Rondferrin

General characteristics. Structure:

Active ingredient: 400 ml of 6% of aqueous solution of a dextran of the m modified with M. 50000 - 70000 in solution of 9 g/l of sodium of chloride; 70 mg of iron (in the form of iron (Sh) of chloride 6 - water), 0,5 mg of copper (in the form of copper dichloride 2-water), 0,006 mg of cobalt (in the form of cobalt chloride 6-water) - 0,006 mg.

The main purpose of a rondferrin - elimination of disturbances macro - and a microhemodynamics, stabilization of rheological properties of blood and stimulation of hemopoietic erythroidal function of marrow.

Pharmacological properties:

Pharmacodynamics. Rondferrin - the blood substitute of the expressed multifunctional action possessing along with hemodynamic effect ability to stimulate a hemogenesis. Is a proofreader of disturbances of a system hemodynamics, volume of the circulating blood and plasma, the average arterial pressure, propulsive ability of a myocardium. Introduction of a rondferrin leads to elimination of a spasm of peripheral vessels, normalizes suspension stability of blood, stabilizes its viscous and haemo rheological characteristics, exerts antiagregantny impact on thrombocytes and erythrocytes, promotes elimination of peripheral staz therefore the nutritive blood stream improves. Drug positively influences oxygen and transport function and gas composition of blood, and surpasses blood-substituting solutions on the basis of the acid hydrolyzed dextran in ability to show buffer properties and to normalizovyvat indicators of acid-base balance.

Infusions of a rondferrin have the direct haemo stimulating antianemic effect, promoting activation of erythropoietic function of marrow and normalization of content in blood of erythrocytes and hemoglobin.

Pharmacokinetics. Rondferrin is brought from an organism preferential by kidneys, and within the first 24 hours about 50% of a blood substitute eliminirutsya, and in 3 days in blood only its traces are defined. A small part of a dekstranovy basis of drug is capable to collect in system of mononuclear phagocytes where gradually is exposed to bioconversion to glucose. The iron which is a part of a rondferrin is laid for longer term - until 3 - 4 months, raising a pool of fabric depot of this microelement.

Rondferrin - hyperosmotic solution with osmolarity of 0,340 - 0,370 mm/kg. Its parenteral administration causes active attraction of intersticial liquid (to 20 - 25 ml on 1 g of a dextran) in a vascular bed.

Indications to use:

- at the depressed cases which were a consequence of acute blood loss, an injury, burn, the combined defeats, intoxication, sepsis and other reasons (as medical and prophylactic at adults);

- before - and the postoperative period (for the purpose of prevention of shock, improvement of haemo rheological indicators of blood and microcirculation, for prevention of development of postoperative anemia);

- the reconvalescence period after course use химио - and radiotheraphy.

Route of administration and doses:

Drug is used in the conditions of a hospital!

Just before use of drug it is necessary to carry out statement of skin test (see the section of the PRECAUTIONARY MEASURE).

Way of introduction of a rondferrin - parenteral (intravenous, intra arterial), doses and speed are defined by indications to use and an individual condition of the patient.

At the developed shock or acute massive blood loss the drug is administered intravenously struyno in a single dose of 400 - 2000 ml (5 - 25 ml on 1 kg of body weight). At recovery of system arterial pressure to 80 - 90 mm Hg usually pass to drop introduction with a speed of 3 - 3,5 ml a minute (60 - 80 thaws/min.). The intra arterial way of introduction in the same dosages is possible. Infusions of drug have to be performed under constant control of the main indicators of a system hemodynamics. In case of substantial increase of the central venous pressure out of average limits of physiological norm reduce a dose and rate of administering, and sometimes and completely stop it.

Introduction of a rondferrin is sufficient for correction of blood loss to 1000 - 1200 ml. At bigger blood loss of infusion of drug it is necessary to combine with packed red cells transfusion or suspensions of the erythrocytes necessary for elimination of a fabric hypoxia, and also the freshly frozen blood plasma containing factors of system of a hemostasis.

For prevention of operational blood loss, and also for the purpose of achievement of artificial hemodilution, prevention of a thrombogenesis and decrease in a tendency to development or progressing of DVS of blood рондферрин enter in doses 5-10 ml/kg of body weight in 30 - 60 minutes prior to operational intervention.

The volume of infusion of drug during surgical influence is defined by the size of operational blood loss and the lower bound of a gematokritny indicator, equal 0,30 l/l.

For stimulation of a marrowy hemopoiesis at patients with the chronic diseases proceeding against the background of the general exhaustion and a postoperative anemization of an organism and also in the recovery period after himio-and radiotheraphy use course introduction of a rondferrin for 4-6 days in a daily dose of 3 - 5 ml on body weight kg.

For the purpose of prevention of possible dehydration of fabrics it is recommended to combine infusions of a rondferrin with administration of crystalloid solutions in a share ratio 1:2.

Frequency rate of administration of drug is defined by the general condition of the patient and a possibility of development of the phenomena of "secondary" shock.

