Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Recombinant human hyaluronidase (rHuPH20)
Sorbitol
L-histidine HCl monohydrate
L-methionine
Polysorbate 20
L-histidine
Water for injections

6.2   Incompatibilities
This medicinal product must not be used with other materials except those mentioned in section 6.6.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
During the shelf-life, the product in unpunctured vials may be stored at room temperature (≤30°C) for a single period of up to 24 hours. Once the product has been taken out of the refrigerator, it must not be returned to the refrigerator (see section 6.6).

Prepared syringe
Chemical and physical in-use stability in syringe has been demonstrated for 24 hours at refrigerated conditions (2 °C-8 °C) protected from light, followed by no more than 12 hours at 15 °C-25 °C and ambient light. From a microbiological point of view, unless the method of opening 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.

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 of the opened medicinal product (see section 6.3).

6.5   Nature and contents of container

15 mL solution in a type 1 glass vial with a rubber stopper and an aluminium seal with a flip-off cap containing 1,800 mg of daratumumab. Pack size of 1 vial.

6.6   Special precautions for disposal and other handling

DARZALEX 120MG/ML S.C. 1,800MG solution for subcutaneous injection is for single use only and is ready to use.

DARZALEX 120MG/ML S.C. 1,800MG solution for subcutaneous injection should be a clear to opalescent and colourless to yellow solution. Do not use if opaque particles, discolouration or other foreign particles are present.

DARZALEX 120MG/ML S.C. 1,800MG solution for subcutaneous injection is compatible with polypropylene or polyethylene syringe material; polypropylene, polyethylene, or polyvinyl chloride (PVC) subcutaneous infusion sets; and stainless steel transfer and injection needles.

Unopened vial

Remove the DARZALEX 120MG/ML S.C. 1,800MG solution for subcutaneous injection vial from refrigerated storage (2°C-8°C) and equilibrate to ambient temperature (≤30°C). The unpunctured vial may be stored at ambient temperature and ambient light for a maximum of 24 hours in the original carton to protect from light. Keep out of direct sunlight. Do not shake.

Prepared syringe

Prepare the dosing syringe in controlled and validated aseptic conditions. Once transferred from the vial into the syringe, store DARZALEX 120MG/ML S.C. 1,800MG solution for subcutaneous injection for up to 24 hours refrigerated followed by up to 12 hours at 15 °C-25 °C and ambient light (see section 6.3). If stored in the refrigerator, allow the solution to reach ambient temperature before administration.

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


The following information is intended for healthcare professionals only: 
DARZALEX solution for subcutaneous injection should be administered by a healthcare professional.

To prevent medication errors, it is important to check the vial labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) and dose is being given to the patient as prescribed. DARZALEX solution for injection should be given by subcutaneous injection only, using the dose specified. DARZALEX subcutaneous formulation is not intended for intravenous administration.

DARZALEX solution for subcutaneous injection is for single use only and is ready to use.
•   DARZALEX solution for subcutaneous injection is compatible with polypropylene or polyethylene syringe material; polypropylene, polyethylene, or polyvinyl chloride (PVC) subcutaneous infusion sets; and stainless steel transfer and injection needles.
•   DARZALEX solution for subcutaneous injection should be a clear to opalescent and colourless to yellow solution. Do not use if opaque particles, discolouration or other foreign particles are present.
•   Remove the DARZALEX solution for subcutaneous injection vial from refrigerated storage (2 °C – 8 °C) and equilibrate to ambient temperature (15 °C–30 °C). The unpunctured vial may 
be stored at ambient temperature and ambient light for a maximum of 24 hours in the original carton to protect from light. Keep out of direct sunlight. Do not shake.
•     Prepare the dosing syringe in controlled and validated aseptic conditions.
•     To avoid needle clogging, attach the hypodermic injection needle or subcutaneous infusion set to the syringe immediately prior to injection.

Storage of prepared syringe
•     If the syringe containing DARZALEX is not used immediately, store the solution of DARZALEX for up to 24 hours refrigerated followed by up to 12 hours at 15 °C-25 °C and ambient light. If stored in the refrigerator, allow the solution to reach ambient temperature before administration.

Administration
•    Inject 15 mL DARZALEX solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3- 5 minutes. Do not inject DARZALEX solution for subcutaneous injection at other sites of the body as no data are available.
•    Injection sites should be rotated for successive injections.
•    DARZALEX solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars.
•    Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose.
•    During treatment with DARZALEX solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as DARZALEX.
•    Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.


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