Ceftaroline fosamil Qilu

Package leaflet: Information for the patient

CEFTAROLINA FOSAMIL QILU 600 mg powder for concentrate for solution for infusion

ceftaroline fosamil
Generic medicine
Please read this leaflet carefully before you are given 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 or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

1. What CEFTAROLINA FOSAMIL QILU is and what it is used for
2. What you need to know before you are given CEFTAROLINA FOSAMIL QILU
3. How CEFTAROLINA FOSAMIL QILU is administered
4. Possible side effects
5. How to store CEFTAROLINA FOSAMIL QILU
6. Contents of the pack and other information

1. What CEFTAROLINA FOSAMIL QILU is and what it is used for

CEFTAROLINA FOSAMIL QILU
CEFTAROLINA FOSAMIL QILU is an antibiotic medicine containing the active substance
ceftarolina fosamil. It belongs to a group of medicines called 'cephalosporin antibiotics'.
What CEFTAROLINA FOSAMIL QILU is used for
CEFTAROLINA FOSAMIL QILU is used to treat children (from birth) and adults with:

• skin and soft tissue infections
• a lung infection called 'pneumonia'.

How CEFTAROLINA FOSAMIL QILU works
CEFTAROLINA FOSAMIL QILU works by destroying certain bacteria that can cause serious infections.

2. What you need to know before being administered CEFTAROLINE FOSAMIL QILU

Do not be administered 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 other cephalosporin antibiotics
• if you have previously experienced severe allergic reactions after taking other antibiotics such as penicillins or carbapenems.

CEFTAROLINE FOSAMIL QILU must not be administered if any of the above conditions apply. If you have any doubts, consult your doctor or nurse before receiving this medicine.

Warnings and precautions

Talk to your doctor or nurse before being administered CEFTAROLINE FOSAMIL QILU:

• if you have kidney problems (your doctor may consider prescribing a lower dose)
• if you have ever had sudden seizures (epileptic seizures or convulsions)
• if you have previously experienced mild allergic reactions after taking other antibiotics such as penicillins or carbapenems
• if you have previously experienced severe diarrhoea while taking other antibiotics

You may develop another infection caused by different bacteria during or after treatment with CEFTAROLINE FOSAMIL QILU.

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

Laboratory tests

You may have an abnormal laboratory test result (called Coombs test), which detects the presence of certain antibodies that may act against red blood cells. If your red blood cell count decreases, your doctor may check whether these antibodies have caused this effect.

If any of the above conditions apply to you (or if you have any doubts), consult your doctor or nurse before being administered CEFTAROLINE FOSAMIL QILU.

Other medicines and CEFTAROLINE FOSAMIL QILU

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

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before being administered this medicine.
Ask your doctor for advice before being administered CEFTAROLINE FOSAMIL QILU if you are pregnant. Do not use this medicine during pregnancy unless specifically instructed by your doctor.

Driving and using machines

CEFTAROLINE FOSAMIL QILU may cause undesirable effects such as dizziness. These effects may impair your ability to drive or operate machinery.

3. How CEFTAROLINA FOSAMIL QILU is administered

CEFTAROLINA FOSAMIL QILU will be administered to you by a doctor or a nurse.
Dose to be taken
The usual recommended dose for adults is 600 mg every 12 hours. Your doctor may increase the 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.
Patients with renal problems
If you have kidney problems, your doctor may reduce the dose, as CEFTAROLINA FOSAMIL QILU is eliminated from the body via the kidneys.
Method of administration
Intravenous use (into a vein) after reconstitution and dilution
This medicine is administered by intravenous infusion into a vein over a period of 5–60 minutes if receiving the usual dose, or over 120 minutes if receiving a higher dose.
Duration of treatment
A treatment course usually lasts from 5 to 14 days for skin infections and from 5 to 7 days for pneumonia.
If you are given more CEFTAROLINA FOSAMIL QILU than you should
If you think you have been given too much CEFTAROLINA FOSAMIL QILU, inform your doctor or nurse immediately.
If you miss a dose of CEFTAROLINA FOSAMIL QILU
If you think you have missed a dose, inform your doctor or nurse immediately.
If you have any doubts about how to use this medicine, consult 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 occur with this medicine:
Inform your doctor immediately if you experience these symptoms, as you may require urgent medical treatment:

• sudden swelling of the lips, face, throat or tongue; a severe skin rash; and difficulty swallowing or breathing. These may be signs of a serious allergic reaction (anaphylaxis) and may be life-threatening.
• diarrhoea that worsens or does not resolve, or stools containing blood or mucus during or after treatment with CEFTAROLINE FOSAMIL QILU. In this case, do not take medicines that stop or slow down intestinal motility.

