Country: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Sodium tetradecyl sulfate 1%{relative}
InterMed Medical Ltd
Sodium tetradecyl sulfate 1% w/v
1 %
Solution for injection
Active: Sodium tetradecyl sulfate 1%{relative} Excipient: Benzyl alcohol Dibasic sodium phosphate Monobasic potassium phosphate Sodium hydroxide Water for injection
Ampoule, glass, 2ml, 5 dose units
Prescription
Prescription
Cambrex Karlskoga AB
The treatment of varicose veins of the leg by injection sclerotherapy.
Package - Contents - Shelf Life: Ampoule, glass, 2ml - 5 dose units - 36 months from date of manufacture stored at or below 25°C
1969-12-31
NEW ZEALAND DATASHEET 1 PRODUCT NAME FIBROVEIN 3.0%, 1.0%, 0.5% and 0.2% intravenous injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Tetradecyl Sulphate 3.0%, 1.0%, 0.5% and 0.2% intravenous injection Contains 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 Fibrovein 3% and 1%: For the treatment of varicose veins of the leg by injection sclerotherapy. Fibrovein 0.5%: For the treatment of varicose veins and venous flares of the leg by injection sclerotherapy. Fibrovein 0.2%: For the treatment of minor venules and spider veins (venous flares) by injection sclerotherapy. 4.2 Dose 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 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 veins with the 1% and 3% solutions. 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. RECOMMENDED DOSES AND DOSAGE SCHEDULES: ADULTS Fibrovein 3.0%: 0.5 to 1.0ml of 3.0% Fibrovein injected intravenously at each of 4 sites (maximum 4ml). Fibrovein 1.0%: 0.25 to 1.0ml of 1.0% Fibrovein injected intravenously into the lumen of an isolated segment of emptied superficial vein, followed by immediate compression. A maximum of 10 sites (10ml total) m Lestu allt skjalið