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FIASP- insulin aspart injection injection, solution


  1. Patient Information
  2. What Is Fiasp?
  3. Do Not Take Fiasp If You:
  4. Before Taking Fiasp, Tell Your Healthcare Provider About All Your Medical Conditions Including, If You:
  5. How Should I Take Fiasp?
  6. While Taking Fiasp Do Not:
  7. Fiasp May Cause Serious Side Effects That Can Lead To Death, Including:
  8. Your Insulin Dose May Need To Change Because Of:
  9. Common Side Effects Of Fiasp May Include:
  10. Active Ingredient:
  11. Inactive Ingredients:
  12. Supplies You Will Need To Give Your Fiasp Injection:
  13. Before Use:
  14. Pen In Use:
  15. General Information About The Safe And Effective Use Of Fiasp:
  16. Manufactured By:
  17. Penfill Cartridges In Use:

Patient Information 

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

Never Share a FIASP FlexTouch Pen Device, PenFill Cartridge or PenFill Cartridge Device Between Patients

Advise patients that they should never share a FIASP FlexTouch pen device, 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 FIASP 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)].

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 FIASP 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[seeWarnings 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.

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions have occurred with FIASP. Inform patients on the symptoms of hypersensitivity reactions[seeWarnings and Precautions(5.6)].

Hypoglycemia due to Medication Errors

Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products.

Women of Reproductive Potential

Advise patients to inform their health care professional if they are pregnant or are contemplating

pregnancy.

Administration

FIASP must only be used if the solution is clear and colorless with no particles visible.

Patients must be advised that FIASP must NOT be diluted or mixed with any other insulin or solution[seeDosage and Administration(2.1)].

Instruct patients on basal-bolus treatment who forget a mealtime dose to monitor their blood glucose level to decide if an insulin dose is needed, and to resume their usual dosing schedule at the next meal.

Date of Issue: 09/2018

Version: 3

Novo Nordisk, FIASP, NovoLog, FlexTouch, and PenFillare registered trademarks of Novo Nordisk A/S.

PATENT Information: http://novonordisk-us.com/patients/products/product-patents.html

2018 Novo Nordisk A/S

Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark

For information about FIASP contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
1-800-727-6500
www.novonordisk-us.com

What Is Fiasp? 

FIASP is a man-made insulin that is used to control high blood sugar in adults with diabetes mellitus.
It is not known if FIASP is safe and effective in children.

Do Not Take Fiasp If You: 

are having an episode of low blood sugar (hypoglycemia).
have an allergy to insulin aspart or any of the ingredients in FIASP.

Before Taking Fiasp, Tell Your Healthcare Provider About All Your Medical Conditions Including, If You: 

have kidney problems.
have liver problems.
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. It is not known if FIASP passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while using FIASP.
are taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.

Before you start taking FIASP, talk to your healthcare provider about low blood sugar and how to manage it.

How Should I Take Fiasp? 

Read the Instructions for Usethat come with your FIASP.
Take FIASP exactly as your healthcare provider tells you to.
FIASP starts acting fast.You should take your dose of FIASP at the beginning of the meal or within 20 minutes after starting a meal.
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.
If you miss a dose of FIASP, monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal.
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 needles with other people. You may give other people a serious infection or get a serious infection from them.

While Taking Fiasp Do Not: 

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

Fiasp 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
low potassium in your blood (hypokalemia).
serious allergic reactions (whole body reactions).Get emergency medical help right away, if you have any of these signs or symptoms of a severe allergic reaction:
a rash over your whole body, trouble breathing, a fast heartbeat, swelling of your face, tongue or throat, sweating, extreme drowsiness, dizziness, confusion.
heart failure.Taking certain diabetes pills called TZDs(thiazolidinediones) with FIASP 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 FIASP. Your healthcare provider should monitor you closely while you are taking TZDs with FIASP. 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 FIASP may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Common Side Effects Of Fiasp May Include: 

skin problems such as eczema, rash, itching, redness and swelling of your skin (dermatitis)
reactions at the injection site such as itching, rash
skin thickening or pits at the injection site (lipodystrophy)
weight gain

These are not all the possible side effects of FIASP. 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 FIASP.

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

Active Ingredient: 

insulin aspart

Inactive Ingredients: 

glycerol, phenol, metacresol, zinc, disodium phosphate dihydrate, arginine hydrochloride, niacinamide and water for injections

Supplies You Will Need To Give Your Fiasp Injection: 

a 10 mL FIASP vial
a U-100 insulin syringe and needle
2 alcohol swabs
1 sharps container for throwing away used needles and syringes.

Do notfreeze FIASP.Do notuse FIASP if it has been frozen.
Keep FIASP away from excessive heat or light.
Store unopened FIASP vials in the refrigerator at 36F to 46F (2C to 8C) or at room temperature below 86F (30C).
Store opened FIASP vials in the refrigerator at 36F to 46F (2C to 8C) or at room temperature below 86F (30C).
Unopened FIASP vials may be used until the expiration date printed on the label, if they are kept in the refrigerator.
If FIASP vials are stored at room temperature prior to first use, they should be used or thrown away within 28 days.
Opened FIASP vials should be thrown away after 28 days, even if they still have insulin left in them.

General information about the safe and effective use of FIASP

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

Before Use: 

Store unused FIASP FlexTouch Pens in the refrigerator at 36 F to 46 F (2 C to 8 C) or at room temperature below 86F (30C).
Do notfreeze FIASP.Do notuse FIASP if it has been frozen.
Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator.
If FIASP FlexTouch Pens are stored at room temperature prior to first use, it should be used or thrown away within 28 days.

Pen In Use: 

Store the Pen you are currently using without the needle attached at room temperature below 86 F (30 C) or in the refrigerator at 36 F to 46 F (2 C to 8 C) for up to 28 days.
Keep FIASP away from excessive heat or light.
The FIASP FlexTouch Pen you are using is to be thrown away after 28 days, even if it still has insulin left in it and the expiration date has not passed.

General Information About The Safe And Effective Use Of Fiasp: 

Keep FIASP FlexTouch Pens and needles out of the reach of children.
Always use a new needle for each injection.
Do notshare FIASP FlexTouch Pens or needles with other people. You may give other people a serious infection, or get a serious infection from them.

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

Manufactured By: 

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

Revised: 09/2018

OR code

For more information go to

www.FIASPflextouch.com

2018 Novo Nordisk

Fiasp FlexTouch Pen

Instructions for Use

Fiasp(fee asp) PenFill3 mL cartridge 100 Units/mL (U-100)

(insulin aspart injection)

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 FIASP the right way before you inject it for the first time.
FIASP PenFillcartridge 100 Units/mL is a prefilled cartridgecontaining 300 units of U-100 FIASP (insulin aspart injection).
After you insert the PenFill cartridge in your device, you can use it for multiple injections. Read theinstruction manualthat comes with your insulin delivery device for complete instructions on how to use the PenFill cartridge with the device.
This PenFill cartridge is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product and your insulin delivery device.
If using anewFIASP PenFill cartridge, start withStep 1.
If the FIASP PenFill cartridge has already beenused, start withStep 2.

Penfill Cartridges In Use: 

Store the PenFill cartridgeyou are currently using in the insulin delivery device at room temperature below 86 F (30 C) for up to 28 days. Do not refrigerate.
Keep FIASP away from heat or light.
The FIASP 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 FIASP.

Keep FIASP PenFill cartridges and needles out of the reach of children.
Do notshare FIASP PenFill cartridgesor 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.

2018 Novo Nordisk



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