Novolin 70/30

What is Novolin 70/30?

Novolin 70/30 is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

What is the most important information I should know about Novolin 70/30?

Do not share your Novolin 70/30 FlexPen or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

Who should not take Novolin 70/30?

Do not use Novolin 70/30 if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to human insulin isophane, human insulin or any of the ingredients in Novolin 70/30. See the end of this Patient Information guide for a complete list of ingredients in Novolin 70/30.

What should I tell my healthcare provider before taking Novolin 70/30?

Before using Novolin 70/30, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems.
• take other medicines, especially ones called TZDs (thiazolidinediones).
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Novolin 70/30.
• are pregnant or plan to become pregnant. Talk with your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
• are breastfeeding or plan to breastfeed. Novolin 70/30 may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while using Novolin 70/30.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Before you start using Novolin 70/30, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take Novolin 70/30?

• Read the detailed Instructions for Use that comes with your Novolin 70/30.
• Use Novolin 70/30 exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Novolin 70/30 to use and when to use it.
• Use Novolin 70/30 about 30 minutes before eating a meal.
• Know the type, strength, and amount of insulin you use. Do not change the type, or amount of insulin you use 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 use different types of insulin.
• Check your insulin label each time you give your injection to make sure you are using the correct insulin.
• Inject Novolin 70/30 under the skin (subcutaneously) in your stomach area, buttocks, upper legs (thighs) or upper arms. Do not inject Novolin 70/30 into your vein (intravenously) or muscle (intramuscularly) or use in an insulin infusion pump.
• Do not mix Novolin 70/30 with any other insulins or liquids.
• Change (rotate) your injection site within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
  • Do not use the exact same spot for each injection.
  • Do not inject where the skin has pits, is thickened, or has lumps.
  • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Keep Novolin 70/30 and all medicines out of the reach of children.

Your dose of Novolin 70/30 may need to change because of:

• change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

What should I avoid while taking Novolin 70/30?

While using Novolin 70/30 do not:

• drive or operate heavy machinery until you know how Novolin 70/30 affects you.
• drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of Novolin 70/30?

Novolin 70/30 may cause serious side effects that can lead to death, including:

• low blood sugar (hypoglycemia). Signs and symptoms of low blood sugar may include:
  • dizziness or lightheadedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood changes, hunger.
    • Your healthcare provider may prescribe a glucagon emergency kit so that others can give you an injection if your blood sugar becomes too low (hypoglycemia) and you are unable to take sugar by mouth.
• severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
  • a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
• low potassium in your blood (hypokalemia).
• heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Novolin 70/30 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Novolin 70/30. Your healthcare provider should monitor you closely while you are taking TZDs with Novolin 70/30. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
  • shortness of breath, swelling of your ankles or feet, sudden weight gain.
    
    Treatment with TZDs and Novolin 70/30 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Get emergency medical help if you have:

• severe hypoglycemia needing hospitalization or emergency room care, and be sure to tell the hospital staff the units of Novolin 70/30 your healthcare provider has prescribed for you.
• trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

The most common side effects of Novolin 70/30 include:

• low blood sugar (hypoglycemia), allergic reactions including reactions at your injection site, skin thickening or pits at the injection site (lipodystrophy), weight gain, swelling (edema) in hands or feet.

These are not all of the possible side effects of Novolin 70/30. 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 Novolin 70/30

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Novolin 70/30 for a condition for which it was not prescribed. Do not give Novolin 70/30 to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information guide summarizes the most important information about Novolin 70/30. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Novolin 70/30 that is written for healthcare providers. For more information, call 1-800-727-6500 or go to www.novonordisk-us.com.

How should I store Novolin 70/30?

Vials

• Do not freeze Novolin 70/30. Do not use Novolin 70/30 if it has been frozen.
• Keep Novolin 70/30 away from heat or light.
• All unopened vials:
  • Store unopened Novolin 70/30 vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Unopened vials may be used until the expiration date printed on the label, if they have been stored in the refrigerator.
  • Unopened vials should be thrown away after 42 days, if they are stored at room temperature below 77°F (25°C).

After vials have been opened:

• Opened Novolin 70/30vials can be stored at room temperature below 77°F (25°C). Do not refrigerate.
• Throw away all opened Novolin 70/30vials after 42 days, even if they still have insulin left in them.

FlexPen

• Do not freeze Novolin 70/30. Do not use Novolin 70/30 if it has been frozen.
• Keep Novolin 70/30 away from heat and light.
• Until first use:
  • Store unused Novolin 70/30 FlexPen in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Unused Novolin 70/30 FlexPen may be used until the expiration date printed on the label, if kept in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Unused Novolin 70/30 FlexPen stored at room temperature should be thrown away after 28 days.
• In-use:
  • Store the Novolin 70/30 FlexPen you are currently using out of the refrigerator at room temperature below 86°F (30°C) for up to 28 days.
  • The Novolin 70/30 FlexPen you are using should be thrown away after 28 days, even if it still has insulin left in it.
  • Store the Novolin 70/30 FlexPen without the needle attached.

What are the ingredients in Novolin 70/30?

Active ingredient: 70% human insulin isophane and 30% human insulin

Inactive ingredients: glycerol, metacresol, zinc, phenol, disodium phosphate dihydrate, protamine sulfate, water for injection, hydrochloric acid and sodium hydroxide.