CEFTAROLINA FOSAMILO QILU 600 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Ceftaroline Fosamil Qilu

Do not useCeftaroline Fosamil Qilu

• if you are allergic to ceftaroline fosamil or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to cephalosporins (a class of antibiotics)
• if you have had severe allergic reactions to other antibiotics such as penicillin or carbapenem.

Do not have ceftaroline fosamil if any of the above applies to you. If you are not sure, talk to your doctor or nurse before you are given this medicine.

Warnings and precautions

Talk to your doctor or nurse before you start usingceftaroline fosamil:

• if you have kidney problems (your doctor may need to prescribe a lower dose)
• if you have ever had seizures (epileptic fits or convulsions)
• if you have ever had a non-severe allergic reaction to other antibiotics such as penicillin or carbapenem
• if you have had severe diarrhea when taking antibiotics in the past.

You may get another infection caused by another bacterium during or after treatment with ceftaroline fosamil.

You may develop signs and symptoms of severe skin reactions such as fever, joint pain, skin rash, scaly red rash, pus-filled bumps on the skin, blisters, or peeling of the skin, red circular patches often with blisters in the center on the trunk, ulcers in the mouth, throat, nose, genitals, and eyes. If this happens, talk to your doctor or nurse immediately.

Lab tests

You may develop an abnormal response to a lab test (called a Coombs test) that detects certain antibodies that can act against your red blood cells. If your red blood cell level decreases, your doctor may check if these antibodies have caused this decrease in red blood cells.

If any of the above applies to you (or you are not sure), talk to your doctor or nurse before you are given ceftaroline fosamil.

Other medicines and Ceftaroline Fosamil Qilu

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before using this medicine.

If you are pregnant, talk to your doctor before using ceftaroline fosamil. Do not use this medicine during pregnancy unless your doctor has told you to.

Driving and using machines

Ceftaroline fosamil may cause side effects such as dizziness. This may affect your ability to drive or use machines

3. How to use Ceftaroline Fosamil Qilu

Ceftaroline fosamil will be given to you by a doctor or nurse.

How much to use

The recommended dose for adults is 600 mg every 12 hours. Your doctor may increase your dose to 600 mg every 8 hours for some infections.

The recommended dose for children depends on the child's age and weight and is given every 8 or 12 hours.

Use in patients with kidney problems

If you have kidney problems, your doctor may reduce your dose because ceftaroline fosamil is removed from the body by the kidneys.

Method of administration

By intravenous infusion (into a vein) after reconstitution and dilution.

This medicine is given through a drip into a vein over 5 to 60 minutes if you receive the standard dose or 120 minutes if you receive a higher dose.

Duration of treatment

A treatment cycle usually lasts from 5 to 14 days for skin infections and 5 to 7 days for pneumonia.

If you use more Ceftaroline Fosamil Qilu than you should

If you think you may have been given too much ceftaroline fosamil, tell your doctor or nurse immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.

If you miss a dose of Ceftaroline Fosamil Qilu

If you think you have missed a dose, tell your doctor or nurse immediately.

If you have any other questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Tell your doctor immediately if you get any of these symptoms, as you may need urgent medical treatment:

• sudden swelling of the lips, face, throat, or tongue; a severe rash; and problems swallowing or breathing. These may be signs of a severe allergic reaction (anaphylaxis) and can be life-threatening;
• severe diarrhea that does not stop or bloody stools during or after stopping treatment with ceftaroline fosamil. In this situation, do not take medicines that stop or slow down bowel movements.

Very common: (may affect more than 1 in 10 people)

• changes in a blood test called “Coombs test” often seen in patients receiving this type of antibiotic. This test detects certain antibodies that can act against your red blood cells.

Common: (may affect up to 1 in 10 people)

• fever
• headache
• feeling dizzy
• itching, skin rash
• diarrhea, stomach pain
• nausea or vomiting
• increased production of liver enzymes (detected in blood tests)
• vein pain or irritation
• redness, pain, or swelling at the injection site.

Uncommon: (may affect up to 1 in 100 people)

• anemia
• raised itchy rash (urticaria)
• an increase in the level of creatinine in the blood. Creatinine indicates how well your kidneys are working
• bleeding or bruising more than usual. This may be due to a decrease in the level of platelets in the blood
• changes in tests that determine how your blood clots
• a decrease in the total number of white blood cells, or a certain type of white blood cells in the blood (leucopenia and neutropenia).
• changes in your mental state, such as confusion, reduced level of consciousness, abnormal movements, or seizures (encephalopathy): these have occurred in people when the dose given is too high, especially in people with kidney problems.

