Zinforo

Posology The recommended durations of treatment are 5-14 days for cSSTI and 5-7 days for CAP. Table 1 Dosage in adults with normal renal function, creatinine clearance (CrCL) > 50 mL/min Indications Posology (mg/infusion) Infusion time (minutes)/Frequency Standard dosea Complicated skin and soft tissue infections (cSSTI) Community-acquired pneumonia (CAP) 5 – 60b/every 12 hours 3 Indications Posology (mg/infusion) Infusion time (minutes)/Frequency High doseb cSSTI confirmed or suspected to be caused by S.

aureus with an MIC = 2 mg/L or 4 mg/L to ceftarolinec 600 mg 120/every 8 hours a For patients with supranormal renal clearance receiving the standard dose, an infusion time of 60 minutes may be preferable. b Infusion times of less than 60 minutes and high dose recommendations are based on pharmacokinetic and pharmacodynamic analyses only.

1. c For treatment of S. aureus for which the ceftaroline MIC is ≤ 1 mg/L, the standard dose is recommended. Table 2 Dosage in paediatric patients with normal renal function, creatinine clearance (CrCL) > 50 mL/min* Indications Age group Posology (mg/infusion) Infusion time (minutes)/Frequency Standard dosea Complicated skin and soft tissue infections (cSSTI) Community-acquired pneumonia (CAP) Adolescents aged from 12 to < 18 years with bodyweight ≥ 33 kg 600 mg 5–60b/every 12 hours Adolescents aged from 12 years to < 18 years bodyweight < 33 kg and children ≥ 2 years to < 12 years 12 mg/kg to a maximum of 400 mg 5–60b/every 8 hours Infants ≥ 2 months to < 2 years 8 mg/kg 5–60b/every 8 hours Neonates from birth to < 2 monthsb 6 mg/kg 60/every 8 hours High doseb cSSTI confirmed or suspected to be caused by S.

aureus with an MIC = 2 mg/L or 4 mg/L to ceftarolinec Children and adolescents aged from ≥ 2 years to < 18 years 12 mg/kg to a maximum of 600 mg 120/every 8 hours Infants ≥ 2 months to < 2 years 10 mg/kg 120/every 8 hours a For patients with supranormal renal clearance receiving the standard dose, an infusion time of 60 minutes may be preferable.

b Infusion times of less than 60 minutes, neonatal and high dose recommendations are based on pharmacokinetic and pharmacodynamic analyses only. 1. c For treatment of S. aureus for which the ceftaroline MIC is ≤ 1 mg/L, the standard dose is recommended.

73 m2) for paediatric patients. 2). 2). The recommended durations of treatment are 5-14 days for cSSTI and 5-7 days for CAP. 4 Table 3 Dosage in adults with impaired renal function, creatinine clearance (CrCL) ≤ 50 mL/min Indications Creatinine clearance (mL/min)a Posology (mg/infusion) Infusion time (minutes)/Frequency Standard dose Complicated skin and soft tissue infections(cSSTI) Community-acquired pneumonia (CAP) > 30 to ≤ 50 400 mg 5–60c/every 12 hours≥ 15 to ≤ 30 300 mg ESRD, including haemodialysisb 200 mg High dosec cSSTI confirmed or suspected to be caused by S.

Summary of the safety profile The most common adverse reactions occurring in ≥ 3% of approximately 3242 patients treated with Zinforo in clinical studies were diarrhoea, headache, nausea, and pruritus, and were generally mild or moderate in severity.

Clostridium difficile-associated disease (CDAD) and severe hypersensitivity reactions may also occur. 4) were observed in a study of adult patients with cSSTI conducted with Zinforo 600 mg administered over 120 minutes every 8 hours.

Tabulated list of adverse reactions The following adverse reactions have been identified during clinical trials and post-marketing experience with Zinforo. Adverse reactions are classified according to System Organ Class and frequency.

Frequency categories are derived according to the following conventions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), not known (cannot be estimated from the available data).

g. 4) * Adverse Drug Reaction (ADR) identified post-marketing. 9). 10 Description of selected adverse reactions Kounis Syndrome Acute coronary syndrome associated with an allergic reaction (Kounis syndrome) has been reported with other beta-lactam antibiotics.

Rash Rash was observed at a common frequency in both the pooled Phase III studies in cSSTI with administration of Zinforo every 12 hours (600 mg administered over 60 minutes every 12 hours) and the study in cSSTI with administration every 8 hours (600 mg administered over 120 minutes every 8 hours).

5%). Paediatric population The safety assessment in paediatric patients is based on the safety data from 2 trials in which 227 patients aged from 2 months to 17 years with cSSTI or CAP received Zinforo. Overall, the safety profile in these 227 patients was similar to that observed in the adult population.

8). 8). Acute generalised exanthematous pustulosis (AGEP) has been reported in association with beta-lactam antibiotics (including cephalosporins) treatment. 6 Patients should be advised of the signs and symptoms and monitored closely for skin reactions.

If signs and symptoms suggestive of these reactions appear, ceftaroline should be withdrawn immediately, and an alternative treatment considered. If the patient has developed a severe skin reaction such as SJS, TEN or DRESS with the use of ceftaroline, treatment with ceftaroline must not be restarted in this patient at any time.

Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterials may also be hypersensitive to ceftaroline fosamil. g. penicillins or carbapenems). If a severe allergic reaction or SCAR occurs during treatment with Zinforo, the medicinal product should be discontinued and appropriate measures taken.

8). Clostridium difficile-associated diarrhoea Antibacterial-associated colitis and pseudomembranous colitis have been reported with ceftaroline fosamil and may range in severity from mild to life threatening. 8). In such circumstance, the discontinuation of therapy with ceftaroline fosamil and the use of supportive measures together with the administration of specific treatment for Clostridium difficile should be considered.

Non-susceptible organisms Superinfections may occur during or following treatment with Zinforo. 3). Clinical study experience with ceftaroline fosamil in patients with pre-existing seizure disorders is very limited. Therefore, Zinforo should be used with caution in this patient population.

Direct antiglobulin test (Coombs test) seroconversion and potential risk of haemolytic anaemia The development of a positive direct antiglobulin test (DAGT) may occur during treatment with cephalosporins. 8). In clinical studies there was no evidence of haemolysis in patients who developed a positive DAGT on treatment.

1. Hypersensitivity to the cephalosporin class of antibacterials. g. g. penicillins or carbapenems).