Stero-fundin isotonic - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspsolution for infusions

Composition:100 ml of the solution contains:

Active substances:
Sodium chloride	6.80 g
Potassium chloride	0.30 g
Calcium chloride dihydrate	0.37 g
Magnesium chloride hexahydrate	0.20 g
Sodium acetate trihydrate	3.27 g
Apple acid	0.67 g
Excipients:
Sodium hydroxide	0.20 g
Water for injections	up to 1000 ml
Concentration of electrolytes:
Sodium	145.0 mmol / l
Potassium	4.0 mmol / l
Calcium	2.5 mmol / L
Magnesium	1.0 mmol / L
Chlorides	127.0 mmol / l
Acetates	24.0 mmol / l
Malaty	5.0 mmol / l
Physico-chemical characteristics:
Theoretical osmolality	309 mOsm / l
pH	from 5,1 to 5,9

Description:Transparent, colorless solution without visible mechanical inclusion

Pharmacotherapeutic group:rehydrating agent

ATX: & nbsp

Electrolytes

Pharmacodynamics:

Stero-fundin isotonic is an isotonic solution of electrolytes with an electrolyte concentration adapted to the concentration of plasma electrolytes. It is used to correct loss of extracellular fluid (ie loss of water and electrolytes in commensurate amounts). The introduction of the solution is aimed at restoring and maintaining the osmotic status in the extracellular and intracellular space.

Anionic composition is represented by a balanced combination of chlorides, acetates and malates approximated by the molar concentration to the anionic composition of the blood plasma,which contributes to the correction of metabolic acidosis.

Pharmacokinetics:

Since Stero-fundin isotonic is administered intravenously, the bioavailability of all its components is 100%.

Sodium and chlorides are mainly distributed in the extracellular space, whereas potassium, magnesium and calcium are localized inside the cells. Sodium, potassium, magnesium and chlorides are excreted mainly through the kidneys, as well as in small amounts through the skin and gastrointestinal tract. Calcium is excreted in approximately equal amounts with urine and endogenous intestinal secretion.

During the infusion of acetates and malates, their concentration in the blood plasma increases to a constant value. Then, after stopping the infusion, their concentration drops sharply. Excretion of acetates and malates with urine increases during infusion. However, the metabolism of these substances in the tissues of the body is so rapid that only a small number of them enter the urine.

Acetates are metabolized in the liver, heart and other tissues under the influence of acetyl coenzyme A (acetyl-CoA) -synthesis. The resulting acetyl-CoA is further metabolized in the reactions of the Corey cycle and ultimately converted to carbon dioxide and water.

Malates are metabolized in the Krebs cycle under the influence of malate dehydrogenase, which catalyzes the conversion of malate to oxaloacetate.

Indications:

Substitution of losses of extracellular fluid in isotonic dehydration in patients with acidosis or the threat of its development.

Contraindications:

- Hypervolaemia;

- chronic heart failure III-IV functional class;

- Pkidney failure with oliguria or anuria;

- tsevere general edema;

- Hyperkalemia;

- hypercalcemia;

- metabolic alkalosis.

Carefully:

Infusion of large volume to patients with cardiac or pulmonary insufficiency should be carried out under constant monitoring.

Solutions containing sodium chloride, should be administered with caution to patients with:

- heart failure of mild or moderate severity, peripheral edema or pulmonary edema, or extracellular hyperhydration,

- hypernatremia, hyperchloremia, hypertonic dehydration, arterial hypertension, impaired renal function, eclampsia or the threat of its occurrence, aldosteroneism and other conditions and treatment methods (eg, corticosteroids) associated with sodium retention.

Solutions containing potassium salts, should be administered with caution to patients with heart disease or a predisposition to hyperkalemia in renal insufficiency or adrenal cortex insufficiency, acute dehydration or extensive destruction of tissues that occurs with severe burns.

Because of the presence of calcium:

- it is necessary to exclude the possibility of extravasal penetration of the solution during intravenous infusion,

- The solution should be administered with caution to patients with impaired renal function or diseases accompanied by increased vitamin concentrations D, such as sarcoidosis,

- after a blood transfusion solution should not be administered using the same infusion system.

Solutions containing metabolizable anions, should be administered with caution to patients with breathing disorders.

It is necessary to monitor serum electrolytes, fluid balance in the body and blood pH.

Stero-fundin isotonic should be used with caution in toxicoses of pregnant women.

Pregnancy and lactation:

Data on the use of the drug Sterofundin isotonic in pregnancy and during breastfeeding are limited.With a constant monitoring of the volume of infusion, the concentration of electrolytes and acid-base balance of complications when using the drug according to indications does not arise.

Dosing and Administration:

Stero-fundin isotonic is injected into the peripheral and central veins.

The dose depends on the age, body weight, clinical and biological condition of the patient and concomitant therapy.

Recommended doses

- elderly, adults and children from 11 years from 500 ml to 3 l / day, which corresponds to 1-6 mmol sodium / kg body weight / day and 0.03-0.17 mmol potassium / kg body weight / day;

- children under 11 years from 20 ml to 100 ml / kg body weight / day, corresponding to 3-14 mmol sodium / kg body weight / day and 0.08-0.40 potassium / kg body weight / day.

