Eraxis Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products or electrolytes except those mentioned in Description.
Special precautions for disposal and other handling: ERAXIS must be reconstituted with 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 ERAXIS with intravenous substances, additives, or medicines 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: Aseptically reconstitute each vial with 30 ml water for injection to provide a concentration of 3.33 mg/ml. The reconstitution time can be up to 5 minutes. After subsequent dilution, the solution is to be discarded if particulate matter or discoloration is identified.
The reconstituted solution may be stored at up to 25°C for 24 hours.
Dilution and infusion: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either particulate matter or discolouration is identified, discard the solution.
Adult Patients: Aseptically transfer the contents of the reconstituted vial(s) into an intravenous bag (or bottle) containing either 9 mg/ml (0.9%) sodium chloride for infusion or 50 mg/ml (5%) glucose for infusion obtaining an anidulafungin concentration of 0.77 mg/ml. 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 7.)

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The rate of infusion should not exceed 1.1 mg/min (equivalent to 1.4 ml/min or 84 ml/hour when reconstituted and diluted per instructions) (see Dosage & Administration, Precautions and Adverse Reactions).
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: (See Equation 1.)

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3. Calculate the total volume of dosing solution (ml) required to provide a final concentration of 0.77 mg/ml: (See Equation 2.)

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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: (See Equation 3.)

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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. Any unused medicinal product or waste materials should be disposed of in accordance with local requirements.