Shelf life: Before first use: NGENLA is stored at 2°C to 8°C.
Before first use, store NGENLA in a refrigerator. 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 to 8°C).
Special precautions for storage: After first use of NGENLA, the pre-filled pen can be stored for up to 28 days of use in a refrigerator 2°C to 8°C. Store away from direct sunlight. Always remove and safely discard the needle after each injection and store the NGENLA pre-filled pen without an injection needle attached. Always use a new needle for each injection. Replace the cap on the pre-filled pen when it is not in use. The pre-filled pen should not be used more than 28 days after first use and should not be used beyond the expiration date.
Store the pre-filled pen at 2°C to 8°C in between each use. 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.
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