Ximaract

Package leaflet: Information for the patient

Ximaract, 50 mg, powder for solution for injection
Cefuroximum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Ximaract is and what it is 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 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 pathogenic microorganisms that cause infections.
This medicine will be used when the patient undergoes cataract surgery (clouding of the lens).
The ophthalmic surgeon will administer this medicine as an intraocular injection at the end of the surgical procedure (cataract surgery) to prevent eye infection.

2. Important information before using Ximaract

Do not use Ximaract if the patient is allergic to cefuroxime or any other
antibiotics of the cephalosporin group or to any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Before using Ximaract, inform the doctor, pharmacist, or nurse:

• if the patient is allergic to other antibiotics, such as penicillin,
• if the patient is at risk of infection caused by bacteria called methicillin-resistant Staphylococcus aureus,
• if the patient is at risk of severe infection,
• if the patient has been diagnosed with complicated cataract,
• if a combined eye surgical procedure is planned,
• if the patient has severe thyroid disease.

Ximaract should be administered under aseptic conditions (meaning clean and free from
microorganisms) during cataract surgery.
Each vial of Ximaract is intended for use in a single patient only.
Ximaract and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Ximaract will be administered to the patient only if the doctor considers it necessary.

3. How to use Ximaract

Ximaract injections will be administered by an ophthalmic surgeon at the end of cataract surgery.
Ximaract is supplied as a sterile powder and is dissolved in saline solution for injection prior to administration.
Use of a higher or lower dose of Ximaract than recommended
The medicine will usually be given by medical personnel. If the patient thinks they have received too low or too high a dose of the medicine, they should inform the doctor or nurse.
If there are any further doubts regarding the use of this medicine, consult the doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your doctor or nurse if you experience any of the following symptoms:

• Severe allergic reaction causing itchy skin rash (urticaria), difficulty breathing, or dizziness. This adverse reaction is very rare (may occur in fewer than 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 adverse reaction is unknown (cannot be estimated from available data).

Reporting adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ximaract

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after: expiry.
The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store the vial in the outer packaging to protect from light.
For single use only.
The product should be used immediately after solution preparation.
After use, any remaining prepared solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ximaract contains

• The active substance is cefuroxime (in the form of cefuroxime sodium).
• Each vial contains 50 mg of cefuroxime.
• After reconstitution, 0.1 ml of solution contains 1 mg of cefuroxime.
• The medicine does not contain any other ingredients.

To prepare the product for intracameral administration, sterile needles (18G x
1½ ", 1.2 mm x 40 mm) with a 5-micron filter (acrylic copolymer membrane) must be used.
For detailed information on the required medical devices and solvent,
see 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.
Each pack contains 1, 10, 25 vials or 1 vial with one sterile filtered needle, 10 vials with 10
sterile filtered needles, 25 vials with 25 sterile filtered needles.
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

Manufacturers
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 European Economic Area and 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

Information intended exclusively for medical professionals:

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

How to prepare and administer Ximaract
Single-use vial for intracameral administration only.
Ximaract must be administered as a prepared solution by intracameral injection, performed by an ophthalmic surgeon under recommended aseptic conditions during cataract surgery.
The prepared solution should be visually inspected and used only if it is clear, colourless or slightly yellow, and free from visible particles.
The product must be used immediately after preparation and must not be reused. The medicinal product should be discarded if particles are visible in the solution.

The 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 EXCEEDING THE RECOMMENDED DOSE.
Vials are for single use only.
Each vial is intended for use in one eye only. The vial label should be attached to the patient’s documentation.

To prepare Ximaract for intracameral administration, follow these instructions:

1. Before removing the flip-off cap, check that it is not damaged.
2. Disinfect the surface of 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, under aseptic conditions, inject 5 ml of sodium chloride solution for injection at a concentration of 9 mg/ml (0.9%) into the vial.
4. Gently shake until a clear, colourless or slightly yellow solution, free from visible particles, is obtained.
5. Attach a sterile needle (18G x 1½'', 1.2 mm x 40 mm) with a 5-micron filter (acrylic copolymer membrane) to a sterile 1 ml syringe. Insert the syringe vertically into the center of the vial stopper, keeping the vial upright.
6. Under aseptic conditions, withdraw at least 0.1 ml of the solution. Discard the remaining diluted solution in the vial (4.9 ml).
7. Remove the 5-micron filtered needle from the syringe and attach to the syringe a sterile cannula intended for intracameral administration.
8. Carefully remove air and excess medication from the syringe by slowly depressing the plunger until the plunger tip aligns with the 0.1 ml mark on the syringe. The syringe is now ready for injection.

After use, any remaining prepared solution must be discarded. Do not store any leftover solution for subsequent use.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Used needles should be placed in a sharps medical waste container.
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