AmBisome Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product as follows.
AmBisome is incompatible with saline solutions and may not be mixed with other drugs or electrolytes.
Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product: Read this entire section carefully before beginning reconstitution.
AmBisome is NOT interchangeable with other amphotericin products.
AmBisome must be reconstituted using Sterile Water for Injection (without a bacteriostatic agent) and diluted in Dextrose solution (5%, 10% or 20%) for infusion only.
The use of any solution other than those recommended, or the presence of a bacteriostatic agent (e.g. benzyl alcohol) in the solution, may cause precipitation of AmBisome.
AmBisome is NOT compatible with saline and must not be reconstituted or diluted with saline or administered through an intravenous line that has previously been used for saline unless first flushed with dextrose solution (5%, 10% or 20%) for infusion. If this is not feasible, AmBisome should be administered through a separate line.
Do NOT mix AmBisome with other drugs or electrolytes.
Aseptic technique must be observed in all handling, since no preservative or bacteriostatic agent is present in AmBisome, or in the material specified for reconstitution and dilution.
Vials of AmBisome Containing 50 mg of Amphotericin are Prepared as Follows: 1. Add 12 ml of Water for Injection to each AmBisome vial, to yield a preparation containing 4 mg/ml amphotericin.
2. IMMEDIATELY after the addition of water, SHAKE THE VIALS VIGOROUSLY for 30 seconds to completely disperse the AmBisome. After reconstitution the concentrate is a translucent, yellow dispersion. Visually inspect the vial for particulate matter and continue shaking until complete dispersion is obtained.
Do not use if there is evidence of precipitation of foreign matter.
3. Calculate the amount of reconstituted (4 mg/ml) AmBisome to be further diluted (see Table 1).
4. The infusion solution is obtained by dilution of the reconstituted AmBisome with between one (1) and nineteen (19) parts dextrose solution (5%, 10% or 20%) for infusion by volume, to give a final concentration in the recommended range of 2.00 mg/ml to 0.20 mg/ml amphotericin as AmBisome (see Table 1).
5. Withdraw the calculated volume of reconstituted AmBisome into a sterile syringe. Using the 5-micron filter provided, instill the AmBisome preparation into a sterile container with the correct amount of Dextrose solution (5%, 10% or 20%) for infusion.
An in-line membrane filter may be used for intravenous infusion of AmBisome. However, the mean pore diameter of the filter should not be less than 1.0 micron.
Preparation of AmBisome for Infusion: An example of the preparation of AmBisome dispersion for infusion at a dose of 3 mg/kg/day in dextrose 5% solution for infusion is provided in Table 1. Note that Table 1 relates to doses of 3 mg/kg/day only, however other doses than this may be prescribed for a patient. If a dose other than 3 mg/kg/day has been prescribed for a patient, then the appropriate calculations must be undertaken and Table 1 cannot be used. (See Table 1.)

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For single use only. Discard any unused contents.
Any unused product or waste material should be disposed of in accordance with local requirements.