Akantior

HOS-288675 · has-adverse-reaction-information · PDF-Seite 4

Summary of safety profile The most common adverse reactions are eye pain (13.0%) and ocular hyperaemia (11.6%). The most serious are corneal perforation (1.4%), corneal transplant (1.4%) and visual impairment (1.4%), 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

Auszug; vollständigen Abschnitt im Original lesen.

HOS-288671 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Subjects with urgent need of ocular surgery due to advanced Acanthamoeba keratitis.

HOS-288670 · has-indication-information · PDF-Seite 2

AKANTIOR is indicated for the treatment of Acanthamoeba keratitis in adults and children from 12 years of age.

HOS-288673 · has-interaction-information · PDF-Seite 3

No interaction studies have been performed. Local interactions with other medicinal products cannot be excluded. 3 If more than one topical ophthalmic product is being used, AKANTIOR must be administered at least 5 minutes after the last administration. As systemic absorption of polihexanide after use of AKANTIOR is negligible or not detectable, no interactions with systemic medicinal products are expected.

HOS-288674 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no data from the use of polihexanide in pregnant women. Animal studies using oral administration do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of AKANTIOR during pregnancy. Breast-feeding It is unknown whether polihexanide is excreted in human milk. A decision must be made as to whether to discontinue breast-feeding or to discontinue/abstain from AKANTIOR therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility There are no data on the effects of polihexanide on human fertility.

HOS-288672 · has-warning-information · PDF-Seite 3

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.