Instruction for use: Trombovazim

Dosage form: Capsules; Lyophilizate for the preparation of solution for infusions; Semi-finished product; tablets

ATX

B01AD Enzyme preparations

Pharmacological group

Fibrinolytic agent [Fibrinolytics]

The nosological classification (ICD-10)

I87.2 Venous insufficiency (chronic) (peripheral): Painful foot fatigue; The pain and feeling of heaviness in the legs; The pain of chronic venous insufficiency; Venous insufficiency; Venous insufficiency of the lower limbs; Venous-lymphatic insufficiency; Venous edema; phlebostasis; Ischemic lesions stop; Lipedema; Microcirculatory-trophic disorders; Violation of venous circulation; Violation of venous circulation of the lower limbs; Disorders of venous circulation; Disorders of the peripheral circulation in the extremities; Lack of chronic venous; Insufficiency of venous circulation; Organic venous insufficiency of the lower limbs; Acute venous insufficiency of the lower limbs; Swelling in the legs; limb edema; Swelling in the legs; Swelling of lower limbs due to chronic venous insufficiency; Swelling of the legs; Edematous pain in venous insufficiency; Swelling and pain in the legs; The feeling of heaviness in the legs; Prevarikozny syndrome; The static heaviness in the legs; Trophic tissue changes; Trophic tissue disorders; Trophic disorders; Heaviness in the legs; Fatigue in the legs; Chronic venous insufficiency; Chronic venous insufficiency of the lower limbs; Chronic ischemic disease of the lower extremities; Chronic insufficiency of venous circulation; The feeling of heaviness in the legs; The feeling of heaviness in the legs during pregnancy; The feeling of heaviness in the legs after prolonged standing

Composition

Capsules - 1 caps.

active substance: Thrombovazim® - 400/600/800 units

Auxiliary substances: potato starch - 0.261 g; MCC - 0.12 g; Sodium chloride 0.009 g

Capsule gelatinous: dyes - azorubin (E122), patent blue V (E131), titanium dioxide (E171); gelatin

Description of the dosage form

Capsules: hard, gelatin, size No. 0, with a white body and a lid of a dark pink color with an overprint of white "TROMBOVAZIM®".

Contents of capsules: powder from white with a yellowish brown tinge to a light brown color.

Pharmachologic effect

Mode of action - Fibrinolytic, anti-inflammatory, antithrombotic, cardioprotective, thrombolytic.

Pharmacodynamics

The drug has a thrombolytic, anti-inflammatory and cardioprotective effect.

The mechanism of thrombolytic action is associated with the direct destruction of filaments of fibrin, which form the basic framework of the thrombus. The mechanism of anti-inflammatory action is associated with the effect on the oxidative function of blood neutrophils and tissue macrophages. The mechanism of cardioprotective action is associated with improved blood supply to the myocardium. Thrombovazim® is a low-toxic drug, does not reduce platelet counts and does not affect the clotting time and bleeding time.

Pharmacokinetics

Bioavailability of the drug for oral administration is 16-18%. The maximum effect occurs after 6 hours. The total clearance is 1.2 ml / min, the elimination rate constant for a single intake is 0.057 min-1. T1 / 2 of the drug when measuring specific activity in the blood is 12 minutes. It does not bind to blood plasma proteins and shaped elements.

Do not accumulate in the body, while observing the recommended doses and the frequency of administration.

The main way of excretion is through the kidneys (80%). Partially metabolized and excreted by the liver (20%).

Indications for the preparation Trombovazim

As an aid in the complex therapy of chronic venous insufficiency.

Contraindications

Hypersensitivity to the drug;

Peptic ulcer of the stomach and duodenum (in the stage of exacerbation);

Simultaneous reception with drugs containing calcium, magnesium, zinc, iron and lithium salts, as well as tetracycline antibiotics (tetracycline, chlorotetracycline hydrochloride and oxytetracycline hydrochloride);

pregnancy;

Lactation period;

Age to 18 years (efficiency and safety not established).

With caution: polyvalent allergy; Chronic obstructive pulmonary disease; The threat of bleeding from the esophagus; Urolithiasis; Stomach ulcer and duodenal ulcer (in remission).

Application of pregnancy and breastfeeding

The drug is contraindicated in pregnancy and lactation.

Side effects

Allergic reactions are possible, in rare cases - dyspeptic phenomena (nausea, vomiting, feeling of heaviness in the stomach). Perhaps a temporary feeling of raspiraniya in the lower limbs.

Interaction

Heparin, dipyridamole, acetylsalicylic acid increase the antithrombotic effect without increasing the threat of bleeding.

The use of tetracycline antibiotics (tetracycline, chlorotetracycline hydrochloride and oxytetracycline hydrochloride) with antibiotics enhances the effect of fibrinolytic agents. If it is necessary to use preparations containing salts of divalent metals (calcium, magnesium, zinc, iron), in connection with a possible decrease in enzyme activity, it is desirable to observe the interval between the Trombovazim® and these preparations at least 40 minutes.

Dosing and Administration

Inside, for 30-40 minutes before meals.

At 800-1600 units / day, divided into 2 receptions.

The maximum daily dose is 2000 units. The course of treatment is 20 days. In the absence of efficacy during the course of treatment should consult a doctor. If necessary, it is possible to conduct repeated courses on the recommendation of a doctor.

Overdose

There were no cases of overdose.

Special instructions

Influence on the ability to drive vehicles or perform work that requires an increased speed of physical and mental reactions. Studies on the possible effect of the drug on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions have not been carried out, because The drug and its components do not belong to substances that can affect the psychomotor state of a person.

Release form

Capsules, 400 units, 600 units, 800 units. In the outline of the cell packaging of PVC film and aluminum foil with applied thermolac with 4 pcs. 1 contour squad packaging in a pack of cardboard. In the outline cell box made of PVC and aluminum foil with applied thermolac with 10 pcs. 1, 3, 5 contour mesh packages in a pack of cardboard.

Manufacturer

CJSC "Siberian Center for Pharmacology and Biotechnology". Russia

Legal address: CJSC "Siberian Center of Pharmacology and Biotechnology". Russia, 630090, Novosibirsk

Conditions of supply of pharmacies

Without recipe.

Storage conditions of the drug Trombovazim

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

The shelf life of the drug Trombovazim

2 years.

Do not use beyond the expiration date printed on the package.