Patient leaflet - Zevtera 500 mg powder for concentrate for solution for infusion
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 diarrhea 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 diarrhea
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
No data is available for use of Zevtera in preterm newborns (born prematurely).
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 sodium
This medicine contains approximately 22 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.1% of the recommended maximum daily dietary intake of sodium for an adult.
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.
Diarrhea 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
Diarrhea, tell your doctor straight away if you get
diarrhea
- 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 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
F50000403340
AMS Component No.: AW-LF-0000965
(v0.6)
Product Description: Zevtera 500 mg 10 vial pack UK
Component: Leaflet
Product Code: 104964
Country: UK
Vendor Name: Basilea
Revision Date: 23-Jan-2025 Revised by: DAJ
Manufacturer: ACS Dobfar S.p.A. Via A. Fleming, 2 37135 Verona (VR) Italy This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Austria: Zevtera 500 mg Pulver für ein T h E P Z in S F a | he following information is intended for ealthcare professionals only: ach vial is for single use only. reparation of Zevtera infusion solutions evtera must be reconstituted and then diluted prior to fusion. tep 1: Reconstitution or adult and paediatric patients ≥ 12 years who require n infusion solution with a ceftobiprole concentration of In paediatric patients ≥ 12 administered should be cal patient body weight and mu of 250 mL (500 mg dose). Preparation of 250 mg dos infusion for adult patients w impairment 5 mL of the reconstituted s from the vial and injected in PVC or PE infusion bags, g | years the volume to be culated based on the st not exceed a maximum e of Zevtera solution for ith severe renal olution should be withdrawn to a suitable container (e.g. lass bottles) containing 50 mL (200 mg dose). Appearance of diluted solution 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. 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 reconstitution and infusion of 2 mg/mL or 4 mg/mL ceftobiprole dilution solutions described in the tables below: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | 2 w 5 F in 4 ei in (i. u di in | mg/mL, the lyophilized powder should be reconstituted ith 10 mL of sterile water for injections or dextrose 0 mg/mL (5%) solution for injection. or paediatric patients < 12 years who require an fusion solution with a ceftobiprole concentration of mg/mL, the lyophilized powder must be reconstituted ther with 10 mL dextrose 50 mg/mL (5%) solution for jection if further dilution with the same diluent solution e., dextrose 50 mg/mL (5%) solution for injection) is sed, or with 10 mL of water for injection if further lution with sodium chloride 9 mg/mL (0.9%) solution for jection is used (see tables below). | 125 mL of sodium chloride for injection, dextrose 50 m injection, or Lactated Ringe The infusion solution shoul 5-10 times to form a homog agitation should be avoided entire contents of the infusi to administer a 250 mg dos Use in paediatric patients < Preparation of Zevtera solu concentration of 4 mg/mL o | 9 mg/mL (0.9%) solution g/mL (5%)solution for r’s solution for injection. d be gently inverted enous solution. Vigorous to prevent foaming. The on bag should be infused e of ceftobiprole. 12 years tion for infusion at a f ceftobiprole | Reconstitution Infusion solution solution diluent diluent Dextrose 50 mg/mL (5%) Sodium chloride solution for injection or 9 mg/mL (0.9%) Water for injection solution for injection Dextrose 50 mg/mL Use in adults and adolescents ≥ 12 years (2 mg/ infusion (including the period of infusion) must b | mL ceftobiprole): Total time by which reconstitution and e completed | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Infusion solutions stored at 25°C Protected NOT protected from light from light | Infusion solutions stored at 2°C–8°C Protected from light | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 24 hours | 8 hours | 96 hours | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 12 hours | 8 hours | 96 hours | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | T di m a di in a c (a m | he vial should be shaken vigorously until complete ssolution, which in some cases may take up to 10 inutes. The volume of the resulting concentrate is pproximately 10.6 mL. Any foam should be allowed to ssipate and the reconstituted solution should be spected visually to ensure the product is in solution nd particulate matter is absent. The reconstituted oncentrate contains 50 mg/mL of ceftobiprole s 66.7 mg/mL of