- Approval Id
- 257f20fae94b4a40
- Drug Name
- ZINFORO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 600MG/VIAL
- Product Name
- ZINFORO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 600MG/VIAL
- Approval Number
- SIN14268P
- Approval Date
- 2012-11-15
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u><br>
The recommended durations of treatment are 5–14 days for cSSTI and 5–7 days for CAP.</p>
<img src="/TGIF/Zinforo-Table1_230524.png" alt="Zinforo Dosage Table 1" /><br><br>
<img src="/TGIF/Zinforo-Table2_230524.png" alt="Zinforo Dosage Table 2" /><br><br>
<p><u>Special populations</u></p>
<p><em>Elderly</em><br>
No dosage adjustment is required for the elderly with creatinine clearance values >50 mL/min (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Renal impairment</em><br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). The recommended durations of treatment are 5–14 days for cSSTI and 5–7 days for CAP.</p>
<img src="/TGIF/Zinforo-Table3_230524.png" alt="Zinforo Dosage Table 3" /><br><br>
<p>Dose recommendations for neonates, infants and children and adolescents are based on pharmacokinetic (PK) modelling.</p>
<p>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).</p>
<p>There is insufficient information to recommend dosage adjustments in paediatric patients <2 years with moderate or severe renal impairment or ESRD.</p>
<img src="/TGIF/Zinforo-Table4_230524.png" alt="Zinforo Dosage Table 4" /><br><br>
<p><em>Hepatic impairment</em><br>
No dosage adjustment is considered necessary in patients with hepatic impairment (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Method of administration</u><br>
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 <em>S. aureus</em> 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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Infusion related reactions (such as phlebitis) can be managed by prolonging the infusion duration.</p>
<p>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.</p>
<p>For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Zinforo is indicated for the treatment of the following infections caused by susceptible isolates of the designated microorganisms:</p>
<ul>
<li>Complicated skin and soft tissue infections (cSSTI)</li>
<li>Community-acquired pneumonia (CAP)</li>
</ul>
<p>Zinforo is indicated in neonates, infants, children, adolescents and adults.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of its excipients.</p>
<p>Hypersensitivity to the cephalosporin class of antibacterials.</p>
<p>Immediate and severe hypersensitivity (e.g., anaphylactic reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or carbapenems).</p>
- Atc Code
- J01DI02
- Atc Item Name
- ceftaroline fosamil
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
- Company Detail Path
- /organization/pfizer-private-limited
