Patient leaflet - Recarbrio 500 mg / 500 mg / 250 mg powder for solution for infusion

1. What Recarbrio is and what it is used for

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

Recarbrio is used in adults and children (from birth to less than 18 years of age) to treat:

certain bacterial infections of the lungs (pneumonia)
infections of the blood associated with the infections of the lung mentioned above
infections caused by bacteria that other antibiotics may not be able to kill

2. What you need to know before you are given Recarbrio

You should not be given Recarbrio if:

you are allergic to imipenem, cilastatin, relebactam or any of the other ingredients
of this medicine (listed in section 6)
you are allergic to carbapenem antibiotics
you ever had a severe allergic reaction to penicillin antibiotics or cephalosporin
antibiotics

You should not be given Recarbrio if any of the above apply to you. If you are not sure, talk to your doctor or nurse before being given Recarbrio.

Warnings and precautions

Talk to your doctor or nurse before being given Recarbrio if:

you are allergic to any medicines - especially antibiotics
you have ever had convulsions (seizures or fits)
you have ever had confusion or muscle twitches with a medicine
you are taking a medicine containing valproic acid
you have had diarrhoea while taking antibiotics in the past
you have kidney problems – your doctor may lower your dose

Tell your doctor right away if you have an allergic reaction, convulsions (seizures or fits), diarrhoea, or develop kidney problems while receiving Recarbrio (see section 3).

Children and adolescents

Do not give this medicine to children with kidney problems who weigh less than 30 kg, children who weigh less than 2 kg, or preterm infants (less than 37 weeks post-menstrual age). This is because it is not known if the medicine is safe to use in these patients.

Other medicines and Recarbrio

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

Tell your doctor about all the medicines you take, especially if you take:

medicines that contain ganciclovir, used for treating some viral infections
medicines that contain valproic acid or divalproex sodium, usually used for
treating epilepsy, bipolar disorder, or migraine
medicines to control blood clotting, such as warfarin

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.

Driving and using machines

Recarbrio may make you feel dizzy, shaky, or cause convulsions or seizures. This may affect your ability to drive or use machines.

Recarbrio contains sodium

This medicine contains approximately 37.5 mg of sodium (main component of cooking/ table salt) in each vial. This is equivalent to about 2 % of the adult recommended maximum amount of sodium you should take daily, and needs to be taken into account if you are on a low-salt diet.

3. How you are given Recarbrio

The usual dose for adults is one vial (containing 500 mg imipenem, 500 mg cilastatin and 250 mg relebactam) every 6 hours. It is given as a drip directly into a vein (‘intravenous infusion’). The infusion will last 30 minutes.

Your doctor or nurse will determine the right dose and infusion time for children based on their age and weight.

If you have kidney problems, your doctor may lower your dose.

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

If you are given more Recarbrio than you should

Recarbrio 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 Recarbrio, tell your doctor or nurse right away.

If you miss a dose of Recarbrio

Tell your doctor or nurse right away if you think you were not given your dose of Recarbrio.

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 right away if you notice any of the following serious side effects - the medicine must be stopped:

allergic reactions – the signs may include hives, swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing
severe skin reactions (e.g., severe rash, skin peeling or blistering)

Other side effects

Common: (may affect up to 1 in 10 people)

nausea, being sick (vomiting), diarrhoea
blood test results that may show changes in the liver
blood test results that may show an increase in the number of some 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 the vein

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

hives
skin itchiness
convulsions (fits) and nervous system problems like tremor
confusion
seeing, hearing or feeling something that is not there (hallucinations)
dizziness, sleepiness
low blood pressure
blood test results that may show changes in the kidney
blood test results that may show a decrease in the number of red blood cells, white blood cells, and blood cells called platelets
blood test results that may show an increase in the number of some blood cells called platelets
abnormal kidney, liver, and blood function detected by blood tests
pain or redness or formation of a lump where the medicine was injected
fever
blood test (called a Coombs test) results showing antibodies that can cause anaemia by destroying red blood cells

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

fungal infection (candidiasis)
changes in taste
disease of the brain, tingling sensation (pins and needles), localised tremor
hearing loss
staining of the teeth and/or tongue
inflammation of the colon with severe diarrhoea (colitis)
low number of white blood cells which may make it difficult for your body to fight infections
inflammation of the liver
liver failure
inability of the kidney to perform normal function
changes in the amount of urine, changes in urine colour
swelling of the skin
painful rash with flu-like symptoms
redness and scaling of the skin

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

inflammation of stomach or intestine (gastro-enteritis)
anaemia due to destruction of red blood cells, leading to symptoms like tiredness, pale skin
headache
worsening of a rare disease associated with muscle weakness (aggravation of myasthenia gravis)
a spinning sensation (vertigo)
ringing in the ears (tinnitus)
irregular heartbeat, the heart beating forcefully or rapidly
chest discomfort, difficulty breathing, abnormally fast and superficial breathing, pain in the upper spine
pain in the throat
flushing, bluish discolouration of the face and lips, changes in skin texture, excessive sweating
increase in the production of saliva
inflammation of intestine with bloody diarrhoea (haemorrhagic colitis)
stomach pain
heartburn
red swollen tongue, overgrowth of the normal projections on the tongue giving it a hairy appearance
severe loss of liver function due to inflammation (fulminant hepatitis)
pain in several joints
itching of the vulva in women
weakness, lack of energy

Not known: (frequency cannot be estimated from the available data)

agitation
abnormal movements
jaundice (yellowing of your skin and eyes)
blood tests showing an increase in a substance called lactic dehydrogenase (LDH)
which may be a sign of tissue damage

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 at 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 Recarbrio

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 after EXP. The expiry date refers to the last day of that month.

