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FIBROVEIN 0.2% SOLUTION FOR INJECTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Fibrovein 3%, 1%, 0.5% and 0.2% Solution for Injection
Sodium tetradecyl sulphate
Read all of this leaflet carefully before
you start using this medicine.
; Keep this leaflet. You may need to read it again.
; If you have any further questions, please ask your doctor
or pharmacist.
; This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their symptoms are
the same as yours.
; If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Fibrovein is and what it is used for
2. What you need to know before you use 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 FIBROVEIN IS AND WHAT IT IS USED FOR
The name of your medicine is Fibrovein, which contains the active
ingredient sodium tetradecyl sulphate.
Different strengths of Fibrovein are used in the treatment of
varicose veins, large, medium or minor venules and spider veins.
This injection belongs to a group of medicines called sclerosants.
Sclerosants are chemical agents, when injected into the affected
vein they cause the lining of the vein walls to swell and the walls
stick together. This stops the flow of blood and the vein turns into
scar tissue. In a few weeks, the vein should fade.
Fibrovein is only for use in adults (including the elderly).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
FIBROVEIN
You should not use Fibrovein if you:
• are allergic (hypersensitive) to sodium tetradecyl sulphate
or to any of the other ingredients in Fibrovein (listed in
section 6)
• cannot walk due to any reason
• have severe inflammation of veins in the legs (acute
phlebitis)
• have blood clots in your veins (thrombosis)
• have risk of developing blood clots in your veins due to:
• inherited blood disorders such as thrombophilia
• being significantly overweight
• immobility for long duration
• having hormonal contraception or hormone
replacement therapy.
• smoking
• have had recent surgery
• have had recent blood clots in superficial or deep veins
or in the lungs
• have evolving cancer
• have twisted veins (varicose veins) caused by pelvic or
abdominal tumours, unless the tumour has been
removed
• have any kind of infection
• have an uncontrolled ailment such as diabetes, asthma,
blood abnormality, blood poisoning, or recent skin
or breathing problems
• have severe heart disease
• have excessive fluid accumulation in the lungs causing
shortness of breath.
• have blockage in an artery
• have been told that you have problems with closing of
valves in deep veins (valvular incompetence)
• have a symptomatic hole in the heart (only if the
sclerosant is used as a foam)
The following information is 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
Please refer to the Summary of Product Characteristics (SmPC)
for further details of this product.
Qualitative and Quantitative Composition
Fibrovein 0.2% Solution for Injection
Each ml solution for injection contains 2mg Sodium Tetradecyl
Sulphate.
Each 5 ml vial contains 10 mg Sodium Tetradecyl Sulphate.
Fibrovein 0.5% Solution for Injection
Each ml solution for injection contains 5mg Sodium Tetradecyl
Sulphate.
Each 2 ml ampoule contains 10 mg Sodium Tetradecyl Sulphate.
Fibrovein 1% Solution for Injection
Each ml solution for injection contains 10mg Sodium Tetradecyl
Sulphate.
Each 2 ml ampoule contains 20 mg Sodium Tetradecyl Sulphate.
Fibrovein 3% Solution for Injection
Each ml solution for injection contains 30mg Sodium Tetradecyl
Sulphate.
Each 2 ml ampoule contains 60 mg Sodium Tetradecyl Sulphate.
Each 5 ml vial contains 150 mg Sodium Tetradecyl Sulphate.
For a full list of excipients, see List of Excipients below.
Pharmaceutical Form
Solution for injection.
A clear, colourless, sterile solution.
Contains benzyl alcohol 20mg/ml.
pH 7.5 – 7.9.
Osmolarity 247 – 273 mOsm/kg.
Therapeutic Indications
For the treatment of uncomplicated primary varicose veins,
recurrent or residual varicose veins following surgery, reticular
veins, venules and spider veins of the lower extremities that show
simple dilation.
Fibrovein is indicated in adults (including the elderly).
Posology and Method of Administration
Fibrovein is for intravenous use only. The strength of solution
required depends on the size and degree of varicosity. Spider
veins should only be treated with the 0.2%, reticular veins with
0.5%, the 1% solution will be found most useful for small to
medium varicosities and the 3% solution for larger varicosities.
The sclerosant should be administered intravenously in small

