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NovoLog

®

 (insulin aspart [rDNA origin] injection)

Patient Information

NovoLog

®

 (N

Ō

-v

ō

-log) 

(insulin aspart [rDNA origin] injection)

What is NovoLog

®

?

• NovoLog

®

 is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

Who should not take NovoLog

®

?

Do not take NovoLog

®

 if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to NovoLog

®

 or any of the ingredients in NovoLog

®

.

Before taking NovoLog

®

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

• pregnant, planning to become pregnant, or are breastfeeding.
• taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.

Before you start taking NovoLog

®

, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take NovoLog

®

?

• 

Read the Instructions for Use

 that come with your NovoLog

®

.

• Take NovoLog

®

 exactly as your healthcare provider tells you to.

• 

NovoLog

®

 starts acting fast. 

You should eat a meal within 5 to 10 minutes after you take your dose of NovoLog

®

.

• Know the type and strength of insulin you take. 

Do not

 change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin 

and the best time for you to take your insulin may need to change if you take different types of insulin.

• 

Check your blood sugar levels.

 Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

• 

Do not share your NovoLog

®

 FlexPen

®

, FlexTouch

®

 or needles with another person.

 You may give another person an infection or get an infection from 

them.

What should I avoid while taking NovoLog

®

?

While taking NovoLog

®

 do not:

• Drive or operate heavy machinery, until you know how NovoLog

®

 affects you.

• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of NovoLog

®

?

NovoLog

®

 may cause serious side effects that can lead to death, including:

Low blood sugar (hypoglycemia).

 Signs and symptoms that may indicate low blood sugar include:

• dizziness or light-headedness 

• blurred vision 

• anxiety, irritability, or mood changes

• sweating 

• slurred speech 

• hunger

• confusion 

• shakiness

• headache 

• fast heart beat

Your insulin dose may need to change because of:

• change in level of physical activity or exercise 

• increased stress 

• change in diet

• weight gain or loss 

• illness

Other common side effects of NovoLog

®

 may include:

• low potassium in your blood (hypokalemia), reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or 

pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

These are not all the possible side effects of NovoLog

®

. Call your doctor for medical advice about side effects. You may report side effects to FDA at  

1-800-FDA-1088.

General information about the safe and effective use of NovoLog

®

.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider 

for information about NovoLog

®

 that is written for health professionals. Do not use NovoLog

®

 for a condition for which it was not prescribed. Do not give 

NovoLog

®

 to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in NovoLog

®

?

Active Ingredient:

 insulin aspart (rDNA origin)

Inactive Ingredients:

 glycerin, phenol, metacresol, zinc, disodium hydrogen phosphate dihydrate, sodium chloride and water for injection

Manufactured by:

 

Novo Nordisk A/S 

DK-2880 Bagsvaerd, Denmark
For more information, go to www.novonordisk-us.com or call 1-800-727-6500.

This Patient Information has been approved by the U.S. Food and Drug Administration

Revised: 10/2013

For more information go to www.novologflextouch.com

NovoLog

®

 is a registered trademark of Novo Nordisk A/S.

© 2002-2014 Novo Nordisk  

0714-00022409-1            7/2014

Summary of Contents for NovoLog

Page 1: ...xternal Pump 2 4 Intravenous Use 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5 1 Administration 5 2 Hypoglycemia 5 3 Hypokalemia 5 4 Renal Impairment 5 5 Hepatic Impair...

Page 2: ...atient s awareness of hypoglycemia Intravenously administered insulin has a more rapid onset of action than subcutaneously administered insulin requiring more close monitoring for hypoglycemia 5 3 Hyp...

Page 3: ...cerevisiae baker s yeast Insulin aspart has the empirical formula C256H381N65079S6 and a molecular weight of 5825 8 Figure 1 Structural formula of insulin aspart NovoLog is a sterile aqueous clear an...

Page 4: ...l nervous system symptoms and requiring the intervention of another person or hospitalization One six month open label active controlled study was conducted to compare the safety and efficacy of NovoL...

Page 5: ...ing complications of insulin therapy timing of dose instruction in the use of injection or subcutaneous infusion devices and proper storage of insulin Patients should be informed that frequent patient...

Page 6: ...to death including Low blood sugar hypoglycemia Signs and symptoms that may indicate low blood sugar include dizziness or light headedness blurred vision anxiety irritability or mood changes sweating...

Page 7: ...pump manual for instructions or talk to your healthcare provider NPH insulin is the only type of insulin that can be mixed with NovoLog Do not mix NovoLog with any other type of insulin NovoLog should...

Page 8: ...the following instructions carefully before using your NovoLog FlexPen NovoLog FlexPen is a disposable dial a dose insulin pen You can select doses from 1 to 60 units in increments of 1 unit NovoLog...

Page 9: ...red Figure C Step 9 Hold the Pen with the needle pointing up Press and hold in the dose button until the dose counter shows 0 The 0 must line up with the dose pointer A drop of insulin should be seen...

Page 10: ...until the expiration date printed on the label if kept in the refrigerator The NovoLog FlexTouch Pen you are using should be thrown away after 28 days even if it still has insulin left in it General I...

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