Insulin Aspart is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Injection: 100 units/mL (U-100) is a clear and colorless solution available as:

• 10 mL multiple-dose vial
• 3 mL single-patient-use PenFill prefilled cartridges for the 3 mL PenFill cartridge delivery device with NovoFine ®disposable needles
• 3 mL single-patient-use FlexPen prefilled pen

Insulin Aspart is contraindicated:

• During episodes of hypoglycemia [see Warnings and Precautions ( 5.3)]
• In patients with hypersensitivity to Insulin Aspart or one of its excipients, [seeWarnings and Precautions ( 5.5)]

1. The following adverse reactions are also discussed elsewhere:
2. Hypoglycemia [seeWarnings and Precautions ( 5.3)]
3. Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4)]
4. Hypersensitivity reactions [see Warnings and Precautions (5.5)]
5. Hypokalemia [seeWarnings and Precautions ( 5.6)]

The table below presents clinically significant drug interactions with Insulin Aspart.

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3, 5.6)] . Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

Insulin aspart is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae(baker's yeast). Insulin aspart has the empirical formula C 256H 381N 650 79S 6and a molecular weight of 5825.8 Da.

Insulin Aspart injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart and the inactive ingredients: disodium hydrogen phosphate dihydrate (1.25 mg), glycerin (16.0 mg), metacresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. Insulin Aspart has a pH of 7.2-7.6. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.

Insulin Aspart injection 100 units/mL (U-100) is available as a clear and colorless solution in:

Five 3 mL single-patient-use PenFill prefilled cartridges* per carton

*Insulin Aspart PenFill cartridges are designed for use with compatible insulin delivery devices with NovoFine disposable needles. FlexPen can be used with NovoFine or NovoTwist disposable needles.

The Insulin Aspart FlexPen dials in 1-unit increments.

NDC: 70518-3865-00

PACKAGING: 5 in 1 CARTON, 3 mL in 1 SYRINGE PLASTIC , TYPE 2

Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused Insulin Aspart in a refrigerator between 2°C to 8°C (36°F to 46°F).  Do not freeze Insulin Aspart and do not use Insulin Aspart if it has been frozen. Do not expose Insulin Aspart to excessive heat or light. Do not withdraw Insulin Aspart into a syringe and store for later use.

Always remove and discard the needle after each injection from the Insulin Aspart FlexPen and store without a needle attached.

*For insulin pump use, the total in-use time is 19 days, including 7 days pump in-use time.

Storage in External Insulin Pump:

Change the Insulin Aspart in the pump reservoir at least every 7 days or in accordance to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 37°C (98.6°F).

Storage of Diluted Insulin Aspart

This Insulin Aspart product diluted with Insulin Diluting Medium for NovoLog (insulin aspart) to a concentration equivalent to U-10 or equivalent to U-50 prepared as indicated under Dosage and Administration (2.2) may remain in patient use at temperatures up to 30°C (86°F) for 28 days.

Storage of Insulin Aspart in Intravenous Infusion Fluids

Infusion bags prepared as indicated under Dosage and Administration (2.2) are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Never Share an Insulin Aspart FlexPen, PenFill Cartridge or PenFill Cartridge Device between Patients

Advise patients that they must never share Insulin Aspart FlexPen, PenFill cartridge or PenFill cartridge devices with another person even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens. Advise patients using Insulin Aspart vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens [seeWarnings and Precautions ( 5.1)] .

Hyperglycemia or Hypoglycemia

Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of Insulin Aspart therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia [see Warnings and Precautions ( 5.3)] .

Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.

Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions ( 5.2)] .

Hypoglycemia with Medication Errors

Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products [seeWarnings and Precautions ( 5.3)] .

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions have occurred with Insulin Aspart. Inform patients of the symptoms of hypersensitivity reactions [seeWarnings and Precautions ( 5.4)] .

