Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Sodium chloride
Citric acid monohydrate
Polysorbate 80
Sodium hydroxide
Hydrochloric acid
Water for injections
6.2   Incompatibilities

No incompatibilities between Rixathon and polyvinyl chloride or polyethylene bags or infusion sets have been observed.

6.3   Shelf life

Unopened vial:
The expiry date of the product is indicated on the packging materials.
Rixathon may be stored at temperatures up to a maximum of 30°C for a single period of up to 7 days, but not exceeding the original expiry date. The new expiry date must be written on the carton. Upon removal from refrigerated storage, Rixathon must not be returned to refrigerated storage.

Diluted solution
• After aseptic dilution in sodium chloride solution: Chemical and physical stability of Rixathon diluted in 0.9% sodium chloride solution has been demonstrated for 30 days at 2°C - 8°C and subsequently 24 hours at room temperature (≤ 25°C).

• After aseptic dilution in glucose solution:
Chemical and physical stability of Rixathon diluted in 5% glucose solution has been demonstrated for 24 hours at 2°C - 8°C and subsequently 12 hours at room temperature (≤ 25°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 in the outer carton in order to protect from light.
For storage conditions of the unopened vial outside the refrigerator, see section 6.3.
For storage conditions after dilution of the medicinal product, see section 6.3.
6.5   Nature and contents of container

10 mL vial: Colorless tubular glass vial with chlorobutyl rubber stopper containing 100 mg of rituximab in 10 ml. Pack of 2 vials.

50 mL vial: Colorless tubular glass vial with chlorobutyl rubber stopper containing 500 mg of rituximab in 50 ml. Packs of 1 vial.

Each box of Rixathon 100 mg contains 2 vials.
Each box of Rixathon 500 mg contains 1 vial.
6.6   Special precautions for disposal and other handling

Rixathon is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Aseptic preparation
Aseptic handling must be ensured when preparing the infusion. Preparation should be: - performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
- prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.

Aseptically withdraw the necessary amount of Rixathon, 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.