Patient leaflet - DILUENT FOR MIOCHOL E
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2. Things to consider before you are given Miochol-E
Some people MUST NOT have Miochol-E.
Talk to your doctor if:
- You think you may be allergic to acetylcholine chloride or to any of the other ingredients. (These are listed at the end of the leaflet.) Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
- You are pregnant or breastfeeding.
Are you taking other medicines?
Some medicines can interfere with the way Miochol-E works. Tell your doctor or nurse if you are applying preparations containing NSAIDs (non-steroidal anti-inflammatory drugs, e.g. ibuprofen or diclofenac) to your skin to treat pain and swelling.
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
Will there be any problems with driving or using machinery?
Your vision may be affected both by the eye surgery and by the use of Miochol-E. You should not drive or use machinery while you have any problems.
3. How Miochol-E is used
Your surgeon will work out the correct dose of Miochol-E for you. In most cases between 0.5 and 2 ml will be a suitable dose. The same dose is used both for adults and the elderly.
Your surgeon will determine when to use Miochol-E. In cataract surgery Miochol-E should only be used after the replacement lens has been inserted into the eye.
Miochol-E is applied drop by drop into the eye during surgery. (This is called intraocular irrigation.)
The solution will be made up just before it is needed by a healthcare professional. The use of Miochol-E in children has not been studied, and therefore it is not recommended.
What if you are given too much?
If you are given more Miochol-E than you need, your doctor may need to give you an injection of either atropine sulphate or adrenaline to control symptoms. Symptoms
of overdose may include slow heart rate, low blood pressure, flushing, breathing difficulties and sweating.
4. Possible side effects
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Break open the ampoule containing the solvent. The One Point Cut (OPC) ampoule must be opened as follows: Hold the bottom part of the ampoule with the thumb pointing to the coloured point. Grasp the top of the ampoule with the other hand, positioning the thumb at the coloured point and press back to break at the existing etched mark under the point.
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5. Remove the needle protector and withdraw the solvent from the ampoule into the syringe. Discard the empty ampoule.
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6. Remove and discard the plastic cap from the top of vial.
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Insert the needle through the centre of the vial stopper.
Transfer the solvent from the syringe to the vial.
Shake gently to dissolve drug.
Slowly withdrawthe solution from the vial through theneedle into the syringe.
Discard needle.
Aseptically open the filter hub pouch.
Aseptically attach the filter hub to the luer tip of syringe with a twisting motion to assure secure fit.
Aseptically attach a sterile blunt tip irrigation cannula to male luer of filter prior to intraocular irrigation.
Discard appropriately after use.
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Do not reuse the filter hub.
The solution must be mixed just before use, since aqueous solutions of acetylcholine are unstable. Do not use unless a clear and colourless solution is produced.
For single use only. Discard any unused solution.
Miochol-E should not be re-sterilised. The filter hub is recommended only for use with Miochol-E. Aspiration through the filter is not recommended. However, if utilised, discard needle and syringe filter to prevent recontamination of fluids during injection. Do not aspirate and inject through the same filter.
How to store Miochol - E
- Do not store Miochol-E above 25°C. Do not freeze.
- Do not use any Miochol-E after the expiry date printed on the box.
- Do not use any Miochol-E pack that is damaged or shows signs of tampering.
- Keep Miochol-E out of the reach and sight of children.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom
Yellow Card Scheme at: . gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
HPRA Pharmacovigilance Website:
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store miochol-e
Keep all medicines out of the reach and sight of children.
Miochol-E should not be stored above 25°C. It should not be frozen.
It should not be used after the expiry date which is printed beside the letters “EXP" on the carton and the blister. The expiry date refers to the last day of that month.
It should not be used if the blister or peelable backing is damaged or broken.
The re-constituted solution should be
PlUKIE04_Miochol-E_20POW_2SOL_UKIE_l 10122_04.indd 2
used immediately.
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6. Further Information