Ceftaroline fosamil Qilu 600 mg powder for concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ceftaroline fosamil Qilu 600 mg powder for concentrate for solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Ceftaroline fosamil Qilu is and what it is used for
2. What you need to know before using Ceftaroline fosamil Qilu
3. How to use Ceftaroline fosamil Qilu
4. Possible side effects
5. How to store Ceftaroline fosamil Qilu
6. Contents of the pack and other information

1. What Ceftaroline Fosamil Qilu is and what it is used for

What Ceftaroline Fosamil Qilu is

Ceftaroline Fosamil Qilu is an antibiotic medicine that contains the active substance ceftaroline fosamil. It belongs to a group of medicines known as "cephalosporin antibiotics".

What Ceftaroline Fosamil Qilu is used for

Ceftaroline fosamil is used to treat children (from birth) and adults with:

• skin and soft tissue infections
• a lung infection called "pneumonia"

How Ceftaroline Fosamil Qilu works

Ceftaroline fosamil works by killing certain bacteria that can cause serious infections.

2. What you need to know before starting to use Ceftaroline fosamil Qilu

Do not use Ceftaroline fosamil Qilu

• if you are allergic to ceftaroline fosamil or to 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 previously had severe allergic reactions to other antibiotics such as penicillin or carbapenem.

Ceftaroline fosamil must not be administered to you if any of the above apply to you. If you are unsure, consult your doctor or nurse before receiving this medicine.

Warnings and precautions

Consult your doctor or nurse before starting ceftaroline 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 previously experienced severe diarrhea when taking antibiotics.

You may develop another infection caused by different bacteria during or after treatment with ceftaroline fosamil.

You may develop signs and symptoms of serious skin reactions such as fever, joint pain, rash, red scaly rash, pus-filled skin bumps, blisters or skin peeling, circular red spots often with central blisters on the trunk, mouth ulcers, or sores in the throat, nose, genitals, and eyes. If this occurs, consult your doctor or nurse immediately.

Laboratory tests

You may develop an abnormal response in a laboratory test (called Coombs test) that detects certain antibodies that may act against red blood cells. If your red blood cell levels decrease, your doctor may check whether these antibodies have caused the reduction in red blood cells.

If any of the above apply to you (or you are unsure), consult your doctor or nurse before receiving ceftaroline fosamil.

Other medicines and Ceftaroline fosamil Qilu

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before receiving this medicine.

If you are pregnant, consult your doctor before receiving ceftaroline fosamil. Do not use this medicine during pregnancy unless your doctor has instructed you to do so.

Driving and operating machinery

Ceftaroline fosamil may cause adverse effects such as dizziness. This may affect your ability to drive or operate machinery.

3. How to use Ceftaroline fosamil Qilu

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

How much to use

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

The usual recommended dose for children depends on the child's age and weight and is administered 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 eliminated from the body through the kidneys.

Method of administration

Intravenous route (into a vein) after reconstitution and dilution.

This medicine is administered by intravenous infusion over 5 to 60 minutes if you receive the usual dose, or over 120 minutes if you receive a higher dose.

Duration of treatment

A treatment course usually lasts 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, inform your doctor or nurse immediately.

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

If you did not receive a dose of Ceftaroline fosamil Qilu

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine:

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

• sudden swelling of the lips, face, throat or tongue; a severe rash; and difficulty swallowing or breathing. These may be signs of a severe allergic reaction (anaphylaxis) and could be life-threatening;
• diarrhoea that becomes severe or does not stop, or stools containing blood or mucus during or after stopping treatment with ceftaroline fosamil. In this situation, you should not take medicines that stop or slow down intestinal movement.

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

• changes in a blood test called the “Coombs test”, frequently observed in patients receiving this type of antibiotic. This test detects certain antibodies that may act against your red blood cells.

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

• fever
• headache
• dizziness
• itching, skin rash
• diarrhoea, stomach pain
• nausea or vomiting
• increased production of liver enzymes (detected in blood tests)
• pain and irritation of the veins
• redness, pain or swelling at the injection site.

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

• anaemia
• itchy, raised rash (urticaria)
• increased level of creatinine in the blood. Creatinine indicates how well your kidneys are functioning
• unusual bleeding or bruising. This may be due to a reduced number of platelets in the blood
• changes in tests that measure how your blood clots
• a decrease in the total number of white blood cells, or certain types of white blood cells in the blood (leucopenia and neutropenia)
• changes in mental state, such as confusion, reduced level of consciousness, abnormal movements or seizures (encephalopathy): these have occurred in people when the dose administered was too high, especially in people with kidney problems.

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

• a significant decrease in certain white blood cells in the blood (agranulocytosis). You may develop fever, flu-like symptoms, sore throat or other infections that could be serious.
• an increase in certain white blood cells in the blood (eosinophilia).

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

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 stated on the container. The expiry date refers to the last day of the month indicated.

Store below 30 °C.

Keep in the original packaging to protect from light.

After reconstitution:

The reconstituted concentrate should be diluted immediately.

After dilution:

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

From a microbiological standpoint, the medicine should be used immediately, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination. If not used immediately, the duration of storage and conditions prior to use are the responsibility of the user.

Medicines must not be disposed of via wastewater or household waste. Hospitals will safely dispose of all waste materials. This helps protect the environment.

6. Contents of the container and other information

Composition of Ceftaroline fosamil Qilu

• 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 component is arginine.

Appearance of the product and contents of the container

Ceftaroline fosamil Qilu is a yellowish-white to light yellow powder for concentrate for solution for infusion in a vial. It is available in pack sizes containing 1 vial and 10 vials.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th Floor, 28046 - Madrid,

Spain

Manufacturer

KYMOS S.L.

Ronda de Can Fatjó, 7B (Parc Tecnològic del Vallès),

Cerdanyola del Vallès,

08290 Barcelona,

Spain

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona.

Spain

Tel.: +34 93 342 78 90

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: 12/2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

This information is intended for healthcare professionals only:

Important: Consult the summary of product characteristics before prescribing.

An aseptic technique must be used to prepare and administer the solution.

The contents of the Ceftarolina fosamile Qilu vial must be reconstituted with 20 ml of water for injections. Immediately after addition, the vial should be shaken immediately, and the resulting concentrate should then be diluted immediately before use. Below are the instructions for reconstituting the Ceftarolina fosamile Qilu vial:

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

The reconstituted solution must be further diluted to prepare the Ceftaroline fosamil Qilu infusion solution. A 250 ml, 100 ml, or 50 ml infusion bag may be used to prepare the infusion, based on the patient's required 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 Lactated Ringer's solution. The resulting solution should be administered according to the selected dose over 5 to 60 minutes for the standard dose or 120 minutes for the high dose, using infusion volumes of 50 ml, 100 ml, or 250 ml.

The total time interval between the start of reconstitution and completion of intravenous infusion preparation must not exceed 30 minutes.

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

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

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

Each vial is for single use only.

Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned above.