Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Trehalose dihydrate
Sodium citrate dihydrate
Citric acid monohydrate
Polysorbate 20

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
No incompatibilities have been observed with standard infusion materials.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Reconstituted solution (prior to dilution)
Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2 °C – 25 °C.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. Do not freeze or shake.

Diluted solution (for infusion)
Chemical and physical in-use stability has been demonstrated for a maximum of 36 hours at 2 °C – 8 °C followed by up to 24 hours at up to 25 °C.
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 – 8 °C, unless dilution has taken place in controlled and validated aseptic conditions. Do not freeze or shake.

6.4   Special precautions for storage

Store in a refrigerator (2 °C – 8 °C).
Keep the vial in the outer carton in order to protect from light. Do not freeze. Do not shake.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
6.5   Nature and contents of container
Clear type I glass vial with a butyl rubber stopper, aluminium seal and a plastic flip-off cap containing 200 mg tafasitamab. Pack size of one vial.

6.6   Special precautions for disposal and other handling

MINJUVI 200 mg is provided in sterile, preservative-free single-use vials.
MINJUVI 200 mg should be reconstituted and diluted prior to intravenous infusion.
Use appropriate aseptic technique for reconstitution and dilution.
Instructions for reconstitution
•      Determine the dose of tafasitamab based on patient weight by multiplying 12 mg by the patient weight (kg). Then calculate the number of tafasitamab vials needed (each vial contains 200 mg tafasitamab) (see section 4.2).
•      Using a sterile syringe, gently add 5.0 mL sterile water for injections into each MINJUVI 200 MG vial. Direct the stream toward the walls of each vial and not directly on the lyophilised powder.
•      Gently swirl the reconstituted vial(s) to aid the dissolution of the lyophilised powder. Do not shake or swirl vigorously. Do not remove the contents until all of the solids have been completely dissolved. The lyophilised powder should dissolve within 5 minutes.
•      The reconstituted solution should appear as a colourless to slightly yellow solution. Before proceeding, ensure there is no particulate matter or discolouration by inspecting visually. If the solution is cloudy, discoloured or contains visible particles, discard the vial(s).

Instructions for dilution
•      An infusion bag containing 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection should be used.
•      Calculate the total volume of the 40 mg/mL reconstituted tafasitamab solution needed.
Withdraw a volume equal to this from the infusion bag and discard the withdrawn volume.
•      Withdraw the total calculated volume (mL) of reconstituted tafasitamab solution from the vial(s) and slowly add to the sodium chloride 9 mg/mL (0.9%) infusion bag. Discard any unused portion of tafasitamab remaining in the vial.
•      The final concentration of the diluted solution should be between 2 mg/mL to 8 mg/mL of tafasitamab.
•      Gently mix the intravenous bag by slowly inverting the bag. Do not shake.

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