VABOREM 1 G Порошок для концентрата для раствора для инфузий

Содержание инструкции

1. Vaborem 1 g/1 g powder for concentrate for solution for infusion
   1. What is Vaborem and what is it used for
   2. What you need to know before you receive Vaborem
   3. How Vaborem will be administered to you
   4. Possible side effects
   5. How to store Vaborem
   6. Contents of the pack and other information

Vaborem 1 g/1 g powder for concentrate for solution for infusion

meropenem/vaborbactam

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

• 1. What Vaborem is and what it is used for
• 2. What you need to know before you receive Vaborem
• 3. How Vaborem will be given to you
• 4. Possible side effects
• 5. How to store Vaborem
• 6. Contents of the pack and other information

1. What is Vaborem and what is it used for

What is Vaborem
Vaborem is an antibiotic medicine that contains two active ingredients: meropenem and vaborbactam.
Meropenem belongs to the class of antibiotics called “carbapenems”. It is able to kill
many types of bacteria by preventing them from building the protective walls around 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 to destroy some
bacteria that it is unable to kill on its own.

What is Vaborem used for
Vaborem is used in adults for the treatment of some severe bacterial infections:
affecting the bladder or kidneys (urinary tract infections)
affecting the stomach and intestines (intra-abdominal infections)
affecting the lungs (pneumonia)
It is also used in the treatment of infections
of the blood associated with one 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 receive Vaborem

Vaborem must not be given to you if
you are allergic to meropenem, vaborbactam or any of the other ingredients of this medicine (listed in
section 6).
you are allergic to other carbapenem antibiotics (the class of antibiotics to which meropenem belongs).
you have ever had a severe allergic reaction to related antibiotics, belonging to the beta-
lactam class (such as penicillins, cephalosporins or monobactams).

Warnings and precautions
Talk to your doctor or nurse before you receive Vaborem if:
you have ever had an allergic reaction to other antibiotics belonging to the beta-lactam class
(such as carbapenems, penicillins, cephalosporins or monobactams)
you have ever developed severe diarrhoea during or after antibiotic treatment
you have ever suffered from convulsions.
If any of the above applies to you or you have doubts, 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, tell
your doctor or nurse immediately so they can treat the symptoms.
Tell your doctor or nurse if you suffer from diarrhoea during treatment.
This medicine can have effects on the liver. Your doctor may prescribe a blood test
to check your liver function during treatment.
New infection
Although Vaborem can fight certain bacteria, there is a possibility that you may develop a
different infection caused by another organism during or after treatment. Your doctor will
monitor you carefully for any new infections and will give you another treatment if
necessary.
Blood tests
Tell your doctor that you are taking Vaborem if you need to have blood tests. This is because it may
give an abnormal result to the so-called “Coombs’ test”. The results of this test reveal the presence
of antibodies that can destroy red blood cells or may affect the response of the immune
system to Vaborem.

Children or adolescents
Vaborem must not be used in children or adolescents under 18 years of age as it is not
known whether the medicine is safe in these age groups.

Other medicines and Vaborem
Tell your doctor if you are taking, have recently taken or might take any other medicines.
It is particularly important that you tell your doctor if you are taking any of the medicines listed
below:
medicines used for the treatment of epilepsy such as valproic acid, sodium valproate or
valpromide, because Vaborem may reduce their effect
a medicine for gout called probenecid
oral anticoagulants such as warfarin (used to treat or prevent blood clots)
hormonal oral contraceptives containing oestrogen and/or progesterone because Vaborem may reduce
their effect. Women of childbearing potential should be advised to use alternative and effective
contraceptive methods during treatment with Vaborem and for a period of 28 days after stopping
treatment.
medicines metabolised predominantly by CYP1A2 (e.g. theophylline), CYP3A4 (e.g.
alprazolam, midazolam, tacrolimus, sirolimus, ciclosporin, simvastatin, omeprazole, nifedipine,
quinidine and ethinylestradiol) and/or CYP2C (e.g. warfarin, phenytoin) and/or transported by P - gp (ad
e.g. dabigatran, digoxin) because Vaborem may reduce their effect.
Tell your doctor before using Vaborem if any of the above applies to you.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor
for advice before receiving this medicine.
As a precautionary measure, this medicine should not be given to you during pregnancy.
It is important that you tell your doctor if you are breastfeeding or intend to breastfeed before receiving
Vaborem. Small amounts of this medicine may pass into breast milk and affect
your baby. You should therefore stop breastfeeding before you are given Vaborem.

Driving and using machines
Vaborem can cause dizziness, drowsiness and weakness, headache or a sensation of pins and needles
(“pins and needles”), or, in rare cases, an epileptic fit or convulsions. This may affect your
ability to drive or operate tools or machines.

Vaborem contains sodium
This medicine contains 250 mg of sodium (the main component of table salt or kitchen salt)
per vial. This is equivalent to 12.5% of the maximum recommended daily intake of sodium for
an adult.

