Gelofusin - instructions for use, dose, 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: & nbspsolution for infusions

Composition:

1000 ml of solution contains:

Active substances:

Succinylated gelatin (average molecular weight Mn 23 200 daltons) 40.00 grams

Sodium chloride 7.01 g

Excipients:

Sodium hydroxide 1.36 g

Water for injection before 1000 ml

Concentration of electrolytes:

Sodium 154 mmol / l

Chlorides 120 mmol / l

Physico-chemical characteristics:

Theoretical osmolality 274 mOsm / l

pH 7,1-7,7

Description:Transparent solution from pale yellow to yellow.

Pharmacotherapeutic group:Plasmasuberant

ATX: & nbsp

Preparations of gelatin

Pharmacodynamics:

Gelofusine is a 4% solution of succinylated gelatin (also known as modified liquid gelatin) for intravenous administration with an average molecular weight of 23,200 daltons. It has a colloid-osmotic pressure of 34 mm Hg. The isoelectric point is reached at pH 4.5. The negative charges that arise in the molecule as a result of succinylation lead to an increase in the molecule in size and, thus, more voluminous protein chains are formed than non-succinic chains, while retaining the molecular weight.As a result, Gelofusin has a sufficient volemic effect within 3-4 hours.

Therapeutic action:

Gelofusin replaces the lack of intravascular fluid volume caused by blood or plasmopomers. Thus, way, mean arterial pressure, left ventricular diastolic pressure, cardiac systolic volume, cardiac index, oxygen delivery and diuresis are increasing.

Mechanism of action:

Colloid-osmotic pressure solution determines the degree of severity of the initial effect. The duration of action depends on the rate of degradation and excretion of the colloid. The volemic effect of Gelofusin is equivalent to the administered amount of solution. Since Gelofusin is a plasma substitute, it does not have the effect of increasing the plasma volume. The loss of plasma proteins is not compensated for by Gelofusin.

Pharmacokinetics:

Distribution:

After administration, Gelofusin is rapidly distributed predominantly in the intravascular space, and a small amount of it can enter the interstitial space. There is no evidence that Gelofusin is deposited in the reticulo-endothelial system or elsewhere in the body.

Metabolism / excretion:

Basically, Gelofusine is excreted through the kidneys. Only small amounts are excreted through the intestine and not more than 1% is metabolized. Small molecules are excreted directly by glomerular filtration, whereas large molecules are first subjected to proteolytic degradation in the liver and then excreted through the kidneys. Proteolytic metabolism adapts so much lEgko, what even at conditions renal insufficiency no accumulation gelatin not observed. After introduction of from the goal of substitution volume of plasma period half-life Gelofusine from the intravascular space is 4-5 hours.

Pharmacokinetics in special clinical conditions:

The half-life of Gelofusin from plasma can be prolonged at patients, of the on hemodialysis (speed glomerular filtration <0.5 ml / min).

Indications:

As a colloidal plasma-substituting agent in the following cases:

- prevention and treatment of absolute and relative hypovolemia (eg, due to hemorrhagic or traumatic shock, peri-operative blood loss, burns, sepsis)

- Prevention of hypotension (for example, in connection with the epidural or spinal anesthesia)

- hemodilution

- extracorporeal circulation (heart-lung apparatus, hemodialysis)

Contraindications:

- known hypersensitivity to gelatin;

- hypervolemia;

- hyperhydration;

- severe heart failure;

- serious violation of blood clotting.

Carefully:

- Hypernatremia, since with gelofusin additionally introduced sodium ions

- the state of dehydration, since in this case, first of all, correction of the water-electrolyte balance is required

- in diseases associated with a violation of the coagulation system, due to the fact that the introduction of gelofusin will lead to dilution of coagulation factors

- Renal failure, because the usual pathway can be compromised

- chronic liver diseases, in which the synthesis of albumin and coagulation factors is disturbed, and the introduction of a colloidal solution will lead to further dilution

Pregnancy and lactation:

There are no confirmations of any embryotoxic effects of Gelofusin.

Because the dangers allergic (anaphylactic / anaphylactoid) reactions can not be completely ruled out, it should to be administered during pregnancy only when the possible benefit to the mother outweighs the potential risk to the fetus.

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

Dosing and Administration:Gelofusine is administered intravenously.

The total dose, duration and rate of administration depend on individual needs, taking into account the results of monitoring the usual circulatory parameters (for example, blood pressure), which, if necessary, must be corrected. To detect, if possible at an earlier stage, the onset of allergic (anaphylactic anaphylactoid) reactions, the first 20-30 ml of Gelofusin should be administered slowly and under close supervision.

Dosages recommended for adult patients

Indications	The average dosage
Prevention of hypovolemia and hypotension. Treatment of mild hypovolemia (for example, with moderate blood and plasma loss)	500-1000 ml
Treatment of severe hypovolemia	1000-2000 ml
In emergency, life-threatening situations	500 ml in the form of fast infusion (under pressure), then, after improving the circulatory parameters, the infusion should be carried out in an amount equivalent to a volume deficit.
Extracorporeal circulation	depending on the circulatory system used, but usually from 500 to 1500 ml

For patients with impaired coagulation, renal insufficiency and chronic liver diseases, it is recommended that the dosage be selected in accordance with the individual clinical situation, while the results of clinical and chemical studies should be taken into account.

The maximum daily dose

Practically depends on the degree of achieved hemodilution. The drop in hematocrit below 25% (in patients with cardiovascular and pulmonary insufficiency - 30%) requires a transfusion of red blood cells or whole blood, after which the administration of Gelofusin can be continued. With massive blood loss, if necessary, it is possible to transfuse up to 10-15 liters of solution per day (subject to the above conditions).

