Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium chloride
Tri-sodium citrate dihydrate
Polysorbate 80
Water for injection

6.2   Incompatibilities

No incompatibilities between rituximab 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 packaging materials.
Diluted medicinal product

• After aseptic dilution in sodium chloride solution
The prepared infusion solution of rituximab in 0.9% sodium chloride solution is physically and chemically stable for 30 days at 2 °C - 8 °C and subsequently 24 hours at room temperature (not more than 30°C).

• After aseptic dilution in D-glucose solution
The prepared infusion solution of rituximab in 5% D-glucose solution in water is physically 
and chemically stable for 24 hours at 2 °C - 8 °C and subsequently 12 hours at room temperature (not more than 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 container (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
Type I glass vials with chlorobutyl rubber stopper containing either: 100 mg of rituximab in 10 mL. Pack of 2 vials.
500 mg of rituximab in 50 mL. Pack of 1 vial.

6.6   Special precautions for disposal and other handling

Truxima is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Use sterile needle and syringe to prepare Truxima. Aseptically withdraw the necessary amount of Truxima, 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.