SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Ethanolamine Oleate Injection (monoethanolamine oleate). Solution for injection.

2. Qualitative and Quantitative Composition

Ethanolamine    0.910% w/v

(monoethanolamine oleate 5.0% w/v, prepared by the interaction of Ethanolamine and Oleic Acid)

For excipients see 6.1.

3 PHARMACEUTICAL FORM

Solution for injection.

5 ml neutral glass ampoule containing a clear solution.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

The injection is recommended for use as a sclerosing agent in the treatment of small, uncomplicated varicose veins in the lower extremities.

4.2 Posology and method of administration

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.

4.3 Contraindications

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.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, Pregnancy and lactation

Safety during pregnancy has not been established. Use in pregnancy is not recommended.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Burning, cramping sensation, urticaria. Allergic reactions and anaphylaxis have been reported following use of sclerosing agents.

Acute nephrotoxicity has been reported in two patients given 15-20ml of a solution containing 5% Ethanolamine with 2% Benzl Alcohol.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

None.

6.    Pharmaceutical Particulars

6.1    List of excipients

Oleic acid

Benzyl alcohol 2.0% v/v (20.8 mg/ml) Water for Injection

6.2    Incompatibilities

Not applicable.

10 DATE OF REVISION OF THE TEXT

20/02/2015