Talk to your doctor before using Fibrovein if you:
• are allergic to any food or medicine or have any other
allergies, you should speak to the doctor before being
given this injection, so that a test dose can be given 24 hours
before any further therapy
• have been told that you have any disease of your arteries or
veins (atherosclerosis)
• have a history of blood clots in superficial or deep veins or in
the lungs
• have severe inflammation and clotting of arteries and veins
affecting the hands and feet (Buerger’s disease)
• have any breathing difficulties (asthma)
• have been told a surgical treatment is required to correct a
valve in the blood vessel
• have a hole in the heart
• suffer from migraine
• have a history of pulmonary hypertension
• have a history of stroke or serious cerebral event
Fibrovein should be administered only by experienced healthcare
professionals experienced in venous anatomy and familiar with
proper injection technique. Before using this injection you may
be tested to see if you have any problems with the closing of the
valves in your veins.
Your doctor will ask you questions about your health and will
inform you about the potential side effects of this procedure.
Your doctor will monitor you during and after the sclerotherapy for
signs of hypersensitivity (redness, itching, cough) or neurological
symptoms (visual disorders, migraine, tingling or numbness).
He will ask you to come back for a follow up visit.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines, including medicines obtained without
a prescription.
Pregnancy and breast-feeding
You must tell the doctor if:
• you are pregnant or think you may be pregnant
• you are planning on becoming pregnant
• you are breast-feeding
There is no adequate information on the use of Fibrovein in
pregnant women. Fibrovein should not be used during pregnancy
unless clearly necessary. Your doctor will decide whether or not
this treatment is appropriate for you.
It is not known whether Fibrovein is excreted in breast-milk. If
you are breast-feeding, the doctor will decide whether Fibrovein
should be used.
Driving and using machinery
After the treatment with this injection, you may be told to wear
a bandage and/or compression stockings to help reduce
inflammation and pigmentation of the skin which could affect your
ability to drive.
3. HOW TO USE FIBROVEIN
You must not try to inject Fibrovein yourself. You should always
be treated by an experienced doctor who is familiar with the
injection technique.
The therapy involves injecting the medicine into the affected vein
using the smallest of the needles and it is to be injected slowly
and with extreme care so that the blood content of these veins is
expelled. The medicine may be manually mixed with air using two
syringes and a connector to create a foam to help expel the blood
in larger veins. In this case, it must be administered by a physician
appropriately trained in the correct generation and administration
of foam.
Your doctor should use ultrasound guidance in the treatment of non
visible varicose veins and for the administration of foam sclerosant.
Your doctor will decide on the areas to treat and the right dose for
you. The usual doses are as follows:
aliquots at multiple sites along the vein to be treated either as
a liquid or as a sclerosant/air mixture (foam) as detailed in the
table below. The objective is to achieve optimal destruction of
the vessel wall with the minimum concentration of sclerosant
necessary for a clinical result. If the concentration is too high
necrosis or other adverse sequelae may occur.
Refer below for instructions for foam preparation. The Tessari
method of preparation of the foam is described. Other techniques
may be used (e.g. DSS, Easyfoam, Sterivein).
Strict aseptic technique must be maintained while handling
Fibrovein. Fibrovein is a single-use parenteral product. Once the
container is opened, use immediately and discard any unused
portion. Visually inspect for particulate matter before use.
Solutions that contain particulate matter should not be used.
This medicinal product is not compatible with heparin.
In the absence of compatibility studies, this medicinal product
should not be mixed with other medicinal products.
Recommended doses and dosage schedules
Adults/Elderly
Normal volume injected
intravenously at suitable
sites
Liquid
Foam*
0.5 to 2ml
0.5 to 2ml
Fibrovein 3%
0.1 to 1ml
0.5 to 2ml
Fibrovein 1%
Not
Fibrovein 0.5%,
0.1 to 1ml
applicable
0.2%
Concentration

Maximum total
volume to be
injected
Liquid Foam*
4ml
16ml
10ml 16ml
Not
10ml
applicable

* volume is the sum of the liquid and air components

Where special caution is indicated (see SmPC) it is recommended
that a test dose of 0.25 to 0.5ml Fibrovein should be given
followed by observation of the patient for several hours before
administration of a second or larger dose.
For spider veins the smallest of needles (for example 30 gauge)
should be used to perform the injection which should be made
slowly so that the blood content of these veins is expelled. In the
treatment of spider veins an air block technique may be used.
When the sclerosant is administered as a foam it should ideally be
administered under ultrasound guidance. It must be administered
by a physician appropriately trained in the correct generation and
administration of the foam.
Special warnings and precautions
Fibrovein should only be administered by a healthcare
professional experienced in venous anatomy and the diagnosis
and treatment of conditions affecting the venous system
and familiar with proper injection technique. Severe adverse
local effects, including tissue necrosis, may occur following

