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Instructions for use, handling and disposal: The powder must be reconstituted with water for injections and the resulting concentrate must then be immediately diluted prior to use. The reconstituted solution is a pale yellow solution and is free of particles.
Zavicefta (ceftazidime/avibactam) is a combination product; each vial contains 2 g of ceftazidime and 0.5 g of avibactam in a fixed 4:1 ratio. Dosage recommendations are based on the ceftazidime component only.
Standard aseptic techniques should be used for solution preparation and administration. Doses may be prepared in an appropriately sized infusion bag.
Parenteral medicinal products should be inspected visually for particulate matter prior to administration.
Each vial is for single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.
The total time interval between starting reconstitution and completing preparation of the intravenous infusion should not exceed 30 minutes.
Instructions for preparing adult and paediatric doses in Infusion Bag: NOTE: The following procedure describes the steps to prepare an infusion solution with a final concentration of 8-40 mg/mL of ceftazidime. All calculations should be completed prior to initiating these steps.
1. Prepare the reconstituted solution (167.3 mg/mL of ceftazidime): a) Insert the syringe needle through the vial closure and inject 10 mL of sterile water for injections.
b) Withdraw the needle and shake the vial to give a clear solution.
c) Insert a gas relief needle through the vial closure after the product has dissolved to relieve the internal pressure (this is important to preserve product sterility).
2. Prepare the final solution for infusion (final concentration must be 8-40 mg/mL of ceftazidime): Infusion bag: Further dilute the reconstituted solution by transferring an appropriately calculated volume of the reconstituted solution to an infusion bag containing any of the following: sodium chloride 9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection, or Lactated Ringer's solution.
Infusion syringe: Further dilute the reconstituted solution by transferring an appropriately calculated volume of the reconstituted solution combined with a sufficient volume of diluent (sodium chloride 9 mg/mL (0.9%) solution for injection or dextrose 50 mg/mL (5%) solution for injection) to an infusion syringe.
Refer to Table 18 as follows. (See Table 18.)
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