1g/1g powder for concentrate for infusion solution, solution
meropenem/vaborbactam
What Vaborem is and what it is used for
What Vaborem is
Vaborem is an antibiotic that contains two active substances: meropenem and vaborbactam.
- Meropenem belongs to a group of medicines called “carbapenems”. It can kill many types of bacteria by preventing them from building the protective pathways that surround their cells.
- Vaborbactam is a “betalactamase inhibitor”. It blocks the effect of an enzyme that makes some bacteria resistant to the effect of meropenem. This helps meropenem kill certain bacteria that it cannot kill on its own.
What Vaborem is used for
Vaborem is used in adults to treat certain serious bacterial infections:
- in the bladder or kidneys (urinary tract infections)
- in the stomach and intestines (intra-abdominal infections)
- in the lungs ( pneumonia ).
It is also used to treat infections:
- in the blood associated with any of the infections listed above
- which is caused by bacteria that other antibiotics cannot kill.
What you need to know before you are given Vaborem
You should not be given Vaborem
- if you are allergic to meropenem, vaborbactam, or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to other carbapenem antibiotics (the group to which meropenem belongs).
- if you have ever had a severe allergic reaction in connection with treatment with antibiotics belonging to the beta-lactam group (including penicillins, cephalosporins, or monobactams).
Warnings and precautions
Talk to your doctor or nurse before you receive Vaborem:
- if you have ever had a severe allergic reaction to other beta-lactam antibiotics (including carbapenems, penicillins, cephalosporins, or monobactams).
- if you have ever had severe diarrhea during or after antibiotic treatment
- if you have ever had seizures
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before using Vaborem.
You may develop signs and symptoms of serious skin reactions (see section 4). If this happens, talk to a doctor or nurse immediately so the symptoms can be treated.
Talk to your doctor or nurse if you get diarrhea during treatment.
This medicine can affect the liver. The doctor may take certain blood tests to check how well your liver is working while you are taking this medicine.
New infection
Although Vaborem can fight some bacteria, there is a possibility that you may get another infection caused by another organism during or after treatment. The doctor will check you carefully for any new infection and, if necessary, give you another treatment.
Blood samples
Tell the doctor that you are taking Vaborem if you are going to give blood samples. This is because you can get an abnormal result on something called a “Coombs test”. This test checks for antibodies that can destroy red blood cells and can be affected by how the immune system responds to Vaborem.
Contraceptive
Tell the doctor if you are taking hormonal contraceptives that contain estrogen and/or progesterone, as simultaneous use with Vaborem can lead to a reduction in their effectiveness. Women of childbearing potential should be advised to use alternative effective contraception during treatment with Vaborem and for 28 days after stopping treatment.
Children and young people
Vaborem should not be used by children or young people under the age of 18. This is because it is not known whether 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 be using other medicines.
You must tell the doctor if you are taking any of the following medicines:
- medicines used to treat epilepsy called valproic acid, sodium valproate, or valpromide because Vaborem can reduce their effect
- a gout medicine called probenecid
- oral anticoagulants, such as warfarin (used to treat or prevent blood clots)
- hormonal contraceptives taken by mouth as Vaborem can reduce their effectiveness.
Talk to your doctor before using Vaborem if any of the above applies to you.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before receiving this medicine.
You must tell your doctor if you are breastfeeding or intend to breastfeed before receiving Vaborem. Small amounts of the medicine can pass into breast milk and it can affect the baby. You must therefore stop breastfeeding before you are given Vaborem.
Driving ability and use of machinery
Vaborem can make you feel dizzy, sleepy, and lethargic, give you a headache or a tingling sensation (such as numbness and tingling), or, in rare cases, induce a seizure or seizure. This may affect your ability to drive, and use tools and machines.
Vaborem contains sodium
This medicine contains 250 mg of sodium (the main ingredient in common/table salt) per vial. This corresponds to 12.5% of the maximum recommended daily intake of sodium for adults.
How you are given Vaborem
You will be given Vaborem by a doctor or nurse as an infusion (a drip) into a vein over 3 hours.
The recommended dose is 2 vials (a total of 2 g meropenem and 2 g vaborbactam), given every 8 hours. The doctor decides how many days you need to be treated, depending on the type of infection.
Patients with kidney problems
If you have kidney problems, your doctor may lower your dose. The doctor may also want to do some blood tests to see how well your kidneys are working.
If you have been given too much Vaborem
You will be given Vaborem by a doctor or nurse, so it is unlikely that you will receive the wrong dose. If you think you have received too much Vaborem, contact a doctor or nurse immediately.
If you have forgotten a dose of Vaborem
If you think you have forgotten a dose, contact 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.
Serious side effects are
Tell your doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment:
- Severe allergic reactions may include swelling of the lips, face, throat, or tongue, difficulty swallowing or breathing or a severe rash or other severe skin reactions, or low blood pressure (which may make you faint or dizzy). Such reactions can be life-threatening.
