Diluent for Miochol-E
Active ingredient: water for injection
- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
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 instillation solution for intraocular use. 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
PL13757/0018
9. Date of first authorisation/renewal of the authorisation
9 March 2011
10. Date of revision of the text
July 2012