Advanced search

Report side effect

Report a suspected side effect or falsified product to the MHRA Yellow Card scheme.
Go to {yellow_card_logo} site
{arrow_up} Back to top

Zevtera 500 mg powder for concentrate for solution for infusion

Active Ingredient:
ceftobiprole medocaril sodium
Company:  
ADVANZ Pharma See contact details
ATC code: 
J01DI01
{info_black}
About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
{info_black}
Last updated on emc: 15 Feb 2024

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 12762/0655.

Zevtera 500 mg powder for concentrate for solution for infusion

Package leaflet: Information for the user

Zevtera 500 mg Powder for concentrate for Solution for Infusion

Ceftobiprole

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

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 is used to treat term neonates, infants, children, adolescents, and 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

Zevtera is not recommended for use in preterm newborns (born prematurely) as safety and efficacy in this age group have not been established.

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 for adults is 500 mg ceftobiprole every 8 hours given as a drip into a vein lasting 2 hours.

The recommended dose for term neonates, infants, children and adolescents depends on the age and weight of the child and is given every 8 hours (infants aged 3 months or older, children and adolescents) or every 12 hours (term neonates and infants younger than 3 months) as a drip into a vein lasting 2 hours.

The infusion solution with a ceftobiprole concentration of 2 mg/mL is used for adults and adolescents. For infants and term neonates, the infusion solution with a ceftobiprole concentration of 4 mg/mL is used.

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

  • Convulsions, seizures, or fits
  • 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)

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:

Mercury Pharmaceuticals Ltd
Dashwood House
69 Old Broad Street
London
EC2M 1QS
UK

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 EEA under the following names:

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

Ireland: Adaluzis 500 mg powder for concentrate for solution for infusion

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

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 500mg powder for concentrate for solution for infusion.

This leaflet was last revised in January 2024.

Detailed information on this medicine is available on the web site of United Kingdom/Medicines and Healthcare Products Regulatory Agency.

ADVANZ Pharma
Company image
Address
Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK
Telephone
+44 (0)208 588 9131
Medical Information Direct Line
+44 (0)208 588 9131
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)208 588 9273