APROKAM Powder for solution for injection Ref.[27679] Active ingredients: Cefuroxime

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.

In patients at risk for infections with resistant strains, e.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”.

Since the systemic exposure is expected to be negligible, systemic interactions are unlikely.

No incompatibility with most commonly used products in cataract surgery was reported in literature.

Fertility

There are no data on the effects of cefuroxime sodium on fertility in humans. Reproductive studies in animals have shown no effects on fertility.

Pregnancy

There are limited amount of data from the use of cefuroxime in pregnant woman. Animal studies do not show any harmful effects on embryonal and foetal development. Cefuroxime reaches the embryo/foetus via the placenta. No effects during pregnancy are anticipated, since systemic exposure to cefuroxime using APROKAM is negligible. APROKAM can be used during pregnancy.

Breastfeeding

Cefuroxime is expected to be excreted in human milk in very small quantities. Adverse effects at therapeutic doses are not expected after APROKAM use. Cefuroxime can be used during breastfeeding.

Not relevant.

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. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.