Insulin Degludec/Aspart 100 Units/ml (Insulin Degludec 70 units/Insulin Aspart 30 units per mL) solution for injection in a pre-filled pen

What Insulin Degludec/Aspart is used for:

Insulin Degludec/Aspart is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus; it may be given to adults, adolescents and children, 2 years of age and older.

Do not use Insulin Degludec/Aspart:

If you:

• are having an episode of low blood sugar (hypoglycemia). 
• have an allergy to Insulin Degludec/Aspart or any of the ingredients in Insulin Degludec/Aspart. 

Warnings and Precautions:

Tell your healthcare provider about all your medical conditions including, if you: 

• have liver or kidney problems. 
• have heart failure or other heart problems

Possible side effects of Insulin Degludec/Aspart:

Insulin Degludec/Aspart can cause serious side effects. These side effects happen only to a small number of people and include:

• low blood sugar (hypoglycemia)
• severe allergic reaction
• low potassium in your blood (hypokalemia)
• heart failure

Other medicines and Insulin Degludec/Aspart:

Tell your healthcare provider about all the medicines you take especially ones called TZDs (thiazolidinediones), including prescription and over-the-counter medicines, vitamins, or herbal supplements.

How to use Insulin Degludec/Aspart:

• Always use this medicine exactly as your doctor has told you. 
• Insulin Degludec/Aspart is injected under the skin (subcutaneously). Insulin Degludec/Aspart can be injected in the abdominal wall, the thigh or upper arm or by continuous infusion in the abdominal wall.
• The effect will be slightly quicker if the insulin is injected into your abdomen. As for all insulins,
• injection sites and infusion sites within an-injection area (abdomen, thigh or upper arm) must be
• rotated from one injection to the next.
• Insulin Degludec/Aspart should be taken shortly (0-15 minutes) before or soon after meals.

How to store Insulin Degludec/Aspart:

• Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the carton and on the label of the pen after “EXP”. The expiry date refers to the last day of that month. 
• Not in-use pens: Store in a refrigerator (2 °C-8 °C). Do not freeze. Do not put the pen next to the freezer compartment or a freezer pack. Keep the pre-filled pen in the outer carton in order to protect from light. 
• In-use pens: Pre-filled pens in use (or carried as a spare) may be stored for a maximum of 4 weeks below 25 °C and away from direct heat or direct light. The pen in use must not be stored in a refrigerator. Do not use it after this time period. 
• Do not use this medicine if it does not appear clear and colorless. 
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.