Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Mannitol
Lactose monohydrate
Hydrochloric acid
Sodium hydroxide

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products or intravenous solutions other than 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 of Xydalba has been demonstrated for both the reconstituted concentrate and for the diluted solution for 48 hours at or below 25 °C. The total in-use stability from reconstitution to administration should not exceed 48 hours.

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 to 8 °C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions. Do not freeze.

6.4   Special precautions for storage

Dry powder: store below 25 °C.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.


6.5   Nature and contents of container

Single-use 48 ml type I glass vial with a gray rubber stopper and a green flip off seal.

Each pack contains 1 vial.
6.6   Special precautions for disposal and other handling

Xydalba must be reconstituted with 25 ml sterile water for injections and subsequently diluted with 50 mg/ml (5 %) glucose solution for infusion.

Xydalba vials are for single use only.

Instructions for reconstitution and dilution
Aseptic technique must be used for reconstitution and dilution of Xydalba.
1.     The content of each vial must be reconstituted by slowly adding 25 ml of sterile water for injections.
2.     Do not shake. To avoid foaming, alternate between gentle swirling and inversion of the vial, until its contents are completely dissolved. The reconstitution time may be up to 5 minutes.
3.     The reconstituted concentrate in the vial contains 20 mg/ml dalbavancin.
4.     The reconstituted concentrate must be a clear, colourless to yellow solution with no visible particles.
5.     The reconstituted concentrate must be further diluted with 50 mg/ml (5 %) glucose solution for infusion.
6.     To dilute the reconstituted concentrate, the appropriate volume of the 20 mg / ml concentrate must be transferred from the vial to an intravenous bag or bottle containing 50 mg/ml (5 %) glucose solution for infusion. For example: 25 ml of the concentrate contains 500 mg dalbavancin.
7.     After dilution the solution for infusion must have a final concentration of 1 to 5 mg/ml dalbavancin
8.     The solution for infusion must be clear, colourless to yellow solution with no visible particles.
9.     If particulate matter or discoloration is identified, the solution must be discarded.

Xydalba must not be mixed with other medicinal products or intravenous solutions. Sodium chloride containing solutions can cause precipitation and should NOT be used for reconstitution or dilution. The compatibility of reconstituted Xydalba concentrate has only been established with 50 mg/ml (5 %) glucose solution for infusion.

If a common intravenous line is being used to administer other medicinal products in addition to Xydalba, the line should be flushed before and after each Xydalba infusion with 5% glucose solution for infusion.

Disposal

Discard any portion of the reconstituted solution that remains unused.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.