Zavicefta Caution For Usage

Incompatibilities: The compatibility of Zavicefta with other medicines has not been established. Zavicefta should not be mixed with or physically added to solutions containing other medicinal products except diluents mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: The powder must be reconstituted with sterile water for injections. The reconstituted solution must be used to prepare the final infusion solution within 30 minutes from initial vial puncture. The reconstituted solution is a pale yellow solution that is free of any 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 or infusion syringe.
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.
Instructions for preparing adult and paediatric doses in INFUSION BAG or INFUSION SYRINGE: 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. For paediatric patients aged 3 to 12 months, detailed steps to prepare a 20 mg/mL concentration (sufficient for most scenarios) are also provided.
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): a) 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.
b) 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 20 as follows. (See Table 20.)

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Preparation of Zavicefta for use in paediatric patients aged 3 to 12 months of age in INFUSION SYRINGE: NOTE: The following procedure describes the steps to prepare an infusion solution with a final concentration of 20 mg/mL of ceftazidime (sufficient for most scenarios). Alternative concentrations may be prepared, but must have a final concentration range of 8-40 mg/mL of ceftazidime.
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 to a final concentration of 20 mg/mL of ceftazidime: a) 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.
b) Refer to Table 21, 22 and 23 as follows to confirm the calculations. Values shown are approximate as it may be necessary to round to the nearest graduation mark of an appropriately sized syringe. Note that the tables are NOT inclusive of all possible calculated doses but may be utilized to estimate the approximate volume to verify the calculation. (See Tables 21, 22 and 23.)

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Click on icon to see table/diagram/image


Click on icon to see table/diagram/image