Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

DLin-MC3-DMA, cholesterol, DSPC, PEG2000-C-DMG

Phosphate buffered saline: sodium chloride sodium phosphate, dibasic, heptahydrate potassium phosphate, monobasic, anhydrous water for injection

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

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

After dilution

Chemical and physical in-use stability has been demonstrated for 16 hours at room temperature (up to 30°C). From a microbiological point of view, it is recommended that the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 16 hours at either 2°C to 8°C or room temperature (up to 30°C), including infusion time.

6.4   Special precautions for storage

Store in a refrigerator (2°C to 8°C).
Do not freeze.
If refrigeration is not available, Onpattro can be stored at room temperature up to 25°C for up to 14 days.

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

6.5   Nature and contents of container
Type I glass vial with a chlorobutyl stopper and an aluminium flip-off cap. Pack size of 1 vial containing 5 mL concentrate.

6.6   Special precautions for disposal and other handling

This medicinal product is for single-use only.
Onpattro must be diluted with sodium chloride 9 mg/mL (0.9%) solution prior to intravenous infusion.
The diluted solution for infusion should be prepared by a healthcare professional using aseptic technique as follows:
•     Remove Onpattro from the refrigerator. Do not shake or vortex.
•     Discard vial if it has been frozen.
•     Inspect visually for particulate matter and discolouration. Do not use if discolouration or foreign particles are present. Onpattro is a white to off-white, opalescent, homogeneous solution. A white to off-white coating may be observed on the inner surface of the vial, typically at the liquid-headspace interface. Product quality is not impacted by presence of the white to off-white coating.
•     Calculate the required volume of Onpattro based on the recommended weight-based dosage (see section 4.2).
•     Withdraw the entire contents of one or more vials into a single sterile syringe.
•     Filter Onpattro through a sterile 0.45 micron polyethersulfone (PES) syringe filter into a sterile container.
•     Withdraw the required volume of filtered Onpattro from the sterile container using a sterile syringe.
•     Dilute the required volume of filtered Onpattro into an infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for a total volume of 200 mL. Use infusion bags that are free of di(2-ethylhexyl)phthalate (DEHP).
•     Gently invert the bag to mix the solution. Do not shake. Do not mix or dilute with other medicinal products.
•     Discard any unused portion of Onpattro. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.