Vortimal Caution For Usage

Instructions for Use: The powder is reconstituted with about 19 ml Water for Injections to obtain an extractable volume of 20 ml of clear concentrate containing 10 mg/ml of voriconazole. Discard the vial if the vacuum does not pull the diluent into the vial. This medicinal product is for single use only and any unused solution should be discarded and only clear solutions without particles should be used.
For administration, the required volume of the reconstituted concentrate is added to a recommended compatible infusion solution (detailed in the table as follows) to obtain a final voriconazole solution containing 0.5-5 mg/ml.
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. (See Table 6.)

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The final voriconazole solution must be infused at a maximum rate of 3 mg/kg per hour over 1 to 3 hours.
The compatibility of voriconazole with diluents other than described previously or in Incompatibilities as follows is unknown.
Incompatibilities: Vortimal must not be infused into the same line or cannula concomitantly with other intravenous products. When the Vortimal infusion is complete, the line may be used for administration of other intravenous products.
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 hypokalaemia, hypomagnesemia and hypocalcaemia should be corrected prior to initiation of voriconazole therapy (see 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 (see Interactions).
Vortimal 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 previously.