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Bausch & Lomb U.K Limited
Bausch & Lomb House, 106 London Road, Kingston-upon-Thames, Surrey, KT2 6TN, UK
Telephone: +44 (0)208 781 2900
Fax: +44 (0)208 781 2901
Medical Information Direct Line: +44(0)1748 828849 or 08 1871 9318
Medical Information e-mail: medicalinformationuk@bausch.com
Customer Care direct line: +44 (0)208781 2991

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Summary of Product Characteristics last updated on the eMC: 18/10/2011
SPC Diluent for Miochol-E


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1. NAME OF THE MEDICINAL PRODUCT

Diluent for Miochol E


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ampoule contains 99.77 % water for injection.

For excipients see 6.1.


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3. PHARMACEUTICAL FORM

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


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

None


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4.2 Posology and method of administration

For intraocular use.

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


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4.3 Contraindications

Not Applicable


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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.


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4.5 Interaction with other medicinal products and other forms of interaction

Not Applicable


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4.6 Pregnancy and lactation

Not Applicable


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4.7 Effects on ability to drive and use machines

Not Applicable


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4.8 Undesirable effects

Not Applicable


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4.9 Overdose

Not Applicable


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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


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5.2 Pharmacokinetic properties

Not Applicable


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5.3 Preclinical safety data

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


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

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


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6.2 Incompatibilities

Not Applicable


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6.3 Shelf life

3 years

Following reconstitution with Miochol-E: 6 hours.


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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.


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6.5 Nature and contents of container

Type 1 clear glass ampoule with filter.


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6.6 Special precautions for disposal and other handling

See Summary of Product Characteristics for Miochol E


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7. MARKETING AUTHORISATION HOLDER

Dr. Gerhard Mann

Chem.-Pharm. Fabrik GmbH

Brunsbuetteler Damm 165-173

13581 Berlin

Germany


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8. MARKETING AUTHORISATION NUMBER(S)

PL13757/0018


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12 January 2006


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10. DATE OF REVISION OF THE TEXT

May 2011


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11. LEGAL CATEGORY

POM



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/25078/SPC/


Active Ingredients/Generics

 
  water for injection