Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Glycerol
Metacresol
Phenol
Zinc acetate
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

6.2   Incompatibilities
This medicinal product must not be mixed with any other medicinal products.
Substances added to Tregludec 100 units/mL may cause degradation of insulin degludec.

Tregludec 100 units/mL must not be added to infusion fluids.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials 
After first opening or carried as a spare, the medicinal product may be stored for a maximum of 8 weeks. Store below 30°C. Can be stored in a refrigerator (2°C – 8°C). Keep the cap on the pen in order to protect from light.
6.4   Special precautions for storage

Before first use:
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep away from the freezing element.
Keep the cap on the pen in order to protect it 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 laminate rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.

Pack sizes of 1 (with or without needles) and 5 (without needles) pre-filled pens.

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

This medicinal product is for use by one person only. It must not be refilled.

Tregludec 100 units/mL must not be used if the solution does not appear clear and colourless.
Tregludec 100 units/mL 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 waste material should be disposed of in accordance with local requirements.

For detailed instructions for use, see the package leaflet.
Tregludec 100 units/mL packaging and label are light green.
The pre-filled pen (FlexTouch) is designed to be used with NovoFine®/NovoTwist® injection needles up to a length of 8 mm. It delivers 1–80 units in steps of 1 unit. Detailed instructions accompanying the pre-filled pen must be followed.