MABELIO 500 mg Порошок И Раствор Для Инъекционного Раствора

Содержание инструкции

1. Mabelio 500 mg powder for concentrate for solution for infusion
   1. What is Mabelio and what is it used for
   2. What you need to know before you use Mabelio
   3. How to use Mabelio
   4. Possible side effects
   5. How to store Mabelio
   6. Contents of the pack and other information
2. Mabelio is a compact or crumbled mass or a powder, of a colour from white to yellowish

Mabelio 500 mg powder for concentrate for solution for infusion

ceftobiprolo

Read this leaflet carefully before using this medicine as 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 Mabelio is and what it is used for
• 2. What you need to know before using Mabelio
• 3. How to use Mabelio
• 4. Possible side effects
• 5. How to store Mabelio
• 6. Contents of the pack and other information

1. What is Mabelio and what is it used for

Mabelio is an antibiotic medicine that contains the active substance ceftobiprolo medocaril
sodium. It belongs to a class of antibiotics called cephalosporins.
Mabelio is used for the treatment of term newborns, infants, children, adolescents and
adults with a lung infection called pneumonia.
Mabelio works by killing certain bacteria, which can cause serious lung infections.

2. What you need to know before you use Mabelio

Do not use Mabelio:

• if you are allergic to ceftobiprolo medocaril sodium or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other cephalosporins or to other beta-lactam antibiotics;
• if you have previously experienced severe allergic reactions to other antibiotics such as penicillins or carbapenems.

Do not use Mabelio if your case falls into any of the above. If you have any doubts, ask your
doctor or nurse before you are given Mabelio.

Warnings and precautions
Talk to your doctor or nurse before you use Mabelio:

• if you have kidney problems (your doctor may need to reduce the dose of this medicine);
• if you have ever had allergic reactions to other antibiotics such as penicillins or carbapenems;
• if you have ever had seizures (of epileptic or other origin);
• if you have diarrhoea before, during or after treatment with this medicine (you may be suffering from an intestinal inflammation called colitis). Do not take medicines fordiarrhoea without first consulting your doctor;
• if you are HIV positive;
• if your immune system is severely weakened;
• if your white blood cell count is very low or if your bone marrow function is suppressed;
• if the lung infection developed more than 48 hours after the start of mechanical ventilation, Mabelio is not suitable for you (your doctor will prescribe a suitable antibiotic for you);
• if the administration of solutions containing calcium, except Ringer's lactate injectable solutions, is required (or may be required) in the same intravenous line, due to the risk of precipitation.

If your doctor thinks you need to take more fluids, you will be asked to drink plenty of
fluids or you may need to have fluids given to you intravenously
with a drip during treatment with Mabelio.
If you start taking Mabelio and subsequently need ventilation, your doctor
will assess whether Mabelio is still suitable for you.
Laboratory tests
If you undergo a laboratory test that looks for the presence in the blood of certain
antibodies potentially capable of acting against red blood cells (Coombs' test), the results of
this test may be abnormal. Mabelio can also interfere with tests to detect
serum creatinine (Jaffé reaction) or with some tests for the determination of
glucose content in urine. These tests may give results that are not
consistent with the truth.
If your case falls into any of the above (or if you have any doubts) ask
your doctor or nurse before using Mabelio.

Children
There is no data available on the use of Mabelio in premature infants (born prematurely).

Other medicines and Mabelio
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 are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor for advice before using this medicine.

Driving and using machines
Mabelio can cause side effects such as dizziness. This may impair your ability
to drive a vehicle or operate machinery.

Mabelio contains sodium
This medicine contains approximately 22 mg of sodium (the main component of table salt)
per dose. This is equivalent to 1.1% of the recommended maximum daily intake
of sodium for an adult.

3. How to use Mabelio

A doctor or nurse will administer Mabelio to you.
The recommended dose for adults is 500 mg of ceftobiprole every 8 hours, administered
as an intravenous infusion for a duration of 2 hours.
The recommended dose for term newborns, infants, children and adolescents depends on the child’s age and
weight and is administered every 8 hours (infants aged 3 months or older, children and adolescents) or every 12 hours (term newborns and infants under 3
months of age) as an intravenous infusion for a duration of 2 hours.
The infusion solution with a ceftobiprole concentration of 2 mg/mL is used for adults
and adolescents. For infants and term newborns, the infusion solution with a
ceftobiprole concentration of 4 mg/mL is used.

Patients with kidney problems
If you have kidney problems, you may need to reduce the dose of Mabelio.

If you use more Mabelio than you should
If you think you have received too much Mabelio, contact your doctor or
nurse immediately.

If you forget to use Mabelio
If you think you have missed a dose, contact your doctor or nurse immediately.
If you have any 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 everyone gets them.
The following side effects may occur with this medicine:

Immediately inform your doctor if you experience these symptoms as you may need
urgent medical treatment:

• Sudden swelling of the lips, face, throat or tongue; severe skin rash; difficulty swallowing or breathing. These may be signs of a severe allergic reaction (anaphylaxis) and can be life-threatening.
• Diarrhoea that becomes severe or does not go away, or the presence of blood or mucus in your stools during or after treatment with Mabelio. In this case, you should not take any medicine to stop or slow down bowel movements.

