Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars

6.1 List of excipients

Glycerol 85%
Sodium acetate trihydrate
Methionine
Metacresol
Hydrochloric acid, concentrated
Sodium hydroxide
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 first use: 14 days

6.4   Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Do not freeze.

Store away from the freezer compartment.

After first use
Store below 30°C. Do not freeze.

Do not store with attached needle. Keep the cap on the pen in order to protect from light.

6.5 Nature and contents of container

Type I glass cartridge with a (bromobutyl) rubber plunger, flanged caps (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the product side and polyisoprene on the outside).
Each cartridge is assembled into a disposable pen.

Each purple pre-filled pen contains 3 ml solution, delivering 14 doses of 20 mcg.

Packs containing 1, 2 and 6 purple pre-filled pens.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Lyxumia should not be used if it has been frozen.
Lyxumia can be used with 29 to 32 gauge disposable pen needles. Pen needles are not included.

The patient should be instructed to discard the needle after each use in accordance with local requirements and to store the pen without the needle attached. This helps prevent contamination and potential needle blockage. The pen is to be used for one patient only.

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