Ovomin

General characteristics. Structure:

Active agent: 60 000 ATE of ovomucoid.

Excipients: sodium chloride, methylparahydroxybenzoate, water for injections.

Pharmacological properties:

Pharmacodynamics. Active ingredient of drug is ovomucoid - a glycoprotein of duck eggs. Has the effect inhibiting proteolysis, promotes elimination of pathological hyperreactivity of proteinazny systems of bodies and fabrics. Drug has polyvalent antiproteinazny activity preferential in relation to serinovy proteinases - trypsin, alpha chymotrypsin, leukocytic and pancreatic elastase, leukocytic cathepsines G, and also some bacterial proteinases. One molecule of ovomucoid is capable to interact with one molecule of alpha chymotrypsin and two molecules of trypsin, inhibiting their activity to 95%.

Causes selective oppression in blood and plasma of proteolytic enzymes, promotes an organism detoxication at the morbid conditions which are followed by activation of proteolysis and fermental intoxication and also prevents irreversible destruction of the substances of the proteinaceous nature which are present at biological liquids. Drug neutralizes the activated forms of proteinases, without changing concentration of inhibitors of these enzymes. A consequence of the balancing reached by introduction of an ovomin in system of proteinase - inhibitors is stabilization of the main indicators of a system hemodynamics, normalization of vascular permeability, decrease in production of kardiotropny, vazotropny and other biologically active peptides.

Intra joint administration of drug leads to neutralization of excess level of proteolytic lizosomalny enzymes (inflammation mediators) in synovial fluid and to stopping of local inflammatory reaction in a joint.

Pharmacokinetics. After intravenous, intra arterial administration drug is quickly distributed in an organism, gets into a liver, kidneys, blood, lungs, a pancreas, heart and a spleen. At an intraperitoneal way of introduction the greatest specific accumulation of ovomucoid is noted in a pancreas, at its rather high concentration in blood; ovomucoid is found also in a liver, kidneys, in a spleen and lungs. Plasma elimination half-life of blood makes about 4 h.

The intravenous, intra arterial way of introduction allows to maintain therapeutic concentration in blood during 4-6 h. At intraperitoneal administration of drug the maximum concentration of drug in blood is reached in 2 h, elimination from an organism is slowed down for 1-2 hours in comparison with intravenous administration. Drug eliminirutsya by kidneys. In 24 h after an injection in an organism ovomucoid traces are found.

Indications to use:

- as medical and prophylactic in complex treatment of various forms of acute and chronic pancreatitis, diffuse purulent peritonitis, extensive necrotic processes of soft tissues, a burn disease, the combined defeats, a krash-syndrome, inclusion syndromes after replantation of large segments of extremities and rejection after organ and tissue transplantation, acute and chronic cholecystitis, an acute and chronic liver and renal failure, acute poisonings in a stage of an endotoxemia, posttransfusion reactions;

- prevention of an enzymatic autolysis of a pancreas at operations on it and nearby the located bodies;

- treatment of synovites at a pseudorheumatism, an osteoarthritis.

Route of administration and doses:

Due to the high risk of development of allergic/anaphylactic reactions obligatory carrying out a bioassey before an initiation of treatment and careful observation is required during treatment. Considering the proteinaceous nature of Ovomin, it is reasonable to carry out administration of drug slowly, only in a prone position, and after introduction of the first 2-3 ml of infusion solution it is necessary to take a break for 10 minutes for assessment of the situation (a bioassey on compatibility). In the absence of negative reactions enter a therapeutic dose of drug. When using Ovomin's it is necessary to have means of acute management at allergic / anaphylactic reaction.

Doses are defined individually with indications and a condition of the patient. Drug is most effective when using at early stages of a disease in the maximum daily therapeutic doses.

The drug is administered intravenously or vnutriarterialno, kapelno, slowly (20-40 thaw/minute). Just before use part ampoule contents in 200-400 ml of isotonic solution of sodium of chloride.

The initial dose makes 1500-1800 ATE (anti-tryptic units) on kg of body weight of the patient. Then pass to maintenance doses of 750-800 ATE/kg every 6 hours within the first days of treatment. The total daily dose of drug entered into an organism in the first 24 hours should not exceed 5000 ATE/kg at intravenous administration. In the next days the daily dose is reduced twice, distributing it evenly during the day and nights. The drug is administered before achievement of clinical effect, but by no more than 6 days.

Ovomin it is possible to enter intraperitoneally that provides an inactivation of the proteinases which are contained in a belly exudate at acute destructive abdominal diseases. The same way of introduction is recommended at operational interventions in areas of a gepatopankreatichesky zone for the purpose of prevention of developing of postoperative reactive pancreatitis. In case of combined (intravenous or intra arterial, intraperitoneal) introductions the maximum therapeutic dose of drug should not exceed 5000 ATE/kg.

At chronic forms of pathological processes, and also for the purpose of prevention of activation of proteolytic enzymes in the postoperative period, decrease in level of a fermentemiya after a course himio-or radiation therapy are appointed овомин within 5-6 days in doses of 750-800 ATE/kg in days under control of these laboratory researches.

