Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1       List of excipients

Glycine
Citric acid monohydrate
Polysorbate 80
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections
6.2       Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Mogamulizumab should not be infused concomitantly in the same intravenous line with other medicinal products.

6.3       Shelf life

Unopened vial :The expiry date of the product is indicated on the packaging materials After opening
POTELIGEO does not contain a preservative. Once opened, the medicinal product should be diluted and infused immediately (see section 6.6).

After preparation of infusion
Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (at 25°C) under ambient room light.
These time limits include storage of the infusion solution in the infusion bag through the duration of infusion. From a microbiological point of view, the product must be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 24 hours at 2°C - 8°C provided that dilution has taken place under controlled and validated aseptic conditions.

6.4       Special precautions for storage

Store in a refrigerator (2ºC to 8ºC).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3 
6.5       Nature and contents of container

5 mL solution in a 10 mL glass vial (type I glass) with a rubber stopper, an aluminium seal and a polypropylene flip-off cap.

Pack of 1 vial.


6.6      Special precautions for disposal and other handling

Preparation
•     Visually inspect the medicinal product for particulate matter and discolouration prior to administration. POTELIGEO is a clear to slightly opalescent, colourless solution. Discard the vial if cloudiness, discolouration or particulates are observed.
•     Calculate the required volume of POTELIGEO needed to prepare the infusion solution for the 1 mg/kg dosage based on patient weight (see section 4.2). Aseptically withdraw the required volume of POTELIGEO into the syringe and transfer into an infusion bag containing 9mg per ml (0.9%) sodium chloride solution for injection. Mix diluted solution by gentle inversion. Do not shake. The final concentration of the diluted solution should be between 0.1 mg/mL to 3.0 mg/mL.
•     Each vial is for single use only. Discard any unused portion left in the vial in accordance with local requirements.

Administration
•    The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags.
•    Do not mix POTELIGEO with, or administer as an infusion with, other medicinal products.
•    POTELIGEO is intended for intravenous use only, and should not be administered subcutaneously, intramuscularly, as a bolus dose or by rapid intravenous administration.
•    Administer infusion solution over at least 60 minutes through an intravenous line containing a sterile, low protein binding 0.22 micron (or equivalent) in-line filter.