Patients Using Continuous Subcutaneous Insulin Pumps

• Train patients in both intensive insulin therapy with multiple injections and in the function of their pump and pump accessories.
• This Insulin Aspart product can be used with continuous subcutaneous insulin infusion pumps labeled for use with NOVOLOG (insulin aspart) - refer to the insulin pump user manual to see if NOVOLOG can be used. See recommended infusion sets in the insulin pump user manual.
• Instruct patients to replace insulin in the reservoir at least every 7 days or according to the user manual, whichever is shorter, infusion sets and infusion set insertion sites should be changed in according to the manufacturer’s user manual. By following this schedule, patients avoid insulin degredation, infusion set occlusion, and loss of the insulin preservative.
• Instruct patients to discard insulin exposed to temperatures higher than 37°C (98.6°F).
• Instruct patients to inform physician and select a new site for infusion if infusion site becomes erythematous, pruritic, or thickened.
• Instruct patients of the risk of rapid hyperglycemia and ketosis due to pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin. If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their physician [see Warnings and Precautions ( 5) and How Supplied/Storage and Handling ( 16.2)] .
• Instruct patients of the risk of hypoglycemia from pump malfunction. If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their physician [see Warnings and Precautions ( 5) and How Supplied/Storage and Handling ( 16.2)] .

Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

Insulin Aspart[ in∙suh∙luhn a∙sprt]

injection, for subcutaneous or intravenous use

This product is NovoLog (insulin aspart).

Do not share your Insulin Aspart FlexPen, PenFill cartridge or PenFill cartridge compatible insulin delivery device 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 Insulin Aspart?

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

Who should not take Insulin Aspart?

Do not take Insulin Aspart if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to Insulin Aspart or any of the ingredients in Insulin Aspart.

Before taking Insulin Aspart, 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 Insulin Aspart, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take Insulin Aspart?

• Read the Instructions for Usethat come with your Insulin Aspart.
• Take Insulin Aspart exactly as your healthcare provider tells you to.
• Insulin Aspart starts acting fast.You should eat a meal within 5 to 10 minutes after you take your dose of Insulin Aspart.
• Know the type and strength of insulin you take. Do notchange 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 reuse or share your needles with other people.You may give other people a serious infection or get a serious infection from them.
• Insulin Aspart can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs) or upper arms, or by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.
• Change (rotate) your injection sites within the area you choose with each doseto reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
• Do notuse the exact same spot for each injection.
• Do notinject where the skin has pits, is thickened, or has lumps.
• Do notinject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

What should I avoid while taking Insulin Aspart?

While taking Insulin Aspart do not:

• Drive or operate heavy machinery, until you know how Insulin Aspart affects you.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of Insulin Aspart?

Insulin Aspart 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 Insulin Aspart 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 Insulin Aspart. 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 Insulin Aspart.

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 Insulin Aspart that is written for health professionals. Do not use Insulin Aspart for a condition for which it was not prescribed. Do not give Insulin Aspart to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in Insulin Aspart?

Active Ingredient:insulin aspart

Inactive Ingredients:disodium hydrogen phosphate dihydrate, glycerin, metacresol, phenol, sodium chloride, zinc, and Water for Injection, USP. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.

Manufactured by:Novo Nordisk Inc., Plainsboro, NJ 08536, U.S. License Number 1261

For more information, call 1-800-727-6500.

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

Revised: 02/2023

INSTRUCTIONS FOR USE

Insulin Aspart [in∙suh∙luhn a∙sprt]

injection, for subcutaneous or intravenous use

10 mL multiple-dose vial (100 units/mL, U-100)

This product is NovoLog (insulin aspart).

Read this Instructions for Use before you start taking Insulin Aspart and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Supplies you will need to give your Insulin Aspart injection:

• 10 mL Insulin Aspart vial
• insulin syringe and needle
• alcohol swabs

Preparing your Insulin Aspart dose:

• Wash your hands with soap and water.
• Before you start to prepare your injection, check the Insulin Aspart label to make sure that you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
• Insulin Aspart should look clear and colorless. Do notuse Insulin Aspart if it is thick, cloudy, or is colored.
• Do notuse Insulin Aspart past the expiration date printed on the label.

Step 1:Pull off the tamper resistant cap (See Figure A).