Maximum infusion rate

The maximum rate of infusion depends on the state of hemodynamics, peripheral microcirculation and diuresis.

Pediatric Use

There is no information regarding the use of Gelofusin in children under the age of one year.

Side effects:

As a result of infusion of Gelofusin, as well as any other plasmasubstitutional solutions, allergic (anaphylactic or anaphylactoid) reactions are possible. There are such reactions in the form of skin rashes (hives, redness in the face and neck). In rare cases, there may be a sharp drop in blood pressure, shock, stopping breathing and cardiac activity. In these cases, the infusion should be stopped immediately.

Tests for the timely detection of patients prone to anaphylactoid or anaphylactic reactions are not known, nor is it possible to predict the course of such reactions.

Allergic (anaphylactic / anaphylactoid) reactions to the gelatin solution can be both histamine-mediated and histamine-independent. The isolation of histamine can be prevented by the use of a combination of blockers H1 and H2 receptors. The validity of the preventive use of corticosteroids has not been proven.

Side effects can appear both in conscious patients and in patients with anesthesia. However, in the acute phase of shock caused by volume deficiency,Allergic (anaphylactic / anaphylactoid) reactions are still not known.

ExtremenntreatmentMr.affilaktandsicandx/anafandlactoidx pactions

Degree of severity	Manifestation	Clinical symptoms	Necessary measures and therapy
1 a	Localized skin reactions	Localized erythema	Discontinuation of infusion				H1 / 12-antihistamines
1 b	Weak system reaction	Parestezi, headache, rush of blood to the face, hives, swelling of the mucous membranes	Discontinuation of infusion				H1 / 12-antihistamines
2.	Cardiovascular reaction	TahikardiI, a drop in blood pressure	Oxygen therapy	Infusion of crystalloids	Catsholamines (dosage and method of administration see in the right column)		1. Adrenaline, for example, inhalation 0.5-1.0 ml 2. Adrenaline 1: 10,000 minutes. ca. 3. Corticosteroids vs. 4. H1 / H2-antihistamines
	Pulmonary reaction	Shortness of breath, cough
	Gastrointestinal Reaction	Nausea, vomiting
3.	Severe systemic reaction	Shock and severe arterial hypotension	Endotracheal intubation	Infusion of colloidal solutions (including human albumin)			1. Catecholamines. For example 1 ml of epinephrine, 1: 10,000 hours.vv, repeat if necessary before the total dose of 10 ml 2. In case of severe bronchospasm theophylline ca.
3.	Severe systemic reaction	Severe shortness of breath and bronchospasm	Endotracheal intubation				3. Corticosteroids vs. 4. H1 / H2 - antihistamines if necessary
4.	Systemic reaction, life-threatening	Stop breathing and heart				Cardiopulmonary resuscitation	- Basic life support -Vetering on success: catecholamines, e.g. 10 ml of epinephrine 1: 10,000 v.v., repeat if necessary - If necessary, other drugs, such as norepinephrine, dopamine, dobutamine - Sodium bicarbonate

Overdose:

Symptoms: The main risk of overdose is associated with the possibility of circulatory overload.

Treatment: The drug should be discontinued immediately and, if necessary, diuretics should be prescribed.

Interaction:

Incompatible with fat emulsions, barbiturates, muscle relaxants, antibiotics, glucocorticosteroids.

Compatible with solutions of electrolytes, carbohydrates, whole blood.

Special instructions:

Impact on laboratory results:

maybe impact on clinical and chemical options. The above laboratory results may be higher than expected: speederythrocyte sedimentation rate, urine specific gravity, as well as indicators of protein content in urine (e.g., by using biuret method).

The following precautions should be observed:

If necessary, electrolyte solutions should be administered.

Necessary control:

It is necessary to monitor the ionogram of the serum and the body's water balance. This is especially important for hypernatremia, dehydration and renal failure.

With violations of blood coagulability and chronic liver diseases, control of the parameters of coagulability of blood and serum albumin is necessary.

Patients receiving gelofusin must be monitored closely because of the possibility of allergic (anaphylactic / anaphylactoid) reactions.

Medical personnel should be informed about the manifestations and severity of possible side effects that may occur after administration of colloidal plasma substitutes:

- preparation of all general and medicamental measures necessary for resuscitation;

- careful observation of the patient during the introduction of the first 20-30 ml of the drug.

In the case of anaphylactic / anaphylactoid reactions, the drug should be discontinued immediately and promptly given appropriate care (see table above).

When used as an infusion under pressure (cuff of a tonometer, pump for infusions) Gelofusin must be heated to body temperature. When the drug is administered under pressure, all air from the vial must be removed beforehand.

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

Form release / dosage:Solution for infusion 4%.

Packaging:

For 500 ml 4% in bottles of low-density polyethylene, meeting the requirements of the European Pharmacopoeia for infusion solutions.

For 10 bottles with an equal number of instructions for use in a cardboard box (for hospitals).

Storage conditions:

Store at a temperature not higher than 25 ° C in places inaccessible to children. Do not freeze.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:For hospitals

Registration number:П N013824 / 01

Date of registration:02.08.2007

Expiration Date:Unlimited

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

Manufacturer: & nbsp

B. BRAUN MEDICAL, AG Germany

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

Information update date: & nbsp20.03.2017

Illustrated instructions

Instructions

Gelofusine (Gelofusine)