Adults and the elderly
• varies between 0.1 and 2 ml for each injection. A maximum
of 10 ml of the three lower strength injections may be used,
however no more than 4 ml is used when the strongest
injection is used.
Due to the limited volume of sclerosant authorised, repeated
sessions of sclerotherapy may be necessary.
Children
• Fibrovein is not intended for use for children.
After you have been treated with Fibrovein, you should follow
your doctor’s advice. You may be told to wear a bandage and
or/compression stockings to help reduce inflammation and
pigmentation of the skin.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fibrovein can cause side effects, although not
everybody gets them.
The most serious side effect is a very severe form of allergic
reaction (anaphylactic shock). It is extremely rare but should be
treated immediately, otherwise it may be fatal. Also a blood clot in
the lungs is very rare. To avoid this very rare serious event, this
product is contra-indicated in patients who have a risk of clots in
veins and arteries (risk of thrombosis).
The most common side effects are pain at the site of injection, red
itchy skin (hives), temporary discolouration of the skin, superficial
thrombophlebitis (blood clot in a superficial vein).
Other side effects that may be experienced are:
Common (at least 1 in 100 but less than 1 in 10 patients):
Pain or burning (short term at the injection site)
Skin discolouration
Superficial inflammation of the vein
Growth of very fine spider veins in the treated area (matting)
Uncommon (at least 1 in 1,000 but less than 1 in 100
patients):
Local allergic and non allergic skin reactions e.g. redness of skin,
itchy skin, rash or swelling of the skin
Blood clots in deep veins (deep vein thrombosis possibly due to
underlying disease)
Visual disturbances (if administered as a foam)
Rare (at least 1 in 10,000 but less than 1 in 1,000 patients):
Local tissue death of skin and more rarely of nerves
Coughing, shortness of breath, sensation of pressure/tightness
in the chest
Burning, tingling, prickling or itching of the skin
Headache, migraine, feeling faint
Confusion, dizziness, loss of consciousness
Very rare (less than or 1 in 10,000 patients):
Fever, hot flushes, asthma, red itchy skin (hives) or severe
allergic reactions (anaphylactic shock)
Nausea, vomiting, diarrhoea, feeling of swollen/thick tongue, dry
mouth
Visual disturbances (if administered as a liquid)
Weakness, stroke like symptoms
Blockage of artery due to a clot (stroke, transient ischemic attack,
pulmonary embolism)
Inflammation of blood vessels, failure of blood circulation
Death of tissue following intra-arterial injection
If you experience any serious side effects or feel that the medicine
is affecting you badly tell your doctor or pharmacist immediately.
5. HOW TO STORE FIBROVEIN
Keep out the reach and sight of children
• This medicinal product does not require any special storage
conditions
• Do not freeze
• The injection should be stored in the outer carton to protect it
from light
• Fibrovein should not be used after the expiry date given on the
carton; the expiry date refers to the last day of the month.
extravasation; therefore, extreme care in intravenous needle
placement and using the minimal effective volume at each
injection site are important. The solution should be injected slowly.
Care should be taken not to inject the solution into an artery as
this may lead to death of the tissue (tissue necrosis) and may
result in loss of the limb.
Special care must be taken when injecting the foot and above and
below the ankle (malleolar area) due to risk to one of the arteries.
Compression must be applied when treating smaller veins as
pigmentation may occur if blood is expelled at the injection site.
Allergic reactions including anaphylaxis have been reported
and the physician should be prepared to treat it appropriately.
Emergency resuscitation equipment should be immediately
available.
The patient should be treated in hospital as a precaution.
To Prepare the Foam (Tessari technique)
Strict aseptic technique must be maintained while manufacturing
the foam.
To create the foam 1ml of liquid sclerosant is drawn into a sterile
syringe and 3ml or 4ml of sterile air is drawn into another sterile
syringe. The air is drawn through a 0.2 μm filter to ensure it is
sterile. The syringes are then connected using a sterile three way
tap/valve (Fig. 1).
The sclerosant/air mixture is then forced back and forth from one
syringe to the other through the 3-way valve approximately 20
times to produce a smooth, consistent foam (Fig. 2&3).
The syringe containing the foam, is then removed and the vein is

injected immediately (Fig. 4).
The sclerosant foam should be used within sixty seconds of
production. After sixty seconds any remaining foam should be
discarded. More foam should be prepared if required.

