CEFTAROLINA 600 mg Порошок Для Концентрата И Раствора Для Инфузий

Содержание инструкции

1. CEFTAROLINA FOSAMIL QILU 600 mg powder for concentrate for solution for infusion
   1. What is CEFTAROLINA FOSAMIL QILU and what is it 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. Package Contents and Other Information

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

ceftarolina fosamil

Equivalent medicinal product

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 any side effects occur, including those not listed in this leaflet, ask 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 CEFTAROLINA FOSAMIL QILU is given to you
• 3. How CEFTAROLINA FOSAMIL QILU is given
• 4. Possible side effects
• 5. How to store CEFTAROLINA FOSAMIL QILU
• 6. Contents of the pack and other information

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

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

What is CEFTAROLINA FOSAMIL QILU used for
CEFTAROLINA FOSAMIL QILU is used for the treatment of children (from birth) and
adults with:

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

How does CEFTAROLINA FOSAMIL QILU work
CEFTAROLINA FOSAMIL QILU works by destroying certain bacteria, which can cause
serious infections.

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

You must not be given CEFTAROLINA 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 other cephalosporin antibiotics
• if you have previously had serious allergic reactions following the use of other antibiotics such as penicillin or carbapenems.

You must not be given CEFTAROLINA FOSAMIL QILU in the presence of any of the conditions indicated above. If you have any doubts, ask your doctor or nurse before you are given this medicine.

Warnings and precautions
Talk to your doctor or nurse before you are given CEFTAROLINA FOSAMIL QILU:

• if you have kidney problems (your doctor may decide to prescribe a lower dose)
• if you have ever had sudden attacks (seizures or convulsions)
• if you have ever had mild allergic reactions following the use of other antibiotics such as penicillin or carbapenems
• if you have ever had serious diarrhea during the use of other antibiotics in the past. You may be at risk of another infection caused by other bacteria during or after treatment with CEFTAROLINA FOSAMIL QILU.

You may develop signs and symptoms of severe skin reactions such as fever, joint pain, rash, rash with red and flaky skin, skin bumps containing pus, blisters or peeling skin, circular red patches that often have blisters in the center on the trunk, ulcers of the mouth, 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 result in a laboratory test (called a Coombs test), which is used to identify the presence of certain antibodies that can act against red blood cells. If the level of your red blood cells decreases, the doctor may check if these antibodies have caused this.
In the event of any of the conditions indicated above (or if you have doubts), ask your doctor or nurse before you are given CEFTAROLINA FOSAMIL QILU.

Other medicines and CEFTAROLINA FOSAMIL QILU
Tell 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, are planning to become pregnant or are breastfeeding, ask your doctor for advice before you are given this medicine.
Ask your doctor for advice before you are given CEFTAROLINA FOSAMIL QILU in case of pregnancy. Do not use this medicine during pregnancy unless your doctor tells you to.

Driving and using machines
CEFTAROLINA FOSAMIL QILU can cause side effects, such as dizziness. These effects may alter your ability to drive or use machines.

3. How CEFTAROLINA FOSAMIL QILU is administered

CEFTAROLINA FOSAMIL QILU will be administered by a doctor or nurse.
Dosage to be taken
The usual recommended dose for adult subjects is 600 mg every 12 hours. Your doctor may
increase the dose to 600 mg every 8 hours for some 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 kidney problems
In case of kidney problems, the doctor may reduce the dose, as CEFTAROLINA FOSAMIL QILU
is eliminated from the body through the kidneys.
Method of administration
Intravenous use (into a vein) after reconstitution and dilution
This medicine is administered by infusion into a vein for a duration of 5-60 minutes if you receive
the usual 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 from 5 to 7 days for
pneumonia.

