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ZEVTERA 500MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CEFTOBIPROLE MEDOCARIL SODIUM

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Package leaflet:
Information for the user

1. What Zevtera is and what it is
used for
Zevtera is an antibiotic medicine that contains the
active substance ceftobiprole medocaril sodium. It
belongs to a group of medicines called ‘cephalosporin
antibiotics’.
®

Zevtera 500 mg
Powder for concentrate
for Solution for Infusion
Ceftobiprole

This medicine is subject to additional monitoring.
This will allow quick identification of new safety
information. You can help by reporting any side
effects you may get. See the end of section 4 for
how to report side effects

Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor
or nurse.
– If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Zevtera is and what it is used for
2. What you need to know before you use Zevtera
3. How to use Zevtera
4. Possible side effects
5. How to store Zevtera
6. Contents of the pack and other information

Zevtera is used to treat adults with infections of the
lungs called ‘pneumonia’.
Zevtera works by killing certain bacteria, which can
cause serious lung infections.

2. What you need to know before you
use Zevtera
Do not use Zevtera:
– if you are allergic to ceftobiprole medocaril
sodium or any of the other ingredients of this
medicine (listed in section 6),
– if you are allergic to other cephalosporin or
­beta-lactam antibiotics,
– if you have had previous severe allergic reactions
to other antibiotics like penicillin or carbapenem.
Do not use Zevtera if any of the above applies to you.
If you are not sure, talk to your doctor or nurse before
being given Zevtera.
Warnings and precautions
Talk to your doctor or nurse before using Zevtera:
– if you have kidney problems (your doctor may
need to lower your dose of this medicine),
– if you have ever had any allergic reactions to
other antibiotics like penicillin or carbapenem,
– if you have ever had fits (seizures or convulsions),
– if you have diarrhoea before, during or after your
treatment with this medicine (you may have an
inflammation of the bowel known as ‘colitis’).
Do not take any medicine to treat diarrhoea

without first checking with your doctor,
– if you are HIV positive,
– if your immune system is severely weakened,
– if your white blood counts are very low or your
bone marrow function is suppressed,

– if  your lung infection is developed more than
48 hours after onset of artificial ventilation
Zevtera is not suitable for you (your doctor
will prescribe a suitable antibiotic for you),
– if you require (or are expected to require)
concomitant calcium-containing solutions,
except Lactated Ringer’s solution for injection,
in the same intravenous administration line
due to the risk of precipitation.
If your doctor thinks you need more fluids, you may
be asked to drink plenty of liquids or you may need
to have liquids given as a drip into a vein while you
are receiving Zevtera.
If you start taking Zevtera and then require ventilation,
your doctor will assess whether Zevtera is still suitable
for you.
Lab tests
You may develop an abnormal lab test (called
Coombs test) that looks for certain antibodies which
may act against your red blood cells. Zevtera may
also interact with tests to measure serum creatinine
(Jaffé reaction) or with some tests to determine the
glucose content in the urine. These tests may
provide you with wrong results.
If any of the above apply to you (or you are not sure),
talk to your doctor or nurse before using Zevtera.
Children and adolescents
Do not give this medicine to children and adolescents
as not enough data exists in this population.
Other medicines and Zevtera
Tell your doctor or nurse if you are taking, have
recently taken or might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor for advice before using this medicine.
Driving and using machines
Zevtera may cause side effects such as dizziness.This
may impair your ability to drive or operate machinery.
Zevtera contains approximately 1.3 mmol
(29 mg) sodium per dose. If you have a controlled
sodium diet, your doctor may need to adjust it.

3. How to use Zevtera
Zevtera will be given to you by a doctor or nurse.
The recommended dose is 500 mg ceftobiprole
every eight hours given as a drip into a vein lasting
two hours.
Patients with kidney problems
You may need a lower dose of Zevtera if you have
kidney problems.
If you use more Zevtera than you should
If you think you have been given too much Zevtera,
talk to your doctor or nurse straight away.
If you forget to use Zevtera
If you think you have missed a dose, talk to your
doctor or nurse straight away.
If you have any further questions on 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 everybody gets them. The
following side effects may happen with this medicine:
Tell your doctor straight away if you get these
symptoms as you may need urgent medical
treatment:
– Sudden swelling of your lips, face, throat or tongue;
a severe rash; and, swallowing or breathing
problems. These may be signs of a severe allergic
reaction (anaphylaxis) and may be lifethreatening.
– Diarrhoea that becomes severe or does not go
away or stool that contains blood or mucus during
or after treatment with Zevtera. In this situation,
you should not take medicines that stop or slow
bowel movement.
Common: may affect up to 1 in 10 people
– Feeling sick (nausea)
– Headache, drowsiness (somnolence)
– Feeling dizzy
– Rash, itching or hives
– Diarrhoea, tell your doctor straight away if you
get diarrhoea
– Being sick (vomiting)

– Stomach pain (abdominal pain), indigestion or
heartburn (dyspepsia)
– Unusual taste (dysgeusia)
– Fungal infections in different parts of your body
– Redness, pain or swelling were the injection was
given
– Low levels of the mineral sodium in your blood
– Increase in the level of some liver enzymes in
your blood
– Hypersensitivity including skin reddening
Uncommon: may affect up to 1 in 100 people
– Temporarily decreased or increased numbers
of certain types of blood cells
– Blood testing showing decreased levels of
potassium
– Sleeplessness and sleep disturbances, maybe
including anxiety, panic attacks and nightmares
– Shortness of breath or difficulty breathing, asthma
– Muscle cramps
– Kidney problems
– Swelling, particularly of the ankles and legs
– Blood testing showing temporarily increased
levels of triglycerides, blood sugar, or creatinine
Not known: frequency cannot be estimated from
the available data
– A more severe decrease in a specific type of
white blood cells (agranulocytosis)
– Convulsions, seizures, or fits
Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme, website:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.