For local therapy of synovites Ovomin's solution is entered vnutrisustavno into large joints (humeral, knee) in a dose 12000-24000 ATE with an interval of 2-3 days, a course - 2-3 injections.

Patents with disturbance of functions of kidneys. At a renal failure it is not required to carry out correction of the mode of dosing.

Patients of advanced age. Change of the mode of dosing is not required from elderly patients.

Features of use:

It is not necessary to administer the drug more than 6 days. 

Use during pregnancy and in the period of a lactation. Safety of use of drug at pregnancy and in the period of a lactation in clinical tests is not established. Use of drug at pregnancy is possible only in that case when the estimated advantage for mother exceeds potential risk for a fruit. For the period of treatment it is necessary to stop breastfeeding.

Precautionary measures. With extra care to use at patients with burdened allergoanamnezy.

At Ovomin's use, especially at repeated use of drug development of allergic / anaphylactic reactions is possible. Therefore before use of drug it is necessary to estimate carefully a ratio advantage/risk. When using Ovomin's it is necessary to have means of acute management at allergic/anaphylactic reaction.

Treatment by drug demands obligatory performance by all patient before treatment of a bioassey and careful observation during treatment. Considering the proteinaceous nature of Ovomin, it is reasonable to carry out administration of drug slowly, only in a prone position, and after introduction of the first 2-3 ml of infusion solution it is necessary to take a break for 10 minutes for assessment of the situation (a bioassey on compatibility).

However allergic/anaphylactic reactions can develop also at introduction of a therapeutic dose of drug even if during introduction of a trial dose of side reactions it was not noted.

If at use of drug there are hypersensitivity reactions, administration of drug it is necessary to stop and hold immediately the standard events directed to treatment of allergic / anaphylactic reaction.

At Ovomin's appointment to patients with a chronic renal failure or belonging to risk group (for example, parallel use of aminoglycosides), the ratio risk/advantage is recommended to analyze carefully.

Drugs for parenteral administration have to pass direct vision just before use. It is impossible to use the solution remains for the subsequent use.

Influence on ability to control of motor transport and potentially dangerous mechanisms: drug does not influence ability to drive the car and to be engaged in the types of activity requiring special attention and reaction.

Side effects:

At the patients who were earlier not applying Ovomin, allergic/anaphylactic reactions develop in rare instances. At repeated use of Ovomin the risk of development of allergic/anaphylactic reactions can be increased. The risk of development of the allergic/anaphylactic reactions connected with repeated administration of drug is increased in case of repeated use less than in 12 months after primary introduction. Even if at repeated use of Ovomin symptoms of allergic reactions were not observed, the subsequent use of drug can lead to development of heavy allergic reactions or an acute anaphylaxis.

Symptoms of allergic/anaphylactic reactions from outside:

Respiratory organs: - bronchospasm

Cardiovascular system: hypotension, increase in heart rate

Skin: urticaria, itch, rash

Alimentary system: nausea, vomiting, abdominal pain.

In case of development of reactions of hypersensitivity it is necessary to stop immediately administration of drug and to provide holding standard urgent actions – infusional introduction of adrenaline/Epinephrinum, corticosteroids.

Another: arterial hypertensia / hypotension, tachycardia, short-term dizziness after an injection, feeling of heat are in rare instances possible.

Interaction with other medicines:

Intravenous drop administration of Ovomin as a part of crystalloid infusion solutions is allowed.

The combined intra joint introduction of Ovomin and glucocorticosteroids of the prolonged action strengthens therapeutic effect of glucocorticosteroids.

Streptokinasa, urokinase, alteplaz (r-tPA):

Depending on a dose at simultaneous use Ovomin reduces activity of these drugs.

Ovomin strengthens effect of heparin.

Pharmaceutical incompatibility: овомин it is necessary to consider as drug, incompatible with other medicines. It is not necessary to mix in one syringe Ovomin with other medicines.

Contraindications:

Hypersensitivity to inhibitors of proteases (Ovomin, Aprotinin), a polyvalent allergy.

Use for patients at whom ovomin-specific IgG come to light is contraindicated, have high risk of development of anaphylactic reaction at treatment by Ovomin.

In case test for ovomin-specific IgG is impossible, Ovomin's use for patients at whom it is impossible to exclude Ovomin's introduction within the last 12 months is contraindicated.

Overdose:

In case of overdose of drug and lack of side reactions medicamentous correction is not carried out. At overdose strengthening of side effects of drug can be observed. In this case symptomatic therapy is shown. For the purpose of acceleration of elimination of drug carry out intravenous administration of infusions of crystalloid solutions against the background of an artificial diuresis.

Storage conditions:

In the place protected from light at a temperature from 4 °C to 20 °C. To store in the place, unavailable to children. Period of validity 3 years.

Issue conditions:

According to the recipe

Packaging:

On 5 ml in ampoules in packaging No. 5 or in a blister strip packaging No. 5x1.