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FIBRO-VEIN 1% W/V

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L

PACKAGE INSERT

NAME OF PRODUCT
fibro-vein*.
PRESENTATION
FIBRO-VEIN is a sterile aqueous solution of sodium tetradecyl sulphate available in four strengths 3%, 1%, 0.5% and 0.2% and is buffered to pH
7.6. The solution also contains: benzyl alcohol, di-sodium hydrogen phosphate, potassium di-hydrogen phosphate and water.
USE
The solution is for intravenous use as a sclerosant in the treatment of varicose veins of the leg by compression sclerotherapy. The action of sodium
tetradecyl sulphate in this technique is considered to be that of irritation to the intima of the vein wall, so that on compression of the vein, fibrosis
takes place and the vein is permanently occluded by the development of fibrosis in the wall of the compressed vein.
The strength of fibro-vein selected depends on the size of the veins to be treated. fibro-vein 3% is for the treatment of large superficial
varicose veins, fibro-vein 1% for the treatment of small varicose veins and the larger venules. Minor venules and spider veins (venous flares)
should be treated with fibro-vein 0.5% or 0.2%.
DOSAGE AND ADMINISTRATION
adults and the elderly (not recommended for use in children)
FIBRO-VEIN 3%.
Dosage 0.5-1ml at each of four sites (maximum 4ml).
A dose of 0.5 to 1ml of fibro-vein 3% is injected intravenously into the lumen of an isolated segment of emptied superficial vein, followed by
immediate continuous compression. A maximum of four sites (4ml total) may be injected during one treatment session.
FIBRO-VEIN 1%.
Dosage 0.25-1ml at each of 10 sites (maximum 10ml).
A dose of 0.25 to 1ml of fibro-vein 1% is injected intravenously into the lumen of an isolated segment of emptied superficial vein, followed by
immediate continuous compression. A maximum of ten sites (10ml total) may be injected during one treatment session.
FIBRO-VEIN 0.5%.
Dosage 0.25-1ml at each of 10 sites (maximum 10ml).
A dose of 0.25 to 1ml of fibro-vein 0.5% is injected intravenously into the lumen of an isolated segment of emptied superficial vein, followed by
immediate continuous compression. A maximum of ten sites (10ml total) may be injected during one treatment session.
FIBRO-VEIN 0.2%.
Dosage 0.1-1ml at each of 10 sites (maximum 10ml).
A dose of 0.1 to 1ml of fibro-vein 0.2% is injected intravenously into the lumen of an isolated segment of emptied superficial vein, followed by
immediate continuous compression. A maximum of ten sites (10ml total) may be injected during one treatment session.
compression therapy technique and aftercare
The treatment of varicose veins by compression sclerotherapy is directed towards the restoration of the efficiency of the synchronised pumping
systems within the leg by permanently destroying the leaking points rather than in the eradication of the superficial tortuous veins which may, in
many cases, be capable of reverting to normal pattern of pressure within the veins of the limb. Localisation of the incompetent perforating veins is
the supremely important object of diagnosis.
Treatment comprises the permanent blocking of the offending leak by producing a short fibrotic segment of vein involving the area of the junction of
the perforating and superficial veins. This can be achieved by carrying out the following procedure:
1. The first injection should be given at the most distal chosen site. The following needle sizes are recommended: fibro-vein 3% 25 gauge needle; fibro-vein 1% 27 gauge needle; fibro-vein 0.5% 30 gauge needle;
fibro-vein 0.2% 30 gauge needle. Compression should be applied immediately and before the adjacent site is injected.
2. The sclerosant should be introduced into the vein after it has been emptied.
3. The sclerosant should be maintained within the empty and isolated segment of the vein for approximately 30 seconds.
4. Compression should be applied immediately. It should be uninterrupted and it must be adequate and maintained for 6 weeks after the last
chosen site is injected. One should feel quite confident that when the patient stands erect, the internal pressure of the blood in the adjacent
unobliterated vein cannot reopen the segment; otherwise compression should be re-applied. The segment of the veins should have become a
palpable, firm, fibrous cord and there should be no sign of tenderness.
5. Application of compression is most suitably obtained by firm bandaging with a number of strong cotton crepe bandages and by incorporating
therein shaped rubber pads over the sites of injection.
A class 1 elastic stocking applied over the bandage aids compression and the retention of the bandage in position.
For fibro-vein 1% the compression regime may be replaced by the use of class 2 or 3 graduated compression elastic stocking at an earlier
stage. It must, however, be remembered that the process of fibrosis is not shortened for smaller veins and adequate compression must be
maintained for 6 weeks. Walking should commence as soon as possible after the completion of treatment and last for at least one hour. Subsequent
daily walking of one hour’s duration is essential.
Patients must be advised to avoid even short periods of standing still.
The injection of fibro-vein 0.5% and fibro-vein 0.2% should be made slowly so that the blood content of these veins is expelled. In the
treatment of spider veins and fine spider veins an air block technique may be used, for this a shaken foam, or a small amount of air (0.05ml) is first
injected into the venous flare followed by the sclerosant which is then seen to flow around the veins with immediate blanching. Even with fibrovein 0.5% and fibro-vein 0.2%, extra vascular injection should be avoided. Injected sites should be compressed with a bandage within half
a minute of injection and this pressure continued whilst other sites are injected at the same session. The bandage may be replaced by a class 2
graduated elastic stocking at the end of the session and this compression maintained throughout the ensuing 2 to 3 weeks. Periods of inactive
standing should be avoided.
The use of a small dose, the isolation of the injection within the vein segment and the application of immediate adequate and lasting compression
are of supreme importance in obtaining a good result.

