Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Powder
5050 DL 4AP Polymer (poly (D,L-lactide-co-glycolide))
Sucrose
Solvent
Carmellose Sodium
Sodium Chloride
Polysorbate 20
Monobasic Sodium Phosphate Monohydrate
Dibasic Sodium Phosphate Heptahydrate sodium hydroxide (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.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
After suspension
The suspension must be injected immediately after mixing the powder and the solvent.

6.4   Special precautions for storage

Store in a refrigerator (2ºC - 8ºC).
Do not freeze.
The pens may be kept for up to 4 weeks below 30ºC prior to use. At the end of this period Bydureon should be used or discarded.
Store in the original package in order to protect from light.

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

6.5   Nature and contents of container
Each dual-chamber pen contains exenatide powder and solvent in a Type 1 glass cartridge sealed at one end with a chlorobutyl rubber stopper and an aluminum seal, and at the other end with a chlorobutyl rubber piston. The two chambers are separated by a second chlorobutyl rubber piston. There is one needle supplied per pen. Each carton also contains one spare needle. Use only the supplied needles with the pen.

Pack size of 4 single-dose pre-filled pens and a multipack containing 12 (3 packs of 4) single-dose pre- filled pens.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling

Pre-filled pen is for single-use only.
The powder in one chamber must be mixed with the solvent in the other chamber of the pre-filled pen.
The solvent should be visually inspected prior to use. The solvent should only be used if it is clear and free of particulate matter. After suspension, the mixture should only be used if it is white to off white and cloudy. Please see the package leaflet and Instructions for the User for additional information on suspension and administration.

Use only the supplied custom needles with the pen.

Bydureon must be injected subcutaneously immediately after mixing of the powder and the solvent BYDUREON that has been frozen must not be used.

The patient should be instructed to discard the pen safely, with the needle still attached, after each injection.

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