Gordox ampoules 10000 Kie 10 ml of 25 pcs

The inhibitor of proteolytic enzymes broad spectrum has antifibrinolytic properties. Forming reversible stoichiometric complexes – enzyme inhibitors, aprotinin inhibits the activity of tissue and plasma kallikrein, trypsin, plasmin, thereby reduces the fibrinolytic activity of blood.

Aprotinin activates the contact phase of coagulation activation, which initiates the coagulation with simultaneous activation of fibrinolysis. The conditions of use of heart-lung machine (AIC) and activation of coagulation of blood caused by contact with foreign surfaces, the additional inhibition of plasma kallikrein would help to minimize disturbances in the coagulation and fibrinolysis systems.

Aprotinin modulates systemic inflammatory response that occurs during operations with cardiopulmonary bypass. Systemic inflammatory response leads to the activation of the hemostatic system of interconnected, fibrinolysis, activation of cellular and humoral immune response. Aprotinin inhibiting numerous mediators (including kallikrein, plasmin, trypsin), attenuates the inflammatory response, reduces fibrinolysis and thrombin formation.

Aprotinin inhibits the release of inflammatory cytokine and maintains homeostasis glycoproteins. Aprotinin reduces loss glycoproteins (GPIb, GPIIb, GPIIIa) and prevents the expression of platelet adhesive glycoproteins antiinflammatory (GPllb) granulocytes.

Use of aprotinin in surgery using AIC reduces the inflammatory response that results in a reduction in the volume of blood loss and transfusion requirements, reducing the incidence of mediastinal repeated revisions to find the source of bleeding.

Active substance:
Aprotinin

Manufacturer

Gedeon Richter, Hungary

Prescribing

Adults are prescribed by a doctor

Composition

1 vial contains:

The active ingredient is:

Aprotinin 100,000 KIU;

Excipients:

 Sodium chloride – 85 mg;

benzyl alcohol – 100 mg;

Water for injection – up to 10 ml

Indications

• bleeding and hemorrhages of different origin;
• acute pancreatitis;
• Various shocks.

Contraindications

Increased sensitivity to the drug.

Side effects

Allergic reactions : rare – allergic, anaphylactic, anaphylactoid reactions; very rarely – anaphylactic shock (potentially life-threatening).

In patients receiving aprotinin for the first time, the development of allergic or anaphylactic reactions unlikely. With repeated administration frequency of allergic (anaphylactic) reactions can be increased to 5%, particularly with repeated use of aprotinin during 6 months. With repeated use of aprotinin more than 6 months, the risk of allergic / anaphylactic reactions is 0.9%.

The risk of severe allergic / anaphylactic reactions is increased if for 6 months aprotinin applied more than 2 times. Even in the event that with repeated use of aprotinin was not observed symptoms of allergic reactions, the subsequent use of the drug can lead to serious allergic reactions or anaphylactic shock, in rare cases, fatal.

Symptoms of allergic / anaphylactic reactions manifested by the disorders of the cardiovascular system (hypotension), digestive system (nausea), respiratory system (asthma / bronchial spasm), skin (itching, hives, rash).

In case of hypersensitivity reactions in the application of aprotinin should immediately discontinue administration of the drug and ensure that standard emergency measures – infusion therapy, administration of adrenaline / epinephrine, corticosteroids.

From the cardiovascular system : rare – myocardial ischemia, thrombosis / occlusion of the coronary arteries, myocardial infarction, pericardial effusion, thrombosis; rarely – arterial thrombosis (with the possible manifestation of dysfunction of vital organs, such as kidneys, lungs, brain); very rarely – pulmonary embolism.

From the hematopoietic system : very rarely – coagulopathy, including DIC.

From the of the urinary system: rarely – renal dysfunction, renal failure.

Local reactions : very rarely – reactions at the injection / infusion, thrombophlebitis.

How to accept, acceptance rate and dosage

in / in , slowly.

Maximal administration rate – 5.10 ml / min. With the introduction of the drug the patient should be in a supine position. Administered drug Gordoks ^® should backbone through a vein and not to use them for the introduction of other drugs.

Due to the high risk of allergic / anaphylactoid reactions in all patients within 10 minutes before administration of the primary drug dose Gordoks ^® test dose to be administered was 1 ml (10 thousand. KIU). In the absence of adverse reactions administered therapeutic dose. Perhaps the use of histamine H ₁ – and H ₂ receptor antagonists for 15 min before administration Gordoks ^® . In any case, should be provided with the standard emergency measures aimed at the treatment of allergic / anaphylactic reaction.