3. How Vaborem will be administered to you

The recommended dose is 2 vials (a total of 2 g of meropenem and 2 g of vaborbactam), and it is
administered every 8 hours. Your doctor will decide how many days the treatment should last, depending
on the type of infection.
Vaborem will be administered to you by a doctor or nurse via infusion (intravenous drip) into a vein
over a period of 3 hours.
Patients with kidney problems
If you have kidney problems, your doctor may reduce the dose to be administered. Your doctor may also
prescribe some blood tests to assess your kidney function.

If you receive more Vaborem than you should
Since Vaborem will be administered by a doctor or nurse, it is unlikely that you will receive an
incorrect dose of medication. If you think you have received an excessive amount of Vaborem, inform your
doctor or nurse immediately.

If you miss a dose of Vaborem
If you think you have missed a dose, inform your doctor or nurse immediately.
If you have any doubts about 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.
manifest.

Serious side effects
Tell your doctor immediately if you notice any of the following serious side effects. You may
need urgent medical treatment:
Severe allergic reactions which may include sudden swelling of lips, face, throat or
tongue, difficulty swallowing or breathing, or a severe skin rash or other serious skin
reaction or a drop in blood pressure (which may cause you to faint or
feel dizzy). These reactions can be life-threatening and potentially fatal.
Diarrhoea that continues to worsen or does not go away, or stools that contain blood or mucus –
this may occur during treatment with Vaborem or after it has been stopped. It may be
caused by a bacterium called Clostridium difficile. If this happens, do not take medicines that
stop or slow down bowel movements.

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)
Increased number of platelets (a type of blood cell) – shown in blood tests
Decreased potassium or sugar levels – shown in blood tests
Headache
Low blood pressure
Diarrhoea
Feeling unwell (nausea) or being sick (vomiting)
Swelling, redness and/or pain in the area where the needle is inserted into a vein for the
administration of the medicine
Fever
Increased production of liver enzymes called alanine aminotransferase or aspartate
aminotransferase – shown in blood tests
Increased level of an enzyme called alkaline phosphatase, which may be a sign of reduced
liver, gallbladder or bone function – shown in blood tests
Increased level of an enzyme called lactate dehydrogenase, which may be a sign of damage
to some organs – shown in blood tests.

Uncommon:(may affect up to 1 in 100 people)
Swelling and irritation of the large intestine or colon – may cause diarrhoea, fever and stomach cramps
and are due to another infection of the colon
Fungal infections, including those of the vagina or mouth
Decreased number of white blood cells or some types of white blood cells called neutrophils and
decreased platelets – shown in blood tests
Increase in a type of white blood cells called eosinophils in the blood – shown in blood
tests
Sudden and severe allergic reaction that needs urgent medical attention and may include
itching, change in skin colour, stomach cramps, swelling, difficulty breathing,
fainting and falling blood pressure
Less severe allergic reaction that may include redness, raised bumps, skin peeling,
itching, feeling generally unwell
Loss of appetite
Increased potassium or sugar levels – shown in blood tests
Difficulty sleeping
Seeing, hearing or feeling things that are not there
Feeling dizzy
Tremor or agitation
Pins and needles sensation
Drowsiness and weakness
Swelling and irritation of the veins
Pain in the veins
Difficulty breathing
Swelling or feeling of fullness in the abdomen
Stomach pain
Itchy skin
Skin rash
Itchy, raised skin rash (“hives”)
Difficulty controlling the bladder
Reduced kidney function
Abnormal sensation in the chest
The following reactions may develop, individually or in combination, at the site where
Vaborem is given into a vein: skin redness (erythema); warmth, tenderness and
swelling of the vein around the needle (phlebitis); formation of a blood clot in the vein where
the needle is inserted (infusion-site thrombosis)
Pain
Increased level of a substance in the blood called creatine phosphokinase, which is a sign of
possible damage to some tissues such as muscles and/or other organs – shown in blood tests
Increased level of a substance in the blood called bilirubin, which is a sign of possible
damage to red blood cells or reduced liver function – shown in blood tests
Increased level of some substances in the blood called urea and creatinine, which is a sign of
reduced kidney function – shown in blood tests
Development of a reaction during or shortly after administration of Vaborem, which presents
as a feeling of general discomfort, which may be accompanied by any of the
following symptoms: low blood pressure, nausea, vomiting, stomach cramps, fever,
flushing, rapid heartbeat or difficulty breathing, headache.

Rare:(may affect up to 1 in 1,000 people)
Convulsions (fits).

Not known:(frequency cannot be estimated from the available data)
Severe decrease in the number of white blood cells – shown in blood tests
Haemolytic anaemia (a condition in which red blood cells are damaged and decrease in
number), which can cause fatigue and yellowing of the skin and eyes
Swelling of the tongue, face, lips or throat
Sudden onset of a severe skin rash with bullseye-like spots or blistering or peeling skin, possibly accompanied by high fever, joint pain, abnormal liver, kidney or lung function (may be signs of more serious conditions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, acute generalized pustulosis or a condition known as drug reaction with eosinophilia and systemic symptoms (DRESS))
Positive result to a test known as “Coombs’ test” used to detect the presence of haemolytic
anaemia (see above) or an immune system reaction 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 side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system reported in
Annex V. 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 packaging. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.

