Wessel Doué F (Vessel Due F)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSulodexideSulodexide
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    Alfa Wassermann SpA     Italy
  • Wessel Doué F
    solution w / m in / in 
    Alfa Wassermann SpA     Italy
    • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    Each ampoule (2 ml) contains:

    Active substance: sulodexide 600 L *;

    Excipients: sodium chloride 18 mg, water for injection up to 2 ml.

    * - lipoprotein lipase unit

    Description:

    Light yellow or yellow, clear solution.

    Pharmacotherapeutic group:Anticoagulant
    ATX: & nbsp

       

    Pharmacodynamics:

    Wessel Douai F (sulodexide) is a biological drug that is a natural mixture of glycosaminoglycans (GAG): a heparin-like fraction with a molecular weight of 8,000 daltons (80%) and dermatan sulfate (20%).

    The mechanism of action of sulodexide is due to two main properties: a high-speed heparin-like fraction has an affinity for antithrombin III (ATIII), and dermatological - to cofactor II heparin (CGII).

    pharmachologic effect: angioprotective, profibrinolytic, anticoagulant, antithrombotic.

    Pharmacodynamics

    Angioprotective action is associated with the restoration of the structural and functional integrity of endothelial vascular cells, with the restoration of the normal density of negative electrical charge of the pores of the basal membrane of the vessels. In addition, the drug normalizes the rheological properties of the blood by reducing the level of triglycerides (stimulates lipolytic enzyme - lipoprotein lipase, hydrolyzing triglycerides, which are part of LDL).

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

    Prefibrinolytic action is caused by a rise in the blood level of the tissue activator plasminogen and a decrease in the content of its inhibitor.

    Anticoagulant effect solution for intravenous and intramuscular administration, which is poorly expressed in the proposed dosage (one ampoule per day) is manifested due to the affinity for antithrombin and cofactor II of heparin, which sequentially reduces the concentrations of activated factor X and thrombin.

    Antithrombotic activity - The result of all types of actions that sulodexide has a vascular wall (angioprotective action), fibrinolysis (profibrinolytic action), blood clotting (mild anticoagulant effect) and inhibition of platelet adhesion.

    Pharmacokinetics:

    Absorption of sulodexide, administered intravenously or intramuscularly fast enough, depends on the speed of circulation at the injection site. The plasma sulodexide concentration after internal bolus administration in a single dose of 50 mg after 15, 30 and 60 minutes was 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 in a concentration 20-30 times higher than the concentration in other tissues. Metabolised in the liver and excreted mainly by the kidneys. In the study of the radioactive labeled preparation, 55.23% of the sulodexide was excreted in the urine during the first 96 hours.

    Indications:

    - Angiopathy with an increased risk of thrombosis, including after a previous myocardial infarction;

    - disturbance of cerebral circulation, including acute period of ischemic stroke and period of early recovery; discirculatory encephalopathy due to atherosclerosis, diabetes mellitus, hypertension; vascular dementia;

    - occlusive lesions of peripheral arteries both atherosclerotic and diabetic;

    - phlebopathy, deep vein thrombosis;

    - microangiopathy (nephropathy, retinopathy, neuropathy) and macroangiopathy in diabetes mellitus (diabetic foot syndrome, encephalopathy, cardiopathy);

    - thrombophilic conditions, antiphospholipid syndrome (prescribe together with acetylsalicylic acid, and also after low-molecular heparins);

    - treatment of heparin-induced thrombotic thrombocytopenia, because it does not cause or aggravate it.

    Contraindications:

    - Hypersensitivity;

    - hemorrhagic diathesis and diseases accompanied by reduced blood coagulability;

    - pregnancy I trimester.

    Carefully:

    When combined with anticoagulants, it is necessary to control the parameters of blood clotting.

    Pregnancy and lactation:

    When pregnancy is prescribed under the strict supervision of a doctor. There is a positive experience with the use of the drug for the treatment and prevention of vascular complications in patients with type I diabetes in the II and III trimesters of pregnancy, with the development of late toxicosis of pregnant women.