Step 2:Wipe the rubber stopper with an alcohol swab (See Figure B).

Step 3:Hold the syringe with the needle pointing up. Pull down on the plunger until the black tip reaches the line for the number of units for your prescribed dose (See Figure C).

Step 4:Push the needle through the rubber stopper of the Insulin Aspart vial (See Figure D).

Step 5:Push the plunger all the way in. This puts air into the Insulin Aspart vial (See Figure E).

Step 6:Turn the Insulin Aspart vial and syringe upside down and slowly pull the plunger down until the black tip is a few units past the line for your dose (See Figure F).

• If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top (See Figure G).

Step 7:Slowly push the plunger up until the black tip reaches the line for your Insulin Aspart dose (See Figure H).

Step 8:Check the syringe to make sure you have the right dose of Insulin Aspart.

Step 9:Pull the syringe out of the vial’s rubber stopper (See Figure I).

• Giving your Injection:

• Inject your Insulin Aspart exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
• Insulin Aspart can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms, infused in an insulin pump (continuous subcutaneous infusion into an area of your body recommended in the instructions that come with your insulin pump), or given through a needle in your arm (intravenously) by your healthcare provider.
• If you inject Insulin Aspart, 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 notuse the same injection site for each injection. Do notinject where the skin has pits, is thickened, or has lumps. Do notinject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• If you use Insulin Aspart in an insulin pump, you should change your infusion set and insertion site according to the manufacturer’s user manual. This Insulin Aspart product can be used with the continuous subcutaneous insulin infusion pumps labeled for use with NovoLog (insulin aspart) - refer to the insulin pump user manual to see if NovoLog can be used. Insulin Aspart should be given into an area of your body recommended in the instructions that come with your insulin pump. Change (rotate) your insertion sites within the area you choose for each insertion to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the insertion sites. Do not insert into the exact same spot for each insertion. Do not insert where the skin has pits, is thickened, or has lumps. Do not insert where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. The insulin in the reservoir should be changed at least every 7 days or according to the pump user manual, whichever is shorter, even if you have not used all of the insulin.
• If you use Insulin Aspart in an insulin pump, see your insulin pump manual for instructions or talk to your healthcare provider.
• NPH insulin is the only type of insulin that can be mixed with Insulin Aspart. Do notmix Insulin Aspart with any other type of insulin.
• Insulin Aspart should onlybe mixed with NPH insulin if it is going to be injected right away under your skin (subcutaneously).
• Insulin Aspart should be drawn up into the syringe beforeyou draw up your NPH insulin.
• Talk to your healthcare provider if you are not sure about the right way to mix Insulin Aspart and NPH insulin.

Step 10: Choose your injection site (stomach area, buttocks, upper legs or upper arms) and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure J).

(Figure J)

Step 11:Insert the needle into your skin. Push down on the plunger to inject your dose (See Figure K). The needle should remain in the skin for at least 6 seconds to make sure you have injected all the insulin.

Step 12:Pull the needle out of your skin. After that, you may see a drop of Insulin Aspart at the needle tip. This is normal and does not affect the dose you just received (See Figure L).

• 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 swab. Do notrub the area.

After your injection:

• Do notrecap the needle. Recapping the needle can lead to a needle stick injury.
• Put the empty insulin vials, used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes and needles in your household trash.
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
• made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant, and 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 the 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.

How should I store Insulin Aspart?

• Do notfreeze Insulin Aspart. Do notuse Insulin Aspart if it has been frozen.
• Keep Insulin Aspart away from heat or light.
• All unopened vials:
• Store unopened Insulin Aspart 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 28 days, if they are stored at room temperature.
• After vials have been opened:
• Opened Insulin Aspart vials can be stored in the refrigerator at 36 °F to 46 °F (2 °C to 8 °C) or at room temperature below 86 °F (30 °C).
• Throw away all opened Insulin Aspart vials after 28 days, even if they still have insulin left in them.
• If using Insulin Aspart in a pump, throw away all opened Insulin Aspart vials after 19 days.

