Fibrovein

Package Leaflet: Information for the Patient

Fibrovein, 0.2%, 0.5%, 1% and 3%, Solution for Injection
Sodium Tetradecyl Sulfate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or nurse.
If the patient experiences any serious side effects, including any not listed in this leaflet, inform the doctor or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Fibrovein and what is it used for

Fibrovein contains the active substance sodium tetradecyl sulfate.
Fibrovein is available in different concentrations and is used to treat varicose veins, large, medium and small dilated veins and spider veins.
The active substance of Fibrovein belongs to a group of so-called sclerosing agents. Sclerosing agents are chemical substances that, when injected into a diseased vein, cause swelling of its inner surface and sticking of its walls. Blood flow through the vein becomes impossible and eventually leads to scarring of the tissue. After a few weeks, the vein usually becomes invisible.
Fibrovein is intended for use only in adults.

2. Important information before using Fibrovein

When not to use Fibrovein:

• genetically determined blood disease, e.g. thrombophilia;
• use of hormonal contraceptives or hormone replacement therapy;
• severe obesity;
• smoking;
• prolonged immobilization;

Warnings and precautions

Before starting treatment with Fibrovein, discuss with your doctor if:
the patient is allergic to any foods or medicines, or if they have any other allergy, before taking the medicine, they should consult a doctor to receive a test dose 24 hours before further treatment;
the patient has had blood clots in superficial or deep veins or lungs in the past;
the patient has a symptomatic hole in the heart (in the case of using the sclerosant in the form of foam).
the patient has migraines;
if the patient has vein disorders in the legs, which is associated with a long-term condition, causing swelling of body tissues (lymphedema). Fibrovein may exacerbate local pain and inflammation for several days or weeks;
the patient has a history of pulmonary hypertension;
the patient has had a transient ischemic attack, stroke, or serious cerebral incident;
the patient has been diagnosed with arterial or venous disease (atherosclerosis);
the patient has been diagnosed with blood clots and inflammation of the arteries and veins of the hands and feet (Buerger's disease);
the patient has breathing difficulties, which are controlled with treatment (asthma).
Fibrovein should only be administered by a doctor, and if national guidelines permit, the medicine may be administered under the supervision of a doctor by appropriately qualified medical personnel who have experience in venous system anatomy and are familiar with the correct injection technique.
Before performing the injection, the doctor may perform an assessment of the patient's venous valve function.
Before starting treatment, the doctor will ask the patient a few questions about their health and provide information about potential side effects related to the treatment.

During treatment

The doctor will monitor the patient during and after the sclerotherapy procedure for signs of hypersensitivity (redness, itching, coughing) or neurological symptoms (vision disturbances, migraines, tingling or numbness).
The doctor will recommend that the patient come for a follow-up visit.

Children and adolescents

The safety and efficacy of Fibrovein in children and adolescents have not been established.

Fibrovein and other medicines

If the patient is taking hormonal contraceptives (so-called "pill") or hormone replacement therapy, they may be at risk of developing blood clots in the veins (see "When not to use Fibrovein").
Inform the doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take, including those available without a prescription.

Pregnancy and breastfeeding

The patient must inform the doctor if:
they are pregnant or think they may be pregnant;
they plan to become pregnant;
they are breastfeeding.
The safety of using Fibrovein during pregnancy has not been established. Fibrovein should not be used in pregnant women unless it is absolutely necessary. The doctor will decide whether the use of Fibrovein is appropriate for the patient.
It is not known whether Fibrovein passes into breast milk. If the patient is breastfeeding, the doctor will decide whether Fibrovein is a suitable medicine for them.

Driving and using machines

After using Fibrovein, to reduce the risk of inflammation and skin discoloration, the doctor may recommend appropriate bandaging of the legs and/or wearing compression stockings, which may affect the ability to drive vehicles.

Fibrovein contains sodium, potassium, and benzyl alcohol

This medicine contains:
less than 1 mmol (23 mg) of sodium per vial/ampoule, i.e. the medicine is considered "sodium-free".
less than 1 mmol (39 mg) of potassium per vial/ampoule, i.e. the medicine is considered "potassium-free".
40 mg of benzyl alcohol in each 2 ml ampoule or 100 mg of benzyl alcohol in each 5 ml vial, which corresponds to 20 mg/ml. Benzyl alcohol may cause allergic reactions. In case of pregnancy, breastfeeding, or liver or kidney disease, consult a doctor or pharmacist. This is because large amounts of benzyl alcohol can accumulate in the body, which can cause side effects (so-called "metabolic acidosis").