The rate of administration

The maximum rate of administration is determined by the patient's needs in fluid and electrolytes, body weight, clinical condition and biological status of the patient.

For children, the rate of administration is on average 5 ml / kg body weight / hour, but it depends on age:

- for children under 1 year 6-8 ml / kg body weight / hour;

- for children from 1 year to 2 years 4-6 ml / kg body weight / h;

- for children from 2 to 11 years 2-4 ml / kg body weight / h.

Duration of application

Stero-fundin isotonic can be administered as long as is required to restore the water-electrolyte balance.

General recommendations for the use of liquid and electrolyte solutions

A dose of 30 ml of solution / kg of body weight / day covers only the physiological needs of the organism in the liquid. In patients undergoing surgery and patients in critical conditions, fluid requirements increase due to reduced renal concentration function and increased excretion of metabolic products, which leads to the need to increase fluid intake to about 40 ml / kg body weight / day. Additional losses (fever, diarrhea, fistula, vomiting, etc.) must be compensated for by an even higher injection of liquid, the level of which is set individually. The actual individual level of fluid demand is determined by sequential monitoring of clinical and laboratory indicators (urine output, serum and urine osmolality, determination of excreted substances).

The main replacement of the most important sodium and potassium cations is 1.5-3.0 mmol / kg body weight / day and 0.8-1.0 mmol / kg body weight / day, respectively.The actual requirements for infusion therapy are determined by the state of the water-electrolyte balance.

Side effects:

There are descriptions of hypersensitivity reactions in the form of urticaria after intravenous administration of magnesium salts.

Despite the fact that enteral administration of magnesium salts stimulates peristalsis, there are isolated reports of the development of paralytic intestinal obstruction after intravenous administration of magnesium sulfate.

Adverse adverse reactions may be associated with the technique of administration and include febrile reactions, infection, pain and other reactions at the puncture site, irritation, thrombosis or phlebitis at the site of puncture or extravascular penetration of the solution.

Adverse adverse reactions may be due to preparations added to Sterofundin isotonic, the nature and likelihood of such reactions is determined by the nature of the drugs added.

Overdose:

Volume overload and electrolyte overdose:

Symptoms

Overdose of the drug may lead to such phenomena as hypertonic hyperhydration, electrolyte disorders, pulmonary edema.

Treatment

Immediate cessation of infusion, the appointment of diuretics with constant monitoring of the concentration of plasma electrolytes; electrolyte balance correction.

Interaction:

To avoid precipitation, steroid isotonic should not be mixed with preparations containing carbonates, phosphates, sulfates or tartrates.

Sodium, potassium, calcium and magnesium are contained in the preparation Sterofundin isotonic at the same concentrations as in blood plasma. Therefore, the use of Sterofundin isotonic in accordance with the indications and contraindications does not lead to an increase in the concentrations of these electrolytes. In the case of an increase in the concentration of any of the electrolytes for other reasons, the following interactions should be taken into account.

Interactions with sodium:

- corticosteroids and carbenoxolone have the ability to retain sodium and water (with the onset of edema and hypertension).

Interactions with potassium:

- suxamethonium,

- potassium-sparing diuretics (amiloride, spironolactone, triamterene),

- tacrolimus, cyclosporine

can increase the concentration of potassium in the blood plasma, which leads to potentially dangerous hyperkalemia, especially in renal failure.

Interactions with calcium:

- with hypercalcemia, the effect of cardiac glycosides may increase, which can lead to severe cardiac arrhythmias with possible fatal outcome.

Vitamin D can cause hypercalcemia.

Special instructions:

The solution has a pH of 5.1-5.9 and a theoretical osmolarity of 309 mOsm / l. Therefore, it can be injected into the peripheral veins.

If the administration is carried out by rapid infusion under pressure, all air must be removed from the polyethylene bottle and the infusion system before starting the infusion, since otherwise there is a risk of air embolism.

Water-electrolyte balance and acid-base state during the infusion should be under constant supervision.

Unused solution must be disposed of.

Use only a clear solution that is practically free of mechanical inclusions.

The solution should be administered with aseptic compliance.

Do not freeze!

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the ability to drive vehicles, mechanisms, as well as engage in potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Solution for infusion.

Packaging:

By 500 ml or 1000 ml into bottles made of polyethylene without additives meeting the requirements of the European Pharmacopoeia for arterial preparations, with a Euro-cap.

For 10 bottles of 500 ml or 1000 ml, along with instructions for use in an appropriate amount in a cardboard box (for hospitals).

Storage conditions:

Store at a temperature of 2 to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:For hospitals

Registration number:LS-001825

Date of registration:25.04.2012

The owner of the registration certificate:B. Brown Mehlungen AGB. Brown Mehlungen AG Germany

Manufacturer: & nbsp

B. BRAUN MELSUNGEN, AG Germany

Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company

Information update date: & nbsp03.03.2016

Illustrated instructions

Instructions

Stero-fundin isotonic (Sterofundin Isotonic)