Sterofundin ISO infusion solution is used to replace intercellular fluid losses in the event of isotonic dehydration in the presence or threat of acidosis.
Composition
: 1000 ml of solution contain (active ingredients):
sodium chloride - 6.80 g; potassium chloride - 0.30 g; magnesium chloride hexahydrate - 0.20 g; calcium chloride dihydrate - 0.37 g; sodium acetate trihydrate - 3.27 g; L-malonic acid - 0.67 g
Electrolyte concentration (mmol/l): sodium - 145; potassium - 4; magnesium - 1; calcium - 2.5; chlorides - 127; acetates - 24; Malathia - 5.
Excipients: water for injections, sodium hydroxide.
Contraindication
Hypersensitivity to any of the active or auxiliary substances included in the preparation; hyperhydration; severe congestive heart failure; renal failure with oliguria or anuria; severe general edema; severe hyperkalemia; hypercalcemia; metabolic alkalosis; severe metabolic acidosis.
Method of application
The dose should be determined depending on the actual need to replenish water and electrolyte levels.
Adults
Maximum daily dose. The volume of the solution administered should not exceed 40 ml/kg body weight per day (corresponding to 5.8 mmol sodium per kg body weight and 0.16 mmol potassium per kg body weight). Additional fluid losses (e.g. due to fever, diarrhoea, vomiting, etc.) should be compensated for depending on the volume and composition of the lost fluid. In case of dehydration, the dose of 40 ml/kg body weight per day may be exceeded. The dose should be calculated taking into account the severity of the dehydration and the clinical condition of the patient. In the treatment of acute fluid deficiency, namely severe or life-threatening hypovolemic shock, high doses are allowed, for example by rapid infusion (under pressure).
Maximum infusion rate. The infusion rate of the medicinal product should not exceed 100 ml/h. In the treatment of dehydration, the maximum infusion rate is 5 ml/kg body weight per hour, which corresponds to 0.7 mmol sodium per kg body weight per hour and 20 µmol potassium per kg body weight per hour. For short-term intravascular volume replacement, the maximum infusion rate depends on the clinical situation of the patient. In life-threatening situations, 500 ml of the product can be rapidly administered under manual pressure.
Diluent. When using Sterofundin ISO infusion solution as a diluent, the dosage and infusion rate are determined primarily based on the characteristics and dosing regimen of the diluent.
Pediatric population: The dose is determined by the doctor. The dose depends on the age, body weight, laboratory parameters, clinical condition and concomitant therapy of the patient.
Maximum daily dose. The following daily doses should not be exceeded:
at the age of 28 days of life - 160 ml/kg of body weight per day; from 2 months - 150 ml/kg of body weight per day; 1-2 years - 120 ml/kg of body weight per day; 3-5 years - 100 ml/kg of body weight per day; 6-12 years - 80 ml/kg of body weight per day; 13-18 years - 70 ml/kg of body weight per day.
Additional fluid losses (e.g. due to fever, diarrhoea, vomiting, etc.) should be compensated for depending on the volume and composition of the lost fluid. In case of dehydration or short-term intravascular volume replacement, the above doses may be increased. The dose should be calculated taking into account the severity of dehydration and the clinical condition of the patient.
Infusion rate. Maximum infusion rate (body weight):
0-10 kg - 4 ml/kg/h; 10-20 kg - 40 ml/h + 2 ml/kg/h above 10 kg; > 20 kg - 60 ml/h + 1 ml/kg/h above 20 kg.
When treating dehydration, the maximum infusion rate is 5 ml/kg/h, which corresponds to 0.7 mmol sodium per kg body weight per hour and 20 µmol potassium per kg body weight per hour.
Elderly patients
Basically, the same doses as for adults are used, but attention should be paid to patients with diseases such as heart failure or kidney failure, which may be associated with old age.
Patients with chronic hyponatremia
To prevent the development of osmotic demyelinating syndrome, the increase in serum sodium should not exceed 9 mmol/L/day. As a general recommendation, dose adjustment should be from 4 to 6 mmol/L/day for most cases, depending on the patient's condition and associated risk factors.
Method of administration
For infusion use only.
"Sterofundin ISO" can be administered into peripheral veins (according to pH and theoretical osmolarity).
When administered by rapid infusion under pressure, all air must be removed from the plastic container and administration set before infusion, as otherwise there is a risk of air embolism during infusion.
Upon admission, fluid balance, plasma electrolyte concentration, and pH should be monitored.
"Sterofundin ISO" can be administered as long as there are indications for fluid replacement.
Application features
Pregnant women
There are no data on the use of Sterofundin ISO infusion solution in pregnant and breastfeeding women. Within the recommended indications, no risk should be expected if the volume of solution administered, electrolyte levels and acid-base parameters are carefully monitored.
"Sterofundin ISO" should be used with caution in case of toxicosis of pregnant women.
Children
The drug can be used in children from 28 days of age according to indications.
Sterofundin ISO infusion solution has no or negligible influence on the ability to drive or use machines.
Overdose
Excessive or too rapid administration of the solution may lead to water or sodium overload with increased skin turgor, venous stasis and the development of edema, especially in cases of impaired renal sodium excretion. In this case, additional hemodialysis may be necessary.
Treatment
Stop the infusion immediately. Further treatment depends on the nature and severity of the symptoms and may include diuretics with frequent monitoring of electrolyte balance, correction of electrolyte and acid-base imbalances. Treatment of hyperkalemia includes the use of calcium, insulin (with glucose), sodium bicarbonate, exchange resins or dialysis.
Side effects
Signs of overdose may appear.
Hypersensitivity reactions, including urticaria.
Hyperhydration, pulmonary edema, and electrolyte disturbances are possible.
Although oral administration of magnesium salts stimulates peristalsis, paralytic intestinal obstruction has been reported in rare cases after administration of magnesium sulfate.
Adverse reactions may be related to the injection technique, including febrile response, infection at the injection site, local pain or local reactions, vein irritation, venous thrombosis or phlebitis extending from the injection site, and extravasation. Adverse reactions may also be related to medications added to the solution; the nature of the added substances will determine the type of any other undesirable effects.
Storage conditions
Keep out of the reach of children at a temperature not exceeding 25 °C. Do not freeze.
Shelf life when stored in polyethylene containers is 3 years, in plastic bags - 2 years.
Shelf life after opening the container. From a microbiological point of view, the product should be used immediately after opening. If the solution is not administered immediately, the person administering the product is responsible for in-use storage times and would normally not be longer than 24 hours at 2-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
