Diluent for Miochol-E

1. Name Of The Medicinal Product

Diluent for Miochol E

2. Qualitative And Quantitative Composition

Each ampoule contains 99.77 % water for injection.

For excipients see 6.1.

3. Pharmaceutical Form

Solvent for use with Miochol-E 20mg powder for solution for intraocular irrigation. Clear, colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

None

4.2 Posology And Method Of Administration

For intraocular use.

Diluent for Miochol-E is given for intraocular use, after reconstitution.

4.3 Contraindications

Not Applicable

4.4 Special Warnings And Precautions For Use

This medicine contains potassium, less than 1mmol (39mg) per 2ml dose. This medicine contains less than 1 mmol sodium (23mg) per 2ml dose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not Applicable

4.6 Pregnancy And Lactation

Not Applicable

4.7 Effects On Ability To Drive And Use Machines

Not Applicable

4.8 Undesirable Effects

Not Applicable

4.9 Overdose

Not Applicable

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: solvents and diluting agents inc irrigation solutions, ATC code: V07AB

5.2 Pharmacokinetic Properties

Not Applicable

5.3 Preclinical Safety Data

Each of the constituents are well established pharmacopoeial ingredients, so no further information is presented.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium acetate trihydrate.

6.2 Incompatibilities

Not Applicable

6.3 Shelf Life

3 years

Following reconstitution with Miochol-E: 6 hours.

6.4 Special Precautions For Storage

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.

6.5 Nature And Contents Of Container

Type 1 clear glass ampoule with filter.

6.6 Special Precautions For Disposal And Other Handling

See Summary of Product Characteristics for Miochol E

7. Marketing Authorisation Holder

Dr. Gerhard Mann

Chem.-Pharm. Fabrik GmbH

Brunsbuetteler Damm 165-173

13581 Berlin

Germany

8. Marketing Authorisation Number(S)

PL13757/0018

9. Date Of First Authorisation/Renewal Of The Authorisation

12 January 2006

10. Date Of Revision Of The Text

May 2011

11. LEGAL CATEGORY

POM