Renal Impairment

The effect of renal impairment on the pharmacokinetics of AmBisome has not been formally studied. Data suggest that no dose adjustment is required in patients undergoing haemodialysis or filtration procedures, however, AmBisome administration should be avoided during the procedure.
Go to top of the page5.3 Preclinical safety data
 In subchronic toxicity studies in dogs (1 month), rabbits (1 month) and rats (3 months) at doses equal to or, in some species, less than the clinical therapeutic doses of 1 to 3 mg/kg/day, the target organs for AmBisome toxicity were the liver and kidneys with thrombocytopenia also observed. All are known targets for amphotericin B toxicity.

AmBisome was found to be non-mutagenic in bacterial and mammalian systems.

Carcinogenicity studies have not been conducted with AmBisome.

No adverse effects on male or female reproductive function were noted in rats.

Go to top of the page6. PHARMACEUTICAL PARTICULARS
 
Go to top of the page6.1 List of excipients
 Hydrogenated soy phosphatidylcholine

Cholesterol

Distearoylphosphatidylglycerol

Alpha tocopherol

Sucrose

Disodium succinate hexahydrate

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

Go to top of the page6.2 Incompatibilities
 AmBisome is incompatible with saline solutions and may not be mixed with other drugs or electrolytes.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Go to top of the page6.3 Shelf life
 3 years

Shelf –life of AmBisome after first opening

As AmBisome does not contain any bacteriostatic agent, from a microbiological point of view, the reconstituted or diluted product should be used immediately.

In-use storage times and conditions prior to administration are the responsibility of the user and would normally not be longer than 24 hours at 2-8˚C, unless reconstitution has taken place in controlled and validated aseptic conditions.

However, the following chemical and physical in-use stability data for AmBisome has been demonstrated:

Shelf-life after reconstitution:

Glass vials for 24 hours at 25±2˚C exposed to ambient light

Glass vials and polypropylene syringes up to 7 days at 2-8˚C

Do not freeze

DO NOT STORE partially used vials for future patient use.

Shelf-life after dilution with Dextrose:

PVC or Polyolefin infusion bags: 25±2˚C exposed to ambient light or at 2-8˚C. Do not freeze. See table below for recommendations.
Diluent
 Dilution
 Concentration of Amphotericin B mg/mL
 Maximum duration of storage at 2-8˚C
 Maximum duration of storage at 25±2˚C
 
5% Dextrose
 1 in 2
 2.0
 7 days
 48 hours
 
1 in 8
 0.5
 7 days
 48 hours
 
1 in 20
 0.2
 4 days
 24 hours
 
10% Dextrose
 1 in 2
 2.0
 48 hours
 72 hours
 
20% Dextrose
 1 in 2
 2.0
 48 hours
 72 hours
Go to top of the page6.4 Special precautions for storage
 AmBisome: Unopened vials; Do not store above 25°C. Do not f