Diluent for Miochol E
Each ampoule contains 99.77 % water for injection.
For excipients see 6.1.
Solvent for use with Miochol-E 20mg powder for instillation solution for intraocular use. Clear, colourless solution.
For intraocular use.
Diluent for Miochol-E is given for intraocular use, after reconstitution.
This medicine contains potassium, less than 1mmol (39mg) per 2ml dose. This medicine contains less than 1 mmol sodium (23mg) per 2ml dose.
Pharmacotherapeutic group: solvents and diluting agents inc irrigation solutions, ATC code: V07AB
Each of the constituents are well established pharmacopoeial ingredients, so no further information is presented.
Calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium acetate trihydrate.
Following reconstitution with Miochol-E: 6 hours.
No special precautions for storage.
Chemical and physical in-use stability has been demonstrated for 6 hours at 2-8°C or for 6 hours at 25°C
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would not normally be longer than 6 hours at 2-8°C or 6 hours at 25°C.
Type 1 clear glass ampoule with filter.
See Summary of Product Characteristics for Miochol E
Dr. Gerhard MannChem.-Pharm. Fabrik GmbHBrunsbuetteler Damm 165-17313581 Berlin
9 March 2011