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Zevtera 500 mg powder for concentrate for solution for infusion
Zevtera 500 mg Powder for concentrate for Solution for Infusion
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 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.
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.
Talk to your doctor or nurse before using Zevtera:
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.
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.
Zevtera is not recommended for use in preterm newborns (born prematurely) as safety and efficacy in this age group have not been established.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
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.
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.
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.
You may need a lower dose of Zevtera if you have kidney problems.
If you think you have been given too much Zevtera, talk to your doctor or nurse straight away.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Not known: frequency cannot be estimated from the available data
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.
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.
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:
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
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.