INFORMATION FOR THE USER
Fibro-Vein 0.2%, 0.5%, 1% and 3%
Intravenous Injection
Sodium sulphate
Read all of this leaflet carefully before you are
given this injection.
− Keep this leaflet. You may need to read it again while
you are receiving your treatment.
− 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 Fibro-Vein Injection is and what it is used for
2. Before you are given Fibro-Vein Injection
3. Your treatment with Fibro-Vein Injection
4. Possible side effects
5. How to store Fibro-Vein Injection
6. Further information
1. What Fibro-Vein Injection is and what it is used for
The name of your medicine is Fibro-Vein Injection, which
contains the active ingredient sodium tetradecyl sulphate.
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.
2. Before you take Fibro-Vein Injection
You should not take Fibro-Vein Injection if you:
• are allergic (hypersensitive) to sodium tetradecyl
sulphate or to any of the other ingredients in
Fibro-Vein Injection (see section 6, Further
information)
• cannot walk due to any reason
• have severe inflammation of veins in the legs
(acute phlebitis)
• have blood clots in your veins (thrombosis)
• have twisted veins (varicose veins) caused by pelvic
or abdominal tumours
• are significantly overweight
• have any kind of infection
• have diabetes which is uncontrolled.
Talk to your doctor before taking Fibro-Vein
Injection if you:

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have been told that you have any disease of your
arteries or veins (atherosclerosis)
have been told a surgical treatment is required
to correct a valve in the blood vessel
have severe inflammation and clotting of arteries
and veins affecting the hands and feet (Buerger’s
disease)
have heart disease
have kidney problems.

If you are allergic to any food or medicine, 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.
Treatment with Fibro-Vein Injection must not be
undertaken in clinics which do not have the facilities
(injections like adrenaline, hydrocortisone, antihistamine,
endotracheal tubation with use of a laryngoscope and
suction) to treat a severe allergic reaction (anaphylactic
shock)
Special care must be taken when injecting above and
below the ankle due to risk to one of the arteries.
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.
The following medicines can affect or be affected by
treatment with Fibro-Vein Injection:
• oral contraceptive pills
• heparin (a medicine used to stop formation of blood
clots) should not be administered in the same syringe
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant or
breast feeding please speak with your doctor before
being given this injection.
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. Treatment with Fibro-Vein Injection
You MUST NOT try to inject Fibro-Vein yourself. You
should always be treated by an experienced doctor
who is familiar with the injection technique.
The therapy involves injecting the medicine to 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.
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CONTRA-INDICATION, WARNINGS, ETC.
The use of FIBRO-VEIN is not recommended for the treatment of varicose veins by compression sclerotherapy when any of the following factors
are present:
1. Allergy to sodium tetradecyl sulphate or any component of the preparation.
2. Patients unable to walk due to any cause.
3. Patients currently taking oral contraceptives.
4. Significant obesity.
5. Acute superficial thrombophlebitis.
6. Local or systemic infection.
7. Varicosities caused by pelvic or abdominal tumours.
8. Uncontrolled systemic disease eg diabetes mellitus.
9. Significant valvular incompetence requiring surgical treatment.
SIDE EFFECTS
1. Local: Pain or burning. Skin pigmentation. Tissue necrosis and ulceration may occur with extravasation. Paraesthesia and anaesthesia may
occur if an injection effects a cutaneous nerve.
2. Vascular: Superficial thrombophlebitis. Deep vein thrombosis and pulmonary embolism are very rare. Inadvertent intra-arterial injection is very
rare but may lead to gangrene. Most cases have involved the posterior tibial artery above the medial malleolus.
3. Systemic reactions: Allergic reactions are rare, presenting as local or generalised rash, urticaria, nausea or vomiting, asthma, vascular
collapse. Anaphylactic shock, which may potentially be fatal, is extremely rare.
PRECAUTIONS
1. fibro-vein should only be administered by practitioners familiar with an acceptable injection technique. Thorough pre-injection assessment
for valvular competence and deep vein patency must be carried out.
Extreme care in needle placement and slow injection of the minimal effective volume at each injection site are essential for safe and efficient
use.
2. A history of allergy should be taken from all patients prior to treatment. Where special caution is indicated a test dose of 0.25 to 0.5ml
FIBRO-VEIN should be given up to 24 hours before any further therapy.
3. Treatment of anaphylaxis may require, depending on the severity of attack, some or all of the following: Injection of adrenaline, injection of
hydrocortisone, injection of antihistamine, endotracheal intubation with use of a laryngoscope and suction.
The treatment of varicose veins by fibro-vein should not be undertaken in clinics where these items are not readily available.
4. Extreme caution in use is required in patients with arterial disease such as severe peripheral atherosclerosis or thromboangiitis obliterans
(Buerger’s disease).
5. Special care is required when injecting above and posterior to the medial malleolus where the posterior tibial artery may be at risk.
6. Pigmentation may be more likely to result if blood is extravasated at the injection site (particularly when treating smaller surface veins) and
compression is not used.
7. Do not use with heparin in the same syringe.
8. Safety for use in pregnancy has not been established. Use only when clearly needed for symptomatic relief and when the potential benefits
outweigh the potential hazards to the foetus.
9. It is not known whether sodium tetradecyl sulphate is excreted in human milk. Caution should be exercised when used in nursing mothers.
PHARMACEUTICAL PRECAUTION
Store below 25°C, away from direct sunlight.
The in use period of each 5ml multidose vial is a single session of therapy and for use in the treatment of a single patient. Unused vial contents
should be discarded immediately afterwards.
LEGAL CATEGORY
Prescription only.
PACKAGE QUANTITIES.
FIBRO-VEIN 3% 10 x 5ml Multidose Vials
FIBRO-VEIN 3% 5 x 2ml Single Dose Ampoules
FIBRO-VEIN 1% 5 x 2ml Single Dose Ampoules
FIBRO-VEIN 0.5% 5 x 2ml Single Dose Ampoules
FIBRO-VEIN 0.2% 10 x 5ml Multidose Vials
PRODUCT LICENCE NUMBErs
FIBRO-VEIN 3%
PL 0398/5000
FIBRO-VEIN 1%
PL 0398/0003
FIBRO-VEIN 0.5% PL 0398/0002
FIBRO-VEIN 0.2% PL 0398/0004
SOLD AND SUPPLIED BY: S.T.D PHARMACEUTICAL PRODUCTS LTD., PLOUGH LANE, HEREFORD HR4 OEL. england
MANUFACTURED BY:
HAMELN PHARMACEUTICALS GMBH, LANGES FELD 13, 31789 HAMELN, GERMANY
*Trade Mark
Date of leaflet: August 2009

