Rizontem Solution for Infusion is used in adults for:

• Complicated urinary tract infections (cUTIs), including pyelonephritis: Serious urinary tract infections that may involve the kidneys.

• Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP): Pneumonia acquired during hospital care, including infections associated with mechanical ventilation.

• Complicated intra-abdominal infections (cIAIs): Serious infections occurring within the abdomen.

Rizontem contains two active ingredients, Aztreonam and Avibactam.

Aztreonam is a monobactam antibacterial that blocks bacterial cell-wall synthesis, causing susceptible bacteria to die. Avibactam is a beta-lactamase inhibitor, meaning it blocks certain enzymes produced by bacteria that can otherwise break down some antibacterial medicines.

Together, Avibactam helps protect Aztreonam from several beta-lactamases, including certain class A and class C enzymes and some class D enzymes. However, the combination does not work against every type of bacteria or every beta-lactamase.

Tell your doctor about all prescription medicines, over-the-counter medicines, vitamins, supplements and herbal products you take.

• Probenecid: Concomitant use is not recommended because it may affect the elimination of Avibactam.

• Nephrotoxic medicines such as aminoglycosides: These medicines may affect kidney function. Kidney function should be monitored when they are used with Rizontem.

• Oral anticoagulants: Aztreonam may prolong prothrombin time. Patients receiving oral anticoagulants may require monitoring of their anticoagulation status.

• Metronidazole: It should be administered alongside Aztreonam/Avibactam when treating complicated intra-abdominal infections in which anaerobic bacteria are known or suspected to contribute to the infection.

• Store Rizontem Solution for Infusion in a refrigerator between 2°C and 8°C.

• Keep the vial in its original package to protect it from light.

• The reconstituted vial should be used within the specified preparation period before dilution.

• Prepared infusion solutions have specific storage limits depending on the diluent and should be handled according to the product instructions.

• Keep the medicine out of the reach of children.

Rizontem Solution for Infusion is administered intravenously by a healthcare professional. It should be given as an infusion over approximately 3 hours.

For adults with creatinine clearance above 50 mL/min, the recommended regimen uses a loading dose followed by Aztreonam 1.5 g + Avibactam 0.5 g every 6 hours. The dose and dosing interval must be adjusted in patients with reduced kidney function.

The duration of treatment depends on the infection. For adults with normal renal function, the usual labelled duration is 5–10 days for complicated intra-abdominal or urinary tract infections and 7–14 days for hospital-acquired pneumonia, although the treating doctor determines the final duration.

Rizontem should only be prepared and administered by trained healthcare professionals. Do not attempt to prepare or administer the infusion yourself.

Rizontem Solution for Infusion may cause side effects, although not everyone experiences them.

Common side effects:

• Anaemia

• Diarrhoea

• Increased alanine aminotransferase (ALT)

• Increased aspartate aminotransferase (AST)

• Nausea

• Vomiting

• Abdominal pain

• Dizziness

• Headache

• Rash

• Infusion-site reactions

• Phlebitis, or inflammation of a vein

Serious side effects:

• Severe allergic reactions, including anaphylaxis, swelling of the face or throat and difficulty breathing

• Severe or persistent diarrhoea due to Clostridioides difficile infection

• Severe skin reactions such as toxic epidermal necrolysis or other extensive blistering or peeling reactions

• Liver inflammation or jaundice

• Seizures, confusion or encephalopathy, particularly when excessive exposure occurs in patients with impaired kidney function

• Severe infusion-site complications

• Significant changes in blood cell counts or bleeding-related abnormalities

Seek immediate medical attention if you develop difficulty breathing, swelling of the face or throat, severe skin reactions, seizures, severe or persistent diarrhoea or other serious symptoms.

• Rizontem should be administered only by a trained healthcare professional.

• Tell your doctor if you have previously experienced an allergy to aztreonam, penicillins, cephalosporins, carbapenems or other beta-lactam antibacterial medicines.

• Your kidney function may need to be monitored during treatment because the dose depends on renal function.

• Tell your doctor about all medicines you are taking, particularly probenecid, aminoglycosides and oral anticoagulants.

• Complete the prescribed course unless your doctor tells you to stop treatment.

• Tell your doctor if you develop severe or persistent diarrhoea during or after treatment.

• Seek immediate medical attention if you develop a severe allergic reaction or difficulty breathing.

• If you are receiving treatment for a complicated intra-abdominal infection, metronidazole may also be prescribed when anaerobic bacteria are suspected.

• Do not attempt to prepare, dilute or administer Rizontem yourself.