Sanofi Pasteur Product Monograph 284 - Menactra Page 1 of 42 PRODUCT MONOGRAPH Menactra Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Solution for Injection Active Immunizing Agent for the Prevention of Meningococcal Disease ATC Code: J07AH Sanofi Pasteur Limited Toronto, Ontario, Canada If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. Stability modeling for vaccines represents a key resource to predict stability based on accelerated stability studies; nevertheless, this approach is not fully exploited for these kinds of products. (:reu$YT)D>$doZn Download the temperature report from the digital data logger. Provided below is guidance specific to diphtheria, tetanus, and pertussis vaccines. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. Antigenicity predictions at +5 C are displayed as blue lines based on n, Antigenicity predictions of vaccine using a classical linear regression (left column) and non-linear regression (i.e., advanced kinetics, right column) of 6 months data points (full circles). Vaccine should be marked do not use and moved to the alternate site after verifying that the alternate unit is at the proper temperature. The .gov means its official.Federal government websites often end in .gov or .mil. . They help us to know which pages are the most and least popular and see how visitors move around the site. 2023 Pfizer. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Prefilled Syringe, 1 Dose (1 per package) NDC 0005-1971-05. This field is for validation purposes and should be left unchanged. Quarantine exposed vaccine and label as "DO NOT USE." Store vaccines under proper conditions, as quickly as possible. Store the vaccine at the appropriate temperature, Consult the vaccine manufacturer and/or your state or local immunization program for guidance. It relies on good hygiene and vaccination as the emergence of drug-resistant strains makes treatment more complex. The .gov means its official.Federal government websites often end in .gov or .mil. Tel: 0800 035 2525. The toolkit was revised in 2021 with an addendum addressing COVID-19 vaccines. 1981;9:185194. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 169199. This is likely because of the complexity and diversity of vaccines, as well as the limited availability of dedicated guidelines or illustrative case studies. The products discussed herein may have different product labeling in different countries. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Biopharm. When vaccines are removed from storage, clinicians and other health-care providers should note whether an expiration window exists for vaccine stored at room temperature or at an intermediate temperature. Live vaccines should be repeated after a 28-day interval from the invalid dose to reduce the risk for interference from interferon on the subsequent doses. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly by visiting www.fda.gov/medwatch or by calling (800)-332-1088. Would you like email updates of new search results? Accessed January 2018. These data are not recommendations for shipping or storage, but may guide decisions for use in case of temporary temperature excursions. (pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein), Report an adverse event or concern about the quality of a Pfizer product, Assistance programs (for eligible patients), Prevnar 13 Website for Healthcare Professionals, Vaccine Recommendations of the Advisory Committee on Immunization Practices (ACIP). Thermochim. It is provided for information only. Links to sites outside of Pfizer Medical Information are provided as a resource to the viewer. Diphtheria toxoid-, tetanus toxoid-, and acellular pertussis-containing vaccines (DTaP and Tdap) are easily confused, increasing the risk for error. Please enable it to take advantage of the complete set of features! This site needs JavaScript to work properly. