Eraxis Caution For Usage

Incompatibilities: This medicinal product must not be mixed or co-administered with other medicinal products or electrolytes except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: Anidulafungin must be reconstituted with sterile water for injections and subsequently diluted with ONLY 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion. The compatibility of reconstituted anidulafungin with intravenous substances, additives, or medications other than 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion has not been established. The infusion solution must not be frozen.
Reconstitution of Water for Injection Presentation: Aseptically reconstitute each vial with 30 mL sterile water for injections to provide a concentration of 3.33 mg/mL. The reconstitution time can be up to 5 minutes.
Dilution and Infusion of Water for Injection Presentation: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter or discoloration is identified, discard the solution.
Adult Patients: Aseptically transfer the contents of the reconstituted vial(s) into an IV bag (or bottle) containing either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion to obtain the appropriate anidulafungin concentration. The table as follows provides the dilution to a concentration of 0.77 mg/mL for the final infusion solution and infusion instructions for each dose. (See Table 4.)

Click on icon to see table/diagram/image

The rate of infusion should not exceed 1.1 mg/min (see Precautions and Adverse Reactions). The rate of infusion is 1.4 mL/min or 84 mL/hour for the 100 mg and 200 mg doses.
Paediatric Patients: For paediatric patients aged 1 month to < 18 years, the volume of infusion solution required to deliver the dose will vary depending on the weight of the patient. The reconstituted solution must be further diluted to a concentration of 0.77 mg/mL for the final infusion solution. A programmable syringe or infusion pump is recommended. The rate of infusion should not exceed 1.1 mg/minute (equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions) (see Dosage & Administration and Precautions).
1. Calculate patient dose and reconstitute vial(s) required according to reconstitution instructions to provide a concentration of 3.33 mg/mL (see Description and Dosage & Administration).
2. Calculate the volume (mL) of reconstituted anidulafungin required:
Volume of anidulafungin (mL) = Dose of anidulafungin (mg) ÷ 3.33 mg/mL
3. Calculate the total volume of dosing solution (mL) required to provide a final concentration of 0.77 mg/mL:
Total volume of dosing solution (mL) = Dose of anidulafungin (mg) ÷ 0.77 mg/mL
4. Calculate the volume of diluent [5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline)] required to prepare the dosing solution:
Volume of diluent (mL) = Total volume of dosing solution (mL) - Volume of anidulafungin (mL)
5. Aseptically transfer the required volumes (mL) of anidulafungin and 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline) into an infusion syringe or IV infusion bag needed for administration.
For single use only. Waste materials should be disposed of in accordance with local requirements.