Patient leaflet - Vaborem
B. PACKAGE LEAFLET
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.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or nurse.
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– 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.
What is in this leaflet
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1. What Vaborem is and what it is used for
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2. What you need to know before you are given Vaborem
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3. How you will be given Vaborem
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4. Possible side effects
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5. How to store Vaborem
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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.
- Meropenem belongs to group of antibiotics called “carbapenems”. It can kill many types of bacteria
by preventing them from building the protective walls that surround their cells.
- Vaborbactam is a “beta lactamase inhibitor”. It blocks the action of an enzyme that allows some
bacteria to resist the action of meropenem. This helps meropenem kill some bacteria that it cannot kill on its own.
What Vaborem is used for
Vaborem is used in adults to treat certain serious bacterial infections:
- of the bladder or kidneys (urinary tract infections)
- of the stomach and gut (intra-abdominal infections)
- of the lungs (pneumonia)
It is also used to treat infections
- of the blood associated with any of the infections mentioned above
- caused by bacteria that other antibiotics may not be able to kill
2. What you need to know before you are given Vaborem
You must not be given Vaborem if
- you are allergic to meropenem, vaborbactam or the other ingredients of this medicine (listed in section 6).
- you are allergic to other carbapenem antibiotics (the group to which meropenem belongs).
- you have ever had a severe allergic reaction to related antibiotics belonging to the beta-lactam group (including penicillins, cephalosporins or monobactams).
Warnings and precautions
Talk to your doctor or nurse before receiving Vaborem if:
- you have ever had any allergic reaction to other antibiotics belonging to the beta-lactam group (including carbapenems, penicillins, cephalosporins, or monobactams)
- you have ever developed severe diarrhoea during or after antibiotic treatment
- you have ever suffered from seizures
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:
- medicines used to treat epilepsy called valproic acid, sodium valproate or valpromide because Vaborem may decrease their effect
- a medicine for gout called probenecid
- oral anticoagulant medicines, such as warfarin (used to treat or prevent blood clots)
- medicines that weaken your body’s immune system, such as tacrolimus, everolimus and
cyclosporine
- a cholesterol-lowering medicine called lovastatin
- a medicine used to treat seizures or given prior to a surgery or certain examinations inside your body such as a colonoscopy, called midazolam
- a medicine to treat issues with getting an erection in men or to treat high blood pressure in the lungs called sildenafil
- a medicine commonly used in medicines to treat a cough called dextromethorphan
- a medicine used to treat depression called desipramine
- a medicine used to treat depression or anxiety called venlafaxine
- a medicine used to treat high blood pressure or chest pain called metoprolol
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 eachvial. 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:
- Severe allergic reactions that could include sudden swelling of your lips, face, throat or tongue, difficulty swallowing or breathing or a severe rash or other severe skin reactions, or a decrease in blood pressure (which could make you feel faint or dizzy). Such reactions may be life-threatening.
- Diarrhoea that keeps getting worse or does not go away, or stools that contains blood or mucus –
this may happen during or after treatment with Vaborem is stopped. It may be due to bacteria called Clostridium difficile. If this happens, do not take medicines that stop or slow bowel movement.
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)
- Increase in the number of platelets (a type of blood cell) – shown in blood tests
- Decrease in the amount of potassium or sugar- seen in blood tests
- Headache
- Low blood pressure
- Diarrhoea
- Feeling sick (nausea) or being sick (vomiting)
- Swelling, redness and/or pain around the needle where the medicine is given into a vein
- Fever
- Increase in the amount of enzymes produced by your liver called alanine aminotransferase or aspartate aminotransferase – shown in blood tests
- Increase in the level of an enzyme called alkaline phosphatase that may be a sign of your liver, gallbladder or bones working less well – shown in blood tests
- Increase in the level of an enzyme called lactate dehydrogenase that may be a sign of damage to some of your body organs – shown in blood tests
Uncommon: (may affect up to 1 in 100 people)
- Swelling and irritation in the large intestine or colon – this can cause diarrhoea, fever and stomach cramps and is due to another colon infection
- Fungal infections, including those of the vagina or mouth
- Decrease in the number of white blood cells or some types of white blood cells called neutrophils and a decrease of platelets – shown in blood tests
- Increase in a type of white blood cell called eosinophils – shown in blood tests
- Sudden and serious allergic reaction that needs urgent medical treatment and may include itching, skin color change, abdominal cramps, swelling, difficulty breathing, fainting and drop in blood pressure
- Less severe allergic reaction that may include redness, red bumps, flaking of the skin, itching,
generally feeling unwell
- A feeling of being less hungry
- Increase in the amount of potassium or sugar – shown in blood tests
- Inability to sleep
- Seeing, hearing or sensing things that are not there
- Feeling dizzy
- Tremor or shaking
