Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Drug Product Concentrate

Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Kolliphor P188 (Poloxamer 188,Pluronic F68), Water for injection Quality Water


Solvent (Diluent)
Sodium Chloride, Sodium Phosphate dibasic, Sodium Phosphate monobasic, Kolliphor P188 (Poloxamer 188,Pluronic F68), Water for injection Quality Water



LUX API DEC23 V5                                                            Based on EU SmPC JUL23 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 vials
The expiry date of the product is indicated on the packaging materials.

After thawing

Once thawed, the medicinal product should not be re-frozen and should be left at room temperature (below 25 °C).

After dilution

Following dilution under aseptic conditions, the solution must be used immediately; if not used immediately, the storage time at room temperature (below 25 °C) should be no longer than 4 hours.

6.4   Special precautions for storage

Concentrate and solvent must be stored frozen at -65 ºC.
For storage conditions after thawing and dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Concentrate
0.5 mL extractable volume of concentrate in 2 mL cyclic olefin polymer vial with a chlorobutyl rubber stopper sealed in place with an aluminium flip-off seal.

Solvent

1.7 mL extractable volume of solvent in a 2 mL cyclic olefin polymer vial with a chlorobutyl rubber stopper sealed in place with an aluminium flip-off seal.

Each foil pouch includes a carton containing 1 vial of concentrate of 0.5 mL and 2 vials of solvent (each containing 1.7 mL).

6.6   Special precautions for disposal and other handling

Precaution to be taken before handling or administering the medicinal product 
This medicinal product contains genetically modified organisms. Personal protective equipment (to include laboratory coat, safety glasses and gloves) should be worn while handling or administering voretigene neparvovec.


Preparation prior to administration
LUX API DEC23 V5                                                            Based on EU SmPC JUL23 Each pack contains 1 vial of concentrate and 2 vials of solvent is for single use only.

Luxturna should be inspected visually prior to administration. If particulates, cloudiness, or discoloration are visible, the single-dose vial must not be used.

Preparation of Luxturna should be performed within 4 hours of beginning the administration procedure, in accordance with the following recommended procedure performed under aseptic conditions.

Thaw one single-dose vial of concentrate and two vials of solvent at room temperature. Once all 3 vials (1 vial of concentrate and 2 vials of diluent) are thawed, dilution should be initiated. Gently invert the vials five times to mix the contents.

Inspect for any visual particulates or any anomalies. Any anomalies or appearance of visual particulates should be reported to the Marketing Authorisation Holder and product should not be used.

Transfer 2.7 mL of solvent taken from the two thawed vials and dispense into a sterile 10 mL empty glass vial using a 3 mL syringe.

For dilution, draw 0.3 mL of thawed concentrate into a 1 mL syringe and add it to the 10 mL sterile vial containing the solvent. Gently invert the vial at least five times for proper mixing. Inspect for any visual particulates. The diluted solution should be clear to slightly opalescent. Label the 10 mL glass ial o tai i g the diluted o e trate as follo s: Diluted Lu tur a .

Do not prepare syringes if the vial shows any damage or if any visual particulates are observed.
Prepare the syringes for injection by drawing 0.8 mL of the diluted solution into a sterile 1 mL syringe. Repeat the same procedure to prepare a backup syringe. The product-filled syringes should then be transferred in a designated transport container to the surgical suite.

Measures to take in case of accidental exposure

Accidental exposure must be avoided. Local biosafety guidelines for preparation, administration and handling of voretigene neparvovec should be followed.
•     Personal protective equipment (to include laboratory coat, safety glasses and gloves) should be worn while handling or administering voretigene neparvovec.
•     Accidental exposure to voretigene neparvovec, including contact with skin, eyes and mucous membranes, is to be avoided. Any exposed wounds should be covered before handling.
•     All spills of voretigene neparvovec must be treated with a virucidal agent such as 1% sodium hypochlorite and blot using absorbent materials.
•     All materials that may have come in contact with voretigene neparvovec (e.g. vial, syringe, needle, cotton gauze, gloves, masks or dressings) must be disposed of in accordance with local biosafety guidelines.

Accidental exposure
•     In the event of an accidental occupational exposure (e.g. through a splash to the eyes or mucous membranes), flush with clean water for at least 5 minutes.
•     In the event of exposure to broken skin or needlestick injury, clean the affected area thoroughly with soap and water and/or a disinfectant.

Precautions to be taken for the disposal of the medicinal product

LUX API DEC23 V5                                                              Based on EU SmPC JUL23 This medicinal product contains genetically modified organisms. Unused medicinal product or waste material must be disposed of in compliance with the local guidance for pharmaceutical waste.