TRIUM UD is indicated for hydration and lubrication of the ocular surface in the presence of post-traumatic alterations of the ocular surface.

TRIUM UD is indicated to be instilled 1-2 drops into the conjunctival sac 3 times a day or more as needed.
The product is intended only for topical use on the ocular surface.
The product is intended to be used by general population for self-treatment purposes and is thus designed for use by unskilled/untrained users.
(see Section 6.6).

• The product is for external ophthalmic use only.
• To eliminate the risk of contamination of the solution, avoid contact of the single-dose container with the eye or with other objects.
• To avoid any damage to the eye surface, do not allow the container to come into contact with the eye during instillation.
• The product is packed in single-dose containers. After administration, the residual content of the single-dose container must be discarded as the product contains no preservatives. The re-use of the residual content may cause ophthalmic infection and/or damage to the patient.
• The product is packed in single-dose containers. The volume contained in the single-dose container is suitable for a single administration.
• Consult your doctor if you are receiving concomitant topical ophthalmic drugs.
• Do not use the product if the single-dose container is damaged.
• Keep the preparation out of sight and reach of children.

Not applicable.

Not applicable.

Not applicable.

No undesirable effects have been reported after administration of the product. In case of adverse reactions, stop using the product and consult a physician. After application of the product, there may be a slight burning of the eye and temporary visual discomfort.

Not applicable.

Pharmacotherapeutic group: ATC Code S01XA20: Artificial tears and other indifferent preparations
TRIUM UD hydrates and lubricates the ocular surface, protects the corneal cells, stabilizes and restores the tear film.
Hyaluronic acid is a mucopolysaccharide physiologically present in the human eye which forms part of numerous human tissues and has the property of adhering to the ocular surface protecting, moisturizing and lubricating it. Due to its mucoadhesive properties, it remains on the ocular surface for a long time and stabilizes the lacrimal film.
Based on clinical trials conducted on TRIUM; the Gingko Biloba extract was proven to have Anti-oxidative, Anti-inflammatory and Neuro-protective action, and, together with the lubricating action of hyaluronic acid, supports the restoring of the altered tear film (post-eye-trauma and post-surgery).

From the results of the biocompatibility studies examined in the Biological Evaluation Report (BER) of Trium, the following conclusions can be drawn:
- cytotoxicity, skin sensitization and ocular irritation tests did not show any cytotoxic, irritant or sensitizing effect.
- the tests were performed according to validated methods; the doses and animal species used in the various tests were suitable for the biological evaluation of the device.
- all components used, including the packaging materials, meet the regulatory requirements for
pharmaceutical or food contact regulations.
- the documentation is to be considered adequate to demonstrate the biocompatibility of TRIUM.
Conclusion: cytotoxicity, delayed hypersensitivity and ocular irritation preclinical tests support the biocompatibility of TRIUM. Each study was conducted for the single-dose unit and OSD forms of the product. The studies were conducted according to the relevant official guidelines. The results of the studies are consistent with the characteristics of the ingredients of the product and are in favour of the safety of the product when utilized in the preconized conditions of use. Preclinical data are reported in detail in the BERs of TRIUM.

From the results of the biocompatibility studies examined in the Biological Evaluation Report (BER) of Trium, the following conclusions can be drawn:
- cytotoxicity, skin sensitization and ocular irritation tests did not show any cytotoxic, irritant or sensitizing effect.
- the tests were performed according to validated methods; the doses and animal species used in the various tests were suitable for the biological evaluation of the device.
- all components used, including the packaging materials, meet the regulatory requirements for
pharmaceutical or food contact regulations.
- the documentation is to be considered adequate to demonstrate the biocompatibility of TRIUM.
Conclusion: cytotoxicity, delayed hypersensitivity and ocular irritation preclinical tests support the biocompatibility of TRIUM. Each study was conducted for the single-dose unit and OSD forms of the product. The studies were conducted according to the relevant official guidelines. The results of the studies are consistent with the characteristics of the ingredients of the product and are in favour of the safety of the product when utilized in the preconized conditions of use. Preclinical data are reported in detail in the BERs of TRIUM.

Monobasic Dihydrate Sodium Phosphate 0,22%, Bibasic Dihydrate Sodium Phosphate 0,95%, Sodium Chloride 0,45%, Water for Injection (q.b. to 100 ml).

Not applicable.

Do not store above 25°C. Do not use the product after the expiry date printed on the single-dose container. Do not use the product after six months from the opening of the aluminium sachet. Do not discard in the environment.

Carton box containing 15 single-dose containers, 3 x 5 single-dose strips wrapped in Aluminium sachet (each container 0.35ml).
A product information leaflet is included in the box.

• Separate a single-dose container from the strip.
• Open it by twisting off the top.
• Apply 1-2 drops on the conjunctival sac.
• Discard the closed single-dose container with the remaining contents.