5. How to store Zevtera
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 carton and 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 carton in order to protect
from light.
For storage of Zevtera reconstituted and diluted
infusion solutions, please see the accompanying
information for medical or healthcare professionals.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

6. Contents of the pack and other
information
What Zevtera contains
– The active substance is ceftobiprole. Each vial
contains 500 mg of ceftobiprole(as 666.6 mg of
ceftobiprole medocaril sodium). After reconstitution,
each ml of concentrate contains 50 mg ceftobiprole,
equivalent to 66.7 mg ceftobiprole medocaril
sodium.
– The other ingredients are citric acid monohydrate
(E330) and sodium hydroxide (E524), see also
section 2.
What Zevtera looks like and contents of the pack
Zevtera is a white, yellowish to slightly brownish,
cake to broken cake or powder for concentrate for
solution for infusion in a 20 mL vial. It is available
in packs containing 10 vials.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Basilea Medical Ltd.
(c/o Cox Costello & Horne Limited)
Langwood House
63-81 High Street
Rickmansworth
Hertfordshire WD3 1EQ
United Kingdom
National contact details of the Marketing
Authorisation Holder for Medical Information:
Phone number: 0800 141 3328
Email: medical.information@basilea.com

Manufacturer:
Patheon UK Ltd
Kingfisher Drive, Covingham
Swindon, Wiltshire, SN3 5BZ
United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria: Zevtera 500 mg Pulver für ein
Konzentrat zur Herstellung einer
Infusionslösung
Belgium: Mabelio 500 mg, poudre pour
solution à diluer pour solution pour
perfusion
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
Luxembourg: Mabelio 500 mg, poudre pour
solution à diluer pour solution pour
perfusion
Norway: Zevtera 500 mg, pulver til konsentrat
til infusjonsvæske, oppløsning
Spain: Zevtera 500 mg, polvo para
concentrado para solución para
perfusión
Sweden: Zevtera 500 mg pulver för koncentrat
till infusionsvätska, lösning
United Kingdom: Zevtera 500mg powder for
concentrate for solution for infusion.
This leaflet was last revised in 12/2014.
Detailed information on this medicine is available
on the web site of United Kingdom/Medicines and
Healthcare Products Regulatory Agency.

The following information is intended
for healthcare professionals only:
Each vial is for single use only.
Preparation of Zevtera infusion solutions
Zevtera must be reconstituted and then diluted
prior to infusion.
Step 1: Reconstitution
10 ml of sterile water for injections or dextrose
50 mg/ml (5%) solution for injection should be added
to the vial and the vial should be shaken vigorously
until complete dissolution, which in some cases may
take up to 10 minutes. The volume of the resulting
concentrate is approximately 10.6 ml. Any foam
should be allowed to dissipate and the reconstituted
solution should be inspected visually to ensure the
product is in solution and particulate matter is absent.
The reconstituted concentrate contains 50 mg/ml
of ceftobiprole (as 66.7 mg/ml of ceftobiprole
medocaril sodium) and must be further diluted
prior to administration. It is recommended that the
reconstituted solution be further diluted immediately.
However, if this is not possible the reconstituted
solution can be stored at room temperature for up
to one hour, or in a refrigerator for up to 24 hours.
Step 2: Dilution
Preparation of 500 mg dose of Zevtera solution
for infusion
10 ml of the reconstituted solution should be
withdrawn from the vial and injected 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 Lactated Ringer’s solution for injection.
The infusion solution should be gently inverted
5-10 times to form a homogenous solution. Vigorous
agitation should be avoided to prevent foaming. The
entire contents of the infusion bag should be infused
to administer a 500 mg dose of ceftobiprole.
Preparation of 250 mg dose of Zevtera solution for
infusion for patients with severe renal impairment
5 ml of the reconstituted solution should be
withdrawn from the vial and injected 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 Lactated
Ringer’s solution for injection. The infusion solution
should be gently inverted 5-10 times to form a
homogenous solution. Vigorous agitation should be
avoided to prevent foaming. The entire contents of
the infusion bag should be infused to administer a
250 mg dose of ceftobiprole.
The solution for infusion should be clear to slightly
opalescent and yellowish in colour. The solution for
infusion should be inspected visually for particulate
matter prior to administration, and discarded if
particulate matter is visible.

From a microbiological point of view, unless the
method of reconstitution/dilution precludes the risk
of microbiological contamination, the product should
be used immediately. If not used immediately, in-use
storage times and conditions prior to use are the
responsibility of the user.
The reconstituted and infusion solutions should not
be frozen or exposed to direct sunlight.
If the infusion solution is stored in the refrigerator,
it should be equilibrated to room temperature prior
to administration. The infusion solution does not need
to be protected from light during administration.
See also section 5 for further information.

See also section 3 for further information.
Storage of Zevtera reconstituted and diluted
infusion solutions
Chemical and physical in-use stability of the
reconstituted solution has been demonstrated for
1 hour at 25°C and up to 24 hours at 2°C–8°C.
Chemical and physical in-use stability data support
the total times for dilution and infusion described in
the table below:
Total time by which reconstitution and infusion
(including a 2-hour period of infusion) must be
completed
Infusion solution diluent

Infusion solutions stored at 25°C

Infusion solutions stored at
2°C–8°C (Refrigerator)

Protected from
light

NOT protected
from light

Sodium chloride 9 mg/ml (0.9%)
solution for injection

24 hours

8 hours

96 hours

Dextrose 50 mg/ml (5%) solution
for injection

12 hours

8 hours

96 hours

Lactated Ringer’s solution for
injection

24 hours

8 hours

Do not refrigerate

Protected from light

109135

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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