Rotarix_Liquid

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Prescribing Information

INDICATIONROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.IMPORTANT SAFETY INFORMATIONContraindications for ROTARIX include a history of any of the following: hypersensitivity to the vaccine or any component of the vaccine; uncorrected congenital malformation of the gastrointestinal tract (such as Meckel’s diverticulum) that would predispose the infant to intussusception; intussusception (in postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose); or Severe Combined Immunodeficiency Disease (SCID)The tip caps of the prefilled oral dosing applicators contain natural rubber latex, which may cause allergic reactionsAdministration in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness in infants with chronic gastrointestinal disorders have not been evaluatedSafety and effectiveness in infants with known primary or secondary immunodeficiencies, including infants with human immunodeficiency virus (HIV), infants on immunosuppressive therapy, or infants with malignant neoplasms affecting the bone marrow or lymphatic system have not been establishedRotavirus shedding in stool occurs after vaccination with peak excretion occurring around Day 7 after Dose 1. One clinical trial demonstrated that vaccinees transmit vaccine virus to healthy seronegative contacts. Caution is advised when considering whether to administer ROTARIX to individuals with immunodeficient close contactsA study conducted after approval of ROTARIX showed an increased risk of intussusception in the 31 days after the first dose of ROTARIX, especially in the first 7 days. In other reports, an increased risk of intussusception has been observed within 7 days after dose 2Safety and effectiveness of ROTARIX when administered after exposure to rotavirus have not been evaluatedIn clinical studies, common (≥5%) solicited adverse reactions among recipients of ROTARIX included fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomitingSafety and effectiveness of ROTARIX in infants younger than 6 weeks or older than 24 weeks of age have not been evaluatedThe effectiveness of ROTARIX in pre-term infants has not been establishedVaccination with ROTARIX may not result in protection in all vaccine recipientsPlease see full Prescribing Information for ROTARIX.

*oral dosing applicator-only presentation

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ROTARIX (liquid formulation)* Digital Demonstration

