated doses can be raised. The dose should be calculated taking into account weight of dehydration and a clinical condition of the patient.

infusion Speed. Maximum speed of infusion (body weight):

• 0-10 kg - 4 ml/kg/h;
• 10-20 kg - 40 ml/hour + 2 ml/kg/h are higher than 10 kg;
• > 20 kg - 60 ml/hour + 1 ml/kg/h is higher than 20 kg.

At treatment of dehydration the maximum speed of infusion is 5 ml/kg/h that corresponds to 0.7 mmol of sodium on one kg of body weight an hour and 20 µmol of potassium on one kg of body weight in hour

Patients of advanced age

same doses, as are generally applied to adults, but it is necessary to pay attention to patients with such diseases as heart failure or a renal failure which can be connected with advanced age.

Patients with a chronic hyponatremia

For prevention of development of an osmotic demyelinating syndrome of increase in level of sodium in blood serum 9 mmol/l/days should not exceed

. As the general recommendation, dose adjustment has to be from 4th to 6 mmol/l/days for the majority of cases depending on a condition of the patient and contributing factors of risk.

Method of administration

Only for introduction by infusion.

"Sterofundin of ISO" can be entered into peripheral veins (on pH and theoretical osmolarity).

for introduction needs to remove with

At introduction by fast infusion under pressure all air before infusion as otherwise there is a risk of developing of an air embolism during infusion from a plastic container and a system.

needs to carry out by

At introduction monitoring of liquid balance, plasma concentration of electrolytes and pH.

"Sterofundin of ISO" can be entered while there are indications for liquid substitution.

Pregnant

Data on use of solution for infusions "Sterofundin does not have

Feature of use

ISO" pregnant and nursing. Within the recommended indications it is not necessary to expect any risk if the volume of the entered solution, the level of electrolytes and acid-base indicators are carefully controlled.

"Sterofundin of ISO" should be applied with care in toxicosis of pregnant women.

Children

children can use Drug aged from 28 days according to indications.

Drivers

Solution for infusions "Sterofundin ISO" does not influence or has insignificant impact on ability to drive the car or to work with other mechanisms.

Overdose

Excess or too fast administration of solution can lead to a water or sodium overload with increase in turgor of skin, venous stagnation and with edematization, especially in case of disturbances sodium removal by kidneys. In this case the additional hemodialysis can be required.

Treatment

Immediately to stop infusion. Further treatment depends on character and weight of symptoms and can include administration of diuretics with frequent control of electrolytic balance, correction of an electrolytic and acid-base imbalance. Treatment of a hyperpotassemia includes use of calcium, insulin (with glucose), sodium of bicarbonate, exchange pitches or dialysis.

Side effects

Can appear signs of overdose.

Reaction of hypersensitivity, including an urtikariya.

overhydratation, a fluid lungs, electrolytic disorders Is possible

.

Though oral administration of salts of magnesium stimulates with

a vermicular movement, after administration of magnesium of sulfate was in rare instances reported about paralytic intestinal impassability.

Side reactions can be connected by

with technology of introduction, including the febrile answer, infections in the injection site, local pain or local reactions, irritation of veins, the vein thrombosis or phlebitis extending from the site of input and an ekstravazation. Side reactions can be also connected with the medicines attached to solution, the nature of the added substances will define type of any other undesirable effects.

Storage conditions

to Store

out of children's reach at a temperature not above 25 °C. Not to freeze.

Expiration date at storage in polyethylene containers - 3 years, in plastic bags - 2 years.

Expiration date after opening of a container. From the microbiological point of view medicament should be used right after opening. If solution is entered not at once, the person using this medicament is responsible for its appropriate storage before the following use, usually should not exceed 24 hours at a temperature of 2-8 °C if in the controlled and confirmed aseptic conditions solution was not restored/is divorced.