Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Sodium acetate trihydrate
Acetic acid, glacial
Arginine hydrochloride
Polysorbate 20
Water for injections
6.2   Incompatibilities

Not applicable.

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

6.4   Special precautions for storage

Store in a refrigerator (2°C to 8°C).
Do not freeze.
Store in the original package in order to protect from light.
Plegridy can be stored at room temperature (up to 25°C) for up to 30 days as long as it is stored away from light. If Plegridy is at room temperature for a total of 30 days, it should be used or discarded. If it is not clear if Plegridy has been stored at room temperature 30 days or more, it should be discarded.

See section 6.3 for additional information on storage at room temperature (up to 25°C).

6.5 Nature and contents of container
Syringe:
1 mL pre-filled syringe made of glass (Type I) with a bromobutyl rubber stopper and thermoplastic and polypropylene rigid needle shield, containing 0.5 mL of solution.
Pen:
A pre-filled syringe of Plegridy is contained within a single-use, disposable, spring-powered pen injector called Plegridy Pen. The syringe inside the pen is a 1 mL pre-filled syringe made of glass (Type I) with a bromobutyl rubber stopper and thermoplastic and polypropylene rigid needle shield, containing 0.5 mL of solution.
The Plegridy Initiation Pack contains 1 x 63 micrograms pre-filled pen or syringe (orange labelled pen or syringe, 1st dose) and 1 x 94 micrograms pre-filled pen or syringe (blue labelled pen or syringe, 2nd dose) in a protective plastic tray (Pen) or sealed plastic trays (syringe).
The Plegridy Maintenance Pack contains 2 x 125 micrograms pre-filled pen or syringe (grey labelled pen or syringe), in a protective plastic tray (Pen) or sealed plastic trays (syringe).
Pack sizes:
Box of 1 x 63 micrograms pre filled pen (orange labelled pen) and 1 x 94 micrograms pre-filled pen (blue labelled pen), in a protective plastic tray.
Box of 1 x 63 micrograms pre filled syringe (orange labelled syringe) and 1 x 94 micrograms pre-filled syringe (blue labelled syringe), in a sealed plastic tray.
Box of two 125 microgram pre-filled pens (grey labelled pens), in a protective plastic tray. 16 Box of two or six 125 microgram pre-filled syringes (grey labelled syringes) in sealed plastic trays.
Multipacks containing 6 (3 packs of 2) 125 microgram pre-filled pens (grey labelled pens). The pack contains 3 inner cartons. Each inner carton contains 2 pens in a protective plastic tray.



6.6   Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Not all pack sizes may be marketed.

Before use check the dosage form to be used. It should not have any cracks or damage and the solution should be clear, colourless and not have any particles in it.