AKANTIOR Eye drops Ref.[113673] Active ingredients: Polihexanide

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.

Adults and children from 12 years of age

The recommended dose is 1 drop of AKANTIOR in the affected eye according to the following regimen:

Intensive 19-day treatment phase:

• 16 times a day at 1-hour intervals, daytime only, for five days
• 8 times a day at 2-hour intervals, daytime only, for further seven days
• 6 times a day at 3-hour intervals, daytime only, for further seven days

Continuation treatment phase:

• 4 times a day at 4-hour intervals, until cure (i.e. corneal healing, absence of corneal inflammation or no evidence of infection) and for no longer than 12 months.

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.

No information is available on overdose in humans; overdose is unlikely to occur after ocular administration.

If overdose occurs, treatment should be symptomatic and supportive.

2 years.

After opening the sachet:

Once the outer sachet has been opened, the single-dose containers must be used within 28 days (after this period, any unused single-dose containers must be discarded).

After opening the single-dose container:

The contents of the single dose container must be used immediately after opening.

This medicinal product does not require any special storage conditions.

For storage conditions after first opening of the medicinal product, see section 6.3.

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:

• 20 single-dose containers
• 30 single-dose containers
• multipack containing 120 (4 packs of 30) single-dose containers

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.