Ximaract

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Ximaract is and what it is used for
2. What you need to know before you are given Ximaract
3. How Ximaract is administered
4. Possible side effects
5. How to store Ximaract
6. Contents of the pack and other information

Talk to your doctor, pharmacist or nurse before you are given Ximaract:

• if you have had a reaction to other antibiotics such as penicillin;
• if you have previously had an antibiotic resistant infection e.g. Methicillin-resistant Staphylococcus aureus;
• if you are at risk of a severe infection;
• if you have been diagnosed with a complicated cataract;
• if combined eye surgery is planned;
• if you have severe thyroid disease.

Ximaract should be administered in aseptic conditions (meaning clean and germ free) of cataract surgery.

One vial of Ximaract must be used for one patient only.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.

You will only be given Ximaract if your doctor thinks it is clearly necessary.

Your medication will usually be given by the health professional. If you think you may have received too little or too much medicine, please tell your doctor or nurse.

• Serious allergic reaction which causes a raised itchy skin rash (urticaria or ‘hives’), difficulty in breathing, or dizziness. The side effect is very rare (may affect up to 1 in 10,000 people).
• Blurry or wavy vision near or in the center of your field of vision (macular oedema). The frequency of this side effect is not known (cannot be estimated from the available data).

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is cefuroxime (as cefuroxime sodium).
• Each vial contains 50 mg of cefuroxime.
• After reconstitution, 0.1 ml solution contains 1 mg of cefuroxime.
• There are no other ingredients.

To prepare the product for intracameral administration, a sterile needle (18G x 1½”, 1.2 mm x 40 mm) with 5-micron filter (acrylic co-polymer membrane) must be used.

For details on the required medical devices and solvent, please refer to “How to prepare and administer Ximaract”.

Ximaract is a white to almost white powder for solution for injection, supplied in a clear, transparent glass vial.

Each box contains 1 vial, 10 vials, 25 vials or 1 vial together with 1 sterile filter needle, 10 vials together with 10 sterile filter needles, 25 vials together with 25 sterile filter needles. Not all pack sizes may be marketed.

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