Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Polysorbate 80 (E433)

Phosal 50 PG (phosphatidylcholine, propylene glycol [E1520], mono-and diglycerides, ethanol, soya fatty acids and ascorbyl palmitate).

6.2 Incompatibilities

Rapamune must not be diluted in grapefruit juice or any other liquid other than water or orange juice (see section 6.6).

Rapamune oral solution contains polysorbate-80, which is known to increase the rate of di-(2- ethylhexyl) phthalate (DEHP) extraction from polyvinyl chloride (PVC). It is important to follow the instructions to drink Rapamune oral solution at once when a plastic container is used for the dilution and/or administration (see section 6.6).

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.
30 days for opened bottle.

24 hours in the dosing syringe (at room temperature, not above 25ºC or in a refrigerator 2ºC -
8ºC).

After dilution (see section 6.6), the preparation should be used immediately.
6.4 Special precautions for storage

Store in a refrigerator (2ºC - 8ºC).
Store in the original bottle in order to protect from light.

If necessary, the patient may store the bottles at room temperatures up to 25ºC for a short period of time (24 hours).

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

6.5 Nature and contents of container
Each pack contains: one bottle (amber glass) containing 60 mL of Rapamune solution, one syringe adapter, 30 dosing syringes (amber polypropylene) and one syringe carry case.

6.6 Special precautions for disposal and other handling

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

Instructions for use and handling:
The dosing syringe should be used to withdraw the prescribed amount of Rapamune from the bottle. Empty the correct amount of Rapamune from the syringe into only a glass or plastic container with at least 60 mL of water or orange juice. No other liquids, including grapefruit juice, should be used for dilution. Stir vigorously and drink at once. Refill the container with an additional volume (minimum of 120 mL) of water or orange juice, stir vigorously, and drink at once.