3. How to use Fibrovein

Do notattempt to self-inject Fibrovein. Treatment should always be performed by an experienced doctor trained in the proper injection techniques.
Treatment involves very careful and slow injection of the medicine using the smallest possible needles into the diseased veins, allowing for the removal of blood from them. The medicine can be mixed manually using two syringes and a connector to create a mixture with air and produce foam, which helps remove blood from larger veins. In this case, the medicine must be administered to the patient by a doctor trained in the proper techniques of producing and administering the medicine in the form of foam.
In the case of treating invisible varicose veins of the lower limbs and foam sclerotherapy, the procedure should be performed under ultrasound control.
The doctor will decide which concentration of Fibrovein to use and which areas to treat. Recommended doses:

Adults and the elderly

• from 0.1 ml to 2 ml of Fibrovein per injection. The doctor may inject a maximum of 10 ml of the three lower concentrations of Fibrovein, but no more than 4 ml in the case of the highest concentration.

Due to the limitations on the maximum daily dose of the sclerosant, it may be necessary to repeat the procedure several times.
After completing treatment with Fibrovein, follow the doctor's instructions. The doctor may recommend appropriate bandaging of the legs and/or wearing compression stockings to reduce the risk of inflammation and skin discoloration.
In case of any further doubts about the use of this medicine, consult a doctor or nurse.

4. Possible side effects

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

Serious side effects may occur. Stop treatment with Fibrovein and contact a doctor or go to the emergency department of the nearest hospital immediately if any of the following symptoms occur:

Uncommon (may affect up to 1 in 100 people):

• Blood clots in deep veins (deep vein thrombosis, most likely caused by the underlying disease). Symptoms include pain, swelling, and tenderness in one leg (usually in the calf), severe pain in the affected area, increased warmth of the skin in the area where the clot forms, or redness of the skin, especially in the back of the leg below the knee.

Rare (may affect up to 1 in 1,000 people):

• Local tissue necrosis or, less frequently, nerve necrosis. Symptoms include pain, change in skin color (redness), swelling, or fluid accumulation, blisters on the skin (which may be filled with clear fluid or blood), dark red, purple, or black skin color, abnormal sensations (tingling, stinging, burning), numbness, or loss of sensation.

Very rare (may affect up to 1 in 10,000 people):

• The most serious side effect is a severe allergic reaction (anaphylactic shock), which can cause difficulty breathing or a sudden drop in blood pressure, leading to a feeling of fainting or loss of consciousness. Anaphylactic shock is rare but can be life-threatening, so if it occurs, the patient should receive immediate treatment.
• Arterial blockage caused by a blood clot, which can lead to:

o
stroke or interruption of blood flow to the brain or eye (transient ischemic attack). Symptoms may include weakness, numbness, or paralysis of the face, arm, or leg, usually on one side of the body, slurred or distorted speech, or difficulty understanding others, blindness in one or both eyes, or double vision.
o
pulmonary embolism. Symptoms may include sudden shortness of breath, sudden, severe chest pain that worsens with deep breathing or coughing, rapid heartbeat, or rapid breathing.
To protect patients from this very rare side effect, the medicine should not be used in patients who are at increased risk of developing blood clots in the veins and arteries (thrombosis risk).

• Circulatory failure. Symptoms may include a feeling of fatigue, dizziness, fainting, chest pain, shortness of breath, weakness, dizziness, nausea, vomiting, and rapid heartbeat.
• Tissue necrosis in case of injection into an artery. Symptoms may vary depending on the amount of medicine injected, the site of injection, and the speed of receiving medical attention. They may range from pain without long-term damage to loss of large areas of tissue, including the foot, which can lead to the need for amputation of the limb.

Other side effects that may occur include:

Very common (may affect more than 1 in 10 people):

• Superficial vein inflammation.

Common (may affect up to 1 in 10 people)

• Pain or burning (short-term at the injection site);
• Skin pigmentation;
• Expansion of subcutaneous blood vessels at the injection site (so-called "matting").

Uncommon (may affect up to 1 in 100 people):

• Local allergic or non-allergic skin reactions, e.g. redness, itching, rash, or swelling;
• Visual disturbances;
• Migraine.

Rare (may affect up to 1 in 1,000 people):

• Cough, shortness of breath, feeling of compression/chest tightness;
• Burning, tingling, stinging, or itching of the skin;
• Headache, feeling of fainting;
• Disorientation, dizziness, loss of consciousness.

