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DailyMed – NOVOLIN 70/30- human insulin injection, suspension


 

Patient Information

NOVOLIN® 70/30 (NO-voe-lin)

(human insulin isophane suspension and human insulin injection)

for subcutaneous use

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.

What is Novolin70/30?

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

Who should not use 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 leaflet for a complete list of ingredients in 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.
arebreastfeeding 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 use 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.
o
Do not use the exact same spot for each injection.
o
Do not inject where the skin has pits, is thickened, or has lumps.
o
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 using 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:
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:
o
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, and swelling (edema) in hands or feet.

These are not all of the possible side effects of Novolin 70/30. Call your doctor formedical 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 leaflet 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.

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.

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

© 2005 – 2019 Novo Nordisk

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

For information about Novolin 70/30 contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, New Jersey 08536

1-800-727-6500

www.novonordisk-us.com

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 11/2019

Patient Instructions for Use

Novolin® 70/30 10 mL multiple-dose 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. Novolin 70/30 can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs (thighs), or upper arms. Change (rotate) your injection sites within the area you choose for 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 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.
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.

How should I store Novolin® 70/30?

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:
o
Store unopened Novolin 70/30 vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
o
Unopened vials may be used until the expiration date printed on the label, if they have been stored in the refrigerator.
o
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:
o
Opened Novolin 70/30vials can be stored at room temperature below 77°F (25°C). Do not refrigerate.
o
Throw away all opened Novolin 70/30vials after 42 days, even if they still have insulin left in them.

Revised: 11/2019

Instructions For Use

Novolin® 70/30 FlexPen®

(human insulin isophane suspension and human insulin injection)

for subcutaneous use

Introduction

Please read the following instructions carefully before using your Novolin 70/30 FlexPen.

Do not share your Novolin 70/30 FlexPen 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.

Novolin 70/30 FlexPen is a disposable dial-a-dose, single-patient-use, insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. Novolin 70/30 FlexPen is designed to be used with NovoFine, NovoFine Plus or NovoTwist needles.

People who are blind or have vision problems should not use Novolin 70/30 FlexPen without help from a person trained to use Novolin 70/30 FlexPen.

Getting ready

Make sure you have the following items:

Novolin 70/30 FlexPen
New NovoFine, NovoFine Plus or NovoTwist needle
Alcohol swab
Gauze pad

Preparing your Novolin 70/30 FlexPen

Wash your hands with soap and water. Before you start to prepare your injection, check the label to make sure that you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin. Novolin 70/30 should look white and cloudy after mixing.

A. Let the insulin reach room temperature before you use it. This makes it easier to mix.

Pull off the pen cap (see diagram A).

B. Gently move the pen up and down twenty times between position 1 and 2 as shown, so the glass ball moves from one end of the cartridge to the other (see diagram B).

Repeat moving the pen until the liquid appears white and cloudy. Do not use the pen if the liquid appears discolored or contains particles.

For everyfollowing injection move the pen up and down between positions 1 and 2 at least ten times until the liquid appears white and cloudy.

After mixing, complete all the following steps of the injection right away. If there is a delay, the insulin will need to be mixed again.

Wipe the rubber stopper with an alcohol swab.

Exclamation point.Before you inject, there must be at least 12 units of insulin left in the cartridge to make sure the remaining insulin is evenly mixed. If there are less than 12 units left in your Novolin 70/30 FlexPen, use a new pen.

Attaching the needle

C. Remove the protective tab from a disposable needle.

Screw the needle tightly onto your Novolin 70/30 FlexPen. It is important that the needle is put on straight (see diagram C).

Never place a disposable needle on your Novolin 70/30 FlexPen until you are ready to take your injection.

D. Pull off the big outer needle cap (see diagram D).

E. Pull off the inner needle cap and dispose of it (see diagram E).

 

Always use a new needle for each injection to help ensure sterility and prevent blocked needles. Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.

Exclamation point.Be careful not to bend or damage the needle before use.

Exclamation point.To reduce the risk of unexpected needle sticks, never put the inner needle cap back on the needle.

Giving the airshot before each injection

Before each injection small amounts of air may collect in the cartridge during normal use. To avoid injecting air and to make sure you take the right dose of insulin:

F. Turn the dose selector to select 2 units (see diagram F).

G. Hold your Novolin 70/30 FlexPen with the needle pointing up. Tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (see diagram G).

H. Keep the needle pointing upwards, press the push-button all the way in (see diagram H). The dose selector returns to 0.

A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

If you do not see a drop of insulin after 6 times, do not use the Novolin 70/30 FlexPen and contact Novo Nordisk at 1-800-727-6500.

