Project Description

Ovomine

(solution for injections 12000 АТЕ/ml) 

(lyophilized powder used to prepare the solution for injections 60000 АТЕ) Ovominum

international nonproprietary name

Not established

Ref

BP-0096

Pharmacotherapeutic group

Proteolysisinhibitor.

Composition of the preparation

“Ovomine solution for injections”: 1 ml of solution contains 12000 АТЕ of ovomine.

“Ovomine for injections”: sterile lyophilized ovomine powder in glass vials (60000 АТЕ)

The agent of the medication is ovomucouid, glycoprotein of duck eggs with molecular mass 30000 and isoelectric point in the acid region.

Pharmacological action

Pharmacodynamics

The medication agent is ovomucouid, glycoprotein of duck eggs. It has a proteolysis inhibitory action, forwards the removal of pathological hyperactivity of proteinase systems of organs and tissues. The medication has a multipartial antiproteinase activity mainly towards serine proteinase – tripsin, alpha-chemotripsin, leukocytic and pancreatic elastase, leukocytic catepsins G, as well as towards some bacterial proteinases. One ovomucoiud molecule is able to interact with a alpha-chemotripsin molecule and two tripsin molecules inhibing their activity up to 95%.

The medication stimulates a selective proteolytic enzyme inhibition in the blood and plasma, leads to the organism detoxication in the pathological condition accompanying by proteolysis activation and enzymatic intoxication, as well as prevents irreversible destruction of protein substances in the biological fluids. The medication neutralizes activated proteinases without changing the inhibitor concentration of these enzymes. The consequence of the balance in the system proteinase-inhibitors reached by ovomine administration is stabilization of the main parameters of the systemic hemodynamics, normalization of vascular penetration, reduction in generation of cardiotropic, vasotropic and other biologically active peptides.

Intra-articular administration of the preparation leads to neutralization of excessive level of proteolytic lysosomal enzymes (inflammation mediators) in the synovial fluid and arresting of the local inflammatory reaction in the joint.

Pharmacokinetics

After intravenous, intra-arterial administration the preparation rapidly distributes in the organism, penetrates into the liver, kidney, blood, lungs, pancreas, heart and spleen. After intraperitoneal administration the biggest specific accumulation of ovomucoid has been registered in the pancreas and relatively high concentration of ovomucoid has been registered in the blood; ovomucoid is revealed also in the liver, kidney, spleen and lungs. The half-period in the blood plasma is about 4 hours.

The intravenous and intra-arterial administration permits to keep the therapy concentration in the blood for 4 – 6 hours. After intraperitoneal administration the max.concentration of the preparation in the blood is reached after 2 hours, elimination from the organism is slowed down for 1 – 2 hours in comparison with intravenous administration.

The preparation is eliminated by the kidney. 24 hours after the injection traces of ovomucoid are revealed in the organism.

Indications 

The medication is used as a therapeutic and prophylactic drug for complex treatment of various forms of acute and chronic pancreatitis, diffuse purulent peritonitis, major necrotic processes of soft tissues, burn diseases, combined lesions, crush syndromes, inclusion syndrome after replantation of large extremities segments and rejection after transplantation of organs and tissues, acute and chronic cholecystitis, acute and chronic liver and kidney failure, acute poisoning in the endotoxemia stage, posttransfusion reactions; prophylaxis of enzymatic autolysis of the pancreas when the pancreas or other organs are operated on; treatment of synovitis in case of rheumatoid arthritis, osteoarthritis.

special indication

The preparation shall not be administered more than 6 days running.

special warning

Not established

Dosage and method of administration

The doses are determined individually taking into account the patient’s parameters and condition. The medication is the most efficient on using at early stages of the disease in max.daily therapeutic doses.

The preparation is administered intravenously or intra-arterially, drop-by-drop, slowly (20-40 drops per minute). The content of the vial (ampul) is diluted immediately before the administration in 200-400 ml of isotonic sodium chloride solution.

The initial dose is 1500-1800 АТЕ (antitripsin units) per 1 kg of the patient’s body weight. Then maintaining doses 750-800 АТЕ/kg are administered every 6 hours during first days of treatment. The overall daily dose of the preparation administered in the organism for first 24 hours shall not exceed 5000 АТЕ/kg on intravenous administration. On subsequent days the daily dose is reduced twice by distributing it evenly during day and night. The preparation is administered till the clinical effect is achieved but not more than 6 days.

Ovominecanbeadministeredintraperitoneallythatprovidesinactivationoftheproteinasesintheabdominaleffusiononacutedestructiveabdominaldiseases. This route is recommended in case of operations on hepatopancreatic zone to prevent post-operation reactive pancreatitis. For combined (intravenous or intra-arterial, intraperiotoneal) administration the max.therapeutic dose shall not be more than 5000 АТЕ/kg.

In case of chronic forms of pathological processes and prophylaxis of proteolytic enzymes activation in the post-operation period, for reduction of the enzyme level after chemotherapy and radiotherapy ovomine is prescribed during 5 – 6 days in doses 750-800 АТЕ/kg per day under control of laboratory tests data.

For local synovitis therapy the solution of ovomine is administered intra-arterially into the large joints (shoulder, knee) in the dose of 12000-24000 АТЕ every 2-3 days, course – about 2 – 3 injections.

overdosage

On overdosing and in the absence of side effects drug correction is not carried out.

Negative effects being present, antihistaminic and cardiovascular preparations, corticosteroids and inspiratory analeptics shall be prescribed. To accelerate the elimination of ovomine intravenous infusions of crystalloid solutions (isotonic sodium chloride, disol, lactosol, etc.) on parallel application of preparations that intensify the secretory function of the kidney (forced diuresis) shall be prescribed.

safety measures

The treatment with this medication requires an obligatory bioassay of the patient condition and a careful monitoring during the treatment.

Taking into account the protein nature of ovomine, the preparation shall be administered slowly in prone position and after first 2—3 ml of the infusion solution there shall be a break for three minutes to assess the situation (bioassay on compatibility).

Special precautions shall be taken in patients with burdened allergy anamnes.

Side effects

As a rule, administration of the preparation does not cause side effects in the principal life support systems. In rare cases arterial hypertension, tachycardia, vertigo of short duration after the injection, fever, bronchospasm, nausea, vomiting, allergic reactions (skin eruption, itching, anaphylactic shock are possible.

Contraindications

Hypersensitivity, systemicmultipleallergy.

Interactions with other medicinal preparations

Intravenous drop-by-drop administration of ovomine in the complex of crystalloid infusion solutions is assumed.

Combined intra-arterial administration of ovomine and long-term glucocorticosteroids increases the therapeutic effect of glucocorticosteroids.

The form of release

“Ovomine solution for injections” is in ampuls or vials of 5 ml (12000 АТЕ/ml), 5 or 10 vials in a container. 5 or 10 ampuls in the container or blister. 1 or 2 contourcellpackinginacontainer.

“Ovomine for injections” in powder or porous mass is in 10 ml vials or 60000 АТЕ ampuls. 5 or 10 vials or ampuls in a container.