General information about the safe and effective use of Insulin Aspart

• Always use a new syringe and needle for each injection.
• Do not share syringes or needles.
• Keep Insulin Aspart vials, syringes, and needles out of the reach of children.

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

INSTRUCTIONS FOR USE

Insulin Aspart [in∙suh∙luhn a∙sprt]

injection, for subcutaneous or intravenous use

PenFill ®3 mL cartridge 100 units/mL (U-100)

This product is NovoLog (insulin aspart).

• Do not share your PenFill cartridge or PenFill cartridge compatible insulin delivery device 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.
• Your healthcare provider should show you or your caregiver how to inject Insulin Aspart the right way before you inject it for the first time.
• Insulin Aspart PenFill cartridge 100 units/mL is a prefilled, single-patient-use cartridgecontaining 300 units of Insulin Aspart.
• After you insert the PenFill cartridge in your device, you can use it for multiple injections. Read the instruction manualthat comes with your insulin delivery device for complete instructions on how to use the PenFill cartridge with the device.
• People who are blind or have vision problems should not use this PenFill cartridge without help from a person trained to use the PenFill cartridge with the device.
• If using a newInsulin Aspart PenFill cartridge, start with Step 1.
• If the Insulin Aspart PenFill cartridge has already been used, start with Step 2.

Supplies you will need to give your Insulin Aspart injection:

• Insulin Aspart PenFill cartridge
• Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery device
• 1 new NovoFine, NovoFine Plus, or NovoTwist needle
• Alcohol swabs
• Adhesive bandage
• Cotton gauze
• A sharps container for throwing away used PenFill cartridges and needles. See “After your injection” at the end of these instructions.

(Figure A)

How to use the Insulin Aspart PenFill cartridge

• Wash your hands with soap and water.
• Before you start to prepare your injection, check theInsulin Aspart PenFill cartridge labelto make sure that it contains the insulin you need. This is especially important if you take more than 1 type of insulin.
• The tamper-resistant foil should be in place before the first use. If the foil has been broken or removed before your first use of the cartridge, do notuse it. Call Novo Nordisk at 1-800-727-6500.
• Carefully look at the cartridge and the insulin inside it. Check that the Insulin Aspart cartridge:
  • is not damaged, for example cracked or leaking
  • is not loose on the threaded end
• Insulin Aspart should look clear and colorless. Do notuse Insulin Aspart if it is cloudy or colored or if the threaded end is loose (See Figure B).

(Figure B)

Step 1:

• Insert a 3 mL cartridge with the threaded end first into your Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery device (See Figure C).
• If you drop your device, check the insulin cartridge for damage such as cracks or leaking. If your cartridge is damaged, throw it away and use a new one.

(Figure C)

Prepare your device with a new needle

Step 2:

• Take a new needle,and tear off the paper tab. Always use a new needle for each injection to make sure the needle is free of germs (sterile) and to prevent blocked needles. Do not attach a new needleto your device until you are ready to give your injection. Do not reuse or share your needles with other people. You may give others a serious infection, or get a serious infection from them.
• Be careful not to bend or damage the needle before you use it.
• Push the needle straight onto the device. Turn the needle clockwise until it is on tight (See Figure D).

(Figure D)

Step 3:

• Pull off the outer needle cap(See Figure E) . Do notthrow it away. You will need it after the injection to safely remove the needle.

(Figure E)

Step 4:

• Pull off the inner needle capand throw it away (See Figure F). Do nottry to put the inner needle cap back on the needle.

(Figure F)

A drop of insulin may appear at the needle tip. This is normal, but you must still check the insulin flow.

1. Check the insulin flow

Step 5:

• Small amounts of air may collect in the cartridge during normal use. You must do an airshot before each injection to avoid injecting air and to make sure you receive the prescribed dose of your medicine.
• Do the airshot as described in the instruction manual that comes with your device.
• Keep testing your Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery device until you see insulin at the needle tip. If you still do not see a drop of insulin after 6 times, change the needle and repeat this step. This makes sure that any air bubbles are removed and that insulin is getting through the needle (See Figure G).

