Label: information for the user

Recarbrio 500mg/500mg/250mg powder for solution for infusion

imipenem/cilastatina/relebactam

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section4.

Recarbrio is an antibiotic. It contains the active ingredients imipenem, cilastatin, and relebactam.

Recarbrio is used in adults to treat:

• specific bacterial lung infections (pneumonia)
• blood infections associated with the aforementioned lung infections
• infections caused by bacteria that other antibiotics are unable to destroy

Recarbrio is used in patients 18 years of age and older.

Do not use Recarbrio

• If you are allergic to imipenem, cilastatina, relebactam, or any of the other components of this medication (listed in section6)
• If you are allergic to carbapenem-type antibiotics
• If you have ever had a severe allergic reaction to penicillin-type antibiotics or cephalosporin-type antibiotics.

You should not receive Recarbrio if any of the above circumstances apply. If you are unsure, consult your doctor or nurse before receiving Recarbrio.

Warnings and precautions

Consult your doctor or nurse before starting to use Recarbrio if:

• You are allergic to any medication‑especially antibiotics
• You have ever had seizures (convulsions or attacks)
• You have ever had confusion or muscle contractions with a medication
• You are taking a medication that contains valproic acid
• You have had diarrhea while receiving antibiotics in the past
• You have kidney problems‑Your doctor may reduce the dose

Inform your doctor immediately if you have an allergic reaction, seizures (convulsions or attacks), diarrhea, or develop kidney problems while receiving Recarbrio (see section3).

Children and adolescents

Recarbrio should not be used in children or adolescents under 18years. This is because it is not known if the medication is safe to use in these patients.

Other medications and Recarbrio

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication.

Inform your doctor about all the medications you receive, especially if you take:

• Medications that contain ganciclovir, used to treat some viral infections
• Medications that contain valproic acid or valproate semisodium, usually used to treat epilepsy, bipolar disorder, or migraine
• Medications to control blood clotting, such as warfarin

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Driving and operating machinery

Recarbrio may make you feel dizzy, agitated, or cause seizures or convulsions, which could affect your ability to drive or operate machinery.

Recarbrio contains sodium

This medication contains approximately 37.5mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to around 2% of the maximum daily sodium intake recommended for an adult, and you should be aware of this if you follow a low-sodium diet.

The recommended dose is one vial (containing 500mg of imipenem, 500mg of cilastatin, and 250mg of relebactam) every 6hours. If you have kidney problems, your doctor may reduce your dose.

It is administered through direct infusion into a vein (“intravenous infusion”). The infusion will last 30minutes.

The treatment cycle usually lasts from 5 to 14days, depending on the type of infection you have and how you respond to treatment.

If you use more Recarbrio than you should

Recarbrio will be administered by a doctor or nurse, so it is unlikely that an incorrect dose will be administered. If you think you have been given too much Recarbrio, inform your doctor or nurse immediately..

If you forgot to use Recarbrio

Inform your doctor or nurse immediately if you think you have not received your dose of Recarbrio.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Inform your doctor immediately if you notice any of the following severe side effects that require the medicine to be discontinued:‑allergic reactions:

• allergic reactions‑symptoms may include hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing
• intense skin reactions (e.g. severe rash, skin peeling, or blistering)

Other side effects

Common: (may affect more than 1in 10people)

• nausea, discomfort (vomiting), diarrhea
• blood test results that may show changes in the liver
• blood test results that may show an increase in the number of certain types of blood cells called “eosinophils”
• blood test results that may show an increase in some white blood cells
• rash
• inflammation and pain caused by a blood clot in a vein

Uncommon: (may affect up to 1in 100people)

• hives
• itching on the skin
• convulsions (seizures) and nervous system problems such as tremors
• confusion
• seeing, hearing, or feeling things that are not there (hallucinations)
• dizziness, drowsiness
• low blood pressure
• blood test results that may show changes in the kidneys
• blood test results that may show a decrease in the number of red blood cells, white blood cells, and platelets
• blood test results that may show an increase in the number of some blood cells called platelets
• abnormal liver, kidney, and blood function detected by blood tests
• pain, redness, or swelling, or the formation of a lump at the site where the medicine was injected
• fever
• blood test results (called the Coombs test) that show antibodies that may cause anemia by destroying red blood cells

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

• fungal infection (candidiasis)
• changes in taste
• brain disease, sensation of tingling (pins and needles), localized tremors
• loss of hearing
• stained teeth and/or tongue
• inflammation of the colon with intense diarrhea (colitis)
• low white blood cell count, which may make it difficult for your body to fight infections
• inflammation of the liver
• liver insufficiency
• kidney failure to perform normal function
• changes in urine output, changes in urine color
• skin swelling
• painful rash with flu-like symptoms
• redness and peeling of the skin

Very rare: (may affect up to 1in 10,000people)

