Zevtera 500 mg powder for concentrate for solution for infusion

• 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.

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

• 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.

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.

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.

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.

• 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)

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.

• 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.

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:

Manufacturer:

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.