(Figure G)

Select your dose

Step 6:

• Check to make sure that the dose counter is set to 0.
• Turn the dose selector clockwise to select the dose you needto inject (See Figure H). The pointer should line up with your dose. When turning the dose selector, be careful not to press the dose button as insulin will come out. You will hear a click for every single unit dialed. Do notset the dose by counting the number of clicks you hear because you may get an incorrect dose.
• Refer to your insulin delivery device manual if necessary.

(Figure H)

Inject your dose

Step 7:

• Do 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.
• Insulin Aspart can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms (See Figure I).

• (Figure I)

• 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.
• Clean your injection site with an alcohol swab. Let your skin dry. Do not touch this area again before injecting.
• Insert the needle into your skin. Press and hold down the dose button until the dose counter shows “0”. Continue to keep the dose button pressed and keep the needle in your skin and slowly count to 6 (see Figure J).
• Remove the needle from your skin.

(Figure J)

You may see a drop of Insulin Aspart at the needle tip after injecting. 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 cotton gauze and cover with an adhesive bandage, if necessary. Do not rub the area.

After your injection

Step 8:

• Lay your outer needle cap on a flat surface. Carefully, lead the needle tip into the outer needle cap without touching the needle (See Figure K) and push the outer needle cap completely on.

(Figure K)

• Hold the black cartridge holder on the insulin delivery device and unscrew the needle counterclockwise (See Figure L).

(Figure L)

• Throw away (dispose of) the needle in an FDA-cleared sharps container as your healthcare professional has instructed you.
• Put your empty Insulin Aspart PenFill cartridge and used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and PenFill cartridges in your household trash.
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use, and
  • leak-resistant and 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. Do not reuse or share your needles or syringes with other people. For more information about the 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.

Step 9:

• Keep the 3 mL PenFill cartridge in the device. Do notstore your device with a needle attached. This will prevent infection or leakage of insulin and will make sure that you receive the right dose of Insulin Aspart.
• Put the pen cap onyour device after each use to protect the insulin from light (See Figure M).

(Figure M)

How should I store my Insulin Aspart PenFill cartridge?

• Do notfreeze Insulin Aspart. Do notuse Insulin Aspart if it has been frozen.
• Keep Insulin Aspart away from heat or light.
• Store the Insulin Aspart PenFill cartridge without the needle attached.

Before use:

• Store unused Insulin Aspart PenFill cartridges in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Unused PenFill cartridges may be used until the expiration date printed on the label, if kept in the refrigerator.
• If Insulin Aspart is stored mistakenly outside of refrigeration between 47°F (9°C) to 86°F (30°C) prior to first use, it should be used within 28 days or thrown away.

PenFill cartridges in use:

• Store the PenFill cartridge you are currently using in the insulin delivery device at room temperature below 86°F (30°C) for up to 28 days. Do not refrigerate.
• The Insulin Aspart PenFill cartridge you are using should be thrown away after 28 days, even if it still has insulin left in it.

General Information about the safe and effective use of Insulin Aspart.

• Keep Insulin Aspart PenFill cartridges and needles out of the reach of children.
• Do notshare Insulin Aspart PenFill cartridges or needles with other people. You may give other people a serious infection, or get a serious infection from them.
• Always carry extra insulin of the same type(s) you use in case of loss or damage.

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

© 2023 Novo Nordisk

INSTRUCTIONS FOR USE

Insulin Aspart [in∙suh∙luhn a∙sprt]

injection, for subcutaneous or intravenous use

3 mL FlexPen ®prefilled pen (100 units/mL, U-100)

This product is NovoLog (insulin aspart).

Introduction

Please read the following instructions carefully before using your Insulin Aspart FlexPen.

Do not share your Insulin Aspart 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.

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

• Δ People who are blind or have vision problems should not use this Pen without help from a person trained to use the Pen.

Getting ready

Make sure you have the following items:

• Insulin Aspart FlexPen
• New NovoFine, NovoFine Plus or NovoTwist needle
• Alcohol swabs

Preparing your Insulin Aspart 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. Insulin Aspart should look clear and colorless. Do not use your Insulin Aspart FlexPen if the liquid contains particles or is colored.

