Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium chloride
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

Unopened
The expiry date of the product is indicated on the packaging materials.
After first opening:
The medicinal product must be used immediately after first opening the container. See also section 6.6.

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 to 8 ° C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage
Store below 25 ͦ C.
Do not freeze.

After first opening/dilution:
For storage conditions of the diluted solution, see section 6.3.
6.5    Nature and contents of container
Fluconazole 2 mg/ml is presented in bottles of low-density polyethylene (LDPE), contents: 50 ml, 100 ml, 200 ml,
Pack sizes: 10 bottles

Not all pack sizes may be marketed.

6.6.   Special precautions for disposal and other handling
This medicinal product is for single use. After use, discard bottle and any remaining contents. Do not reconnect partially used bottles.

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

The product should be inspected visually for particles and discoloration prior to administration. Only solutions free of particles should be used. Do not use if the bottle is damaged.

Do not connect bottles to each other. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.

The solution should be administered with sterile equipment using an aseptic technique.
The equipment should be primed with the solution in order to prevent air entering the system.

Fluconazole 2 mg/ml should be administered via intravenous infusion at a rate no greater than 10 ml/min.

Fluconazole 2 mg/ml is compatible with the following solutions: a) Glucose 200 mg/ml solution for infusion (if available) b) Ringer’s solution for infusion c) Hartmann’s solution, Lactated Ringer’s solution (if available) d) Potassium chloride solution 20 mEq/l in glucose 50 mg/ml (if available) e) Sodium bicarbonate 84 mg/ml (8.4%) solution for infusion (if available) f) Sodium Chloride 9 mg/ml (0.9%) solution for infusion g) Sterofundin ISO solution for infusion (if available)

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.