XIMARACT

Package leaflet: Information for the patient

Ximaract 50 mg powder for injectable solution

cefuroxime
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Ximaract is and what it is used for

Ximaract contains the active substance cefuroxime (in the form of cefuroxime sodium), which belongs to a
group of antibiotics called cephalosporins. Antibiotics are used to kill bacteria or germs that cause
infections.
This medicine will be used if you are undergoing eye surgery due to cataract (clouding of the lens).
The ophthalmic surgeon will administer this medicine by injection into the eye at the end of cataract surgery
in order to prevent an eye infection.

2. What you need to know before you are given Ximaract

Do not take Ximaract if you are allergic to cefuroxime or to any other antibiotic belonging to the
cephalosporin class, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Ximaract

• if you are allergic to other antibiotics, such as penicillin;
• if you have previously had an antibiotic-resistant infection, for example Staphylococcus aureus resistant to methicillin;
• if you are at risk of severe infection;
• if you have been diagnosed with complicated cataract;
• if combined eye surgery is planned;
• if you have severe thyroid disease.

Ximaract must be administered under aseptic conditions as required for cataract surgery (i.e., in a clean, germ-free environment).
Each vial of Ximaract must be used for a single patient only.
Other medicines and Ximaract
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, please consult your doctor or pharmacist before you are given this medicine.
Ximaract will be administered to you only if your doctor clearly considers it necessary.

3. How Ximaract is administered

Ximaract will be administered to you by an ophthalmic surgeon as an injection into the eye, at the end of cataract surgery.
Ximaract is a sterile powder that must be dissolved in an injectable saline solution prior to administration.
If too much or too little Ximaract is administered
The medicine is administered by a healthcare professional. If you think you have received too little or too much medicine, inform your doctor or pharmacist.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or nurse immediately if you experience any of the following symptoms.

• Severe allergic reaction causing raised, itchy rash (hives), difficulty in breathing or dizziness. This side effect is very rare (may affect up to 1 in 10,000 people).
  • Blurred or distorted vision near or in the center of the visual field (macular edema). The frequency of this side effect is "not known", i.e. cannot be estimated from the available data.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ximaract

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label of the vial after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C. Store the vial in the outer carton to protect the medicine from light.
For single use only.
After reconstitution, the product must be used immediately.
Any remaining reconstituted solution must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ximaract contains

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

To prepare the product for intracameral administration, a **sterile needle **(18G x 1½”, 1.2 mm x 40 mm) with a 5-micron filter (acrylic copolymer membrane) must be used.
The filter, needle, and any other equipment required for the preparation of Ximaract are NOT included in the
package.
For details regarding the necessary medical devices and solvents, see the section "How Ximaract is administered".

Description of the appearance of Ximaract and contents of the pack
Ximaract is a white or almost white powder for injectable solution, contained in a clear glass vial.
Each pack contains 1 vial, or 10 or 25 vials. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Bausch & Lomb – IOM S.p.A.
Viale Martesana, 12
20090 Vimodrone (MI)
Italy

Manufacturer:
ACS Dobfar S.p.A.
Via Alessandro Fleming, 2
37135 Verona
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria, Belgium, Bulgaria, Estonia, Italy, Germany, Lithuania, Norway, Netherlands, Poland, Portugal, United Kingdom, Spain, Slovakia, Sweden, Hungary:
Ximaract
France: iCéCA

The following information is intended exclusively for physicians or healthcare professionals:

Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned below:
injectable solution containing sodium chloride 9 mg/ml (0.9%).

How to prepare and administer Ximaract
Single-dose vial for a single intracameral administration.
After reconstitution, Ximaract must be administered by intracameral injection into the anterior chamber of the eye by an ophthalmic surgeon under aseptic conditions recommended for cataract surgery.
The reconstituted solution should be inspected visually and used only if it is a clear, colorless to slightly yellow solution, free from visible particles.
The product must be used immediately after reconstitution and must not be reused.
The medicinal product must be discarded if particles are visible in the solution.

The recommended dose of cefuroxime is 1 mg dissolved in 0.1 ml of an injectable solution of sodium chloride 9 mg/ml (0.9%).
THE RECOMMENDED DOSE MUST NOT BE EXCEEDED.
Single-dose vial for single administration.
Each vial must be used for the treatment of one eye only. If applicable, the detachable label from the vial can be affixed to the patient's medical record.

To prepare the product for intracameral administration, follow these instructions:

1. Check the integrity of the flip-off cap before removing it.
2. Disinfect the outer surface of the vial’s rubber stopper before inserting a sterile needle.
3. Insert the needle perpendicularly into the center of the vial stopper, keeping the vial in an upright position. Inject 5 ml of sodium chloride 9 mg/ml (0.9%) injectable solution into the vial using aseptic technique.
4. Gently shake until the solution becomes clear, colorless to slightly yellow, and free from visible particles.
5. Assemble the sterile needle (18G x 1½”, 1.2 mm x 40 mm) equipped with a 5-micron filter (acrylic copolymer membrane) with a sterile 1 ml syringe. Then, insert the sterile 1 ml syringe perpendicularly into the center of the vial stopper, keeping the vial upright.
6. Aseptically withdraw at least 0.1 ml of the solution. The remaining reconstituted solution in the vial (4.9 ml) must be discarded.
7. Disconnect the 5-micron filter needle from the syringe and attach the syringe to an appropriate cannula for anterior chamber injection.
8. Carefully expel air and excess drug from the syringe by slowly depressing the plunger until the tip of the plunger aligns with the 0.1 ml mark on the syringe. The syringe is now ready for injection.

After use, discard any remaining reconstituted solution. Do not store for later use.
Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.