EPIPEN JR Dailymed

Spl Patient Package Insert Section

PATIENT INFORMATION and INSTRUCTIONS FOR USE

EPIPEN (epinephrine) Auto-Injector 0.3 mg Epipen = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3 mL) EPIPEN JR (epinephrine) Auto-Injector 0.15 mg Epipen Jr = one dose of 0.15 mg epinephrine (USP, 1:2000, 0.3 mL) ^{® ® ® ®}

For allergic emergencies (anaphylaxis)

Patient Information

Read this Patient Information Leaflet carefully before using the EpiPen or EpiPen Jr Auto-Injector and each time you get a refill. There may be new information. You, your parent, caregiver, or others who may be in a position to administer EpiPen or EpiPen Jr Auto-Injector, should know how to use it before you have an allergic emergency. ^{® ®}

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about the EpiPen and EpiPen Jr?

• EpiPen and EpiPen Jr contain, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening, can happen with minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes. 1.
• Symptoms of anaphylaxis may include:  
• • trouble breathing •
  • wheezing •
  • hoarseness (changes in the way your voice sounds) •
  • hives (raised reddened rash that may itch) •
  • severe itching •
  • swelling of your face, lips, mouth, or tongue •
  • skin rash, redness, or swelling •
  • fast heartbeat •
  • weak pulse •
  • feeling very anxious •
  • confusion •
  • stomach pain •
  • losing control of urine or bowel movements (incontinence) •
  • diarrhea or stomach cramps •
  • dizziness, fainting, or “passing out” (unconsciousness) •
• 2. Always carry your EpiPen or EpiPen Jr with you because you may not know when anaphylaxis may happen.
• Talk to your healthcare provider if you need additional units to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your EpiPen or EpiPen Jr and how to use it before you need it. You may be unable to speak in an allergic emergency.  
• 3. When you have an allergic emergency (anaphylaxis)
  • • Use EpiPen or EpiPen Jr right away.
  • You may need further medical attention. You may need to use a second EpiPen or EpiPen Jr if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode. • Get emergency medical help right away.

What are EpiPen and EpiPen Jr?

• EpiPen and EpiPen Jr are disposable, prefilled automatic injection devices (auto-injectors) used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Each device contains a single dose of epinephrine. •
• EpiPen and EpiPen Jr are for immediate self (or caregiver) administration and do not take the place of emergency medical care. You should get emergency help right away after using EpiPen and EpiPen Jr. •
• EpiPen and EpiPen Jr are for people who have been prescribed this medicine by their healthcare provider. •
• The EpiPen Auto-Injector (0.3 mg) is for patients who weigh 66 pounds or more (30 kilograms or more). •
• The EpiPen Jr Auto-Injector (0.15 mg) is for patients who weigh about 33 to 66 pounds (15 to 30 kilograms). •
• It is not known if EpiPen and EpiPen Jr are safe and effective in children who weigh less than 33 pounds (15 kilograms). •

What should I tell my healthcare provider before using the EpiPen or EpiPen Jr?

  Before you use EpiPen or EpiPen Jr, tell your healthcare provider about all your medical conditions, but especially if you:

• have heart problems or high blood pressure •
• have diabetes •
• have thyroid problems •
• have asthma •
• have a history of depression •
• have Parkinson’s disease •
• have any other medical conditions •
• are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby. •
• are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breast milk. •

, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider of all known allergies. Tell your healthcare provider about all the medicines you take

Especially tell your healthcare provider if you take certain asthma medicines.

EpiPen or EpiPen Jr and other medicines may affect each other, causing side effects. EpiPen or EpiPen Jr may affect the way other medicines work, and other medicines may affect how EpiPen or EpiPen Jr works.

Know the medicines you take. Keep a ul of them to show your healthcare provider and pharmacist when you get a new medicine.

Use your EpiPen or EpiPen Jr for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicines you take.

How should I use EpiPen and EpiPen Jr?

