Sclerosis of the varices of medium and large calibres.

Administration mode

Intravenous use (IV) strict.

Strict aseptic conditions are required when handling AETOXISCLEROL

The choice of concentration will depend on the type and diameter of varices to be sclerosed. For non-visible varicose veins, the diameter should be measured by ultrasound.
The sclerosant is administered in small quantities at several injection sites along the vein, in liquid or foam form. The foam form (sclerosant / air mixture) is obtained from 2% and 3% solutions and should be used exclusively for veins of medium and large sizes

The objective is to achieve optimum destruction of the vessel wall with the minimum concentration of sclerosing agent necessary for a clinical result, an amount and / or a concentration which is too high to cause pigmentation or Other undesirable sequelae

The number of injections will be evaluated by the practitioner, depending on the diameter and length of the varicose vein. The dose is independent of weight. Since the volume to be injected per session is limited, several sessions are usually required (2 to 4 on average).

It is desirable to begin each injection session by administering a minimal test dose to ensure the absence of allergy. >
Visually inspect solution before use. Solutions containing particles should not be used.

Make sure the position of the needle in the varicose is ideally under echographic control.



AEOXISCLEROL is a product for single parenteral use. Once the bulb is opened, use immediately and discard any unused residual amount.
Dosage

Liquid Form

The recommended total dose is 1 to 4 ml of solution for injection per session (1/2 to 2 ampoules), divided into several sites (0.1 to 2 ml per injection site).
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Do not exceed the maximum dose of 4 ml of fluid per session, regardless of body weight.

Shape Foam

The recommended total dose is 2 to 8 ml of injectable foam per session (liquid + air), divided into several sites (0.1 to 2 ml per site of injection).
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Do not exceed the maximum dose of 16 ml of foam per session, regardless of body weight.

Preparation of the foam

The specialties AETOXISCLEROL 2% and 3% can be converted into a foam for the treatment of large caliber veins Concentrations of 0.25 to 0.5% do not allow a good quality foam < Code>
The foam should be prepared extemporaneously by a practitioner previously trained in this particular technique of preparation and administration. The administration should be carried out ideally under ultrasound control.


In practice, not all foams are identical. Their physical parameters, important criteria for determining the quality of the foam (bubble size, viscosity, homogeneity), may be different. The criteria for a foam suitable for injection for sclerotherapy, as well as examples of devices for obtaining the foam, are defined in paragraph 6.6.
In adults, a total dose of 10 ml of foam per session per day - irrespective of body weight - should not be exceeded. In practice, the dosages used are often well below the maximum amounts indicated, on average 2-8 ml per session (injected in one or both legs). >
In the case of sclerotherapy, in the foam of non-visible varicose veins, direct puncture and injection should be monitored by ultrasound (preferably by echo Doppler).
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Population, pediatric

AETOXISCLEROL is not indicated in children

Pharmacotherapeutic class

ANTIVAROUS THERAPEUTIC / SCLEROSANT DRUGS FOR LOCAL INJECTION. Code: ATC: C05BB02.

Lauromacrogol 400 is a sclerosing agent. Intravenous injection induces the formation of a thrombus. This usually results in occlusion of the vein at the site of injection. The resultant fibrous tissue formation is at the origin of partial or total venous obliteration which may or may not be permanent.
In a multicenter, randomized, open-label study (ESAF), 106 patients with varicose veins were treated with either Aetoxisclerol 3% in the form of foam, using the EasyFoam® kit Of foam, or with 3% Aetoxisclerol in liquid form. The primary evaluation criterion was the disappearance of a reflux of more than 0.5 second, measured by echo-doppler 3 cm below the junction, sapheno-femoral 3 months after the last injection. Code>
After the foam injection of Aetoxisclerol, a significantly higher percentage of patients (69%) met the criterion of evaluation compared to the control group (27%).

The criteria for secondary evaluation (vein occlusion, reflux time, filling time, patient satisfaction, etc.) have also been improved under treatment with Aetoxisclerol foam.

The number of treatment sessions needed to achieve a therapeutic result was on average 1.3 in the foamed Aetoxisclerol group versus 1.6 in the control group.

