XIMARACT

Intracameral use. One vial for single-use only. e. 1 mg of cefuroxime. 9). Paediatric population The optimal dose and the safety of Ximaract have not been established in the paediatric population.

Elderly:

No dose adjustment is necessary.

Patients with hepatic and renal impairment:

Considering the low dose and the expected negligible systemic exposure to cefuroxime using Ximaract, no dose adjustment is necessary. Method of administration Ximaract must be administered after reconstitution by intraocular injection in the anterior chamber of the eye (intracameral use), by an ophthalmic surgeon, in the recommended aseptic conditions of cataract surgery.

6). After reconstitution, Ximaract should be inspected visually for particulate matter and discoloration prior to administration. 1 ml of the reconstituted solution should be slowly injected into the anterior chamber of the eye. Each vial should only be used for the treatment of a single eye.

1 ml). The extractable reconstituted volume (5 ml) is not to be used in total. Injection of the entire volume will result in an overdose. After injection any unused product must be discarded. 6.

No particular adverse reactions were reported in the literature when cefuroxime is administered as intraocular injection except the following: Immune system disorders Very rare (<1/10,000): Anaphylactic reaction.

Eye disorders Not known (frequency cannot be estimated from the available data):

Macular oedema. 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.

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Treatment with Ximaract is for intracameral use only. Special care is indicated in patients who have experienced an allergic reaction to penicillins or any other beta-lactam antibiotics as cross-reactions may occur. g. those with known previous infection or colonisation with MRSA (Methicillin-resistant Staphylococcus aureus), alternative prophylactic antibiotic should be considered.

In the absence of data for special patient groups (patients with severe risk of infection, patients with complicated cataracts, patients having combined operations with cataract surgery, patients with severe thyroid disease, patients with less 2,000 corneal endothelial cells), Ximaract should only be used after careful risk/benefit assessment.

The use of cefuroxime should not be regarded as an isolated measure but other circumstances are also of importance like prophylactic antiseptic treatment. Corneal endothelial toxicity has not been reported at the recommended concentration of cefuroxime; nevertheless, this risk cannot be excluded and in the post-surgical surveillance, physicians should have in mind this potential risk.

Hypersensitivity to the active substance or to the cephalosporin group of antibiotics