MIOCHOL-E Powder and solvent for instillation solution (2014)
Active ingredients: Acetylcholine
Product Name and Form
Miochol-E, 20mg, Powder and Solvent for instillation solution for intraocular use.
Powder and solvent for instillation solution for intraocular use.
Vial: white solid or powder
Ampoule: clear, colourless solution
Filter: syringe filter
Qualitative and Quantitative Composition
Each powder vial contains 20mg acetylcholine chloride. Miochol-E contains 10mg/ml of acetylcholine chloride, (20mg in 2ml) upon reconstitution. For excipients, see section 6.1.
Sodium acetate trihydrate
Magnesium chloride hexahydrate
Calcium chloride dihydrate
Water for injections
Pack sizes and Marketing
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)
DR GERHARD MANN CHEM-PHARM FABRIK GMBH BRUNSBUTTELER DAMM 165-173 13581 BERLIN GERMANY
1 May 2001