There were no differences in the incidence of adverse events between the 2 groups.
No data,

· Hypersensitivity to Lauromacrogol 400 or to any of its excipients

· Patients immobilized or bedridden in a prolonged manner, whatever the cause

Patients at high risk of thrombosis: familial thrombophilia, risk factors, multiple (hormonal contraception, hormone replacement therapy, prolonged obesity, tobacco, prolonged immobility, etc.)

Recent thromboembolic episode (thrombosis, acute superficial, deep venous thrombosis, embolism, pulmonary)

· Recent surgery

· Varicose veins induced by a pelvic or abdominal tumor (unless the tumor has been removed)

Uncontrolled systemic disease (type I diabetes, thyrotoxicosis, tuberculosis, asthma, tumor, systemic infection, dyscrasia, blood, acute respiratory disease, skin condition)

· Evolving Cancer

· Significant valvular infertility in the deep venous network

· Arterial disease obliterans

Superficial veins of very large caliber presenting important communications with the venous network deep

· Migratory Phlebitis

· Erysipelas and lymphangitis in the area to be treated

· Acute Infection

· Foramen ovale known symptomatic permeable

The use of AETOXISCLEROL should be reserved for practitioners experienced in venous anatomy, diagnosis and treatment of pathologies affecting the venous system and previously trained, injection technique. >
Prior to treatment, the practitioner should investigate the risk factors and inform the patient of the risks involved in the proposed technique.
Sclerotherapy is contraindicated in patients with a high risk of thromboembolic events but must also be avoided in most risky situations. In particular, it is not recommended in patients with a history of thromboembolic events. However, if sclerotherapy is deemed necessary, preventive anticoagulation therapy may be initiated.

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The use of AETOXISCLEROL is not recommended in patients with known but asymptomatic FOP. In the case of administration, it is advisable to use lower volumes and avoid any effort, with closed glottis (Valsalva maneuver) during the minutes following the injection. In migraine patients, it is advisable to use lower volumes.


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Due to the risk of extension of thrombosis in the deep venous system, it is essential to carefully evaluate the continence of the valves before injection and to slowly inject small amounts of product into the varicose vein (not more than 2 Ml). The permeability of deep veins should be evaluated by a non-invasive method such as duplex ultrasound. Venous sclerotherapy should not be performed if significant valvular incontinence or deep venous insufficiency is detected in the Trendelenburg or Perthes tests or in phlebography for example

If venous insufficiency is associated with lymphedema, sclerosing injection may aggravate pain and inflammation, local for several days or several weeks. Patients should be informed of the eventuality of this phase, which in no way undermines the effectiveness.

The association with beta-blockers may reduce the cardiovascular reactions of compensation in case of anaphylactic shock.

Pigmentation may be promoted in the presence of blood effusion at the site of injection (especially when treating veins, small-size superficial with 0.25% concentrations, or 0.50%), and when The compression is not used.

Precautions to be taken at the time of injection

Any injection outside a vein can cause severe necrosis. Similarly, an intra-arterial injection is particularly severe and can result in large muscular or cutaneous necrosis or even the need for amputation. Use caution when positioning the needle intravenously and use the minimum effective volume at each injection site.) Ultrasound guidance is recommended to avoid extravasation and intra- Arterial diseases.

In the treatment of varicose veins, the injection of foam must be carried out at a minimum distance of 8 to 10 cm from the stock, taking into account the risk of passage of a bolus of foam into the venous system Deep.
Extreme caution is recommended in the case of injection at the foot and malleolar zone because of the increased risk of injection, accidental intra-arterial. Only the 0.50% concentration can be used for the sclerosis of varicosities and varicose veins of the foot and the region, perimalleolar

Surveillance, post-injection

Allergic reactions (including anaphylactic reactions) that have been observed, the physician should be prepared for the possible occurrence of an anaphylactic reaction and should be prepared and treated appropriately. Emergency resuscitation equipment must be available immediately. Special attention should be given to patients with breathing, difficulty (bronchial asthma) or a strong predisposition, allergies (see Dosage and Mode of Administration)
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Hypersensitivity (redness of the skin and conjunctiva, pruritus, cough, etc.) and neurological manifestations (scotomas, amaurosis, migraine with aura, paresthesia, Focused).