Common: may affect up to 1 in 10 people

• Nausea
• Headache, drowsiness
• Dizziness
• Rash, itching or hives
• Diarrhoea (if you have diarrhoea, inform your doctor immediately)
• Vomiting
• Stomach pain (abdominal pain), indigestion or  heartburn  (dyspepsia)
• Strange taste in the mouth (dysgeusia)
• Fungal infections in various parts of the body
• Redness, pain or swelling at the injection site
• Low levels of  sodium , a mineral in the blood
• Increased levels of certain liver enzymes in the blood
• Hypersensitivity, including skin redness

Uncommon: may affect up to 1 in 100 people

• Convulsions, seizures
• Temporary decrease or temporary increase of certain blood cells
• Decreased potassium levels in blood tests
• Insomnia and sleep disturbances, possibly with anxiety, panic attacks and nightmares
• Shortness of breath or difficulty breathing, asthma
• Muscle cramps
• Kidney problems
• Swelling, particularly of the ankles and legs
• Temporary increase in levels of triglycerides, sugars and creatinine in blood tests

Not known: frequency cannot be estimated from available data

• A more serious reduction of a particular type of white blood cells (agranulocytosis)

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 Mabelio

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 package and on the
vial after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2  C–8  C).
Keep the vial in the outer packaging to protect the medicine from light.
For the storage of reconstituted and diluted Mabelio infusion solutions, please consult the
package leaflet intended for doctors and healthcare professionals.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Mabelio contains

• The active ingredient is ceftobiprole. Each vial contains 500 mg of ceftobiprole (equivalent to 666.6 mg of ceftobiprole medocaril sodium). After reconstitution, each mL of concentrate contains 50 mg of ceftobiprole, equivalent to 66.7 mg of ceftobiprole medocaril sodium.
• The other ingredients are citric acid monohydrate (E330) and sodium hydroxide (E524); see also section 2.

Description of the appearance of Mabelio and contents of the pack

Mabelio is a compact or crumbled mass or a powder, of a colour from white to yellowish

to slightly brown, for concentrate for solution for infusion in a vial of 20 mL.
It is available in packs containing 10 vials each.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Advanz Pharma Limited
Unit 17, Northwood House
Northwood Crescent
Dublin 9
D09 V504
Ireland
National contact details of the Marketing Authorisation Holder for medical information:
Tel.: 02 600 63037
Email: [email protected]
Manufacturer:
ACS DOBFAR S.p.A.
Via A. Fleming, 2
37135 Verona (VR)
Italy

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Austria: Zevtera 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Denmark: Zevtera
Finland: Zevtera 500 mg, kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos
France: Mabelio 500 mg, poudre pour solution à diluer pour solution pour perfusion
Germany: Zevtera 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Italy: Mabelio 500 mg, polvere per concentrato per soluzione per infusione
Ireland: Adaluzis 500 mg powder for concentrate for solution for infusion
Luxembourg: Mabelio 500 mg, poudre pour solution à diluer pour solution pour perfusion
Norway: Zevtera 500 mg, pulver til konsentrat til infusjonsvæske, oppløsning
Poland: Zevtera, 500 mg, proszek do sporządzania koncentratu roztworu do infuzji
Portugal: Zevtera 500 mg pó para concentrado para solução para perfusão
Spain: Zevtera 500 mg, polvo para concentrado para solución para perfusión
Sweden: Zevtera 500 mg pulver till koncentrat till infusionsvätska, lösning
United Kingdom (Northern Ireland): Zevtera 500 mg powder for concentrate for solution for
infusion.
More detailed information on this medicinal product is available on the website of the Italian
Medicines Agency https://www.aifa.gov.it/.
___________________________________________________________________________

The following information is intended exclusively for doctors or healthcare professionals:
Each vial is for single use only.

Preparation of Mabelio infusion solutions
Mabelio must be reconstituted and then diluted before infusion.
Step 1: Reconstitution
For adult and paediatric patients aged ≥ 12 years requiring an infusion solution
with a ceftobiprole concentration of 2 mg/mL, the lyophilised powder must be
reconstituted with 10 mL of sterile water for injections or dextrose 50
mg/mL (5%) solution for injection.
For paediatric patients aged < 12 years requiring an infusion solution with a
ceftobiprole concentration of 4 mg/mL, the lyophilised powder must be reconstituted with
10 mL of dextrose 50 mg/mL (5%) solution for injection if further dilution
is used with the same diluent solution (i.e. dextrose 50 mg/mL (5%) solution for injection) or with
10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection if further dilution is used with
(see the tables below).
The vial must be shaken vigorously until the powder is completely dissolved, which
may take up to 10 minutes in some cases. The volume of the resulting concentrate is approximately
10.6 mL. Allow any foam formed to dissolve and visually inspect the
reconstituted solution to ensure complete dissolution of the medicinal product and
the absence of particles. The reconstituted concentrate contains 50 mg/mL of ceftobiprole
(i.e. 66.7 mg/mL of ceftobiprole medocaril sodium) and must be further diluted
before administration. It is recommended to dilute the reconstituted solution immediately.
If this is not possible, the reconstituted solution can be stored at room temperature for a maximum of 1 hour, or in a refrigerator
for a maximum of 24 hours.
Step 2: Dilution (solution for infusion)
Use in adult and paediatric patients aged ≥ 12 years

