Project Description

Neorondex

(solution for infusion) 400 ml

international nonproprietary name

Dextran.

Ref

BP-0088

Pharmacotherapeutic group

Rehydratants. Regulators of water-salt balance and acid-base balance (ABB). Detoxicants.

Composition of the preparation

1 ml of solution for infusions contains 60 mg of modified dextran with molecular weight of 62500 ± 7500 and 9 g of sodium chloride.

Pharmacological action

Pharmacodynamics

Neorondex is a blood substitute of apparent hemodynamic action. It is a high-performance drug with respect to elimination of systemic hemodynamics, adjustment of volume of circulating blood and plasma, mean blood pressure, stroke and minute blood volume, elimination of peripheral vessels spasm. Introduction of Neorondex positively manifests itself in normalization of basic quotients of acid-base balance and gas composition of blood. The preparation increases

suspension resistance of blood, reduces its viscosity characteristics, has an apparent antiadhesive and antiaggregatory influence to thrombocytes, promoting to elimination of peripheral stasis and erythrocyte aggregation, so resulting in improvement of rheological properties of blood, activation of microcirculation and increase of  tissual blood flow. Infusions of Neorondex block the development of disseminated intravascular coagulation (DIC).

Pharmacokinetics

Neorondex is excreted from organism predominantly by kidneys, within the first 24 hours about 50% of drug is eliminated and in three days there are determined only its signs. Little part of dextran is accumulated in reticulo-endothelial system where it is bioconverted with dextranases to glucose.

Indications 

Neorondex is used with the aim of prophylaxis and treatment of shock states as a result of acute hemorrhage, injury, combination involvements, intoxication, sepsis, operative and burn shock, for adding to perfusion fluid when using medical apparatuses of artificial circulation , for detoxication at common  purulent peritonitis, vast purulo-necrotic processes of soft tissues, crush  syndrome,  “inclusion”, “revasculization” and “rejection” syndromes in transplantology, as well as for improvement of hemorheology, microcirculation and resolution of tendency to thrombosis at surgeries and conservative treatment of states accompanied with syndrome of hyper viscosity and blood clotting.

The main target administration of Neorondex is elimination of deranged macro- and micro hemodynamics, improvement of rheological properties of blood, normalization of arterial and venous blood flow, resolution of tendency to thrombosis and syndrome ДВС.

special indication

Not established

special warning

Not established

Dosage and method of administration

Mode of Neorondex introduction is parenteral (intravenous, intra-arterial). Dosage is determined in accordance with the indications to use and individual state of a patient.

At developed shock and acute hemorrhage the drug is introduced by intravenous stream injection in doses of 400-2000 ml for adults (2-35 ml per 1 kilogram of patient’s body weight). For recovery of systemic blood pressure to 80-90 mm Hg there is provided a change to drop-feed with the rate of 3-3.6 ml/min (60-80 drops per minute). Arterial mode of introduction is also possible (within the same dosage). Drug infusions should be performed under the continuous control for the main indices of system hemodynamics.

At significant increase of central venous pressure outside the average statistical ranges of  physiologic norms dose and rate of introduction are reduced and sometimes completely discontinued.

Introduction of  Neorondex  is quite sufficient for correction of blood loss up to 1000-1200 ml. At larger hemorrhage drug infusions should be combined with transfusion of packed red cell or  red cell solution required for elimination of tissue hypoxia and also with  fresh frozen plasma containing hemostasis system factor.

For prevention of blood loss during operation, as well as with the aim of artificial hemodilution, prevention of tromboformation and lowering of tendency for development or progress of disseminated intravascular coagulation syndrome Neorondex is introduced in dosage of 5 to 10 ml per kilogram of body weight  30 – 60 minutes  prior to operative intervention. Extent of preparation infusions during surgery is defined by the size of operative blood loss. Thereat  hematocrit index  should  be lowered to 0.30 l/l.

Disintoxication  effect of Neorondex declares itself being introduced in daily dosage of 5 to 10 ml per kilogram of body weight, but in such a case it is advisable to use repeated course infusions of solution during 3 –5 days.

It should be considered that with the aim of preventing from possible dehydration of tissues it is recommended to combine Neorondex infusions with introduction of crystalloid solutions in volume-part ratio of 1:2. Multiplicity of introduction is determined by general state of patient and possible development of secondary shock.

overdosage

Not established

safety measures

Not established

Side effects

Usually no adverse reactions and unfavorable effects from the side of basic life support systems at  intra-arterial introduction of Neorondex are observed.

In case of arising of anaphylactic reaction during infusion (reddening and skin itch, Quincke’s edema,  etc.) it is necessary to cease introduction of preparation and, without extracting needle from vein to start to conduction of all provided by the corresponding instructions therapeutic procedures for elimination of transfusion reaction (antihistamines and cardiovascular drugs, corticosteroids, respiratory analeptics, etc.).

Contraindications

Neorondex infusions are contraindicated at decompensated cardiovascular collapse, continuous internal hemorrhages (liver, lungs, kidneys), craniocerebral injuries with hypertension of intracranial pressure, kidneys disease, accompanied by anuria, at thrombocytopenia , as well as at all the situations when introduction of massive doses of fluid are not recommended (hypertension, hypervolemia on the background of hematocrit number index below 0.30 l/l).

Interactions with other medicinal preparations

The preparation may be used at one time with other traditional transfusion means.

The form of release

Solution for infusions in bottles of 400 ml.