Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Powder: Front compartment                  Solvent: Rear compartment
Glycine , Sodium dihydrogen                Water for injections, Metacresol, phosphate anhydrous, Disodium              Mannitol phosphate anhydrous, Mannitol

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.
6.4    Special precautions for storage

Before reconstitution:
Store in a refrigerator (2°C – 8°C) or for a maximum of 1 month at or below 25°C. Keep the pre-filled pen in the outer carton in order to protect from light.

After reconstitution:

Reconstituted Genotropin can be stored, protected from light, at 2°C-8°C for up to 28 days.
Alternatively, reconstituted Genotropin can be stored, protected from light, at room temperature conditions (up to 25°C) for up to 2 hours per day, and within 28 days from reconstitution, during the approved shelf-life. not freeze.


6.5    Nature and contents of container


Powder and 1 ml solvent in a two-chamber glass cartridge (type I glass) separated by a rubber plunger (bromobutyl). The cartridge is sealed at one end with a rubber disc (bromobutyl) and an aluminium cap and at the other end by a rubber stopper (bromobutyl). The two-chamber cartridge is supplied in a disposable multidose pre-filled pen, GoQuick.


The 5.3 mg pre-filled pen GoQuick is colour coded blue.
The 12 mg pre-filled pen GoQuick is colour coded purple.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling
Only reconstitute the powder with the solvent supplied.

Two-chamber cartridge:The solution is prepared by screwing the reconstitution device or injection device together so that the solvent will be mixed with the powder in the two chamber cartridge. Gently dissolve the powder with a slow, swirling motion. Do not shake vigorously, this might cause denaturation of the active substance. The reconstituted solution is almost colourless or slightly opalescent. The reconstituted solution for injection is to be inspected prior to use and only clear solutions without particles should be used.


When using an injection device the injection needle should be screwed on before reconstitution.
Disposal instructions: Any unused product or waste material should be disposed of in accordance with local requirements.