If you are given more CEFTAROLINA FOSAMIL QILU than you should
If you think you have received an excessive amount of 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 the use of 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:
Tell your doctor immediately if you experience these symptoms, as urgent medical treatment may be needed:

• sudden swelling of the lips, face, throat or tongue; a severe skin rash; and difficulty swallowing or breathing. These can be signs of a serious allergic reaction (anaphylaxis) and can be life-threatening.
• diarrhoea that becomes severe or does not go away, or stools that contain blood or mucus during or after treatment with CEFTAROLINA FOSAMIL QILU. In this case, you should not take medicines that stop or slow down the movement of the intestines.

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

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

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

• fever
• headache
• dizziness
• itching, rash
• diarrhoea, stomach pain
• feeling unwell (nausea) or being sick (vomiting)
• higher levels of enzymes produced by the liver (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
• itchy rash (urticaria)
• increased level of creatinine in the blood. Creatinine indicates how well the kidneys are working.
• bleeding or bruising more easily than usual. This can happen because of a decrease in the level of platelets in the blood.
• changes in tests that measure the ability of the blood to clot.
• decrease in the total number of white blood cells or the number of a certain type of white blood cells in the blood (leucopenia and neutropenia).
• changes in mental status such as confusion, decreased level of consciousness, abnormal movements or convulsions (encephalopathy) have been found in people taking too high a dose of the medicine, especially 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). You may experience fever, flu-like symptoms, sore throat or any other infection that can 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 the lungs in increased numbers (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 should
occur, seek immediate medical attention from a doctor or nurse.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the vial and the packaging. The
expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Store in the original package to protect the medicine from light.
After reconstitution:
The reconstituted concentrate must be diluted immediately.
After dilution:
Chemical and physical stability during use has been demonstrated for up to 24 hours at 2-8ºC and 6 hours at 25ºC.
From a microbiological point of view, unless the opening/reconstitution/ dilution method
prevents the risk of microbial contamination, the medicine must be used immediately. If
not used immediately, the storage times and conditions before use are the responsibility
of the user.
Medicines should not be disposed of via wastewater or household waste. The hospital will dispose
of any material safely. This will help protect the environment.

6. Package Contents and Other Information

What CEFTAROLINA FOSAMIL QILU Contains

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

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

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:

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The following information is intended exclusively for physicians or healthcare professionals:
Important: Refer to the Summary of Product Characteristics before prescribing this
medicinal product.
Aseptic technique must be used to prepare the solution for infusion. The contents of the
vial of CEFTAROLINA FOSAMIL QILU must be reconstituted with 20 mL of sterile water
for injections. After addition, the vial must be shaken immediately and the resulting
concentrate must then be diluted immediately before use. Instructions for the
reconstitution of the vial of CEFTAROLINA FOSAMIL QILU are summarised below:
The reconstitution time is less than 2 minutes. Gently but immediately mix to
reconstitute and verify that the contents have completely dissolved. Parenteral drugs
must be visually inspected for particulate matter before administration.
The reconstituted solution must be further diluted to obtain the CEFTAROLINA
FOSAMIL QILU solution for infusion. A 250 mL, 100 mL or 50 mL infusion bag can be used for
preparation of the infusion based on the volume appropriate for the patient. Appropriate
diluents for infusion are the following: sodium chloride 9 mg/mL (0.9%) solution for
injections, a 50 mg/mL (5%) dextrose solution for injections, a 4.5 mg/mL sodium chloride and
25 mg/mL dextrose solution for injections (0.45% sodium chloride and 2.5% dextrose) or a Ringer's
lactate solution. The resulting solution must be administered based on the chosen dose for 5-60
minutes for the standard dose or for 120 minutes for the high dose with infusion volumes of 50 mL,
100 mL or 250 mL.
The total time interval between the start of reconstitution and the completion of preparation
of the intravenous infusion must not exceed 30 minutes.
The color of the infusion solution ranges from clear to light yellow depending on the
concentration and storage conditions. It does not contain particles. When stored as
recommended, the potency of the medicinal product remains unchanged.
Infusion volumes for pediatric patients will vary depending on 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 a 9 mg/mL (0.9%)
sodium chloride solution for injections to ensure complete dose delivery.
Each vial is for single use.
Unused medicinal product and waste materials derived from such 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.