Legal Notice and Privacy Policy

Legal/Privacy

Thank you for visiting our website. Amedra Pharmaceuticals LLC maintains this site for general informational and educational purposes. You should read this Legal Notice and Privacy Policy before using this website. By using this website, you agree to abide by the following terms and conditions. If you do not accept these conditions, do not use this website. Amedra may change this Privacy Policy and User Agreement (Agreement) from time to time, based upon any changes to our website and our users' experience on it.

Privacy Policy

Amedra Pharmaceuticals LLC respects the privacy of visitors to all of our websites. This Privacy Policy ("policy") describes how we handle personal information collected in connection with our public web sites. We have established this policy to protect the content of our websites, including all information provided by users of our websites, from unauthorized access, disclosure, or release. In this policy, the term "personally identifiable information" means information that identifies, or can be used to identify, an individual.

Aggregate Data

Like most standard web servers, we may use log files and outside services to collect certain usage information, such as the number and frequency of visitors to this website. This includes internet protocol (IP) addresses, browser type, internet service provider (ISP), referring/exit pages, platform type, date/time stamp, and number of clicks to analyze trends, administer the site, track user's movement in the aggregate, and gather broad demographic information for aggregate use. If we use such data at all, it will be on an aggregate basis, and we will not disclose to third parties any information that could be used to identify you personally. No personally identifiable information is collected in this process. We do not employ cookies. Our objective is to monitor the quality of the user experiences on our websites. IP addresses and other log information are not linked to personally identifiable information.

Personally Identifiable Information

If you voluntarily submit information to our websites, for example, in a request for general information, we may record and use any personally identifiable information, such as your name, phone number and e-mail address, for reasonable business purposes including, but not limited to, fulfilling your request. We will not use your personally identifiable information for any other purpose without your permission.

We may use internal service providers to operate our websites and employ other persons to perform work on our behalf, such as sending postal mail and e-mail. These persons may have access to the personally identifiable information you submit through the website, but only for the purpose of performing their duties. These persons may not use your personally identifiable information for any other purpose.

We will not sell, share, or rent collected information to others in ways different from what is disclosed in this policy.

We will not provide any personally identifiable information to any other persons, except if we are required to make disclosures to the government or private parties by law enforcement authorities or in connection with a lawsuit, subpoena or other court order, investigation or similar proceeding. We can (and you authorize us to) disclose any such information in those circumstances.

Security

We maintain reasonable precautions designed to ensure the security of personal information covered by this Policy, and to protect such personal information from loss, misuse or unauthorized access, alteration, destruction or disclosure. Although we make every effort to ensure security of such information, no data transmission over the Internet can be guaranteed to be 100% secure.

User Agreement

Restrictions on Use

Any person using this website is permitted to copy and print individual website pages for non-commercial purposes. Users may also copy or print minimal copies of any research or reports posted on the site solely for informational, non-commercial use. These copies must not alter the original website content, including all legal notices and legends. Our prior permission is required for (i) any commercial use of materials on this website; (ii) making more than minimal copies of website materials; and (iii) copying large portions of our website, such as by bots, robots or spiders that "harvest" the website. If you seek permission for such use of our website, please contact us.

Linking and Framing

We do not permit others to frame this website or any portion thereof.

Please note that this Privacy Policy and User Agreement applies only to this website and not to other websites that may be accessible from this website via hyperlink. Certain links in this website may lead to resources or other sites owned and operated by third parties over whom we have no control. We are responsible only for the content of our own website, and we make no representations or warranties as to the accuracy of, or any other aspect relating to, those third-party resources. We encourage you to review the privacy policies and user agreements of all other websites that you visit.

Ownership

All content included on this website, such as graphics, logos, articles and other materials, is the property of our organization or others and is protected by copyright and other laws. All trademarks and logos displayed on this website are the property of their respective owners, who may or may not be affiliated with our organization.

