INVANZ

).  Complicated intra-abdominal infections due to Escherichia coli, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus species, Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides uniformis, or Bacteroides thetaiotaomicron.

 Complicated skin and skin structure infections due to Staphylococcus aureus (methicillin- susceptible strain only), Streptococcus pyogenes, Escherichia coli and Peptostreptococcus species, as well as, diabetic foot infections due to Staphylococcus aureus (methicillin-susceptible strain only) and Peptostreptococcus species.

INVANZ® has not been studied in diabetic foot infections with concomitant osteomyelitis or severe ischemia (see 14 CLINICAL TRIALS).  Community acquired pneumonia due to Streptococcus pneumoniae (penicillin-susceptible strain only), Haemophilus influenzae (β-lactamase negative strain only), or Moraxella catarrhalis.

 Complicated urinary tract infections including pyelonephritis due to Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis.  Acute pelvic infections including postpartum endomyometritis, septic abortion and post -surgical gynecologic infections due to Streptococcus agalactiae, Escherichia coli, Peptostreptococcus species, Bacteroides fragilis, Porphyromonas asaccharolytica, or Prevotella species.

Prevention INVANZ® is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery. To reduce the development of drug-resistant bacteria and maintain the effectiveness of INVANZ® and other antibacterial drugs, INVANZ® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ertapenem. Initial therapy with INVANZ® may be instituted empirically for the treatment of bacterial infections, including mixed infections, while awaiting the results of these tests.

5 Post-Market Adverse Drug Reactions).  Seizures and other CNS (Central Nervous System) adverse experiences, have been reported during treatment with INVANZ®. , brain lesions or history of seizures) and/or compromised renal function (see 7 WARNINGS AND PRECAUTIONS, Neurologic, Renal and 8 ADVERSE REACTIONS).

 Case reports in the literature have shown that co-administration of carbapenems, including ertapenem, to patients receiving valproic acid or divalproex sodium results in a reduction in serum valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures.

In some cases of co-administration of ertapenem with valproic acid, breakthrough seizures have occurred. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction.  The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended.

Anti-bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of INVANZ® is necessary, supplemental anti-convulsant therapy should be considered (see

3 Pediatrics and 14 CLINICAL TRIALS, Pediatric Patients): • Complicated Intra-Abdominal Infections • Complicated Skin and Skin Structure Infections • Community Acquired Pneumonia • Complicated Urinary Tract Infections • Acute Pelvic Infections INVANZ® is not recommended in the treatment of meningitis in the pediatric population due to lack of sufficient cerebrospinal fluid (CSF) penetration.

Pediatrics (< 3 months of age):

INVANZ® is not recommended in infants under 3 months of age as no data are available. Therefore, Health Canada has not authorized an indication for this population. 2 Geriatrics Geriatrics (≥ 65 years of age): In clinical studies, the efficacy and safety of INVANZ® in the elderly (≥ 65 years) was comparable to that seen in younger patients (< 65 years).

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see 7 WARNINGS AND PRECAUTIONS and 4 DOSAGE AND ADMINISTRATION).

2 CONTRAINDICATIONS INVANZ® (ertapenem sodium) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Due to the use of lidocaine HCl as a diluent, INVANZ® administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type and in patients with severe shock or heart block (refer to the Product Monograph for lidocaine HCl).

INVANZ® (ertapenem sodium) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Due to the use of lidocaine HCl as a diluent, INVANZ® administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type and in patients with severe shock or heart block (refer to the Product Monograph for lidocaine HCl).