A. Pull off the pen cap (see diagram A).

Wipe the rubber stopper with an alcohol swab.

B. Attaching the needle

Remove the protective tab from a disposable needle.

Screw the needle tightly onto your FlexPen. It is important that the needle is put on straight (see diagram B).

Never place a disposable needle on your Insulin Aspart FlexPen until you are ready to take your injection.

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

D.Pull off the inner needle cap and throw it away (dispose of it) (see diagram D).

• ΔAlways use a new needle for each injection to make sure the needle is free of germs (sterile) and to 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.
• ΔBe careful not to bend or damage the needle before use.
• ΔTo 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 ensure proper dosing:

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

F.Hold your Insulin Aspart 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 F).

G.Keep the needle pointing upwards, press the push-button all the way in (see diagram G). 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 Insulin Aspart 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.

H.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 H). 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 because you may get an incorrect dose.

• Δ Do not use the cartridge scale printed on the cartridge to measure your dose of insulin.

Giving the injection

Do 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.

Insulin Aspart 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 notuse the same injection site for each injection. Do notinject where the skin has pits, is thickened, or has lumps. Do notinject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

I.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 I). Be careful only to push the button when injecting.

Turning the dose selector will not inject insulin.

J.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 J). 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 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 Insulin Aspart 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.

• The used Insulin Aspart FlexPen may be thrown away in your household trash after you have removed the needle.
• 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:
• made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant, and
• 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 the 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 Insulin Aspart FlexPen for your prescribed dose, the Insulin Aspart FlexPen may be thrown away in your household trash after you have removed the needle. The Insulin Aspart FlexPen prevents the cartridge from being completely emptied. It is designed to deliver 300 units.

K. Put the pen cap on the Insulin Aspart FlexPen and store the Insulin Aspart FlexPen without the needle attached (see diagram K).

Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.

How should I store Insulin Aspart FlexPen?

• Do notfreeze Insulin Aspart. Do notuse Insulin Aspart if it has been frozen.
• Keep Insulin Aspart away from heat or light.
• Store the Insulin Aspart FlexPen without the needle attached.
• Until first use:
• Store unused Insulin Aspart FlexPen in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Unused FlexPen may be used until the expiration date printed on the label, if kept in the refrigerator.
• Unused Insulin Aspart FlexPen stored at room temperature should be thrown away after 28 days.
• In-use:
• Store the FlexPen you are currently using out of the refrigerator at room temperature below 86°F (30°C) for up to 28 days.
• The Insulin Aspart FlexPen you are using should be thrown away after 28 days, even if it still has insulin left in it.

Maintenance

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

ΔRemove the needle from the Insulin Aspart 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.

ΔBe careful when handling used needles to avoid needle sticks and transfer of infectious diseases.

ΔKeep your Insulin Aspart FlexPen and needles out of the reach of children.

ΔUse Insulin Aspart FlexPen as directed to treat your diabetes.

Δ Do notshare your Insulin Aspart FlexPen or needles with other people. You may give other people a serious infection, or

get a serious infection from them.

ΔAlways use a new needle for each injection.

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

Nordisk.

ΔAs a precautionary measure, always carry a spare insulin delivery device in case your Insulin Aspart FlexPen is lost or damaged.

ΔRemember to keep the disposable Insulin Aspart 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.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Insulin Aspart

GENERIC: insulin aspart

DOSAGE: INJECTION, SOLUTION

ADMINSTRATION: INTRAVENOUS

NDC: 70518-3865-0

PACKAGING: 3 mL in 1 SYRINGE, PLASTIC

OUTER PACKAGING: 5 in 1 CARTON

ACTIVE INGREDIENT(S):

• INSULIN ASPART 100[iU] in 1mL

INACTIVE INGREDIENT(S):

• SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
• GLYCERIN
• HYDROCHLORIC ACID
• METACRESOL
• PHENOL
• SODIUM CHLORIDE
• SODIUM HYDROXIDE
• ZINC