Features of use:

Therapy rondferriny has to be performed by doctors and the prepared medical staff.

Use during pregnancy and in the period of a lactation. Data on efficiency and safety of use of drug during pregnancy and in the period of a lactation are absent.

Precautionary measures. Infusions of drug have to be performed under constant control of the main indicators of a system hemodynamics.

The risk of development of allergic and anaphylactoid reactions is rather high for patients with bronchial asthma, a disease Krone, chronic polyarthritis, reduced ability of binding of iron and/or insufficiency of folic acid.

Due to a possibility of development the dextran - the induced allergic reactions needs to be carried out statement of skin test: after processing the antiseptic agent of the place of a prick in a middle part of an internal surface of a forearm of the patient, vnutrikozhno enters 0,05 ml of medicine. Correctness of administration of solution is controlled visually (formation of a lemon crust). The accounting of results of skin test is carried out by the doctor in 20 minutes. Criteria of positive local reaction: a hyperemia, an itch, hypostasis with a diameter of blister more than 10 mm, or emergence of the general symptoms: small tortoiseshell, Quincke's disease, bronchospasm, hypotension.

Considering the increased individual sensitivity of the patient observed in rare instances on metallodekstranovy drugs, for the purpose of the prevention of undesirable side reactions, infusion surely should be begun most slowly kapelno and after introduction of the first 2 - 5 ml of drug to take a break for three minutes for assessment of the situation (a bioassey on compatibility). In the absence of reaction administration of drug continues. Results of a bioassey on compatibility surely are registered in the history of a disease.

Side effects:

The side reactions which are listed below decide on the help of the following classification: very often (> 1/10); often (> 1/100 to <1/10), sometimes (> 1/1000 to <1/100), it is rare (> 1/10000 to <1/1000), is very rare (<1/10000), it is unknown (cannot be estimated on the basis of the available data).

From cardiovascular system: seldom - arrhythmia, tachycardia, pain and weight in a breast, hypotension, a collapse; very seldom - bradycardia at a fruit, heartbeat, a hypertension.

From circulatory and lymphatic system: very seldom - hemolysis, a hyperadenosis; it is unknown - a leukocytosis.

From a nervous system and sense bodys: sometimes - a vision disorder, numbness; seldom - spasms, dizziness, concern, a tremor; very seldom - a headache, paresthesias, the passing deafness; it is unknown - the taking place taste disturbance (especially metal smack in a mouth).

From respiratory organs, a thorax and mediastinum: sometimes - a bronchospasm, an asthma; it is unknown - an apnoea.

From digestive tract: sometimes - nausea, vomiting, abdominal pains; seldom - diarrhea.

From skin and hypodermic cellulose: sometimes - an itch, urticaria, rash, an erythema; seldom - a Quincke's edema, perspiration, brown coloring in the place of an injection; it is unknown - a purpura.

From a musculoskeletal system and connecting fabric: sometimes - muscular spasms; seldom - a mialgiya; it is unknown - an arthralgia, arthritis, dorsodynias.

From immune system: sometimes - anaphylactic reactions (including short wind, urticaria, skin rash, an itch, nausea and a fever); very seldom - acute heavy anaphylactic reactions (sudden difficulty of breath and/or cardiovascular insufficiency).

General frustration: sometimes - heat; seldom - anaphylactic reactions (which seldom include a joint pain), an adynamy, an indisposition; it is unknown - fever, a fever.

Mental disorders: seldom - change of the mental status; it is unknown - confusion of consciousness.

In case of emergence during infusion of reactions of anaphylactic type (reddening and an itch of integuments, a Quincke's edema, etc.), it is necessary to stop immediately administration of drug and, without taking out a needle from a vein, to start carrying out all the therapeutic actions provided by the corresponding instructions for elimination of transfusion reaction (antihistaminic and cardiovascular means, corticosteroids, respiratory analeptics, etc.).

Interaction with other medicines:

Use together with other traditional transfusion means is allowed.

Aminocapronic acid, гидралазин, warfarin, 95% ethanol solution, dexamethasone are incompatible with the dextran which is a part of drug.

Contraindications:

Infusions of a rondferrin are contraindicated with hypersensitivity to its components, at dekompensirovanny cardiovascular insufficiency, a craniocereberal injury with the increased intracranial pressure, diseases of the kidneys which are followed by an anury, thrombocytopenia; at excess of iron in an organism (hemochromatosis, a hemosiderosis); hemoglobin synthesis disturbances (the anemia caused by poisoning with lead, sideroblastny anemia); heavy disturbances of a hemostasis (hemophilia), and also in all situations at which introduction of massive doses of liquid is not recommended (the increased arterial pressure, a hypervolemia against the background of an indicator of a hematocrit is lower than 0,30 l/l, etc.). With care appoint drug at the proceeding internal bleeding (a liver, kidneys, lungs, etc.).

Overdose:

So far about cases of overdose of drug it was not reported.

Storage conditions:

At a temperature not above 25 °C. Period of validity 2 years. Not to use after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

In bottles of 400 ml in packaging No. 1, No. 24.