8. Advantages of IM Injections. Autoject 2 Self-injection Device Use with fixed needle syringes. As an added security precaution, we deploy various methods of protection such as host intrusion prevention and detection systems to maintain the integrity and confidentiality of data. Please note that, while we make reasonable efforts to comply with such requests, deletion of your personal information does not ensure complete and comprehensive removal of that data from all systems. Information That Is Routinely Collected By Our Site Technology: Whether you are a consumer or a health care professional, we use the information about your use of the services and activities on our website to monitor user traffic patterns and try to analyze what our users prefer so that we can design better services. (E) Hold the auto-injector firmly in place for at least 10 seconds to allow the injection to finish. These devices are designed around conventional single dose pre-filled syringes, which is a primary drug container, offering ease of transition for potential pharmaceutical partners. Antares is committed to protecting the privacy of users of this website located at www.antarespharma.com or any website owned, operated, licensed or controlled by us (the “Site”). Needle Guide Assistant for Self-Injection and Medical Care Intramuscular⦠We also may use a third party verification provider to verify your identity. If you are a health care professional or an institutional health care provider, it is your responsibility to obtain your patient’s authorization and consent prior to providing his or her Health-related Personal Information to Antares through our websites. Use with fixed needle syringes. Makena Auto-Injector is HCP administered. American Medical Association. The product continues to remain available to patients and prescribers. Quarterly healthcare common procedure coding system (HCPCS) drug/biological code changesâ2017 update. If you do not wish to receive emails or other communications from us, you may contact us at [email protected] and request that your Personal Information be removed from our list. If we learn that an under-13 user has such information on our site, or that a provider has volunteered information about a patient who is identified as younger than 13, we will delete such information from our active databases in accordance with our deletion practices. Personal Information. Competitive Advantages of VIBEX® and QuickShot® Disposable Auto Injectors. Am J Obstet Gynecol. If we allow a third party contractor to have access to your Personal Information or health-related personal information, we will not authorize them to take it or use it for any purpose that is not consistent with this Privacy Statement. AMAG Pharmaceuticals, Makena, Makena Care Connection, and the logo designs presented in this material are trademarks or registered trademarks of AMAG Pharmaceuticals, Inc. or its subsidiaries. To fulfill our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests. 6. Chicago, IL: American Medical Association; 2016. Needle-free delivery eliminates the risk of needlestick injuries as well, which occur frequently in institutions in the U.S., and can result in disease transmission to healthcare workers. We have begun to scale up tooling and molds for potential commercial scale production. B12 automatical medicine injector enable useres with reduced physical abillities to inject thenself with their Medicine. There may be some confusion in the healthcare community about the current status of Makena. Corporate Governance and Committee Charters, Reduces psychological barriers since the patient never sees the needle, Reliable subcutaneous or intramuscular injection, Designed around conventional pre-filled syringes. We are developing products based on the VIBEX® QS system, including the VIBEX® QS T for delivery of testosterone as replacement therapy in men who have testosterone deficiency, VIBEX® QS M with an undisclosed drug for treatment of a CNS indication, and VIBEX® QS for use with the progestin hormone drug Makena® used to lower the risk of preterm birth. Swing and push the auto-injector firmly until it âclicks.â The click signals that the injection has started. The primary goal of the VIBEX® and QuickShot® disposable pressure assisted auto injector platforms is to provide a fast, safe, and time-efficient methods of self-injection. If at any point, we decide to use personally identifiable information or health-related personal information in a manner different from that stated at the time it was collected, you will be given a choice to allow or disallow any additional uses or disclosures of your personally identifiable information or health-related personal information. 