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Powder for solution for infusion: Blood products and concentrated electrolytes: Voriconazole must not be infused concomitantly with any blood product or any short-term infusion of concentrated electrolytes, even if the two infusions are running in separate intravenous lines (or cannulas). Electrolyte disturbances such as hypokalemia, hypomagnesemia and hypocalcemia should be corrected prior to initiation of voriconazole therapy (see Dosage & Administration and Precautions).
Intravenous solutions containing (non-concentrated) electrolytes: Voriconazole can be infused at the same time as other intravenous solutions containing (non-concentrated) electrolytes, but must be infused through a separate line.
Total parenteral nutrition (TPN): Voriconazole can be infused at the same time as total parenteral nutrition, but must be infused in a separate line. If infused through a multiple-lumen catheter, TPN needs to be administered using a different port from the one used for voriconazole.
Voriconazole must not be diluted with 4.2% Sodium Bicarbonate Infusion. Compatibility with other concentrations is unknown.
This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: Film-coated tablets: Not applicable.
Powder for solution for infusion: Voriconazole is supplied in single use vials. The vial contents are reconstituted with 19 mL of Water for Injections to obtain a clear solution containing 10 mg/mL of voriconazole and an extractable volume of 20 mL. Discard the vial if vacuum does not pull the diluent into the vial. For administration, the required volume of the reconstituted solution (table as follows) is added to a recommended compatible infusion solution (detailed as follows) to obtain, where appropriate, a final voriconazole solution containing 0.5-5 mg/mL.
Dilution: Voriconazole must be infused over 1 to 3 hours, at a concentration of 5 mg/mL or less. Therefore, the required volume of the 10 mg/mL voriconazole concentrate should be further diluted as follows (appropriate diluents listed as follows): 1. Calculate the volume of 10 mg/mL voriconazole concentrate required based on the patient's weight (see table as follows).
2. In order to allow the required volume of voriconazole concentrate to be added, withdraw and discard at least an equal volume of diluent from the infusion bag or bottle to be used.
The volume of diluent remaining in the bag or bottle should be such that when the 10 mg/mL voriconazole concentrate is added, the final concentration is not less than 0.5 mg/mL nor greater than 5 mg/mL.
3. Using a suitable size syringe and aseptic technique, withdraw the required volume of voriconazole concentrate from the appropriate number of vials and add to the infusion bag or bottle. DISCARD PARTIALLY USED VIALS.
The final voriconazole solution must be infused over 1 to 3 hours at a maximum rate of 3 mg/kg per hour. (See Table 10.)
Click on icon to see table/diagram/imageVoriconazole is a single dose unpreserved sterile lyophile. Therefore, from a microbiological point of view, the product must be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
The reconstituted solution can be diluted with: 0.9% Sodium Chloride Intravenous Infusion, Compound Sodium Lactate Intravenous Infusion, 5% Glucose and Compound Sodium Lactate Intravenous Infusion, 5% Glucose and 0.45% Sodium Chloride Intravenous Infusion, 5% Glucose Intravenous Infusion, 5% Glucose in 20 mEq Potassium Chloride Intravenous Infusion, 0.45% Sodium Chloride Intravenous Infusion, 5% Glucose and 0.9% Sodium Chloride Intravenous Infusion.
The compatibility of voriconazole with diluents other than described previously is unknown.
