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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The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate as adjuvant2-phenoxyethanol not as a preservative and water for injection. PT is detoxified with glutaraldehyde, FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration.

Adacel TDAP

These include anaphylaxis or infodmation shock within 7 days; brachial neuritis within 28 days; an acute complication or sequelae including death of an illness, disability, injury, or condition referred to above, or any events that would contraindicate further doses of vaccine, according to this Adacel vaccine package insert. The systemic intoxication is caused by diphtheria exotoxin, an extracellular protein metabolite of toxigenic strains of C diphtheriae.

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.

Throughout the 6-month follow-up period in the principal safety study, serious adverse events were reported in 1. Product which has been exposed to freezing should not be used. There were no vaccine related fetal malformations or other evidence of teratogenesis noted in this study.

This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Acceptable booster responses to each of the pertussis antigens were also demonstrated, i. Unsolicited adverse events and serious adverse events were collected for 28 days post-vaccination.

The cut-off value for diphtheria was 2. If these conditions exist, the vaccine should not be administered.

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Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. The safety and effectiveness of concomitant administration of Adacel vaccine with other vaccines has not been evaluated.

Separate injection sites and separate syringes must be used in case of addacel administration. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. 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 precsribing the Vaccine Injury Table.

Local and systemic adverse events were monitored for 14 days post-vaccination using a diary card. The demonstration of a booster response depended on the antibody concentration to each antigen prior informatiob immunization. Encephalopathy within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause is a contraindication to vaccination with Adacel vaccine. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion.

Adacel® | BDI Pharma

Spores of C tetani are ubiquitous. In the concomitant vaccination study with Adacel and Hepatitis B vaccines see Clinical Studies for description of study design and number of participantslocal and systemic adverse events were monitored daily for 14 days post-vaccination using a diary card. However, the pertussis components in Adacel vaccine i. However, the rates of injection site erythema The rates of fever and injection site erythema and swelling were similar for recipients of concurrent and separate administration of Adacel vaccine and TIV.

The use of Adacel vaccine as a primary series or to complete the primary series for tetanus, diphtheria, or pertussis has not been studied.

A total of 4, randomized participants were vaccinated. The ACIP has published recommendations on vaccination for diphtheria prophylaxis in individuals who have had contact with a person with confirmed or suspected diphtheria. We comply with the HONcode standard for trustworthy health information – verify here. Subscribe to receive email notifications whenever new articles are published.

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Sore and Swollen Joints. The frequency of selected solicited adverse events erythema, swelling, pain and fever occurring during Days following informahion dose of Adacel vaccine or Td vaccine are presented in Table 5. The toxin causes neuromuscular dysfunction, with rigidity and spasms of skeletal muscles.

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

Other ingredients per dose include 1. Enrollment was stratified by age to ensure adequate representation across the entire age range. Health-care providers should also report these events to Sanofi Pasteur Inc. 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. After shaking, the vaccine is a white, pprescribing, cloudy suspension.

If they are pregnant or become aware they were pregnant at the time of Adacel vaccine immunization, they are encouraged to contact directly or have their health-care professional contact Sanofi Pasteur Inc.

Because many drugs are excreted in human milk, caution should be exercised when Adacel vaccine asacel given to a nursing woman. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered. See Table 1 and Table 2.