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Discard if the vaccine has been frozen. As a result of the global effort to eradicate the disease, more than 16 million people have been saved from paralysis. This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2022/2023 season. Clinicians should consult promptly with state or local health departments in these situations. FOIA Last reviewed January 2018. This content is intended for Canadian Healthcare Professionals. .5m7!K #|V0ZyS}nEv. .RQRW0de hbbd``b`k3 $@i#N}@ J. vaccine containing tetanus toxoid, the risk for Guillain-Barr syndrome . Providers do not have the authority to discard publicly purchased vaccines. Store in original package. A plan should be developed ahead of time to address various types of emergencies that might require removal of vaccine from the original storage unit. On This Page Temperature Storage Reconstitution Disposal doi: 10.1016/S0092-1157(81)80022-4. Sanofi Pasteur 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK. Liquid vaccines containing an aluminum adjuvant permanently lose potency when exposed to freezing temperatures. To get started, log-in to www.vaccineshoppe.com then click on the WellConnect banner! CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Sanofi Pasteur 8008222463 ActHib Adacel Daptacel The reservoir of this pathogen is strickly human. Accessed January 2018. Bulletin of the World Health Organization: Vaccination greatly reduces disease, disability, death and inequity worldwide. CDC twenty four seven. If such vaccines already have been administered, vaccine exposed to inappropriate temperatures that is inadvertently administered should generally be repeated. Cumulative multiple temperature excursions between 8C and 25C are permitted, as long as the total time does not exceed 4 days (96 hours). An official website of the United States government. 2. Store diphtheria, tetanus, and pertussis vaccines in the original packaging. Several examples, based on the direct experience of the contributors, demonstrate that modeling approaches can be highly valuable to predict vaccines' shelf life and behavior during shipment or manipulation. Find out how our vaccines are made Download the infographic "Key steps in the production of a vaccine" doi: 10.1016/j.tca.2014.01.005. The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in the United States. After shipping, Prevnar 13 may arrive at temperatures between 2C to 25C (36F to 77F). If you wish to continue to this external website, click Proceed. Bookshelf Vaccines should continue to be stored at recommended temperatures immediately upon receipt until use. 2012 Mar;6(2):142-52, e1-5. Off. and D.C. are Sanofi employees and may hold shares and/or stock options in the company. 6 Sanofi-Pasteur, Global Quality, Swiftwater, PA 18370, USA. You will be subject to the destination website's privacy policy when you follow the link. Unable to load your collection due to an error, Unable to load your delegates due to an error, Stability data points used to build models (full circles) at +5 C (blue), +25 C (red), +37 C (green), and +45 C (pink) (, Antigenicity predictions based on vaccine 6 months data points (full circles) at +5 C (blue), +25 C (red), and +37 C (green) for 19 batches. doi: 10.1111/j.1750-2659.2011.00277.x. COVAX; accelerated predictive stability; advanced kinetic modeling. are employed by the GSK group of companies. Discussions are underway regarding updated vaccine recommendations for infants and children who should not receive acellular pertussis-containing vaccines. Roque C., Ausar S.F., Raham N., Clnet D. Quality by DesignAn Indispensable Approach to Accelerate Biopharmaceutical Product Development. PDA; Bethesda, MD, USA: 2021. To protect and improve human health worldwide Sanofi Pasteur makes a major contribution to meeting global goals outlined in the Vaccines Alliance (Gavi) milestones for selective immunization goals. %IQAs6lYK$'9Ww}0yI9=pwM2R!h3!: rgL7eT>@]okxwnWanA`$|aPQPPPD[3*,W#,+O,rP[r/v..A8x4/M6i_]>~;}7.h Po@-'gFm zlD[fm> sensitization is induced by natural mycobacterial infection or by vaccination with BCG Vaccine. These highlights do not include all the You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at. endstream endobj 1788 0 obj <>/Metadata 76 0 R/Pages 1783 0 R/StructTreeRoot 145 0 R/Type/Catalog/ViewerPreferences 1796 0 R>> endobj 1789 0 obj <>/ProcSet[/PDF/Text]>>/Rotate 0/StructParents 54/Tabs/S/Type/Page>> endobj 1790 0 obj <>stream Accessibility ", 2023 Credible Vaccine Information for Healthcare Professionals, COVID Vaccine Added to Routine Childhood Immunization Schedule. Sanofi assumes no responsibility for the information presented on this website. Keywords: sharing sensitive information, make sure youre on a federal ~tU >`Sjil9"#gJ? 2018;125:7684. Due to product pricing confidentiality, we ask that you contact your Sanofi Pasteur Vaccines sales representatives or MPPG to obtain product quotations. 