Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sucrose
L-histidine
L-methionine
Polysorbate 20 (E 432)
Acetic acid (pH adjustment)
Water for injections

6.2   Incompatibilities

•     Do not mix Lunsumio with, or administer through the same infusion line, as other medicinal products.
•     Do not use solvents other than sodium chloride 9 mg/mL (0.9%) solution for injection or sodium chloride 4.5 mg/mL (0.45%) solution for injection to dilute Lunsumio since its use has not been tested.
•     No incompatibilities have been observed between Lunsumio and intravenous infusion bags with product contacting materials of polyvinyl chloride (PVC), or polyolefins (PO) such as polyethylene (PE) and polypropylene (PP). In addition, no incompatibilities have been observed with infusion sets or infusion aids with product contacting materials of PVC, PE, polyurethane (PUR), polybutadiene (PBD), silicone, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polyetherurethane (PEU), fluorinated ethylene propylene (FEP), or polytetrafluorethylene (PTFE), or with drip chamber filter membrane composed of polyamide (PA).
•     Do not use an in-line filter.

6.3   Shelf life

Unopened vial
The expiry date of the product is indicated on the packaging materials.

Diluted solution

Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C - 8 °C and 24 hours at 9 °C - 30 °C.


From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions 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.

6.4   Special precautions for storage

Store in a refrigerator (2 °C - 8 °C).
Do not freeze.
Keep the vial 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

1 mg concentrate for solution for infusion

Type I glass-vial with a butyl rubber stopper and an aluminium seal with a plastic dark grey flip-off cap containing 1 mg of concentrate for solution for infusion.

Pack of one vial.

30 mg concentrate for solution for infusion
Type I glass-vial with a butyl rubber stopper and an aluminium seal with a plastic light blue flip-off cap containing 30 mg of concentrate for solution for infusion.

Pack of one vial.

6.6   Special precautions for disposal and other handling
General precautions

Lunsumio contains no preservative and is intended for single-dose only. Proper aseptic technique throughout the handling of this medicinal product should be followed. Do not shake.

Instructions for dilution

Lunsumio must be diluted into a PVC or polyolefin (PO) such as polyethylene (PE) and polypropylene infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection or sodium chloride 4.5 mg/mL (0.45%) solution for injection by a healthcare professional using aseptic technique prior to administration.

Use sterile needle and syringe to prepare Lunsumio. Discard any unused portion.

A dedicated infusion line should be used during intravenous administration.
Do not use an in-line filter to administer Lunsumio.

Drip chamber filters can be used to administer Lunsumio.

Preparation for infusion
1.    Withdraw and discard a volume of sodium chloride 9 mg/mL (0.9%) solution for injection or sodium chloride 4.5 mg/mL (0.45%) solution for injection equal to the volume of the Lunsumio required for the patient’s dose from the infusion bag according to the Table 6 below.
2.    Withdraw the required volume of Lunsumio from the vial using a sterile syringe and dilute into the infusion bag. Discard any unused portion left in the vial.

Table 6: Dilution of Lunsumio

Volume of Lunsumio in sodium chloride 9 mg/mL
(0.9%) or 4.5 mg/mL
Dose of              (0.45%) solution for
Day of treatment       Lunsumio             injection                    Size of infusion bag Cycle 1     Day 1      1 mg                 1 mL                         50 mL or 100 mL Day 8    2 mg                 2 mL                         50 mL or 100 mL Day 1    60 mg                60 mL                        100 mL or 250 mL 5
Cycle 2       Day 1    60 mg                60 mL                        100 mL or 250 mL Cycle 3       Day 1    30 mg                30 mL                        100 mL or 250 mL and beyond

3.    Gently mix the infusion bag by slowly inverting the bag. Do not shake.
4.    Inspect the infusion bag for particulates and discard if present.
5.    Apply the peel-off label from the leaflet to the infusion bag.

For storage conditions of the infusion bags, see section 6.3.

Disposal

The release of pharmaceuticals into the environment should be minimised. Medicinal products should not be disposed of via wastewater and disposal through household waste should be avoided.
The following points should be strictly adhered to regarding the use and disposal of syringes and other medicinal sharps:
•     Needles and syringes should never be reused.
•     Place all used needles and syringes into a sharps container (puncture-proof disposable container).

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)
172-15-37418-00