SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Ethanolamine Oleate Injection BP

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Oleic Acid BP    4.23%    w/v

Ethanolamine    0.91%    w/v

3.    PHARMACEUTICAL FORM

Solution for injection.

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

Ethanolamine oleate is used as a sclerosing    agent in the injection treatment of varicose veins

and oesophageal varices.

4.2    Posology and method of administration

For intravenous injection only.

Adults and the elderly.

For sclerotherapy of varicose veins, 2 - 5ml of a 5% solution of ethanolamine oleate is injected into empty, isolated sections of vein, divided between 3 or 4 sites. Injection into full veins is also possible. For sclerotherapy of oesophageal varices, a suggested dose is 1.5 -5ml of a 5% solution per varix to a maximum total dose of 20ml per treatment session. Treatment may be repeated at intervals until the varices are occluded.

Children

Not recommended.

Contraindications

When used to treat varicose veins of the legs, ethanolamine oleate should not be used in patients with thrombosis or a tendency to thrombosis; acute phlebitis; inability to walk; obese legs; marked arterial, cardiac or renal disease; local or systemic infections; or uncontrolled metabolic disorders such as diabetes mellitus, or with known hypersensitivity. Ethanolamine oleate should not be used in patients taking oral contraceptives.

4.4    Special warnings and precautions for use

Ethanolamine oleate is irritant to skin and mucous membranes. Local injection may cause sloughing, ulceration and in severe cases, necrosis. Adrenaline injection should be available for use in the emergency treatment of an acute allergic reaction. Treatment should be symptomatic and supportive.

4.5    Interaction with other medicinal products and other forms of interaction

None known.

4.6    Pregnancy and lactation

Safety in pregnancy and lactation has not been established and its use is not recommended.

4.7    Effects on ability to drive and use machines

None known.

4.8    Undesirable effects

Pain may occur at the site of injection. Patients receiving treatment for oesophageal varices may develop pleural effusion or infiltration. Hypersensitivity reactions have been reported. Allergic reaction and anaphylaxis have been reported.

4.9    Overdose

Acute reversible renal toxicity has been reported in a patient given 20ml of a 5% solution with 2% benzyl alcohol.

PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Ethanolamine oleate is a sclerosant and injection into a vein results in intraluminal thrombosis. The thrombus occludes the vein and results in intravascular fibrous organisation causing permanent occlusion of a vein.

5.2    Pharmacokinetic properties

Ethanolamine oleate is a locally acting agent and absorption from the site of administration is not anticipated as its mode of action is to cause permanent obstruction of vein.

5.3    Preclinical safety data

None stated

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Benzyl alcohol and Water for Injections.

6.2    Incompatibilities

None stated.

6.3    Shelf life

60 months.

6.4    Special precautions for storage

Protect from light.

Nature and contents of container

Clear colourless ampoules of neutral glass containing 2ml and 5ml of solution. Packed into cartons of 10 ampoules.

6.6    Instructions for use/handling

None stated.

7.    MARKETING AUTHORISATION HOLDER

Macarthys Laboratories Ltd t/a Martindale Pharmaceuticals Bampton Road, Harold Hill, Romford, RM3 8UG

8.    MARKETING AUTHORISATION NUMBER

PL 1883/6132R

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

First authorised 30^th December 1988 Last Renewed June 2004

10.    DATE OF REVISION OF TEXT

June 2004