Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Mannitol
Trometamol (Tris[hydroxymethyl]aminomehtane) Polysorbate 80
Disodium edetate dihydrate Hydrochloric acid (for pH adjustment)

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 
After reconstitution

The reconstituted solution should be transferred from the vial to the infusion bag immediately.
After dilution
Chemical and physical in-use stability after reconstitution and dilution has been demonstrated for 24 hours at 2-8°C and for 4 hours at 25°C during this period.

From a microbiological point of view, unless the method of reconstituting and dilution precludes the risk for microbial contamination, the product should be used immediately.
If not used immediately, in-use storage conditions are the responsibility of the user. The solution should be stored protected from light.

6.4   Special precautions for storage

Store in a refrigerator (2-8°C). Do not freeze.
Store in the original package in order to protect from light.

For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container
Idefirix is supplied in a vial (Type I glass) with a stopper (bromobutyl rubber) and flip off seal (aluminum).

Pack sizes of 1 vial or 2 x 1 vials.

6.6   Special precautions for disposal and other handling
Reconstitution of powder

Introduce 1.2 mL of sterile water for injections into the Idefirix vial, taking care to direct the water to the glass wall and not into the powder.

Swirl the vial gently for at least 30 seconds to dissolve the powder completely. Do not shake so as to minimise the likelihood of forming foam. The vial will now contain imlifidase 10 mg/mL and up to 1.1 mL of the solution can be withdrawn.

The reconstituted solution should be clear and colourless. Do not use if particles are present or the solution is discoloured. It is recommended to transfer the reconstituted solution from the vial to the infusion bag immediately.

Preparation of the solution for infusion

Slowly add the correct amount of reconstituted imlifidase solution to an infusion bag containing 50 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion. Invert the infusion bag several times to thoroughly mix the solution. The infusion bag should be protected from light. A sterile, inline, non-pyrogenic, low protein binding filter (pore size of 0.2 μm) infusion set must be used. For further information on administration see section 4.2.

Prior to use the solution for infusion should be inspected visually for particulate matter or discolouration.
Discard the solution if any particulate matter or discolouration is observed.

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