Submissions

As our website indicates, we welcome your questions about us. Please be advised that any comments, suggestions, ideas or other information that you send to us through our website will not be treated as confidential, and that we will own and have the right to use them as we choose, without payment to you.

Medical Information

This website and the information contained in it is intended to provide general information on a particular subject or subjects and is not an exhaustive treatment of such subjects. Among other subjects, our websites may include general information regarding medical conditions and their treatment. This information is provided for informational purposes only and is not intended to provide professional advice or meant to be a substitute for advice from a doctor. Patients should not use the information contained in this website to diagnose any health care issue or disease. Patients should consult with their doctor for medical advice, diagnosis and treatment.

International Use

Due to the global nature of the Internet, this website may be accessed by users in countries other than the United States. We make no warranties that materials on this website are appropriate or available for use in such locations outside of the United States. If it is illegal or prohibited in your country of origin to access or use this website, then you should not do so. Those who choose to access this site outside the United States do so on their own initiative and are responsible for compliance with all local laws and regulations.

Limitations of Liability

We are not responsible for any damages or injury, including but not limited to special or consequential damages, that result from your use of (or inability to use) this website, including any damages or injury caused by any failure of performance, error, omission, interruption, defect, delay in operation, computer virus, line failure, or other computer malfunction. You acknowledge that we provide the contents of this website on an "as is" basis, and that we make no express or implied representations or warranties of any kind regarding this website. Your use of this website and use or reliance upon any of the materials on it is solely at your own risk. We make no representations or warranties as to the merchantability, fitness for a particular purpose, or completeness of the information available on this website.

Governing Law

You agree that your use of this website, this Privacy Policy and User Agreement and any disputes relating to any of them shall be governed in all respects by the laws of the State of New Jersey. Any dispute relating to the above shall be resolved solely in the state or federal courts located in New Jersey.

Effective Date of Policy: June 2012

INDICATION:

Twinject (epinephrine injection, USP 1:1000) is indicated in the emergency treatment of severe allergic reactions (Type I) including anaphylaxis to stinging insects (e.g. order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g. triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g. radiocontrast media), and other allergens, as well as anaphylaxis to unknown substancess (idiopathic anaphylaxis) or exercise-induced anaphylaxis. Twinject is intended for immediate administration in patients with a history of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to patient body weight (See DOSAGE AND ADMINISTRATION section). Such reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema. Twinject is designed as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.

IMPORTANT SAFETY INFORMATION ABOUT TWINJECT:

Twinject should only be injected into the anterolateral aspect of the thigh. Accidental injection into the hands or feet may result in loss of blood flow to the affected area and should be avoided.

If there is an accidental injection into these areas, advise the patient to inform the healthcare provider of the accidental injection when he/she goes to the nearest emergency room for further treatment of anaphylaxis. Avoid possible inadvertent intravascular administration. Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to a sharp rise in blood pressure. DO NOT INJECT INTRAVENOUSLY. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration.

Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium bisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations, even if the patient is sulfite-sensitive.

Epinephrine should be administered with caution to patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In patients with coronary insufficiency or ischemic heart disease, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. It should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute life-threatening situation.

Epinephrine is light sensitive and should be stored in the carrying-case provided. Store at room temperature (20°-25°C/68°-77°F) with excursions permitted to 15°-30°C (59°-86°F). Do not refrigerate; protect from freezing. Patients should periodically check the solution in Twinject for any discoloration and/or precipitates. If the solution is discolored or contains a precipitate, the patient should replace their Twinject.

Twinject is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek appropriate medical care. More than two sequential doses of epinephrine should only be under direct medical supervision. Twinject is not suitable for patients, or caregivers, with such disabilities as severe debilitating arthritis of the hands, because the use of this product requires some manual dexterity to administer. IN ALL CASES, THE PHYSICIAN SHOULD INSTRUCT THE PATIENT AND/OR ANY OTHER PERSON WHO MIGHT BE IN A POSITION TO ADMINISTER THE EPINEPHRINE, IN THE PROPER USE OF Twinject.

