Vaborem (meropenem + vaborbactam) 1g/1g powder for solution for infusion. Rx. EF.

ATC-code: J01DH52

Therapeutic indications: Vaborem is indicated for the treatment of the following infections in adults: • Complicated urinary tract infection (cUTI), including pyelonephritis • Complicated intra-abdominal infection (cIAI) • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Vaborem is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Dosing: Vaborem should be used to treat infections due to aerobic Gram-negative organisms in adult patients with limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases. For full information see: www.fass.se

Contraindications: Hypersensitivity to the active substances or to any of the excipients. Hypersensitivity to any carbapenem antibacterial agent. Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins, cephalosporins or monobactams).

Warnings and precautions: Serious and occasionally fatal hypersensitivity reactions have been reported with meropenem and/or meropenem/vaborbactam. Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibacterial agents may also be hypersensitive to meropenem/vaborbactam. Before initiating therapy with Vaborem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. Seizures have been reported during treatment with meropenem. For full information see: www.fass.se

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Storage: Do not store above 25 °C. The reconstituted vial should be further diluted immediately. The chemical and physical in-use stability has been demonstrated for up to 4 hours at 25 °C or within 22 hours at 2 – 8 °C. From a microbiological point of view, the medicinal product should be used immediately upon reconstitution and dilution.

Pack size: 50 ml clear glass vial (Type 1) closed with a rubber (bromobutyl) stopper and aluminium overseal with flip-off cap. The medicinal product is supplied in packs of 6 vials.

For full information regarding prescription and SPC (June 2019) please see www.fass.se