Keep this medicine in the outer carton to protect from light.

Do not throw away any medicines via wastewater. 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 Recarbrio contains

The active substances are imipenem, cilastatin, and relebactam. Each vial contains 500 mg imipenem, 500 mg cilastatin, and 250 mg relebactam.
The other ingredient is sodium hydrogen carbonate.

What Recarbrio looks like and contents of the pack

Recarbrio is a white to light yellow powder supplied for solution for infusion in glass vials. Pack size is 25 vials.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London EC2M 6UR, UK

Manufacturer

FAREVA Mirabel, Route de Marsat, Riom, 63963, Clermont-Ferrand Cedex 9, France

For any information about this medicine, please contact:

Merck Sharp & Dohme Limited

Tel: +44 (0) 208 154 8000

Email: medicalinformationuk@msd.com

This leaflet was last revised in January 2026.

II-036

The following information is intended for healthcare professionals only:

Recarbrio is supplied as a dry powder in a single-dose vial that must be reconstituted and further diluted using aseptic technique prior to intravenous infusion as outlined below:

Adult patients

To prepare infusion solution, contents of the vial must be transferred to 100 mL of an appropriate infusion solution (see Summary of Product Characteristics sections 6.2 and 6.3): 9 mg/mL (0.9 %) sodium chloride. In exceptional circumstances where 9 mg/mL (0.9 %) sodium chloride cannot be used for clinical reasons 5 % glucose may be used instead. Please note that pre-filled infusion bags are overfilled and, to obtain a correct concentration, it is important to be assured that exactly 100 mL of the diluent is used in this step when a part of the content of the infusion bag is administered (e.g., in the case of paediatric weight-based dosing).

Withdraw 20 mL (10 mL times 2) of diluent from the appropriate infusion bag and reconstitute the vial with 10 mL of the diluent. The reconstituted suspension
must not be administered by direct intravenous infusion.
After reconstitution, shake vial well and transfer resulting suspension into the remaining 80 mL of the infusion bag.
Add the additional 10 mL of infusion diluent to the vial and shake well to ensure complete transfer of vial contents; repeat transfer of the resulting suspension to
the infusion solution before administering. Agitate the resulting mixture until clear.

Adult patients with renal impairment and paediatric patients weighing at least 30 kg with renal impairment

A reduced dose of Recarbrio will be administered according to the patient’s CrCl or eGFR, as determined from the table below.

Prepare 100 mL of infusion solution as directed above for adult patients.
Select the volume (mL) of the final infusion solution needed for the appropriate dose of Recarbrio as shown in the table below.

Paediatric patients weighing 2 kg to less than 30 kg with normal renal function

Prepare 100 mL of infusion solution as directed above for adult patients.
The volume of the final infusion solution (with a concentration of 12.5 mg/mL) to be administered is calculated based on patient weight as follows:
•• Infusion volume (mL) = (Weight (kg) x 37.5 mg/kg) / 12.5 mg/mL
•• Note: The entire volume in the infusion bag (100 mL) will not be required.
Transfer the calculated infusion volume from the prepared 100 mL solution to an adequately sized infusion bag or infusion syringe.
The infusion volume will be administered over 60 minutes via infusion or infusion syringe pump.

Preparation of Recarbrio solution for intravenous infusion in adult and paediatric patients (weighing at least 30 kg)

Estimated renal function (CrCl [mL/min]* or eGFR [mL/min/1.73 m²]^†)	Dose of Recarbrio (imipenem/cilastatin/ relebactam) (mg)	Volume (mL) of solution to be removed and discarded from preparation	Volume (mL) of final infusion solution needed for dose
Greater than or equal to 90	500/500/250	N/A	100
Less than 90 to greater than or equal to 60	400/400/200	20	80
Less than 60 to greater than or equal to 30	300/300/150	40	60
Less than 30 to greater than or equal to 15 or ESRD on haemodialysis	200/200/100	60	40
*CrCl calculated using the Cockcroft-Gault formula for adult patients
^†eGFR calculated using the bedside Schwartz formula for paediatric patients weighing ≥ 30 kg

Reconstituted solutions of Recarbrio range from colourless to yellow. Variations of colour within this range do not affect the potency of the product. Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. Discard if discolouration or visible particles are observed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Compatible medicinal products

The physical compatibility of Recarbrio with selected injectable medicinal products was evaluated in two commonly available diluents at a Y-infusion site. Compatible medicinal products with the corresponding compatible diluent (i.e., 5 % Dextrose Injection or 0.9 % Sodium chloride Injection) are listed below. Recarbrio should not be co-administered through the same intravenous line (or cannula), with other medicinal products not listed below, as no compatibility data are available. Refer to the respective prescribing information of the co-administered medicinal product(s) to confirm compatibility of simultaneous co-administration. This medicinal product must not be mixed with other medicinal products except those mentioned below.

List of Compatible Injectable Medicinal Products for use with 5 % Dextrose or 0.9 % Sodium chloride Injection as Diluents

dexmedetomidine
dopamine
epinephrine
fentanyl
heparin
midazolam
norepinephrine
phenylephrine

Compatible intravenous bags and infusion set materials

Recarbrio is compatible with the following intravenous container bags and infusion set materials. Any intravenous bags or infusion set materials not listed below should not be used.

Intravenous Container Bag Materials

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

Intravenous Infusion Set Materials (with tubing)

PVC + Di-(2-ethylhexyl)phthalate (DEHP) and polyethylene (PE)-lined PVC

Incompatible medicinal products

Recarbrio for solution for infusion is physically incompatible with propofol in 5 % Dextrose (also named Glucose) or 0.9 % Sodium chloride.

After reconstitution and dilution

Diluted solutions should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed two hours.