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Terms of UseNovember 2022 Please read this agreement carefully. By downloading the App from an app store, you agree to adhere to these terms (“the Agreement”), which apply to your use of the application and any services accessible through it (unless otherwise indicated) (the “App”) provided by GlaxoSmithKline LLC (“GSK”). Your use of the App is also subject to any rules or policies applied by any app store provider or operator from whose site you downloaded the App. We do not sell the App to you and there is no price payable by you in the context of downloading or using the App. We remain the owners of the App at all times. This app is intended for US residents only. If you do not agree with the terms of this Agreement, you may not use the App.Changes GSK reserves the right, at its discretion, to change, modify, add or remove portions of these Terms of Use at any time. It is your responsibility to check these Terms of Use periodically for changes. Your continued use of the App constitutes your agreement to the Agreement and any updates without notice provided by GSK. You can always choose not to continue using the App if you do not agree to any terms.Safe and Appropriate Use While you are using our app, please be aware of your surroundings. You agree that in conjunction with your use of the App, you will maintain safe and appropriate contact with other people in the real world. You agree that your use of the app is at your own risk, and that you will not use the app to violate any applicable law, regulation, event policies, or instructions as outlined in these Terms of Use and you will not encourage or enable any other individual to do so.Our Responsibility and Limits on Our Responsibility The App has been developed as a service of GSK. Like any other service, despite our best efforts the information in the App may become out of date over time. GSK shall not be liable for any loss or damage resulting from use of, nor any failure to update, the information contained in the App. GSK is not liable for any direct or indirect damages, including but not limited to, damages for personal injury or lost data related to your use of the App. Your use of the App is at your own risk, but we do not exclude or limit in any way our liability to you where it would be unlawful to do so.Your Use of the App GSK only supplies the App for personal, non-commercial use by users, and we can revoke your right to use it (this is known as a limited, non-exclusive, nontransferable, revocable license).You may not: • use the App for any commercial, business or resale purposes, and we have no liability to you for any loss of profit, loss of business, business interruption, or loss of business opportunity; • rent, lease, sell, sublicense, assign, reverse engineer, disassemble, modify or transfer the App. You may not download the App in violation of any applicable laws or regulations; • use the App in any unlawful manner, for any unlawful purpose, or in any manner inconsistent with this Agreement, or act fraudulently or maliciously, for example by hacking into or inserting malicious viruses, or harmful data, in the App or any operating system; • infringe our intellectual property rights or those of any third party in relation to your use of the App; • transmit any material that is defamatory, offensive or otherwise objectionable in relation to your use of the App; use the App in any way that could damage, disable, overburden, impair or compromise our systems or security or interfere with other users; or collect or harvest any information or data from any of our systems or attempt to decipher or intercept any transmissions to or from the servers running the App.You also agree to comply with all technology control and/or export laws and regulations that apply to the technology used and/or supported by the App.GSK reserves the right to withdraw or amend the App without notice. GSK will not be liable if for any reason the App is unavailable at any time or for any period. GSK reserves the right, if you violate this Agreement, to suspend or terminate any account you have created on the App, or restrict your access to the App.Medical Information The App is not intended to be a medical or health device. The content in the App should not be construed as the giving of medical advice and it should not be used by itself to provide you with specific medical advice or recommendation. It is important that you rely only on the advice of a healthcare professional to advise you on your specific situation.Reporting of Side Effects If you have a side effect to report for the GSK product(s) that is the subject of the App—or for any other GSK product—please contact us using the form found at this website.Access and Service Fees To download, access and use the App as intended, you may need to access the Internet through devices that access Internet-based content and pay any service fees associated with such access and downloading.Operating System Requirements This app requires a minimum of 150 MB of memory on the following types of device.IOS: • Compatible with iPhone® 6s and above, with iOS Ver. 12.1 and above installed. • Not compatible with iPod Touch device. • Compatibility with tablet devices is not guaranteed. • Compatibility is not guaranteed for all devices.Android: • Compatible with Android devices that have 2 GB RAM or more and have Android Ver. 7.x and above installed. • Not compatible with Android devices that use Intel Atom processors. • Compatibility with tablet devices is not guaranteed. • Application may not run on certain devices even if they have compatible OS versions installed.Notes: • It is required to use while connected to a 3G/4G network in order to access certain content elements. • Compatibility information may be changed at any time on either iOS or Android platforms. • Compatibility is not guaranteed for all devices.Links to Third-Party Websites The App may provide links to, or embed, third-party websites that GSK does not control. This Agreement does not apply to those websites. If you choose to access such a linked site, you agree that GSK is not responsible for its availability and does not review or endorse and shall not be liable, directly or indirectly, for: • how these websites treat your personal information; • the content of such websites; • whether such websites are secure or virus-free; or • the use that others make of these websites.Links to third-party sites may be provided for the interest or convenience of users of the App. GSK assumes no responsibility for the content of non-GSK websites to which it provides links, and accepts no liability for any information or opinion contained in any third-party website or breach or omission in the privacy policies of third parties.Please ensure you check and agree with the legal and privacy statement(s) posted on any website you access before entering any personal information.Our Rights in the App The copyright in all material contained on, in, or available through the App including all information, data, text, music, sound, photographs, graphics, audiovisual combinations and videos, the selection and arrangement thereof, and all source code, software compilations and other material (“Material“) is owned by or licensed to the GlaxoSmithKline group of companies. All rights are reserved. You can view, print or download extracts of the Material for your own personal use but you cannot otherwise copy, edit, vary, reproduce, publish, display, distribute, store, transmit, commercially exploit, disseminate in any form whatsoever or use the Material without GSK’s express prior written permission.You acknowledge that all intellectual property rights in the App anywhere in the world belong to us or our licensors, that rights in the App are licensed (not sold) to you, and that you have no rights in, or to, the App other than the right to use it in accordance with the terms of this Agreement. You should assume that all trademarks appearing on this App, whether they appear in large print or with the trademark symbol, are trademarks of GSK, its affiliates, related companies, or its licensors or joint venture partners, unless otherwise indicated. You should assume that everything you see or read on this App is protected by copyright, or GSK has been granted permission to use it, unless otherwise noted and may not be used except as provided in this Agreement or without the written permission of GSK. No license to or right in any proprietary right of the GSK group of companies (including patents, trademarks and copyright) or any third party is granted to or conferred upon you by use of this App. The use or misuse of these trademarks, copyrights, or other materials, except as otherwise permitted herein, is expressly prohibited and may be in violation of copyright law, trademark law, or other laws, statutes or regulations. GSK claims no ownership in, nor any affiliation with, any third-party trademarks appearing on this App. Such third-party trademarks are used only to identify the products and services of their respective owners, and no sponsorship or endorsement on the part of GSK should be inferred from the use of these marks. You acknowledge that you have no right to have access to the App in source-code form. GSK does not maintain an obligation to provide technical support or maintenance for the App. The App is provided on an "as is" and "as available" basis. GSK does not make any warranty that the App will meet your requirements or that the use of the App will be uninterrupted, timely, secure or error free.Termination Your rights to use the App are effective until terminated by you or GSK, which may occur at any time. Upon termination the App must not be used and all copies must be permanently uninstalled.Resolution of Disputes If any dispute arises between you and GSK concerning these Terms of Use or your use of this site, it shall be resolved through good-faith negotiations. If such efforts prove unsuccessful, all controversies, claims, or disputes shall be submitted to binding arbitration (including pursuant to the Federal Arbitration Act, 9 U.S.C. §1 et seq.) for determination by a sole arbitrator. The International Institute for Conflict Prevention and Resolution Rules for Non-Administered Arbitration shall apply to the conduct of the hearing. The arbitration award shall be final and binding and may be confirmed and enforced in any court of competent jurisdiction. The parties shall bear equally the costs of the arbitration, but each party shall pay its own attorney’s fees incurred in connection with the arbitration or confirmation or enforcement of any award.Jurisdiction This Terms of Use Agreement and your use of the site shall be governed by the laws of the United States of America and the State of Delaware without regard to conflicts of law principles.

