Acetylcholine 1% Intraocular Solution

VERBATIM UK SPC §4.2 (Miphtel 20 mg powder and solvent for solution for intraocular irrigation): 'MIPHTEL is for intraocular use. The lyophilised powder should be reconstituted with the solvent just before use as described in section 6.6. The reconstituted solution should be clear and colourless. The reconstituted solution should be slowly withdrawn from the ampoule into a suitable sterile syringe and should be administered into the anterior chamber of the eye during surgery. In cataract surgery, acetylcholine should be used only after delivery of the lens. Following surgery, if miosis is necessary, it must be maintained by longer acting topical miotics such as pilocarpine or physostigmine. 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.' §2: 'Each powder ampoule contains 20mg acetylcholine chloride. 2ml of the reconstituted solution contain 20mg of acetylcholine chloride. Each ml of the reconstituted solution provides 10mg of acetylcholine chloride.' §4.1: 'To obtain rapid and complete miosis after delivery of the lens in cataract surgery as well as in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid complete miosis is required.' The SPC prints no maximum volume and no paediatric dose (children: not established), so none is given.