Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Mannitol
Sulfuric acid (for pH-adjustment)
Nitrogen

6.2   Incompatibilities

In the absence of compatibility studies, 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 
Chemical and physical in-use stability after reconstitution and dilution has been demonstrated for 24 hours at 2 °C to 8 °C, or 6 hours at room temperature.

From a microbiological point of view, the product 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 reconstitution and dilution have taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store in a refrigerator (2 °C to 8 °C).
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
6.5 Nature and contents of container
One 10 mL Type I glass vial with rubber stopper and an aluminum cap with plastic seal.

6.6   Special precautions for disposal and other handling

Reconstitution
One vial of the powder for concentrate for solution for infusion should be reconstituted by addition of 5 mL water for injections to the vial. The reconstituted concentrate contains 40 mg isavuconazole per Cresemba 200 mg IV, LPD, Israel      WC 16 Sep 2024 mL. The vial should be shaken to dissolve the powder completely. The reconstituted solution should be inspected visually for particulate matter and discoloration. Reconstituted concentrate should be clear and free of visible particulate. It must be further diluted prior to administration.

Dilution

After reconstitution, the entire content of the reconstituted concentrate should be removed from the vial and added to an infusion bag containing 250 mL of either sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) dextrose solution. The infusion solution contains approximately 0.8 mg isavuconazole per mL).

Administration

After the reconstituted concentrate is further diluted, the diluted solution may show fine white-to- translucent particulates of isavuconazole that do not sediment (but will be removed by in-line filtration). The diluted solution should be mixed gently, or the bag should be rolled to minimise the formation of particulates. Unnecessary vibration or vigorous shaking of the solution should be avoided. The solution for infusion must be administered via an infusion set with an in-line filter (pore size 0.2 μm to 1.2 μm) made of polyethersulfone (PES). Infusion pumps can be used and must be placed before the infusion set. Regardless of the infusion solution container size used, the entire volume of the container should be administered to ensure the complete dose is administered.


Isavuconazole should not be infused into the same line or cannula concomitantly with other intravenous products.

Storage conditions after reconstitution and dilution are provided in section 6.3.

If possible, the intravenous administration of isavuconazole should be completed within 6 hours after reconstitution and dilution at room temperature. If this is not possible, the infusion solution should be immediately refrigerated after dilution, and infusion should be completed within 24 hours. Further information regarding the storage conditions after reconstitution and dilution of the medicinal product is provided in section 6.3.

An existing intravenous line should be flushed with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) dextrose solution.

This medicinal product is for single use only. Discard partially-used vials.

This medicinal product may pose a risk to the environment (see section 5.3).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.