For single use only. Once the container is opened, the contents
should be used immediately. Any remaining product should be
discarded.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines
no longer required. These measures will help protect the
environment.
6. CONTENTS OF THE PACK AND FURTHER INFORMATION
What Fibrovein contains
The active ingredient is: sodium tetradecyl sulphate.
For the 0.2%:
Each ml of solution for injection contains 2mg Sodium Tetradecyl
Sulphate.
Each 5 ml vial contains 10 mg Sodium Tetradecyl Sulphate.
For the 0.5%:
Each ml of solution for injection contains 5mg Sodium Tetradecyl
Sulphate.
Each 2 ml ampoule contains 10 mg Sodium Tetradecyl Sulphate.
For the 1%:
Each ml of solution for injection contains 10mg Sodium
Tetradecyl Sulphate.
Each 2 ml ampoule contains 20mg Sodium Tetradecyl Sulphate.
For the 3%:
Each ml of solution for injection contains 30mg Sodium
Tetradecyl Sulphate.
Each 2ml ampoule contains 60mg Sodium Tetradecyl Sulphate.
Each 5ml vial contains 150mg Sodium Tetradecyl Sulphate.
The other ingredients are: benzyl alcohol (20 mg/ml), disodium
phosphate dodecahydrate, potassium dihydrogen phosphate,
water for injections, sodium hydroxide (to adjust the pH).
What Fibrovein looks like and the contents of the pack
This medicinal product is presented as a solution for injection in
clear glass ampoules or vials. The solution is clear and colourless.
For the 0.2%: pack size 2, 5 or 10 vials of 5 ml
For the 0.5%: pack size of 5 ampoules of 2 ml
For the 1%: pack size of 5 ampoules of 2 ml
For the 3%: pack size of 5 ampoules of 2 ml or 2, 5 or 10 vials of
5 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
STD Pharmaceutical Products Ltd.
Plough Lane, Hereford, HR4 0EL, United Kingdom
Manufacturer:
STD Pharmaceutical Products Ltd.
Plough Lane, Hereford, HR4 0EL, United Kingdom
This medicinal product is authorised in the Member States of the
EEA under the following names: UK, FR and CZ: Fibrovein
ES and PT: Veinfibro
Other sources of information:
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge: 0800 198 5000 (UK Only).
Please be ready to give the following information:
Product Name
Fibrovein 3%
Fibrovein 1%
Fibrovein 0.5%
Fibrovein 0.2%

Reference Number
PL 00398/0207
PL 00398/0206
PL 00398/0205
PL 00398/0204

This is a service provided by the Royal National Institute of Blind
People.
This leaflet was last revised in 08/2012

L0020

The quality of the foam should be checked before its
administration. It should appear homogenous with no large
bubbles visible to the naked eye.
The quality of foam depends on specific criteria:
1. The product concentration: Foam can only be prepared with
concentrations of 1 to 3% sodium tetradecyl sulphate.
2. The proportion of liquid to air: Usually, this proportion is 1
volume of liquid for 3 volumes of air.
3. Number of backwards and forwards passes: The physician
should follow precisely the number of movements defined for
each technique.
4. Macroscopic consistency of the foam: The quality of
the foam should be checked outside of the syringe
before administration. The foam should be homogeneous,
soft and cohesive with no visible large bubbles. If
large bubbles are visible, the foam should be thrown
away and new foam prepared.
5. The total time of preparation of the foam: The preparation
should take around 10 seconds from the first to the
last backwards and forwards movement.
6. The maximum time between preparation and injection:
The sclerosant foam must be used within sixty seconds of
production. After sixty seconds, any remaining foam should be
discarded. More foam should be prepared if required.
Pharmaceutical Particulars
List of excipients
Benzyl alcohol
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Sodium hydroxide (for pH adjustment)
Water for injections
Shelf life
3 years.
After first opening, the product should be used immediately.
Special precautions for storage
This medicinal product does not require any special storage
conditions.
Do not freeze.
Keep the vial/ampoule in the outer carton in order to protect from
light.
Nature and contents of containers
5ml vials (Type 1 glass) with a stopper and aluminium seal with
flip-off cap.
2ml ampoules (Type 1 glass).
Special precautions for disposal
There are no special requirements for disposal.
L0020

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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