Preparation of a 500 mg dose of Mabelio solution for infusion (2 mg/mL of

ceftobiprole)
Withdraw 10 mL of reconstituted solution from the vial and inject it into a suitable container
(e.g. PVC or PE infusion bags, glass bottles) containing 250 mL of sodium chloride
9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection
or Ringer’s lactate solution for injection. Gently invert the infusion solution 5-10 times to obtain a homogeneous solution. Avoid vigorous shaking
to prevent foam formation.
In adults, the entire contents of the infusion bag must be infused to administer a dose of 500 mg of ceftobiprole.
In paediatric patients aged ≥ 12 years, the volume to be administered must be calculated
based on the patient’s body weight and must not exceed a maximum of 250 mL (500 mg dose).

Preparation of a 250 mg dose of Mabelio solution for infusion in case of adult patients

with severe renal impairment
Withdraw 5 mL of reconstituted solution from the vial and inject it into a suitable container (e.g.
PVC or PE infusion bags, glass bottles) containing 125 mL of sodium chloride
9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection or
Ringer’s lactate solution for injection. Gently invert the infusion solution 5-
10 times to obtain a homogeneous solution. Avoid vigorous shaking to
prevent foam formation. The entire contents of the infusion bag must be
infused to administer a dose of 250 mg of ceftobiprole.
Use in paediatric patients aged < 12 years

Preparation of Mabelio solution for infusion at a concentration of 4 mg/mL of

ceftobiprole
Administration via infusion bags, bottles or syringes:
The reconstituted solution prepared with 10 mL of dextrose 50 mg/mL (5%) solution
for injection must be diluted with the same diluent solution (i.e. dextrose 50 mg/mL
(5%) solution for injection). The reconstituted solution prepared with 10 mL of water for
injections must be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection.
10 mL must be withdrawn from an infusion container (e.g. PVC or PE infusion bags,
glass bottles) containing 125 mL of diluent and replaced with 10 mL
of the reconstituted solution withdrawn from the vial. The infusion solution must be
gently inverted 5-10 times to form a homogeneous solution. Avoid vigorous shaking
to prevent foam formation. The volume to be administered must be
calculated based on the patient’s body weight and must not exceed a maximum of 125 mL
(500 mg dose).
For administration via a 50 mL syringe if the calculated dose does not exceed 200 mg, 4
mL of the reconstituted solution (equivalent to 200 mg of ceftobiprole) prepared with dextrose
50 mg/mL (5%) solution for injection or water for injections must be
withdrawn from the vial and diluted with 46 mL of the appropriate diluent for the infusion solution (see table below). The infusion solution must be gently inverted
5-10 times to form a homogeneous solution. Avoid vigorous shaking
to prevent foam formation. The volume to be administered must be calculated in
based on the patient’s body weight and must not exceed 50 mL (200 mg dose).
Appearance of the diluted solution
The infusion solution should appear from transparent to slightly opalescent
and yellowish in colour. The infusion solution must be visually inspected for
the presence of particles before administration and discarded if particles are visible.
See also section 3 for further information.

Storage of reconstituted and diluted Mabelio infusion solutions
The chemical and physical stability in use of the reconstituted solution has been demonstrated for 1 hour at
25 °C and up to 24 hours at 2 °C–8 °C.
Stability data confirm the total times for reconstitution and infusion of solutions with dilution of ceftobiprole 2 mg/mL or 4 mg/mL and are described
in the tables below:

Use in adults and adolescents aged ≥ 12 years (2 mg/mL of ceftobiprole): Total time
within which the reconstitution and infusion of the drug (including the infusion period) must
be completed

Use in children, infants and newborns (< 12 years) (4 mg/mL of ceftobiprole): Time
total within which reconstitution and infusion must be completed (including the infusion period).

From a microbiological point of view, the medicinal product must be used immediately unless the reconstitution/dilution method eliminates the risk of microbiological
contamination. If the product is not used immediately, the times and conditions of
storage before use are the responsibility of the user.
The reconstituted solution and the infusion solution must not be frozen or exposed
to direct sunlight.
If the infusion solution is stored in a refrigerator, it must be brought to
room temperature before administration. It is not necessary to protect the
infusion solution from light during administration.
See also section 5 for further information.