Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium tetradecyl sulfate
STD Pharmaceutical Products Ltd
C05BB04
Sodium tetradecyl sulfate
30mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02130000; GTIN: 5019363132018
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 Read the complete document
OBJECT 1 FIBROVEIN 3% Summary of Product Characteristics Updated 19-Feb-2016 | STD Pharmaceutical Products Ltd 1. Name of the medicinal product Fibrovein 3.0%, 1.0%, 0.5%, 0.2% Solution for Injection 2. Qualitative and quantitative composition Fibrovein 3.0% Each ml solution for injection contains 30mg Sodium Tetradecyl Sulfate. Each 2ml ampoule contains 60mg Sodium Tetradecyl Sulfate. Each 5ml vial contains 150mg Sodium Tetradecyl Sulfate. Fibrovein 1.0% Each ml solution for injection contains 10mg Sodium Tetradecyl Sulfate. Each 2ml ampoule contains 20mg Sodium Tetradecyl Sulfate. Fibrovein 0.5% Each ml solution for injection contains 5mg Sodium Tetradecyl Sulfate. Each 2ml ampoule contains 10 mg Sodium Tetradecyl Sulfate. Fibrovein 0.2% Each ml solution for injection contains 2mg Sodium Tetradecyl Sulfate. Each 5ml vial contains 10 mg Sodium Tetradecyl Sulfate. Contain benzyl alcohol 20mg/ml. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection. Clear, colourless, sterile solution. pH 7.5 7.9. Osmolarity 247 273 mOsm/kg. 4. Clinical particulars 4.1 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. 4.2 Posology and method of administration 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 size of non-visible varicose veins should be measured under ultrasound. 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), for the treatment of larger vei Read the complete document