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Approved SPC FR/H/296/01/II/18
Diclofenac did not show mutagenic and carcinogenic potential.
No effects were observed after repeated instillation of diclofenac 1 mg/ml in the eye of the rabbit for up to 3
months.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Macrogolglycerol ricinoleate
Trometamol
Boric acid
Water for injections
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the medicinal product as packaged for sale: 2 years
Shelf life after first opening of the container: 8 weeks.
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
10 ml in bottle (PE) with a dropper equipped with an antimicrobial filter (polyethersulphone) and a media
(LDPE), closed by a cap (PE).
6.6 Special precautions for disposal and other handling
No special requirements.
7. MARKETING AUTHORISATION HOLDER
Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
8. MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
[To be completed nationally]
10. DATE OF REVISION OF THE TEXT
[To be completed nationally]
11. DOSIMETRY
