ERTAPENEM KABI POWDER FOR INJECTION 1G/VIAL

FRESENIUS KABI (SINGAPORE) PTE LTD

FRESENIUS KABI (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**DOSAGE AND ADMINISTRATION** The usual dose of ertapenem in patients 13 years of age and older is 1 g given once a day. The usual dose of ertapenem in patients 3 months to 12 years of age is 15 mg/kg twice daily (not to exceed 1 g/day). Ertapenem Kabi is administered by IV infusion over a period of 30 minutes. The usual duration of therapy with ertapenem is 3–14 days, but varies by the type of infection and causative pathogen(s) (see **INDICATIONS**). When clinically indicated, a switch to an appropriate oral antimicrobial may be implemented if clinical improvement has been observed. In controlled clinical studies, patients were treated 3–14 days. Total treatment duration was determined by the treating physician based on site and severity of the infection, and on the patient’s clinical response. In some studies, treatment was converted to oral therapy at the discretion of the treating physician after clinical improvement had been demonstrated. Patients with Renal Insufficiency Ertapenem may be used for the treatment of infections in adult patients with renal insufficiency. In patients whose creatinine clearance is > 30 mL/min/1.73m2, no dosage adjustment is necessary. Adult patients with advanced renal insufficiency (creatinine clearance ≤30 mL/min/1.73m2), including those on haemodialysis, should receive 500 mg daily. There are no data in paediatric patients with renal insufficiency. Patients on Haemodialysis In a clinical study in adults, following a single 1 g IV dose of ertapenem given immediately prior to a haemodialysis session, approximately 30% of the dose was recovered in the dialysate. When patients on haemodialysis are given the recommended daily dose of 500 mg of ertapenem within 6 hours prior to haemodialysis, a supplementary dose of 150 mg is recommended following the haemodialysis session. If ertapenem is given at least 6 hours prior to haemodialysis, no supplementary dose is needed. There are no data in paediatric patients undergoing haemodialysis. There are no data in adult and paediatric patients undergoing peritoneal dialysis or haemofiltration. When only the serum creatinine is available, the following formulaii may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function.  No dosage adjustment is recommended in patients with impaired hepatic function (see **PHARMACOLOGY**, **Pharmacokinetics**, Pharmacokinetics in Special Populations, _Hepatic Impairment_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In patients 13 years of age and older, the recommended dose of ertapenem can be administered without regard to age or gender. **Instructions for Use/Handling** Preparation for IV Administration DO NOT MIX OR CO-INFUSE ERTAPENEM KABI WITH OTHER MEDICATIONS, OTHER THAN HEPARIN OR POTASSIUM CHLORIDE. DO NOT USE DILUENTS CONTAINING GLUCOSE. **ERTAPENEM KABI MUST BE RECONSTITUTED AND THEN DILUTED PRIOR TO ADMINISTRATION.** Patients 13 years of age and older 1. Reconstitute the contents of a 1 g vial of Ertapenem Kabi with 10 mL of one of the following: Water for Injections or 0.9% Sodium Chloride Injection or Bacteriostatic Water for Injections. 2. Shake well to dissolve and immediately transfer the contents of the reconstituted vial to 50 mL of 0.9% Sodium Chloride Injection. The resulting solution is chemically and physically stable only if used within 6 hours at room temperature, or stored for 24 hours at 2–8°C and used within 4 hours after removal from refrigeration. 3. To ensure adequate potency and to avoid microbiological hazard, the ertapenem solution should be used as soon as practicable after reconstitution and further dilution. If storage is unavoidable, the solution should be held at 2–8°C for not more than 24 hours, and used as soon as practicable within 4 hours after removal from refrigeration. The solution should not be frozen. 4. The solution should be infused over a period of 30 minutes. Paediatric patients 3 months to 12 years of age 1. Reconstitute the contents of a 1 g vial of Ertapenem Kabi with 10 mL of one of the following: Water for Injections or 0.9% Sodium Chloride Injection or Bacteriostatic Water for Injections. 2. Shake well to dissolve and immediately withdraw a volume equal to 15 mg/kg of body weight and dilute in 0.9% Sodium Chloride Injection to a final concentration of 20 mg/mL or less. The resulting solution is chemically and physically stable only if used within 6 hours at room temperature, or stored for 24 hours at 2–8°C and used within 4 hours after removal from refrigeration. 3. To ensure adequate potency and to avoid microbiological hazard, the ertapenem solution should be used as soon as practicable after reconstitution and further dilution. If storage is unavoidable, the solution should be held at 2–8° C for not more than 24 hours, and used as soon as practicable within 4 hours after removal from refrigeration. The solution should not be frozen. 4. The solution should be infused over a period of 30 minutes. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to use, whenever solution and container permit. Solutions of Ertapenem Kabi range from colourless to pale yellow. Variations of colour within this range do not affect the potency of the product. Product is for single use in one patient only. Discard any residue. **Compatibility** Compatibility of Ertapenem Kabi with intravenous solutions containing heparin sodium or potassium chloride has been demonstrated. * * * 1. Cockcroft and Gault equation: Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976