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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.

Pharmaceutical form

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.

Chemical substance
Description
Acetylcholine

Acetylcholine is a physiological neuromediator of postganglionic parasympathetic nerve fibres (muscarinic action), skeletal muscles and ganglia of the sympathetic system (nicotinic action).

List of excipients

Vial:

Mannitol

Ampoule:

Sodium acetate trihydrate
Magnesium chloride hexahydrate
Potassium chloride
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)

Marketing authorization holder
Authorization dates

DR GERHARD MANN CHEM-PHARM FABRIK GMBH BRUNSBUTTELER DAMM 165-173 13581 BERLIN GERMANY

1 May 2001

Marketing authorization number:

PL 13757/0017