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o Blocks activation of the complement.
o Inhibits the synthesis of leukotrenes (SRS-A) by sensitized cells; mast cells,
complement proteins and leukotrenes play an important role in the triggering and
course of allergic reactions and therefore, in the generation of signs and symptoms of
ocular inflammation.
In ocular application, N-Acetyl Aspartyl Glutamic Acid acts locally, thus preventing ocular allergic
inflammatory reactions triggered by one or more allergens (pollen, house dust, etc.).
5.2 Pharmacokinetic properties
Ocular pharmacokinetic studies have indicated penetration of the eye drops in the conjunctiva
enabling a high concentration of the active agent during several hours.
5.3 Preclinical safety data
Not reported.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium hydroxide or hydrochloric acid, water for injections.
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Before opening: 2 years
After opening: 3 months
6.4 Special precautions for storage
Store below 25° C
6.5 Nature and contents of container
Bottle of 5 ml (PE)
Bottle of 10 ml (PE)
6.6 Special precautions for disposal and other handling
Not applicable
7. MARKETING AUTHORISATION HOLDER
LABORATOIRES THEA
12, RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
8. MARKETING AUTHORISATION NUMBER(S)
3
