Description

This is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections: Complicated intra-abdominal infection (cIAI) Complicated urinary tract infection (cUTI), including pyelonephritis Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Treatment of adult patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. This is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Hypersensitivity to the active substances or to any of the excipients. Hypersensitivity to any cephalosporin antibacterial agent. Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of β-lactam antibacterial agent (e.g. penicillins, monobactams or carbapenems).

Animal studies with ceftazidime do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Animal studies with avibactam have shown reproductive toxicity without evidence of teratogenic effects. Ceftazidime/avibactam should only be used during pregnancy if the potential benefit outweighs the possible risk. Ceftazidime is excreted in human milk in small quantities. It is unknown whether avibactam is excreted in human milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast feeding or to discontinue/abstain from ceftazidime/avibactam therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

This medicinal product does not require any special storage conditions. Store in the original package in order to protect from light.

Elderly: No dosage adjustment is required in elderly patients. Renal impairment: No dosage adjustment is required in patients with mild renal impairment.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.