ERTAPENEM KABI POWDER FOR INJECTION 1G/VIAL [SIN16029P]

Product Info

ERTAPENEM KABI POWDER FOR INJECTION 1G/VIAL

[SIN16029P]

INDICATIONS
Ertapenem is indicated for the treatment of patients with moderate to severe infections caused by susceptible strains of microorganisms, as well as initial empiric therapy prior to the identification of causative organisms in the infections listed below:

• Complicated Intra-Abdominal Infections

• Complicated Skin and Skin Structure Infections including diabetic lower extremity infections

• Community-Acquired Pneumonia

• Complicated Urinary Tract Infections including pyelonephritis

• Acute Pelvic Infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections

To reduce the development of drug-resistant bacteria and maintain effectiveness of Ertapenem and other antibacterial drugs, Ertapenem 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 absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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.

2. Cockcroft and Gault equation: Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976

CONTRAINDICATIONS
Ertapenem Kabi is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.