Aethoxysklerol 2%

Chemische Fabrik Kreussler & Co. Aethoxysklerol 2% (amp.)
GmbH

Package leaflet: Information for the user

Aethoxysklerol 2%, 20 mg/ml solution for injection
Lauromacrogol 400
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or nurse immediately. See section 4.

Table of contents of the leaflet

1. What Aethoxysklerol 2% is and what it is used for
2. Important information before using Aethoxysklerol 2%
3. How to use Aethoxysklerol 2%
4. Possible side effects
5. How to store Aethoxysklerol 2%
6. Contents of the pack and other information

1. What Aethoxysklerol 2% is and what it is used for

Aethoxysklerol 2% is a sclerosing agent (sclerotherapy) used for injecting through a fine needle into a vein, delivering lauromacrogol 400 (previously also known as polidocanol or macrogol lauryl ether), which causes fibrosis of the vein wall, leading to closure and disappearance of the varicose vein. Aethoxysklerol 2% is used in sclerotherapy of varicose veins of the lower limbs.

2. Important information before using Aethoxysklerol 2%

When not to use Aethoxysklerol 2%:

• if the patient is allergic to lauromacrogol 400 or any of the other ingredients of this medicine (listed in section 6)
• if the patient has an acute, serious illness (particularly untreated)
• if the patient is immobilized
• if the patient has severe obstructive arterial disease of the lower limbs (stage III and IV according to Fontaine classification)
• if the patient has thromboembolic disorders
• if the patient has a high risk of thrombosis (e.g. confirmed hereditary predisposition to thrombosis or multiple risk factors such as use of hormonal contraceptives or hormone replacement therapy, obesity, smoking, or prolonged periods of immobilization)
• if sclerotherapy is to be performed with microfoam: if the patient has symptoms caused by a diagnosed hole in the heart (diagnosed, symptomatic left-to-right shunt).

Special caution is required when:

• bronchial asthma and strong predisposition to allergies are present
• fever is present
• in patients with very poor general health status
• if lower limb edema due to fluid accumulation is present, which cannot be treated with compression therapy
• in case of spider veins: arterial occlusion (stage II according to Fontaine classification)
• if inflammatory skin conditions are present at the site where sclerotherapy is to be performed
• if symptoms of occlusion of the smallest and thinnest vessels are present, e.g. due to diabetes (microangiopathy), and reduced sensation (neuropathy)
• in patients with limited mobility. Sclerotherapy with microfoam:
• if the patient has a diagnosed hole in the heart, even if it causes no symptoms (diagnosed, asymptomatic left-to-right shunt)
• if the patient has previously experienced: impaired vision or nerve disturbances (visual or neurological symptoms) after prior microfoam sclerotherapy.

Warnings and precautions
Before starting treatment with Aethoxysklerol 2%, consult a doctor or nurse.
This medicine must not be administered intra-arterially, due to the risk of causing necrosis, which may lead to amputation. In such a case, the patient must be treated immediately by a vascular surgeon. Administration of the medicine in the facial area may reverse arterial pressure and consequently lead to permanent visual disturbances (blindness). In certain locations, e.g. in case of varicose veins near the ankle joint, the risk of accidental intra-arterial injection may be higher; therefore, only small amounts should be used with extreme caution during administration.

Aethoxysklerol 2% and other medicines
Inform your doctor about all medicines currently or recently used, as well as any medicines you plan to use.
The active substance lauromacrogol 400 is also used as a local analgesic (local anesthetic agent). Therefore, if it is used simultaneously with another anesthetic within 24 hours, there is a risk of enhanced effect, which may cause bradycardia (slowed heart function).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Aethoxysklerol 2% should not be used during pregnancy except in absolutely necessary cases. There are no adequate data on the use of Aethoxysklerol 2% in pregnant women. Animal studies have not shown clear evidence of developmental abnormalities.
If sclerotherapy is necessary in breastfeeding women, breastfeeding should be interrupted for 2 to 3 days, as there are no human studies on the passage of lauromacrogol 400 into breast milk.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
The medicine contains 5% v/v ethanol (alcohol), i.e. up to 84 mg per dose, equivalent to 2 ml of beer or 0.83 ml of wine per dose. Harmful in patients with alcohol-related disease. This should be taken into account when using the medicine in pregnant or breastfeeding women, children, and individuals at high risk, such as patients with liver disease or epilepsy. The medicine contains less than 1 mmol (39 mg) of potassium per dose, meaning it is considered "potassium-free". The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Aethoxysklerol 2%

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor.
Aethoxysklerol 2% is used in sclerotherapy of medium-sized varicose veins of the lower
limbs.
This medicine may be administered in liquid form or as a standardized, homogeneous,
fine-bubble, sticky microfoam.

