Summary of Product Characteristics (SmPC) - Ethanolamine Oleate injection BP
1 NAME OF THE MEDICINAL PRODUCT
Ethanolamine Oleate Injection (monoethanolamine oleate). Solution for injection.
2. Qualitative and Quantitative Composition
Ethanolamine 0.910% w/v
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.
4.9 Overdose
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.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C. Keep the ampoule in the outer carton.
6.5 Nature and contents of container
5 ml Neutral Glass (Type 1) Ampoules.
6.6 Special precautions for disposal
The product is used only as a sclerosant and injected directly into the varicose vein.
7 MARKETING AUTHORISATION HOLDER
Phoenix Labs
Suite 12, Bunkilla Plaza
Bracetown Business Park
Clonee
Co. Meath
Ireland
8 MARKETING AUTHORISATION NUMBER(S)
PL 35104/0007
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27 March 1987 / 26 May 1994 / 27 May 1999
10 DATE OF REVISION OF THE TEXT
20/02/2015