ROTARIX (liquid formulation)* Digital Demonstration

Terms of UseNovember 2022 Please read this agreement carefully. By downloading the App from an app store, you agree to adhere to these terms (“the Agreement”), which apply to your use of the application and any services accessible through it (unless otherwise indicated) (the “App”) provided by GlaxoSmithKline LLC (“GSK”). Your use of the App is also subject to any rules or policies applied by any app store provider or operator from whose site you downloaded the App. We do not sell the App to you and there is no price payable by you in the context of downloading or using the App. We remain the owners of the App at all times. This app is intended for US residents only. If you do not agree with the terms of this Agreement, you may not use the App.ChangesGSK reserves the right, at its discretion, to change, modify, add or remove portions of these Terms of Use at any time. It is your responsibility to check these Terms of Use periodically for changes. Your continued use of the App constitutes your agreement to the Agreement and any updates without notice provided by GSK. You can always choose not to continue using the App if you do not agree to any terms.Safe and Appropriate UseWhile you are using our app, please be aware of your surroundings. You agree that in conjunction with your use of the App, you will maintain safe and appropriate contact with other people in the real world. You agree that your use of the app is at your own risk, and that you will not use the app to violate any applicable law, regulation, event policies, or instructions as outlined in these Terms of Use and you will not encourage or enable any other individual to do so.Our Responsibility and Limits on Our ResponsibilityThe App has been developed as a service of GSK. Like any other service, despite our best efforts the information in the App may become out of date over time. GSK shall not be liable for any loss or damage resulting from use of, nor any failure to update, the information contained in the App. GSK is not liable for any direct or indirect damages, including but not limited to, damages for personal injury or lost data related to your use of the App. Your use of the App is at your own risk, but we do not exclude or limit in any way our liability to you where it would be unlawful to do so.Your Use of the AppGSK only supplies the App for personal, non-commercial use by users, and we can revoke your right to use it (this is known as a limited, non-exclusive, nontransferable, revocable license).You may not:• use the App for any commercial, business or resale purposes, and we have no liability to you for any loss of profit, loss of business, business interruption, or loss of business opportunity; • rent, lease, sell, sublicense, assign, reverse engineer, disassemble, modify or transfer the App. You may not download the App in violation of any applicable laws or regulations; • use the App in any unlawful manner, for any unlawful purpose, or in any manner inconsistent with this Agreement, or act fraudulently or maliciously, for example by hacking into or inserting malicious viruses, or harmful data, in the App or any operating system; • infringe our intellectual property rights or those of any third party in relation to your use of the App; • transmit any material that is defamatory, offensive or otherwise objectionable in relation to your use of the App; use the App in any way that could damage, disable, overburden, impair or compromise our systems or security or interfere with other users; or collect or harvest any information or data from any of our systems or attempt to decipher or intercept any transmissions to or from the servers running the App.You also agree to comply with all technology control and/or export laws and regulations that apply to the technology used and/or supported by the App.GSK reserves the right to withdraw or amend the App without notice. GSK will not be liable if for any reason the App is unavailable at any time or for any period. GSK reserves the right, if you violate this Agreement, to suspend or terminate any account you have created on the App, or restrict your access to the App.Medical InformationThe App is not intended to be a medical or health device. The content in the App should not be construed as the giving of medical advice and it should not be used by itself to provide you with specific medical advice or recommendation. It is important that you rely only on the advice of a healthcare professional to advise you on your specific situation.Reporting of Side EffectsIf you have a side effect to report for the GSK product(s) that is the subject of the App—or for any other GSK product—please contact us using the form found at this website.Access and Service FeesTo download, access and use the App as intended, you may need to access the Internet through devices that access Internet-based content and pay any service fees associated with such access and downloading.Operating System RequirementsThis app requires a minimum of 150 MB of memory on the following types of device. IOS: • Compatible with iPhone® 6s and above, with iOS Ver. 12.1 and above installed. • Not compatible with iPod Touch device. • Compatibility with tablet devices is not guaranteed. • Compatibility is not guaranteed for all devices. Android: • Compatible with Android devices that have 2 GB RAM or more and have Android Ver. 7.x and above installed. • Not compatible with Android devices that use Intel Atom processors. • Compatibility with tablet devices is not guaranteed. • Application may not run on certain devices even if they have compatible OS versions installed.Notes: • It is required to