It is recommended to carry out a clinical and ultrasound follow-up, within a period of approximately 1 month, in order to check the effectiveness of the treatment and the occurrence of any adverse effects. Indeed, cases of deep vein thrombosis and pulmonary embolism have been reported after sclerotherapy of superficial varices, up to 4 weeks after treatment, sclerosing. Post-treatment compression may also be considered to reduce the risk of deep vein thrombosis

This medicinal product contains lower amounts of ethanol (alcohol), less than 100 mg per ampoule.

None, drug interaction study has been carried out

Veinoscleol must be used alone.

The use of a higher concentration than that recommended in small veins may lead to local pigmentation and / or tissue necrosis

Injection of too large a volume may induce systemic undesirable effects

Pregnancy

Safety during pregnancy is not established. To date, there are few or no data on the administration of AETOXISCLEROL in pregnant women. Animal studies and reprotoxicity studies are insufficient. Treatment can only be initiated after pregnancy.

AETOXISCLEROL should be used only if necessary for symptomatic relief if the potential benefits outweigh the potential risks to the fetus. >
Breastfeeding

It is not known whether lauromacrogol 400 is excreted in human milk

Fertility

It is not known if lauromacrogol 400 affects fertility.

The most frequently reported adverse reactions are: pain at the injection site, urticaria, superficial thrombophlebitis and skin pigmentation, temporary after treatment. Very rarely, permanent discoloration may persist along the segment of sclerotic vein. Ulceration may occur due to extravasation of the drug. It is important to use the lowest amount and / or possible concentration to sclerose the vein because most of the most frequent side effects are due to an excessive concentration.
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Very rarely, intra-arterial injection is the cause of significant tissue necrosis, up to and including amputation. >
The most serious adverse reactions are anaphylactic shock and pulmonary embolism, and deaths have been reported in patients receiving lauromacrogol.


Organ system

Undesirable effects

Immune system disorders

Anaphylactic shock, angioedema, urticaria, asthma

Nervous system disorders

Headache, migraine, paresthesia, loss of consciousness, state, confusion, dizziness, ischemic stroke, transient (TIA), stroke, dysgeusia >
Eye disorders

Phosphenes, scotomes, amauros

Cardiac disorders

Palpitations.
Because of the arrhythmogenic properties of lauromacrogol the possibility of cardiovascular collapse linked to the systemic passage of the product

Vascular disorders

Neovascularization

Thrombophlebitis, superficial phlebitis

Deep venous thrombosis

Pulmonary embolism

Vasovagal Syncope

Vasculitis, vasculitis, leucocytoclastic

Arterial spasm

Circulatory collapse

Respiratory, thoracic and mediastinal disorders

Dyspnea, sensation, oppression, cough

Gastrointestinal disorders

Nausea

Skin and tissue disorders

Subcutaneous

Hyperpigmentation of the skin, ecchymosis

Allergic dermatitis, contact urticaria, erythema

Hypertrichosis (in the treated area)

General Disorders and Administration Site Accidents

Injection site pain (short term), injection site thrombosis (blood clots, local intravaricous), hematoma at the injection site

Induration, edema

Local necrotic reactions, particularly at the level of skin and tissue, underlying (and in some cases, nerve-like) have been observed in the treatment of varicose veins, Inadvertent injection into the surrounding tissues (paravenous injection). The risk is increased, with increasing concentrations of Aetoxisclerol and volumes injected.

Fever, flushing of heat

Investigations

Blood pressure, abnormal

Lesions and intoxications

Lesion of the nerve

The undesirable effects reported with the foam form are the same as those reported with the liquid form. Visual and neurological disorders of the scotoma, migraine type are reported, more frequently with the foam form than with the liquid form.


Reporting of suspected adverse reactions

The reporting of suspected adverse effects after authorization of the drug is important. It provides continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Pharmacovigilance Centers - Website: www.ansm. Sante.fr

Sclerosis of the varices of medium and large calibres.