- A tingling feeling (pins and needles)
- A feeling of being sleepy and sluggish
- Swollen and red and irritated veins
- Painful veins
- Difficulty breathing
Bloating or a feeling of fullness in your abdomen
Stomach pain
Itchy skin
Rash
Raised itchy skin rash (“hives”)
Difficulty to control the bladder
Reduction in the way your kidneys work
Abnormal feeling in the chest
The following reactions may develop, alone or in combination, where Vaborem is given into a vein: reddened skin (erythema); hot, tender and swollen vein around the needle (phlebitis); a blood clot in the vein where the needle was put through your skin (infusion site thrombosis)
Pain
Increase in the level of a substance in the blood called creatine phosphokinase that is a sign of possible damage to certain tissues such as your muscles and/or other organs – shown in blood tests Increase in the level of a substance in the blood called bilirubin that is a sign of possible damage to your red blood cells or that your liver is working less well – shown in blood tests
Increase in the level of some types of substances in the blood called urea and creatinine that are signs that your kidneys are working less well – shown in blood tests
Reaction that occurs during or shortly after Vaborem is given that presents as a malaise (generally feeling unwell) possibly with any of the following: reduced blood pressure, nausea, vomiting, abdominal cramps, fever, flushing, rapid heart beats or difficulty to breathe, headache
Rare ( may affect up to 1 in 1000 people)
- Seizures (fits)
Unknown: (frequency cannot be estimated from the available data)
- A severe and very low white blood cell count – shown in blood tests
- Haemolytic anaemia (a condition where red blood cells are damaged and reduced in number),
which may make you feel tired and turn your skin and eyes yellow
- Swelling of the tongue, face, lips or throat
- Sudden onset of a severe rash with bullseye-like spots or blistering or peeling skin, possibly with a high fever, joint pain, abnormal function of your liver, kidney or lung (these may be signs of more serious medical conditions called toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, acute generalised exanthematous pustulosis, or a condition known as drug reaction with eosinophilia and systemic symptoms (DRESS))
- A positive result from a test called“Coombs” used to identify haemolytic anemia (see above) or reaction of your immune system to Vaborem
- Acute disorientation and confusion (delirium)
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 national reporting system listed in 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
- The active substances are meropenem and vaborbactam. Each vial contains 1 g meropenem (as meropenem trihydrate) and 1 g vaborbactam.
- The other ingredient is sodium carbonate.
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
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
L-1611, Luxembourg
Luxembourg
Manufacturer
ACS Dobfar, S.p.A.
Nucleo Industriale S. Atto
(loc. S. Nicolo’ a Tordino)
64100 Teramo (TE)
Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| B e lgie/Belgique/Belgien Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545 | Lietuva UAB “BERLIN-CHEMIE MENARINI BALTIC” Tel: +370 52 691 947 |
| EtnrapHH EepjnH-Xevin/Á. MeHapnHn Etnrapua EOO^ men.: +359 24540950 | Luxembourg/Luxemburg Menarini Benelux NV/SA Tel/Tel: + 32 (0)2 721 4545 |
| Česká republika Berlin-Chemie/A.Menarini Ceska republika s.r.o. Tel: +420 267 199 333 | Magyarorszag Berlin-Chemie/A. Menarini Kft. Tel.: +36 23501301 |
| Danmark Menarini International Operations Luxembourg S.A. Tlf: +352 264976 | Malta Menarini International Operations Luxembourg S.A. Tel: +352 264976 |
| Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67070 | Nederland Menarini Benelux NV/SA Tel: +32 (0)2 721 4545 |
| Eesti OÜ Berlin-Chemie Menarini Eesti Tel: +372 667 5001 | Norge Menarini International Operations Luxembourg S.A. Tlf: +352 264976 |
| EZ/.áňa MENARINI HELLAS AE Tqk +30 210 8316111–13 | Österreich A. Menarini Pharma GmbH Tel: +43 1 879 95 85–0 |
| España Laboratorios Menarini S.A. Tel: +34–93 462 88 00 | Polska Berlin-Chemie/Menarini Polska Sp. z o.o. Tel.: +48 22 566 21 00 |
| France MENARINI France Tél: +33 (0)1 45 60 77 20 | Portugal A. Menarini Portugal – Farmacéutica, S.A. Tel: +351 210 935 500 |
| Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: + 385 1 4821 361 | Romania Berlin-Chemie A.Menarini S.R.L. Tel: +40 21 232 34 32 |
| Ireland A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744 | Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 01 300 2160 |
| Ísland Menarini International Operations Luxembourg S.A. Sími: +352 264976 | Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o Tel: +421 2 544 30 730 |
| Italia A. Menarini – Industrie Farmaceutiche Riunite -s.r.l. Tel: +39–055 56801 | Suomi/Finland Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760 |
| Kúnpog MENARINI HELLAS AE Tqk +30 210 8316111–13 | Sverige Pharmaprim AB Tel: +46 8355933 |
| Latvija SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210 | Unite d Kingdom A. Menarini Farmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856400 |
This leaflet was last revised in:
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: ------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:
Vaborem is intended for intravenous (IV) administration, only after reconstitution and dilution.
Standard aseptic techniques must be used for solution preparation and administration.
The number of vials used for a single dose will depend on the creatinine clearance (CrCl) of the patient.
Reconstitution :
20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline) should be withdrawn from a 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection for each vial and reconstituted with the appropriate number of vials of meropenem/vaborbactam for the corresponding Vaborem dosage:
- Reconstitute 2 vials for the Vaborem 2 g/2 g dose
- Reconstitute 1 vial for the Vaborem 1 g/1 g and Vaborem 0.5 g/0.5 g doses