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Description
The instruction for medical use
of medicine
WESSEL of DUE F
Trade name
of Wessel Due F
International unlicensed
name Sulodeksid Lekarstvennye forms
of the Capsule 250 LE Structure One Capsule contains
active agent – sulodeksid 250 LE *,
excipients: sodium the lauryl sarcosinate, silicon besieged, triglycerides,
structure of a cover: gelatin, glycerin, sodium ethylparaoxybenzoate, sodium propilparaoksibenzoat, titan dioxide (E 171), ferrous oxide red (E 172).
*-lipoproteinlipazny unit
Description
Soft capsules of an oval form of brick-red color. Contents of capsules – homogeneous suspension from white till gray color.
Pharmacotherapeutic group
Anticoagulants direct.
The code of automatic telephone exchange B01AB11
the Pharmacological
Sulodeksid’s Pharmacokinetics of 90% properties collects in an endothelium of vessels that exceeds its concentration in fabrics of other bodies at 20-30 times. Sulodeksid is absorbed in digestive tract. It is metabolized in a liver and allocated through kidneys. Distribution of a sulodeksid on bodies showed that drug undergoes extracellular diffusion in a liver and kidneys in 4 hours after introduction.
In 24 hours after intravenous administration of drug the excretion with urine is 50% of connection, and in 48 hours – 67%.
Wessel Due’s pharmacodynamics F possesses antitrombotichesky, anti-coagulative (at parenteral administration), angioprotektivny and pro-fibrinolytic actions.
Wessel Due F (sulodeksid) is the natural product extracted and allocated from a mucous membrane of a small intestine of a pig. Represents natural mix of glucosaminoglycans (EIDERS): geparinopodobny fraction with a molecular weight of 8,000 dalton (80%) and the dermatansulfat (20%).
The mechanism of action of a sulodeksid is caused by two main properties:
the high-speed geparinopodobny fraction has affinity to antithrombin III (ATIII) and dermatanovy – to a cofactor of heparin II (KGII).
The mechanism of antitrombotichesky action of Wessel Due F is connected with suppression of the factor activated Ha, with strengthening of synthesis and secretion of prostacyclin (I2 prostaglandin), with decrease in level of fibrinogen in blood plasma.
The mechanism of pro-fibrinolytic action of Wessel Due F is caused by increase in blood of level of the fabric plasminogen activator (FPA) in blood and decrease in content of its inhibitor (TAPAS).
The mechanism of angioprotektivny action of Wessel Due F is connected with recovery of structural and functional integrity of cells of an endothelium of vessels, restoration of normal density of negative electric charge of a time of a basal membrane of vessels. Drug normalizes rheological properties of blood due to decrease in level of the triglycerides (as stimulates lipolytic enzyme – the lipoproteinlipase hydrolyzing triglycerides) which are a part of LDL (lipoproteins of low density).
The efficiency of use of drug at a diabetic nephropathy is defined by ability of a sulodeksid to reduce thickness of a basal membrane and products of an extracellular matrix due to decrease in proliferation of cells of mesangium.
Anti-coagulative action of Wessel Due F is shown due to affinity to antithrombin III and a cofactor of heparin II which inactivates thrombin.
Indications
– angiopatiya with the increased risk of a thrombogenesis, including after the postponed myocardial infarction
– disturbance of cerebral circulation, including an acute period of an ischemic stroke and the period of early restoration, the distsirkulyatorny encephalopathy caused by atherosclerosis, diabetes, a hypertension, vascular dementia
– occlusal damages of peripheral arteries of both atherosclerotic, and diabetic genesis
– flebopatiya, a deep vein thrombosis
– a mikroangiopatiya (nephropathy, a retinopathy, neuropathy) and a macrovascular disease in diabetes (syndrome of diabetic foot, encephalopathy, a cardiopathy)
– trombotichesky states, an anti-phospholipidic syndrome (appoint along with acetylsalicylic acid)
– for continuation of treatment at development of geparinindutsirovanny trombotichesky thrombocytopenia
the Route of administration and doses
On 1 capsule 2 times a day inside between meals within 30-40 days. The maximum single dose makes 4 capsules, a daily dose – 8 capsules. It is necessary to repeat a full course of treatment not less than 2 times a year. In case of exacerbation of a disease or at a heavy course, treatment needs to be begun with parenteral administration of Wessel Due F, and then to continue by reception of capsules within 20-40 days.
Side effects
– nausea, vomiting, pains in epigastriums
– skin rash (allergic reaction)
of the Contraindication
– hypersensitivity to drug components
– the hemorrhagic diathesis and diseases which are followed by the lowered blood clotting
– pregnancy in the I trimester
Medicinal interactions
of Significant interaction of Wessel Due F with other drugs it is not established.
The special
instructions Use in pediatrics
safety Given on study and efficiency of drug at children and teenagers up to 18 years are absent.
Pregnancy and a lactation
Is available positive experience of use of drug of Wessel Due by F patients with achrestic diabetes in II and III trimesters of pregnancy for the purpose of treatment and prevention of vascular complications (a gestosis * – late toxicosis of pregnant women).
* – the gestoses arising against the background of: a nephropathy of I and II degree, a hypertension and the IDCS on hypertensive type, a chronic glomerulonephritis, thrombophlebitis and risk of tromboembolic episodes, a pregnancy miscarriage at an anti-phospholipidic syndrome, the raised blood clotting indicators in various options of pathologies.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
drug does not affect ability to driving of the car and control of the machine equipment.
The overdose
Is not present messages about overdose cases.
Treatment: in case of overdose performing symptomatic and maintenance therapy.
The form of release and packing
On 25 capsules in blister strip packaging, 2 blister strip packagings and an iinstruktion on medical use in the state and Russian languages are placed in a cardboard pack.
To Store storage conditions at a temperature not above + 30 °C.
To store out of children’s reach!
Not to use a period of storage of 5 years after the specified expiration date
Prescription status
According to the prescription
Producer
S. Alpha Wassermann of the item. And.
Via Enrico Fermi, 1 – 65020 Alanno (Pescara), Milan – Italy
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
the Representative in the Republic of Kazakhstan
N.D. Sadybekov
Almaty Pushkin St., 13
phone number: 273-70-92
Additional information
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