• inflammation of the stomach or intestines (gastroenteritis)
• anemia due to the destruction of red blood cells, leading to symptoms such as fatigue and pale skin
• headache
• worsening of a rare disease associated with muscle weakness (worsening of myasthenia gravis)
• sensation of spinning (vertigo)
• ringing in the ears (tinnitus)
• irregular heartbeat, strong or rapid heartbeats
• chest discomfort, difficulty breathing, abnormal breathing rate and depth, pain in the upper back
• sore throat
• flushing, change in skin color, blue discoloration of the face and lips, changes in skin texture, excessive sweating
• increased saliva production
• inflammation of the intestine with bloody diarrhea (colitis hemorrhagica)
• stomach pain
• heartburn
• red, swollen tongue, excessive growth of normal tongue protuberances giving a hairy appearance
• severe liver dysfunction due to inflammation (fulminant hepatitis)
• pain in various joints
• itching in the vulva of women
• weakness, lack of energy

Unknown frequency: (frequency cannot be estimated from available data)

• agitation
• abnormal movements
• jaundice (yellowing of the skin and eyes)
• blood tests showing an increase in a substance called lactate dehydrogenase (LDH), which may indicate tissue damage.

Reporting side effects

If you experience any type of side effect, consult yourdoctor or nurse,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included intheAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Keep this medication in the outer packaging to protect it from light.

Medications should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Recarbrio

• The active ingredients are imipenem, cilastatin, and relebactam. Each vial contains 500 mg of imipenem, 500 mg of cilastatin, and 250 mg of relebactam.
• The other components are sodium hydrogen carbonate.

Appearance of the product and contents of the container

Recarbrio is a white to light yellow powder that is supplied for intravenous solution in glass vials. The container size is 25 vials.

Holder of the marketing authorization and responsible for manufacturing

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Last review date of this leaflet:{MM/YYYY}.

The detailed information about this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

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This information is intended solely for healthcare professionals:

Recarbrio is supplied as a dry powder in a single-dose vial that must be reconstituted and further diluted using aseptic techniques before intravenous infusion, as follows:

• To prepare the infusion solution, the contents of the vial must be transferred to 100ml of an appropriate infusion solution: sodium chloride 9mg/ml (0.9%) solution for injection. In exceptional circumstances where 0.9%) sodium chloride solution for injection cannot be used for clinical reasons, 5% glucose solution for injection may be used instead.
• Draw out 20ml (2 times 10ml) of diluent from the infusion bag and reconstitute the vial with 10ml of the diluent. The reconstituted suspension must not be administered by direct intravenous infusion.
• After reconstitution, shake the vial well and transfer the resulting suspension to the remaining 80ml of the infusion bag.
• Add the additional 10ml of infusion diluent to the vial and shake well to ensure complete transfer of the vial contents; repeat the transfer of the resulting suspension to the infusion solution before administration. Shake the resulting mixture until it is transparent.
• The reconstituted solutions of Recarbrio range from colorless to yellow. Variations in color within this range do not affect the potency of the product.
• In patients with renal insufficiency, Recarbrio will be administered at a reduced dose according to theClCrof the patient, as determined by the following table. Prepare 100ml of infusion solution as indicated above. Select the volume(ml)of the final infusion solution needed for the appropriate dose ofRecarbrioas shown in the following table.

Parenteral drugs must be visually inspected for particulate matter and discoloration before administration, whenever the solution and container permit. Discard them if a change in color or visible particles are observed.

Preparation of Recarbrio doses

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Compatible Medications

The physical compatibility ofRecarbriowith selected injectable medications in two infusion solutions in Y use has been evaluated. The following medications are compatible with the corresponding compatible diluent(i.e., 5% dextrose solution for injection or 0.9%) sodium chloride solution for injection).Recarbriomust not be administered concomitantly through the same intravenous route (or cannula), with other medications not listed below, as there is no data on compatibility. See the relevant product label for the administered medication(s) to confirm the compatibility of simultaneous administration. This medication must not be mixed with other medications except those listed below.

List of injectable medications compatible for use with 5% dextrose solution or 0.9% sodium chloride solution for injection as diluents

• dexmedetomidine
• dopamine
• epinephrine
• fentanyl
• heparin
• midazolam
• norepinephrine
• phenylephrine

Compatible IV bags and infusion equipment

Recarbrio is compatible with the following IV bags and infusion equipment. No other IV bags or infusion equipment should be used.

Materials of the infusion bag for intravenous administration

Polyvinyl chloride (PVC) and polyolefin (polypropylene and polyethylene)

Infusion equipment for intravenous administration (with tubing)

PVC + Di‑(2-ethylhexyl)phthalate (DEHP) and PVC coated with polyethylene (PE)

Incompatible Medications

Recarbrio for infusion solution is physically incompatible with propofol in 5% dextrose solution (also known as glucose) or 0.9% sodium chloride solution.

After reconstitution and dilution

The diluted solutions must be used immediately. The time interval between the start of reconstitution and the end of intravenous infusion must not exceed two hours.