Akantior

AKANTIOR should be prescribed by physicians experienced in the diagnosis and treatment of Acanthamoeba keratitis. Posology AKANTIOR should be started as early as possible in the course of Acanthamoeba infection. e. corneal healing, absence of corneal inflammation or no evidence of infection) and for no longer than 12 months.

2 Reinitiation of intensive treatment. The 19-day intensive regimen phase may be reinitiated if a deterioration (or exacerbation) of ocular inflammation occurs during the continuation treatment phase and Acanthamoeba culture is negative.

Treatment with AKANTIOR should be stopped if deterioration is accompanied by a positive culture. Discontinuation of treatment. AKANTIOR should be discontinued in patients with failure to achieve cure within 12 months of treatment start.

Special populations Paediatric population The safety and efficacy of AKANTIOR in children younger than 12 years has not yet been established. No data are available. Elderly No dose adjustment is required in patients 65 years of age and older.

Method of administration For ocular use. For single use only. The contents of the single-dose container must be used immediately after opening. Patients should be instructed: • To avoid contact between the single-dose container tip and the eye or eyelids.

• To use the solution immediately after opening the single-dose container and to discard it afterwards. • To instil AKANTIOR at least 5 minutes after any other ophthalmic product.

6%). 4%), which are also part of the natural history of the disease. Tabulated list of adverse reactions The adverse reactions listed below were observed in clinical trials in patients treated with AKANTIOR with a reasonable possibility of causality to the medicinal product.

Adverse reactions are presented according to MedDRA system organ classification (SOC and Preferred Term Level). They are classified according to the subsequent convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000) and not known (cannot be estimated from available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 4 Table 1: Adverse reactions observed in clinical trial 043/SI System organ class Frequency Adverse reactions Infections and infestations Common Conjunctivitis Eye infection Eye disorders Very common Eye pain Ocular hyperaemia Common Corneal perforation Visual impairment Ulcerative keratitis Corneal epithelium defects Corneal infiltrates Punctate keratitis Tearing Conjunctival hyperaemia Eye inflammation Eye irritation Photophobia Conjunctival papillae Eye pruritus Eye discharge Eye swelling Foreign body sensation Ocular discomfort Dry eye General disorders and administration site conditions Common Condition aggravated Application site pain Application site discomfort Product intolerance Application site pruritus Injury, poisoning and procedural complications Common Persistent epithelial defect Toxicity to various agents Surgical and medical procedures Common Corneal transplant Adverse reactions reported in phosphate containing eye drops Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

AKANTIOR may cause mild to moderate eye discomfort (such as eye pain) and eye redness. The patient should be advised to contact the doctor in case of concern or a severe eye reaction. No data are available on the use of AKANTIOR in subjects with immunodeficiency disorders or requiring systemic immunosuppressive therapy.

Excipients AKANTIOR contains phosphates. Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

1. Subjects with urgent need of ocular surgery due to advanced Acanthamoeba keratitis.