Recommended dose
Depending on the size of the varicose veins being treated and the individual condition of each
patient, the physician will decide on the appropriate treatment. In case of uncertainty, the
smallest possible dose should be chosen.
The daily dose must not exceed 2 mg of lauromacrogol 400 per kg of body weight, meaning
that for a patient weighing 70 kg, no more than 7 ml of 2% solution should be administered
per day.
In routine cases, regardless of the patient's body weight and the concentration of
lauromacrogol 400 used, the maximum recommended volume of microfoam per session and
per day is 10 ml. Higher volumes of microfoam may be used following individual assessment
of benefit-risk ratio.
In patients with a known history of drug hypersensitivity, during the first obliteration
procedure, no more than 1 injection should be performed. In subsequent sessions,
lauromacrogol 400 may be administered in several injections, provided the dose does not exceed
the maximum.
Depending on the diameter of the varicose veins being treated, Aethoxysklerol 2% or 3% is
used.
During the first procedure, only one injection of Aethoxysklerol 2% or 3% in liquid form
should be administered, in a volume of 0.5 to 1 ml. Depending on treatment outcome and the
size of the treated area, during subsequent sessions multiple injections may be given, with no
more than 2 ml of liquid/solution per injection, provided the maximum dose is not exceeded.
When administering Aethoxysklerol 2% as microfoam, e.g. for treating perforator veins or
feeding vein varicosities, up to 2 ml of microfoam is injected per puncture. When
administering Aethoxysklerol 2% or 3% as microfoam, e.g. for treating reticular veins, up to
4 ml of microfoam is injected per puncture for small reticular veins and up to 6 ml of
microfoam for large reticular veins.

Methods of administration:
All injections must be administered intravenously; needle position must be verified (e.g. by
aspirating blood).
Regardless of the method of venous puncture (in the patient standing with an infusion cannula
or in the patient sitting with a syringe ready for injection), the injection must be performed only
with the leg placed in a horizontal position.
For performing sclerotherapy, single-use syringes with smooth plunger movement and needles
of various diameters depending on indication are recommended.
When injecting the product in microfoam form, the lower limb may be placed horizontally or
elevated approximately 30–45° above horizontal. Direct puncture and injection into invisible
veins should be performed using duplex ultrasound (USG). The needle must not be smaller
than 25G.
Depending on the severity and extent of varicose veins, multiple treatment sessions at weekly
or biweekly intervals may be necessary.

Note:
Local thrombi that occasionally form should be removed by puncturing and expressing them.

Compression after injection of Aethoxysklerol 2%
After dressing the puncture site, a compression bandage or elastic stocking should be applied.
After application of the dressing, the patient should walk for 30 minutes, preferably near the
clinic.
Following sclerotherapy with liquid Aethoxysklerol, compression is applied immediately after
injection. After microfoam sclerotherapy, the patient's leg is initially immobilized for about
2–5 minutes. The Valsalva maneuver and muscle activation should be avoided during this
time.
Compression on the limb should not be applied immediately, but 5–10 minutes after
injection. Compression should be maintained for several days to several weeks after the
injection, depending on the extent and severity of the varicose veins.
To prevent slippage of the bandage, especially from the thigh or limbs with a conical shape, it
is recommended to use an additional foam dressing underneath the proper compression
bandage.
The success of sclerotherapy depends on careful and attentive post-procedural compression
therapy.

Use in children
Aethoxysklerol is not indicated for use in children and adolescents.

Overdose of Aethoxysklerol 2%
If a dose higher than recommended is administered, local tissue necrosis may occur,
especially following perivascular injection.

