Pharmaceutical particulars : מידע רוקחי

6.       PHARMACEUTICAL PARTICULARS

6.1     List of excipients
Sucrose
L-Histidine hydrochloride monohydrate
L-Histidine
Polysorbate 80
Water for injections

6.2     Incompatibilities

This 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.
After dilution
Chemical and physical in-use stability of SARCLISA infusion solution has been demonstrated for 48 hours at 2°C - 8°C, followed by 8 hours (including the infusion time) at room temperature.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
No protection from light is required for storage in the infusion bag.

6.4     Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package 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
5 ml concentrate containing 100 mg of isatuximab in a 6 mL type I colourless clear glass vial closed with ETFE (copolymer of ethylene and tetrafluoroethylene)-coated bromobutyl stopper. The vials are crimped with an aluminium seal with a grey flip-off button. The fill volume has been established to ensure removal of 5 mL (i.e. 5.4 mL). Pack size of one or three vials.

25 ml concentrate containing 500 mg of isatuximab in a 30 mL type I colourless clear glass vial closed with ETFE (copolymer of ethylene and tetrafluoroethylene)-coated bromobutyl stopper. The vials are crimped with an aluminium seal with a blue flip-off button. The fill volume has been established to ensure removal of 25 mL (i.e. 26 mL). Pack size of one vial.

Not all pack sizes may be marketed.

6.6     Special precautions for disposal and other handling
Preparation for the intravenous administration
The preparation of the infusion solution must be done under aseptic conditions.

•     The dose (mg) of SARCLISA concentrate should be calculated based on patient weight (measured prior to each cycle to have the administered dose adjusted accordingly, see section 4.2). More than one vial may be necessary to obtain the required dose for the patient.
•     Vials of SARCLISA concentrate should be visually inspected before dilution to ensure they do not contain any particles and are not discolored.
•     Do not shake vials.
•     The volume of diluent equal to the required volume of SARCLISA concentrate should be removed from a 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 5% solution diluent bag.
•     The appropriate volume of SARCLISA concentrate should be withdrawn from the SARCLISA vial and diluted in the 250 mL infusion bag with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose5% solution.
•     The infusion bag must be made of polyolefins (PO), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC) with di (2-ethylhexyl) phthalate (DEHP) or ethyl vinyl acetate (EVA).
•     Gently homogenize the diluted solution by inverting the bag. Do not shake.

Administration
• The infusion solution must be administered by intravenous infusion using an intravenous tubing infusion set (in PE, PVC with or without DEHP, polybudadiene (PBD) or polyurethane (PU)) with a 0.22 micron in-line filter (polyethersulfone (PES), polysulfone or nylon).
• The infusion solution should be administered for a period of time that will depend on the infusion rate (see section 4.2).
• No protection from light is required for the prepared infusion bag in a standard artificial light environment.
• Do not infuse SARCLISA solution concomitantly in the same intravenous line with other agents.

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

7.        MARKETING AUTHORISATION HOLDER

Sanofi Israel Ltd, Greenwork Park, P.O box 47, Yakum