Cefamil-5^TM

Indication:
Cefamil-5^TM is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria:
• Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age)
• Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older

Dosage & Administration:
Adult Patients (with normal renal function, creatinine clearance CrCl>50 ml/min): The recommended dosage of Cefamil-5^TM is 600 mg administered every 12 hours by intravenous (IV) infusion over 5 to 60 minutes in patients ≥ 18 years of age.
• Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Recommended duration of treatment 5-14 days
• Community Acquired Bacterial Pneumonia (CABP): Recommended duration of treatment 5-7 days

Pediatric Patients (with normal renal function, creatinine clearance CrCl>50 ml/min): The recommended dosage of Cefamil-5^TM in pediatric patients is based on the age and weight of the child.
• 2 months to <2 years: Recommended dose is 8 mg/kg every 8 hours by intravenous infusion over 5 to 60 minutes for 5-14 days.
• ≥2 years to <18 years (≤33 kg): Recommended dose is 8 mg/kg every 8 hours by intravenous infusion over 5 to 60 minutes for 5-14 days.
• ≥2 years to <18 years (>33 kg): Recommended dose is 400 mg every 8 hours, or 600 mg every 12 hours by intravenous infusion over 5 to 60 minutes for 5-14 days.
Pediatric Patients Birth to less than 2 months (for ABSSI): The recommended dose is 6 mg/kg every 8 hours by intravenous infusion over 30-60 minutes for 5-14 days.

Preparation:
Cefamil-5^TM powder for IV infusion: Each vial contains sterile mixture of Ceftaroline Fosamil with L-arginine equivalent to Ceftaroline Fosamil INN 600 mg and each of two ampoules contains 10 ml Water for Injections BP (Sterile).