Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: SIFI S.p.A., Via Ercole Patti, 36, 95025 Aci SantAntonio (CT), Italy
AKANTIOR 0.8 mg/mL eye drops, solution in single-dose container.
| Pharmaceutical Form |
|---|
|
Eye drops, solution in single-dose container (eye drops). Clear, colourless solution, practically free of visible particles. pH: 5.6 – 6.0 Osmolality: 270 – 330 mOsmol/kg |
Each mL of solution contains 0.8 mg polihexanide (0.08% w/w). One drop (about 0.032 g) contains on average 0.025 mg polihexanide.
Excipients with known effect:
Each drop of the solution contains approximately 0.4 mg phosphates which is equivalent to 11 mg/mL.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Polihexanide |
Polihexanide acts on both the active trophozoite and dormant cystal forms of Acanthamoeba. Polihexanide is a polycationic polymer composed of hexamethylene biguanide units and has a dual-targeted mechanism of action that involves disruption of Acanthamoeba cell membranes and DNA binding. |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate monohydrate |
AKANTIOR is contained in low density polyethylene (LDPE) single-dose containers filled with 0.3 mL solution.
The single-dose containers are moulded in 5-unit sealed strips which in turn are wrapped in a polyester/aluminium/polyethylene sachet and packaged inside a carton box.
Pack sizes:
Not all pack sizes may be marketed.
SIFI S.p.A., Via Ercole Patti, 36, 95025 Aci Sant’Antonio (CT), Italy
EU/1/24/1840/001
EU/1/24/1840/002
EU/1/24/1840/003
| Drug | Countries | |
|---|---|---|
| AKANTIOR | Austria, Estonia, Finland, Lithuania |
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