APROKAM

Intracameral use. One vial for single-use only. e. 1mg of cefuroxime. 9).

Paediatric population:

The optimal dose and the safety of APROKAM 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 APROKAM, no dose adjustment is necessary. Method of administration APROKAM 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, APROKAM should be inspected visually for particulate matter and discoloration prior to administration. 1ml of the reconstituted solution into the anterior chamber of the eye at the end of the cataract surgery.

6.

No particular adverse effects were reported in the literature when cefuroxime is administered as intraocular injection except the following: Eye disorders Not known (cannot be estimated from the available data): Macular oedema.

Immune system disorders Very rare (<1/10,000):

Anaphylactic reaction. 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 Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Treatment with APROKAM 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 2000 corneal endothelial cells), APROKAM 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.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.

Hypersensitivity to cefuroxime or to the cephalosporin group of antibiotics.