Very rare (may affect up to 1 in 10,000 people):

• Fever, hot flashes, red itchy skin (hives);
• Nausea, vomiting, diarrhea, feeling of a swollen tongue or increased tongue volume, dry mouth;
• Vein inflammation.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, inform the doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Fibrovein

Store the medicine out of sight and reach of children.
There are no special storage temperature recommendations for the medicine.

• Do not freeze.
• Vials and ampoules should be stored in the outer packaging to protect from light.
• Do not use this medicine after the expiry date stated on the carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month stated.

For single use only. The contents of the packaging should be used immediately after opening.
Any unused product should be disposed of.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fibrovein contains

The active substance of Fibrovein is sodium tetradecyl sulfate.
For the 0.2% concentration
Each ml of the solution for injection contains 2 mg of sodium tetradecyl sulfate.
Each 5 ml vial contains 10 mg of sodium tetradecyl sulfate.
For the 0.5% concentration
Each ml of the solution for injection contains 5 mg of sodium tetradecyl sulfate.
Each 2 ml ampoule contains 10 mg of sodium tetradecyl sulfate.
For the 1% concentration
Each ml of the solution for injection contains 10 mg of sodium tetradecyl sulfate.
Each 2 ml ampoule contains 20 mg of sodium tetradecyl sulfate.
For the 3% concentration
Each ml of the solution for injection contains 30 mg of sodium tetradecyl sulfate.
Each 2 ml ampoule contains 60 mg of sodium tetradecyl sulfate.
Each 5 ml vial contains 150 mg of sodium tetradecyl sulfate.
The other ingredients of Fibrovein are: benzyl alcohol (20 mg/ml), disodium phosphate dodecahydrate, potassium dihydrogen phosphate, water for injections, sodium hydroxide (for pH adjustment). See section 2 "Fibrovein contains sodium and potassium".

What Fibrovein looks like and contents of the pack

Fibrovein is a solution for injection contained in glass ampoules or vials. The solution is clear, colorless, sterile, and free from visible particles.
Fibrovein, 0.2%: the pack contains 2, 5, or 10 vials of 5 ml.
Fibrovein, 0.5%: the pack contains 5 ampoules of 2 ml.
Fibrovein, 1%: the pack contains 5 ampoules of 2 ml.
Fibrovein, 3%: the pack contains 5 ampoules of 2 ml or 2, 5, or 10 vials of 5 ml.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

STD Pharmaceutical (Ireland) Limited
Block 1, Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin 15
D15 AKK1, Ireland
+353 1588 6916

Manufacturer:

Medipha Sante
Les Fjords-Immeuble Oslo
19 Avenue de Norvege
91953 Courtaboeuf CEDEX
France
Chemische Fabrik Kreussler & Co. GmbH
Rheingaustrasse 87-93
65203 Wiesbaden,
Germany

This medicine is authorized for use in the Member States of the European Economic Area under the following names:

Fibrovein
Bulgaria, Czech Republic, France, Germany, Ireland, Netherlands, Poland, Romania
Austria, Spain
Veinfibro
Date of last revision of the leaflet:05/2024

Other sources of information:

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
www.urpl.gov.pl

Information intended for healthcare professionals only:

Fibrovein, 0.2%, Solution for Injection

Fibrovein, 0.5%, Solution for Injection

Fibrovein, 1%, Solution for Injection

Fibrovein, 3%, Solution for Injection

Additional information about this product can be found in the Summary of Product Characteristics (SPC).

Dosage and administration

Dosage
Fibrovein is intended for intravenous administration only. Depending on the size and severity of the venous changes, different concentrations are required. Spider veins should only be treated with 0.2% concentration, and reticular veins with 0.5% concentration. The 1% concentration is most effective for small and medium-sized varicose veins, while the 3% concentration is used for larger varicose veins. The size of invisible varicose veins of the lower limbs should be determined under ultrasound control.
The sclerosant should be administered intravenously in small equal portions along the course of the diseased vein. Fibrovein at concentrations of 0.2% and 0.5% should be administered in the form of a liquid. Fibrovein at concentrations of 1% and 3% can be administered in the form of a liquid sclerosant or a mixture of sclerosant with air (foam form) in accordance with the description below. The goal of the procedure is to achieve optimal destruction of the vessel walls with the minimum effective concentration of the medicinal product necessary for effective treatment. Too high a concentration of the medicinal product can lead to tissue necrosis or other complications.
Adults

*Sum of liquid and air volumes
In cases where special caution is required, a test dose is recommended, administering 0.25 to 0.5 ml of Fibrovein to the patient and observing them for several hours, and then administering a second or larger dose.
The procedure often requires repetition (on average, the patient needs 2 to 4 additional procedures) due to the limited dose that can be used during one procedure. To protect the patient from an allergic reaction, it is recommended to administer a small test dose of Fibrovein at the beginning of each procedure.
Fibrovein, 1% and 3% Solution for Injection
In the case of foam administration
The foam intended for the treatment of larger veins can be prepared using Fibrovein at concentrations of 1% and 3%. The foam should be prepared immediately before administration. It must be administered to the patient by a doctor trained in the proper techniques of producing and administering the medicinal product in the form of foam. It is recommended that the foam sclerotherapy procedure be performed under ultrasound control.

