Summary of Product Characteristics
last updated on the eMC:
15/09/2005
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SPC
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Ethanolamine Oleate Injection BP (UCB Pharma Ltd)
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Go to top of the page | Ethanolamine Oleate Injection (monoethanolamine oleate). Solution for injection. | |
Go to top of the page | Oleic acid 4.23% w/vEthanolamine 0.910% w/vFor excipients see 6.1. | |
Go to top of the page | Solution for injection.5 ml neutral glass ampoule containing a clear solution. | |
Go to top of the pageGo to top of the page | The injection is recommended for use as a sclerosing agent in the treatment of small, uncomplicated varicose veins in the lower extremities. | |
Go to top of the page | Ethanolamine Oleate is administered by slow intravenous injection. Adults Including The Elderly The product is used only as a sclerosant and injected directly into the varicose vein. A dose of 2 to 5ml, divided between 3 or 4 sites, administered by slow injection into empty isolated segments of vein.Children The product is not recommended for use in children. | |
Go to top of the page | Inability to walk, acute phlebitis, oral contraceptive use, obese legs, known hypersensitivity to Ethanolamine Oleate or benzyl alcohol. Superficial thrombophlebitis and deep vein thrombosis in the region of the varicose veins. Marked arterial, cardiac or renal disease. Uncontrolled metabolic disorders such as diabetes mellitus. Patients with local or systemic infections. | |
Go to top of the page | Care should be taken to ensure that the injection does not leak into perivenous tissue which could cause sloughing, ulceration and in severe cases, necrosis. | |
Go to top of the pageGo to top of the page | Safety during pregnancy has not been established. Use in pregnancy is not recommended. | |
Go to top of the pageGo to top of the page | Burning, cramping sensation, urticaria. Allergic reactions and anaphylaxis have been reported following use of sclerosing agents. | |
Go to top of the page | Acute nephrotoxicity has been reported in two patients given 15-20ml of a solution containing 5% Ethanolamine with 2% Benzl Alcohol. | |
Go to top of the pageGo to top of the page | ATC Code: C05B B 01; sclerosing agent for local injection.Ethanolamine Oleate is an irritant. An injection of Ethanolamine Oleate into a vein irritates the intimal endothelium resulting in the formation of a thrombus. The thrombus occludes the vein and fibrous tissue develops resulting in a permanent obliteration of the vein. | |
Go to top of the page | Ethanolamine Oleate is a locally acting agent. Absorption from the site of administration is not anticipated as its mode of action is to cause a permanent obstruction in the vein. | |
Go to top of the pageGo to top of the pageGo to top of the page | Benzyl alcohol Water for Injection | |
Go to top of the pageGo to top of the pageGo to top of the page | Do not store above 25°C. Keep the ampoule in the outer carton. | |
Go to top of the page | 5 ml Neutral Glass (Type 1) Ampoules. | |
Go to top of the page | The product is used only as a sclerosant and injected directly into the varicose vein. | |
Go to top of the page | UCB Pharma Limited208 Bath RoadSloughBerkshireSL1 3WEUK | |
Go to top of the pageGo to top of the page | 27 March 1987 / 26 May 1994 / 27 May 1999 | |
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