• Each EpiPen or EpiPen Jr Auto-Injector contains only 1 dose of medicine. •
• EpiPen or EpiPen Jr should be injected into the middle of your outer thigh (upper leg). It can be injected through your clothing if needed. •
• Read the Instructions for Use at the end of this Patient Information Leaflet about the right way to use EpiPen and EpiPen Jr. •
• Your healthcare provider will show you how to safely use the EpiPen or EpiPen Jr Auto-Injector. •
• Use your EpiPen or EpiPen Jr exactly as your healthcare provider tells you to use it. You may need to use a second EpiPen or EpiPen Jr if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode. •
• The needle comes out of the orange tip. Accidental injection into finger, hands or feet may cause a loss of blood flow to these areas. Tell the healthcare provider where on your body you received the accidental injection. • Caution: Never put your thumb, fingers, or hand over the orange tip. Never press or push the orange tip with your thumb, fingers, or hand. If this happens, go immediately to the nearest emergency room.
• Your EpiPen and EpiPen Jr Auto-Injector may come packaged with an EpiPen Trainer and separate Trainer Instructions for Use. Periodically practice with your EpiPen Trainer before an allergic emergency happens to make sure you are able to safely use the real EpiPen and EpiPen Jr Auto-Injector in an emergency. Always carry your real EpiPen or EpiPen Jr Auto-Injector with you in case of an allergic emergency. Additional training resources are available at www.epipen.com. • The EpiPen Trainer has a grey color. The grey EpiPen Trainer contains no medicine and no needle.
• Do not drop the carrier tube or auto-injector. If the carrier tube or auto-injector is dropped, check for damage and leakage. Dispose of the auto-injector and carrier tube, and replace if damage or leakage is noticed or suspected. •

What are the possible side effects of the EpiPen and EpiPen Jr?

EpiPen and EpiPen Jr may cause serious side effects.

• inject the EpiPen or EpiPen Jr into your: • The EpiPen or EpiPen Jr should only be injected into the middle of your outer thigh (upper leg). Do not
  • veins o
  • buttocks o
  • fingers, toes, hands, or feet o
• If you accidentally inject EpiPen or EpiPen Jr into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.  
• Talk to your healthcare provider about all your medical conditions. • If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your EpiPen or EpiPen Jr.

Common side effects of EpiPen and EpiPen Jr include:

• fast, irregular or “pounding” heartbeat •
• sweating •
• headache •
• weakness •
• shakiness •
• paleness •
• feelings of over exclient, nervousness or anxiety •
• dizziness •
• nausea or vomiting •
• breathing problems •

These side effects may go away with rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of the EpiPen or EpiPen Jr. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store EpiPen and EpiPen Jr?

• Store EpiPen and EpiPen Jr at room temperature between 68° to 77° F (20° to 25° C). •
• Protect from light. •
• expose to extreme cold or heat. For example,   store in your vehicle’s glove box and   store in the refrigerator or freezer. • Do not do not do not
• Examine the contents in the clear window of your auto-injector periodically. The solution should be clear. If the solution is discolored (pinkish or brown color) or contains solid particles, replace the unit. •
• Always keep your EpiPen or EpiPen Jr Auto-Injector in the carrier tube to protect it from damage; however, the carrier tube is not waterproof. •
• The blue safety release helps to prevent accidental injection. Keep the blue safety release on until you need to use EpiPen or EpiPen Jr. •
• Your EpiPen or EpiPen Jr has an expiration date. Replace it before the expiration date. •

Keep EpiPen and EpiPen Jr and all medicines out of the reach of children.

General information about the safe and effective use of EpiPen and EpiPen Jr:

Medicines are sometimes prescribed for purposes other than those uled in a Patient Information Leaflet. Do not use the EpiPen or EpiPen Jr for a condition for which it was not prescribed. Do not give your EpiPen or EpiPen Jr to other people.

This Patient Information Leaflet summarizes the most important information about EpiPen and EpiPen Jr. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about EpiPen and EpiPen Jr that is written for health professionals.

For more information and video instructions on the use of EpiPen and EpiPen Jr, go to or call 1-800-395-3376. www.epipen.com

What are the ingredients in EpiPen and EpiPen Jr?

• Epinephrine   Active Ingredients:
• sodium chloride, sodium metabisulfite, hydrochloric acid, and water.   Inactive Ingredients:

Important Information

• • The EpiPen Auto-Injector has a yellow colored label.
• • The EpiPen Jr Auto-Injector has a green colored label.
• • The EpiPen Trainer has a grey color and contains no medicine and no needle.
• • Your auto-injector is designed to work through clothing.
• • The blue safety release on the EpiPen and EpiPen Jr Auto-Injector helps to prevent accidental injection of the device. Do not remove the blue safety release until you are ready to use it.
• • Only inject into the middle of the outer thigh (upper leg). Never inject into any other part of the body.
• • Never put your thumb, fingers, or your hand over the orange tip. The needle comes out of the orange tip.
• • If an accidental injection happens, get medical help right away.
• • Do not place patient information or any other foreign objects in the carrier tube with the Auto-Injector, as this may prevent you from removing the Auto-Injector for use.

