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ETHANOLAMINE OLEATE INJECTIONS BP

Active substance(s): ETHANOLAMINE / OLEIC ACID

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Package leaflet: information for the user

Ethanolamine Oleate Injection BP
Read all this leaflet carefully before you are given
Ethanolamine Oleate Injection

C9132200000

• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your
doctor or nurse
• If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or nurse

In this leaflet:
1. What Ethanolamine Oleate Injection is and what it is
used for
2. Before Ethanolamine Oleate Injection is used
3. How Ethanolamine Oleate Injection will be given
4. Possible side effects
5. Storing Ethanolamine Oleate Injection
6. Further information
This leaflet is a summary of the information available for
this medication.

1. What Ethanolamine Oleate Injection is
and what it is used for
Ethanolamine Oleate Injection is used to seal veins in the
body that have become too large (varicose veins).
It works by irritating the inside of blood vessels causing
them to harden and scar tissue to form, which stops the
blood flowing through them.

4. Possible side effects
If you experience any of the following side effects
you should tell your doctor immediately. These are
symptoms of an allergic reaction.
• difficulty in breathing with or without swelling of the
face, lips, tongue and/or throat
• swelling of the face, lips tongue and/or throat, which
may cause difficulty in swallowing
• severe itching of the skin (with raised lumps).
Tell the doctor or nurse immediately if you
experience a burning sensation (irritation) at the site of
injection or feel unwell during treatment with Ethanolamine
Oleate Injection.
Ethanolamine Oleate may also cause any of the
following:
• Pain at the site of injection.
• Skin loss, ulceration or, in severe cases, permanent
tissue damage, if injected into local tissue.
• Fluid in the lungs may develop if used to treat veins in
the oesophagus (gullet).
• Reversible kidney damage in patients treated with the
maximum recommended dose of the injection.
Symptoms will include reduction in the amount of
urine passed, vomiting and confusion.
If you experience any of these or other side effects tell a
doctor or nurse immediately.

5. Storing Ethanolamine Oleate Injection
2. Before Ethanolamine Oleate Injection is
given
Tell your doctor before this medicine is given if any of
the following apply to you, as your treatment may need
to be changed:
• You suffer from thrombosis (blood clots) or are
aware that you have a tendency to thrombosis
• You are allergic (hypersensitive) to any of the
ingredients in the product (listed in section 6)
• You suffer from any diseases of the heart, kidneys or
blood vessels
• You suffer from any uncontrolled metabolic disorder
such as diabetes mellitus (type 2 diabetes)
• You are suffering from any infections
• You are suffering from an inflammation of a vein
• You are unable to walk
• You are to have treatment for varicose veins in your
legs and your legs are obese
• You are taking oral contraceptives (birth control)
• You are pregnant or are breast-feeding.

3. How Ethanolamine Oleate Injection
will be given
Your doctor will inject Ethanolamine Oleate Injection
into the empty varicose vein avoiding contact with the
surrounding area, as this may be harmful.
Adults and the Elderly
Treatment of varicose veins within the oesophagus
(gullet):
The usual dose is 1.5 - 5ml injected into each vein to a
maximum of 20ml per session.
The treatment may be repeated at intervals until all the
varicose veins are closed.

This product has an expiry date on the ampoule and
carton labels. The doctor or nurse will check that the
product has not passed this date. Any product that has
passed this date must be returned to a pharmacist for
safe disposal.
Protect from light.
Keep out of the reach and sight of children.

6. Further Information
What is in this medicine:
The active ingredients are Oleic Acid (4.23% w/v) and
Ethanolamine (0.91% w/v).
The other ingredients are Benzyl Alcohol and water for
injections.
What this medicine looks like and contents of the pack
Ethanolamine Oleate Injection BP is a clear pale yellow
liquid in 2ml or 5ml clear glass ampoules in packs of
10 ampoules.
Marketing Authorisation Holder and Manufacturer
Martindale Pharmaceuticals, Bampton Road, Romford,
RM3 8UG.
Product Licence Number: PL 1883/6132R
Date of revision:
© Martindale Pharmaceuticals

Treatment of other varicose veins:
The usual dose is 2 - 5ml injected into empty sections of
the vein, divided between 3 - 4 sites.
Children
Not recommended.

C9132200000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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