Pharmaceutical particulars : מידע רוקחי

6.       PHARMACEUTICAL PARTICULARS

6.1      List of excipients
Glycerol
Phenol
Zinc acetate
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections
6.2      Incompatibilities

Substances added to Xultophy may cause degradation of the active substances.

Xultophy must not be added to infusion fluids.
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 first opening, the medicinal product can be stored for 21 days at a maximum temperature of 30°C or stored in a refrigerator (2°C – 8°C). The medicinal product should be discarded 21 days after first opening.

6.4      Special precautions for storage

Before first opening: Store in a refrigerator (2 °C – 8 °C). Keep away from the freezing element. Do not freeze. Keep the cap on the pre-filled pen in order to protect from light.

After first opening: Store at a maximum of 30 °C or store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep the cap on the pre-filled pen in order to protect from light.

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

6.5      Nature and contents of container
3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a stopper (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene, polycarbonate and acrylonitrile butadiene styrene.

Pack sizes of 1, 3, 5.

Not all pack sizes may be marketed.
6.6      Special precautions for disposal and other handling

The pre-filled pen is designed to be used with NovoTwist® or NovoFine® injection needles up to a length of 8 mm and as thin as 32G.

The pre-filled pen is for use by one person only.

Xultophy must not be used if the solution does not appear clear and colourless.
Xultophy which has been frozen must not be used.

A new needle must always be attached before each use. Needles must not be re-used. The patient should discard the needle after each injection.

In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
For detailed instructions for use, see the package leaflet.


7. MANUFACTURER AND ADDRESS:

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

8. REGISTRATION HOLDER:

Novo Nordisk Ltd.
1 Atir Yeda St.
Kfar-Saba, 4464301