Novolin® 70/30, 70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection (recombinant DNA origin)

NOVOLIN 70/30 - insulin human injection, suspension 
Novo Nordisk

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PATIENT PACKAGE INSERT

Patient Information for Novolin® 70/30

NOVOLIN® 70/30 (NO-voe-lin)

70% NPH, Human Insulin Isophane Suspension and

30% Regular, Human Insulin Injection

(recombinant DNA origin) 100 units/mL

Important:

Know your insulin. 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.

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 70/30 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 70/30?

Novolin 70/30 is a man-made insulin (recombinant DNA origin) which is a mixture of 70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection 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 70/30?

Do not take Novolin 70/30 if:

Tell your healthcare provider:

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

How should I take Novolin 70/30?

Only use Novolin 70/30 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 70/30 comes in:

Read the instructions for use that come with your Novolin 70/30 product. Talk to your healthcare provider if you have any questions. Your healthcare provider should show you how to inject Novolin 70/30 before you start taking it. Follow your healthcare provider’s instructions to make changes to your insulin dose.

  • 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

Your insulin dosage may need to change because of:

  • illness
  • change in diet
  • stress
  • change in physical activity or exercise
  • other medicines you take
  • surgery

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

What should I avoid while using Novolin 70/30?

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

  • 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

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 70/30. 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 70/30?

All Unopened Novolin 70/30:

Novolin 70/30 in use:

Vials

General advice about Novolin 70/30

Novolin 70/30 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 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 leaflet summarizes the most important information about Novolin 70/30. If you would like more information about Novolin 70/30 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.

Novolin 70/30 ingredients include:

Novolin 70/30 ingredients include:

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

All Novolin 70/30 vials are latex-free.

ReliOn®

Date of issue: May 14, 2010

Version: 5

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

ReliOn® is a trademark owned by Access LLC

ReliOn® is licensed by Novo Nordisk Inc.

© 2005-2010 Novo Nordisk A/S

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

For information about Novolin 70/30 contact:

Novo Nordisk Inc.

100 College Road West

Princeton, New Jersey 08540

Patient Instructions for Use

Novolin® 70/30 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 70/30 vial?

  1. Check to make sure that you have the correct type of insulin.
  2. Look at the vial and the insulin. The insulin should be a cloudy or milky suspension. The tamper-resistant cap should be in place before the first use. If the cap had been removed before your first use of the vial, or 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.
  3. Wash your hands with soap and water. If you clean your injection site with an alcohol swab, let the injection site dry before you inject. Talk with your healthcare provider about how to rotate injection sites and how to give an injection.
  4. If you are using a new vial, pull off the tamper-resistant cap. Wipe the rubber stopper with an alcohol swab.
  5. Roll the vial gently 10 times in your hands to mix it. This procedure should be carried out with the vial in a horizontal position. The rolling procedure must be repeated until the suspension appears uniformly white and cloudy. Shaking right before the dose is drawn into the syringe may cause bubbles or froth, which could cause you to draw up the wrong dose of insulin.
  6. Pull back the plunger on the syringe until the black tip reaches the marking for the number of units you will inject.
  7. Push the needle through the rubber stopper of the vial, and push the plunger all the way in to force air into the vial.
  8. Turn the vial and syringe upside down and slowly pull the plunger back to a few units beyond the correct dose.
  9. If there are any air bubbles, tap the syringe gently with your finger to raise the air bubbles to the top. Then slowly push the plunger to the marking for your correct dose. This process should move any air bubbles present in the syringe back into the vial.
  10. Check to make sure you have the right dose of Novolin 70/30 in the syringe.
  11. Pull the syringe with needle out of the vial’s rubber stopper.
  12. Your doctor should tell you if you need to pinch the skin before inserting the needle.  This can vary from patient to patient so it is important to ask your doctor if you did not receive instructions on pinching the skin.  Insert the needle into the skin. Press the plunger of the syringe to inject the insulin. When you are finished injecting the  insulin, pull the needle out of your skin. You may see a drop of Novolin 70/30 at the needle tip. This is normal and has no effect on the dose you just received. If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol wipe. Do not rub the area.
  13. After your injection, do not recap the needle. Place used syringes, needles and used insulin vials in a disposable puncture-resistant sharps container, or some type of hard plastic or metal container with a screw on cap such as a detergent bottle or coffee can.
  14. Ask your healthcare provider about the right way to throw away used syringes and needles. There may be state or local laws about the right way to throw away used syringes and needles. Do not throw away used needles and syringes in household trash or recycle.

Principal Display Panel

NDC 59060-1837-2

Novolin® 70/30

70% NPH, Human Insulin Isophane Suspension and

30% Regular, Human Insulin Injection

(recombinant DNA origin)

100 units/mL

ReliOn®

Novolin 70/30 ReliOn Carton

NOVOLIN  70/30
human insulin injection, suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59060-1837
Route of AdministrationSUBCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
INSULIN HUMAN (INSULIN HUMAN) INSULIN HUMAN100 [USP'U]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
METACRESOL 
PHENOL 
PROTAMINE SULFATE 
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 
ZINC CHLORIDE 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:59060-1837-21 VIAL in 1 CARTONcontains a VIAL
110 mL in 1 VIALThis package is contained within the CARTON (59060-1837-2)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01999106/15/200008/31/2012

Labeler - Novo Nordisk (012177531)
Establishment
NameAddressID/FEIOperations
Novo Nordisk Pharmaceuticals Industries Inc.622920320MANUFACTURE
Establishment
NameAddressID/FEIOperations
Novo Nordisk A/S312296002MANUFACTURE
Establishment
NameAddressID/FEIOperations
Novo Nordisk A/S305156788API MANUFACTURE

Revised: 02/2012 Novo Nordisk