ADACEL PRESCRIBING INFORMATION PDF

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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All unsolicited reactions occurring through day 14 were collected. Unsolicited reactions including immediate reactions, serious adverse events and events that elicited seeking medical attention were collected at a clinic visit or via predcribing interview for the duration of the trial, i.

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

Adacel® | BDI Pharma

A total of 4, randomized participants were vaccinated. Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Information regarding adverse events that occurred in the 6 infromation post-vaccination time period was obtained from the participant via telephone.

Most of these events were reported at a similar frequency in recipients of both Adacel vaccine and Td vaccine.

Adacel TDAP – FDA prescribing information, side effects and uses

Epinephrine Hydrochloride Solution 1: Females of child-bearing potential should be informed that Sanofi Pasteur Inc. It is not known whether Adacel vaccine is excreted in human milk. An additional adolescents and adults received Adacel vaccine in three supportive Canadian studies used as the basis for licensure in other countries.

The ACIP has published recommendations on vaccination for diphtheria prophylaxis in individuals who have had contact with a person with confirmed or suspected diphtheria. Most joint complaints were mild in intensity with a mean duration of 1. Body Ache or Muscle Weakness.

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There were no spontaneous reports of whole-arm swelling of the injected limb in this study, nor in the other three studies which contributed to the safety database for Adacel vaccine. There were no vaccine related fetal malformations or other evidence of teratogenesis noted in this study.

The toxin causes neuromuscular dysfunction, with rigidity and spasms of skeletal muscles. The cut-off value for tetanus was 2. C diphtheriae may cause both localized and generalized disease.

For tetanus prone wounds e. Other ingredients per dose include 1. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

Individuals who have completed primary immunization against tetanus and who sustain wounds that are minor and uncontaminated, should receive a booster dose of a tetanus toxoid containing preparation if they have not received tetanus toxoid within the preceding 10 years. This gram-negative coccobacillus produces a variety of biologically active components, though their role in pathogenesis is not clearly defined. 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.

No interference in tetanus and diphtheria seroprotection rates and responses to influenza vaccine, detoxified PT, FIM or FHA were observed when Adacel vaccine was administered concomitantly with TIV compared to separate administration.

Animal fertility studies have not been conducted with Adacel vaccine. Rates of moderate and severe pain in adolescents did not significantly differ between the Adacel vaccine and Td vaccine groups.

This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs.

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Adacel TDAP

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.

Unsolicited adverse events and serious adverse events were collected for 28 days post-vaccination. The primary measures of immunogenicity were a the percentage of participants attaining an antibody level of at least 0.

Prescribkng and systemic solicited reactions occurred at similar rates in Adacel vaccine and Td vaccine recipients in the 3 day post-vaccination period. Sera were obtained before and approximately 35 days after vaccination.

Acceptable booster responses to each of the pertussis antigens were also demonstrated, i. A booster response was defined as a four-fold rise in antibody concentration if the pre-vaccination concentration was equal to or below the cut-off value and a two-fold rise in antibody concentration if the pre-vaccination concentration was above the cut-off value. A severe allergic reaction e. Certain neurological conditions have been reported in temporal association with some tetanus toxoid containing vaccines or tetanus and diphtheria toxoid containing vaccines.

In the concomitant vaccination study with Adael vaccine and trivalent inactivated influenza vaccine see Clinical Studies for description of study design and number of participantslocal and systemic adverse events were monitored for 14 days post-vaccination using a diary card. The mechanism of protection from B pertussis disease is not well understood. The following adverse events have been spontaneously reported during informmation post-marketing use of Adacel vaccine in the US and other countries.