Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sucrose
L-histidine hydrochloride monohydrate
L-histidine
Polysorbate 80
Edetate disodium dihyrate
Water for injection

6.2   Incompatibilities
No incompatibilities between Ruxience and polyvinyl chloride or polyethylene bags or infusion sets have been observed.

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


6.3   Shelf life
Unopened vial

The expiry date of the product is indicated on the packging materials.

Diluted medicinal product
• After aseptic dilution in sodium chloride solution
The prepared infusion solution of Ruxience in 0.9% sodium chloride solution is physically and chemically stable for 35 days at 2 °C – 8 °C plus an additional 24 hours at ≤ 30 °C.

• After aseptic dilution in D-glucose solution
The prepared infusion solution of Ruxience in 5% D-glucose solution is physically and chemically stable for 24 hours at 2 °C – 8 °C plus an additional 24 hours at ≤ 30 °C.

From a microbiological point of view, the prepared infusion solution 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 – 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store in a refrigerator (2 °C – 8 °C). Keep the vial in the outer carton in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container
Ruxience 100 mg concentrate for solution for infusion

Clear Type I glass vials with chlorobutyl stopper and crimp seal with flip-off cap .containing 100 mg of rituximab in 10 mL.
Pack of 1 vial.

Ruxience 500 mg concentrate for solution for infusion

Clear Type I glass vials with chlorobutyl stopper and crimp seal with flip-off cap. containing 500 mg of rituximab in 50 mL.
Pack of 1 vial.


6.6   Special precautions for disposal and other handling
Ruxience is provided in sterile, preservative-free, non-pyrogenic, single use vials.

Use a sterile needle and syringe to prepare Ruxience. Aseptically withdraw the necessary amount of Ruxience and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water. For mixing the solution, gently invert the bag in order to avoid foaming. Care must be taken to ensure the sterility of prepared solutions. Since the medicinal product does not contain any anti-microbial preservative or bacteriostatic agents, aseptic technique must be observed.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.

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