Meropenem

1): • Severe pneumonia, including hospital and ventilator-associated pneumonia. • Broncho-pulmonary infections in cystic fibrosis • Complicated urinary tract infections • Complicated intra-abdominal infections • Intra- and post-partum infections • Complicated skin and soft tissue infections • Acute bacterial meningitis Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Meropenem for Injection USP and Sodium Chloride Injection USP is indicated for treatment of the following infections when caused by susceptible strains of the designated micro-organisms: • Lower Respiratory Tract Community-acquired pneumonia caused by Staphylococcus aureus (methicillin- susceptible strains only), Streptococcus pneumoniae, Escherichia coli and Haemophilus influenzae (including β-lactamase-producing strains).

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible strains only), Escherichia coli, Haemophilus influenzae (non-β-lactamase-producing), Klebsiella pneumoniae and Pseudomonas aeruginosa. • Urinary Tract Complicated urinary tract infections caused by Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens.

• Intra-abdominal Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Pseudomonas aeruginosa, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus species.

1 INDICATIONS AND USAGE Meropenem for Injection, USP is a penem antibacterial indicated for the treatment of: Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). 1 ) Complicated intra-abdominal infections (adult and pediatric patients).

2 ) Bacterial meningitis (pediatric patients 3 months of age and older only). 3 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection, USP and other antibacterial drugs, Meropenem for Injection, USP should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only) Meropenem for Injection, USP is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae , viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.

1): • 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.

1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.