4. Possible adverse reactions

Like any medicinal product, this medicine may cause adverse reactions, although not
everyone will experience them.
The following adverse reactions have been reported worldwide in association with the use
of lauromacrogol 400. In some cases, symptoms were troublesome but in most cases
transient.
Since reports were usually derived from spontaneous reports, without reference to a defined
patient population or a control group, it is not possible to determine the exact frequency or
establish a causal relationship with the administered medicine for each reported event.
However, some estimation of frequency is possible based on long-term experience.
Local adverse reactions (e.g. necrosis), particularly of the skin and deeper tissues (and rarely
nerves), have been observed following accidental injection into surrounding tissue
(perivascular injection). The occurrence of adverse reactions is dose- and
concentration-dependent. Additionally, the following adverse reactions have been
observed:
Very rare (may occur in not more than 1 in 10,000 patients): anaphylactic shock,
angioedema, generalized urticaria, asthma (asthma attacks), cerebral circulation disorders,
hemiplegia, headache, migraine (rarely following foam sclerotherapy), local sensory
disturbances (paraesthesia), reduced sensation in the oral cavity, loss of consciousness,
dizziness, speech disorders, movement coordination disorders, disorientation, impaired
vision (visual disturbances) (rarely following foam sclerotherapy), cardiac arrest, broken
heart syndrome (stress-induced cardiomyopathy), palpitations, irregular heartbeat
(tachycardia, bradycardia), pulmonary embolism, fainting, circulatory or cardiac collapse,
vasculitis, dyspnoea, chest discomfort (feeling of pressure in the chest), cough, taste
disturbances, nausea, vomiting, excessive hair growth at the site of sclerotherapy, fever,
sudden flushing, malaise, weakness, blood pressure disturbances.
Rare (may occur in not more than 1 in 1,000 patients): deep vein thrombosis (possible
association with underlying diseases), limb pain.
Uncommon (may occur in not more than 1 in 100 patients): thrombophlebitis, phlebitis,
allergic dermatitis, contact urticaria, erythema, skin allergic reactions, necrosis, sclerosis,
swelling, nerve damage.
Common (may occur in not more than 1 in 10 patients): neovascularization (formation of
blood vessels based on pre-existing vessels), haematomas, skin discoloration, bruising,
pain (short-term at the site of sclerotherapy), thrombosis at the injection site (local blood
clots within varicose veins).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet,
inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the
Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal
Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions enables further collection of information on the safety of the
medicine.

5. How to store Aethoxysklerol 2%

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The immediate packaging is for single use only.

6. Contents of the pack and other information

What Aethoxysklerol 2% contains
The active substance is lauromacrogol 400.
The other ingredients are: ethanol 96%, disodium phosphate dihydrate, potassium dihydrogen phosphate, water for injections.

What Aethoxysklerol 2% looks like and contents of the pack
The pack contains 5 ampoules. 1 ampoule of 2 ml contains 40 mg of lauromacrogol 400.

Marketing Authorisation Holder and Manufacturer
Chemische Fabrik Kreussler & Co. GmbH
Rheingaustr. 87-93
65203 Wiesbaden
Germany

For further information, please contact:
Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96, 00-807 Warsaw
Tel: 22 824 03 64
email: [email protected]

Information intended exclusively for medical professionals:

Special Warnings
Aethoxysklerol must be administered by a physician experienced in performing sclerotherapy procedures. When preparing standardized microfoam for varicose vein sclerotherapy, instructions regarding appropriate methods must be followed.

Sclerotherapy of varicose veins
Medicinal products for obliteration of varicose veins must never be injected into arteries, as this may cause severe tissue necrosis, potentially leading to the need for amputation. In the event of such an occurrence, immediate consultation with a vascular surgeon is required.

Indications for use in the facial area must be carefully evaluated due to all possible sclerosing agents, since intravenous injection may lead to reversal of pressure in the arteries, resulting in irreversible visual disturbances (blindness).

In certain body regions, such as the feet and ankles, the risk of inadvertent intra-arterial injection may be increased. Therefore, only small quantities of the medicinal product at low concentration should be used, and particular caution must be exercised during treatment.

Management of poisoning following incorrect administration of the medicinal product
a) Intra-arterial injection

1. Leave the cannula in place; if the cannula has already been removed, re-identify the puncture site
2. Inject 5 to 10 ml of local anesthetic without adrenaline
3. Administer heparin at a dose of 10,000 IU
4. Apply cotton and keep the ischemic limb in a dependent position
5. As a precaution, hospitalize the patient (vascular surgery)

b) Perivenous injection
Depending on the amount and concentration of Aethoxysklerol injected subcutaneously, inject 5 to 10 ml of physiological saline at the injection site, mixed with hyaluronidase if possible. If the patient experiences severe pain, a local anesthetic (without adrenaline) may be administered.

Emergency procedures and corrective measures
Anaphylactic reactions
Anaphylactic reactions are rare but may be life-threatening. The attending physician must be prepared to initiate emergency measures and must have access to an appropriate emergency kit.
Treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors may influence the management of anaphylactic shock due to their effects on the circulatory system.