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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fibrovein 3%, 1%, 0.5% and 0.2% Solution for Injection Sodium tetradecyl sulfate

Read all of this leaflet carefully before you start using this medicine.

b

b If you have any further questions, please ask your doctor or pharmacist.

b 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.

b If any of the side effects get serious, or if you notice any

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 sulfate.

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

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 sulfate or to any of the other ingredients in Fibrovein (listed in section 6)

•    cannot walk due to any reason

•

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

•

•    immobility for long duration

•    having hormonal contraception or hormone replacement therapy.

•    smoking

•    have had recent surgery

•

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

•

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)

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)

•

the lungs

affecting the hands and feet (Buerger's disease)

•

•    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

r

ability to drive.

3. How to use Fibrovein

You must not

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:

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

Sulfate.

Each 5 ml vial contains 10 mg Sodium Tetradecyl Sulfate.

Fibrovein 0.5% Solution for Injection

Each ml solution for injection contains 5mg Sodium Tetradecyl

Sulfate.

Each 2 ml ampoule contains 10 mg Sodium Tetradecyl Sulfate.

Fibrovein 1% Solution for Injection

Each ml solution for injection contains 10mg Sodium Tetradecyl

Sulfate.

Each 2 ml ampoule contains 20 mg Sodium Tetradecyl Sulfate.

Fibrovein 3% Solution for Injection

Each ml solution for injection contains 30mg Sodium Tetradecyl

Sulfate.

Each 2 ml ampoule contains 60 mg Sodium Tetradecyl Sulfate. Each 5 ml vial contains 150 mg Sodium Tetradecyl Sulfate.

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

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

* 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

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Adults and the elderly

•    varies between 0.1 and 2 ml for eachinjection. A maximum of 10 ml of the three lower strength! injections may be used, however no more ttian 4 ml is used when the strongest injectionis used.

Due to the l imited volume of sclerosant authorised, repeated sessions of sclerotherapy may be necessary.

Children

•    Fibrovein Is not Intended for use for children.

Afferyou have been treated with: Fibrovein, you should follow your doctor's advice. You may be told to wear a bandage and or/compresslon stockings to help reduce inflammation and pigmentation of the skin.

• Fibrovein should not be used after the expiry date given on the carton; the expiry date refers to the Iast day of the month.

For singles use only. Once the container I s opened, the contents should be used I immediately. Any remaining product should be discarded.

Medicines should not be disposed ofvia wastewater orhousehold waste. Ask your pharmacist how to dispose of medicines no I onger required. These measures will help) protect the environment

6. Contents of the pack and further information

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, otherwiseit may be fatal Also a blood clot In the I ungs I s very rare. To avoid t his very rare serious event, t his product Is contra-indicatedin 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).

Othier side effects that may be experienced are:

Common (at least 1 in 100 but lessthan 1 in10patients):

Pain or burning (short term at the Injection sites)

Skin discolouration Superficial inflammation of the vein Growth of very fine spider veins in the treated area (matting) Uncommon (at least 1 in1,000 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 ininththeecchheesstt

Burning, tingllng, prickling or Itching of the skin Headache, migraine, feeling faint Confusion, dizziness, Ioss 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 flf administered as allquid)

Weakness, stroke Iike symptoms

Blockage of artery due to a clot (stroke, transient Ischemic attack, pulmonary embolism)

Inflammation of blood vessels, failure of blood circulation

Deatri of tissue following Intra-arterial injection

It you experience any serious side effects or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately.

What Fibrovein contains

The activeingredient Is: sodium tetradecyl sulfate.

For the 0.2%:

Each ml of solution for injection contains 2mg Sodium Tetradecyl Sulfate.

Each 5 ml vial contains 10 mg Sodium Tetradecyl Sulfate.

For I hie 0.15%:

Each ml of solution for injection contains 5mg Sodium Tetradecyl Sulfate.

Each 2 ml ampoule contains 10 mg Sodium Tetradecyl Sulfate. Forthie 1%:

Each ml of solution forinjection contains 10mg Sodium Tetradecyl Sulfate.

