•
Store the Pen you are currently using out of the refrigerator below 86 OF.
•
Keep TRESIBA away from heat or light.
•
The TRESIBA FlexTouch Pen you are using should be thrown away after 56 days, even if it still has insulin left in it and the expiration date has not passed.
General Information about the safe and effective use of TRESIBA.
•
Keep TRESIBA FlexTouch Pens and needles out of the reach of children.
•
Always use a new needle for each injection.
•
Do not share TRESIBA FlexTouch Pens or needles with other people. You may give other people a serious infection, or get a serious infection from them.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
Revised: 09/2015
For more information go to www.TRESIBA.com
© 2015 Novo Nordisk
PRINCIPAL DISPLAY PANEL U-100(What is this?)
NDC 0169-2660-15
List: 266015
TRESIBA®
FlexTouch®
(insulin degludec injection)
For Single Patient Use Only
100 units/mL (U-100)
5×3 mL Prefilled Pens
For subcutaneous use only
Rx Only
Recommended for use with NovoFine®,
NovoFine® Plus or NovoTwist® disposable needles.
Keep in a cold place until first use.
Store at 36°F - 46°F (2°C - 8°C).
Do not freeze.
Protect from light.
PRINCIPAL DISPLAY PANEL U-200
NDC 0169-2550-13
List: 255013
TRESIBA®
FlexTouch®
(insulin degludec injection)
For Single Patient Use Only
200 units/mL (U-200)
3×3 mL Prefilled Pens
For subcutaneous use only
Rx Only
Recommended for use with
NovoFine®, NovoFine® Plus or NovoTwist®
disposable needles.
Keep in a cold place
until first use.
Store at 36°F - 46°F (2°C - 8°C).
Do not freeze.
Protect from light.
INGREDIENTS AND APPEARANCE
TRESIBA
insulin degludec injection injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-2660
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN DEGLUDEC (UNII: 54Q18076QB) (INSULIN DEGLUDEC - UNII:54Q18076QB) INSULIN DEGLUDEC 100 U in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 19.6 mg in 1 mL
PHENOL (UNII: 339NCG44TV) 1.50 mg in 1 mL
METACRESOL (UNII: GGO4Y809LO) 1.72 mg in 1 mL
ZINC (UNII: J41CSQ7QDS) 32.7 ug in 1 mL
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0169-2660-15 5 in 1 CARTON
1 3 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
2 NDC:0169-2660-97 1 in 1 CARTON
2 3 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203314 09/25/2015
TRESIBA
