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GLUCAGEN HYPOKIT- glucagon hydrochloride kit


  1. Patient Information
  2. Glucagen Is A Prescription Medicine Used:
  3. Who Should Not Use Glucagen?
  4. Before Using Glucagen, Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  5. How Should I Use Glucagen?
  6. While Using Glucagen Do Not:
  7. Glucagen May Cause Serious Side Effects, Including:
  8. The Most Common Side Effects Of Glucagen Include:
  9. Before You Mix The Glucagen Powder And Liquid:
  10. Active Ingredient:
  11. Inactive Ingredients:
  12. Important:
  13. After You Mix The Glucagen Powder And Liquid:
  14. Manufactured By:
  15. For Information Contact:

Patient Information 

[See FDA-Approved Patient Information and Instructions for Use.]

17.1 Physician Instructions

Refer patients and family members to the FDA-approved patient labeling for instructions describing the method of preparing and injecting GlucaGen. Advise the patient and family members to become familiar with the technique of preparing GlucaGen before an emergency arises. Instruct patients to use 1 mg for adults or the adult dose (0.5 mg) for children weighing less than 55 lb (25 kg). To prevent severe hypoglycemia, patients and family members should be informed of the symptoms of mild hypoglycemia and how to treat it appropriately. Family members should be informed to arouse the patient as quickly as possible because prolonged hypoglycemia may result in damage to the central nervous system. Patients should be advised to inform their physician each time a hypoglycemic reaction occurs so that the treatment regimen may be adjusted if necessary.

No studies on the effects on the ability to drive and use machines have been performed. After diagnostic procedures, hypoglycemia has been reported infrequently. The patient s ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating machinery. Therefore, these activities should be avoided until the patient has had intake of oral carbohydrates.

Date of issue: July 6, 2018

Version: 9

GlucaGenand HypoKitare registered trademarks of Novo Nordisk A/S

1998-2018 Novo Nordisk

For information contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536, USA
1-800-727-6500
www.novonordisk-us.com

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

Glucagen Is A Prescription Medicine Used: 

to treat very low blood sugar (severe hypoglycemia) in people with diabetes who use insulin.

Who Should Not Use Glucagen? 

Do not use GlucaGenif:

you are allergic to glucagon or lactose or any of the ingredients in GlucaGen.

Before Using Glucagen, Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

have kidney problems.
have pancreas problems. Tumors in your pancreas called glucagonomas.
have not had food or water for a long time (prolonged fasting or starvation).
have low blood sugar that does not go away (chronic hypoglycemia).
have heart problems.
are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed. It is not known if GlucaGen passes into your breast milk.

Tell your doctor about all the medicines you take,including prescription and over the counter medicines, vitamins and herbal supplements. GlucaGenmay affect the way other medicines work, and other medicines may affect how GlucaGenworks. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How Should I Use Glucagen? 

Read the detailedInstructions for Usethat come with GlucaGen.
Use GlucaGen exactly as your doctor tells you to.
Make sure that you and your family know how to use GlucaGen the right way before you need it.
Act quickly. Having very low blood sugar for a period of time may be harmful.
Call for emergency medical help right after you use GlucaGen.
Eat sugar or a sugar-sweetened product such as a regular soft drink or fruit juice as soon as you are able to swallow.
Tell your doctor each time you use GlucaGen. Your doctor may need to change the dose of your diabetes medicines.

1

While Using Glucagen Do Not: 

drive or operate machinery until you have eaten sugar or a sugar-sweetened product such as a regular soft drink or fruit juice.

What are the possible side effects of

Glucagen May Cause Serious Side Effects, Including: 

High blood pressure. High blood pressure is common after taking GlucaGen and can be severe.
Low blood sugar. GlucaGen can cause low blood sugar in patients with tumors in their pancreas called insulinomas and glucagonomas by making too much insulin in their bodies.
Allergic reactions.Symptoms of a serious allergic reaction to GlucaGen may include rash, difficulty breathing, or low blood pressure (hypotension).

The Most Common Side Effects Of Glucagen Include: 

nausea
vomiting
temporary fast heartbeat or pounding in your chest (tachycardia).

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of GlucaGen. For more information, ask your doctor or pharmacist. 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

Before You Mix The Glucagen Powder And Liquid: 

Store GlucaGen at room temperature between 68 F to 77 F (20 C to 25 C) for up to 24 months (2 years).
Check the expiration date on your vial of GlucaGen. Do not use GlucaGen if the expiration date has passed.
Do not freeze GlucaGen.
Keep GlucaGen in its original package, and keep GlucaGen out of light.

Active Ingredient: 

glucagon

Inactive Ingredients: 

lactose monohydrate andsterile water for reconstitution

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

GlucaGenand HypoKitare registered trademarks of Novo Nordisk A/S; 1998-2018 Novo Nordisk.

For more information, go to www.novonordisk-us.com or call 1-800-727-6500.

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

Revised: April 18, 2018

Instructions for Use

GlucaGen(Gl -ka-Gen)

(glucagon) for injection

HypoKit

Read this Instructions for Use before you start using GlucaGen and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor or pharmacist if you have any questions about how to use GlucaGen.

Important: 

Read and become familiar with this Instructions for Use before an emergency happens.
Show your family members and others where you keep your GlucaGen HypoKit and how to use it the right way.
Call for emergency medical help right after you use GlucaGen.
Do not share your GlucaGen syringes or needles with another person. You may give other people a serious infection or other people may get a serious infection from you.
The prefilled syringe that comes with your GlucaGen HypoKit is meant for use with GlucaGen only. Do not use GlucaGen syringes to inject other medicines.

After You Mix The Glucagen Powder And Liquid: 

Use GlucaGen right away.
Throw away any unused GlucaGen.
Do not use GlucaGen if a gel has formed, or if you

Put used syringes in a FDA-cleared sharps disposal container right away after use.Do not throw away (dispose of) loose needles and syringes in your household trash.
If you do not haveaFDA-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 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.

Keep GlucaGen and all medicines out of the reach of children.

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

Manufactured By: 

Novo Nordisk A/S

2880 Bagsvaerd, Denmark

GlucaGenand HypoKitare registered trademarks of Novo Nordisk A/S

1998-2018 Novo Nordisk

For Information Contact: 

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

1-800-727-6500

www.novonordisk-us.com

Revised: April 18, 2018



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