Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium chloride m-Cresol *
Trisodium citrate dihydrate
Poloxamer 188
L-Histidine
Citric acid monohydrate
Water for injections

* Named as Metacresol in the USP

6.2   Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

Before first use
The expiry date of the product is indicated on the packaging materials.

Prior to the first use store Ngenla in a refrigerator at 2 °C to 8 °C. Do not freeze. Keep Ngenla in the outer carton in order to protect from light. The unopened pre-filled pen may temporarily be held for up to 4 hours at temperatures up to 32 °C .

After first use

28 days.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep Ngenla with the pen cap attached in order to protect from light.
Ngenla may be held at room temperature (up to 32 °C) for up to 4 hours with each injection for a maximum of 5 times. Return Ngenla to the refrigerator again after each use. Do not expose Ngenla to temperatures above 32 °C or leave at room temperature for more than 4 hours with each use. The Ngenla pen should be discarded if it has been used 5 times, if it has been exposed to temperatures higher than 32 °C or if it has been removed from the refrigerator for more than 4 hours with each use.

Chemical and physical in-use stability has been demonstrated for 28 days from the date of first use of the pre-filled pen, when the pre-filled pen has been stored at 2 °C to 8 °C in between each use.

6.4   Special precautions for storage

Store in a refrigerator (2 °C to 8 °C). Do not freeze. Keep Ngenla in the outer carton in order to protect from light.

For storage conditions before and after first use of the medicinal product, see section 6.3.

6.5   Nature and contents of container
Ngenla 24 mg solution for injection in pre-filled pen
This multi-dose disposable pre-filled pen, which consists of a cartridge (Type I clear glass) permanently sealed in a plastic pen, contains 1.2 mL of somatrogon. The cartridge is closed at the bottom with a rubber stopper (Type I rubber closures) shaped as a plunger and at the top with a rubber stopper (Type I rubber closures) shaped as a disc and sealed with an aluminium cap. The pen cap, dose button and label on the pen are coloured lilac.

Pack size of 1 pre-filled pen.

Ngenla 60 mg solution for injection in pre-filled pen
This multi-dose disposable pre-filled pen, which consists of a cartridge (Type I clear glass) permanently sealed in a plastic pen, contains 1.2 mL of somatrogon. The cartridge is closed at the bottom with a rubber stopper (Type I rubber closures) shaped as a plunger and at the top with a rubber stopper (Type I rubber closures) shaped as a disc and sealed with an aluminium cap. The pen cap, dose button and label on the pen are coloured blue.

Pack size of 1 pre-filled pen.

6.6   Special precautions for disposal and other handling
The solution should appear clear and colourless to slightly light yellow solution and be free of particles. Do not inject the medicinal product if it is cloudy, dark yellow, or contains particulate matter. Do not shake, shaking can damage the medicinal product.

Each Ngenla pre-filled pen is for use by a single patient. A Ngenla pre-filled pen must never be shared between patients, even if the needle is changed.

The pre-filled pen should only be used up to 28 days after first use and before the expiry date.

Do not freeze the medicinal product. Do not expose to heat (above 32 °C). Do not use Ngenla if it has been frozen or exposed to heat, discard (see section Disposal).

Dose preparation

The pen may be used straight from the refrigerator. For a more comfortable injection, the pre-filled pen containing the sterile solution of somatrogon may be allowed to reach room temperature up to 32 °C for up to 30 minutes. The solution in the pen should be inspected for flakes, particles and colouration. The pen should not be shaken. If flakes, particles or discolouration are observed, the pen should not be used.

Administration

The designated injection site should be prepared as instructed in the Instructions for Use. It is recommended to rotate the injection site at each administration. When in use, always replace the pen cap on the pre-filled pen after each injection. Return Ngenla to the refrigerator again after each use. A new needle must always be attached before use. Needles must not be re-used. The injection needle should be removed after each injection and the pen should be stored without a needle attached. This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.

In the event of blocked needles (i.e. liquid does not appear at the needle tip), patients must follow the instructions described in the Instructions for Use accompanying the package leaflet.

Sterile needles are required for administration but are not included. Ngenla can be administered with a needle from 4 mm to 8 mm and 31 or 32G.
Instructions for the preparation and administration of the product are given in the package leaflet.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. If the pre-filled pen is empty, has been exposed to temperatures higher than 32 °C, has been removed from the refrigerator for more than 4 hours with each use, has been used 5 times, or it has been more than 28 days after first use, it should be disposed of even if it contains unused medicinal product. A small amount of the sterile somatrogon solution may remain in the pen after all doses have been correctly given. Patients should be instructed not to use the remaining solution, but to properly discard the pen.