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

• changes in a blood test called the ‘Coombs test’, commonly observed in patients treated with this type of antibiotic. This test detects the presence of certain antibodies that may act against red blood cells.

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

• fever
• headache
• dizziness
• itching, skin rash
• diarrhoea, stomach pain
• feeling unwell (nausea) or being unwell (vomiting)
• increased levels of liver enzymes (detected by 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
• skin rash associated with itching (urticaria)
• increased level of creatinine in the blood. Creatinine is an indicator of kidney function.
• unusual bleeding or bruising. This may occur due to a decrease in the level of platelets in the blood.
• changes in blood tests measuring blood clotting ability.
• decrease in the total number of white blood cells or in the number of a certain type 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), observed in people who received too high a dose of the medicine, particularly in people with kidney problems.

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

• significant reduction in the number of a certain type of white blood cells in the blood (agranulocytosis). Symptoms may include fever, flu-like symptoms, sore throat or any other infection that may be serious.
• increase in the number of a certain type of white blood cells in the blood (eosinophilia).

Not known: (frequency cannot be estimated from the available data)

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

With other medicines of the same type, sudden chest pain has been observed, which could be a sign of a potentially serious allergic reaction called Kounis syndrome. If this occurs, seek immediate medical advice from a doctor or nurse.

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

5. How to store CEFTAROLINA 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 vial and outer carton.
The expiry date refers to the last day of that month.
Store below 30°C.
Keep in the original packaging to protect the medicine from light.

After reconstitution:
The reconstituted concentrate must 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, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the medicine should be used immediately. If not used immediately, the times and conditions of storage prior to use are the responsibility of the user.

Medicines must not be disposed of via wastewater or household waste. The hospital will ensure the safe disposal of all materials. This will help protect the environment.

6. Package contents and other information

What CEFTAROLINA FOSAMIL QILU contains

• The active substance is ceftaroline fosamil. Each vial contains 600 mg of ceftaroline fosamil.
• After reconstitution, 1 mL of infusion solution contains 30 mg of ceftaroline fosamil.
• The other component is arginine.

Description of the appearance of CEFTAROLINA FOSAMIL QILU and contents of the pack
CEFTAROLINA FOSAMIL QILU is a white to pale yellowish to light yellow powder for concentrate for solution for infusion, contained in a vial. It is available in packs containing 1 vial and 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Marketing Authorisation 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 (Parque Tecnológico del Vallès),
Cerdanyola del Vallès,
08290 Barcelona,
Spain

Eurofins Analytical Services Hungary Kft.
Anonymus utca 6.
Budapest, H-1045,
Hungary

This medicinal product is authorised in the European Economic Area Member States under the following names:

The following information is intended exclusively for physicians or healthcare professionals:
Important: Refer to the Summary of Product Characteristics before prescribing this
medicinal product.
An aseptic technique must be used to prepare the infusion solution. The contents of the
CEFTAROLINA FOSAMIL QILU vial must be reconstituted with 20 mL of sterile water for
injections. Immediately after addition, the vial must be shaken immediately, and the resulting concentrate must then be diluted immediately prior to use. Instructions for reconstitution of the CEFTAROLINA FOSAMIL QILU vial are summarised below:

The reconstitution time is less than 2 minutes. Mix gently but immediately to reconstitute, and 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 obtain the CEFTAROLINE FOSAMIL QILU infusion solution. For the preparation of the infusion, an infusion bag of 250 mL, 100 mL or 50 mL may be used, depending on the appropriate volume for the patient. The following infusion diluents are suitable: sodium chloride solution 9 mg/mL (0.9%) for injectable preparations, dextrose solution 50 mg/mL (5%) for injectable preparations, sodium chloride 4.5 mg/mL and dextrose 25 mg/mL solution for injectable preparations (0.45% sodium chloride and 2.5% dextrose), or Ringer's lactate solution. The resulting solution should be administered according to the selected dose over 5–60 minutes for the standard dose or over 120 minutes for the higher dose, with infusion volumes of 50 mL, 100 mL or 250 mL.
The total time interval between the start of reconstitution and completion of the intravenous infusion preparation must not exceed 30 minutes.
The colour of the infusion solution may vary from transparent to pale yellow, depending on concentration and storage conditions. It contains no particles. When stored as recommended, the potency of the medicinal product remains unchanged.
Infusion volumes for paediatric patients will vary according to the child's weight. The concentration of the infusion solution during reconstitution and administration must not exceed 12 mg/mL of ceftaroline fosamil.
After administration, it is recommended to flush the intravenous line with sodium chloride 9 mg/mL (0.9%) solution for injectable preparations to ensure complete delivery of the dose.
Each vial is for single use only.
Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned above.