Active substanceSodium tetradecyl sulfateSodium tetradecyl sulfate
Similar drugsTo uncover
  • Fibro-Wayne®
    solution
  • Fibro-Wayne®
    solution in / in 
  • Dosage form: & nbspsolution for intravenous administration
    Composition:

    in 1 ml contains:

    Active substance - sodium tetradecyl sulfate 2.0 mg, 5.0 mg, 10.0 mg or 30.0 mg Excipients - gasoline alcohol 20.0 mg, sodium hydrogen phosphate dodecahydrate 7.5 mg, potassium dihydrogen phosphate 1.0 mg, sodium hydroxide to pH 7.65-7.75, water for injection up to 1.0 ml

    Description:clear, colorless solution
    Pharmacotherapeutic group:venosclerosing agent
    ATX: & nbsp

    C.05.B.B.04   Sodium tetradecyl sulfate

    Pharmacodynamics:

    The introduction of sodium tetradecyl sulfate into the lumen of the varicose vein leads to damage to the endothelium of the vessel, followed by fibrosis, adhesion of the vein walls and its irreversible obliteration. The subsequent adequate compression of the site of the vein, intended for sclerotherapy, helps to form a dense sclerotome as small as possible. If there is no compression of the vein after administration of the drug, a large thrombus can form in its lumen, and the severity of fibrosis will be insignificant.

    Pharmacokinetics:Not applicable (the drug does not have a systemic effect).
    Indications:

    Sclerotherapy in the course of compression therapy of varicose veins of the lower extremities, telangiectasias.

    Contraindications:

    - hypersensitivity to the components of the drug;

    - severe liver and kidney disease;

    - systemic diseases in the stage of decompensation (for example, bronchial asthma, diabetes, toxic hyperthyroidism, oncological diseases, pathological changes in peripheral blood);

    - heart defects requiring surgical intervention;

    - fever;

    - local or generalized infectious and bacterial diseases (including respiratory and skin diseases);

    - Varicose disease, as a consequence of swelling of the abdominal cavity and small pelvis;

    - acute and chronic heart failure in the stage of decompensation;

    - systemic diseases requiring bed rest;

    - conditions with a high risk of thrombosis (eg, hereditary thrombophilia, risk factors for thrombosis: the use of hormonal contraceptives or hormone replacement therapy, with obesity, smoking or motor immobilization);

    - acute thrombosis and thrombophlebitis; phlebosclerosis; diabetic angiopathy;

    - extensive and pronounced varicose veins (including deep veins) with valve insufficiency requiring surgical correction;

    - pregnancy and lactation;

    - age to 18 years.

    Carefully:

    - obliterans peripheral arteriosclerosis, obliterating thrombarteritis (Buerger's disease);

    - when the drug is administered to the site above and back of the medial malleolus; there is a posterior tibial artery.

    Pregnancy and lactation:contraindicated
    Dosing and Administration:

    Intravenous introduction into the lumen of an isolated area of ​​a previously released blood vein, followed by immediate long-term compression of this site.

    The drug can be used only physicians who possess the technique of sclerotherapy and sufficient experience of the procedure in medical institutions provided that the availability of anti-shock therapy is available. In each case, the doctor uses that technique of compression sclerotherapy, which is most suitable for a specific clinical situation. To obtain the maximum therapeutic effect and reduce the risk of developing adverse events (AEs), the following basic principles of compression sclerotherapy should be observed:

    - Before the introduction of the drug, it is necessary to assess the condition of deep veins and the presence of valvular insufficiency (see the section "Contraindications"),

    - Before the course of venosclerosis therapy, a trial application of the drug should be performed to identify possible individual intolerance (see section "Special instructions").

    - The very first administration of the drug Fibro-vein® is performed in most distal from the planned points. The compression bandage should be applied immediately, before the drug is injected into the adjacent target point.

    - Sclerosant should be administered immediately after the release of blood from the intended site of the vein.

    - The sclerosant should be kept in an empty and isolated section of the vein for about 30 seconds.

    - Compression bandage should be applied immediately. Compression should be adequate and maintained for 6 weeks from the moment of drug administration at the last designated point.

    - Optimum compression is achieved by using elastic bandages of medium degree of extensibility and special latex pads to provide local compression,

    - To prevent possible damaging effects on the endothelium of deep veins with their subsequent thrombosis,patients are advised to walk for at least 1 hour after the injection. The following daily hourly walks are compulsory.

    The choice of drug concentration and needle size depends on the diameter of the varicose vein to be treated.

    Fibro-vein solution 30 mg / ml is designed for obliteration of varicose veins of large diameter (1 cm and more).

    Fibro-vein solution of 10 mg / ml is used to treat superficial varicose veins with a diameter of up to 1 cm.

    Fibro-vein® solutions of 2 mg / ml and 5 mg / ml are used for injective sclerotherapy of intradermal varicose veins and telangiectasias.

    In the presence of a widespread widespread varicose process, injections of the solution are repeated 2-10 times at intervals of 3-5 days.

    Fibro-vein® solution 30 mg / ml: administered at the rate of 0.5-1.0 ml for every 10 cm of varicose veins. The maximum dose for one treatment session is 4 ml (1.0 ml x 4 points), the recommended needle is 25 G x 5/8 ".

    Fibro-vein® solutions of 10 mg / ml and 5 mg / ml: administered at the rate of 0.25-1.0 ml for every 5 cm of varicose veins. The maximum dose for one treatment session is 10 ml, the recommended needle is 27 G x 1/2 ", 30 G x 1/2 ".