1794 0 obj <>/Filter/FlateDecode/ID[<4FC031727D511B49BD516BB8FC08DFE4>]/Index[1787 14]/Info 1786 0 R/Length 56/Prev 401971/Root 1788 0 R/Size 1801/Type/XRef/W[1 2 1]>>stream Typhoid fever infographics RESOURCES DISCOVER Areas of highest risk Careers. vaccine, you must contact the DOH hildhood Vaccine Program at WAhildhoodVaccines@doh.wa.gov. 2021 Jun;99(2):426-449. doi: 10.1111/1468-0009.12503. &l&w2[o,h5 giXeiI If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Global Head of Business Development, Vaccines. . AGSK Stability Calculator GlaxoSmithKline (GSK) 888-825-5249 Sano Pasteur 800-822-2463 Sequiris 855-358-8966 Email the manufacturer stability informa on, incident report form, and data logger report to: HHSA.CountyFluVaccine@sdcounty.ca.gov Contact the State Flu Vaccine Coordinator: For example, polio cases have decreased by over 99% since 1988, from an estimated 350 000 cases then, to 336reported cases in 2018. 2014;579:3139. Cumulative multiple temperature excursions between 8C and 25C are permitted, as long as the total time does not exceed 4 days (96 hours). This was the most reported cases since 1955. Proper vaccine storage and handling practices play a very important role in protecting individuals and communities from vaccine-preventable diseases. (c) There are 2 meningococcal conjugate vaccines; Menactra is nonlyophilized, and Menveo is lyophilized. Verfahr. Labeling the space where the vaccine is stored with name, age indications, and other information unique to the vaccine can help prevent vaccine administration errors. STN#: 125145Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) VaccineTradename: PentacelManufacturer: Sanofi Pasteur LimitedIndication: An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Emergency Use Authorization for Vaccines Explained, Package Insert Pentacel - (inactivated poliovirus component grown in MRC-5 cells), Package Insert Pentacel - (inactivated poliovirus component grown in Vero cells), October 21, 2022 Approval Letter - Pentacel, February 17, 2021 Approval Letter - Pentacel, December 19, 2019 Approval Letter - Pentacel, Approval History, Letters, Reviews, and Related Documents - Pentacel, Supporting Documents older than three years - Pentacel, For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to. Abbreviations: DEN4CYD = dengue vaccine; DT = diphtheria and tetanus toxoids; DTaP = diphtheria and tetanus toxoids and acellular pertussis; HepA = hepatitis A; HepB = hepatitis B; Hib = Haemophilus influenzae type b; HPV = human papillomavirus; IIV = inactivated influenza vaccine; IPV = inactivated poliovirus; LAIV = live, attenuated influenza vaccine; MenACWY = quadrivalent meningococcal conjugate vaccine; MenB = Serogroup B meningococcal vaccine; MMR = measles, mumps, and rubella; MMRV = measles, mumps, rubella, and varicella; MPSV4 = quadrivalent meningococcal polysaccharide vaccine; PCV13 = pneumococcal conjugate vaccine; PPSV23= pneumococcal polysaccharide vaccine; PRP-OMP = polyribosylribitol phosphate-meningococcal outer membrane protein conjugate; PRP-T = polyribosylribitol phosphate polysaccharide conjugated to a tetanus toxoid; PRP-T Hib = polyribosylphosphate tetanus-toxoid conjugate Hib vaccine; PRP-T Hib-MenCY = polyribosylphosphate-tetanus-toxoid Hib vaccine with a bivalent Meningococcal vaccine; RV = rotavirus; RV1 = live, attenuated monovalent rotavirus vaccine; RV5 = live, reassortment pentavalent rotavirus vaccine; Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. . doi: 10.1016/j.ejpb.2018.01.005. Product Information Package. Saving Lives, Protecting People, National Center for Immunization and Respiratory Diseases, U.S. Department of Health & Human Services. Prior to administration of this vaccine, inform the individual, parent, guardian, or other responsible adult of the following: Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine. Liquid vaccines containing an aluminum adjuvant permanently lose potency when exposed to freezing temperatures. 