Incompatibilities

This medicinal product must not be mixed with heparin.
Do not mix the medicinal product with other medicinal products, as compatibility studies have not been performed.

Special warnings and precautions

Fibrovein should only be administered by a doctor, and if national guidelines permit, the medicinal product may be administered under the supervision of a doctor by appropriately qualified medical personnel who have experience in venous system anatomy and are familiar with the correct injection technique.
Allergic reactions, including anaphylactic shock, have also been reported, so the doctor administering the medicinal product should be prepared to provide emergency treatment.
During the procedure, the doctor must have direct access to emergency resuscitation equipment.
Due to special caution, the patient should be treated in a hospital.
In the event of extravasation, serious local side effects may occur, including tissue necrosis, so caution should be exercised when inserting the needle and the minimum effective dose should be injected at each injection site. The solution should be injected slowly.
Special caution should be exercised to avoid injecting the solution into an artery, as this can cause tissue necrosis, potentially leading to the need for amputation of the limb.
Special caution should be exercised when performing injections in the foot and above and below the ankle (malleolus) due to the risk to one of the arteries. In the treatment of smaller veins, compression should be applied, as the likelihood of pigmentation may be higher if blood extravasation occurs at the injection site.

Preparing the foam and administration

General recommendations
The quality of the foam depends on specific conditions:
Concentration of the product: Foam can only be prepared using sodium tetradecyl sulfate at a concentration of 1% to 3%.
Liquid-to-air ratio: This ratio is usually 1 volume of liquid to 3 to 4 volumes of air.
Number of times the sclerosant/air mixture is pumped from one syringe to another: The doctor should follow the number of pumpings specified for each technique.
Macroscopic consistency of the foam: Before administration, the quality of the foam should be checked outside the syringe. The foam should be uniform, soft, and consistent without visible large bubbles.
If the foam contains large bubbles, it should be discarded and new foam prepared.
Total time for foam preparation: Preparing the foam should take about 10 seconds from the first to the last pumping of the liquid from one syringe to the other.
Maximum time between preparation and injection of the foam: The sclerosant foam should be used within 60 seconds of preparation. After 60 seconds, any unused foam should be discarded. If necessary, more foam can be prepared.

Preparing the foam (Tessari technique)

When preparing Fibrovein for administration, strict aseptic conditions should be maintained.
To prepare the foam for one sterile syringe, 1 ml of the liquid sclerosant is drawn up, and 3 ml or 4 ml of sterile air is drawn up into the other sterile syringe. The air is aspirated into the syringe through a 0.2 μm sterile filter, ensuring its sterility. The syringes are connected using a sterile three-way connector/valve (Fig. 1). When preparing the foam, it is recommended to use Luer Lock syringes and eye protection. Connecting a syringe with a Luer slip connector to a three-way valve under pressure may result in failure and uncontrolled leakage of the product.
After connecting the syringes, the sclerosant/air mixture is dynamically pumped about 20 times from one syringe to the other through the three-way valve until a foam with a uniform, smooth consistency is obtained (Figs. 2 and 3).
The syringe containing the foam is removed from the connector and used to immediately perform the intravenous injection, through which the foam is administered to the vessel (Fig. 4).
The sclerosant foam should be used within 60 seconds of preparation. After 60 seconds, any unused foam should be discarded. If necessary, more foam can be prepared.
Before administering the foam, its quality should be checked. The foam should have a uniform consistency, be white, and not contain visible large bubbles.

Excipients
This medicinal product contains:
less than 1 mmol (23 mg) of sodium per vial/ampoule, i.e. the medicine is considered "sodium-free".
less than 1 mmol (39 mg) of potassium per vial/ampoule, i.e. the medicine is considered "potassium-free".
40 mg of benzyl alcohol in each 2 ml ampoule or 100 mg of benzyl alcohol in each 5 ml vial, which corresponds to 20 mg/ml. Benzyl alcohol may cause allergic reactions. It may cause metabolic acidosis in case of pregnancy, breastfeeding, or liver or kidney disease.