Ximaract

Package Leaflet: Information for the Patient

Ximaract, 50 mg, Powder for Solution for Injection

Cefuroxime

Read All of This Leaflet Carefully Before Using This Medicine Because It Contains Important Information for You.

• You should 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.

Contents of the Pack and Other Information

• 1. What is Ximaract and What is it Used For
• 2. Important Information Before Using Ximaract
• 3. How to Use Ximaract
• 4. Possible Side Effects
• 5. How to Store Ximaract
• 6. Contents of the Pack and Other Information

1. What is Ximaract and What is it Used For

Ximaract contains the active substance cefuroxime (as cefuroxime sodium), which belongs to a group of antibiotics called cephalosporins. Antibiotics are used to kill bacteria or microorganisms that cause infections. This medicine will be used when the patient is undergoing cataract surgery (clouding of the lens). The eye surgeon will administer this medicine as an injection into the eye at the end of the cataract surgery to prevent eye infection.

2. Important Information Before Using Ximaract

Do Not Use Ximaractif you are allergic to cefuroximeor any other cephalosporin antibioticsor any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Before using Ximaract, tell your doctor, pharmacist, or nurse:

• if you are allergic to other antibiotics, such as penicillin,
• if you have a risk of infection caused by bacteria called methicillin-resistant Staphylococcus aureus,
• if you have a risk of severe infection,
• if you have complicated cataract,
• if you are scheduled for combined eye surgery,
• if you have severe thyroid disease.

Ximaract should be administered in aseptic conditions (meaning a clean and microorganism-free environment) during cataract surgery. Each vial of Ximaract is for single use only.

Ximaract and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Ximaract will only be given to you if your doctor thinks it is necessary.

3. How to Use Ximaract

Ximaract injections will be given by the eye surgeon at the end of the cataract surgery. Ximaract is supplied as a sterile (aseptic) powder and is dissolved in a saline solution for injection before use.

Using More Than the Recommended Dose or Less Than the Recommended Dose of Ximaract

The medicine will usually be given by medical staff. If you think you have been given too much or too little of this medicine, tell your doctor or nurse. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should tell your doctor or nurse immediately if you get any of the following:

• Severe allergic reaction, which causes itching skin rash(hives), difficulty breathing, or dizziness. This side effect is very rare (may affect up to 1 in 10,000 people).
• Blurred or wavy vision in the center of the visual field or near it (macular edema). The frequency of this side effect is not known (cannot be estimated from the available data).

Reporting Side Effects

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 to the national medicines agency via their website: https://smz.ezdrowie.gov.pl. 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 which is stated on the carton and vial after: EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Store the vial in the outer carton in order to protect from light. For single use only. The product should be used immediately after preparation of the solution. After use, dispose of any remaining prepared solution. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Ximaract Contains

• The active substance is cefuroxime (as cefuroxime sodium).
• One vial contains 50 mg of cefuroxime.
• After preparation, 0.1 ml of the solution contains 1 mg of cefuroxime.
• The other ingredients are not listed.

In order to prepare the product for intracameral use, sterile needles (18G x 1½’’, 1.2 mm x 40 mm)with a 5-micron filter (acrylic copolymer membrane) should be used. For detailed information on the required medical devices and solvent, see the section “How to Prepare and Administer Ximaract”.

What Ximaract Looks Like and Contents of the Pack

Ximaract is a white to almost white powder for solution for injection, supplied in clear glass vials. One pack contains 1, 10, 25 vials, or 1 vial with one sterile needle with filter, 10 vials with 10 sterile needles with filter, 25 vials with 25 sterile needles with filter. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: BAUSCH + LOMB IRELAND LIMITED, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland. Manufacturer: ACS DOBFAR S.P.A., Via Alessandro Fleming 2, 37135 Verona, Italy. PRESPACK Sp. z o.o., ul. Sadowa 38, 60-185 Skórzewo, Poland.

This Medicinal Product is Authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

Sweden - Ximaract, Austria - Ximaract 50 mg Pulver zur Herstellung einer Injektionslösung, Belgium - Ximaract 50 mg, poudre pour solution injectable, Germany - Ximaract 50 mg Pulver zur Herstellung einer Injektionslösung, Estonia - Ximaract, Spain - Ximaract 50 mg, polvo para solución inyectable, France - iCéCA 50 mg, poudre pour solution injectable, Hungary - Ximaract 50 mg por oldatos injekcióhoz, Italy - Ximaract, Lithuania - Ximaract 50 mg milteliai injekciniam tirpalui, Netherlands - Ximaract 50 mg, poeder voor injectievloeistof, Norway - Ximaract, Poland - Ximaract, Portugal - Ximaract 50 mg Pó para solução injectável, Slovakia - Ximaract 50 mg prášok na injekčný roztok, United Kingdom (Northern Ireland) - Ximaract, Date of Last Revision of the Leaflet:November 2021

Information Intended for Healthcare Professionals Only:

Incompatibilities

Do not mix this medicinal product with other medicinal products except for those mentioned below (sodium chloride 9 mg/ml (0.9%) solution for injection).

How to Prepare and Administer Ximaract

Single-dose vial for intracameral use only. Ximaract must be administered after preparation of the solution, as an intracameral injection by the eye surgeon, under recommended aseptic conditions during cataract surgery. The prepared solution should be inspected visually and should only be used if it is clear, colorless, or yellowish without visible particles. The product should be used immediately after preparation of the solution and not reused.The medicinal product should be discarded if particles are visible in the solution.

Recommended Dose of Cefuroxime is 1 mg in 0.1 ml of Sodium Chloride (Injection Solution) at a Concentration of 9 mg/ml (0.9%).

DO NOT INJECT A DOSE LARGER THAN RECOMMENDED.

Vials are for Single Use Only.

Each Vial is Intended for Use in One Eye Only. The Label of the Vial Should be Affixed to the Patient’s Documentation.

To Prepare Ximaract for Intracameral Use, Follow These Instructions:

• 1. Before removing the flip-off cap, check if it is damaged.
• 2. Disinfect the rubber stopper before step 3.
• 3. Insert the needle vertically into the center of the vial stopper, keeping the vial in an upright position. Then, maintaining asepsis, inject 5 ml of sodium chloride injection solution at a concentration of 9 mg/ml (0.9%) into the vial.
• 4. Gently shake until a clear, colorless, or yellowish solution without visible particles is obtained.
• 5. Mount a sterile needle (18G x 1½’’, 1.2 mm x 40 mm) with a 5-micron filter (acrylic copolymer membrane) on a sterile 1 ml syringe. Insert the syringe vertically into the center of the vial stopper, keeping the vial in an upright position.
• 6. Under aseptic conditions, withdraw at least 0.1 ml of the solution. The remaining diluted solution in the vial (4.9 ml) should be discarded.
• 7. Disconnect the needle with the 5-micron filter from the syringe and attach a sterile cannula intended for intracameral use to the syringe.
• 8. Carefully remove air and excess medicine from the syringe by slowly pressing 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, Dispose of Any Remaining Prepared Solution. Do Not Store Remaining Solution for Reuse.

Any Unused Product or Waste Material Should be Disposed of in Accordance with Local Requirements.

Used Needles Should be Placed in a Sharps Container. {Logo}