Adults: initial dose of 1-2 million KIU component is introduced into / in slowly over 15-20 minutes after induction of anesthesia and prior to sternotomy. Following 1-2 million KIU added to the primary volume of the heart-lung machine. Aprotinin to be added to the primary volume into the recirculation period to ensure sufficient dilution of the drug and prevent interaction with heparin.

After closure bolus infusion set with a constant introduction rate of 250-500 thousand. KIU / h up closure operation. The total amount of aprotinin during the course should not exceed 7 million KIU.

Patients with impaired renal function: is not required to carry out a correction mode.

Children: the drug is contraindicated under the age of 18 years (effectiveness and safety have been established).

Elderly patients: Changing dosing regimen in elderly patients is not required.

Storage conditions

In the dark place at a temperature not higher than 30 ° C

Active substance

Aprotinin

Interaction

With simultaneous application Gordoks drug streptokinase, urokinase, alteplase reduced activity of these drugs.

pharmaceutical incompatibility

Gordoks compatible with 20% glucose solution, a solution of hydroxyethylated starch, lactate Ringer’s solution.

Gordoks should not be mixed with other drugs.

Special conditions

In the application of aprotinin, especially with repeated use of the preparation, may develop allergic / anaphylactic reactions. Therefore, before using the product, you need to carefully assess the benefit / risk ratio. For 10 min before administration of the primary drug dose Gordoks test dose administered was 1 ml (10 thousand. KIU).

15 min before administration of therapeutic dose of the drug can be applied Gordoks histamine H ₁ – and H ₂ receptor. However allergic / anaphylactic reaction may develop, and when administered therapeutic doses of the drug, even if during the introduction of a test dose of adverse reactions were noted.

In case of hypersensitivity reactions in the application of aprotinin should immediately discontinue administration of the drug and ensure that the standard of urgent measures aimed at the treatment of allergic / anaphylactic reactions.

When carrying out operations on the thoracic aorta using AIC and using deep cold cardioplegia Gordoks be applied very carefully against adequate heparin therapy.

Determination of the activated clotting time is not a standardized test to determine the ability of blood coagulation and the application of aprotinin can affect the various techniques of the test. measuring the degree of coagulation test (ACT) is influenced by different effects upon dilution and temperature exposure. Kaolin ACT test is not increased to such an extent in the presence of aprotinin as ACT test celite. Because of differences in the protocols recommended to take the minimum value ACT Test – 750 sec and ACT test kaolin – 480 sec in the presence of aprotinin, regardless of the effects of hemodilution and hypothermia.

The standard dose of heparin administered to the heart and kanulyatsii amount of heparin added to the primary volume in AIC, should be at least 350 IU / kg. An extra dose of heparin is determined by the patient’s body weight and length of the period of extracorporeal circulation. protamine titration method is not affected by aprotinin. Additional heparin dose determined based on the concentration of heparin, calculated by this method.

The concentration of heparin during shunting should not fall below 2.7 U / mL (0.2 mg / kg) or below the level determined before the application of aprotinin. In patients receiving the drug Gordoks, heparin neutralization with protamine should be carried out only after an interruption of extracorporeal circulation, on the basis of a fixed amount of heparin administered or controlled by the method of protamine titration.

Gordoks comprises benzyl alcohol. The daily dose of benzyl alcohol should not exceed 90 mg / kg body weight.

Aprotinin is not a substitute for heparin.

Formulations for parenteral administration should be visually checked immediately prior to use. Do not use solution leftovers for later use.

Use in Pediatrics

Contraindicated for use in children and adolescents under the age of 18 years (effectiveness and safety have been established).

Effects on ability to drive vehicles and management mechanisms

Data on the effect of the drug Gordoks on ability to drive and work with no mechanisms.

Pregnancy and lactation

Research on the Application of the drug Gordoks not conducted in pregnant women. In pregnancy, the use is possible only in those cases where the intended benefits to the mother outweighs the potential risk to the fetus.

In assessing the benefit / risk ratio should be considered a negative effect on the fetus of severe adverse reactions, possible when using the drug, such as anaphylactic reactions, cardiac arrest and so on, as well as therapeutic measures undertaken to address these reactions.

Use of the drug has not been studied Gordoks lactation. The drug is potentially safe when ingested child breast milk as has no oral bioavailability.

For children under 18 years efficacy and safety have not been established.

Overdose

Currently, the cases of drug overdose have been reported.

An antidote to the drug does not exist.