    Fibro-vein® solution 2 mg / ml: administered at the rate of 0.1-1.0 ml for every 3-5 cm of intradermal varicose veins or telangiectasia.The maximum dose for one treatment session is 10 ml, the recommended needle is 30 G x 1/2 ".

    For one treatment session, the drug is injected into 2-6 points of 0.3-0.5 ml each (preferably 1 ml).

    If it is necessary to perform stage-by-stage sclerosing treatment, sclerosis of superficial veins starts from the lateral branches, and the introduction into the main venous trunk is performed last. When combined treatment in conjunction with a surgical operation - is introduced into varicose tributaries (after removal of surface trunk shafts).

    Side effects:

    Local Reactions: pain or burning sensation; skin pigmentation; Necrosis of tissues and ulceration can develop after the drug has entered the circumveneous area; paresthesia and anesthesia occur when the drug enters the cutaneous nerve.

    Vascular reactions: superficial thrombophlebitis; deep vein thrombosis and thromboembolism of the pulmonary artery develops very rarely; random intraarterial administration is very rare, but can lead to gangrene of the affected limb. Most of these cases are described for the posterior tibial artery passing over the medial ankle.

    Systemic reactions: allergic reactions develop rarely, manifested as a local and generalized rash, urticaria, nausea or vomiting, bronchospasm, vascular collapse.

    Anaphylactic shock, which can be life-threatening, develops very rarely.

    Overdose:

    No cases of drug overdose have been reported.

    Interaction:

    Pharmacologically incompatible with heparin (do not mix in one syringe).

    It is not recommended to combine with oral contraceptives.

    Special instructions:

    - Treatment with Fibro-vein® should be carried out in medical institutions where antishock therapy is available.

    - Fibro-vein® should be used by doctors who possess the technique of sclerotherapy. Before making a decision on the introduction of the drug, it is necessary to assess valvular insufficiency and the condition of deep veins using an appropriate clinical and instrumental examination (eg, angiography or ultrasound).

    - Sclerotherapy of veins is carried out with caution, with absolute confidence in the patency of deep and communicative veins of the lower extremities.

    - Before starting treatment, you need to know the patient's allergic history.When indicating possible hypersensitivity to the patient, a test dose of 0.25-0.5 ml of the drug is administered (the recommended concentration of the drug and the size of the needle are indicated in the section "Method of administration and dose") to the appropriate site of the vein, planned for sclerotherapy, a few hours before the introduction of a full dose. In the case of anaphylaxis, it is recommended (depending on the severity of the reaction) parenteral administration of epinephrine, hydrocortisone, antihistamines, endotracheal intubation using the laryngoscope and suction.

    - Particular attention should be paid to the technique of drug administration, namely, maintaining a slow rate of introduction of sclerosant and using a minimally effective volume at each point of administration.

    - Avoid extravasal (paravenous) and intra-arterial administration.

    - Hyperpigmentation of the skin is most often the result of blood entering the circumveneal area, most likely in the treatment of shallow superficial veins in cases where compression dressings are not used.

    - The drug should not be used if there is a precipitate or discoloration of the solution.

    - When the temperature is lowered, a precipitate may form in the solution, which dissolves upon heating.

    - Unused contents of the vial or ampoule must be disposed of in accordance with RF rules.

    - To prevent relapse after treatment, patients are advised to wear a compression knitwear.

    - Studies of the effect of sodium tetradecyl sulfate on the reproduction of animals have not been carried out. Experience with the drug during pregnancy is not available, the possible risks are unknown. Therefore, it is not recommended to pregnant women with Fibro-vein®.

    - Data on the excretion of sodium tetradecyl sulfate with breast milk are absent. When administering the drug during lactation, breastfeeding should be stopped for the period of treatment.

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

    Studies on the effect of the drug on the ability to drive vehicles and mechanisms were not conducted.

    Form release / dosage:

    Solution for intravenous administration 30 mg / ml:

    A) 5 ml per bottle, sealed with a cork made of bromobutyl rubber and an aluminum crimping ring with a plastic lid "FlipOff"; 10 vials with instructions for use in a cardboard box.

    B) 2 ml per ampoule, 5 ampoules with instructions for use in a cardboard pack.

    Solution for intravenous administration of 5 mg / ml and 10 mg / ml: 2 ml per ampoule, 5 ampoules with instructions for use in a cardboard pack.

    Solution for intravenous administration 2 mg / ml: 5 ml per bottle, sealed with a cork made of bromobutyl rubber and an aluminum crimping ring with a plastic lid "FlipOff"; 10 vials with instructions for use in a cardboard box.
    Packaging:ampoules (5) -package cardboard
    bottles (1) -tacks, cardboard
    bottles (10) -tacks, cardboard
    Storage conditions:

    Store in a dark place at a temperature of no higher than 25 ° C. Do not freeze. Keep out of the reach of children.

    Shelf life:

    3 years

    Do not use after expiration date

    Terms of leave from pharmacies:On prescription
    Registration number:P N014787 / 01-2003
    Date of registration:02.03.2009
    The owner of the registration certificate: STD Pharmaceutical Products Co., Ltd. STD Pharmaceutical Products Co., Ltd. United Kingdom
    Manufacturer: & nbsp
    Representation: & nbspMEDI RUS, LLCMEDI RUS, LLC
    Information update date: & nbsp18.12.2012
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