Amphotericin B Liposome For Injection Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in the following text.
Amphotericin B Liposome for Injection 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.
Amphotericin B Liposome for Injection is NOT interchangeable with other amphotericin products.
Amphotericin B Liposome for Injection must be reconstituted using sterile water for injection (without a bacteriostatic agent) and diluted in Dextrose solution (5%) 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 Amphotericin B Liposome for Injection.
Amphotericin B Liposome for Injection is NOT compatible with saline and must not be reconstituted or diluted with saline or administered through intravenous line that has previously been used for saline unless first flushed with dextrose solution (5%) for infusion. If this is not feasible, Amphotericin B Liposome for Injection should be administered through a separate line.
Do NOT mix Amphotericin B Liposome for Injection with other drugs or electrolytes.
Aseptic technique must be observed in all handling, since no preservative or bacteriostatic agent is present in Amphotericin B Liposome for Injection, or in the material specified for reconstitution and dilution.
Vials of Amphotericin B Liposome for Injection containing 50 mg of amphotericin are prepared as follows: 1. Add 12 ml of water for injection to each Amphotericin B Liposome for Injection 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 Amphotericin B Liposome for Injection. 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) Amphotericin B Liposome for Injection to be further diluted (see Table 1 as follows).
4. The infusion solution is obtained by dilution of the reconstituted Amphotericin B Liposome for Injection with between one (1) and nineteen (19) parts dextrose solution (5%) 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 Amphotericin B Liposome for Injection (see Table 1 as follows).
5. Withdraw the calculated volume of reconstituted Amphotericin B Liposome for Injection into a sterile syringe. Using the 5-micron filter provided, instill the Amphotericin B Liposome for Injection preparation into a sterile container with the correct amount of Dextrose solution (5%) for infusion.
An in-line membrane filter may be used for intravenous infusion of Amphotericin B Liposome for Injection. However, the mean pore diameter of the filter should not be less than 1.0 micron.
Preparation of Amphotericin B Liposome for Injection for infusion: An example is provided in the table as follows of the preparation of Amphotericin B Liposome for Injection dispersion for infusion at a dose of 3 mg/kg/day in dextrose 5% solution for infusion. Note that this table 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 the table 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.