Esomeprazole Sun Pharmaceutical Industries Limited

Package leaflet: Information for the patient

CEFTAROLINE FOSAMIL QILU 600 mg powder for concentrate for solution for infusion
ceftaroline fosamil
Equivalent medicine
Please read this leaflet carefully before this medicine is administered to you 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 get any side effects, including those not listed in this leaflet, tell your doctor or nurse. 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 you are given CEFTAROLINE FOSAMIL QILU
3. How CEFTAROLINE FOSAMIL QILU is administered
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

CEFTAROLINE FOSAMIL QILU
CEFTAROLINE FOSAMIL QILU is an antibiotic medicine that contains the active substance
ceftaroline fosamil. It belongs to a group of medicines called 'cephalosporin antibiotics'.

What CEFTAROLINE FOSAMIL QILU is used for
CEFTAROLINE FOSAMIL QILU 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 QILU works by killing certain bacteria that can cause serious infections.

2. What you need to know before you are given CEFTAROLINA FOSAMIL QILU

Do not be given CEFTAROLINA FOSAMIL QILU if:

• you are allergic to ceftaroline fosamil or to any of the other ingredients of this medicine (listed in section 6)
• you are allergic to other cephalosporin antibiotics
• you have previously experienced severe allergic reactions after taking other antibiotics such as penicillins or carbapenems.

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

Warnings and precautions
Talk to your doctor or nurse before being given CEFTAROLINA 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 episodes of diarrhoea while taking other antibiotics

You may develop another infection caused by different bacteria during or after treatment with CEFTAROLINA 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 skin lesions, blisters or skin peeling, red circular patches often with central blisters on the trunk, mouth ulcers, or sores in the throat, nose, genitals and eyes. If you experience any of these conditions, seek immediate medical advice from your doctor or nurse.

Laboratory tests
You may have an abnormal result in a laboratory test (called the Coombs test), which detects the presence of 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 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 CEFTAROLINA FOSAMIL QILU.

Other medicines and CEFTAROLINA 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, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before this medicine is administered.

Ask your doctor for advice before being given CEFTAROLINA FOSAMIL QILU if you are pregnant. Do not use this medicine during pregnancy unless specifically instructed by your doctor.

Driving and using machines
CEFTAROLINA 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 adult patients 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 body weight and is administered every 8 or 12 hours.
Patients with renal problems
If you have renal impairment, your doctor may reduce the dose, since 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 you receive the usual dose, or over 120 minutes if you receive 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 forget to take 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 any of 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 severe allergic reaction (anaphylaxis) and can 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)
• higher levels 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 rash (urticaria)
• increased level of creatinine in the blood. Creatinine indicates the degree of kidney function.
• bleeding or bruising more than usual. This may occur due to a decrease in the number 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 receiving too high a dose of the medicine, particularly in those 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 could 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 severe 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 effect, including those not listed in this leaflet, inform 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 .
By reporting side effects, you 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 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 for 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 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 yellowish or pale 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 Authorization Holder
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 (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 authorized in the Member States of the European Economic Area 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 should be reconstituted with 20 mL of sterile water
for injections. After addition, the vial should be shaken immediately, and the resulting concentrate must then be diluted immediately before use. Instructions for reconstituting the CEFTAROLINA FOSAMIL QILU vial are summarized below:

The reconstitution time is less than 2 minutes. Mix gently but immediately to reconstitute, and check that the contents have dissolved completely. Parenteral medicinal products should be inspected visually for particulate matter prior to administration. The reconstituted solution must be further diluted to obtain the CEFTAROLINA FOSAMIL QILU infusion solution. A 250 mL, 100 mL or 50 mL infusion bag may be used for the preparation of the infusion, based on the volume appropriate for the patient. The suitable infusion diluents are the following: 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 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 ranges from clear 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 body weight. The concentration of the infusion solution during reconstitution and administration must not exceed 12 mg/mL of ceftarolina fosamil.
After administration, it is recommended to flush the intravenous line with sodium chloride 9 mg/mL (0.9%) solution for injection to ensure complete delivery of the dose.
Each vial is for single use only.
Any unused medicinal product and waste materials derived from this medicinal product should be disposed of in accordance with local requirements.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned above.