Medicinal Products

AETOXISCLEROL 3% TAMPON (60 mg / 2 mL)

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Lauromacrogol 400
laboratory: Kreussler Pharma

IV injectable solution
Box of 5 ampoules of 2 ml
All forms

Indication

Sclerosis of medium and large varicose veins.

Dosage AETOXISCLEROL TAMPONNE 3% (60 mg / 2 mL) Solution for injection IV Box of 5 ampoules of 2 ml

Administration mode

Strict intravenous (IV) route.

Strict aseptic conditions are required when handling AETOXISCLEROL.

The choice of concentration will depend on the type and diameter of varicose veins to be sclerosed. For non-visible varicose veins, the diameter should be measured by ultrasound.

Sclerosant is administered in small amounts at several injection sites along the vein, in liquid or foam form. The foam form (sclerosant mixture / air) is obtained from 2% and 3% solutions and must be used exclusively for medium and large size veins.

The objective is to achieve the optimal destruction of the vessel wall with the minimum concentration of sclerosant required for a clinical result, a quantity and / or too high concentration may result in pigmentation or other undesirable sequelae.

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

It is desirable to start each injection session with a minimal test dose to ensure that there is no allergy.

Visually inspect the solution before use. Solutions that contain particles should not be used.

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

AEOXISCLEROL is a single-use parenteral product. Once the bulb is open, use immediately and discard any unused residual.

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).

Do not exceed the maximum dose of 4 ml of fluid per session, regardless of body weight.

Mousse shape

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 injection site).

Do not exceed the maximum dose of 16 ml of foam per session, regardless of body weight.

Preparation of the foam

The 2% and 3% AETOXISCLEROL specialties can be converted into a foam form for the treatment of large veins. The concentrations of 0.25 to 0.5% do not allow to obtain a good quality foam.

The foam must be prepared extemporaneously by a practitioner previously trained in this particular technique of preparation and administration. Administration should ideally be performed under ultrasound control.

The foam is prepared extemporaneously by an experienced practitioner by incorporating sterile air, that is to say filtered on 0.2μm if taken from the ambient air, to the solution for injection. This is done using a device most often composed of two syringes connected to each other. The reciprocating pistons of the syringes allow the incorporation of air and lead to the transformation of the liquid foam. Special precautions for handling are detailed in section 6.6.

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 an injection-specific foam for sclerotherapy as well as examples of devices for obtaining foam are defined in section 6.6.

In adults, a total dose of 10 ml of foam per session per day - regardless 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 into one or both legs).

In non-visible varicose vein sclerotherapy, direct puncture and injection should be checked by ultrasound (preferably by Doppler echo).

Pediatric population

AETOXISCLEROL is not indicated in children.

Against indications

Hypersensitivity to Lauromacrogol 400 or any of its excipients

· Patients immobilized or bedridden for a long time, whatever the cause

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

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

· Recent surgery

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

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

· Evolutionary cancer

· Significant valvular incompetence in the deep venous network,

· Arteriopathy obliterans

Superficial superficial veins presenting important communications with the deep venous network

· Migrating phlebitis

· Erysipelas and lymphangitis in the area to be treated

· Acute infection

· Foramen ovale known symptomatic ovale

Adverse effects Aetoxisclerol Buffer 3%

The most commonly reported adverse reactions are: injection site pain, urticaria, superficial thrombophlebitis, and temporary skin pigmentation after treatment. Very rarely, permanent discoloration may persist along the segment of sclerotic vein. Ulceration may occur following extravasation of the drug. It is important to use the smallest amount and / or concentration possible to scleroser the vein because most of the most common side effects are due to too much concentration.

Very rarely, the intra-arterial injection is at the origin of an important tissue necrosis, up to amputation.

The most serious side effects are anaphylactic shock and pulmonary embolism; deaths have been reported in patients receiving lauromacrogol.

Adverse events are listed below by organic class:

Organ system

Side effects

Immune system disorders

Anaphylactic shock, angioedema, urticaria, asthma

Nervous system disorders

Headache, migraine, paresthesia, unconsciousness, confusional state, vertigo, transient ischemic attack (TIA), stroke, dysgeusia

Eye disorders

Phosphenes, scotomes, amaurosis

Heart conditions

Palpitations.

Due to the arrhythmogenic properties of lauromacrogol possibility of cardiovascular collapse due to the systemic passage of the product

Vascular disorders

neovascularization

Superficial thrombophlebitis, phlebitis

Deep vein thrombosis

Pulmonary embolism

Vasovagal syncope

Vasculitis, leukocytoclastic vasculitis

Arterial spasm

Circulatory collapse

Respiratory, thoracic and mediastinal disorders

Dyspnoea, feeling of oppression, coughing

Gastrointestinal disorders

nausea

Skin and tissue disorders

subcutaneous

Hyperpigmentation of the skin, bruise

Allergic dermatitis, contact urticaria, erythema

Hypertrichosis (in the treated area)

General disorders and accidents related to the site of administration

Injection site pain (short term), injection site thrombosis (local intravarious blood clots), injection site hematoma

Induration, edema

Local reactions such as necrosis, particularly in the skin and underlying tissues (and in some rare cases, in the nerves), have been observed in the treatment of varicose veins of the legs after inadvertent injection into the skin. the surrounding tissues (para-venous injection). The risk is increased with increasing concentrations of Aetoxisclerol and volumes injected.

Fever, hot flashes

investigations

Abnormal blood pressure

Injury and poisoning

Nerve damage

The adverse effects reported with the foam form are the same as those reported with the liquid form. Visual and / or neurological disorders such as scotomas and migraines are reported more frequently with the foam than with the liquid form.

Patients with patent foramen ovale (FOP) have been shown to be more likely to suffer from temporary neurological adverse effects, such as visual disturbances and migraines, particularly after sclerosing foam injections.

Reporting of suspected adverse reactions:

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

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