Epinephrine is essential for the treatment of anaphylaxis. Patients with a history of severe allergic reactions should be instructed about the circumstances under which epinephrine should be used. It should be determined that the patient is at risk of future anaphylaxis, since there are some concerns in specific patients with epinephrine administration. (a) Epinephrine should be used with caution in patients with cardiac arrhythmias, coronary artery or organic heart disease, hypertension, or in patients who are on medications that may sensitize the heart to arrhythmias, e.g., digitalis, diuretics, or anti-arrhythmics. In such patients, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. (b) The effects of epinephrine may be potentiated by tricyclic antidepressants and monoamine oxidase inhibitors. (c) Some patients may be at greater risk of developing adverse reactions after epinephrine administration. These include patients with hyperthyroidism, cardiovascular disease, hypertension, diabetes, and elderly individuals, and pregnant women. It must be noted that, despite these concerns, epinephrine is essential for the treatment of anaphylaxis. Therefore, patients with these conditions, or any other person who might be in a position to administer epinephrine to a patient with these conditions experiencing anaphylaxis, should be instructed about the circumstances under which epinephrine should be used.

Drug Interactions

Patients who receive epinephrine while concomitantly taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias.

The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, sodiumlevothyroxine, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine. The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as propranolol. The vasoconstricting and hypertensive efffects are antagonized by alpha-adrenergic blocking drugs, such as phentolamine. Ergot alkaloids and phenothiazines may also reverse the pressor effects of epinephrine.

Pregnancy

Pregnancy Category C. Epinephrine has been shown to have developmental effects in rabbits at a subcutaneous dose of 1.2 mg/kg (approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis), in mice at a subcutaneous dose of 1 mg/kg (approximately 7 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis), and in hamsters at a subcutaneous dose of 0.5 mg/kg (approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis). These effects were not seen in mice at a subcutaneous dose of 0.5 mg/kg (approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis). Although there are no adequate and well-controlled studies in pregnant women, epinephrine crosses the placenta and could lead to fetal anoxia, spontaneous abortion or both. Therefore, epinephrine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Since the doses of epinephrine delivered from Twinject are fixed, the physician should consider other forms of injectable epinephrine if doses lower than those available from Twinject are felt to be necessary (e.g., patients who weigh less than 15 kilograms approximately 33 pounds). IN ALL CASES, THE PHYSICIAN SHOULD INSTRUCT THE PATIENT AND/OR ANY OTHER PERSON WHO MIGHT BE IN A POSITION TO ADMINISTER THE EPINEPHRINE, IN THE PROPER USE OF TWINJECT.

ADVERSE REACTIONS

Adverse reactions to epinephrine include transient, moderate anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache, and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism. Large doses of epinephrine can cause acute hypertension. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see (3) Drug Interactions]. Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Angina may occur in patients with coronary artery disease. The potential for epinephrine to produce these types of adverse reactions does not contraindicate its use in an acute, life-threatening allergic reaction.

Twinject is a patient (or caregiver) actuated, dual-dose product that contains 1.1 mL of epinephrine injection, USP (1:1000 or 1 mg/mL), of which an initial dose can be delivered by auto-injection, and a second dose is available by manual administration. THE REMAINING VOLUME THAT IS LEFT AFTER THESE TWO FIXED DOSES CANNOT BE FURTHER ADMINISTERED AND SHOULD BE DISCARDED WITH THE DEVICE AS OUTLINED IN THE PATIENT INFORMATION LEAFLET.

Please see complete prescribing information for more details.

Your doctor can give you more information about Twinject or call 1-888-894-6528. Ask your doctor if Twinject may be right for you.

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.

This web site and its contents are intended for use only by residents of the United States. Products discussed may have different labeling, regulatory requirements, and/or medical practices in other countries that may require reference to different or additional information.