ADACEL PRESCRIBING INFORMATION PDF

“We are pleased the FDA has expanded the age indication for Adacel vaccine, For more information about Adacel vaccine, please see the full Prescribing. Sanofi US Vaccines and Biologics, Prescribing Information, Medication Guide, websites. Adacel® Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular. Adacel® is a vaccine indicated for active booster immunization against tetanus, For indications, dosing and other information, please refer to the prescribing.

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Adacel TDAP – FDA prescribing information, side effects and uses

The individual antigens are adsorbed onto aluminum phosphate. The mechanism of protection from B pertussis disease is not well understood. Clinicians should refer to guidelines for tetanus prophylaxis in routine wound management. Pertussis whooping cough is a disease of the respiratory tract, most often caused by B pertussis. Concomitant immunization of Adacel vaccine with Hepatitis B vaccine did not result in reduced antibody responses to any of the antigens from asacel vaccine.

Sore and Presdribing Joints. Most joint complaints were mild in intensity with a mean duration of 1.

The efficacy of the tetanus toxoid and diphtheria toxoid used in Adacel vaccine was based on the immune response to these antigens compared to a US licensed Tetanus and Diphtheria Toxoids Adsorbed For Adult Use Td vaccine manufactured by Sanofi Pasteur Inc.

The incidence of other solicited and unsolicited adverse events were not different between the 2 study groups. The demonstration of a booster response depended on the antibody concentration to each antigen prior to immunization.

Participants had not received a tetanus or diphtheria toxoid containing vaccine within the previous 5 years. For ‘Any’ Fever the non-inferiority criteria was met, however, ‘Any’ Fever was statistically higher in adolescents receiving Adacel vaccine.

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Adacel vaccine should be administered as a single injection of one dose 0. Throughout the 6-month follow-up period in the principal safety study, serious adverse events were reported in 1. When administering a dose from a rubber-stoppered vial, do not remove either the stopper or the metal seal holding it in place.

From days 28 to 6 months post-vaccination, participants were monitored for unexpected visits to a physician’s office or to an emergency room, onset of serious illness and hospitalizations.

The Act further requires the health-care professional to report to the US Department of Health and Human Services the occurrence following immunization of any event set forth in the Vaccine Injury Table. This study was a randomized, double-blind, multi-center trial designed to assess lot consistency as measured by the safety and immunogenicity of 3 lots of Adacel vaccine when given as a booster dose to adolescents years of age inclusive.

If Adacel vaccine is administered to inforamtion persons, including persons receiving immunosupressive therapy, the expected immune response may not be obtained. Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered.

Separate injection sites and separate syringes must be used in case of concomitant administration. It is not known whether Adacel vaccine is excreted in human milk.

Complete immunization significantly reduces the risk of developing diphtheria and immunized persons who develop disease have milder illness.

Adacel vaccine is not indicated for individuals 65 years of age and older. Adacdl providers should also report these events to Sanofi Pasteur Inc.

Two serious adverse events in adults were neuropathic events that occurred within 28 days of Adacel vaccine administration; one severe migraine with unilateral facial paralysis and one diagnosis of nerve compression in neck and left arm.

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Adacel TDAP

In all the studies, participants were monitored for serious adverse events throughout the duration of the study.

FDA alerts for all medications. Protection against disease attributable to C tetani is due to the development of neutralizing antiboides to tetanus toxin. No data are available regarding the safety and effectiveness of Adacel vaccine in individuals 65 years of age and older as clinical studies of Adacel vaccine did not include participants in the geriatric population.

Following immunization, protection generally persists for at least 10 years.

Adacel® | BDI Pharma

Before administration of Adacel vaccine, the patient’s current health status and medical history should be reviewed in order to determine whether any contraindications exist and to assess the benefits and risks of vaccination. A total of 5, individuals years of age inclusive 3, adolescents years of age and 2, adults years received a single dose of Adacel vaccine.

The rates reported for fever and injection site pain at the Adacel vaccine administration site were similar when Adacel and Hep B vaccines were given concurrently or separately. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Unsolicited adverse events and serious adverse events were collected for 28 days post-vaccination.