2012;206(5):376-386. AMAG Pharmaceuticals is not responsible for the information contained in any of the linked third-party sites. Please see full Prescribing Information for Makena. The new b12 injector includes both intramuscular and subcutaneous injection ⦠Please see Instructions for Use before administering Makena using the subcutaneous autoâinjector. Auto-Injector: 30 kg or greater: 0.3 mg IM or subcutaneously into anterolateral aspect of thigh; repeat as needed Comments:-The manufacturer product information for the specific auto ⦠Only some categories of information identify you directly, but each category offers some information about your interests and activities that could be used to make inferences about you. ©2019 AMAG Pharmaceuticals, Inc. All rights reserved. This Privacy Policy applies solely to the information that we collect through the Site. In addition, we will use commercially reasonable efforts not to disclose any personal information stored in a non-erasable format after receiving your request for removal, except as required by law. We have signed two license agreements with Teva for our VIBEX® system. Each EpiPen autoinjector delivers a single dose of 0.3 mg epinephrine by injection ⦠Since uniform standards for “Do Not Track” signals have not yet been adopted, Antares does not process or respond to “Do Not Track” signals. Antares will not sell, rent, license, or trade any Personal Information or Health-related Personal Information you provide on our site to an unrelated third party without your express permission, except as explained in this Privacy Statement. EVZIO is not made with natural rubber latex. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. Am J Obstet Gynecol. Remove the auto-injector from the thigh. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. Marketed by AMAG Pharmaceuticals, Inc. Waltham, MA 02451 If you do not have an account with us, we may ask for your email address, other forms of identification information. Concealment of the needle also guards against accidental injury. You are now leaving makenahcp.com. The AtroPen Auto-Injector is indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides. 2018 Table of Drugs. This is because when certain medications, vitamins, and hormones are taken ⦠Makena Care Connection can be reached at 1-800-847-3418 (MâF, 8AMâ8PM ET) or by emailing [email protected]. If you have any questions, we welcome you to contact AMAG Pharmaceuticals at 1-877-411-2510 or by emailing [email protected]. Fitted with safety ⦠Personal Information That You Voluntarily Provide. However, needle-free devices may be commercially limited due to the high cost of the product and the need for consumable disposables. The patented retracting collar springs back and locks in place as a protective needle guard after the injection, making the device safe for general disposal. Watch video To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. Centers for Medicare and Medicaid Services, US Department of Health and Human Services. One of these agreements is for a product containing epinephrine and the other is for sumatriptan. Summary: Intramuscular injection is recommended for fast adrenaline effect. Stevanato Group and Duoject Medical Systems are developing a reliable and user-friendly auto-injector ⦠The design of the QuickShot® platform also accommodates fast injection of highly viscous drug products that stall less-powerful conventional auto injectors. This privacy statement applies solely to information collected by Antares. The EpiPen and EpiPen Jr autoinjectors contain 2 mL of epinephrine injection for emergency intramuscular use. The injectors were initially designed to overcome the hesitation associated ⦠Chemically, naloxone hydrochloride is the ⦠The needles of some currently available auto-injectors are too short to reach the thigh muscle in many patients. Pressure assisted auto injection is a form of parenteral drug delivery that continues to gain acceptance among the medical and patient community. The ergonomic, ⦠Needle-free injection combines proven delivery technology for molecules that require parenteral administration with a device that eliminates the part of the injection that patients dislike – the needle. B12 automatical medicine injector enable useres with reduced physical abillities to inject thenself with their Medicine. Autoject 2 Self-injection Device. Society for Maternal-Fetal Medicine Publications Committee. Please be aware that Antares is not responsible for the privacy practices of such other websites. VIBEX® QS is designed to enhance performance on the attributes most critical to patient acceptance—speed, comfort and discretion. We have designed disposable, pressure assisted auto injector devices to address acute and chronic medical needs, such as rheumatoid arthritis and psoriasis, allergic reactions, migraine headaches, acute pain and other undisclosed therapies. If you have any questions about this Privacy Policy, or about the use, amendment, or deletion of Personal Information that you have provided to us, please contact us at [email protected]. The Site may contain links to other websites. Transmittal 3776. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (“Antares”). Our latest advancement in our proprietary line of VIBEX ® auto injectors is the VIBEX® QS auto injector system which offers a dose capacity of 1 mL and greater in a compact design. 3. We have signed a license agreement with Teva for our pen injector device for two products: an undisclosed pen device under development for use in U.S. and Europe, and an exenatide pen which has an ANDA under active review at the FDA. Autoject ® 2 auto-injector devices conceal the syringe and needle and enable effective drug delivery at a touch of a button. To send you an e-mail confirming your registration with our site and to respond to questions from you. Epinephrine injection, USP auto-injector 0.3 mg and 0.15 mg is an auto-injector and a combination product containing drug and device components. Hold firmly in place for 3 seconds (count slowly 1, 2, 3). https://www.cms.gov/âMedicare/âCoding/âHCPCSReleaseCodeSets/âDownloads/â2018-Table-of-Drugs.pdf. True auto-injector: Needle hidden before injection: Safety lock to prevent accidental activation: Visual end-of-dose indication: Needle shield removal feature: Fixed dose: Syringe type: Glass pre-filled or ⦠2007;110(4):865-872. VIBEX® QS achieves these advancements by incorporating a novel triggering mechanism and space-saving spring configuration. At this time, it is important to know that Makenaâs approval and product label remain unchanged. Women receiving Makena should be monitored if they: Have conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction, Have a history of clinical depression; Makena should be discontinued if depression recurs, Develop jaundice; consider whether benefit of use warrants continuation, Certain pregnancy-related fetal and maternal complications or events were numerically increased in Makena-treated subjects as compared to placebo subjects, including miscarriage (2.4% vs. 0%) and stillbirth (2% vs. 1.3%), admission for preterm labor (16% vs. 13.8%), preeclampsia or gestational hypertension (8.8% vs. 4.6%), gestational diabetes (5.6% vs. 4.6%), and oligohydramnios (3.6% vs. 1.3%), In a study where the Makena intramuscular injection was compared with placebo, the most common adverse reactions reported with Makena intramuscular injection (reported incidence in â¥2% of subjects and higher than in the control group) were: injection site reactions (pain [35%], swelling [17%], pruritus [6%], nodule [5%]), urticaria (12%), pruritus (8%), nausea (6%), and diarrhea (2%), In studies where the Makena subcutaneous injection using auto-injector was compared with Makena intramuscular injection, the most common adverse reaction reported with Makena Auto-Injector use (and higher than with Makena intramuscular injection) was injection site pain (10% in one study and 34% in another). All Rights Reserved. The majority of these molecules have not, to date, been amenable to oral administration due to a combination of several factors, including breakdown in the gastrointestinal tract, fundamentally poor absorption, or high first pass liver metabolism. An intramuscular (IM) dose of 0.3 to 0.5 mg of EPINEPHrine is recommended for anaphylaxis in adults, but no comparative trials have been conducted to determine which dose is most clinically effective. The Personal Information and Health-related Personal Information that you provide may be used to create customized offers, information, and services tailored to your interests and preferences. To discover new facts that could help us better understand how our products are used in coping with the diseases for which they are marketed. Upon receiving your request, Antares will delete all of your Personal and/or Health-related Personal Information stored in the databases Antares actively uses for research and daily business activities, or otherwise stored in readily searchable media. Choose the most effective delivery system Disposable line. You may report an adverse event related to AMAG Pharmaceuticals’ products by calling 1-877-411-2510 or emailing [email protected]. We have implemented appropriate security measures, including encryption practices, to prevent your Personal Information and Health-related Personal Information from being accidentally lost, used or accessed in an unauthorized way, altered or disclosed. Designed for ease of use, the FDAâapproved Makena subcutaneous autoâinjector is: Proper injection technique for Makena subcutaneous auto-injector. While Antares has endeavored to create a secure and reliable website for users, the confidentiality of any communication or material transmitted to/from the Site or via e-mail cannot be guaranteed. Each epinephrine injection, USP auto ⦠If you submit health-related personal information through our website to participate in a clinical trial, we may use that information to assess whether you qualify for enrollment in the trial, to contact you about potential participation in the trial, and to provide you with additional information about the trial. 