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Novolin N NPH, Human Insulin Isophane Suspension (recombinant DNA origin) 100 units/mL


PATIENT PACKAGE INSERT

Patient Information for Novolin N ®

NOVOLIN N (NO-voe-lin) ®

NPH,

Human Insulin Isophane Suspension Injection

(recombinant DNA origin) units/mL 100


OTC - PURPOSE SECTION

Important:

. Do not change the type of insulin you use unless told to do so by your healthcare provider. The amount of insulin you take as well as the best time for you to take your insulin may need to change if you take a different type of insulin. Know your insulin

Make sure that you know the type and strength of insulin that is prescribed for you.

Read the Patient Information leaflet that comes with Novolin N before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your diabetes or your treatment. Make sure you know how to manage your diabetes. Ask your healthcare provider if you have any questions about managing your diabetes. ®

What is Novolin N? ®

Novolin N is a man-made insulin (recombinant DNA origin) NPH, Human Insulin Isophane Suspension that is structurally identical to the insulin produced by the human pancreas that is used to control high blood sugar in patients with diabetes mellitus. ®

Who should not use Novolin N? ®

Do not take Novolin N if: ®

Tell your healthcare provider:

Keep a list of your medicines with you to show all your healthcare providers when you get a new medicine. Know the medicines you take.

  • Your blood sugar is too low (hypoglycemia). •
  • You are allergic to anything in Novolin N. See the end of this leaflet for a complete list of ingredients in Novolin N. Check with your healthcare provider if you are not sure. •®®

DOSAGE & ADMINISTRATION SECTION

How should I take Novolin N? ®

Only use Novolin N if it appears cloudy or milky. There may be air bubbles. This is normal. If the precipitate (the white deposit at the bottom of the vial) has become lumpy or granular in appearance or has formed a deposit of solid particles on the wall of the vial, do not use it, and call Novo Nordisk at 1-800-727-6500. This insulin should not be used if the liquid in the vial remains clear after the vial has been gently rotated. ®

Novolin N comes in: ®

  • 10 mL vials (small bottles) for use with syringe •

INDICATIONS & USAGE SECTION

Talk to your healthcare provider if you have any questions. Your healthcare provider should show you how to inject Novolin N before you start taking it. Follow your healthcare provider’s instructions to make changes to your insulin dose. Read the instructions for use that come with your Novolin N product. ®®

Ask your healthcare provider how often you should check your blood sugar levels for hypoglycemia (too low blood sugar) and hyperglycemia (too high blood sugar). Check your blood sugar levels.

Your insulin dosage may need to change because of:

See the end of this patient information for instructions about preparing and giving the injection.

 

What should I avoid while using Novolin N? ®

What are the possible side effects of Novolin N? ®

Severe low blood sugar (hypoglycemia) can cause unconsciousness (passing out), seizures, and death. Know your symptoms of low blood sugar. Follow your healthcare provider’s instructions for treating low blood sugar. Talk to your healthcare provider if low blood sugar is a problem for you.

These are not all of the possible side effects from Novolin N. Ask your healthcare provider or pharmacist for more information. ®

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Novolin N? ®

All Unopened Novolin N: ®

Novolin N in use: ®

Vials

General advice about Novolin N ®

Novolin N is used for the treatment of diabetes only. Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use Novolin N for a condition for which it was not prescribed. Do not give Novolin N to other people, even if they have the same symptoms you have. It may harm them. ®®®

This leaflet summarizes the most important information about Novolin N. If you would like more information about Novolin N or diabetes, talk with your healthcare provider. For more information, call 1-800-727-6500 or visit www.novonordisk-us.com. ®®

Helpful information for people with diabetes is published by the American Diabetes Association, 1701 N Beauregard Street, Alexandria, VA 22311 and on www.diabetes.org.

