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TRESIBA

®

 (insulin degludec injection) 10 mL vial

Revised: 11/2018 

Novo Nordisk

®

 and TRESIBA

®

 are registered trademark of 

Novo Nordisk A/S.

Patent Information: http://novonordisk-us.com/patients/

products/product-patents.html

Manufactured by:

 

Novo Nordisk A/S 

DK-2880 Bagsvaerd, Denmark
For information contact: 

Novo Nordisk Inc. 

800 Scudders Mill Road 

Plainsboro, New Jersey 08536 

1-800-727-6500 (Se habla español) 

www.novonordisk-us.com
© 2015-2018 Novo Nordisk  

US18TSM00504      December 2018

How should I store TRESIBA

®

Before use:

• Store unopened TRESIBA

®

 vials in the refrigerator at 36°F to 

46°F (2°C to 8°C) in the original carton to protect from light.

• 

Do not

 freeze TRESIBA

®

Do not

 use TRESIBA

®

 if it has been 

frozen.

• Unused TRESIBA

®

 vials may be used until the expiration date 

printed on the label, if they are kept in the refrigerator.

• After 56 days, throw away TRESIBA

®

 vials that have been kept 

at room temperature (below 86°F (30°C)).

Vial in use:

• Store the TRESIBA

®

 vial you are currently using in the 

refrigerator between 36°F to 46°F (2°C to 8°C) or keep at 

room temperature below 86°F (30°C) in the original carton to 

protect from light.

• Keep TRESIBA

®

 away from direct heat or light.

• The TRESIBA

®

 vial 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

®

 vials, syringes, and needles out of 

the reach of children.

• 

Always

 use a new syringe and needle for each injection to 

help ensure sterility and prevent blocked needles.

• 

Do not

 reuse or share syringes 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.

Summary of Contents for FlexTouch

Page 1: ...heart failure with concomitant use of Thiazolidinediones TZDs Observe for signs and symptoms of heart failure consider dosage reduction or discontinuation if heart failure occurs 5 7 ADVERSE REACTIONS...

Page 2: ...le prefilled pens should never be shared between patients even if the needle is changed Patients using TRESIBA vials should never share needles or syringes with another person Sharing poses a risk for...

Page 3: ...etes percentages of adult and pediatric patients with type 1 diabetes randomized to TRESIBA who experienced at least one episode of hypoglycemia in clinical trials see Clinical Studies 14 and adults w...

Page 4: ...observed with human insulin which were probably secondary to maternal hypoglycemia 8 2 Lactation Risk Summary There are no data on the presence of insulin degludec in human milk the effects on the bre...

Page 5: ...TRESIBA at steady state was independent of age Geriatrics Pharmacokinetic and pharmacodynamic response of TRESIBA was compared in 13 younger adult 18 35 years and 14 geriatric 65 years subjects with t...

Page 6: ...once daily according to the approved labeling The any time each day TRESIBA arm was designed to simulate a worst case scenario injection schedule of alternating short and long once daily dosing inter...

Page 7: ...in HbA1c was analyzed using ANOVA with treatment region sex and anti diabetic treatment at screening as fixed effects and age and baseline HbA1c as covariates In Study E there were 12 3 of subjects in...

Page 8: ...administered in both treatment arms The mean age of the trial population was 55 7 years and mean duration of diabetes was 7 7 years 58 6 were male 61 3 were White 7 6 Black or African American 21 0 w...

Page 9: ...vial pack U 200 single patient use FlexTouch Pen 3 mL 200 units mL 600 Units 0169 2550 13 160 Units 2 Unit 3 pens pack TRESIBA U 100 FlexTouch dials in 1 unit increments TRESIBA U 200 FlexTouch dials...

Page 10: ...hem Never inject TRESIBA into a vein or muscle Never use a syringe to remove TRESIBA from the FlexTouch pen What should I avoid while taking TRESIBA While taking TRESIBA do not Drive or operate heavy...

Page 11: ...e Figure B Figure B Step 2 Check the liquid in the Pen See Figure C TRESIBA should look clear and colorless Do not use it if it looks cloudy or colored Figure C Step 3 Select a new needle Pull off the...

Page 12: ...ing the Pen NovoFine NovoTwist Figure R Figure S Step 16 Replace the Pen cap by pushing it straight on See Figure T Figure T After your injection Put your used TRESIBA FlexTouch Pen and needles in a F...

Page 13: ...se counter Dose selector Dose pointer Dose button Figure A Step 1 Pull Pen cap straight off See Figure B Figure B Step 2 Check the liquid in the Pen See Figure C TRESIBA should look clear and colorles...

Page 14: ...needle attached Storing without the needle attached helps prevent leaking blocking of the needle and air from entering the Pen NovoFine NovoTwist Figure R Figure S Step 16 Replace the Pen cap by push...

Page 15: ...let any air bubbles rise to the top See Figure G Figure G Step 7 Slowly push the plunger up until the tip of the plunger reaches the line for your prescribed TRESIBA dose See Figure H Figure H Step 8...

Page 16: ...are kept in the refrigerator After 56 days throw away TRESIBA vials that have been kept at room temperature below 86 F 30 C Vial in use Store the TRESIBA vial you are currently using in the refrigera...

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