Instructions for Use

EPIPEN (epinephrine) Auto-Injector 0.3 mg Epipen = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3 mL) EPIPEN JR (epinephrine) Auto-Injector 0.15 mg Epipen Jr = one dose of 0.15 mg epinephrine (USP, 1:2000, 0.3 mL) ^{® ® ® ®}

For allergic emergencies (anaphylaxis)

Read these Instructions for Use carefully before you use EpiPen or EpiPen Jr. Before you need to use your EpiPen or EpiPen Jr, make sure your healthcare provider shows you the right way to use it. Parents, caregivers, and others who may be in a position to administer EpiPen or EpiPen Jr Auto-Injector should also understand how to use it as well. If you have any questions, ask your healthcare provider.

Your EpiPen and EpiPen Jr Auto-Injector

A dose of EpiPen or EpiPen Jr requires 3 simple steps: Prepare, Administer and Get emergency medical help ^®

Step 1. Prepare EpiPen or EpiPen Jr for injection

	Remove the EpiPen or EpiPen Jr from the clear carrier tube.
	Flip open the yellow cap of your EpiPen or the green cap of your EpiPen Jr carrier tube.
	Tip and slide the auto-injector out of the carrier tube.
	Grasp the auto-injector in your fist with the orange tip pointing downward. With your other hand, without bending or twisting it remove the blue safety release by pulling straight up .

•   Note:
• The needle comes out of the orange tip. •
• To avoid an accidental injection, never put your thumb, fingers or hand over the orange tip. If an accidental injection happens, get medical help right away •

  Step 2. Administer EpiPen or EpiPen Jr

	Hold the auto-injector with orange tip near the middle of the outer thigh (upper leg). until it ‘clicks’. Keep the auto-injector firmly pushed against the thigh at a 90° angle (perpendicular) to the thigh. Swing and firmly push the orange tip against the middle of the outer thigh
	to deliver the medicine. The injection is now complete. Hold firmly against the thigh for approximately 10 seconds
	The orange tip will extend to cover the needle. Remove the auto-injector from the thigh.
	Massage the injection area for 10 seconds.

You may need further medical attention. You may need to use a second EpiPen or EpiPen Jr Auto-Injector if symptoms continue or recur. Step 3. Get emergency medical help now.

• Take your used auto-injector with you when you go to see a healthcare provider. •
• Tell the healthcare provider that you have received an injection of epinephrine. Show the healthcare provider where you received the injection. •
• Give your used EpiPen or EpiPen Jr Auto-Injector to the healthcare provider for inspection and proper disposal. •
• Ask for a refill, if needed. •

Note:

• The used auto-injector with extended needle cover will not fit in the carrier tube. •
• EpiPen and EpiPen Jr are single-use injectable devices that deliver a fixed dose of epinephrine. The auto-injector cannot be reused. It is normal for most of the medicine to remain in the auto-injector after the dose is injected. The correct dose has been administered if the orange needle tip is extended and the window is blocked. •
• Your EpiPen and EpiPen Jr Auto-Injector may come packaged with an EpiPen Trainer and separate Trainer Instructions for Use. The EpiPen Trainer has a grey color. The grey EpiPen Trainer contains no medicine and no needle. Practice with your EpiPen Trainer, but always carry your real EpiPen or EpiPen Jr Auto-Injector in case of an allergic emergency. •
• Do not try to take the EpiPen or EpiPen Jr Auto-Injector apart. •

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

Manufactured for:

Mylan Specialty L.P., Morgantown, WV 26505, U.S.A. by Meridian Medical Technologies, Inc., Columbia, MD 21046, U.S.A., a Pfizer company

EpiPen and EpiPen Jr are registered trademarks of Mylan Inc. licensed exclusively to its wholly-owned affiliate, Mylan Specialty L.P. of, Morgantown, WV 26505, U.S.A. ^{® ®}

2014 by Meridian Medical Technologies, Inc. ^©

Revised: April 2014

EPIP-N:R00

EpiPen (Epinephrine) Auto-Injector 0.3 mg ^®

EpiPen Jr (Epinephrine) Auto-Injector 0.15 mg ^®

MyEpiPen.com

Register your EpiPen or EpiPen Jr Auto-Injector at and find out more about: MyEpiPen.com

• Free EpiPen Auto-Injector . It is important to keep your auto-injector up-to-date. • Refill Reminder Program

