Inverdia

Solution for injection 5 mg / ml 
(colorless, clear)

Read all of this leaflet carefully before you are given this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor.

– If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Aethoxysclerol is and what it is used for 
2. What you need to know before you are given Aethoxysclerol 
3. How Aethoxysclerol is given 
4. Possible side effects 
5. How to store Aethoxysclerol 
6. Contents of the packaging and other information 

1. What Aethoxysclerol is and what it is used for

Aethoxysclerol contains the active substance lauromacrogol 400 which causes a controlled inflammation which is used for therapeutic purposes. Aethoxysclerol is injected into the blood vessel to be treated and affects the inside of the blood vessel so that after inflammation it heals and blood no longer flows through the vessel. The whole process takes about four weeks. Aethoxysclerol also has a local anesthetic effect.

Aethoxysclerol is used to treat:

  • varicose veins (telangiectasia)
  • varicose veins (varices)
  • hemorrhoids
  • bleeding from the stomach / small intestine or esophageal hernia

2. What you need to know before you are given Aethoxysclerol

Aethoxycyclerol should not be given to you

  • if you are allergic to lauromacrogol 400 or any of the other ingredients of this medicine (listed in section 6).

Varicose veins / Varicose veins

  • if you suffer from brittle skin (skin atrophy )
  • infectious skin diseases or skin diseases with a risk of blood poisoning
  • if you have edema (swelling) due to decreased blood flow in veins (blood vessels that carry blood to the heart)
  • If you have diabetes, impaired blood flow in the small arteries are (blood vessels that carry blood from the heart)
  • state with reduced blood flow in the artery was
  • if you are bedridden
  • if you have a blood clot ( thrombosis ) or an increased risk of getting blood clots
  • if you have had superficial blood clots then a month of symptom relief must pass before new treatment for varicose veins can be given
  • if you have a right-left shunt (heart malformation where oxygen-poor blood is sent out into the body) that causes symptoms and needs to be treated with foamed Aethoxysclerol (foam sclerotherapy)

Hemorrhoids

  • if you have an acute inflammation of the rectum

Bleeding from the stomach / small intestine or esophageal hernia

  • if you have impaired pumping capacity from the heart ( heart failure )
  • if ECG ( electrocardiogram ) indicates that you have an effect on your heart rate ( AV block )

Warnings and cautions

Talk to your doctor/nurse before giving Aethoxysclerol if you have or have had any of the following:

Varicose veins / Varicose veins

  • heart failure
  • atherosclerosis with high blood pressure
  • asthma
  • liver or kidney disease
  • right-left shunt (heart malformation where oxygen-poor blood is sent out into the body) without symptoms and should undergo treatment with foamed Aethoxysclerol (foam sclerotherapy)
  • visual impairment, mental symptoms or disorders of the nervous system after previous treatment with foamed Aethoxysclerol (foam sclerotherapy)

Hemorrhoids

  • fever

Bleeding from the stomach / small intestine or esophageal hernia

  • heart failure
  • kidney disease
  • asthma

Other medicines and Aethoxysclerol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Aethoxysclerol has a weak blood-thinning effect and may therefore be unsuitable for you if you are being treated with blood thinners. Aethoxysclerol also has a local anesthetic effect. When combined with anesthetics, there is therefore a risk of an increased effect on the cardiovascular system.

Pregnancy, breastfeeding, and fertility

Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, before taking this medicine.

Experience from the treatment of pregnant women is lacking.

There is no information on whether Aethoxysclerol passes into breast milk.

Driving and using machines

Aethoxysclerol has no known effect on the ability to drive or use machines.

Aethoxysclerol contains excipients

Aethoxycyclerol contains 5% (v / v) ethanol (alcohol), i.e. 42 mg per ml, equivalent to 1 ml strong beer or 0.42 ml wine. Harmful to those suffering from alcoholism. Should be considered in the treatment of pregnant or lactating women, children, and high-risk patients such as patients with liver disease or epilepsy.

Aethoxysclerol contains potassium , but less than 0.5 mmol (19.5 mg) per ampoule , ie is next to “potassium free”.

Aethoxysclerol contains sodium , but less than 0.5 mmol (11.5 mg) per ampoule , ie is next to “sodium free”.

How Aethoxysclerol is given

Aethoxysclerol is given to you as an injection in solution or foamed with air. The injection is placed in or adjacent to the blood vessel to be treated. One or more injections are given at the same time. For each disease condition to be treated, a special injection technique and subsequent treatment are used.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

If you think you have a serious side effect, contact your doctor immediately. Symptoms of these side effects are described below:

Varicose veins. Varicose veins.

  • Swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing. These symptoms may be signs of an anaphylactic reaction, anaphylactic shock, or angioedema, which have been reported as very rare side effects (may affect up to 1 in 10,000 people).
  • Severe and sudden bone swelling. This may be a sign of a blood clot in a deep vein, which has been reported as a rare side effect (may affect up to 1 in 1,000 people).
  • Chest pain and difficulty breathing. This may be a sign of a blood clot in the lung, which has been reported as a very rare side effect (may affect up to 1 in 10,000 people). Chest pain may also be a sign of pre-myocardial infarction, which has been reported (occurring in an unknown number of users).
  • A sudden impact on consciousness, speech, or balance. This can be a sign of a stroke, which has been reported as a very rare side effect (may affect up to 1 in 10,000 people).

Bleeding from the stomach / small intestine.

  • Pain from the abdomen. This may be a sign of tissue death, as reported (occurs in an unknown number of users).

Matstrupsåderbråck.

  • Pain from the neck down to the abdomen. This may be a sign of tissue death, perforation of the esophageal wall which has been reported as a less common side effect (may affect up to 1 in 100 people).

Other side effects ar

Varicose veins. Varicose veins.

Common (may affect up to 1 in 10 people): Hemorrhage, vascular regeneration, pigmentation of the skin adjacent to the treated blood vessel, injection site pain (short-term), blood clot at the injection site.

Uncommon (may affect up to 1 in 100 people): Inflammation of blood vessels near the treated vessel. Simultaneously with inflammation, blood clots can also occur. Skin reactions such as hives or blisters, allergic inflammation, redness, itching, eczema, or swelling. Damaged skin (tissue death), skin hardening, or decreased sensation in the skin (nerve damage) at the injection site.

Rare (may affect up to 1 in 1,000 people): Pain in the legs.

Very rare (may affect up to 1 in 10,000 people): Asthma, hives (all over the body), headache, migraine, confusion, loss of consciousness, dizziness, palpitations, fainting, shortness of breath, chest discomfort, visual disturbances (short-term), taste disturbances, nausea, fever, flushing, weakness, malaise, abnormal blood pressure, sensory disturbances and increased hair growth in the area being treated.

Hemorrhoids.

Common (may affect up to 1 in 10 people): Pressure/pain from the injection site.

Uncommon (may affect up to 1 in 100 people): In association with treated hemorrhoids: minor bleeding, minor tissue death.

Bleeding from the stomach / small intestine.

Uncommon (may affect up to 1 in 100 people): Increase in size of existing stomach ulcer.

Matstrupsåderbråck.

Common (may affect up to 1 in 10 people ): Pulmonary embolism, ulceration, esophageal stricture, fever.

Uncommon (may affect up to 1 in 100 people): Bleeding after sclerosis, varicose veins.

Has been reported (occurs in an unknown number of users): Cases of heart failure after overdose, pneumonia after inhalation of foreign matter.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.

The Medical Products Agency

Box 26,

751 03 Uppsala;

website: www.lakemedelsverket.se

5. How to store Aethoxysclerol

Keep this medicine out of the sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the ampoule and on the outer carton. The expiration date is the last day of the specified month.

This medicine is for single use only. The remaining solution should be discarded.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is lauromacrogol 400.

One ml Aethoxysclerol 5 mg / ml contains 5 mg lauromacrogol 400

One ml Aethoxysclerol 10 mg / ml contains 10 mg lauromacrogol 400

One ml of Aethoxysclerol 30 mg/ml contains 30 mg of lauromacrogol 400

The other ingredients are 96% ethanol, potassium dihydrogen phosphate, disodium phosphate dihydrate, and water for injections.

What the medicine looks like and the contents of the pack

5 mg / ml solution for injection

Ampoule (glass): 5 × 2 ml.

10 mg / ml solution for injection

Ampoule (glass): 5 × 2 ml

30 mg / ml solution for injection

Ampoule (glass): 5 × 2 ml.

Marketing Authorization Holder and Manufacturer

Chemische Fabrik Kreussler & Co GmbH

PO Box 120454

D-65203 Wiesbaden, Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Inverdia AB

Ekbacksv. 20

S-16869 Bromma

Tel: +4686275044

info@inverdia.com

This leaflet was last modified on 2 February 2019

The following information is intended for healthcare professionals only:

Dosage and route of administration

Teleangiectasias and varices.

Dosage:

In general, the daily dose should not exceed 2 mg/kg body weight. When using a foamed solution, it is recommended not to exceed 10 ml of foam per treatment session and day, regardless of the strength of Aethoxysclerol and the patient’s weight.

Injection techniques.

A brief description of the injection technique for the various sub-indications follows below. However, it is recommended that practical knowledge be gained about the various injection techniques before starting patient treatment.

Teleangiectasia (Aethoxysclerol 5 mg / ml).

Intravascularly injected for vascular whitening, usually <0.5 ml; a total of 2-4 ml at a time. Perivasally, 0.05-0.1 ml is injected into the dermis at 1 cm intervals; 3-4 injections of 0.05 ml at the first opportunity, then about 10 injections of 0.05-0.1 ml at normal tolerance. Local compression of treated vessels is recommended to facilitate healing. After the treatment, the vessel turns red, some time blue, to slowly disappear from about 3 weeks.

Reticular varices (Aethoxysclerol 10 mg / ml).

Solution:

Intravascularly injected 0.1-0.5 ml per puncture. Adequate interaction with the endothelium of the venous segment in the puncture area is sought.

Small varices (Aethoxysclerol 10 mg / ml).

Solution:

Intravasally, 0.1-1.0 ml is injected per puncture. Adequate interaction with the endothelium of the venous segment in the puncture area is sought.

Foam preparation:

Foam preparation of Aethoxysclerol 10 mg/ml is suitable for the treatment of e.g. branches to v. safena Magna. For the production of foam, preparation sees under Medium and large varices. As a rule, the venous segment is punctured distally and the injection volume is determined by the amount necessary for adequate interaction with the endothelium. The total volume per injection should not exceed 6 ml.

Medium and large varices (Aethoxysclerol 30 mg / ml).

Solution:

Each varix is injected with 0.2-2 ml. Several varices are often treated at the same time. To assess individual response, only two varices should be injected for the first time and with a maximum of 1 ml per varix.

Foam preparation:

