Geloplasmatic balance - instructions for use, doses, side effects, contraindications

Active substanceGelatinGelatin

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Geloplasmatic balance

solution d / infusion

Fresenius Kabi Deutschland GmbH Germany

Gelofusine

solution d / infusion

B. Brown Mehlungen AG Germany

Gelatinol®

solution d / infusion

SAMSON-MED, LLC Russia

Dosage form: & nbsp

solution for infusion 3%

Composition:

1 liter of solution contains:
Active substances
Gelatin modified liquid * (in terms of anhydrous gelatin)
Excipients:
Sodium chloride	5.382 g
Magnesium chloride hexahydrate	0.305 g
Potassium chloride	0.373 g
Sodium lactate solution	3,360 g
(in terms of sodium lactate anhydrous)
Water for injections	up to 1 liter
* partially hydrolyzed and succinated gelatin
Ionic composition
Sodium	150 meq / L (corresponding to 150 mmol / L)
Potassium	5 meq / L (corresponding to 5 mmol / L)
Magnesium	3 m / eq / l (corresponding to 1.5 mmol / L)
Chloride	100 meq / L (corresponding to 100 mmol / L)
Lactate	30 meq / L (corresponding to 30 mmol / L)
Osmolality	295 mOsm / kg

Description:

A clear, colorless or pale yellow solution.

Pharmacotherapeutic group:Plasmasuberant

ATX: & nbsp

B.05.A.A.06 Preparations of gelatin

Pharmacodynamics:

Geloplasmic balance is a 3% solution of succinated gelatin or modified liquid gelatin for intravenous administration with an average molecular weight of 45,000 Da. It has a colloidal pressure of 34 mm / b.

The isoelectric point is reached at pH 4.5.The negative charges that arise in the molecule as a result of succination lead to an increase in the molecule in size, and thus more voluminous protein chains are formed than non-succinic ones, while maintaining the molecular weight. As a result of Geloplasmas, the balance has a sufficient volemic effect within 3-4 hours.

Geloplasma balance replaces the lack of intravascular fluid caused by blood or plasmomotor. Thus, mean arterial pressure, ventricular diastolic pressure, cardiac systolic volume, cardiac index, oxygen delivery and diuresis is increased.

Increases the volume of circulating blood, which leads to an increase in venous return and a minute volume of circulation, an increase in blood pressure, and an improvement in the perfusion of peripheral tissues. Calling for osmotic diuresis, it ensures the maintenance of kidney function in shock. Reduces the viscosity of blood, improves microcirculation. Due to its colloid-osmotic properties it prevents or reduces the likelihood of developing interstitial edema.

Pharmacokinetics:

The colloid-osmotic pressure of the solution determines the degree of manifestation of the initial effect.The duration of action depends on the rate of degradation and excretion of the colloid.

The volemic effect of the Geloplasma balance is equivalent to the amount of the injected solution. Geloplasma balance quickly leaves the bloodstream, which is explained by the presence of a large number of low molecular weight fractions (after 2 hours in the blood there are about 20% of the injected drug).

T1 / 2 - 9 hours. It is excreted by the kidneys - 75%, through the intestine - 15% (10% is cleaved in tissues through proteolysis and included in the protein metabolism). Do not cumulate.

Indications:

- Hypovolemia (prevention and treatment): hemorrhagic, traumatic, burn and toxic shock.

- Prevention and treatment of arterial hypotension with spinal or epidural anesthesia.

- Extracorporeal circulation.

- Hemodilution.

Contraindications:Hypersensitivity, hypervolemia, Heavy cardiac failure, serious violation of blood clotting, hyperhydration.

Carefully:

Chronic renal failure, hemorrhagic diathesis, pulmonary edema, hypokalemia, hypernatremia, a state of dehydration (in this case, first of all correction of water-electrolyte balance is required), chronic liver diseases,at which the synthesis of albumin and coagulation factors is disturbed, and the introduction of a colloidal solution will lead to their further dilution.

Pregnancy and lactation:

No cases of embryotoxic action of the Geloplasmatic balance were noted, but the possibility of allergic reactions can not be ruled out completely. In pregnancy, the drug should be administered when the possible benefit to the mother exceeds the potential risk to the fetus.

There are no data on the penetration of the Geloplasma balance into breast milk.

No information on the application Geloplasmic balance in children under the age of one year is not available.

Dosing and Administration:

In / in the drip, the duration of the infusion and the volume of the administered solution are corrected taking into account the dynamics of heart rate, blood pressure, diuresis, perfusion state of peripheral tissues. With moderate blood loss and with a prophylactic goal in the preoperative period or during the operation is administered at a dose of 0.5-1 L for 1-3 hours. In the treatment of severe hypovolemia -1-2 l. In emergency, life-threatening situations, 500 ml is injected in the form of fast infusion (under pressure), then after an improvement in blood circulation, the infusion is performed in an amount equivalent to a volume deficit. To maintain the BCC in shock - up to 10-15 liters within 24 hours.Extracorporeal circulation: 0.5-1.5 l (depending on the system used).

Side effects:

As a result of infusion of Geloplasmas, allergic reactions (anaphylactoid or anaphylactic) reactions are possible, as with any other plasma-substituting solutions, with massive administration - hypocoagulation (caused by the effect of dilution).

Overdose:

The main risk of overdose is associated with the possibility of circulatory overload, which in the future can adversely affect the function of the heart and lungs. If symptoms of circulatory congestion occur, discontinue the infusion immediately after the overdose!

Interaction:

Pharmaceutically incompatible with fat emulsions, barbiturates, muscle relaxants, antibiotics, glucocorticosteroids. Compatible from solutions of electrolytes, carbohydrates, whole blood.

Special instructions:

Impact on laboratory indicators

Geloplasmic balance can change the indicators of diagnostic tests for glucose, fructose, cholesterol, fatty acids, as well as ESR, specific gravity of urine, indicators of protein in the urine (including the biuretic method). Turbulent solutions do not use.Before the gelatin transfusion, the physician should perform a visual inspection of the bags intended for infusion. The preparation is considered suitable for use under condition of the tightness of the package. The drug should be transparent.

The degree of decrease in hematocrit should not exceed 25% (in the elderly, as well as in cardiovascular and pulmonary insufficiency - 30%). With CHF, infusion is slow because of possible circulatory overload. If more than 2-3 liters are administered during the operation, the serum concentration of the protein should be monitored in the postoperative period, especially if there is tissue swelling (if necessary, human / albumin administration is advisable for further plasma replacement therapy).

With violations of blood coagulability and chronic liver diseases, control of the parameters of coagulability of blood and serum albumin is necessary. When used as an infusion under pressure (cuff of the tonometer, infusion pump), the solution must be heated to body temperature. When the preparation is administered under pressure, all air from the bag must be removed beforehand.

Effect on the ability to drive transp. cf. and fur:Not noted.

Form release / dosage:

Solution for infusions 3%.

Packaging:500 ml in a double-layer plastic polyvinylchloride bag equipped with two ports (Heb.) 15 bags in a carton box along with 15 instructions for use (for hospitals).

Storage conditions:

Store at a temperature of no higher than 25 ° C. Do not freeze! Keep out of the reach of children!

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:For hospitals

Registration number:LSR-009253/08

Date of registration:21.11.2008

Expiration Date:Unlimited

The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany

Manufacturer: & nbsp

FRESENIUS KABI FRANCE France

Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany

Information update date: & nbsp20.03.2017

Illustrated instructions

Instructions

Geloplasmatic balance (Geloplasma balance)