Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sorbitol
Sodium acetate trihydrate
Glacial acetic acid
Sodium hydroxide
Water for injection

6.2   Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3   Shelf life

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

6.4   Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
Store in the original carton to protect from light.

6.5   Nature and contents of container

A Type I glass vial with a stopper (cholorobutyl), and a seal (aluminium) with a flip-off cap (polypropylene) containing 54 mg pegcetacoplan/1 mL of sterile solution.

Each single pack contains 1 vial.

Multipack containing 8 (8 packs of 1) vials.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling

ASPAVELI comes as a ready-to-use solution in single-use vials. Because the solution contains no preservative, this medicinal product should be infused immediately after preparing the syringe.

ASPAVELI is a clear, colourless to slightly yellowish aqueous solution. Do not use if the liquid looks cloudy, contains particles, or is dark yellow.

Always bring the vial to the room temperature for approximately 30 minutes before use.

Remove the protective flip cap from the vial to expose the central portion of the gray rubber stopper of the vial. Clean the stopper with a new alcohol wipe and allow the stopper to dry. Do not use if the protective flip cap is missing or damaged.

Option 1: If using a needleless transfer device (such as a vial adapter), follow the instructions provided by the device manufacturer.

Option 2: If transfer is done using a transfer needle and a syringe, follow the instructions below:
•     Attach a sterile transfer needle to a sterile syringe.
•     Pull back the plunger to fill the syringe with air, which should be about 20 mL.
•     Make sure the vial is in upright position. Do not turn the vial upside down.
•     Push the air-filled syringe with transfer needle attached through the centre of the vial stopper.
•     The tip of the transfer needle should not be in the solution to avoid creating bubbles.
•     Gently push the air from the syringe into the vial. This will inject the air from the syringe into the vial.
•     Invert the vial.
•     With the transfer needle tip in the solution, slowly pull the plunger to fill the syringe with all the liquid.
•     Remove the filled syringe and the transfer needle from the vial.
•     Do not recap the transfer needle. Unscrew the needle and throw it away in the sharps container.

Follow the device manufacturer’s instructions to prepare the infusion pump and tubing.

Potential areas for infusion include the abdomen, thighs, hips, or upper arms. Rotate infusion sites from one infusion to the next. If there are multiple infusion sites, they should be at least 7.5 cm apart.

The typical infusion time is approximately 30 minutes (if using two sites) or approximately 60 minutes (if using one site).

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