The foam preparation is suitable for the treatment of large varicose veins, e.g. varices on v. safena Magna, v. safena Parva, and large branches to these. EasyFoam Kit should be used for the production of a standardized, homogeneous, fine-bubble, and viscous microfoam (see below). With the EasyFoam Kit, the ratio of sclerosant to air is 1+ 4.6 (1.6 ml Aethoxysclerol is mixed with 7.4 ml air). The recommended volume of foam preparation per treatment session is 2-8 ml; the maximum volume – regardless of the patient’s weight – per treatment session (for one or more injections ) is 10 ml. Administration of one of the foam can be done via injection cannula at one or more sites, or via a catheter. Puncture is usually made distal to the varicose veins segment but not closer to the entrance of the femoral vein in the femoral vein than 8-10 cm. Recommended volumes per puncture are up to 6 ml foam for v. Safena Magna and up to 4 ml foam for v. Safena Parva; the total volume injected is determined by the amount necessary to adequately fill the treated vein segment, determined by ultrasound. However, the maximum daily dose (2 mg/kg body weight) of Aethoxysklerol 30 mg/ml must not be exceeded. Foam sclerotherapy of invisible veins should be performed under ultrasound guidance (preferably of the duplex type). Short, visible segments of varicose veins can be injected without ultrasound; the injection volume is determined by the amount required for adequate interaction with endothelium et. Upon injection of foam, the cannula should not be less than 25 G. Regardless of venipuncture, the injection s performed only on one leg in horizontal or pupil guest mode. After administration one, to support a slow flow of foam from the treated bone, it is recommended that the bone be kept elevated for 5 minutes and that the patient be completely still; Waltz maneuvering or other muscular activity should also be avoided. If immediately after the treatment, during ultrasound check, a foam accumulation is found in the deep vein system, muscle activation, e.g. dorsiflexion with the ankle, performed by the patient.

General in sclerotherapy of telangiectasia / varices.

In the presence of several areas with telangiectasias or varices, it is advantageous that the treatment is performed on several occasions to get good control of the treatment effect, which gives the best medical and aesthetic results. Compression of treated areas results in better healing of vessels and a lesser degree of unwanted phlebitis and hemosiderin storage in the skin in connection with treated vessels. On return visits, repeated treatment may be necessary and any clots, which sometimes form, can be removed if necessary, e.g. by incision and then expression. These measures reduce pain and skin pigmentation.

Hemorrhoids (Aethoxysclerol 30 mg / ml).

Monotherapy: Initially 0.5 ml per grade I and II hemorrhoid. At subsequent treatment, 0.5-1 ml per grade I hemorrhoid and 0.5-1.5 ml per grade II hemorrhoid are given. The maximum total dose per treatment session 2.5 ml. Injection one is placed submucosal immediately above the origin of hemorrhoid. Within a week, symptoms of hemorrhoids subside (bleeding, prolapse) and proctoscopy should then show regenerated hemorrhoids. Combination therapy with ligation: Per ligated hemorrhoid 0.3 ml. Maximum total dose as above. After ligation, injection is placed proximal to the ligature and submucosal in the base of hemorrhoid. Treatment control as with ligation only.

Gastroduodenal lesion (Aethoxysclerol 10 mg / ml).

Inject 0.5-2 ml into each quadrant around bleeding vessels, non-bleeding vessels, leaking bleeding source, or coagulum. The injection should be placed near the source of bleeding and cause swelling of the mucous membrane that compresses the source of bleeding. Intravascular injections should not be performed due to the risk of necrosis. The local maximum dose per treatment and 24 hours are 15 ml. The maximum daily dose is 4 mg/kg body weight.

Esophageal varices (Aethoxysclerol 10 mg / ml).

2 or more injections of 0.5-1 ml paravaricost, if necessary followed by 3-5 ml intravaricost per varix or only 3-5 ml intravaricost per varix using, for example, the so-called outer tube. The maximum daily dose is 4 mg/kg body weight. At least 6 days should pass between repeated treatments. A series of treatments should continue until the varicose veins are covered with fibrotic tissue or obliterated; usually at least 3 treatments.

Preparation of Aethoxycyclerol in foam preparation

EasyFoam Kit should be used for the production of a standardized, homogeneous, fine-bubble, and viscous microfoam. The EasyFoam Kit contains two syringes, a smaller one in which 1.6 ml of Aethoxysclerol is drawn up, and a larger one pre-filled with 7.4 ml of sterile air. The entire contents of the EasyFoam Kit are pumped from one syringe to the other 20 times without interruption and within about 10 seconds. The microfoam is of the desired quality if there are no visible bubbles and if there is no unmixed solution and/or air.

Warnings

If Aethoxysclerol is accidentally splashed in the eyes, wash eyes with water.

Muhammad Nadeem

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