6. Contents of the pack and other information

What Vaborem contains
The active substances are meropenem and vaborbactam. Each vial contains 1 g of meropenem
(as meropenem trihydrate) and 1 g of vaborbactam.
The other component is sodium carbonate.

Description of Vaborem and contents of the pack
Vaborem is a powder for concentrate for solution for infusion, from white to light yellow in colour
supplied in a vial.
Vaborem is available in packs of 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)
64 100 Teramo (TE)
Italy
For further information on this medicine, contact the local representative of the marketing authorisation holder:

Lietuva
UAB “BERLIN-CHEMIE MENARINI
BALTIC”
Tel: +370 52 691 947

България
Берлин-Хеми/А. Менарини България EООД
тел.: +359 24540950

België/Belgique/Belgien
Menarini Benelux NV/SA
Tél/Tel: + 32 (0)2 721 4545

Luxembourg/Luxemburg
Menarini Benelux NV/SA
Tél/Tel: + 32 (0)2 721 4545

Česká republika
Berlin-Chemie/A.Menarini Ceska republika s.r.o.
Tel: +420 267 199 333

Magyarország
Berlin-Chemie/A. Menarini Kft.
Tel.: +36 1799 732

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

Ελλάδα
MENARINI HELLAS AE
Τηλ: +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 – Farmacêutica, S.A. Tel: +351 210 935 500

Hrvatska
Berlin-Chemie Menarini Hrvatska d.o.o.
Tel: + 385 1 4821 361

România
Berlin-Chemie A.Menarini S.R.L.
Tel: +40 21 232 34 32

Ireland

• A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744 SlovenijaBerlin-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 AG / 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/FinlandBerlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760

Κύπρος
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13

Sverige
Pharmaprim AB
Tel: +46 8355933

Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103210

United Kingdom (Northern Ireland)

• A. Menarini Farmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856400

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency:
http://www.ema.europa.eu .
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The following information is intended exclusively for healthcare professionals:
Vaborem is intended for intravenous (IV) administration only after reconstitution and
dilution.
Standard aseptic techniques should be used for the preparation and administration of the solution.
The number of vials used for a single dose will depend on the patient's creatinine clearance (CrCl).
Reconstitution:
For each vial, draw up 20 mL of sodium chloride 9 mg/mL (0.9%) solution for injection
from a 250 mL bag of sodium chloride 9 mg/mL (0.9%) solution for injection
and reconstitute with the correct number of meropenem/vaborbactam vials for the
corresponding Vaborem dosage:

• Reconstitute 2 vials for a Vaborem 2 g/2 g dose
• Reconstitute 1 vial for Vaborem 1 g/1 g and Vaborem 0.5 g/0.5 g doses

Mix gently to dissolve. The reconstituted meropenem/vaborbactam solution will have an
approximate meropenem concentration of 0.05 g/mL and an approximate vaborbactam concentration of
0.05 g/mL. The final volume is approximately 21.3 mL. The reconstituted solution must not be injected
directly, it must be diluted before intravenous infusion.
Dilution:
To prepare Vaborem 2 g/2 g for administration by intravenous infusion: immediately
after reconstituting two vials, draw up the entire reconstituted contents from each vial
and add it back to the 250 mL bag containing sodium chloride 9 mg/mL (0.9%) solution for injection
(normal saline). The concentration of meropenem and vaborbactam in the final infusion solution will be approximately 8 mg/mL for each.
To prepare Vaborem 1 g/1 g for administration by intravenous infusion: immediately
after reconstituting one vial, draw up the entire reconstituted contents and add it back
to the 250 mL bag containing sodium chloride 9 mg/mL (0.9%) solution for injection
(normal saline). The concentration of meropenem and vaborbactam in the final infusion solution will be approximately 4 mg/mL for each.
To prepare Vaborem 0.5 g/0.5 g for administration by intravenous infusion:
immediately after reconstituting one vial, draw up 10.5 mL of the reconstituted contents and
add it back to the 250 mL bag containing sodium chloride 9 mg/mL (0.9%) solution for injection
(normal saline). The concentration of meropenem and vaborbactam in the final infusion solution will be approximately 2 mg/mL for each.
The diluted solution must be visually inspected for particles. The colour of the
diluted solution is from clear to light yellow.
After dilution, the infusion must be completed within 4 hours if stored at 25 °C or within 22 hours if
stored in a refrigerator at 2-8 °C.
From a microbiological point of view, the reconstituted and diluted medicine must be used immediately.
Vaborem is chemically incompatible with glucose-containing solutions. This
medicine must not be mixed with other medicines except those mentioned in paragraph

• 6.6 of the SmPC.