Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Sodium chloride
Hydrochloric acid, sodium hydroxide (for pH adjustment)
Water for injection

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.
Once opened the product should be used immediately.
Any unused infusion should be discarded.
From a microbiological point of view, the dilutions should 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° C to 8° C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage
Store in a dry place, below 25˚C. Do not freeze.

6.5   Nature and contents of container
Clear Type I, glass bottle, closed with bromobutyl rubber stoppers and aluminium caps.
Pack sizes:
1 vial containing 50 ml or 200 ml.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Fluconazole intravenous infusion is compatible with the following administration fluids: a) Dextrose 20% b) Ringer's solution c) Hartmann's solution d) Potassium chloride in dextrose e) Sodium bicarbonate 4.2% f) Sodium chloride 9 mg/ml (0.9%)

Fluconazole may be infused through an existing line with one of the above- listed fluids. Although no specific incompatibilities have been noted, mixing with any other medicinal products prior to infusion is not recommended.

The solution for infusion is for single use only.
The dilution is to be made under aseptic conditions. The solution is to be 

inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free from particles.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.