Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
D-Sucrose
L-histidine hydrochloride monohydrate
L-methionine
L-histidine
Polysorbate 20
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.


Diluted solution for intravenous infusion

Chemical and physical in-use stability have been demonstrated for a maximum of 72 hours at 2 °C to 8 °C and 24 hours at 30 °C followed by a maximum infusion time of 8 hours.

From a microbiological point of view, the diluted 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 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.
Do not shake.
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

•    2.5 mL concentrate for solution for infusion in a 6 mL vial (colourless Type I glass) with stopper (butyl rubber).
Pack size of 1 vial.
•    10 mL concentrate for solution for infusion in a 15 mL vial (colourless Type I glass) with stopper (butyl rubber).
Pack size of 1 vial.

6.6       Special precautions for disposal and other handling

Instructions for dilution

•         Columvi contains no preservative and is intended for single use only.
•         Columvi must be diluted by a healthcare professional using aseptic technique, prior to intravenous administration.
•         Visually inspect the Columvi vial for particulate matter or discoloration prior to administration.
Columvi is a colorless, clear solution. Discard the vial if the solution is cloudy, discolored or contains visible particles.
•         Withdraw the appropriate volume of sodium chloride 9 mg/mL (0.9%) solution for injection or sodium chloride 4.5 mg/mL (0.45%) solution for injection, as described in Table 6, from the infusion bag using a sterile needle and syringe and discard.
•         Withdraw the required volume of Columvi concentrate for the intended dose from the vial using a sterile needle and syringe and dilute into the infusion bag (see Table 7). Discard any unused portion left in the vial.
•         The final glofitamab concentration after dilution must be 0.1 mg/mL to 0.6 mg/mL.
•         Gently invert the infusion bag to mix the solution in order to avoid excessive foaming. Do not shake.
•         Inspect the infusion bag for particulates and discard if present.
•         Prior to the start of the intravenous infusion, the content of the infusion bag should be at room temperature (25°C).


Table 7. Dilution of Columvi for infusion

Volume of sodium chloride 9 mg/mL (0.9%)
Volume of Columvi
Dose of Columvi to     Size of infusion     or 4.5 mg/mL (0.45%) concentrate to be be administered             bag           solution for injection to added be withdrawn and discarded
50 mL                    27.5 mL                    2.5 mL
2.5 mg
100 mL                   77.5 mL                    2.5 mL
50 mL                     10 mL                     10 mL
10 mg
100 mL                    10 mL                     10 mL
50 mL                     30 mL                     30 mL
30 mg
100 mL                    30 mL                     30 mL

Only sodium chloride 9 mg/mL (0.9%) or 4.5 mg/mL (0.45%) solution for injection should be used to dilute Columvi, since other solvents have not been tested.

When diluted with sodium chloride 9 mg/mL (0.9%) solution for injection, Columvi is compatible with intravenous infusion bags composed of polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP) or non-PVC polyolefin. When diluted with sodium chloride 4.5 mg/mL (0.45%) solution for injection, Columvi is compatible with intravenous infusion bags composed of PVC.

No incompatibilities have been observed with infusion sets with product-contacting surfaces of polyurethane (PUR), PVC or PE, and in-line filter membranes composed of polyethersulfone (PES) or polysulfone. The use of in-line filter membranes is optional.

Disposal

Columvi vial is for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.