2017 ed. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. In order to minimize the anxiety and perceived pain associated with injection-based technologies, the VIBEX® and QuickShot® systems feature a triggering collar that shields the needle from view. The most frequently prescribed auto-injector ⦠4. Society for Maternal-Fetal Medicine Publications Committee. To perform the contract we are about to enter into or have entered into with you. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. The security of your data is very important to Antares. Place tip of the auto-injector on the skin at a 90-degree angle; Press button to release medication Hold for 10 seconds; May feel a slight pinch and tingling as the medication goes in; ⦠By using the Site, you signify your acceptance of this Privacy Policy. DESCRIPTION EVZIO (naloxone hydrochloride injection, USP) is a pre-filled, single-use auto-injector. The choice of progestogen for the prevention of preterm birth in women with singleton pregnancy and prior preterm birth. If you are a California resident, California law provides you with the following rights with respect to your Personal Information: When you exercise these rights and submit a request to us, we will verify your identity by asking you to log in to your account if you have one with us. PP-MKN-US-00558 05/19, Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history. 2. Do not use Makena in women with any of the following conditions: Current or history of thrombosis or thromboembolic disorders, Known or suspected breast cancer, other hormone-sensitive cancer or history of these conditions, Undiagnosed abnormal vaginal bleeding unrelated to pregnancy, Liver tumors, benign or malignant, or active liver disease, Makena should be discontinued if thrombosis or thromboembolism occurs, Allergic reactions, including urticaria, pruritus and angioedema, have been reported with use of Makena or with other products containing castor oil. American Medical Association. The new b12 injector includes both intramuscular and subcutaneous injection specially ⦠III. When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. Your exercise of these rights will have no adverse effect on the price and quality of our services. 5. Depending on dose, our pens can hold up to thirty days of drug dosing. 7. Intramuscular delivery into the anterolateral aspect of the thigh is recommended for optimal onset of action of epinephrine. ©2020 AMAG Pharmaceuticals, Inc. All rights reserved. The special tip is designed to reduce the sensation of pain at injection. This easy-to-follow instructional video reviews the proper technique for administering Makena for subcutaneous use. Please be aware that Antares may not comply with a consumer’s request to amend or remove information that was provided to Antares by a health care professional or a consumer regarding an adverse drug event. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Centers for Medicare and Medicaid Services, US Department of Health and Human Services website. Tailor - made to fit your choice of syringe. This site ©2020 Antares Pharma. VIBEX ® QS is designed ⦠Packaged 1 auto-injector ⦠All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. Why Makena Auto-Injector? Our proprietary VIBEX® and QuickShot® disposable auto injector systems combine a spring-based power source with a shielded needle, which delivers the needed drug solution subcutaneously or intramuscularly. No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. Learn More. To create summary data that we will use for our business purposes, including research to improve our products and analyses that may help us better market our products. Chicago, IL: American Medical Association; 2016. References: 1. Our latest advancement in our proprietary line of VIBEX® auto injectors is the VIBEX® QS auto injector system which offers a dose capacity of 1 mL and greater in a compact design. By submitting any such information, you represent and warrant that you have obtained your patient’s authorization to do so. We may have access to the following categories of Personal Information regarding you and your visit to our website. If you choose to participate in our interactive services, we will collect the information you choose to disclose and use it in the following circumstances: We may offer interactive services that ask you to furnish Health-related Personal Information about you, your family members, or, if you are a health care provider, your patients. It is also recognized that greater willingness to accept injection therapy could have a beneficial impact on disease outcomes. You control the rate at which the medicine is injected. Baltimore, MD: Centers for Medicare and Medicaid Services; 2017. We will only use your Personal Information when the law allows us to. (F) Remove the AtroPen ® and massage the injection site for several seconds. ⦠Makena® (hydroxyprogesterone caproate injection) prescribing information, AMAG Pharmaceuticals, 2018. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. As you work through the evolving guidance from the CDC in response to the COVID-19 pandemic, please know our team at Makena Care Connection remains available to support your office and your patients. 1: Auto-Injector: Intramuscular: Active ingredient: Hydroxyprogesterone caproate: Hydroxyprogesterone caproate: Concentration: 250 mg/mL: 250 ⦠Minors under 18 years of age may have the Personal Information that they have provided to Antares through the Site deleted by sending an email to [email protected] requesting deletion. AUTOJECT® EI - FIXED NEEDLE INJECTOR MOST SUITED FOR TRIMIX-BIMIX-QUADMIX Intracavernosal Penile Injections(1) Raised trigger button for firing(2) Window showing the injection is completed(3) ⦠... Administration Type Intramuscular injection. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088. A military autoinjector in use An autoinjector (or auto-injector) is a medical device designed to deliver a dose of a particular drug. The needle size for intramuscular ⦠If you are a health care provider and you submit health-related personal information about a patient in order for them to participate in a clinical trial, that information will be maintained in accordance with this Privacy Statement. Encompassing a wide variety of sizes and designs, this technology operates by using pressure to force the drug, in solution or suspension, through the skin and deposits the drug into the subcutaneous tissue. The information you disclose and provide in interactive services may be linked (pursuant to all applicable laws) with the Personal Information you may choose to provide elsewhere on our site and together this may provide us with Personal Information about your health and health care. The right to know what personal information we have collected, used, disclosed and sold about you. If you have concerns of therapy disruptions for your patients, please call Makena Care Connection. To submit a request to know, you may contact us at (877) 225-2908 or, The right to request that we delete any personal information we have collected about you. If you do not agree to the terms of this Privacy Policy, please do not use the Site. The need to back-up our systems to protect information from inadvertent loss means that a copy of information about you or your health-related interests may exist in non-erasable forms that will be difficult or impossible for us to locate. To customize your site experience by anticipating the information and services that may be of interest to you. Obstet Gynecol. When considering needle length, select a needle that is long enough to reach the appropriate site of subcutaneous or intramuscular tissue to optimize immune response and to reduce the risk of injection site reactions. Improving patient comfort through needle-free injection may increase compliance and mitigate the problem of daily injections. Another example of a user-centric device that has experienced much market success is the Emerade ® Auto Injector, an intuitive disposable two-step auto injector designed to deliver adrenaline for emergency use via intramuscular injection⦠One of the primary factors influencing development in the category of needle-free injection is the inherent problematic dependence on needles. This Privacy Policy describes how we gather and use information about visitors to our Site (“Visitors”). Simultaneously inserts needle and delivers medications. ⦠Please review the site's Privacy Policy and Terms of Use, as AMAG's policies do not apply to third-party sites. Northen AT, Norman GS, Anderson K. et al; Follow-up of children exposed in utero to 17 α-hydroxyprogesterone caproate compared with placebo. To personalize content provided on the website. Simple, versatile autoinjector takes the anxiety out of injecting. Last updated October 24, 2017. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. ICD-10-CM: The Complete Official Codebook. More Than Makena. If we determine that your patient is eligible for the trial, we will use the information you submit to contact you about your patient’s potential participation in the trial and to provide you with additional information. Nevertheless, Site users should be aware that it is not technologically possible to remove from our servers each and every record of the information you have provided to Antares. Download, per state laws on the Makena Prescription Form and submit to Makena Care Connection, the importance of drug + support provided only by Makena with your patients, in your prescribing decision to help ensure patients receive Makena + support when pharmacists ask about generic substitution, Personalized Patient Support.
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