ZINFORO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 600MG/VIAL [SIN14268P]

Product Info

ZINFORO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 600MG/VIAL

[SIN14268P]

4.1 Therapeutic indications

Zinforo is indicated for the treatment of the following infections caused by susceptible isolates of the designated microorganisms:

• Complicated skin and soft tissue infections (cSSTI)

• Community-acquired pneumonia (CAP)

Zinforo is indicated in neonates, infants, children, adolescents and adults.

4.2 Posology and method of administration

Posology
The recommended durations of treatment are 5–14 days for cSSTI and 5–7 days for CAP.

Special populations

Elderly
No dosage adjustment is required for the elderly with creatinine clearance values >50 mL/min (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
The dose should be adjusted when creatinine clearance (CrCL) is ≤50 mL/min, as shown in Tables 3 and 4 (see sections 4.9 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The recommended durations of treatment are 5–14 days for cSSTI and 5–7 days for CAP.

Dose recommendations for neonates, infants and children and adolescents are based on pharmacokinetic (PK) modelling.

There is insufficient information to recommend dosage adjustments in adolescents aged from 12 to <18 years with bodyweight <33 kg and in children aged from 2 to 12 years with end-stage renal disease (ESRD).

There is insufficient information to recommend dosage adjustments in paediatric patients <2 years with moderate or severe renal impairment or ESRD.

Hepatic impairment
No dosage adjustment is considered necessary in patients with hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
Intravenous use. Zinforo is administered by intravenous infusion over 5 to 60 minutes for standard dose or 120 minutes for high dose (for cSSTI caused by S. aureus with MIC of 2 or 4 mg/L to ceftaroline) in infusion volumes of 50 mL, 100 mL or 250 mL (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Infusion related reactions (such as phlebitis) can be managed by prolonging the infusion duration.

Infusion volumes for paediatric patients will vary according to the weight of the child. The infusion solution concentration during preparation and administration should not exceed 12 mg/mL ceftaroline fosamil.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substance or to any of its excipients.

Hypersensitivity to the cephalosporin class of antibacterials.

Immediate and severe hypersensitivity (e.g., anaphylactic reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or carbapenems).