    Dosing and Administration:
    1 ampoule per day, intramuscularly or intravenously, for 15-20 days.

    Then the therapy should be continued for 30-40 days, taking the drug inside as a dosage form - capsules. Assign 1-2 capsules 2 times a day before meals.

    The full course of treatment should be repeated at least 2 times a year.

    Depending on the results of clinical and diagnostic examination of the patient, the dosage regimen can be changed at the doctor's discretion.

    Side effects:According to clinical studies.

    Data on the incidence of undesirable drug reactions associated with the use of sulodexide were obtained in clinical trials involving patients treated with standard doses of the drug at the usual duration of therapy.

    Undesirable reactions associated with the use of sulodexide were classified according to the system-organ class and distributed according to the frequency of occurrence in the following order: very often (≥ 1/10), often (≥ 1/100 to <1/10) infrequently (≥ 1 / 1000 to <1/100), rarely (≥ 1/10000 to <1/1000), very rarely (<1/10000).

    Nervous System: infrequently - headache, rarely - loss of consciousness.

    The organ of hearing: often - dizziness.

    Gastrointestinal tract: often - pain in the upper abdomen, diarrhea, nausea, infrequently - a feeling of discomfort in the abdomen, dyspepsia, flatulence, vomiting, rarely - gastric bleeding.

    Allergic reactions: often - skin rash of different localization, infrequently - eczema, erythema, urticaria.

    General disorders and disorders at the site of administration: infrequently - pain at the injection site, hematoma at the injection site, rarely peripheral edema.

    According to post-registration observations.

    During the post-marketing application of sulodexide, additional undesirable phenomena were recorded. The frequency of these undesirable effects can not be estimated due to the fact that information about them comes in the form of spontaneous messages. Accordingly, the frequency of these undesirable phenomena is classified as "unknown" (it can not be calculated on the basis of available data).

    From the side of the psyche: derealization.

    From the nervous system: convulsions, tremor.

    From the side of the organ of vision: visual disturbances.

    From the cardiovascular system: a feeling of heartbeat, hot flashes.

    On the part of the respiratory system, the organs of the thorax and the mediastinum: hemoptysis.

    From the skin and subcutaneous tissues: skin itch, purpura, generalized erythema.

    From the urinary system: stenosis of the neck of the bladder, dysuria.

    General disorders and disorders at the site of administration: pain in the chest, pain, burning at the injection site.

    Overdose:

    Bleeding is the only phenomenon that can occur with an overdose. In case of development of bleeding it is necessary to administer protamine sulfate (1% solution), used for bleeding caused by heparin.

    Interaction:

    Significant interaction of the preparation of Wessel Doué F with other drugs has not been established.

    When using sulodexide, it is not recommended to simultaneously use drugs that affect the hemostasis 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 coagulation time.

    Wessel Doué F increases the normal indices of activated partial thromboplastin time by approximately one and a half times.

    Effect on the ability to drive transp. cf. and fur:

    The ability to control vehicles and mechanisms, the preparation of Wessel Douai F is not affected.

    Form release / dosage:

    Solution for intravenous and intramuscular injection, 600 leu / 2 ml.

    Packaging:

    2 ml per ampoule of dark glass with a line of breaking.

    By 5 ampoules in each of the two contoured cell packs or 10 ampoules in one contour acupule pack with instructions for medical use in a cardboard bundle.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children.
    Shelf life:

    5 years

    Do not use after expiration date
    Terms of leave from pharmacies:On prescription
    Registration number:П N012490 / 02
    Date of registration:04.04.2008 / 30.03.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Alfa Wassermann SpAAlfa Wassermann SpA Italy
    Manufacturer: & nbsp
    Representation: & nbspALPHA VASSERMANN LLC ALPHA VASSERMANN LLC Italy
    Information update date: & nbsp26.09.2017
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