Rare: (may affect up to 1 in 1,000 people)

• a significant decrease in the number of certain white blood cells in the blood (agranulocytosis). You may get a fever, symptoms similar to flu, sore throat, or another infection that could be serious.
• an increase in the number of certain white blood cells in the blood (eosinophilia).

Frequency not known (cannot be estimated from the available data)

• a type of lung disease where eosinophils (a type of white blood cell) appear in the lungs in greater numbers (eosinophilic pneumonia).

Sudden chest pain, which may be a sign of a potentially serious allergic reaction, observed with other medicines of the same type called Kounis syndrome. If this happens, talk to a doctor or nurse immediately.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftaroline Fosamil Qilu

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. The expiry date refers to the last day of the month shown.

Store below 30°C.

Store in the original package to protect from light.

After reconstitution:

The reconstituted concentrate should be diluted immediately.

After dilution:

Chemical and physical stability has been demonstrated for up to 24 hours at 2-8°C and 6 hours at 25°C.

From a microbiological point of view, the product should be used immediately, unless the method of opening/reconstitution/dilution prevents the risk of microbial contamination. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. The hospital will dispose of all waste materials safely. This will help protect the environment.

6. Contents of the pack and other information

What Ceftaroline Fosamil Qilu contains

• The active substance is ceftaroline fosamil. Each vial contains 600 mg of ceftaroline fosamil.
• After reconstitution, 1 ml of concentrate contains 30 mg of ceftaroline fosamil.
• The other ingredient is arginine.

Appearance and pack size

Ceftaroline Fosamil Qilu is a white to light yellow powder for concentrate for solution for infusion in a vial. It is available in packs containing 1 vial and 10 vials.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

Planta 8, 28046 - Madrid,

Spain

Manufacturer

KYMOS S.L.

Ronda de Can Fatjó, 7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès,

08290 Barcelona,

Spain

or

Eurofins Analytical Services Hungary Kft.

Anonymus utca 6.

Budapest, H-1045,

Hungary

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona.

Spain

Phone: +34 93 342 78 90

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:12/2024

Detailed information on this medicine is available on the website of the Spanish Medicines and Healthcare Products Agency (AEMPS) (http://www.aemps.gob.es/)

This information is intended only for healthcare professionals:

Important: Consult the summary of product characteristics before prescribing.

Aseptic technique should be used to prepare and administer the solution.

The contents of the vial of Ceftaroline Fosamil Qilu should be reconstituted with 20 ml of water for injection. After addition, the vial should be shaken immediately, and the resulting concentrate should be diluted immediately before use. The instructions for reconstitution of the vial of Ceftaroline Fosamil Qilu are summarized below:

The reconstitution time is less than 2 minutes. Mix gently but immediately to reconstitute and check visually that the contents have dissolved completely. Parenteral medicines should be inspected visually for particulate matter and discoloration prior to administration.

The reconstituted solution should be further diluted to produce the Ceftaroline Fosamil Qilu infusion solution. A 250 ml, 100 ml, or 50 ml infusion bag can be used to prepare the infusion, based on the required patient volume. Suitable diluents for infusion include sodium chloride 9 mg/ml (0.9%) solution for injection, dextrose 50 mg/ml (5%) solution for injection, sodium chloride 4.5 mg/ml and dextrose 25 mg/ml solution for injection (0.45% sodium chloride and 2.5% dextrose), or Ringer's lactate solution. The resulting solution should be administered over 5 to 60 minutes for the standard dose or 120 minutes for the high dose in infusion volumes of 50 ml, 100 ml, or 250 ml.

The total time between the start of reconstitution and the end of preparation of the intravenous infusion should not exceed 30 minutes.

The color of the infusion solution ranges from clear, pale yellow to yellow depending on the concentration and storage conditions. It is free from particles. When stored as recommended, the potency of the product is not affected.

The infusion volumes for pediatric patients will vary according to the child's weight. The concentration of the infusion solution during preparation and administration should not exceed 12 mg/ml of ceftaroline fosamil.

After administration, it is recommended to flush the intravenous line with a sodium chloride 0.9% (9 mg/ml) injection solution to ensure that the entire dose is administered.

Each vial is for single use only.

Disposal of unused medicine and all materials that have been in contact with it should be done in accordance with local regulations.

Incompatibilities

This medicine should not be mixed with other medicines, except for those mentioned above.