PITTSBURGH, Feb. 23, 2015 /PRNewswire/ -- Mylan Specialty, the full integrated specialty pharmaceutical business of Mylan Inc. (NASDAQ: MYL), today announced it will present new study results at the 2015 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in Houston. Three poster presentations will include analyses of results from an exploratory, cross-sectional, web-based survey of schools participating in the EpiPen4Schools® program. A fourth poster presentation evaluates epinephrine auto-injector design as it impacts human factors of efficient drug delivery in children.
“Anaphylaxis is a serious and often unpredictable health problem in the U.S., particularly among children and adolescents,” said Roger D. Graham, President, Mylan Specialty. “The EpiPen4Schools® survey results provide information regarding anaphylaxis management in schools, and it is our hope that it contributes to the growing body of data related to this important issue. There have been too many tragedies reinforcing that when anaphylaxis occurs, every minute matters, and immediate access to epinephrine and emergency medical care is crucial. Mylan is committed to continuing our leadership role in supporting those at increased risk for anaphylaxis in the school setting and beyond. We are pleased to see legislative efforts continue to enhance access to epinephrine, and we look forward to supporting future efforts toward improved access, ultimately advancing the understanding and management of anaphylaxis.”
The EpiPen4Schools® program, launched in 2012, provides four free EpiPen® or EpiPen Jr® (epinephrine injection) Auto-Injectors to qualifying* schools.
Presentations to be featured during the meeting include:
- EpiPen4Schools® Survey
- EpiPen4Schools® Survey: Characteristics of Anaphylaxis and Common Triggers
Poster 684, Feb. 23, 2015; 10:45-11:45 a.m. ET
Explores findings from a survey of schools participating in the EpiPen4Schools® program during the 2013-2014 school year to assess the characteristics of anaphylactic events and associated allergic triggers.
- Epinephrine Administration for Cases of Anaphylaxis in a U.S. School Setting: Results From the EpiPen4Schools® Survey
Poster 685, Feb. 23, 2015; 10:45-11:45 a.m. ET
Reviews results from the survey of reported anaphylactic events and treatment(s) administered at each responding school during the 2013-2014 school year. - Occurrence of Anaphylaxis by School Grade Level and Staff Training: Findings From the EpiPen4Schools® Survey
Poster 686, Feb. 23, 2015; 10:45-11:45 a.m. ET
Examines characteristics of anaphylactic events including grade level and frequency of food-related triggers and staff preparedness to respond to such events in schools that participated in the program during the 2013-2014 school year.
- EpiPen4Schools® Survey: Characteristics of Anaphylaxis and Common Triggers
- Designing Auto-Injectors for Children: Effect of Form Factor on the Human Factors of Efficient Drug Delivery
Poster 678; Feb. 23, 2015; 10:45-11:45 a.m. ET
Evaluates the design of three different types of epinephrine auto-injectors (cylindrical, elliptical and prismatic), against their effect on human factors of efficient drug delivery (application force, force angle and grip ergonomics) in children.
Session details and full abstracts for the 2015 AAAAI Annual Meeting can be found on the AAAAI meeting website at http://annualmeeting.aaaai.org/.
*A school will only receive EpiPen® Auto-Injectors in accordance with all applicable laws. The school must submit a valid prescription in order to qualify for this program. There is no requirement for a school to purchase additional EpiPen® or EpiPen Jr® Auto-Injectors or any other Mylan products.
Indications
EpiPen® (epinephrine injection) 0.3 mg and EpiPen Jr® (epinephrine injection) 0.15 mg Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. EpiPen® and EpiPen Jr® are intended for immediate administration as emergency supportive therapy only. Seek immediate emergency medical help right away.
Important Safety Information
EpiPen® and EpiPen Jr® Auto-Injectors contain a single dose of epinephrine, which you (or your caregiver or others who may be in a position to administer EpiPen® or EpiPen Jr®) inject into the middle of your outer thigh (upper leg) (through clothing, if necessary). Get emergency medical help right away. You may need further medical attention. Only a health care professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. DO NOT INJECT INTO YOUR VEINS, BUTTOCKS, FINGERS, TOES, HANDS OR FEET. In case of accidental injection, please seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.
Tell your doctor if you have certain medical conditions such as asthma, depression, thyroid disease, Parkinson’s disease, diabetes, high blood pressure or heart disease, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your doctor all the medicines you take, especially medicines for asthma. 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 EpiPen® or EpiPen Jr®.
The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea or vomiting, difficulty breathing, paleness, dizziness, weakness, shakiness, headache, apprehension, nervousness or anxiety. These side effects may go away if you rest. Tell your health care professional if you have any side effect that bothers you or that does not go away.
Please see the full Prescribing Information and Patient Information.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For additional information, please contact us at 800-395-3376.
About Anaphylaxis
Anaphylaxis is a life-threatening allergic reaction that has many possible triggers, occurs quickly, without warning, and must be treated immediately with epinephrine. Symptoms may include hives, swelling or redness of the skin, tightness in the throat, nausea, dizziness, breathing problems, a decrease in blood pressure and/or fainting. Anaphylaxis can be caused by triggers, such as food, stinging and biting insects, medicines, latex or even exercise. While symptoms of an allergic reaction vary from person to person, reactions can quickly progress to become life-threatening.
An epinephrine auto-injector, such as EpiPen® Auto-Injector, should be given at the first sign of anaphylaxis, followed by seeking immediate emergency medical care. Antihistamines do not relieve the life-threatening symptoms of anaphylaxis. Delays in epinephrine administration have been associated with negative health consequences, even possibly death.
About EpiPen® (epinephrine injection) Auto-Injector
EpiPen® (epinephrine injection) and EpiPen Jr® (epinephrine injection) Auto-Injectors are used for the emergency treatment of life-threatening allergic reactions. Each EpiPen 2-Pak® and EpiPen Jr 2-Pak® contains two single auto-injectors, instructions for use and an EpiPen® Trainer, with no drug or needle, to help patients become familiar with the administration technique. EpiPen® Auto-Injector should be administered immediately at the first sign of an anaphylactic reaction. EpiPen® Auto-Injector is not a substitute for emergency medical treatment. Patients should seek emergency medical attention immediately following administration. EpiPen® Auto-Injector has been the No. 1 prescribed epinephrine auto-injector in the U.S. for more than 25 years and has a simple, three-step administration process. For more information about EpiPen® Auto-Injector, please visit www.EpiPen.com.
About Mylan Specialty
Mylan Specialty, a subsidiary of Mylan Inc. (NASDAQ: MYL), is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, life-threatening allergic reactions and psychiatric disorders. For more information, please visit mylanspecialty.com.
About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 25,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. Learn more at mylan.com
EpiPen®, EpiPen Jr®, EpiPen 2-Pak® and EpiPen Jr 2-Pak® are registered trademarks of Mylan Inc. licensed exclusively to its wholly-owned subsidiary, Mylan Specialty L.P.
EpiPen4Schools® is a registered trademark of Mylan Inc.
© 2015 Mylan Specialty L.P. All rights reserved.
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SOURCE Mylan Inc.
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