Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium chloride
Disodium hydrogen phosphate
Potassium chloride
Potassium dihydrogen phosphate
Poloxamer 188
Water for injections

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

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

After thawing and opening

Once thawed, the medicinal product should not be re-frozen.
The filled syringe prepared under aseptic conditions for delivery to the surgical site should be used immediately; if not used immediately, it can be stored at room temperature (below 25°C) and used within 6 hours of starting product thaw.


Upstaza-SPC-0424-V1
6.4   Special precautions for storage
Store and transport frozen at ≤ -65° C.
Keep the vial in the outer carton.
For storage conditions after thawing and opening of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Type I borosilicate glass vial, with a siliconised chlorobutyl stopper with coating sealed with an aluminium/plastic cap.

Pack size of one vial.

6.6   Special precautions for disposal and other handling
Each vial is for single use only. This medicinal product should only be infused with the SmartFlow ventricular cannula.

Precautions to be taken before handling or administering the medicinal product 
This medicinal product contains genetically modified virus. During preparation, administration, and disposal, personal protective equipment (including gown, safety glasses, mask, and gloves) should be worn when handling eladocagene exuparvovec and materials that have been in contact with the solution (solid and liquid waste).

Thawing in the hospital pharmacy

•     Upstaza is delivered to the pharmacy frozen and must be maintained in the outer carton at ≤ -65 ºC until prepared for use.
•     Upstaza should be handled aseptically under sterile conditions.
•     Allow the frozen vial of Upstaza to thaw upright at room temperature until the content is completely thawed. Gently invert the vial approximately 3 times, do NOT shake.
•     Inspect Upstaza after mixing. If particulates, cloudiness, or discolouration are visible, do not use the product.

Preparation prior to administration

•     Transfer the vial, syringe, needle, syringe cap, sterile bags, or sterile wrappings compliant with hospital procedure for transfer and use of the filled syringe in the planned surgical suite, and label into the Biological Safety Cabinet (BSC). Wear sterile gloves and other personal protective equipment (including gown, safety glasses and mask) as per normal procedure for BSC work.
•     Open the 1 mL or 5 mL syringe [1 mL or 5 mL, polypropylene syringes with latex-free elastomer plunger, lubricated with -medical grade- silicone oil] and label as the product-filled syringe per pharmacy procedure and local regulations.
•     Attach the 18- or 19-gauge filter needle [18- or 19-gauge, 1.5-inch, stainless steel, 5-µm filter needles] to the syringe.
•     Draw the full volume of the vial of Upstaza into the syringe. Invert the vial and syringe and partially withdraw or angle the needle as necessary to maximise recovery of product.
•     Draw air in the syringe so that the needle is emptied of product. Carefully remove the needle from 1 mL or 5 mL syringe containing Upstaza. Purge the air from the syringe until there is no air bubble and then cap with a syringe cap.
•     Wrap the syringe in one sterile plastic bag (or several bags based on standard hospital procedure) and place in an appropriate secondary container (eg, hard plastic cooler) for delivery Upstaza-SPC-0424-V1
to the surgical suite at room temperature. Use of the syringe (ie, connecting the syringe to the syringe pump and starting priming of the cannula) should begin within 6 hours of starting product thaw.

Administration in the surgical suite

•     Tightly connect the syringe containing Upstaza to the SmartFlow ventricular cannula.
•     Install the Upstaza syringe into a syringe infusion pump compatible with the 1 mL or 5 mL syringe. Pump Upstaza with the infusion pump at 0.003 mL/min until the first drop of Upstaza can be seen from the tip of the needle. Stop and wait until ready for infusion.

Precautions to be taken for the disposal of the medicinal product and accidental exposure 
•     Accidental exposure to eladocagene exuparvovec, including contact with skin, eyes, and mucous membranes, is to be avoided.
•     In the event of exposure to skin, the affected area must be thoroughly cleaned with soap and water for at least 5 minutes. In the event of exposure to eyes, the affected area must be thoroughly flushed with water for at least 5 minutes.
•     In the event of needlestick injury, the affected area must be cleaned thoroughly with soap and water and/or a disinfectant.
•     Any unused eladocagene exuparvovec or waste material should be disposed of in compliance with local guidance for pharmaceutical waste. Potential spills should be wiped with absorbent gauze and disinfected using a bleach solution followed by alcohol wipes.
•     After administration, the risk of shedding is considered to be low. It is recommended that caregivers and patient families are advised on and follow proper handling precautions of patient bodily fluids and waste for 14 days after administration of eladocagene exuparvovec (see section 4.4).