- Diarrhea that gets worse or does not go away, or stools that contain blood or mucus – this may occur during treatment or after treatment with Vaborem has stopped. This may be due to a bacteria called Clostridium difficile. If this occurs, do not take medications that stop or impair bowel movements.
Other side effects are
Tell your doctor or nurse if you notice any of the following side effects:
Common: (may affect up to 1 in 10 users)
- Increased number of platelets (a type of blood cell ) – seen in blood tests
- Decrease in the amount of potassium or sugar – seen in blood tests
- Headache
- Low blood pressure
- Diarrhea
- Nausea or vomiting
- Swelling, redness, and/or pain around the needle where you get medicine into a vein
- Fever
- Increase in the number of enzymes produced in the liver called alanine aminotransferase or aspartate aminotransferase – seen in blood tests
- Increase in the amount of an enzyme called alkaline phosphatase which can be a sign that the liver, gallbladder, or bones are not working well – seen in blood tests
- An increase in the amount of an enzyme called lactate dehydrogenase which can be a sign of damage to certain organs in the body – seen in blood tests
Uncommon: (may affect up to 1 in 100 users)
- Swelling and irritation in the colon – this can cause diarrhea, fever, and stomach cramps and is due to another infection in the colon
- Fungal infections, including those in the vagina or mouth
- Decreased number of white blood cells or certain types of white blood cells called neutrophils and decreased number of platelets – seen in blood tests
- Increase in a type of white blood cell called eosinophils – seen in blood tests
- Sudden and severe allergic reactions requiring emergency medical treatment and may include itching, skin discoloration, stomach cramps, swelling, difficulty breathing, fainting, and a drop in blood pressure
- The less severe allergic reactions which may include redness, red bumps, skin peeling, itching, and general malaise
- A feeling of being less hungry
- Decrease in the amount of potassium or sugar – seen in blood tests
- Insomnia
- See, hear or sense things that are not there
- Dizziness
- Trembling or shaking
- A tingling sensation (numbness and tingling)
- Drowsiness and lethargy
- Swollen and red and irritated veins
- Painful veins
- Breathing problems
- Bloating or feeling of fullness in the abdomen
- Stomach ache
- Itchy skin
- Rash
- Raised, itchy rash ( hives )
- Difficulty controlling the bladder
- Impaired kidney function
- Abnormal feeling in the chest
- The following reactions may occur, alone or in combination, when Vaborem is given into a vein: reddening of the skin ( erythema ); feeling of warmth, tenderness, and swelling of the vein around the needle ( phlebitis ); a blood clot in the vein where the needle has passed through the skin ( infusion site thrombosis )
- Pain
- Increase of a substance in the blood called creatine phosphokinase which is a sign of possible damage to certain tissues such as muscles and/or other organs – seen in blood tests
- An increase of a substance in the blood called bilirubin which is a sign of possible damage to the red blood cells or that the liver is not working well – seen in blood tests
- Increases in certain types of substances in the blood called urea or creatinine which are signs that the kidneys are working less well – seen in blood tests
- The reaction that occurs during or soon after you receive Vaborem that manifests as a general feeling of being unwell, possibly with any of the following: low blood pressure, nausea, vomiting, stomach cramps, fever, flushing, fast heartbeat or breathing problems, headache
Rare (may affect up to 1 in 1,000 users)
- Convulsions (seizures)
Frequency not known (cannot be estimated from available data)
- Severe and very low white blood cell count – seen in blood tests
- Hemolytic anemia (a condition where the red blood cells are damaged or reduced in number), which makes you feel tired and the skin and eyes turn yellow
- Swelling of the tongue, face, lips, or throat
- Sudden onset of a severe rash with target-like spots or blisters or skin peeling, possibly with high fever, joint pain, abnormal liver, kidney, or lung function (these may be signs of more serious medical conditions called toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, acute generalized exanthematous pustulosis, or a condition known as drug reaction with eosinophilia and systemic symptoms (DRESS))
- A positive result on a test called ‘Coombs’ which is used to identify hemolytic anemia (see above) or immune system reaction to Vaborem
- Acute disorientation and confusion ( delirium ).
How to store Vaborem
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the container. The expiration date is the last day of the specified month.
Store at a maximum of 25 °C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are meropenem and vaborbactam. Each vial contains 1 g of meropenem (as meropenem trihydrate) and 1 g of vaborbactam.
- Another ingredient is sodium carbonate.
Appearance and package sizes of the medicine
Vaborem is a white to light yellow powder to concentrate for infusion, a solution supplied in a vial.
Vaborem is available in packs containing 6 vials.
Marketing Authorisation Holder
Menarini International Operations Luxembourg SA 1, Avenue de la Gare L-1611, Luxembourg Luxembourg
Manufacturer
ACS Dobfar, SpA
Nucleo Industriale S. Atto
(loc. S. Nicolo’ a Tordino) 64100 Teramo (TE)
Italy