ERTAPENEM

6). 6).

Prevention Adults:

To prevent surgical site infections following elective colorectal surgery, the recommended dosage is 1 g administered as a single intravenous dose to be completed within 1 hour prior to the surgical incision. Paediatric population The safety and efficacy of Ertapenem Fresenius Kabi in children below 3 months of age have not yet been established.

No data are available. Patients with renal impairment Ertapenem Fresenius Kabi may be used for the treatment of infections in adult patients with mild to moderate renal impairment. 73 m2, no dosage adjustment is necessary. There are inadequate data on the safety and efficacy of ertapenem in patients with severe renal impairment to support a dose recommendation.

2). There are no data in children and adolescents with renal impairment. Patients on haemodialysis There are inadequate data on the safety and efficacy of ertapenem in patients on haemodialysis to support a dose recommendation. Therefore, ertapenem should not be used in these patients.

2). Elderly The recommended dose of Ertapenem Fresenius Kabi should be administered, except in cases of severe renal impairment (see Patients with renal impairment).

Method of administration Intravenous administration:

Ertapenem Fresenius Kabi should be infused over a period of 30 minutes. The usual duration of therapy with Ertapenem Fresenius Kabi is 3 to 14 days but may vary depending on the type and severity of infection and causative pathogen(s).

When clinically indicated, a switch to an appropriate oral antibacterial agent may be implemented if clinical improvement has been observed. Solutions of Ertapenem Fresenius Kabi range from colourless to pale yellow. 6.

Summary of the safety profile Adults The total number of patients treated with ertapenem in clinical studies was over 2,200 of which over 2,150 received a 1 g dose of ertapenem. e. considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported in approximately 20 % of patients treated with ertapenem.

3 % of patients. An additional 476 patients received ertapenem as a single 1 g dose prior to surgery in a clinical study for the prophylaxis of surgical site infections following colorectal surgery. 8 %). 0 %).

Paediatric Population (3 months to 17 years of age):

The total number of patients treated with ertapenem in clinical studies was 384. The overall safety profile is comparable to that in adult patients. 8 % of patients treated with ertapenem. 5 % of patients. 1 %). 8 %). Tabulated list of adverse reactions For patients who received only Ertapenem, the following adverse reactions were reported during therapy plus follow-up for 14 days after treatment was stopped: Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data).

4) Eye disorders Rare: Scleral disorder Cardiac disorders Uncommon: Sinus bradycardia Rare: Arrhythmia, tachycardia Vascular disorders Common: Infused vein complication, phlebitis/thrombophlebitis Uncommon: Hypotension Rare: Haemorrhage, increased blood pressure Uncommon: Hot flush, hypertension Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea, pharyngeal discomfort Rare: Nasal congestion, cough, epistaxis, rales/rhonchi, wheezing Gastrointestinal disorders Common: Diarrhoea, nausea, vomiting Uncommon: Constipation, acid regurgitation, dry mouth, dyspepsia, abdominal pain Rare: Dysphagia, faecal incontinence, pelvic peritonitis Not known: teeth staining Common: Diarrhoea Uncommon: Faeces discoloured, melaena Hepato-biliary disorders Rare: Cholecystitis, jaundice, liver disorder Skin and subcutaneous tissue disorders Common: Rash, pruritus Uncommon: Erythema, urticaria Rare: Dermatitis, desquamation, hypersensitivity vasculitis Not known: Acute Generalised Common: Diaper dermatitis Uncommon: Erythema, rash, petechiae Exanthematous Pustulosis (AGEP) Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) Musculoskeletal and connective tissue disorders Rare: Muscle cramp, shoulder pain Not known: Muscular weakness Renal and urinary disorders Rare: Renal insufficiency, acute renal insufficiency Pregnancy, puerperium and perinatal conditions Rare: Abortion Reproductive system and breast disorders Rare: Genital bleeding General disorders and administration site conditions Uncommon: Extravasation, asthenia/fatigue, fever, oedema/swelling, chest pain Rare: Injection-site induration, malaise Common: Infusion site pain Uncommon: Infusion site burning, infusion site pruritus, infusion site erythema, injection site erythema, infusion site warmth Investigations Chemistry Common: Elevations in ALT, AST, alkaline phosphatase Uncommon: Increases in total serum bilirubin, direct serum bilirubin, indirect serum bilirubin, serum creatinine, serum urea, serum glucose Rare: Decreases in serum bicarbonate, serum creatinine and serum potassium; increases in serum LDH, serum phosphorus, serum potassium Common: Elevations in ALT and AST Haematology Common: Elevation in platelet count Uncommon: Decreases in white blood cells, platelet count, segmented neutrophils, haemoglobin and haematocrit; increases in […]

Hypersensitivity Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens.

3). 8), discontinue the therapy immediately. Serious anaphylactic reactions require immediate emergency treatment. Superinfection Prolonged use of ertapenem may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential.

If superinfection occurs during therapy, appropriate measures should be taken. Antibiotic-associated colitis Antibiotic-associated colitis and pseudomembranous colitis have been reported with ertapenem and may range in severity from mild to life-threatening.

Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents. Discontinuation of therapy with Ertapenem and the administration of specific treatment for Clostridium difficile should be considered.

Medicinal products that inhibit peristalsis should not be given. Seizures Seizures have been reported during clinical investigation in adult patients treated with ertapenem (1 g once a day) during therapy or in the 14-day follow-up period.

g. brain lesions or history of seizures) and/or compromised renal function. Similar observations have been made in the post-marketing environment. 8). g. myoclonus, seizures, altered mental status, depressed level of consciousness), discontinuation of ertapenem should be considered.

Patients with renal impairment are at higher risk of ertapenem-induced encephalopathy and the resolution may be prolonged. 5). Sub-optimal exposure Based on the data available it cannot be excluded that in the few cases of surgical interventions exceeding 4 hours, patients could be exposed to sub-optimal ertapenem concentrations and consequently to a risk of potential treatment failure.

g. g. penicillins or cephalosporins).