A small air bubble may remain at the needle tip, but it will not be injected.

Selecting your dose

Check and make sure that the dose selector is set at 0.

I. Turn the dose selector to the number of units you need to inject. The pointer should line up with your dose.

The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer (see diagram I). When turning the dose selector, be careful not to press the push-button as insulin will come out.

You cannot select a dose larger than the number of units left in the cartridge.

You will hear a click for every single unit dialed. Do not set the dose by counting the number of clicks you hear.

Exclamation point.Do not use the cartridge scale printed on the cartridge to measure your dose of insulin.

Giving the injection

Give the injection exactly as shown to you by your healthcare provider. Your healthcare provider should tell you if you need to pinch the skin before injecting. Wipe the skin with an alcohol swab and let the area dry.

Novolin 70/30 can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs (thighs), or upper arms.

For each injection, change (rotate) your injection site within the area of skin that you use. Change (rotate) your injection sites within the area you choose for 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 same injection site 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.

J. Insert the needle into your skin.

Inject the dose by pressing the push-button all the way in until the 0 lines up with the pointer (see diagram J). Be careful only to push the button when injecting.

Turning the dose selector will not inject insulin.

K. Keep the needle in the skin for at least 6 seconds, and keep the push-button pressed all the way in until the needle has been pulled out from the skin (see diagram K). This will make sure that the full dose has been given.

You may see a drop of insulin at the needle tip. This is normal and has no effect on the dose you just received. If blood appears after you take the needle out of your skin, press the injection site lightly with a gauze pad or an alcohol swab. Do not rub the area.

After the injection

Do not recap the needle. Recapping can lead to a needle stick injury. Remove the needle from the Novolin 70/30 FlexPen after each injection and dispose of it. This helps to prevent infection, leakage of insulin, and will help to make sure you inject the right dose of insulin.

If you do not have a sharps container, carefully slip the needle into the outer needle cap. Safely remove the needle and throw it away as soon as you can.

Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash.
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

o
made of a heavy-duty plastic
o
can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
o
upright and stable during use
o
leak-resistant
o
properly labeled to warn of hazardous waste inside the container
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
 
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
When there is not enough medicine left in your Novolin 70/30 FlexPen for your prescribed dose, the Novolin 70/30 FlexPen may be thrown away in your household trash after you have removed the needle. The Novolin 70/30 FlexPen prevents the cartridge from being completely emptied. It is designed to deliver 300 units.

L. Put the pen cap on the Novolin 70/30 FlexPen and store the Novolin 70/30 FlexPen without the needle attached (see diagram L). Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.

Put the pen cap on FlexPen.

How should I store Novolin 70/30 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:
o
Store unused Novolin 70/30 FlexPen in the refrigerator at 36°F to 46°F (2°C to 8°C).
o
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).
o
Unused Novolin 70/30 FlexPen stored at room temperature should be thrown away after 28 days.
In-use:
o
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.
o
The Novolin 70/30 FlexPen you are using should be thrown away after 28 days, even if it still has insulin left in it.
o
Store the Novolin 70/30 FlexPen without the needle attached.

Maintenance

For the safe and proper use of your Novolin 70/30 FlexPen be sure to handle it with care. Avoid dropping your Novolin 70/30 FlexPen as it may damage it. If you are concerned that your Novolin 70/30 FlexPen is damaged, use a new one. You can clean the outside of your Novolin 70/30 FlexPen by wiping it with a damp cloth. Do not soak or wash your Novolin 70/30 FlexPen as it may damage it. Do not refill your Novolin 70/30 FlexPen.

Exclamation point.Remove the needle from Novolin 70/30 FlexPen after each injection. This helps to ensure sterility, prevent leakage of insulin, and will help to make sure you inject the right dose of insulin for future injections.

Exclamation point.Be careful when handling used needles to avoid needle sticks and transfer of infectious diseases.

Exclamation point.Keep your Novolin 70/30 FlexPen and needles out of the reach of children.

Exclamation point.Use Novolin 70/30 FlexPen as directed to treat your diabetes.

 

Do not share your Novolin 70/30 FlexPen or needles with other people. You may give other people a serious infection, or get a serious infection from them.

Exclamation point.Always use a new needle for each injection.

 

Novo Nordisk is not responsible for harm due to using this insulin pen with products not recommended by Novo Nordisk.

 

As a precautionary measure, always carry a spare insulin delivery device in case your Novolin 70/30 FlexPen is lost or damaged.

 

Remember to keep the disposable Novolin 70/30 FlexPen with you. Do not leave it in a car or other location where it can get too hot or too cold.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 11/2019



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