imipenem / cilastatin / relebaktam
What Recarbrio is and what it is used for
Recarbrio is an antibiotic. It contains the active substances imipenem, cilastatin, and sulbactam.
Recarbrio is used in adults to treat:
- some bacterial infection in your lungs ( pneumonia )
- infection in the blood linked to infection in the lungs mentioned above
- the infection you caused by bacteria that other antibiotics may not be able to kill
Recarbrio is used in patients 18 years of age or older.
What you need to know before you get Recarbrio
You should not receive Recarbrio if:
- you are allergic to imipenem, cilastatin, sulbactam or any of the other ingredients of this medicine (listed in section 6)
- you are allergic to carbapenem antibiotics
- you have ever had a severe allergic reaction to antibiotics, such as penicillin er or cephalosporin er
You should not receive Recarbrio if any of the above apply to you. If you are not sure, talk to your doctor or nurse before taking Recarbrio.
Warnings and cautions
Talk to your doctor or nurse before receiving Recarbrio:
- if you are allergic to any medicines – especially antibiotics
- if you have ever had seizures (seizures or seizures)
- if you have ever had confusion or muscle twitching due to a drug
- if you are taking a medicine containing valproic acid
- if you have had diarrhea after taking antibiotics in the past
- if you have kidney problems – your doctor may need to lower your dose.
Contact a doctor immediately if you have an allergic reaction, seizures (cramps or seizures), diarrhea, or kidney problems while being treated with Recarbrio (see section 3).
Children and young people
Recarbrio should not be used in children and adolescents under 18 years of age. This is because it is not known whether it is safe for these patients to use the medicine.
Other medicines and Recarbrio
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor about all the medicines you are taking, especially if you are taking:
- medicines containing ganciclovir, which are used to treat certain viral infections
- medicines containing valproic acid or divalproex sodium commonly used to treat epilepsy, bipolar disorder, or migraine
- blood-thinning drugs 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 using this medicine.
Driving and using machines
Recarbrio can make you feel dizzy, shaky, or have seizures or seizures. This may affect your ability to drive or use machines.
Recarbrio contains sodium
This medicine contains approximately 37.5 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to about 2% of the highest recommended daily intake of sodium for adults and needs to be considered if you have been prescribed a low-salt diet.
How to get Recarbrio
The usual dose is one vial (containing 500 mg imipenem, 500 mg cilastatin, and 250 mg sulbactam) every 6 hours. If you have kidney problems, your doctor may need to lower your dose.
Recarbrio is given as a drip directly into a blood vessel (“intravenous infusion”). Infusion one lasts for 30 minutes.
The treatment usually lasts from 5 up to 14 days, depending on the type of infection you have and how you respond to the treatment.
If you take more Recarbrio than you should
You will receive Recarbrio from a doctor or nurse, so it is unlikely that you will receive the wrong dose. If you think you have had too much Recarbrio, talk to your doctor or nurse immediately.
If you have not received your dose of Recarbrio
Tell your doctor or nurse immediately if you think you have not received your dose of Recarbrio.
If you have any further questions on the use of this product, 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
Contact a doctor immediately if you notice any of the following serious side effects – treatment must be stopped:
- allergic reactions – signs may include hives, swelling of the face, lips, tongue, and/or throat, difficulty breathing or swallowing
- severe skin reactions (such as severe rash, dandruff, or blistering)
Other side effects are
Common : (may affect up to 1 in 10 people)
- nausea, vomiting, diarrhea
- blood test results that may indicate changes in the liver
- blood test results that may show an increase in the number of certain types of blood cells, so-called “eosinophils”
- blood test results that may indicate an increase in certain white blood cells
- rash
- inflammation and pain caused by a blood clot in a vein
Uncommon: (may affect up to 1 in 100 people)
- hives
- itching of the skin
- seizures and other problems with the nervous system such as tremors
- confusion
- to see, hear or feel something that does not exist (hallucinations)
- dizziness, fatigue
- low blood pressure
- blood test results that may indicate changes in the kidneys
- blood test results that may show a decrease in the number of red blood cells, white blood cells, and blood cells called platelets ( platelets )
- blood test results that may show an increase in the number of blood cells, called platelets ( platelets )
- abnormal kidney, liver, and blood function detected with blood tests
- pain, redness, or hardening at the injection site
- fever
- blood test results show antibodies that can cause anemia by destroying red blood cells (called the Coombs test)
Rare: (may affect up to 1 in 1,000 people)
- fungal infection ( candida infection )
- taste changes
- brain disease, stinging sensation, local tremors
- hearing loss
- discoloration of teeth and/or tongue
- colitis with severe diarrhea ( colitis )
- the low number of white blood cells which can make it difficult for the body to fight infection you
- inflammation of the liver
- liver failure
- the inability of the kidney to function normally
- changes in urine output and color
- skin swelling
- a painful rash with flu-like symptoms
- redness and flaking of the skin
Very rare: (may affect up to 1 in 10,000 people)
- inflammation of the stomach or intestines (gastrointestinal catarrh )
- 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 )
- dizziness
- tinnitus _ _
- irregular heartbeat, the heart beats powerfully or fast
- the feeling of discomfort in the chest, difficulty breathing, abnormally fast and shallow breathing, pain in the upper spine
- pain in the throat
- redness, bluish discoloration of the face and lips, altered skin structure, excessive sweating
- increased saliva production
- inflammation of the intestine with bloody diarrhea ( hemorrhagic colitis )
- abdominal pain
- heartburn
- red swollen tongue, growth of normal parts of the tongue which gives a hairy appearance
- severe hepatic impairment due to inflammation ( fulminant hepatitis )
- pain in several joints
- genital itching in women
- weakness, lack of energy
No known frequency: (can not be calculated from the available data)
- anxiety / upset
- abnormal movements
- jaundice (yellowing of the skin and whites of the eyes)
- blood test results show an increase in a substance called lactate dehydrogenase (LDH) which may be a sign of tissue damage
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 vial. The expiration date is the last day of the specified month.
Store the medicine in the outer carton. Sensitive to light.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substances are imipenem, cilastatin, and sulbactam. One vial contains 500 mg imipenem, 500 mg cilastatin, and 250 mg sulbactam.
- The other ingredient is sodium bicarbonate.
What the medicine looks like and the contents of the pack
Recarbrio is a white to light yellow powder for solution for infusion in a glass vial. Pack size: 25 vials.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Netherlands
Manufacturer
FAREVA Mirabel
Route de Mars, Riom
63963, Clermont-Ferrand Cedex 9
France
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