increased thirst •fruity smell on breath •
frequent urination and dehydration •high amounts of sugar and ketones in your urine •
confusion or drowsiness •nausea, vomiting (throwing up) or stomach pain •
loss of appetite •a hard time breathing •
illness •change in diet •
stress •change in physical activity or exercise •
other medicines you take •surgery •
sweating •trouble concentrating or confusion •
dizziness or lightheadedness •blurred vision •
shakiness •slurred speech •
hunger •anxiety, irritability or mood changes •
fast heart beat •headache •
tingling of lips and tongue •
  • •Take Novolin N exactly as prescribed. ®
  • The effects of Novolin N start working 1½ hours after injection. •Novolin N is an intermediate-acting insulin. ®®
  • The greatest blood sugar lowering effect is between 4 and 12 hours after the injection. This blood sugar lowering may last up to 24 hours. •
  • any change of insulin should be made cautiously and only under medical supervision. Doses of oral anti-diabetic medicines may also need to change, if your insulin is changed. •While using Novolin N, ®
  • with any insulins other than Regular human insulin in the same syringe. •Do not mix Novolin N ®
  • Novolin N may affect your blood sugar levels sooner if you inject it into the skin of your stomach area. •Inject Novolin N into the skin of your stomach area, upper arms, buttocks or upper legs. ®®Never inject Novolin N into a vein or into a muscle. ®
  • •Change (rotate) your injection site within the chosen area (for example, stomach or upper arm) with each dose. Do not inject into the same spot for each injection.
  • You can treat mild low blood sugar (hypoglycemia) by drinking or eating something sugary right away (fruit juice, sugar candies, or glucose tablets). It is important to treat low blood sugar (hypoglycemia) right away because it could get worse and you could pass out (become unconscious). If you pass out, you will need help from another person or emergency medical services right away, and will need treatment with a glucagon injection or treatment at a hospital. See “What are the possible side effects of Novolin N?” for more information on low blood sugar (hypoglycemia). •If you take too much Novolin  N, your blood sugar may fall low (hypoglycemia). ®® 
  • If  high blood sugar (hyperglycemia) is not treated it can lead to diabetic ketoacidosis, which can lead to serious problems, like loss of consciousness (passing out), coma or even death. Follow your healthcare provider’s instructions for treating high blood sugar (hyperglycemia), and talk to your healthcare provider if high blood sugar is a problem for you. Severe or continuing high blood sugar (hyperglycemia) requires prompt evaluation and treatment by your healthcare provider. Know your symptoms of high blood sugar (hyperglycemia) and diabetic ketoacidosis which may include: •If you forget to take your dose of Novolin  N, your blood sugar may go too high (hyperglycemia). ®

OTC - ACTIVE INGREDIENT SECTION

Novolin N ingredients include: ®

  • Human Insulin Isophane Suspension (recombinant DNA origin) •

INACTIVE INGREDIENT SECTION

All Novolin N vials are latex-free. ®

Date of issue: March 9, 2013

Version: 6

Novolin   and Novo Nordisk are registered trademarks of Novo Nordisk A/S. ®®

© 2005-2013 Novo Nordisk

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

For information about Novolin N contact: ®

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, New Jersey 08536

PATIENT INSTRUCTIONS FOR USE

Novolin N 10 mL vial (100 Units/mL, U-100) ®

Before starting, gather all of the supplies that you will need to use for preparing and giving your insulin injection.

Never re-use syringes and needles.

How should I use the Novolin N vial?

How should I mix Novolin N with Regular human insulin?

Different insulins should be mixed only under instruction from a health care provider. Novolin N should be mixed only when injections with syringes are used.  Insulin syringes may vary in the amount of space between the bottom line and the needle (“dead space”), so if you are mixing two types of insulin be sure to discuss any change in the model and brand of syringe you are using with your healthcare provider. Novolin N can be mixed with Regular human insulin right before use. When you are mixing Novolin N insulin with Regular human insulin, always draw the Regular human (clear) insulin into the syringe first. Do not mix Novolin N with any other type of insulin besides Regular human insulin.

  • Metacresol •
  • Zinc chloride •
  • Glycerol •
  • Sodium hydroxide •
  • Hydrochloric acid •
  • Phenol •
  • Protamine sulfate •
  • Disodium phosphate dihydrate •
  • Water for injections •