Active substanceProurokinaseProurokinase
Similar drugsTo uncover
  • Hemase®
    lyophilizate for injections 
    TECHNOGEN NPP, LLC     Russia
  • Puroolase®
    lyophilizate in / in 
  • Dosage form: & nbsplyophilizate for solution for injection
    Composition:

    1 ampoule with a capacity of 1 ml or 2 ml contains:

    active substance: prourokinase recombinant 5000 ME;

    Excipients: sodium chloride, dextran 40.

    Description:

    Amorphous powder or porous mass of white color, odorless.

    Pharmacotherapeutic group:Fibrinolytic agent - plasminogen activator
    ATX: & nbsp

    B.01.A.D.   Enzyme preparations

    Pharmacodynamics:

    Fibrinolytic is a recombinant urokinase-type plasminogen activator. It is a recombinant prourokinase (RPA) and catalyzes the transformation of plasminogen into plasmin, which is capable of lysing fibrin clots. The specificity of the action of the RPU is based on the fact that it predominantly activates fibrin-bound plasminogen having a different conformation than plasminogen circulating in the bloodstream to the plasmin and in the region of the fibrin clot is not sensitive to specific inhibitors present in the blood plasma. A single-stranded molecule of polyurethane under the action of plasmin is converted into a double-stranded molecule, which unlike the single-stranded pro forma is much more active in relation to fibrin-bound plasminogen.A "chain reaction" is formed between the interaction of the RPA and the fibrin-linked plasminogen, as a result of which the fibrin clot breaks down. Specific enzymatic activity of the drug Hemaz® from 4500 to 5500 ME in the ampoule.

    Pharmacokinetics:With local periocular administration, the maximum concentration of Hemase ® in the eye tissues is reached by 1-2 hours, the concentration of the drug gradually decreases, after 12-24 hours the drug is found in trace amounts. The maximum concentration of the drug is determined in intraocular structures with intraocular guidance. The half-life of the drug is 4-6 hours. Since the dose for topical application is small (up to 5000 ME), there are no concentrations in the blood that are significant for the systemic effect of the drug.
    Indications:

    The drug Hemaz® is used in ophthalmology for the treatment of the following pathology:

    - hyphema, hemophthalmus;

    - preretinal, subretinal and intra-retinal hemorrhages;

    - fibrinoid syndrome of different genesis;

    - occlusion of the central artery of the retina and its branches;

    - thrombosis of the central vein of the retina and its branches;

    - prevention of adhesions in the postoperative period for antiglaucomatous operations.

    Contraindications:

    - Individual hypersensitivity to the components of the drug;

    - a condition with a high risk of bleeding, including blood diseases (hemorrhagic diathesis);

    - gastrointestinal bleeding;

    - bacterial endocarditis;

    - active form of tuberculosis;

    - proliferative diabetic retinopathy with gliosis III-IV degrees;

    - arterial hypertension with diastolic blood pressure more than 105 mm Hg. p.

    - hypertensive crisis (due to the possible development of recurrence of intraocular hemorrhage);

    - chronic renal failure (serum creatinine level more than 0.02 g / l, urea more than 0.5 g / l);

    - severe hepatocellular insufficiency (blood albumin less than 3 g%);

    - pregnancy and the period of breastfeeding;

    - age to 18 years.

    Dosing and Administration:

    The contents of 1 ampoule of Hemase ® is diluted in 0.5 ml of 0.9% sodium chloride solution. The resulting solution contains a dose corresponding to 5000 ME. The drug is administered parabulbarically or subconjunctivally up to 10 injections per course.

    To rinse the anterior chamber of the eye with massive fibrin efflorescence in the anterior chamber or hyphae, the lyophilized substance (5000 ME) is diluted in 1 ml of 0.9% sodium chloride solution, after which 0.2 ml (1000 ME) or 0.1 ml (500 ME) of the resulting solution and diluted to 0.5 ml with 0.9% sodium chloride solution.

    For intravitreal administration, 5000 ME lyophilisate is diluted in 1 ml of a 0.9% solution of sodium chloride, taken 0.1 ml (500 ME) of the solution obtained and diluted with 0.1-0.2 ml of 0.9% sodium chloride solution. The resulting volume (0.2-0.3 ml) is administered intravitreally once.

    In the presence of fibrin exudate and hyphema after cataract extraction recommended or subconjunctival administration parabulbarly Gemaza® preparation and introduction into the anterior chamber. When vitreous hemorrhage, retinal vascular occlusive lesions of the retina and optic nerve shown parabulbarnom Gemaza® preparation. With hemophthalmia of various etiologies and fibrinoid syndrome, intravitreal administration of the drug is possible.

    For the prevention of adhesions in the postoperative period when operations Gemaza® antiglaucomatous drug is diluted in the proportions indicated for subconjunctival injection, and injected into the filter pad in the early postoperative period, in an amount of 1-3 injections (at the discretion of the surgeon).

    Side effects:

    There may be an allergic reaction, manifested in the edema and hyperemia of the skin of the face on the side of administration of the drug, the phenomena of allergic tenonitis (chemosis, conjunctival hyperemia, decreased mobility of the eyeball).

    Overdose:

    With local administration of the drug Hemaz® in doses of 5000 ME there is no risk of systemic bleeding.

    When an overdose of the drug that when using the recommended dose (up to 5000 ME once) is unlikely, a relapse of intraocular hemorrhage is possible.

    With a single administration of the drug in a dose exceeding 5000 ME, the risk of allergic reactions indicated in side effects increases.

    When an overdose of the drug and during surgery on the background of the course of treatment with Hemaz ® to reduce the risk of hemorrhage is recommended the general use of etamzilate in injections of 250-500 mg intramuscularly.

    Interaction:

    The combined use of the drug with proteolytic agents has shown that it is not feasible to combine the drug Hemase ® with injections of collalisin.

    Combination of Hemase ® with other thrombolytics should be applied with caution.

    Possible the combined use of solutions of the drug Hemaz® and emoxipin, as well as the drug Hemaz® and dexamethasone.

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

    The ability of the drug Hemaz® to influence the reaction rate when driving vehicles or other mechanisms is not noted. But depending on the individual reaction of the patient to the drug Hemaz® during the course of treatment with the drug should be careful when driving a car and controlling the mechanisms.

    Form release / dosage:

    Liofilizate for solution for injection, 5000 ME.

    Packaging:

    In ampoules of neutral glass with a capacity of 1 ml or 2 ml.

    For 3 or 5 ampoules in a planar cell package with foil or without foil.

    1 contour cell with 3 ampoules or 1 or 2 contour packs with 5 ampoules together with instructions for use in a cardboard package.

    Storage conditions:

    In a place protected from light, inaccessible to children at a temperature of 2 to 20 ° C.

    Shelf life:

    4 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N001837 / 01
    Date of registration:02.03.2009 / 21.01.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:TECHNOGEN NPP, LLC TECHNOGEN NPP, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspFGU RKNPK ROSZDRAVA - EPMPP FGU RKNPK ROSZDRAVA - EPMPP Russia
    Information update date: & nbsp20.03.2017
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