Active ingredient
- meropenem trihydrate
- vaborbactam
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/18/1334/001.
Vaborem 1 g/1 g powder for concentrate for solution for infusion
Package leaflet: Information for the patient
Vaborem 1 g/1 g powder for concentrate for solution for infusion
meropenem/vaborbactam
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Vaborem is and what it is used for
2. What you need to know before you are given Vaborem
3. How you will be given Vaborem
4. Possible side effects
5. How to store Vaborem
6. Contents of the pack and other information
1. What Vaborem is and what it is used for
What Vaborem is
Vaborem is an antibiotic medicine that contains two active substances: meropenem and vaborbactam.
What Vaborem is used for
Vaborem is used in adults to treat certain serious bacterial infections:
It is also used to treat infections
2. What you need to know before you are given Vaborem
You must not be given Vaborem if
Warnings and precautions
Talk to your doctor or nurse before receiving Vaborem if:
If any of the above apply to you or you are not sure, talk to your doctor or nurse before using Vaborem.
You may develop signs and symptoms of severe skin reactions (see section 4). If this happens talk to your doctor or nurse immediately so that they can treat the symptoms.
Talk to your doctor or nurse if you suffer from diarrhoea during your treatment.
This medicine can affect your liver. Your doctor may take some blood to check how well your liver is working while taking the medicine.
New infection
Although Vaborem can fight certain bacteria, there is a possibility that you may get a different infection caused by another organism during or after your treatment. Your doctor will monitor you closely for any new infections and give you another treatment if necessary.
Blood tests
Tell your doctor that you are taking Vaborem if you are going to have any blood tests. This is because you may get an abnormal result with something called a “Coombs test”. This test looks for the presence of antibodies that can destroy red blood cells or may be affected by the response of your immune system to Vaborem.
Children or adolescents
Vaborem should not be used in children or adolescents under 18 years of age. This is because it is not known if the medicine is safe to use in these age groups.
Other medicines and Vaborem
Tell your doctor if you are using, have recently used or might use any other medicines.
It is particularly important to tell your doctor if you are taking any of the following medicines:
Tell your doctor before using Vaborem if any of the above apply to you.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving Vaborem. Small amounts of this medicine may pass into the breast milk and it may affect the baby. Therefore, you must discontinue breastfeeding before you are given Vaborem.
Driving and using machines
Vaborem may make you feel dizzy, sleepy and sluggish, give you a headache or tingling sensation (like “pins and needles”) or, in rare cases, cause a fit or seizure. This may affect your ability to drive, use tools or machines.
Vaborem contains sodium
This medicine contains 250 mg of sodium (main component of cooking salt) in each vial. This is equivalent to 12.5% of the recommended maximum daily dietary intake of sodium salt for an adult.
3. How you will be given Vaborem
Vaborem will be given to you by a doctor or nurse by infusion (a drip) into a vein, lasting 3 hours.
The recommended dose is 2 vials (a total of 2 g meropenem and 2 g vaborbactam), given every 8 hours. Your doctor will decide how many days of treatment are needed, depending on the type of infection.
Patients with kidney problems
If you have kidney problems, your doctor may lower your dose. Your doctor may also want to do some blood tests to see how well your kidneys are working.
If you are given more Vaborem than you should
Vaborem will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose. If you think you have been given too much Vaborem, tell your doctor or nurse straight away.
If you miss a dose of Vaborem
If you think you have missed a dose, tell 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.
Serious side effects
Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Other side effects
Tell your doctor or nurse if you notice any of the following side effects:
Common: (may affect up to 1 in 10 people)
Uncommon: (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1000 people)
Unknown: (frequency cannot be estimated from the available data)
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 the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vaborem
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 container. The expiry date refers to the last day of that month.
Do not store above 25 °C.
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 Vaborem contains
What Vaborem looks like and contents of the pack
Vaborem is a white to light yellow powder for concentrate for solution for infusion supplied in a vial.
Vaborem is available in packs containing 6 vials.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in: 10/2020.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
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