ceftobiprole medocaril sodium) and ust be further diluted prior to administration. It is | Administration via infusion The reconstituted solution p dextrose 50 mg/mL (5%)so diluted with the same dilue 50 mg/mL (5%)solution for reconstituted solution prepa injection solution must be d 9 mg/mL (0.9%) solution fo 10 mL should be withdrawn (e.g. PVC or PE infusion ba | bags, bottles or syringes: repared with 10 mL lution for injection must be nt solution (i.e., dextrose injection). The red with 10 mL water for iluted with sodium chloride r injection. from an infusion container gs, glass bottles) | (5%) solution for injection Lactated Ringer’s solution for injection Reconstitution Infusion solution solution diluent diluent Use in children, infants, and neonates (< 12 years reconstitution and infusion (including the period | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 24 hours | 8 hours | Do not refrigerate | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ) (4 mg/mL ceftobiprole): Total time by which of infusion) must be completed | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Infusion solutions stored at 25°C NOT protected | Infusion solutions stored at 2°C–8°C Protected | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
infusjonsvæske, oppløsning Poland: Zevtera, 500 mg, proszek do sporza˛dzania 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 | re di re fo S U P in 1 w c | commended that the reconstituted solution be further luted immediately. However, if this is not possible the constituted solution can be stored at room temperature r up to 1 hour, or in a refrigerator for up to 24 hours. tep 2: Dilution (infusion solution) se in adult and paediatric patients ≥ 12 years reparation of 500 mg dose of Zevtera solution for fusion (2 mg/mL ceftobiprole) 0 mL of the reconstituted solution should be ithdrawn from the vial and injected into a suitable ontainer (e.g. PVC or PE infusion bags, glass bottles) | containing 125 mL of diluen with 10 mL of the reconstitu from the vial. The infusion s inverted 5–10 times to form Vigorous agitation should b foaming. The volume to be calculated based on the pa not exceed a maximum of 1 For administration via a 50 calculated dose does not e reconstituted solution (equi | t solution and replaced ted solution withdrawn olution should be gently a homogenous solution. e avoided to prevent administered should be tient body weight and must 25 mL (500 mg dose). mL syringe if the xceed 200 mg, 4 mL of the valent to 200 mg | From a microbiological point of view, unless the method of reconstitution/dilution precludes the risk o Dextrose 50 mg/mL Dextrose 50 mg/mL (5%) solution for (5%) solution for injection injection Water for injection Sodium chloride 9 mg/mL (0.9%) solution for injection | from light | from light | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 12 hours | 24 hours | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 8 hours | 8 hours | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
f administration. The infusion solution does not need to be protected from light during administration. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sweden: Zevtera 500 mg pulver till koncentrat till infusionsvätska, lösning United Zevtera 500mg powder for concentrate Kingdom: for solution for infusion. This leaflet was last revised in January 2025. Detailed information on this medicine is available on the web site of United Kingdom/Medicines and Healthcare Products Regulatory Agency. c s fo T 5 a In s c | ontaining 250 mL of sodium chloride 9 mg/mL (0.9%) olution for injection, dextrose 50 mg/mL (5%) solution r injection, or Lactated Ringer’s solution for injection. he infusion solution should be gently inverted -10 times to form a homogenous solution. Vigorous gitation should be avoided to prevent foaming. adults, the entire contents of the infusion bag hould be infused to administer a 500 mg dose of eftobiprole. ceftobiprole) prepared with solution for injection or wat withdrawn from the vial and appropriate infusion solutio The infusion solution shoul times to form a homogenou agitation should be avoided volume to be administered on the patient body weight | dextrose 50 mg/mL (5%) er for injection should be diluted with 46 mL of the n diluent (see table below). d be gently inverted 5–10 s solution. Vigorous to prevent foaming. The should be calculated based and must not exceed 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 | AW-LF-0000965 (v0.6) See also section 5 for further information. F50000403340 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
AMS Component No.: AW-LF-0000965
(v0.6)
Product Description: Zevtera 500 mg 10 vial pack UK
Component: Leaflet
Product Code: 104964
Country: UK
Vendor Name: Basilea
Revision Date: 23-Jan-2025 Revised by: DAJ