MIOCHOL-E Powder and solvent for instillation solution Ref.[6058] Active ingredients: Acetylcholine

Miochol-E is for intraocular irrigation only. A freshly prepared 1% solution should be used in the anterior chamber of the eye during surgery.

Adults and Elderly

In most cases a satisfactory miosis, which will last for approximately 20 minutes, is produced in seconds by 0.5-2.0ml. A second application may be made at the discretion of the surgeon if prolonged miosis is required.

Children

Safety and effectiveness in children has not been established.

Route of administration

Intraocular irrigation during surgery.

The symptoms of overdosage are likely to be effects resulting from systemic absorption, ie bradycardia, hypotension, flushing, breathing difficulties and sweating. Atropine sulphate (0.5-1mg) should be given intramuscularly or intravenously and should be readily available to counteract possible overdosage. Adrenaline (0.1-1mg subcutaneously) is also of value in overcoming severe cardiovascular or bronchoconstrictor responses.

Shelf life

Unopened: 24 months.

Opened: Use immediately after reconstitution.

Do not store above 25°C. Do not freeze. Do not resterilise.

Miochol-E is supplied as packs containing 1 blister and 1 filter hub.

Packs are subjected to antimicrobial treatment with ethylene oxide.

One blister contains:

• vial containing powder; clear, colourless type 1 glass with rubber stopper and plastic cap.
• ampoule containing solvent: clear, colourless type 1 glass ampoule with One Point cut (OPC).

One filter hub with 5 micron filter, luer lock (CE marking number: CE 0123)

The reconstituted preparation is a clear, colourless solution.

Warning: Do not use if blister or peelable backing is damaged or broken. Open under aseptic conditions only. The contents of the blister can be guaranteed as sterile.

Directions for preparing Miochol-E:

1. Inspect unopened blister to ensure that it is intact. Peel open blister.
2. Aseptically transfer the ampoule, vial and syringe tip filter hub to sterile field. Maintain asepsis during preparation of solution.
3. Aseptically attach a sterile 18 to 20 gauge, bevelled needle to the luer tip of a sterile disposable syringe with twisting motion to assure secure fit.
4. 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 cut under the point.
5. Remove the needle protector and withdraw the solvent from the ampoule into the syringe. Discard ampoule.
6. Remove and discard plastic cap from top of vial.
7. Insert the needle through the centre of the vial stopper.
8. Transfer the solvent from the syringe to the vial.
9. Shake gently to dissolve drug.
10. Slowly withdraw the solution from the vial through the needle into the syringe.
11. Discard needle.
12. Aseptically open tip filter hub pouch.
13. Aseptically attach filter hub onto luer tip of syringe with a twisting motion to assure secure fit.
14. Aseptically attach a sterile blunt tip irrigation cannula to male luer of filter prior to intraocular irrigation.
15. Discard appropriately after use. Do not reuse the filter hub.

The solution must be mixed just before use since aqueous solutions of acetylcholine are unstable. Only clear and colourless solutions should be used.

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.

Do not use unless a clear and colourless solution is produced. For single use only. Discard any unused solution.