Register up to 6 EpiPen or EpiPen Jr Auto- Injectors and receive automatic . Refill Reminder Alerts

• Receive periodic information related to allergies and allergens. •
• Instructional Video •

For more information about EpiPen or EpiPen Jr Auto-Injectors and proper use of the product, call Mylan at 1-877-446-3679 or visit . www.epipen.com

EpiPen Trainer Instructions for Use

In an emergency: Do not use the grey Trainer. Use your real yellow EpiPen or green EpiPen Jr Auto-Injector. ^{® ®}

Important Information

• • The Trainer label has a grey color.
• • The Trainer contains no medicine and no needle.
• Periodically practice with the grey colored Trainer before an allergic emergency (anaphylaxis) happens to make sure you are able to safely use the real yellow EpiPen or green EpiPen Jr Auto-Injector in case of an emergency. •
• Always carry your real yellow EpiPen or green EpiPen Jr Auto-Injector in case of an allergic emergency. •

The EpiPen Trainer

Familiarize yourself with this grey Trainer. Practice until you are comfortable using it.

Your grey colored Trainer:

• Never put your thumb, other fingers, or hand over the Orange Tip. •
• The Orange Tip is where the needle comes out of your EpiPen or EpiPen Jr Auto-Injector. •

Practice Instructions
Grasp the grey Trainer in your fist with the orange tip pointing downward.

With your other hand, without bending or twisting it.

remove blue safety release by pulling straight up

Removing the blue safety release unlocks the Trainer.

until it ‘clicks.’ Keep the Trainer firmly pushed against the thigh at a 90º angle (perpendicular) to the thigh.

Swing and firmly push the orange tip against the middle of the outer thigh Hold firmly against the thigh for approximately 10 seconds.

and massage the injection area for 10 seconds. The orange tip automatically extends out after use.

Remove the Trainer from the thigh

In an actual emergency, you would need to seek medical help right away

The actual auto-injector is made to work through clothing

Do not inject into any other part of the body

Place the orange tip on a hard surface

Squeeze the sides of the orange tip and push down on the Trainer with the other hand

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	the Trainer for Simulated Injection 1 Prepare
	2 Administer the Trainer Simulation
	Hold the Trainer with the orange tip near the middle of the outer thigh (upper leg).
	Note:
	3 To reset the Trainer
	Put the blue safety release back on the Trainer

Note: With the real yellow EpiPen or green EpiPen Jr Auto-Injector, the orange tip covers the needle after self-injection to help protect you from accidentally sticking yourself or others.

Practice Session Information

In case of an allergic emergency, use the real yellow EpiPen or green EpiPen Jr Auto-Injector and not the grey Trainer.

Follow instructions above. Repeat as often as needed until you are able to self-inject quickly and correctly.

Reread:

• These Trainer Instructions for Use •
• The “Patient Information” that comes with your EpiPen or EpiPen Jr Auto-Injector •

Train others who could help you in an emergency:

• Your parents, caregivers, and others who may be in a position to administer EpiPen or EpiPen Jr should know how to help you during an allergic emergency (anaphylaxis). Before an emergency occurs, have them: •
  • Practice activating the Trainer o
  • Read these Trainer Instructions and the “Patient Information” o

For more information about the EpiPen and EpiPen Jr Auto-Injector and the proper use of the products, go to www.epipen.com.

Caution:

Important differences between the Trainer and your real yellow EpiPen or green EpiPen Jr Auto-Injector

	TRAINER (Grey)	EpiPen (Yellow)	EpiPen Jr (Green)
Contains medication?	NO	YES	YES
Has needle?	NO	YES	YES
Comes in Carrier Tube?	NO	YES	YES
Color of Label	Grey	Yellow	Green
Has expiration date?	NO	YES	YES
Can be reused?	YES	NO (use only once)	NO (use only once)
Okay to remove and replace safety release?	YES	NO (remove just once before use)	NO (remove just once before use)
Pressure needed to hold against thigh?	Moderate	Strong	Strong

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

Manufactured for Mylan Specialty L.P., Morgantown, WV 26505, U.S.A. by Meridian Medical Technologies, Inc., Columbia, MD 21046, U.S.A., a Pfizer company

EpiPen and EpiPen Jr are registered trademarks of Mylan Inc. licensed exclusively to its wholly-owned affiliate, Mylan Specialty L. P. of Morgantown, WV 26505, U.S.A. ^{® ®}

• ©2014 by Meridian Medical Technologies, Inc.  
• Revised: April 2014  

EPIP-TN:R00