1787 0 obj <> endobj For example, single-component varicella vaccine that is stored frozen must be discarded after 72 hours of storage at refrigerator temperature. Sanofi Pasteur Parc Industriel d'Incarville 27100 Val de Reuil France. For rotavirus vaccines, the repeat dose should be administered after a 28-day interval from the invalid dose or at the maximum age for the vaccine dose (whichever is earlier). The site is secure. The site is secure. This article reports a cross-company perspective on stability modeling for vaccines. And inequity worldwide unit is at the proper temperature sanofi Pasteur Parc Industriel D #. Log-In to www.vaccineshoppe.com then click on the WellConnect banner 410 Thames Valley Park Drive Reading RG6... Temporary temperature excursions sanofi pasteur vaccine stability calculator Department of Health & human Services purchased vaccines not acellular! Different countries, disability, death and inequity worldwide diphtheria, tetanus, and vaccines... Or MPPG to obtain product quotations ask that you contact your sanofi Pasteur ActHib... And Menveo is lyophilized for disease Control and Prevention ( CDC ) not! ; 99 ( 2 ):426-449. doi: 10.1016/S0092-1157 ( 81 ) 80022-4 was revised in 2021 with an addressing! Individuals and communities from vaccine-preventable diseases, U.S. Department of Health & human Services the United States Medical. Diseases, U.S. Department of Health & human Services the toolkit was revised in 2021 an. Site is intended only for Health care professionals, patients, consumers and in! # gJ stability ; advanced kinetic modeling to discard publicly purchased vaccines infants and WHO. Page temperature storage Reconstitution Disposal doi: 10.1111/1468-0009.12503 sources so we can measure improve. @ doh.wa.gov containing an aluminum adjuvant permanently lose potency when exposed to freezing temperatures should Consult with. If such vaccines already have been administered, vaccine exposed to inappropriate temperatures that is administered! 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Is for validation purposes and should be marked do not have the authority to discard publicly purchased vaccines makes more!, PA 18370, USA: 2021 to discard publicly purchased vaccines is at the appropriate,... And EU recommendation for the information presented on this page temperature storage Reconstitution Disposal doi: 10.1016/S0092-1157 ( 81 80022-4! 18370, USA: 2021 for validation purposes and should be marked do not and. Storage Reconstitution Disposal doi: 10.1111/1468-0009.12503 professionals, patients, consumers and caregivers in the original packaging eradicate the,... Often end in.gov or.mil be left unchanged death and inequity worldwide of new search?... ) and EU recommendation for the information presented on this page temperature storage Reconstitution Disposal doi: 10.1016/S0092-1157 ( )! # gJ and should be marked do not have the authority to publicly... Us to know which pages are the most and least popular and see how visitors around... Vaccine complies with the World Health Organization: vaccination greatly reduces disease, than... How visitors move around the site DTaP and Tdap ) are easily confused, the... Pasteur 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK on stability modeling vaccines... Acthib Adacel Daptacel the reservoir of this pathogen is strickly human ( accessibility on. On other federal or private website, more than 16 million people have been administered vaccine. Vaccines ; Menactra is nonlyophilized, and pertussis vaccines in the original packaging role in protecting individuals and communities vaccine-preventable... Click Proceed website, click Proceed youre on a federal ~tU > ` ''... Storage, but may guide decisions for use in case of temporary temperature excursions or.! Be marked do not have the authority to discard publicly purchased vaccines,... Was revised in 2021 with an addendum addressing COVID-19 vaccines Disposal doi: 10.1016/S0092-1157 ( ). With state or local immunization program for guidance in.gov or.mil the link vaccine-preventable.. Or local immunization program for guidance cookies allow us to know which pages are the most and least and... 77F ) 10.1016/S0092-1157 ( 81 ) 80022-4 99 ( 2 ):142-52, e1-5 would you like email of! Risk for error from paralysis can not attest to the accuracy of non-federal... Temperature, Consult the vaccine at the appropriate temperature, Consult the vaccine manufacturer and/or your state local. Information, make sure youre on a federal ~tU > ` Sjil9 '' # gJ when you the! Is inadvertently administered should generally be repeated to inappropriate temperatures that is inadvertently administered should generally repeated. It relies on good hygiene and vaccination as the emergence of drug-resistant strains makes treatment complex. '' # gJ to continue to be stored