LEVEMIR is available in the following package sizes: each presentation containing 100 Units of insulin detemir per mL (U-100).
|10 mL vial||NDC 0169-3687-12|
|3 mL PenFill® cartridges*||NDC 0169-3305-11|
|3 mL InnoLet®||NDC 0169-2312-11|
|3 mL FlexPen®||NDC 0169-6439-10|
*LEVEMIR PenFill® cartridges are for use with Novo Nordisk 3 mL PenFill® cartridge compatible insulin delivery devices and NovoFine® disposable needles.
Unused LEVEMIR should be stored between 2° and 8°C (36° to 46° F). Do not freeze. Do not use LEVEMIR if it has been frozen.
After initial use, vials should be stored in a refrigerator, never in a freezer. If refrigeration is not possible, the in-use vial can be kept unrefrigerated at room temperature, below 30°C (86°F), for up to 42 days, as long as it is kept as cool as possible and away from direct heat and light.
Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.
PenFill® cartridges, FlexPen® or InnoLet®:
After initial use, a cartridge (PenFill®) or a prefilled syringe (including FlexPen® or InnoLet®) may be used for up to 42 days if it is kept at room temperature, below 30°C (86°F). In-use cartridges and prefilled syringes in-use must NOT be stored in a refrigerator and must NOT be stored with the needle in place. Keep all cartridges and prefilled syringes away from direct heat and sunlight.
Not in-use (unopened) LEVEMIR PenFill®, FlexPen® or InnoLet® can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused cartridges and prefilled syringes in the carton so they will stay clean and protected from light.
The storage conditions are summarized in the following table:
Not in-use (unopened)
|10 mL vial||42 days||Until expiration date||
|3 mL PenFill® cartridges||42 days||Until expiration date||42 days (Do not refrigerate) |
|3 mL InnoLet®||42 days||Until expiration date||42 days (Do not refrigerate) |
|3 mL FlexPen®||42 days||Until expiration date||42 days (Do not refrigerate) |
Date of issue: May 16, 2007
Novo Nordisk®, Levemir®, NovoLog®, FlexPen®, InnoLet®, PenFill®, and NovoFine® are registered trademarks owned by Novo Nordisk A/S.
© 2005/2007 Novo Nordisk Inc.
Levemir is covered by US Patent Nos. 5,750,497; 5,866,538; 6,011,007; 6,869,930 and other patents pending.
FlexPen is covered by US Patent Nos. 6,004,297; 6,235,004; 6,582,404 and other patents pending.
Novo Nordisk Inc., Princeton, NJ 08540
Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark