Amphotericin B Liposome For Injection Storage

Storage condition: Do not store above 25°C.
Shelf life: Unopened Product: 3 years.
Product once reconstituted with water for injections: Amphotericin B Liposome for Injection is a single dose unpreserved sterile lyophile. Therefore from a microbiological point of view, once reconstituted, 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 2-8°C, unless reconstitution and dilution has taken place under controlled and validated aseptic conditions.
Where reconstitution and dilution are conducted under controlled and validated aseptic conditions the following may be used in determining use periods.
Chemical and physical stability have been demonstrated for storage as follows: Glass vials: 24 hours at 25±2°C.
Glass vials: up to 7 days at 2-8°C.
Polypropylene syringes: Up to 7 days at 2-8°C.
Do not freeze.
Product once reconstituted with water for injections and further diluted in dextrose: Chemical and physical stability have been demonstrated at the following storage conditions using dextrose infusion as the dilution medium in PVC bag. (See Table 2.)

Click on icon to see table/diagram/image

Special precaution for storage: DO NOT STORE partially used vials for future patient use.