500 mg powder for concentrate for infusion solution
ceftobiprole
What Zevtera is and what it is used for
Zevtera is an antibiotic medicine that contains the active substance ceftobiprole medical sodium. It belongs to a group of medicines called “cephalosporin antibiotics”.
Zevtera is used to treat newborn babies (not born prematurely), infants, children, adolescents, and adults with an infection in the lungs, i.e. pneumonia
Zevtera works by killing certain bacteria, which can cause serious lung infections.
What you need to know before you use Zevtera
Do not use Zevtera
- if you are allergic to ceftobiprole medical sodium or any of the other ingredients of this medicine (listed in section 6),
- if you are allergic to other cephalosporins or beta-lactam antibiotics,
- if you have previously had severe allergic reactions to other antibiotics such as penicillin or carbapenems,
Do not use Zevtera if any of the above apply to you. If you are not sure, talk to your doctor before receiving 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 an allergic reaction to other antibiotics such as penicillin or carbapenems,
- if you have ever had seizures,
- if you have diarrhea before, during, or after your treatment with this medicine (you may have a bowel inflammation called “colitis”). Do not take any other medicine to treat diarrhea without first consulting your doctor,
- if you are HIV positive,
- if your immune system is severely weakened,
- if you have a low white blood cell count or inhibited bone marrow function,
- if your lung infection occurred more than 48 hours after starting artificial ventilation (breathing), Zevtera is not suitable for you (your doctor will prescribe the appropriate antibiotic for you),
- if you need (or are expected to need) simultaneous solutions containing calcium, except lactated Ringer’s solution for injection, in the same intravenous catheter due to the risk of precipitation.
If your doctor thinks you need more fluids, you will be told to drink plenty of fluids, or you may need to receive fluids as a drip into a vein, while you are receiving Zevtera.
If you start using Zevtera and then need ventilation, your doctor will assess whether Zevtera is still suitable for you.
Lab tests
You may develop an abnormal lab test (called the Coombs test), which looks for certain antibodies that can act against red blood cells. Zevtera may also affect tests to measure serum creatinine (Jaffé’s reaction) or some tests to determine the glucose content of urine. These tests can give you wrong results.
If any of the above apply to you, or if you are not sure, talk to your doctor or nurse before you start using Zevtera.
Children and young people
Zevtera is not recommended for use in premature babies (premature babies) 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, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Driving ability and use of machinery
Zevtera can cause side effects such as dizziness. This may impair your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Zevtera contains approximately 1.3 mmol (29 mg) of sodium per dose. If you are on a diet with controlled salt intake, your doctor may need to adjust this.
How to use Zevtera
You will be given Zevtera by a doctor or nurse.
The recommended dose for adults is 500 mg of ceftobiprole every 8 hours as a drip into a vein over 2 hours.
The recommended dose for newborns, infants, children, and adolescents depends on the child’s age and weight and is given every 8 hours (infants from 3 months and older, children and adolescents), or every 12 hours (newborns and infants younger than 3 months) as a drip into a vein over 2 hours.
An infusion solution with a ceftobiprole concentration of 2 mg/ml is used for adults and adolescents. For infants and newborns, an infusion solution with a ceftobiprole concentration of 4 mg/ml should be used.
Patients with kidney problems
If you have kidney problems, you may need to take a lower dose of Zevtera.
If you use too much Zevtera
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 immediately.
If you have any further questions about this medicine, ask your doctor or nurse.
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 get these symptoms, as you may need urgent treatment:
- Sudden swelling of the lips, face, throat, or tongue, severe rash, and swallowing or breathing problems. This can be a sign of a serious allergic reaction (anaphylaxis) and can be life-threatening.
- Diarrhea that becomes severe or does not go away, or stools that contain blood or mucus during or after treatment with Zevtera. In this situation, you should not take medicines that stop or delay bowel movements.
Common: may affect up to 1 in 10 people
- Nausea
- Headache, sleepiness
- Dizziness
- Rash, itching, or hives
- Diarrhea. If you develop diarrhea, tell your doctor immediately
- vomiting
- Stomach pain ( abdominal pain ), indigestion, or heartburn ( dyspepsia )
- Unusual taste ( dysgeusia )
- Fungal infections in various parts of the body
- Redness, pain, or swelling where the injection was given
- Low levels of the mineral sodium in the blood
- Increase in the level of certain liver enzymes in the blood
- Hypersensitivity, including skin redness
Uncommon: may affect up to 1 in 100 people
- Seizures
- Temporarily decreased or increased number of certain types of blood cells
- Blood tests showing decreased levels of potassium
- Insomnia and sleep disturbances, possibly including anxiety, panic attacks, and nightmares
- Shortness of breath or difficulty breathing, asthma
- Muscle cramps
- Kidney problems
- Swelling, especially in the ankles and legs
- Blood tests that show 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 cell ( agranulocytosis )
How to store Zevtera
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and vial after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C–8 °C).
Store the vial in the outer carton. Light sensitive.
For storage of prepared and diluted Zevtera infusion solutions, see the attached information for healthcare professionals.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is ceftobiprole. Each vial contains 500 mg of ceftobiprole (666.6 mg of ceftobiprole medical sodium). After reconstitution, each ml of concentrate will contain 50 mg of ceftobiprole, corresponding to 66.7 mg of ceftobiprole medical sodium.
- Other ingredients are citric acid monohydrate (E330) and sodium hydroxide (E524), see also section 2.
Appearance and package sizes of the medicine
Zevtera is a white, yellowish to slightly brownish, cake to broken cake or powder to concentrate to solution for infusion in a 20 ml vial. It is available in packs containing 10 vials.
Marketing Authorisation Holder
Basilea Pharmaceutica Deutschland GmbH
Marie-Curie-Strasse 8
79539 Lörrach
Germany
ACS Dobfar SpA
Via A. Fleming, 2
37135 Verona (VR)
Italy
This medicine is authorized 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 välikonsentratiksi infüzionesestättä värten, liuos
France: Mabelio 500 mg, poudre pour solution à diluter 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 diluter pour solution pour perfusion
Norway: Zevtera 500 mg, powder for concentrate for infusion, solution
Poland: Zevtera, 500 mg, proszek do sporządzania koncentratu słottu do infusji
Portugal: Zevtera 500 mg pó para concentrado para solução para perfusão
Spain: Zevtera 500 mg, polvo para concentrado para solución para perfusión
United Kingdom (Northern Ireland): Zevtera 500 mg powder for concentrate for solution for infusion .