Your doctor will decide on the areas to treat and the
right dose for you. The usual doses are as follows:
Adults and the elderly
• varies between 0.1 and 1ml for each injection.
A maximum of 10ml of the three lower strength
injections
may be used, however no more than 4ml is used
when the strongest injection is used.
Children
• Fibro-Vein Injection is not recommended for children.
After you have been treated with Fibro-Vein Injection,
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, Fibro-Vein Injection can cause side
effects, although not everybody gets them.
• pain
• burning sensation
• skin pigmentation
• discolouration of the skin
• tingling or numbness
• tissue damage if the injection is outside the vein
• blood clots causing inflammation on the surface
of the skin
• very rarely clots may be formed in the lungs
(pulmonary embolism) or in deep in the veins
(deep vein thrombosis)
• accidental injection into an artery is very rare but
may lead to death of tissue and cells below injection
site (gangrene).
As can happen with any medicine, a few people may
develop an allergic reaction causing
• rash
• itching red skin
• nausea
• vomiting
• difficulty breathing
• feeling faint
A very severe form of allergic reaction (anaphylactic
shock) is extremely rare but should be treated
immediately which otherwise may be fatal.
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 Fibro-Vein Injection
Keep out of the reach and sight of children.
• Fibro-Vein Injection should be stored below 25º C
and away from direct sunlight
• the injection should be stored in the outer carton
to protect it from light

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Fibro-Vein Injection should not be used after the
expiry date given on the carton; the expiry date
refers to the last day of the month.

Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of
6. Further information
What Fibro-Vein Injection contains
The active ingredient is: sodium tetradecyl sulphate
The other ingredients are: benzyl alcohol, disodium
hydrogen phosphate, potassium dihydrogen phosphate,
water for injection, sodium hydroxide or sodium carbonate
may be used to adjust the ph.
What Fibro-Vein Injection looks like and the
contents of the pack
Fibro-Vein Injection is available in 4 different
strengths in the following pack sizes:

Pack size
0.2%w/v
10X5ml vials
0.5%w.v
5X2ml ampoules
1.0% w/v
5X2ml ampoules
3%w/v
5X2ml ampoules
3%w/v
10X5ml vials
Marketing Authorisation Holder:
STD Pharmaceutical Products Ltd.
Plough Lane
Hereford
HR4 0EL
United Kingdom
Manufacturer:
Hameln Pharmaceuticals GMBH
Langes Feld 13
31789 Hameln
GERMANY
Other formats:
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
Fibro-Vein Injection

Reference number
PL 003981/0002

This is a service provided by the Royal
Institute of Blind People
Fibro-Vein 0.2%
PL 00398/0004
Fibro-Vein 0.5%
PL 00398/0002
Fibro-Vein 1%
PL 00398/0003
Fibro-Vein 3%
PL 00398/5000
Leaflet Prepared: August 2009

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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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