use while connected to a 3G/4G network in order to access certain content elements. • Compatibility information may be changed at any time on either iOS or Android platforms. • Compatibility is not guaranteed for all devices.Links to Third-Party WebsitesThe App may provide links to, or embed, third-party websites that GSK does not control. This Agreement does not apply to those websites. If you choose to access such a linked site, you agree that GSK is not responsible for its availability and does not review or endorse and shall not be liable, directly or indirectly, for: • how these websites treat your personal information; • the content of such websites; • whether such websites are secure or virus-free; or • the use that others make of these websites.Links to third-party sites may be provided for the interest or convenience of users of the App. GSK assumes no responsibility for the content of non-GSK websites to which it provides links, and accepts no liability for any information or opinion contained in any third-party website or breach or omission in the privacy policies of third parties.Please ensure you check and agree with the legal and privacy statement(s) posted on any website you access before entering any personal information.Our Rights in the AppThe copyright in all material contained on, in, or available through the App including all information, data, text, music, sound, photographs, graphics, audiovisual combinations and videos, the selection and arrangement thereof, and all source code, software compilations and other material (“Material“) is owned by or licensed to the GlaxoSmithKline group of companies. All rights are reserved. You can view, print or download extracts of the Material for your own personal use but you cannot otherwise copy, edit, vary, reproduce, publish, display, distribute, store, transmit, commercially exploit, disseminate in any form whatsoever or use the Material without GSK’s express prior written permission.You acknowledge that all intellectual property rights in the App anywhere in the world belong to us or our licensors, that rights in the App are licensed (not sold) to you, and that you have no rights in, or to, the App other than the right to use it in accordance with the terms of this Agreement. You should assume that all trademarks appearing on this App, whether they appear in large print or with the trademark symbol, are trademarks of GSK, its affiliates, related companies, or its licensors or joint venture partners, unless otherwise indicated. You should assume that everything you see or read on this App is protected by copyright, or GSK has been granted permission to use it, unless otherwise noted and may not be used except as provided in this Agreement or without the written permission of GSK. No license to or right in any proprietary right of the GSK group of companies (including patents, trademarks and copyright) or any third party is granted to or conferred upon you by use of this App. The use or misuse of these trademarks, copyrights, or other materials, except as otherwise permitted herein, is expressly prohibited and may be in violation of copyright law, trademark law, or other laws, statutes or regulations. GSK claims no ownership in, nor any affiliation with, any third-party trademarks appearing on this App. Such third-party trademarks are used only to identify the products and services of their respective owners, and no sponsorship or endorsement on the part of GSK should be inferred from the use of these marks. You acknowledge that you have no right to have access to the App in source-code form. GSK does not maintain an obligation to provide technical support or maintenance for the App. The App is provided on an "as is" and "as available" basis. GSK does not make any warranty that the App will meet your requirements or that the use of the App will be uninterrupted, timely, secure or error free.TerminationYour rights to use the App are effective until terminated by you or GSK, which may occur at any time. Upon termination the App must not be used and all copies must be permanently uninstalled.Resolution of DisputesIf any dispute arises between you and GSK concerning these Terms of Use or your use of this site, it shall be resolved through good-faith negotiations. If such efforts prove unsuccessful, all controversies, claims, or disputes shall be submitted to binding arbitration (including pursuant to the Federal Arbitration Act, 9 U.S.C. §1 et seq.) for determination by a sole arbitrator. The International Institute for Conflict Prevention and Resolution Rules for Non-Administered Arbitration shall apply to the conduct of the hearing. The arbitration award shall be final and binding and may be confirmed and enforced in any court of competent jurisdiction. The parties shall bear equally the costs of the arbitration, but each party shall pay its own attorney’s fees incurred in connection with the arbitration or confirmation or enforcement of any award.JurisdictionThis Terms of Use Agreement and your use of the site shall be governed by the law of the United States of America and the State of Delaware without regard to conflicts of laws principles.

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ROTARIX (liquid formulation) Digital Demonstration

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ROTARIX (liquid formulation) Digital Demonstration

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Prescribing Info

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ROTARIX (liquid formulation)* Digital Demonstration

Oral dosing applicator

ROTARIX (liquid formulation)* Digital Demonstration

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