Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Citrate ions
Sodium chloride
Polysorbate 80
Sodium hydroxide
Hydrochloric acid
Water for injections

6.2   Incompatibilities
No incompatibilities between MabThera 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 MabThera in 0.9% sodium chloride solution is physically and chemically stable for 30 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 MabThera in 5% D-glucose solution is physically and chemically stable for 24 hours at 2 °C - 8 °C and plus additional 12 hours at room temperature.

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 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
MabThera 100 mg concentrate for solution for infusion
Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Pack of 2 vials.

MabThera 500 mg concentrate for solution for infusion
Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 mL Pack of 1 vial.


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

Use sterile needle and syringe to prepare MabThera. Aseptically withdraw the necessary amount of MabThera, 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.


7.    MARKETING AUTHORISATION HOLDER
Roche Pharmaceuticals (Israel) Ltd., P.O. Box 6391, Hod Hasharon 4524079.

8.    MARKETING AUTHORISATION NUMBER(S)

MABTHERA 10mg/ml I.V.                                   112.51.29472.00