Vessel Due F, 600 le/2ml 2 ml 10 pcs

Vessel® Due F (sulodexide) is a biological medicine which is a natural mixture of glycosaminoglycans (GAGs): a heparin-like fraction with a molecular weight of 8000 dalton (80%) and dermatansulfate (20%).

The mechanism of action of sulodexide is due to two main properties: the fast acting heparin-like fraction has an affinity for antithrombin III (ATIII) and the dermatan-like fraction has an affinity for heparin cofactor II (KGII).

Pharmacological action:

angioprotective, profibrinolytic, anticoagulant, antithrombotic.

Pharmacodynamics

The angioprotective effect is associated with restoration of structural and functional integrity of vascular endothelial cells, with restoration of the normal density of the negative electric charge of pores of the basal membrane of vessels. Besides, the preparation normalizes rheological properties of blood due to reduction of triglycerides level (it stimulates lipolytic enzyme – lipoprotein lipase which hydrolyzes triglycerides being a part of LDL).

The effectiveness of the drug in diabetic nephropathy is determined by the ability of sulodexide to decrease the thickness of basal membrane and extracellular matrix production due to decrease of mesangium cell proliferation.

Profibrinolytic effect is due to an increase in blood levels of tissue plasminogen activator and a decrease of its inhibitor.

The anticoagulant effect of the solution for intravenous and intramuscular administration, which is weakly expressed in the suggested dosage (one ampoule per day) is due to affinity for antithrombin and heparin cofactor II, which consistently reduces the concentrations of activated factor X and thrombin.

The antithrombotic activity is the result of all the actions that sulodexide has on the vascular wall (angioprotective effect), fibrinolysis (profibrinolytic effect), blood clotting (weak anticoagulant effect) and inhibition of platelet adhesion.

Pharmacokinetics

The absorption of sulodexide administered intravenously or intramuscularly is fairly rapid and depends on the rate of blood circulation at the injection site. Plasma concentrations of sulodexide after internal bolus administration of a single dose of 50 mg after 15, 30, and 60 minutes were 3.86 ± 0.37 mg/L, 1.87 ± 0.39 mg/L, and 0.98 ± 0.09 mg/L, respectively.

Sulodexide is distributed in the vascular endothelium at a concentration 20-30 times greater than that in other tissues. It is metabolized in the liver and excreted mainly by the kidneys. In a study of the radioactive labeled drug, 55.23% of sulodexide was excreted with the urine during the first 96 hours.

Indications

Impaired cerebral circulation, Consequences of stroke, Diabetic retinopathy, Thrombosis prevention, Diabetic nephropathy, Vascular lesions in diabetes, Thrombophlebitis – angiopathies with increased risk of thrombosis, including after myocardial infarction;
– cerebral circulatory disorders, including the acute period of ischemic stroke and the early recovery period; discirculatory encephalopathy due to atherosclerosis, diabetes, hypertension; vascular dementia;
– Peripheral arterial occlusive lesions both of atherosclerotic and diabetic genesis;
– phlebopathies, deep vein thrombosis;
– microangiopathies (nephropathy, retinopathy, neuropathy) and macroangiopathies with diabetes (diabetic foot syndrome, encephalopathy, cardiopathy);
– thrombophiliac conditions, antiphospholipid syndrome (administered together with acetylsalicylic acid, as well as after low-molecular-weight heparin);
– treatment of heparin-induced thrombotic thrombocytopenia, because it does not cause or aggravate it.

Active ingredient

Sulodexide

Composition

Each ampule (2 ml) contains:

The active ingredient:

sulodexide 600 LE*

Associates:

sodium chloride 18 mg,

water for injection up to 2 ml.

* – lipoproteinlipase unit

How to take, the dosage

1 ampoule a day, intramuscularly or intravenously, for 15-20 days. Then the therapy should be continued for 30-40 days taking the drug orally in the form of capsules. Administration of 1-2 capsules 2 times a day before meals.

The full course of treatment should be repeated at least twice a year.

The dosing regimen can be changed at the discretion of the physician, depending on the results of the clinical and diagnostic examination of the patient.

Interaction

No significant interaction of the drug Vessel® Due F with other drugs has been established. When using sulodexide, it is not recommended to use simultaneously drugs that affect the hemostatic system as anticoagulants (direct and indirect).

Special Instructions

At the beginning and end of treatment it is advisable to determine the following parameters: activated partial thromboplastin time, antithrombin III, bleeding time and clotting time. Vessel® Due F increases normal activated partial thromboplastin time by approximately one and a half times.

Influence on driving and operating ability

The ability to drive and operate vehicles and machines is not affected by Vessel® Due F.

Contraindications

– Hypersensitivity;
– hemorrhagic diathesis and diseases accompanied by low blood clotting;
– pregnancy in the first trimester.

With caution:

– When combined with anticoagulants, blood clotting parameters should be monitored.

Side effects

According to clinical studies

Data on the frequency of adverse drug reactions associated with the use of sulodexide were obtained from clinical studies involving patients treated with standard doses of the drug at the usual duration of therapy.

The adverse reactions associated with the use of sulodexide were classified in the system-organ class and categorized by frequency of occurrence in the following order: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), infrequent (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000).

Nervous system: infrequent – headache, very rare – loss of consciousness.

Hearing organ: frequent – dizziness. Gastrointestinal tract: frequently – upper abdominal pain, diarrhea, nausea, rarely – abdominal discomfort, dyspepsia, flatulence, vomiting, very rarely – gastric bleeding.

Allergic reactions: frequently – skin rash of various localizations, rarely – eczema, erythema, urticaria. General disorders and disorders at the injection site: infrequent – pain at the injection site, hematoma at the injection site, very rare – peripheral edema.

According to post-registration observations.

During post-registration use of sulodexide additional adverse events were registered. The frequency of these adverse events cannot be estimated due to the fact that they are reported spontaneously. Accordingly, the frequency of these adverse events is classified as “unknown” (cannot be calculated on the basis of available data).

Mental: derealization.

Nervous system: seizures, tremor.

Visual: visual disturbances.

Cardiovascular system: palpitations, hot flashes.

Respiratory system, thoracic and mediastinal organs: hemoptysis.

Skin and subcutaneous tissues: skin itching, purpura, erythema generalized.

Urinary system: bladder neck stenosis, dysuria. General disorders and disorders at the injection site: chest pain, pain, burning at the injection site.

Overdose

Bleeding is the only phenomenon that can occur in an overdose.

Pregnancy use

In pregnancy Vessel Due F is prescribed under the close supervision of a physician.

There is positive experience of use for the treatment and prevention of vascular complications in patients with type 1 diabetes in the second and third trimesters of pregnancy, in the development of late toxicosis of pregnant women – gestosis.

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