Each 2 ml ampoule contains 20mg Sodium Tetradecyl Sulfate. For the 3%:

Each ml of solution forinjection contains 30mg Sodium Tetradecyl Sulfate.

Each 2ml ampoule contains 60mg Sodium Tetradecyl Sulfate. Each 5ml vial contains 150mg Sodium Tetradecyl Sulfate.

The otheringredients are: benzyl alcohol (20 mg/ml), disodium phosphates! dodecahydrate, potassium dihydrogen phosphate!, waterfor Injections, sodium hydroxide (to adjust the pH).

What Fibrovein looks like and the contents of the pack

This medicinal product I s presented as a solution for I njection I n

clear glass ampoules or vials. The solutionis clear and colouriess.

For the 0.2%: pack size 2, 5or 10vials of 5 ml

For Ihe 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 of5ampoules of 2 ml or2, 5or 10vials of

5 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

STD Pharmaceutical Products Ltd.

Plough Lane, Hereford, HR40EL, United Kingdom

Manufacturer:

STD Pharmaceutical Products Ltd.

Plough Lane, Hereford, HR40EL, United Kingdom

This medicinal product I s authorisedin the Member States of the EEA under the following names: UK, FR, PT and CZ: Fibrovein ES 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 followinginformation:

5. How to store Fibrovein

Keep out the reach and sight of chiidren

•    This medicinal product does not require any special storage conditions

•    Do not freeze

• Theinjection should be stored In the outer carton to protectit from I ight

This Is a service provided by Ihe Royal National Institute of Blind People.

This leaflet was last revised on 08/2014

extravasation; therefore, extreme care I n I ntravenous needle placement and using the minimal effective volume at each injection site are importanti The solution should beinjected slowly. Care should be taken not to I nject the solutioninto an artery as this may I ead to death of the tissue (tissue necrosis) and may result I n I oss of the I imb.

Special care must be taken wheninjecting the foot and above and below the ankle (malleolar area) due to risk to one of the arteries. Compression must be applled when treating smallerveins as pigmentation may occur If blood Is expelled at theinjection site. Allergic reactions Including anaphylaxis have been reported and the physician should be prepared to treatit appropriately. Emergency resuscitation equipment should be immediately available.

The patient should be treatedin hospital as a precaution.

To Prepare the Foam (Tessari technique)

Strict aseptic technique must be maintained whiiemanufacturing the foam.

To create the foam 1ml ofllquid sclerosant Is drawninto a steriie syringe and 3ml or 4ml of steriie air is drawn Into anothier sterile

s

sterile. The syringes are then connected using a steriie thiree way tap/valve (Fig. 1))

The sclerosant/air mixtureis then forced back and forth from one syringe to the othier thirough 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

Fig 1

Fig 2

Fiji 3

Fig -4

injected Immediately (Fig. 4))

The sclerosant foam should be used withiin sixty seconds of production. After sixty seconds any remaining foam should be discarded. More foam should be preparedif required.

The quality of the foam should be checked before I ts administration. It should appear homogenous with nolarge bubbles visible to I hie naked eye.

The quality of foam depends on specific criteria:

1.    The product concentration: Foam can only be prepared withi concentrations of 1 to 3% sodium tetradecyl sulfate.

2. The proportion of Iiquid to air Usually, this proportion Is 1 volume ofllquid for 3 volumes of air

3.    Numberof 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, soff and cohesive withi no visible large bubbles. It

large bubbles are visible, the foam should be thirown 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 movementi

6.    The maximum time between preparation and I njection:

The sclerosant foammust be used withiin sixty seconds of production. After sixty seconds, any remaining foam should be discarded. More foam should be preparedif required.

Pharmaceutical Particulars List of excipients

Benzyl alcohol

Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Sodium hydroxide ((for pH adjustment)

Water for Injections

Shelf llfe

33yyeeaarrss..

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 feeze.

Keep the vial/ampoule I n the outer carton I n order to protect from light

Nature and contents (of containers

5ml vials (Type 1 glass) withi a stopper and aluminium seal withi

flip-off cap.

2ml ampoules (Type 1 glass).

Special precautions for disposal

There are no special requirements Ior disposal.

LL00004488

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