Project Description

Rondferrin

(solution for infusion) Rondferrinum

international nonproprietary name

Not established

Ref

BP-0127

Pharmacotherapeutic group

Regulators of water-salt balance and ABB. Rehydrators. Haemopoiesisstimulators.

Composition of the preparation

Rondferrin — water solution of 6% modified dextran with molecular mass of 60000, containing 0,0175 g of iron, 0,125 g of copper, 1,5 μg of cobalt (in the form of metalic-dextran complexes) and 0,9 g of natrium chloride in 100 ml.

Pharmacological action

Pharmacodynamics

The basic special-purpose designation of rondofferin is the elimination of infringements macro- and microhemodynamics, stabilization of rheological properties of blood and stimulation of hemopoietic erythroid functions of a bone brain.

Rondferrin — blood substitute with expressed multifunctional action, possessing alongside with hemodynamic effect ability to stimulate haemopoiesis. Is the proof-reader of infringements hemodynamic system, volume of circulating blood and plasma, average arterial pressure,propulsion abilities of a myocardium. Rondferrin introduction is leads to liquidation of a spasm of peripheral vessels, normalizes suspension stability of blood, stabilizes it frictional and hemorheological characteristics, renders antiaggregantal influence on platelets and erythrocytes, promotes elimination peripheral stasises therefore improves nutritious blood circulation. The preparation has positive influence on oxygen-transport function and gas structure of blood, and on ability to show buffer properties and to normalize the parameters of acid-alkaline balance surpasses blood substitute solutions on the basis of acid-hydrolized dextran.

Rondferrin infusions has direct hemostimulating antianemic actions, promoting activation of erythropoietic function of a bone brain and normalization and maintenance in blood erythrocytes and hemoglobin.

Pharmacokinetics

Rondferrin is deduced from organism mainly by kidneys, and within the first 24 hours about 50 % of blood substitude id eliminated, and in 3 days in blood its traces are defined only. The small part of a preparation dextran bases is capable to collect mononuclear phagocytes in system where gradually is exposed to bioconversion up to glucose. Iron as a part of rondferrin is postponed for longer term – till 3-4 months, raising a pool of fabric depot of this microcell.

Rondferrin — hyperosmotic solution with osmolarity of 0,340-0,370 mm/kg. It parenteral introduction causes active attraction of interstitial liquid (up to 20-25 ml on 1 g of dextran) in a bloodstream.

Indications 

Rondferrin is applied as medical and preventive drug at adults at the shock conditions that was consequence of acute blood loss, traumas, a burn, the combined lesions, an intoxication, a sepsis and other reasons; in pre- and postoperative periods with the purpose of preventive maintenance of a shock, improvement of gemoreologic parameters of blood and microcirculation, for preventive maintenance of development of a postoperative anemia; during reconvalestention after course application hemo- and radiotheraphy.

special indication

Rondferrin therapy should be carried out by doctors and prepared medical staff.

special warning

Not established

Dosage and method of administration

Preparation applied in a hospital.

The way of rondferrin introduction  – parenteral (intravenous, intraarterial), dozes and speed are defined by indications to application and an individual condition of the patient.

At the developed shock or acute blood loss the preparation of 400-2000 ml (enter intravenously by stream in a single doze of 5-25 ml on 1 kg of body weight). At restoration of system arterial pressure up to 80-90 mm Hg usually the way of introduction is changed to drop-by-drop with speed of 3-3,5 ml per minute (60-80 drops/mines). The intraarterial way of introduction in the same dosages is possible. Infusions of a preparation should be carried out under the constant control of the basic hemodynamic parameters. In case of substantial increase of the central venous pressure for average limits of physiological norm reduce a doze and speed of introduction, and sometimes it should be completely it stop.

Rondferrin introduction is sufficient for correction of blood loss up to 1000-1200 ml. At greater blood loss infusions of a preparation are necessary for combining with transfusion of red blood cells or erythrocytes suspensions, necessary for liquidation of tissue hypoxia, and also fresh-frozen blood plasma containing hemostasis system factors.

For prevention of operational blood loss, and also with the purpose of artificial hemodilution achievement, prevention of clotting and decrease in the tendency to development or progressing DVS of blood rondferrin entered in dozes of body weight of 5-10 ml/kg 30-60 minutes prior to operational intervention.

The volume of infusions of the preparation during operation is defined by size of operational blood loss and the lowest border of haematocrit parameter, equal to 0,30 l/l.

For stimulation of marrowy haemopoiesis at patients with the chronic diseases proceeding on a background of the general exhaustion and postoperative anemia of an organism, and also in the regenerative period after hemo- and radiotheraphy use course introduction of rondferrin during 4-6 days in a daily doze of 3-5 ml on kg of body weight.

With the purpose of prevention of possible tissue dehydration it is recommended to rondferrin infusion to combine with introduction of crystalloid solutions in a share parity 1:2.

Frequency rate of preparation introduction is defined by the general condition of the patient and an opportunity of development of the phenomena of a “secondary” shock.

overdosage

Symptoms: nausea, vomiting, drowsiness, liver enlargement, jaundice, bilirubin and hepatic transaminase level in blood plasma increase; mahogany of orange skin, urine, saliva, sweat, tears and feces in proportion to preparation dosage accepted.

Treatment: preparation intake should be stopped. Symptomatic therapy (specific antidote is not existed). Vital functions maintenance.

safety measures

Considering the raised individual sensitivity of the patient observable in rare cases on dextran consisting preparations, with the purpose of the prevention of undesirable collateral reactions, infusion necessarily should be begun as much as possible slowly drop-by-drop and after introduction of the first 2-5 ml of a preparation to make a break for three minutes for an estimation of a situation (biological test on compatibility).

Side effects

Usually at intravenous or intraarterial rondferrin introduction collateral reactions and adverse effects from the basic life-support systems at patients it is not noted. Nevertheless, inrarecasesofallergicreactionsarepossible.

In case of occurrence of anaphylactic type reactions during infusion (reddening and an itch of integuments, angioneurotic edema, etc.), is necessary to stop introduction of the preparation immediately and to start caрrrying out of all therapeutic actions stipulated by corresponding instructions for liquidation of transfusion reactions (antihistaminic and cardiovascular means, corticosteroids, respiratory analeptics, etc.) not taking out a needle from a vein.

Contraindications

Rondferrin infusions are countraindicative at decompensate cardiovascular insufficiency, craniocereberal trauma with the raised intracranial pressure, diseases of the kidneys accompanied anuria, thrombocytopenia, and also in all situations at which introduction of massive dozes of a liquid (the raised arterial pressure, hypervolemia on a background of a haematocrit parameter below 0,30 l/l, etc.) is not recommended.

In case of proceeding internal bleeding (a liver, kidneys, lungs, etc.) the preparation should be prescribed with care.

Interactions with other medicinal preparations

Usage together with others traditional transfusion drugs is accepted.

The form of release

Bottles for blood with solution for infusion per 400 ml.