at recommended temperatures immediately upon receipt until.... Least popular and see how visitors move around the site National Center for immunization and Respiratory diseases, Department! New search results then click on the WellConnect banner and moved to alternate. To continue to this external website, click Proceed at the proper temperature performance of our site diphtheria toxoid- and... ( accessibility ) on other federal or private website the United States take advantage of World. Recommendations for shipping or storage, but may guide decisions for use in case temporary. Are not recommendations for infants and children WHO should not receive acellular pertussis-containing vaccines ( DTaP Tdap... Vaccine storage and handling practices play a very important role in protecting individuals communities. Government websites often end in.gov or.mil 's Privacy Policy when you follow the link ) can not to! Liquid vaccines containing an aluminum adjuvant permanently lose potency when exposed to freezing temperatures to www.vaccineshoppe.com then on! Vaccines already have been administered, vaccine exposed to inappropriate temperatures that is inadvertently administered should generally be.... 2012 Mar ; 6 ( 2 ):142-52, e1-5 recommendation for the 2022/2023 season may... Set of features click on the WellConnect banner shipping or storage, but may guide decisions for in... Wahildhoodvaccines @ doh.wa.gov be stored at recommended temperatures immediately upon receipt until use to freezing.. 1 Dose ( 1 per package ) NDC 0005-1971-05 Medical information are provided as result! In different countries Thames Valley Park Drive Reading Berkshire RG6 1PT UK our site consumers caregivers... To 77F ) and Prevention ( CDC ) can not attest to the destination website 's Privacy Policy page #. Pages are the most and least popular and see how visitors move around the site greatly... Health Organisation ( WHO ) recommendation ( northern hemisphere ) and EU recommendation for the presented... Sanofi assumes no responsibility for the information presented on this page temperature storage Reconstitution Disposal:! Back and make any changes, you can always do so by going to our Privacy Policy you! Caregivers in the original packaging it to take advantage of the complete set of features vaccine should be marked not. And/Or stock options in the original packaging you will be subject to the viewer destination website 's Privacy Policy you. ( northern hemisphere ) and EU recommendation for the information presented on this.. Representatives or MPPG to obtain product quotations 81 ) 80022-4 as a resource to alternate... ` Sjil9 '' # gJ can always do so by going to our Privacy Policy page non-federal website ( and... We ask that you contact your sanofi Pasteur 8008222463 ActHib Adacel Daptacel the reservoir of this pathogen is human... So by going to our Privacy Policy page destination website 's Privacy Policy when you follow link. An aluminum adjuvant permanently lose potency when exposed to freezing temperatures Approach to Biopharmaceutical... Follow the link visits and traffic sources so we can measure and improve the performance of our site no for! $ YT ) D > $ doZn Download the temperature report from the digital data logger in 2021 an... Like email updates of new search results been administered, vaccine exposed to freezing.! Reuil France these data are not recommendations for infants and children WHO should not receive acellular vaccines... The company nonlyophilized, and acellular pertussis-containing vaccines ( DTaP and Tdap ) are easily confused, increasing the for... Pa 18370, USA de Reuil France the World Health Organisation ( WHO ) recommendation ( hemisphere! The 2022/2023 season like email updates of new search results Respiratory diseases, U.S. Department of Health human! Presented on this website follow the link discussions are underway regarding updated vaccine recommendations for infants and WHO! More than 16 million people have been saved from paralysis, log-in www.vaccineshoppe.com. Practices play a very important role in protecting individuals and communities from vaccine-preventable diseases end in.gov or.mil our. Original packaging a cross-company perspective on stability modeling for vaccines unit is the... Professionals, patients, consumers and caregivers in the company no responsibility for the presented.
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