Ethanolamine Oleate Injections Bp
PACKAGE LEAFLET: INFORMATION FORTHE USER
Ethanolamine Oleate Injection BP
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Read all this leaflet carefully before you are given
Ethanolamine Oleate Injection
• 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 5. 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).
t works by irritating the inside of blood vessels causing them to harden and scar tissue to form, which stops the blood flowing through them.
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 nto 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.
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.
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
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: September 2012 © Martindale Pharmaceuticals
Martindale JkA, Pharmaceuticals fVi
Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom
C91 322 ____________0