Trombovazim

сapsules
OTC

  • Thrombolytic
  • Anti-inflammatory
  • Cardioprotective effects

The mechanism of thrombolytic action is associated with direct destruction of fibrin, which form the basic framework of thrombus.

The mechanism of anti-inflammatory action is associated with effect on the oxidative function of blood neutrophils and tissue macrophages

Cardioprotective mechanism of action is associated with improved myocardial perfusion.

Indications for use: as an adjunct in the treatment of chronic venous insufficiency.

Contraindications for use: hypersensitivity to the drug, pregnancy, lactation, age 18 years (the efficacy and safety have not been established), peptic ulcer and duodenal ulcer (acute phase), co-administration with drugs containing divalent metal salts (calcium, magnesium, zinc, iron), and tetracycline antibiotics (tetracycline, chlortetracycline hydrochloride and oxytetracycline hydrochloride).

Dosing regimen, route of administration: The drug is used inside for 30 - 40 minutes before a meal to 800-1600 IU per day, divided into two doses. The maximum daily dose - 2000 units. The treatment course is 20 days. In the absence of efficiency throughout the course of treatment should consult a doctor. If necessary, may conduct repeated courses on the recommendation of a physician.

Precautions: polyvalent allergy, chronic obstructive pulmonary disease, the threat of bleeding from esophageal varices, urolithiasis, peptic ulcer and duodenal ulcer (in remission).

Symptoms of overdose, measures to aid in overdose: overdose was not observed.

Possible side effects: Allergic reactions, in rare cases, dyspeptic symptoms (nausea, vomiting, a feeling of heaviness in the stomach). Perhaps a temporary feeling of fullness in the lower extremities.

Axis Technology

Immobilization of biologic active substances on water soluble electron-beam activated polymers.

Without chemical reactions and catalysis.

Electron beam as an instrument:

  • precisely
  • clean
  • economically effective

Main Principle of Axis Technology

  • Reduction of toxic effects
  • Reduction of allergic effects
  • Increasing of therapeutic efficiency
  • Increasing of bioaccessibility efficiency in case of “per oral” intake
  • Increasing of stability for instable and short time living substances

Instruction

Registration number: 007166/09

Commercial name: Trombovazim®

Pharmaceutical form: Capsules

Code АТХ: В01АD

Pharmacotherapeutic group: Fibrinolytic agent

Pharmacological properties

The drug has thrombolytic, anti-inflammatory and cardioprotective activity.

Pharmacodynamic

Thrombolitic mechanism is connected with direct destruction of fibrin strings, which form the main frame of thrombus. Anti-inflammatory mechanism is connected with influence on blood neutrophils and tissue macrophages oxidizing function. Cardioprotective mechanism is connected with myocarditis blood supply improvement. Trombovazim is a low-toxic preparation. Trombovazim® neither decreases platelet levels, nor influences coagulation time and bleeding duration.

Pharmacokinetics

Bioavailability of the drug when taken inside is 16-18 %. Maximum effect is observed 6 h. after intake. Systemic clearance is 1.2 ml/min, elimination rate constant with single intake is 0,057 min-1. It does not bind to blood plasma proteins and blood corpuscles. The preparation half-life at blood specific activities measurement is 12 minutes. It does not bind to plasma proteins and blood corpuscles. The drug has no cumulative effect if recommended doses and dosage frequency are observed. The preparation major pathway is renal (80 %). Partially metabolized and excreted by liver (20 %).

Composition

A capsule contains

Active substance – Trombovazim® 400 U, 600 U, 800 U;

Potato starch 0,261 g

Microcrystalline cellulose 0,120 g

Sodium chloride 0,009 g

Gelatin capsules contain

Dyes: Azorubine Е 122, Patent-Blue V Е 131, Titania Е 171, Gelatin

Therapeutic indications

As an adjuvant in complex therapy in venous insufficiency.

Contraindications

  • Preparation hypersensitivity;
  • Pregnancy;
  • Lactation;
  • Age under 18 (efficacy and safety are not determined);
  • gastric and duodenal ulcer (acute);
  • Simultaneous intake of drugs containing bivalent metal salts (calcium, magnesium, zinc, iron) and antibiotics of tetracycline group (tetracycline, Chlorotetracyclin HCl, and oxytetracycline HCl).

Dosage regimen, route of administration

The drug should be taken orally 30-40 minutes before meals in the doses of 800-1600 U/day divided into two doses. Maximum daily dose is 2000 U. Course of treatment is 20 days. If no efficacy observed during the course of treatment, one should consult the doctor. Courses of retreatment can be given if necessary upon the doctor’s recommendation.

Potential side effects

Allergic reactions and occasional dyspeptic effects (nausea, vomiting, sense of heaviness in stomach) are possible. Temporary sense of arching in lower limbs.

Overdose symptoms, overdose first aid measures

No cases of overdose was observed.

Interaction with other pharmaceutical drugs

Heparin, dipiridamol, acetylsalicylic acid increase antithrombotic effect not increasing the risk of bleeding. Administration of the drug with antibiotics of tetracycline group (tetracycline, chlortetracycline, hydrochloride, oxytetracycline hydrochloride) increases effect of fibrinolytics. When necessary to use drugs containing bivalent metal salts (calcium, magnesium, zinc, iron) one should observe time interval of 40 minutes minimum between intake of Trombovazim and the drugs mentioned because of the possible enzyme activity reduction.

Administration details in case of pregnancy and lactation

The drug is contraindicated in pregnancy and lactation period.

Pharmaceutical form

Capsules

Description: Hard gelatin capsules # 0 with a white body-part and a dark-rose cap with white overprint "Trombovazim®". Capsules content – white with a yellowish-brown hue to pale brown powder.

Storage conditions

Store in dry, protected from light place at temperature not exceeding 25 °С. Keep away from children.

Shelf-life

Do not use after shelf-life.

Contact Information

«Siberian Center of Pharmacology and Biotechnology»

CJSC, phone/fax: (383) 354-02-10
Legal address: 630090, RF. г. Novosibirsk, Academician Lavrentyev Av, 10.
Manufacture address: 630056, RF., Novosibirsk, Sofiyskaya Str., 20.