Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Mannitol
Sodium chloride
Sodium acetate trihydrate
Polysorbate 20
Glacial acetic acid
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 vials
The expiry date of the product is indicated on the packaging materials.
After dilution
From a microbiological point of view, unless the method of opening/ dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and should be no more than 24 hours at refrigerated conditions (2°C-8°C) protected from light, followed by 15 hours (including infusion time) at room temperature (15°C-25°C) and room light. If stored in the refrigerator, allow the solution to reach ambient temperature before administration.


6.4   Special precautions for storage

Store in a refrigerator (2°C-8°C).
Do not freeze or shake .
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 in a type 1 glass vial with a rubber stopper and an aluminium seal with a flip-off cap containing 100 mg of daratumumab. Pack size of 1 vial.
20 mL concentrate in a type 1 glass vial with a rubber stopper and an aluminium seal with a flip-off cap containing 400 mg of daratumumab. Pack size of 1 vial.

6.6   Special precautions for disposal and other handling

This medicinal product is for single-use only.
Prepare the solution for infusion using aseptic technique as follows: 
•     Calculate the dose (mg), total volume (mL) of DARZALEX 20MG/ML I.V solution required and the number of DARZALEX 20MG/ML I.V vials needed based on patient weight.
•     Check that the DARZALEX 20MG/ML I.V solution is colourless to yellow. Do not use if opaque particles, discolouration or other foreign particles are present.
•     Using aseptic technique, remove a volume of sodium chloride 9 mg/mL (0.9%) solution for injection from the infusion bag/container that is equal to the required volume of DARZALEX 20MG/ML I.V solution.
•     Withdraw the necessary amount of DARZALEX 20MG/ML I.V solution and dilute to the appropriate volume by adding to an infusion bag/container containing sodium chloride 9 mg/mL (0.9%) solution for injection (see section 4.2). Infusion bags/containers must be made of polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE) or polyolefin blend (PP+PE).
Dilute under appropriate aseptic conditions. Discard any unused portion left in the vial.
•     Gently invert the bag/container to mix the solution. Do not shake.
•     Visually inspect parenteral medicinal products for particulate matter and discolouration prior to administration. The diluted solution may develop very small, translucent to white proteinaceous particles, as daratumumab is a protein. Do not use if visibly opaque particles, discolouration or foreign particles are observed.
•     Since DARZALEX 20MG/ML I.V does not contain a preservative, diluted solutions should be administered within 15 hours (including infusion time) at room temperature (15°C-25°C) and in room light.
•     If not used immediately, the diluted solution can be stored prior to administration for up to 24 hours at refrigerated conditions (2°C-8°C) and protected from light. Do not freeze. If stored in the refrigerator, allow the solution to reach ambient temperature before administration.
•     Administer the diluted solution by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.22 or 0.2 micrometre). Polyurethane (PU), polybutadiene (PBD), PVC, PP or PE administration sets must be used.
•     Do not infuse DARZALEX 20MG/ML I.V concomitantly in the same intravenous line with other agents.
•     Do not store any unused portion of the infusion solution for reuse. Any unused product or waste material should be disposed of in accordance with local requirements.

Manufacturer:Cilag AG, Hochstrasse 201, 8200 Schaffhausen, Switzerland Registration holder: J-C Health Care Ltd., Kibbutz Shefayim 6099000, Israel 
Revised in 05-2024 according to MOHs guidelines.