Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Trehalose dihydrate
Sodium citrate dihydrate
L-histidine
L-histidine hydrochloride monohydrate
Citric acid monohydrate
Polysorbate 20
Water for injections

6.2   Incompatibilities
In the absence of compatibility studies, 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 opening

Once opened, the medicinal product should be diluted and infused immediately (see section 6.6 for instructions on dilution of the medicinal product before administration).

After preparation of solution for infusion

Tevimbra does not contain a preservative. Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C. The 24 hours include storage of the diluted solution under 
refrigeration (2°C to 8°C) for no more than 20 hours, time required for returning to room temperature (25°C or below) and time to complete the infusion within 4 hours.

From a microbiological point of view, unless the method of 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. The diluted solution must not be frozen.

6.4   Special precautions for storage

Store in a refrigerator (2°C – 8°C).
Do not freeze.

Store in the original 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

10 ml of Tevimbra concentrate is provided in a clear Type 1 glass vial, with a grey chlorobutyl stopper with FluroTec coating and seal cap with a flip-off button.

Tevimbra is available in unit packs containing 1 vial and in multipacks containing 2 (2 packs of 1) vials.

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
The diluted solution for infusion should be prepared by a healthcare professional using aseptic technique.

Preparation of solution for infusion

•     Two Tevimbra vials are required for each dose.

•     Remove the vials from the refrigerator, taking care not to shake them.

•     Inspect each vial visually for particulate matter and discolouration prior to administration. The concentrate is a clear to slightly opalescent, colourless to slightly yellowish solution. Do not use a vial if the solution is cloudy, or if visible particles or discolouration are observed.

•     Invert the vials gently without shaking. Withdraw the solution from the two vials (a total of 200 mg in 20 ml) into a syringe and transfer into an intravenous infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection, to prepare a diluted solution with a final concentration ranging from 2 to 5 mg/ml. Mix diluted solution by gentle inversion to avoid foaming or excessive shearing of the solution.

Administration

•     Administer the diluted Tevimbra solution by infusion through an intravenous administration line with a sterile, non-pyrogenic, low-protein-binding 0.2 micron or 0.22 micron in-line or add-on filter with a surface area of approximately 10 cm².


•     The first infusion should be delivered over 60 minutes. If well tolerated, subsequent infusions may be administered over 30 minutes.

•     Other medicinal products should not be co-administered through the same infusion line.

•     Tevimbra must not be administered as an intravenous push or single bolus injection.

•     The intravenous line must be flushed at the end of the infusion.

•     Discard any unused portion left in the vial.

•     Tevimbra vials are for single use only.

Disposal

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


7.    REGISTRATION HOLDER
BeiGene Pharmaceuticals Israel Ltd.
89 Medinat HaYehudim St.,
Herzliya.