Contracal® (Contrykal®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAprotininAprotinin
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    • Dosage form: & nbsplyophilizate for solution preparation for intravenous and intraperitoneal administration
    Composition:

    1 bottle contains:

    active substance: aprotinin (as a concentrated solution) 10,000 ATPE (antitrypsin units);

    Excipients: mannitol 10 mg, hydrochloric acid 1% q.s. (for pH adjustment, maximum 0.3125 μl).

    In 1 ampoule contains a solvent for the preparation of medicinal forms for injection 0.9% (sodium chloride 18.00 mg, water for injection up to 2.0 ml).

    Description:Lyophilized powder of white or almost white color; the solvent is a clear, colorless liquid.
    Pharmacotherapeutic group:Proteolysis inhibitor
    ATX: & nbsp

    B.02.A.B   Inhibitors of plasma proteinases

    B.02.A.B.01   Aprotinin

    Pharmacodynamics:

    Polyvalent protease inhibitor isolated from light bovine animals. It has antiproteolytic, antifibrinolytic and hemostatic effects. Inactivates the most important proteases (trypsin, chymotrypsin, kallikrein), which play an important role in pathophysiological processes. Brakes as a total proteolytic activity, and activity of individual proteolytic enzymes.

    Aprotinin completely inactivates the proteolytic activity of plasmin, blocks the activation of plasminogen.

    Antiprotease activity of aprotinin determines the effectiveness of lesions pancreas and other conditions with a high content of kallikrein and other proteinases in plasma and tissues. Reduces the fibrinolytic activity of the blood, inhibits fibrinolysis and exerts a haemostatic effect with coagulopathy.

    The blockade of the kallikrein-kinin system allows us to use it for prevention and treatment of various forms of shock.

    Pharmacokinetics:

    After intravenous administration aprotinin fast is distributed in the extracellular space, briefly accumulates in the liver. Destroyed by lysosomal enzymes of the kidneys. Half-life of blood plasma is 2 hours. It is excreted in the urine.

    Indications:Bleeding and hemorrhages due to hyperfibrinolytic disorders of hemostasis, including postoperative, post-traumatic; before, after and during childbirth; hemorrhagic complications of thrombolytic therapy.
    Contraindications:

    Hypersensitivity to aprotinin or other bovine proteins; syndrome of disseminated intravascular coagulation (with the exception of the coagulopathy phase); when using cardiopulmonary bypass surgery during surgery; aorto-coronary bypass surgery; the first and third trimesters of pregnancy; lactation period (safety of use not established).

    Carefully:Prior therapy with aprotinin, allergic diathesis, a tendency to develop allergic reactions.
    Dosing and Administration:

    For intravenous administration.

    1 ATPE (antitrypsin unit) is equivalent to 1.33 KIE (calllecrine inhibitory units).

    The content of 1 vial is dissolved with a sodium chloride solution of 0.9% in the ratio 1: 1 (1 bottle: 1 ampoule).

    The solution is injected intravenously (slowly, up to 2-3 ml per 1 minute) or by a short or prolonged drop infusion.

    The initial dose of 350000 ATPE (465500 KIE), then every 4 hours is administered at a dose of 140,000 ATPE (186,200 KIE).

    With violations of hemostasis before, after and during childbirth the initial dose of 700,000 ATPE (931,000 IUU), then 14,000 APU (186,200 IUU) every hour until the bleeding stops.

    Children Contrikal® is administered at a daily dose of 14,000 ATPE (18620 KIE) per 1 kg of body weight.

    Side effects:

    From the cardiovascular system: decrease in arterial pressure, tachycardia, pallor of the skin;

    From the central nervous system: psychotic reactions, hallucinations, confusion;

    Allergic: reactions: rash, rhinitis, conjunctivitis, anaphylactic reactions (up to anaphylactic shock);

    From the digestive system: nausea, vomiting (with rapid administration);

    From the urinary system: renal insufficiency.

    Local reactions: thrombophlebitis at the site of administration (with prolonged infusion).

    Other: bronchospasm, excessive sweating, myalgia, increased serum creatinine concentration.

    Interaction:

    Countercial® dose-dependent decreases the activity of streptokinase and urokinase. The drug should not be combined with other drugs, especially with β-lactam antibiotics, heparin, hormones of the adrenal cortex.

    Aprotinin can inhibit the activity of nonspecific serum cholinesterase. Simultaneous use of aprotinin and suxamethonium chloride can prolong the period of apnea.

    Special instructions:

    When using aprotinin, allergic reactions sometimes occur, especially after repeated injections for 6 months. In the event that during the second administration the symptoms of hypersensitivity did not develop, then the third administration may trigger a hypersensitivity reaction by the type of anaphylaxis. In case of an allergic reaction and the appearance of symptoms of shock, the administration of Countercial® should be stopped immediately. If necessary, in such cases, conventional measures are taken to eliminate these complications, such as, for example, single or multiple intravenous injection of adrenaline in a dose of 0.05-0.1 mg, intravenous administration of prednisolone at a dose of 250-1000 mg, and administration of plasma substitutes.

    Before the introduction of the drug Contrikal ® in patients with allergic diathesis is shown the preliminary administration of antihistamines.

    In rare cases, treatment with aprotinin causes renal failure.

    Effect on the ability to drive transp. cf. and fur:

    When using Contrikal®, caution should be exercised when driving vehicles and controlling mechanisms due to the fact that side reactions from the central nervous system (confusion) that affect the ability to concentrate attention and the speed of psychomotor reactions may develop.

    Form release / dosage:

    Lyophilizate for the preparation of a solution for intravenous administration of 10 thousand ATPE.

    Packaging:10 thousand ATPE active substance in a bottle of colorless glass with a stopper, an aluminum cap, a lid of polyethylene.

    2 ml of solvent in ampoules of colorless glass.

    5 vials with active substance and 5 ampoules with solvent into the contour cell package.

    2 contour mesh packages together with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    Lyophilizate - 3 years; solvent - 5 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012371 / 01
    Date of registration:23.11.2011 / 05.06.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp03.02.2018
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