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

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: DR GERHARD MANN CHEM-PHARM FABRIK GMBH BRUNSBUTTELER DAMM 165-173 13581 BERLIN GERMANY

Contraindications

There are no known contra-indications to the use of Miochol-E in cataract or anterior segment surgery.

Special warnings and precautions for use

If miosis is to be obtained quickly and completely, obstructions to miosis such as anterior or posterior synechiae may require surgery prior to administration of Miochol-E. In cataract surgery Miochol-E should be used only after delivery of the lens.

If blister or paper backing is damaged or broken, sterility of the Miochol-E vial cannot be assured. The solvent should be in the upper chamber before use. If the centre rubber plug in the univial does not go down when the plunger-stopper is pressed or is already down, the vial should not be used.

Aqueous solutions of Miochol-E are unstable. The solution should therefore be prepared immediately before use. Any remainder should be discarded.

Interaction with other medicinal products and other forms of interaction

Although clinical studies with acetylcholine chloride and animal studies with acetylcholine or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine and carbachol have been ineffective when used in patients treated with topical non-steroidal anti-inflammatory agents.

Pregnancy and lactation

The safety and efficacy of Miochol-E in pregnancy and lactation have not been established. Miochol-E should not be used in pregnant or lactating patients.

Effects on ability to drive and use machines

Not applicable.

Undesirable effects

Adverse reactions which are indicative of systemic absorption have been reported rarely in the literature. Symptoms include bradycardia, hypotension, flushing, breathing difficulties and sweating. Isolated cases of corneal oedema, corneal clouding and corneal decompensation have been reported with the use of Miochol-E, although a causal relationship has not been established.

Incompatibilities

None known. The filter hub is recommended only for use with Miochol-E.

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