Diluent For Miochol E
SUMMARY OF PRODUCT CHARACTERISTICS
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 solutions, ATC code: V07AB
5.2 Pharmacokinetic properties
Not Applicable
irrigation
5.3
Preclinical safety data
Each of the constituents are well established pharmacopoeial ingredients, so no further information is presented.
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 28 °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
See Summary of Product Characteristics for Miochol E
MARKETING AUTHORISATION HOLDER
DR GERHARD MANN
CHEM-PHARM FABRIK GMBH BRUNSBUTTELER DAMM 165-173 13581 BERLIN GERMANY
8 MARKETING AUTHORISATION NUMBER(S)
PL 13757/0018
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/03/2011
10 DATE OF REVISION OF THE TEXT
19/07/2012