Gemase (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Technogen S&PE, LLC (Russia)

Manufactured By

Experimental Production of MBP RK NPC (Russia)

ATC Code

B01AD (Enzyme preparations)

Active Substance

Prourokinase (Grouping name)

Dosage Form

Gemase

Lyophilisate for the preparation of solution for injection 5 thousand IU: amp. 3, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

5 thousand IU – ampoules (3) – carton packs.
5 thousand IU – ampoules (5) – carton packs.
5 thousand IU – ampoules (10) – carton packs.

Clinical-Pharmacological Group

Thrombolytic – tissue plasminogen activator

Pharmacotherapeutic Group

Fibrinolytic agent

Pharmacological Action

Thrombolytic agent, which is a serine protease in the form of a single-chain molecule with a molecular weight of 54,000 daltons, consisting of 2 polypeptide chains with molecular weights of 20 and 34 thousand Da, which are connected by a disulfide bridge.

It specifically stimulates the conversion of profibrinolysin (plasminogen) into fibrinolysin (plasmin) – an enzyme capable of lysing fibrin clots.

Indications

For intravenous administration: coronary vessel occlusion (acute myocardial infarction).

For subconjunctival, parabulbar, intracameral, intravitreal administration: hyphema, hemophthalmos; preretinal, subretinal, and intraretinal hemorrhages; fibrinoid syndrome of various origins; 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 after antiglaucoma surgeries.

ICD codes

Dosage Regimen

For acute myocardial infarction, administer intravenously as a bolus injection of 2 million IU, followed by an intravenous infusion of 3 million IU over 60 minutes.

For ophthalmic use, administer via subconjunctival, parabulbar, intracameral, or intravitreal routes. Prepare the solution immediately before administration using 0.9% sodium chloride injection.

For hyphema and hemophthalmos, the typical subconjunctival or parabulbar dose is 0.5 ml of a solution containing 5000 IU.

For preretinal, subretinal, and intraretinal hemorrhages, administer 0.5 ml of a 5000 IU solution parabulbarly.

For fibrinoid syndrome and prevention of postoperative adhesions after antiglaucoma surgery, use 0.5 ml of a 5000 IU solution.

For retinal vascular occlusions (central artery or vein thrombosis), the recommended intravitreal dose is 0.2 ml of a solution containing 5000 IU.

Do not exceed the recommended dosages. Monitor for signs of bleeding or allergic reactions during and after administration.

Adverse Reactions

Allergic reactions: skin manifestations, as well as edema and hyperemia of the facial skin on the side of drug administration, allergic tenonitis (chemosis, conjunctival hyperemia, decreased mobility of the eyeball).

From the cardiovascular system: decreased blood pressure.

From the blood coagulation system: bleeding of varying severity from puncture sites and surgical incisions.

Contraindications

Tendency to bleeding (including hemorrhagic diathesis, hemophilia, thrombocytopenia, etc.), increased risk of bleeding (gastrointestinal bleeding within the last 4 weeks, major surgical intervention or major trauma within the last 4 weeks, intracranial or intraspinal interventions within the last 8 weeks, head trauma within the last 4 weeks), resuscitation measures (including cardiopulmonary resuscitation lasting more than 10 minutes), liver diseases with severe hemostasis system impairment, puncture of large vessels (e.g., subclavian vein), diabetic hemorrhagic retinopathy, condition after hemorrhagic stroke (including in history), increase in systolic blood pressure to 180 mm Hg and above or diastolic blood pressure to 110 mm Hg and above, cardiogenic shock (Killip class IV), suspected aortic dissection, septic endocarditis, pregnancy, hypersensitivity to prourokinase.

Use in Pregnancy and Lactation

Contraindicated during pregnancy.

Use in Hepatic Impairment

Contraindicated in liver diseases with severe hemostasis system impairment.

Special Precautions

If arterial hypotension (systolic blood pressure less than 90 mm Hg) and bradycardia (heart rate less than 50 beats/min) develop, it is recommended to suspend the administration of the drug until blood pressure and heart rate normalize.

Cross-reactions with streptase-streptokinase and allergies with streptococcal sensitization, as a rule, do not occur.

When performing surgical interventions against the background of prourokinase action, to reduce the risk of hemorrhage, intramuscular administration of etamsylate at a dose of 250-500 mg is recommended.

Use with caution in combination with other thrombolytic agents.

Drug Interactions

When used concomitantly with prourokinase, acetylsalicylic acid and anticoagulants increase the risk of bleeding.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.