For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Go to top of the page6.5 Nature and contents of container
 AmBisome is presented in 15 ml, 20 ml or 30 ml sterile, Type I glass vials. The closure consists of a grey butyl rubber stopper and aluminium ring seal fitted with a removable plastic cap. Single-dose vials are packed ten per carton with 10 filters. Not all pack sizes may be marketed.

Go to top of the page6.6 Special precautions for disposal and other handling
 READ THIS ENTIRE SECTION AND SECTION 4.4 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 strictly observed in all handling, since no preservative or bacteriostatic agent is present in AmBisome, or in the materials specified for reconstitution and dilution.

AmBisome Must Be Reconstituted By Suitably Trained Staff.

Vials of AmBisome Containing 50 mg of Amphotericin are Prepared as Follows:

1.Add 12 ml of Sterile 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 VIAL 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 any evidence of precipitation of foreign matter.
 
3.Calculate the amount of reconstituted (4 mg/ml) AmBisome to be further diluted (see table below).
 
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 below).
 
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.
Example of the preparation of AmBisome solution for infusion at a dose of 3mg/kg/day in dextrose 5% solution for infusion.
Weight (kg)
 Number of vials
 Amount AmBisome (mg) to be withdrawn for further dilution
 Volume of reconstituted AmBisome (ml)*
 To make up a 0.2mg/ml concentr