Zevtera

Each vial is for single use only. Zevtera must be reconstituted and then further diluted prior to infusion. Step 1.‍‍‍‍‍‍​​​‍​​​​​​ Reconstitution For adult and paediatric patients ≥ 12 years who require an infusion solution with a ceftobiprole concentration of 2 mg/mL, the lyophilized powder should be reconstituted with 10 mL of sterile water for injections or dextrose 50 mg/mL (5%) solution for injection. For paediatric patients < 12 years who require an infusion solution with a ceftobiprole concentration of 4 mg/mL, the lyophilized powder must be reconstituted either with 10 mL dextrose 50 mg/mL (5%) solution for injection if further dilution with the same diluent solution (i.e., dextrose 50 mg/mL (5%) solution for injection) is used, or with 10 mL of water for injection if further dilution with sodium chloride 9 mg/mL (0.9%) solution for injection is used (see section 6.3 tables). The vial should be shaken vigorously until complete dissolution, which in some cases may take up to 10 minutes. The volume of the resulting concentrate is approximately 10.6 mL. Any foam should be allowed to dissipate and the reconstituted solution should be inspected visually to ensure the product is in solution and particulate matter is absent. The reconstituted concentrate contains 50 mg/mL of ceftobiprole (as 66.7 mg/mL of ceftobiprole medocaril sodium) and must be further diluted prior to administration. It is recommended that the reconstituted solution be further diluted immediately. However, if this is not possible the reconstituted solution can be stored at room temperature for up to 1 hour, or in a refrigerator for up to 24 hours. Step 2. Dilution (infusion solution) Use in adult and paediatric patients ≥ 12 years Preparation of 500 mg dose of Zevtera solution for infusion (2 mg/mL ceftobiprole) 10 mL of the reconstituted solution should be withdrawn from the vial and injected into a suitable container (e.g. PVC or PE infusion bags, glass bottles) containing 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection, or Lactated Ringer's solution for injection. The infusion solution should be gently inverted 5‑10 times to form a homogenous solution. Vigorous agitation should be avoided to prevent foaming. In adults, the entire contents of the infusion bag should be infused to administer a 500 mg dose of Zevtera. In paediatric patients ≥ 12 years, the volume to be administered should be calculated based on the patient body weight (see section 4.2) and must not exceed a maximum of 250 mL (500 mg dose). Preparation of 250 mg dose of Zevtera solution for infusion for adult patients with severe renal impairment 5 mL of the reconstituted solution should be withdrawn from the vial and injected into a suitable container (e.g. PVC or PE infusion bags, glass bottles) containing 125 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection, or Lactated Ringer's solution for injection. The infusion solution should be gently inverted 5‑10 times to form a homogenous solution. Vigorous agitation should be avoided to prevent foaming. The entire contents of the infusion bag should be infused to administer a 250 mg dose of Zevtera. Use in paediatric patients < 12 years Preparation of Zevtera solution for infusion at a concentration of 4 mg/mL of ceftobiprole Administration via infusion bags, bottles or syringes: The reconstituted solution prepared with 10 mL dextrose 50 mg/mL (5%) solution for injection must be diluted with the same diluent solution (i.e ., dextrose 50 mg/mL (5%) solution for injection). The reconstituted solution prepared with 10 mL water for injection solution must be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection. 10 mL should be withdrawn from an infusion container (e.g., PVC or PE infusion bags, glass bottles) containing 125 mL of diluent solution and replaced with 10 mL of the reconstituted solution withdrawn from the vial. The infusion solution should be gently inverted 5–10 times to form a homogenous solution. Vigorous agitation should be avoided to prevent foaming. The volume to be administered should be calculated based on the patient body weight (see section 4.2) and must not exceed a maximum of 125 mL (500 mg dose). For administration via a 50 mL syringe if the calculated dose does not exceed 200 mg, 4 mL of the reconstituted solution (equivalent to 200 mg ceftobiprole) prepared with dextrose 50 mg/mL (5%) solution for injection or water for injection should be withdrawn from the vial and diluted with 46 mL of the appropriate infusion solution diluent (see section 6.3). The infusion solution should be gently inverted 5–10 times to form a homogenous solution. Vigorous agitation should be avoided to prevent foaming. The volume to be administered should be calculated based on the patient body weight (see section 4.2) and must not exceed a maximum of 50 mL (200 mg dose). Appearance of diluted solution The solution for infusion should be clear to slightly opalescent and yellowish in colour. The solution for infusion should be inspected visually for particulate matter prior to administration, and discarded if particulate matter is visible. Detailed information on the time by which reconstitution, dilution and infusion must complete is provided in section 6.3. Disposal Any unused medicinal product or waste material should be disposed of in accordance with local requirements.