Expiration date: 01/2025

Composition

1 ampoule contains:

Active substance: Recombinant prourokinase 5000 IU.

Excipients Sodium chloride, dextran 40.

Packaging

In an ampoule with a capacity of 1 or 2 ml of 5000 IU of lyophilizate. The package contains 5 ampoules.

Pharmacological action

Hemase-fibrinolytic-recombinant urokinase-type plasminogen activator. It is a recombinant prourokinase (RPU) and catalyzes the conversion of plasminogen into plasmin, which is able to lyse fibrin clots.

The specificity of the action of RPU is based on the fact that it mainly activates the fibrin-bound plasminogen, which has a different conformation compared to the circulating plasminogen in the bloodstream, in the plasma, and in the region of the fibrin clot is not sensitive to specific inhibitors present in the blood plasma.

Single-chain molecule RPU under the influence of plasmin turns into a double-chain molecule, which, unlike single-chain proforma is much more active against fibrin-bound plasminogen. A "chain reaction" of the interaction of the RPU with the fibrin-bound plasminogen is formed, as a result of which the fibrin clot is destroyed. Specific enzymatic activity of the drug "Hemase" from 4500 to 5500 IU in the ampoule.

Indications

• Used in ophthalmology for the treatment of the following pathology:
  
• Hyphema, hemophthalmus.
  
• Preretinal, subretinal and intraretinal hemorrhages.
  
• Fibrinoid syndrome of different Genesis.
  
• Occlusion of the Central retinal artery and its branches.
  
• Thrombosis of the Central retinal vein and its branches.
  
• Prevention of adhesions in the postoperative period with antiglaucomatous operations.
  

Contraindications

• Individual hypersensitivity to the components of the drug.
  
• Conditions 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 degree.
  
• Hypertension with diastolic blood pressure more than 105 mm Hg. art.
  
• Hypertensive crisis (due to the possible development of relapse 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 lactation.
  
• Age up to 18 years.
  

Dosage and administration

The contents of 1 ampoule of the drug "Gemaza" diluted in 0, 5 ml 0, 9% sodium chloride solution . The resulting solution contains a dose corresponding to 5000 IU.

The drug is administered parabulbarno subconjunctival or up to 10 injections per course.

• For washing the anterior chamber of the eye with a massive discharge of fibrin into the anterior chamber or hyphema, the Lyophilized substance (5000 IU) is diluted in 1 ml 0, 9% sodium chloride solution, after which 0, 2 ml (1000 IU) or 0.1 ml (500 IU) of the resulting solution is taken and diluted to 0, 5 ml 0, 9% sodium chloride solution.
  
• For intravitreal administration 5000 IU lyophilizate diluted in 1 ml 0, 9% sodium chloride solution, taken 0, 1 ml (500 IU) of the resulting solution and diluted 0, 1-0, 2 ml 0, 9% sodium chloride solution. The resulting volume (0, 2-0, 3 ml) is administered intravitreally once.
  
• In the presence of hyphema and fibrin effusion after cataract extraction, subconjunctival or parabulbar administration of the drug "Hemase", as well as administration to the anterior chamber is Recommended.
  
• With hemorrhages in the vitreous, retina, occlusive lesions of the retina and optic nerve, a parabulbar administration of the drug "Hemase"is Shown.
  
• When gemofthalm different etiology and fibrinoidnogo syndrome Possible intravitreal drug.
  
• For the prevention of adhesions in the postoperative period after antiglaucomatous operations Drug "Gamesa" is diluted at the rate specified for subconjunctival injection, and injected into a filtering bleb in the early postoperative period in the amount of 1-3 injections (at the discretion of the surgeon).
  

Side effect

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

Special instruction

• Effects on ability to drive vehicles and management mechanisms the ability of the drug "Gamesa" to influence the reaction rate when driving motor transport or operating other mechanisms are not marked. But depending on the individual patient's reaction to the drug "Gemaza" during the course of treatment with the drug should be careful when driving and driving mechanisms.
  

Interaction

The joint application of a preparation with proteolytic means showed that the combined drug "Gamesa" with injections kulalisena inappropriate.

The combination of the drug "Hemase" with other thrombolytics should be used with caution.

The combination of solutions of the drug "Gamesa" and emoxipin , and drug "Gamesa" and dexamethasone .

Overdose

With the local administration of the drug "Hemase" in doses of 5000 IU, there is no risk of systemic bleeding.

• Symptoms: with an overdose of the drug, that using the recommended doses (up to 5000 IU once) is unlikely, a relapse of intraocular hemorrhage is possible. With a single administration of the drug at a dose exceeding 5000 IU, the risk of allergic reactions indicated in the side effects increases.
  
• Treatment: in case of overdose of the drug and during surgery on the background of the course of treatment with the drug "Hemase" to reduce the risk of hemorrhage, it is recommended that the General use of etamzilate in injections of 250-500 mg intramuscularly.
  

Storage conditions

• Store in a dark place at a temperature of 2 to 20 °C.
  
• Keep out of reach of children.
  
• Do not use after the expiration date.
  

Shelf life 4 years.