VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilu
Time 2022-09-14 13:30:53Web Name: VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilu
WebSite: http://www.vaxelis.com
ID:314754
Keywords:
Toxoids,Acellular,Pertussis,TetanusDescription:
Indication: VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b (Hib). VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).
When 6 work together as 1, you can experience the benefits of fewer shots with VAXELIS1,2,3,4
When 6 work together as 1,
you can experience the benefits of
fewer shots with VAXELIS1,2,3,4
A combination of tried and tested antigens1,2,5,6
See the immunogenicity data for VAXELIS >May reduce shot burden1,2,3,4
See the immunization schedule for VAXELIS >May help improve efficiencies and reduce administrative tasks7
See how VAXELIS may simplify some aspects of vaccine-related tasks1,2,3,4,7 >VAXELIS is now available to order
To order directly:
VaccineShoppe.com
For authorized distributors:
VaxelisContract.com
VAXELIS is now available to order
To order directly:
VaccineShoppe.com
For authorized distributors:
VaxelisContract.com
Important Safety InformationDo not administer VAXELIS to anyone with a history of severe allergic reaction to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine.Do not administer VAXELIS to anyone with a history of encephalopathy within 7 days of a pertussis-containing vaccine with no other identifiable cause.Do not administer VAXELIS to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.Carefully consider benefits and risks before administering VAXELIS to persons with a history of: fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE), or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine; and/or seizures within 3 days after a previous pertussis-containing vaccine.If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following VAXELIS.Apnea following intramuscular vaccination has been observed in some infants born prematurely. Consider the individual infant’s medical status and potential benefits and possible risks of intramuscular vaccination in deciding when to administer VAXELIS to an infant born prematurely.Vaccination with VAXELIS may not protect all individuals.The solicited adverse reactions 0-5 days following any dose were irritability (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%).The 3-dose immunization series consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age.A 3-dose series of VAXELIS does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.Before administering VAXELIS, please read the Prescribing Information. The Patient Information also is available.
Important Safety Information
Do not administer VAXELIS to anyone with a history of severe allergic reaction to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine.Do not administer VAXELIS to anyone with a history of encephalopathy within 7 days of a pertussis-containing vaccine with no other identifiable cause.Do not administer VAXELIS to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.Carefully consider benefits and risks before administering VAXELIS to persons with a history of: fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE), or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine; and/or seizures within 3 days after a previous pertussis-containing vaccine.If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following VAXELIS.Apnea following intramuscular vaccination has been observed in some infants born prematurely. Consider the individual infant’s medical status and potential benefits and possible risks of intramuscular vaccination in deciding when to administer VAXELIS to an infant born prematurely.Vaccination with VAXELIS may not protect all individuals.The solicited adverse reactions 0-5 days following any dose were irritability (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%).The 3-dose immunization series consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age.A 3-dose series of VAXELIS does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.Before administering VAXELIS, please read the Prescribing Information. The Patient Information also is available.
Reference
1. Pentacel. Prescribing Information. Sanofi Pasteur; 2021.Reference
2. Pentacel. Prescribing Information. Sanofi Pasteur; 2019.Reference
3.PEDIARIX. Prescribing Information. GlaxoSmithKIine; 2019.
Reference
4. Centers for Disease Control and Prevention. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2022. Accessed February 23, 2022. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdfReference
5. Oliver SE, Moore KL. Licensure of a diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b conjugate, and hepatitis B vaccine, and guidance for use in infants. MMWR Morb Mortal Wkly Rep. 2020;69(5):136–139. doi:10.15585/mmwr.mm6905a5Reference
6. Marshall GS, Adams GL, Leonardi ML, et al. Immunogenicity, safety, and tolerability of a hexavalent vaccine in infants. Pediatrics. 2015;136(2):e323-e332. doi:10.1542/peds.2014-4102Reference
7. Pellissier JM, Coplan PM, Jackson LA, May JE. The effect of additional shots on the vaccine administration process: results of a time-motion study in 2 settings. Am J Manag Care. 2000;6(9):1038-1044Reference
8. Block SL, Klein NP, Sarpong K, et al. Lot-to-lot consistency, safety, tolerability, and immunogenicity of an investigational hexavalent vaccine in US infants. Pediatr Infect Dis J. 2017;36(2):202-208. doi:10.1097/INF.0000000000001405Reference
9.RECOMBIVAX HB. Prescribing Information. Merck & Co., Inc.; 2020.
Reference
10.Liquid PedvaxHIB. Prescribing Information. Merck & Co., Inc; 2020.
Reference
11.Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-VAX-00622.
Reference
12.Centers for Disease Control and Prevention. General best practice guidelines for immunization. Accessed February 15, 2022. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html
Reference
13.De Coster I, Fournie X, Faure C, et al. Assessment of preparation time with fully-liquid versus non-fully liquid paediatric hexavalent vaccines. A time and motion study. Vaccine. 2015;33(32):3976 -3982. doi:10.1016/j.vaccine.2015.06.030
Reference
14.Ciarametaro M, Bradshaw SE, Guiglotto J, Hahn B, Meier G. Hidden efficiencies: making completion of the pediatric vaccine schedule more efficient for physicians. Medicine (Baltimore). 2015;94(4):e357. doi:10.1097/MD.0000000000000357
Reference
15.Kennedy A, Lavail K, Nowak G, Basket M, Landry S. Confidence about vaccines in the United States: understanding parents’ perceptions. Health Aff (Millwood). 2011 Jun;30(6):1151-9. doi:10.1377/hlthaff.2011.0396
Reference
16.Sanofi Pasteur. Product Catalog, Vaccines & Biologics, VAXELIS, 1 carton of 10 prefilled syringes. VaccineShoppe.com. Accessed February 15, 2022. https://www.vaccineshoppe.com/us/vsh/en/USD/Product-Catalog/Vaccines-%26-biologics/Vaxelis%E2%84%A2/p/243-15
Reference
17.Sanofi Pasteur. Product Catalog, Vaccines & Biologics, VAXELIS, 1 carton 10 vials. VaccineShoppe.com. Accessed February 15, 2022. https://www.vaccineshoppe.com/us/vsh/en/USD/Product-Catalog/Vaccines-%26-biologics/Vaxelis%E2%84%A2/p/243-10
Reference
18.Sanofi Pasteur. Pentacel packaging update. Accessed February 15, 2022. https://www.vaccineshoppe.com/assets/pdf/SAUS.PENTC.18.09.5275_FINAL.pdf
Reference
19.GlaxoSmithKline. PEDIARIX pre-filled syringe ordering information. Accessed February 15, 2022. https://www.gskdirect.com/gsk/en/USD/RootCategory/Vaccines%28non-flu%29/PEDIARIX-PFS1DOSE-0-5ML-NO-NDL-10S-LM/p/58160081152?pro-from=product-list
Reference
20.Kurosky SK, Davis KL, Krishnarajah G. Effect of combination vaccines on completion and compliance of childhood vaccinations in the United States. Hum Vaccin Immunother. 2017;13(11):2494-2502. doi:10.1080/21645515.2017.1362515
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TAGS:Toxoids Acellular Pertussis Tetanus
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