Fibro-vein 3.0%, 1.0%, 0.5%, 0.2%

Active ingredient

Fibro-vein 3% Sodium Tetradecyl Sulphate BP 3.0% w/v

Fibro-vein 1% Sodium Tetradecyl Sulphate BP 1.0% w/v

Fibro-vein 0.5% Sodium Tetradecyl Sulphate BP 0.5% w/v

Fibro-vein 0.2% Sodium Tetradecyl Sulphate BP 0.2% w/v

For excipients, see 6.1

Intravenous injection

Fibro-vein 3%

For the treatment of varicose veins of the leg by injection sclerotherapy.

Fibro-vein 1%

For the treatment of small varicose veins and the larger venules of the leg by injection sclerotherapy.

Fibro-vein 0.5%

For the treatment of minor venules and spider veins (venous flares) of the leg by injection sclerotherapy.

Fibro-vein 0.2%

For the treatment of minor venules and spider veins (venous flares) by injection sclerotherapy.

Route of administration

For intravenous administration into the lumen of an isolated segment of emptied vein followed by immediate continuous compression.

Recommended doses and dosage schedules.

Adults

Fibro-vein 3%

0.5 to 1.0ml of 3.0% Fibro-vein injected intravenously at each of 4 sites (maximum 4ml).

Fibro-vein 1%

0.25 to 1.0ml of 1.0% Fibro-vein injected intravenously at each of 10 sites (maximum 10ml).

Fibro-vein 0.5%

0.25 to 1.0ml of 0.5% Fibro-vein injected intravenously at each of 10 sites (maximum 10ml).

Fibro-vein 0.2%

0.1 to 1.0ml of Fibro-vein 0.2% injected intravenously at each of 10 sites (maximum 10ml).

The smallest of needles (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.

Children

Not recommended in children

The elderly

As for adults

1. Allergy to sodium tetradecyl sulphate or to 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. Surgical valvular incompetence requiring surgical treatment.

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.

Do not use with heparin in the same syringe

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.

It is not known whether sodium tetradecyl sulphate is excreted in human milk. Caution should be exercised when used in nursing mothers.

None known

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.

Not applicable.

Sodium tetradecyl sulphate damages the endothelium cells within the lumen of the injected vein. The object of compression sclerotherapy is then to compress the vein so that the resulting thrombus is kept to the minimum and the subsequent formation of scar tissue within the vein produces a fibrous cord and permanent obliteration. Non-compressed veins permit the formation of a large thrombus and produce less fibrosis within the vein.

Not applicable.

Not applicable

Benzyl Alcohol BP 2.0% w/v

Di-Sodium Hydrogen Phosphate BP 0.75% w/v

Potassium Di-Hydrogen Phosphate BP 0.1% w/v

Water For Injection BP to 100%

Potassium Di-Hydrogen Phosphate* BP qs

Sodium Carbonate (anhydrous)* BP qs

Sodium Hydroxide (5% soln)* BP qs

* Either sodium carbonate or sodium hydroxide is used for adjustment of pH

Do not use with heparin in the same syringe

36 months

Store below 25°C away from direct sunlight

2ml ampoules type 1 neutral hydrolytic glass conforming with EP requirements for injectable preparations. Five 2ml ampoules per pack.

5ml glass vials type 1 neutral hydrolytic glass conforming with EP requirements for injectable preparations. Sealed with a chlorobutyl rubber bung and silver aluminium "tear off" seal conforming with the European Pharmacopoeia requirements. Ten 5ml vials per pack.

Fibro-vein 3.0% available as 5 x 2ml ampoules and 10 x 5ml vials

Fibro-vein 1.0% available as 5 x 2ml ampoules

Fibro-vein 0.5% available as 5 x 2ml ampoules

Fibro-vein 0.2% available as 5 x 2ml ampoules and 10 x 5ml vials

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.

STD Pharmaceutical Products Ltd

Plough Lane

Hereford

HR4 0EL

United Kingdom

Fibro-vein 3.0% PL 0398/5000R

Fibro-vein 1.0% PL 0398/0003

Fibro-vein 0.5% PL 0398/0002

Fibro-vein 0.2% PL 0398/0004

Fibro-vein 3.0% 23/02/2006

Fibro-vein 1.0% 26/03/2008

Fibro-vein 0.5% 26/03/2008

Fibro-vein 0.2% 26/03/2008

26/03/2008